Multispecialty physician networks in Ontario.

PubMed

Stukel, Therese A; Glazier, Richard H; Schultz, Susan E; Guan, Jun; Zagorski, Brandon M; Gozdyra, Peter; Henry, David A

2013-01-01

Large multispecialty physician group practices, with a central role for primary care practitioners, have been shown to achieve high-quality, low-cost care for patients with chronic disease. We assessed the extent to which informal multispecialty physician networks in Ontario could be identified by using health administrative data to exploit natural linkages among patients, physicians, and hospitals based on existing patient flow. We linked each Ontario resident to his or her usual provider of primary care over the period from fiscal year 2008/2009 to fiscal year 2010/2011. We linked each specialist to the hospital where he or she performed the most inpatient services. We linked each primary care physician to the hospital where most of his or her ambulatory patients were admitted for non-maternal medical care. Each resident was then linked to the same hospital as his or her usual provider of primary care. We computed "loyalty" as the proportion of care to network residents provided by physicians and hospitals within their network. Smaller clusters were aggregated to create networks based on a minimum population size, distance, and loyalty. Networks were not constrained geographically. We identified 78 multispecialty physician networks, comprising 12,410 primary care physicians, 14,687 specialists, and 175 acute care hospitals serving a total of 12,917,178 people. Median network size was 134,723 residents, 125 primary care physicians, and 143 specialists. Virtually all eligible residents were linked to a usual provider of primary care and to a network. Most specialists (93.5%) and primary care physicians (98.2%) were linked to a hospital. Median network physician loyalty was 68.4% for all physician visits and 81.1% for primary care visits. Median non-maternal admission loyalty was 67.4%. Urban networks had lower loyalties and were less self-contained but had more health care resources. We demonstrated the feasibility of identifying informal multispecialty physician networks in Ontario on the basis of patterns of health care-seeking behaviour. Networks were reasonably self-contained, in that individual residents received most of their care from providers within their respective networks. Formal constitution of networks could foster accountability for efficient, integrated care through care management tools and quality improvement, the ideas behind "accountable care organizations."

One size fits some: the impact of patient treatment attitudes on the cost-effectiveness of a depression primary-care intervention.

PubMed

Pyne, Jeffrey M; Rost, Kathryn M; Farahati, Farah; Tripathi, Shanti P; Smith, Jeffrey; Williams, D Keith; Fortney, John; Coyne, James C

2005-06-01

Despite their impact on outcomes, the effect of patient treatment attitudes on the cost-effectiveness of health-care interventions is not widely studied. This study estimated the impact of patient receptivity to antidepressant medication on the cost-effectiveness of an evidence-based primary-care depression intervention. Twelve community primary-care practices were stratified and then randomized to enhanced (intervention) or usual care. Subjects included 211 patients beginning a new treatment episode for major depression. At baseline, 111 (52.6%) and 145 (68.7%) reported receptivity to antidepressant medication and counseling respectively. The intervention trained the primary-care teams to assess, educate, and monitor depressed patients. Twelve-month incremental (enhanced minus usual care) total costs and quality-adjusted life years (QALYs) were calculated. Among patients receptive to antidepressants, the mean incremental cost-effectiveness ratio was dollar 5,864 per QALY (sensitivity analyses up to dollar 14,689 per QALY). For patients not receptive to antidepressants, the mean incremental QALY score was negative (for both main and sensitivity analyses), or the intervention was at least no more effective than usual care. These findings suggest a re-thinking of the 'one size fits all' depression intervention, given that half of depressed primary-care patients may be non-receptive to antidepressant medication treatment. A brief assessment of treatment receptivity should occur early in the treatment process to identify patients most likely to benefit from primary-care quality improvement efforts for depression treatment. Patient treatment preferences are also important for the development, design, and analysis of depression interventions.

Effect of Patient Experience on Bypassing a Primary Care Gatekeeper: a Multicenter Prospective Cohort Study in Japan.

PubMed

Aoki, Takuya; Yamamoto, Yosuke; Ikenoue, Tatsuyoshi; Kaneko, Makoto; Kise, Morito; Fujinuma, Yasuki; Fukuhara, Shunichi

2018-05-01

To discuss how best to implement the gatekeeping functionality of primary care; identifying the factors that cause patients to bypass their primary care gatekeepers when seeking care should be beneficial. To examine the association between patient experience with their primary care physicians and bypassing them to directly obtain care from higher-level healthcare facilities. This prospective cohort study was conducted in 13 primary care clinics in Japan. We assessed patient experience of primary care using the Japanese version of Primary Care Assessment Tool (JPCAT), which comprises six domains: first contact, longitudinality, coordination, comprehensiveness (services available), comprehensiveness (services provided), and community orientation. The primary outcome was the patient bypassing their usual primary care physician to seek care at a hospital, with this occurring at least once in a year. We used a Bayesian hierarchical model to adjust clustering within clinics and individual covariates. Data were analyzed from 205 patients for whom a physician at a clinic served as their usual primary care physician. The patient follow-up rate was 80.1%. After adjustment for patients' sociodemographic and health status characteristics, the JPCAT total score was found to be inversely associated with patient bypass behavior (odds ratio per 1 SD increase, 0.44; 95% credible interval, 0.21-0.88). The results of various sensitivity analyses were consistent with those of the primary analysis. We found that patient experience of primary care in Japan was inversely associated with bypassing a primary care gatekeeper to seek care at higher-level healthcare facilities, such as hospitals. Our findings suggest that primary care providers' efforts to improve patient experience should help to ensure appropriate use of healthcare services under loosely regulated gatekeeping systems; further studies are warranted.

Alerts in electronic medical records to promote a colorectal cancer screening programme: a cluster randomised controlled trial in primary care.

PubMed

Guiriguet, Carolina; Muñoz-Ortiz, Laura; Burón, Andrea; Rivero, Irene; Grau, Jaume; Vela-Vallespín, Carmen; Vilarrubí, Mercedes; Torres, Miquel; Hernández, Cristina; Méndez-Boo, Leonardo; Toràn, Pere; Caballeria, Llorenç; Macià, Francesc; Castells, Antoni

2016-07-01

Participation rates in colorectal cancer screening are below recommended European targets. To evaluate the effectiveness of an alert in primary care electronic medical records (EMRs) to increase individuals' participation in an organised, population-based colorectal cancer screening programme when compared with usual care. Cluster randomised controlled trial in primary care centres of Barcelona, Spain. Participants were males and females aged 50-69 years, who were invited to the first round of a screening programme based on the faecal immunochemical test (FIT) (n = 41 042), and their primary care professional. The randomisation unit was the physician cluster (n = 130) and patients were blinded to the study group. The control group followed usual care as per the colorectal cancer screening programme. In the intervention group, as well as usual care, an alert to health professionals (cluster level) to promote screening was introduced in the individual's primary care EMR for 1 year. The main outcome was colorectal cancer screening participation at individual participant level. In total, 67 physicians and 21 619 patients (intervention group) and 63 physicians and 19 423 patients (control group) were randomised. In the intention-to-treat analysis screening participation was 44.1% and 42.2% respectively (odds ratio 1.08, 95% confidence interval [CI] = 0.97 to 1.20, P = 0.146). However, in the per-protocol analysis screening uptake in the intervention group showed a statistically significant increase, after adjusting for potential confounders (OR, 1.11; 95% CI = 1.02 to 1.22; P = 0.018). The use of an alert in an individual's primary care EMR is associated with a statistically significant increased uptake of an organised, FIT-based colorectal cancer screening programme in patients attending primary care centres. © British Journal of General Practice 2016.

Primary care physician assistant and advance practice nurses roles: Patient healthcare utilization, unmet need, and satisfaction.

PubMed

Everett, Christine M; Morgan, Perri; Jackson, George L

2016-12-01

Team-based care involving physician assistants (PAs) and advance practice nurses (APNs) is one strategy for improving access and quality of care. PA/APNs perform a variety of roles on primary care teams. However, limited research describes the relationship between PA/APN role and patient outcomes. We examined multiple outcomes associated with primary care PA/APN roles. In this cross-sectional survey analysis, we studied adult respondents to the 2010 Health Tracking Household Survey. Outcomes included primary care and emergency department visits, hospitalizations, unmet need, and satisfaction. PA/APN role was categorized as physician only (no PA/APN visits; reference), usual provider (PA/APN provide majority of primary care visits) or supplemental provider (physician as usual provider, PA/APN provide a subset of visits). Multivariable logistic and multinomial logistic regressions were performed. Compared to people with physician only care, patients with PA/APNs as usual providers [5-9 visits RRR=2.4 (CI 1.8-3.4), 10+ visits RRR=3.0 (CI 2.0-4.5): reference 2-4 visits] and supplemental providers had increased risk of having 5 or more primary care visits [5-9 visits RRR=1.3 (CI 1.0-1.6)]. Patients reporting PA/APN as supplemental providers had increased risk of emergency department utilization [2+ visits: RRR 1.8 (CI 1.3, 2.5)], and lower satisfaction [very dissatisfied: RRR 1.8 (CI 1.03-3.0)]. No differences were seen for hospitalizations or unmet need. Healthcare utilization patterns and satisfaction varied between adults with PA/APN in different roles, but reported unmet need did not. These findings suggest a wide range of outcomes should be considered when identifying the best PA/APN role on primary care teams. Copyright © 2016 Elsevier Inc. All rights reserved.

Osteoporosis improvement: a large-scale randomized controlled trial of patient and primary care physician education.

PubMed

Solomon, Daniel H; Katz, Jeffrey N; Finkelstein, Joel S; Polinski, Jennifer M; Stedman, Margaret; Brookhart, M Alan; Arnold, Marilyn; Gauthier, Suzanne; Avorn, Jerry

2007-11-01

We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. There was no difference in the probability of the primary composite endpoint (BMD test or osteoporosis medication) or in either of its components comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). Fractures from osteoporosis are associated with substantial morbidity, mortality, and cost. However, only a minority of at-risk older adults receives screening and/or treatment for this condition. We evaluated the effect of educational interventions for osteoporosis targeting at-risk patients, primary care physicians, or both. We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. The at-risk patients were women >or=65 yr of age, men and women >or=65 yr of age with a prior fracture, and men and women >or=65 yr of age who used oral glucocorticoids. The primary outcome studied was a composite of either undergoing a BMD test or initiating a medication used for osteoporosis. The secondary outcome was a hip, humerus, spine, or wrist fracture. We randomized 828 primary care physicians and their 13,455 eligible at-risk patients into four study arms. Physician and patient characteristics were very similar across all four groups. Across all four groups, the rate of the composite outcome was 10.3 per 100 person-years and did not differ between the usual care and the combined intervention groups (p = 0.5). In adjusted Cox proportional hazards models, there was no difference in the probability of the primary composite endpoint comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). There was also no difference in either of the components of the composite endpoint. The probability of fracture during follow-up was 4.2 per 100 person-years and did not differ by treatment assignment (p = 0.9). In this trial, a relatively brief program of patient and/or physician education did not work to improve the management of osteoporosis. More intensive efforts should be considered for future quality improvement programs for osteoporosis.

Does Physician Education on Depression Management Improve Treatment in Primary Care?

PubMed Central

Lin, Elizabeth H B; Simon, Gregory E; Katzelnick, David J; Pearson, Steven D

2001-01-01

OBJECTIVE To assess the effect of physician training on management of depression. DESIGN Primary care physicians were randomly assigned to a depression management intervention that included an educational program. A before-and-after design evaluated physician practices for patients not enrolled in the intervention trial. SETTING One hundred nine primary care physicians in 2 health maintenance organizations located in the Midwest and Northwest regions of the United States. PATIENTS/PARTICIPANTS Computerized pharmacy and visit data from a group of 124,893 patients who received visits or prescriptions from intervention and usual care physicians. INTERVENTIONS Primary care physicians received education on diagnosis and optimal management of depression over a 3-month training period. Methods of education included small group interactive discussions, expert demonstrations, role-play, and academic detailing of pharmacotherapy, criteria for urgent psychiatric referrals, and case reviews with psychiatric consultants. MEASUREMENTS AND MAIN RESULTS Pharmacy and visit data provided indicators of physician management of depression: rate of newly diagnosed depression, new prescription of antidepressant medication, and duration of pharmacotherapy. One year after the training period, intervention and usual care physicians did not differ significantly in the rate of new depression diagnosis (P = .95) or new prescription of antidepressant medicines (P = .10). Meanwhile, patients of intervention physicians did not differ from patients of usual care physicians in adequacy of pharmacotherapy (P = .53) as measured by 12 weeks of continuous antidepressant treatment. CONCLUSIONS After education on optimal management of depression, intervention physicians did not differ from their usual care colleagues in depression diagnosis or pharmacotherapy. PMID:11556942

A randomized trial of a lay person-led self-management group intervention for back pain patients in primary care.

PubMed

Von Korff, M; Moore, J E; Lorig, K; Cherkin, D C; Saunders, K; González, V M; Laurent, D; Rutter, C; Comite, F

1998-12-01

Randomized, controlled trial. To evaluate a four-session self-management group intervention for patients with pain in primary care, led by trained lay persons with back pain. The intervention was designed to reduce patient worries, encourage self-care, and reduce activity limitations. Randomized trials of educational interventions suggest that activating interventions may improve back pain outcomes. Expert opinion increasingly regards effective self-management of back pain as important in achieving good outcomes. In this study, an educational intervention designed to activate patients and support effective self-management was evaluated. Six to 8 weeks after a primary care visit for back pain, patients were invited to participate in an educational program to improve back pain self-management. Those showing interest by returning a brief questionnaire became eligible for the study. Participants (n = 255) randomly were assigned to either a self-management group intervention or to a usual care control group. The effect of the intervention, relative to usual care, was assessed 3, 6, and 12 months after randomization, controlling for baseline values. The intervention consisted of a four-session group applying problem-solving techniques to back pain self-management, supplemented by educational materials (book and videos) supporting active management of back pain. The groups were led by lay persons trained to implement a fully structured group protocol. The control group received usual care, supplemented by a book on back pain care. Participants randomly assigned to the self-management groups reported significantly less worry about back pain and expressed more confidence in self-care. Roland Disability Questionnaire Scores were significantly lower among participants in the self-management groups relative to the usual care controls at 6 months (P = 0.007), and this difference was sustained at 12 months at borderline significance levels (P = 0.09). Among self-management group participants, 48% showed a 50% or greater reduction in Roland Disability Questionnaire Score at 6 months, compared with 33% among the usual care controls. Self-management groups led by trained lay persons following a structured protocol were more effective than usual care in reducing worries, producing positive attitudes toward self-care, and reducing activity limitations among patients with back pain in primary care.

Effectiveness of Collaborative Care for Depression in Public-Sector Primary Care Clinics Serving Latinos.

PubMed

Lagomasino, Isabel T; Dwight-Johnson, Megan; Green, Jennifer M; Tang, Lingqi; Zhang, Lily; Duan, Naihua; Miranda, Jeanne

2017-04-01

Quality improvement interventions for depression care have been shown to be effective for improving quality of care and depression outcomes in settings with primarily insured patients. The aim of this study was to determine the impact of a collaborative care intervention for depression that was tailored for low-income Latino patients seen in public-sector clinics. A total of 400 depressed patients from three public-sector primary care clinics were enrolled in a randomized controlled trial of a tailored collaborative care intervention versus enhanced usual care. Social workers without previous mental health experience served as depression care specialists for the intervention patients (N=196). Depending on patient preference, they delivered a cognitive-behavioral therapy (CBT) intervention or facilitated antidepressant medication given by primary care providers or both. In enhanced usual care, patients (N=204) received a pamphlet about depression, a letter for their primary care provider stating that they had a positive depression screen, and a list of local mental health resources. Intent-to-treat analyses examined clinical and process-of-care outcomes at 16 weeks. Compared with patients in the enhanced usual care group, patients in the intervention group had significantly improved depression, quality of life, and satisfaction outcomes (p<.001 for all). Intervention patients also had significantly improved quality-of-care indicators, including the proportion of patients receiving either psychotherapy or antidepressant medication (77% versus 21%, p<.001). Collaborative care for depression can greatly improve care and outcomes in public-sector clinics. Social workers without prior mental health experience can effectively provide CBT and manage depression care.

Integrated management of type 2 diabetes mellitus and depression treatment to improve medication adherence: a randomized controlled trial.

PubMed

Bogner, Hillary R; Morales, Knashawn H; de Vries, Heather F; Cappola, Anne R

2012-01-01

Depression commonly accompanies diabetes, resulting in reduced adherence to medications and increased risk for morbidity and mortality. The objective of this study was to examine whether a simple, brief integrated approach to depression and type 2 diabetes mellitus (type 2 diabetes) treatment improved adherence to oral hypoglycemic agents and antidepressant medications, glycemic control, and depression among primary care patients. We undertook a randomized controlled trial conducted from April 2010 through April 2011 of 180 patients prescribed pharmacotherapy for type 2 diabetes and depression in primary care. Patients were randomly assigned to an integrated care intervention or usual care. Integrated care managers collaborated with physicians to offer education and guideline-based treatment recommendations and to monitor adherence and clinical status. Adherence was assessed using the Medication Event Monitoring System (MEMS). We used glycated hemoglobin (HbA(1c)) assays to measure glycemic control and the 9-item Patient Health Questionnaire (PHQ-9) to assess depression. Intervention and usual care groups did not differ statistically on baseline measures. Patients who received the intervention were more likely to achieve HbA(1c) levels of less than 7% (intervention 60.9% vs. usual care 35.7%; P < .001) and remission of depression (PHQ-9 score of less than 5: intervention 58.7% vs. usual care 30.7%; P < .001) in comparison with patients in the usual care group at 12 weeks. A randomized controlled trial of a simple, brief intervention integrating treatment of type 2 diabetes and depression was successful in improving outcomes in primary care. An integrated approach to depression and type 2 diabetes treatment may facilitate its deployment in real-world practices with competing demands for limited resources.

Cost-effectiveness of acupuncture in an employee population: A retrospective analysis.

PubMed

Borah, Bijan J; Naessens, James M; Glasgow, Amy E; Bauer, Brent A; Chon, Tony Y

2017-04-01

To determine whether acupuncture is a cost-effective adjunct to usual care for Mayo Clinic employees and their dependents experiencing pain symptoms. Retrospective review of the medical and billing records of 466 employee-patients and their dependents who had received acupuncture as part of their care and 466 propensity score-matched control patients. Usual care in combination with acupuncture compared with usual care alone. The primary outcome measure was the total costs of care for all medical care and pharmacy services incurred from 1year before the index visit to 14 months after the index date. Secondary outcomes included the number of hospital visits, total inpatient days, emergency department visits, primary care or general medicine office visits, specialty office visits, and physical therapy services. Pain scores (patient-rated scores from 0 to 10) were extracted from the medical record, if available. Costs of care were similar between the 2 groups. No cost savings were noted for the acupuncture group. Several limitations to the study may have precluded a finding of cost-effectiveness. Future studies should include prospective evaluation of costs and other outcomes in a comparison between acupuncture and usual care in a randomized control trial. Copyright © 2017 Elsevier Ltd. All rights reserved.

Pilot Trial of a Licensed Practical Nurse Intervention for Hypertension and Depression

PubMed Central

Bogner, Hillary R.; de Vries, Heather F.; Kaye, Elise M.; Morales, Knashawn H.

2014-01-01

BACKGROUND AND OBJECTIVES Depression is a risk factor for hypertension, and risk of depression is increased substantially in patients with hypertension. Our objective was to examine whether an intervention carried out by Licensed Practical Nurses (LPNs) integrating depression treatment into care for hypertension improved blood pressure control and depressive symptoms. METHODS In all, 60 patients ages 41 to 92 years with hypertension and depressive symptoms at a large primary care practice in Philadelphia were randomly assigned to an integrated care intervention carried out by LPNs (n=30) or usual care (n=30). Intervention and control groups did not differ statistically on baseline measures. Outcomes assessed at baseline and 12 weeks included standard laboratory procedures to measure blood pressure control and the Patient Health Questionnaire (PHQ-9) to assess depression. RESULTS Patients in the integrated care intervention had lower diastolic blood pressure (intervention 74.2 mmHg versus usual care 82.0 mmHg) and fewer depressive symptoms (PHQ-9 mean scores, intervention 2.4 versus usual care 7.1) compared with patients in the usual care group at 12 weeks after adjustment for baseline values. Patients in the integrated care intervention also had lower systolic blood pressure (intervention 130.0 mmHg versus usual care 140.6 mmHg) compared with patients in the usual care group at 12 weeks although the results approached but did not reach conventional levels of statistical significance. CONCLUSION Training existing primary care practice office staff will facilitate implementation in real world practices with limited resources and competing demands. PMID:23681683

After-hours care and its coordination with primary care in the U.S.

PubMed

O'Malley, Ann S; Samuel, Divya; Bond, Amelia M; Carrier, Emily

2012-11-01

Despite expectations that medical homes provide "24 × 7 coverage" there is little to guide primary care practices in developing sustainable models for accessible and coordinated after-hours care. To identify and describe models of after-hours care in the U.S. that are delivered in primary care sites or coordinated with a patient's usual primary care provider. Qualitative analysis of data from in-depth telephone interviews. Primary care practices in 16 states and the organizations they partner with to provide after-hours coverage. Forty-four primary care physicians, practice managers, nurses and health plan representatives from 28 organizations. Analyses examined after-hours care models, facilitators, barriers and lessons learned. Based on 28 organizations interviewed, five broad models of after-hours care were identified, ranging in the extent to which they provide continuity and patient access. Key themes included: 1) The feasibility of a model varies for many reasons, including patient preferences and needs, the local health care market supply, and financial compensation; 2) A shared electronic health record and systematic notification procedures were extremely helpful in maintaining information continuity between providers; and 3) after-hours care is best implemented as part of a larger practice approach to access and continuity. After-hours care coordinated with a patient's usual primary care provider is facilitated by consideration of patient demand, provider capacity, a shared electronic health record, systematic notification procedures and a broader practice approach to improving primary care access and continuity. Payer support is important to increasing patients' access to after-hours care.

Predicting Outcome in Computerized Cognitive Behavioral Therapy for Depression in Primary Care: A Randomized Trial

ERIC Educational Resources Information Center

de Graaf, L. Esther; Hollon, Steven D.; Huibers, Marcus J. H.

2010-01-01

Objective: To explore pretreatment and short-term improvement variables as potential moderators and predictors of 12-month follow-up outcome of unsupported online computerized cognitive behavioral therapy (CCBT), usual care, and CCBT combined with usual care for depression. Method: Three hundred and three depressed patients were randomly allocated…

Preliminary examination of metabolic syndrome response to motivational interviewing for weight loss as compared to an attentional control and usual care in primary care for individuals with and without binge-eating disorder.

PubMed

Barnes, Rachel D; Barber, Jessica A

2017-08-01

Motivational interviewing (MI) treatment for weight loss is being studied in primary care. The effect of such interventions on metabolic syndrome or binge eating disorder (BED), both highly related to excess weight, has not been examined in primary care. This study conducted secondary analyses from a randomized controlled trial to test the impact of MI for weight loss in primary care on metabolic syndrome. 74 adult participants with overweight/obesity recruited through primary care were randomized to 12weeks of either MI, an attentional control, or usual care. Participants completed measurements for metabolic syndrome at pre- and post-treatment. There were no statistically significant differences in metabolic syndrome rates at pre-, X 2 (2)=0.16, p=0.921, or post-, X 2 (2)=0.852, p=0.653 treatment. The rates in metabolic syndrome, however, decreased for MI (10.2%) and attentional control (13.8%) participants, but not for usual care. At baseline, metabolic syndrome rates did not differ significantly between participants with BED or without BED across treatments. At post-treatment, participants with BED were significantly more likely to meet criteria for metabolic syndrome than participants without BED, X 2 (1)=5.145, p=0.023, phi=0.273. Across treatments, metabolic syndrome remitted for almost a quarter of participants without BED (23.1%) but for 0% of those with BED. These preliminary results are based on a small sample and should be interpreted with caution, but they are the first to suggest that relatively low intensity MI weight loss interventions in primary care may decrease metabolic syndrome rates but not for individuals with BED. Copyright © 2017 Elsevier Ltd. All rights reserved.

REDUCING SUICIDAL IDEATION AND DEPRESSION IN OLDER PRIMARY CARE PATIENTS: 24-MONTH OUTCOMES OF THE PROSPECT STUDY

PubMed Central

Alexopoulos, George S.; Reynolds, Charles F.; Bruce, Martha L.; Katz, Ira R.; Raue, Patrick J.; Mulsant, Benoit H.; Oslin, David; Have, Thomas Ten

2010-01-01

Objective The PROSPECT Study evaluated the impact of a care management intervention on suicidal ideation and depression in older primary care patients. This is the first report of outcomes over a 2-year period. Method The subjects (N=599) were older (>=60 years) patients with major or minor depression selected after screening 9,072 randomly identified patients of 20 primary care practices randomly assigned to the PROSPECT intervention or usual care. The intervention consisted of services of 15 trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 24 months. Results Intervention patients had a higher likelihood to receive antidepressants and or psychotherapy (84.9–89% vs. 49–59%) and a 2.2 times greater decline in suicidal ideation than usual care patients over 24 months. Treatment response occurred earlier in intervention patients and continued to increase from the 18th to the 24th month, while there was no appreciable increase in usual care patients during the same period. Among patients with major depression, a greater number achieved remission in the intervention than the usual care group at 4 (26.6 vs. 15.2%), 8 (36% vs. 22.5%), and 24 (45.4% vs. 31.5%) months. Patients with minor depression had favorable outcomes regardless of treatment assignment. Conclusions Sustained collaborative care maintains high utilization of antidepressant treatment, reduces suicidal ideation, and improves the outcomes of major depression over two years. These observations suggest that sustained collaborative care increases depression-free days. PMID:19528195

Interventions to Improve Access to Primary Care for People Who Are Homeless: A Systematic Review

PubMed Central

2016-01-01

Background People who are homeless encounter barriers to primary care despite having greater needs for health care, on average, than people who are not homeless. We evaluated the effectiveness of interventions to improve access to primary care for people who are homeless. Methods We performed a systematic review to identify studies in English published between January 1, 1995, and July 8, 2015, comparing interventions to improve access to a primary care provider with usual care among people who are homeless. The outcome of interest was access to a primary care provider. The risk of bias in the studies was evaluated, and the quality of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. Results From a total of 4,047 citations, we identified five eligible studies (one randomized controlled trial and four observational studies). With the exception of the randomized trial, the risk of bias was considered high in the remaining studies. In the randomized trial, people who were homeless, without serious mental illness, and who received either an outreach intervention plus clinic orientation or clinic orientation alone, had improved access to a primary care provider compared with those receiving usual care. An observational study that compared integration of primary care and other services for people who are homeless with usual care did not observe any difference in access to a primary care provider between the two groups. A small observational study showed improvement among participants with a primary care provider after receiving an intervention consisting of housing and supportive services compared with the period before the intervention. The quality of the evidence was considered moderate for both the outreach plus clinic orientation and clinic orientation alone, and low to very low for the other interventions. Despite limitations, the literature identified reports of interventions developed to overcome barriers in access to primary care in people who are homeless. The interventions studied are complex and include multiple components that are consistent with proposed dimensions of access to care (availability, affordability, and acceptability). Conclusions Our systematic review of the literature identified various types of interventions that seek to improve access to primary care by attempting to address barriers to care encountered by people who are homeless. Moderate-quality evidence indicates that orientation to clinic services (either alone or combined with outreach) improves access to a primary care provider in adults who are homeless, without serious mental illness, and living in urban centres. PMID:27099645

Interventions to Improve Access to Primary Care for People Who Are Homeless: A Systematic Review.

PubMed

2016-01-01

People who are homeless encounter barriers to primary care despite having greater needs for health care, on average, than people who are not homeless. We evaluated the effectiveness of interventions to improve access to primary care for people who are homeless. We performed a systematic review to identify studies in English published between January 1, 1995, and July 8, 2015, comparing interventions to improve access to a primary care provider with usual care among people who are homeless. The outcome of interest was access to a primary care provider. The risk of bias in the studies was evaluated, and the quality of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. From a total of 4,047 citations, we identified five eligible studies (one randomized controlled trial and four observational studies). With the exception of the randomized trial, the risk of bias was considered high in the remaining studies. In the randomized trial, people who were homeless, without serious mental illness, and who received either an outreach intervention plus clinic orientation or clinic orientation alone, had improved access to a primary care provider compared with those receiving usual care. An observational study that compared integration of primary care and other services for people who are homeless with usual care did not observe any difference in access to a primary care provider between the two groups. A small observational study showed improvement among participants with a primary care provider after receiving an intervention consisting of housing and supportive services compared with the period before the intervention. The quality of the evidence was considered moderate for both the outreach plus clinic orientation and clinic orientation alone, and low to very low for the other interventions. Despite limitations, the literature identified reports of interventions developed to overcome barriers in access to primary care in people who are homeless. The interventions studied are complex and include multiple components that are consistent with proposed dimensions of access to care (availability, affordability, and acceptability). Our systematic review of the literature identified various types of interventions that seek to improve access to primary care by attempting to address barriers to care encountered by people who are homeless. Moderate-quality evidence indicates that orientation to clinic services (either alone or combined with outreach) improves access to a primary care provider in adults who are homeless, without serious mental illness, and living in urban centres.

Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial.

PubMed

Kalter-Leibovici, Ofra; Freimark, Dov; Freedman, Laurence S; Kaufman, Galit; Ziv, Arnona; Murad, Havi; Benderly, Michal; Silverman, Barbara G; Friedman, Nurit; Cukierman-Yaffe, Tali; Asher, Elad; Grupper, Avishay; Goldman, Dorit; Amitai, Miriam; Matetzky, Shlomi; Shani, Mordechai; Silber, Haim

2017-05-01

The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems. This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies. In this multicenter open-label trial, 1,360 patients recruited after hospitalization for heart failure exacerbation (38%) or from the community (62%) were randomly assigned to either disease management or usual care. Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists. The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause. Secondary endpoints included the number of all hospital admissions, health-related quality of life and depression during follow-up. Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center. During the follow-up, 388 (56.9%) patients assigned to disease management and 387 (57.1%) assigned to usual care had a primary endpoint event. The median (range) time elapsed until the primary endpoint event or end of study was 2.0 (0-5.0) years among patients assigned to disease management, and 1.8 (0-5.0) years among patients assigned to usual care (adjusted hazard ratio, 0.908; 95% confidence interval, 0.788 to 1.047). Hospital admissions were mostly (70%) unrelated to heart failure. Patients assigned to disease management had a better health-related quality of life and a lower depression score during follow-up. This comprehensive disease management intervention was not superior to usual care with respect to the primary composite endpoint, but it improved health-related quality of life and depression. A disease-centered approach may not suffice to make a significant impact on hospital admissions and mortality in patients with chronic heart failure who have universal access to health care. Clinicaltrials.gov identifier: NCT00533013 . Trial registration date: 9 August 2007. Initial protocol release date: 20 September 2007.

Problem-Solving Treatment and Coping Styles in Primary Care for Minor Depression

ERIC Educational Resources Information Center

Oxman, Thomas E.; Hegel, Mark T.; Hull, Jay G.; Dietrich, Allen J.

2008-01-01

Research was undertaken to compare problem-solving treatment for primary care (PST-PC) with usual care for minor depression and to examine whether treatment effectiveness was moderated by coping style. PST-PC is a 6-session, manual-based, psychosocial skills intervention. A randomized controlled trial was conducted in 2 academic, primary care…

Multispecialty physician networks in Ontario

PubMed Central

Stukel, Therese A; Glazier, Richard H; Schultz, Susan E; Guan, Jun; Zagorski, Brandon M; Gozdyra, Peter; Henry, David A

2013-01-01

Background Large multispecialty physician group practices, with a central role for primary care practitioners, have been shown to achieve high-quality, low-cost care for patients with chronic disease. We assessed the extent to which informal multispecialty physician networks in Ontario could be identified by using health administrative data to exploit natural linkages among patients, physicians, and hospitals based on existing patient flow. Methods We linked each Ontario resident to his or her usual provider of primary care over the period from fiscal year 2008/2009 to fiscal year 2010/2011. We linked each specialist to the hospital where he or she performed the most inpatient services. We linked each primary care physician to the hospital where most of his or her ambulatory patients were admitted for non-maternal medical care. Each resident was then linked to the same hospital as his or her usual provider of primary care. We computed “loyalty” as the proportion of care to network residents provided by physicians and hospitals within their network. Smaller clusters were aggregated to create networks based on a minimum population size, distance, and loyalty. Networks were not constrained geographically. Results We identified 78 multispecialty physician networks, comprising 12 410 primary care physicians, 14 687 specialists, and 175 acute care hospitals serving a total of 12 917 178 people. Median network size was 134 723 residents, 125 primary care physicians, and 143 specialists. Virtually all eligible residents were linked to a usual provider of primary care and to a network. Most specialists (93.5%) and primary care physicians (98.2%) were linked to a hospital. Median network physician loyalty was 68.4% for all physician visits and 81.1% for primary care visits. Median non-maternal admission loyalty was 67.4%. Urban networks had lower loyalties and were less self-contained but had more health care resources. Interpretation We demonstrated the feasibility of identifying informal multispecialty physician networks in Ontario on the basis of patterns of health care–seeking behaviour. Networks were reasonably self-contained, in that individual residents received most of their care from providers within their respective networks. Formal constitution of networks could foster accountability for efficient, integrated care through care management tools and quality improvement, the ideas behind “accountable care organizations.” PMID:24348884

DIABETES, DEPRESSION, AND DEATH: A RANDOMIZED CONTROLLED TRIAL OF A DEPRESSION TREATMENT PROGRAM FOR OLDER ADULTS BASED IN PRIMARY CARE (PROSPECT)

PubMed Central

Bogner, Hillary R; Morales, Knashawn H; Post, Edward P; Bruce, Martha L

2009-01-01

OBJECTIVE Our a priori hypothesis was that depressed patients with diabetes in practices implementing a depression management program would have a decreased risk of mortality compared to depressed patients with diabetes in usual care practices. RESEARCH DESIGN AND METHODS Multi-site practice-randomized controlled trial PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 5/99-8/01 and supplemented with a search of the National Death Index. Twenty primary care practices participated from New York City, Philadelphia, and Pittsburgh. In all, 584 participants who were identified though a two-stage, age-stratified (60-74; 75+) depression screening of randomly sampled patients and were classified as depressed with complete information on diabetes status are included in these analyses. Of all the 584 participants, 123 (21.2%) reported a history of diabetes. A depression care manager worked with primary care physicians to provide algorithm-based care. Vital status was assessed at 5 years. RESULTS After a median follow-up of 52.0 months, 110 depressed patients had died. Depressed patients with diabetes in the Intervention Condition were less likely to have died during the 5-year follow-up interval than were depressed persons with diabetes in Usual Care after accounting for baseline differences among patients (adjusted hazard ratio 0.49, 95% CI [0.24, 0.98]). CONCLUSIONS Older depressed primary care patients with diabetes in practices implementing depression care management were less likely to die over the course of a 5-year interval than were depressed patients with diabetes in usual care practices. PMID:17717284

A review of recent literature - nurse case managers in diabetes care: equivalent or better outcomes compared to primary care providers.

PubMed

Watts, Sharon A; Lucatorto, Michelle

2014-07-01

Primary care has changed remarkably with chronic disease burden growth. Nurse case managers assist with this chronic disease by providing if not significantly better care, than equivalent care to that provided by usual primary care providers. Chronic disease management requires patient-centered skills and tools, such as registries, panel management, review of home data, communicating with patients outside of face-to-face care, and coordinating multiple services. Evidence reviewed in this article demonstrates that registered nurse care managers (RNCM) perform many actions required for diabetes chronic disease management including initiation and titration of medications with similar or improved physiologic and patient satisfaction outcomes over usual care providers. Selection and training of the nurse case managers is of utmost importance for implementation of a successful chronic disease management program. Evidence based guidelines, algorithms, protocols, and adequate ongoing education and mentoring are generally cited as necessary support tools for the nurse case managers.

Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol.

PubMed

Jauregui, Amale; Ponte, Joaquín; Salgueiro, Monika; Unanue, Saloa; Donaire, Carmen; Gómez, Maria Cruz; Burgos-Alonso, Natalia; Grandes, Gonzalo

2015-03-20

In contrast with the recommendations of clinical practice guidelines, the most common treatment for anxiety and depressive disorders in primary care is pharmacological. The aim of this study is to assess the efficacy of a cognitive-behavioural psychological intervention, delivered by primary care psychologists in patients with mixed anxiety-depressive disorder compared to usual care. This is an open-label, multicentre, randomized, and controlled study with two parallel groups. A random sample of 246 patients will be recruited with mild-to-moderate mixed anxiety-depressive disorder, from the target population on the lists of 41 primary care doctors. Patients will be randomly assigned to the intervention group, who will receive standardised cognitive-behavioural therapy delivered by psychologists together with usual care, or to a control group, who will receive usual care alone. The cognitive-behavioural therapy intervention is composed of eight individual 60-minute face-to face sessions conducted in eight consecutive weeks. A follow-up session will be conducted over the telephone, for reinforcement or referral as appropriate, 6 months after the intervention, as required. The primary outcome variable will be the change in scores on the Short Form-36 General Health Survey. We will also measure the change in the frequency and intensity of anxiety symptoms (State-Trait Anxiety Inventory) and depression (Beck Depression Inventory) at baseline, and 3, 6 and 12 months later. Additionally, we will collect information on the use of drugs and health care services. The aim of this study is to assess the efficacy of a primary care-based cognitive-behavioural psychological intervention in patients with mixed anxiety-depressive disorder. The international scientific evidence has demonstrated the need for psychologists in primary care. However, given the differences between health policies and health services, it is important to test the effect of these psychological interventions in our geographical setting. NCT01907035 (July 22, 2013).

Alerts in electronic medical records to promote a colorectal cancer screening programme: a cluster randomised controlled trial in primary care

PubMed Central

Guiriguet, Carolina; Muñoz-Ortiz, Laura; Burón, Andrea; Rivero, Irene; Grau, Jaume; Vela-Vallespín, Carmen; Vilarrubí, Mercedes; Torres, Miquel; Hernández, Cristina; Méndez-Boo, Leonardo; Toràn, Pere; Caballeria, Llorenç; Macià, Francesc; Castells, Antoni

2016-01-01

Background Participation rates in colorectal cancer screening are below recommended European targets. Aim To evaluate the effectiveness of an alert in primary care electronic medical records (EMRs) to increase individuals’ participation in an organised, population-based colorectal cancer screening programme when compared with usual care. Design and setting Cluster randomised controlled trial in primary care centres of Barcelona, Spain. Method Participants were males and females aged 50–69 years, who were invited to the first round of a screening programme based on the faecal immunochemical test (FIT) (n = 41 042), and their primary care professional. The randomisation unit was the physician cluster (n = 130) and patients were blinded to the study group. The control group followed usual care as per the colorectal cancer screening programme. In the intervention group, as well as usual care, an alert to health professionals (cluster level) to promote screening was introduced in the individual’s primary care EMR for 1 year. The main outcome was colorectal cancer screening participation at individual participant level. Results In total, 67 physicians and 21 619 patients (intervention group) and 63 physicians and 19 423 patients (control group) were randomised. In the intention-to-treat analysis screening participation was 44.1% and 42.2% respectively (odds ratio 1.08, 95% confidence interval [CI] = 0.97 to 1.20, P = 0.146). However, in the per-protocol analysis screening uptake in the intervention group showed a statistically significant increase, after adjusting for potential confounders (OR, 1.11; 95% CI = 1.02 to 1.22; P = 0.018). Conclusion The use of an alert in an individual’s primary care EMR is associated with a statistically significant increased uptake of an organised, FIT-based colorectal cancer screening programme in patients attending primary care centres. PMID:27266861

Systematic review of integrated models of health care delivered at the primary-secondary interface: how effective is it and what determines effectiveness?

PubMed

Mitchell, Geoffrey K; Burridge, Letitia; Zhang, Jianzhen; Donald, Maria; Scott, Ian A; Dart, Jared; Jackson, Claire L

2015-01-01

Integrated multidisciplinary care is difficult to achieve between specialist clinical services and primary care practitioners, but should improve outcomes for patients with chronic and/or complex chronic physical diseases. This systematic review identifies outcomes of different models that integrate specialist and primary care practitioners, and characteristics of models that delivered favourable clinical outcomes. For quality appraisal, the Cochrane Risk of Bias tool was used. Data are presented as a narrative synthesis due to marked heterogeneity in study outcomes. Ten studies were included. Publication bias cannot be ruled out. Despite few improvements in clinical outcomes, significant improvements were reported in process outcomes regarding disease control and service delivery. No study reported negative effects compared with usual care. Economic outcomes showed modest increases in costs of integrated primary-secondary care. Six elements were identified that were common to these models of integrated primary-secondary care: (1) interdisciplinary teamwork; (2) communication/information exchange; (3) shared care guidelines or pathways; (4) training and education; (5) access and acceptability for patients; and (6) a viable funding model. Compared with usual care, integrated primary-secondary care can improve elements of disease control and service delivery at a modestly increased cost, although the impact on clinical outcomes is limited. Future trials of integrated care should incorporate design elements likely to maximise effectiveness.

Effects of allergen and trigger factor avoidance advice in primary care on asthma control: a randomized-controlled trial.

PubMed

Bobb, C; Ritz, T; Rowlands, G; Griffiths, C

2010-01-01

Allergy contributes significantly to asthma exacerbation, yet avoidance of triggers, in particular allergens, is rarely addressed in detail in regular asthma review in primary care. To determine whether structured, individually tailored allergen and trigger avoidance advice, given as part of a primary care asthma review, improves lung function and asthma control. In a randomized-controlled trial 214 adults with asthma in six general practices were either offered usual care during a primary care asthma review or usual care with additional allergen and trigger identification (by skin prick testing and structured allergy assessment) and avoidance advice according to a standardized protocol by trained practice nurses. Main outcome measures were lung function, asthma control, asthma self-efficacy. Both intervention groups were equivalent in demographic and asthma-related variables at baseline. At 3-6-month follow-up, patients receiving the allergen and trigger avoidance review showed significant improvements in lung function (assessed by blinded research nurses) compared with those receiving usual care. Significantly more patients in the intervention group than in the control group showed improvements in forced expiratory volume in 1 s > or =15%. No significant differences were found in self-report measures of asthma control. Asthma-specific self-efficacy improved in both groups but did not differ between groups. Allergen and trigger identification and avoidance advice, given as part of a structured asthma review delivered in primary care by nurses results in clinically important improvements in lung function but not self-report of asthma control. ISRCTN45684820.

The cost of a primary care-based childhood obesity prevention intervention

PubMed Central

2014-01-01

Background United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting. Primary care-based interventions can be effective in improving health behaviors, but also costly. The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity, measured against usual care. Methods High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children’s nutrition and TV viewing habits through a motivational interviewing intervention. We assessed visit-related costs from a societal perspective, including provider-incurred direct medical costs, provider-incurred equipment costs, parent time costs and parent out-of-pocket costs, in 2011 dollars for the intervention (n = 253) and usual care (n = 192) groups. We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results. Results The total costs for the intervention group and usual care groups in the first year of the intervention were $65,643 (95% CI [$64,522, $66,842]) and $12,192 (95% CI [$11,393, $13,174]). The mean costs for the intervention and usual care groups were $259 (95% CI [$255, $264]) and $63 (95% CI [$59, $69]) per child, respectively, for a incremental difference of $196 (95% CI [$191, $202]) per child. Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls. Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses. Conclusions High Five for Kids was a resource-intensive intervention. Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions. Trial registration ClinicalTrials.gov Identifier: NCT00377767. PMID:24472122

The cost of a primary care-based childhood obesity prevention intervention.

PubMed

Wright, Davene R; Taveras, Elsie M; Gillman, Matthew W; Horan, Christine M; Hohman, Katherine H; Gortmaker, Steven L; Prosser, Lisa A

2014-01-29

United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting. Primary care-based interventions can be effective in improving health behaviors, but also costly. The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity, measured against usual care. High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children's nutrition and TV viewing habits through a motivational interviewing intervention. We assessed visit-related costs from a societal perspective, including provider-incurred direct medical costs, provider-incurred equipment costs, parent time costs and parent out-of-pocket costs, in 2011 dollars for the intervention (n = 253) and usual care (n =192) groups. We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results. The total costs for the intervention group and usual care groups in the first year of the intervention were $65,643 (95% CI [$64,522, $66,842]) and $12,192 (95% CI [$11,393, $13,174]). The mean costs for the intervention and usual care groups were $259 (95% CI [$255, $264]) and $63 (95% CI [$59, $69]) per child, respectively, for a incremental difference of $196 (95% CI [$191, $202]) per child. Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls. Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses. High Five for Kids was a resource-intensive intervention. Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions.

Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial.

PubMed

Bleijenberg, Nienke; Drubbel, Irene; Schuurmans, Marieke J; Dam, Hester Ten; Zuithoff, Nicolaas P A; Numans, Mattijs E; de Wit, Niek J

2016-09-01

To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. Primary care setting, 39 general practices in the Netherlands. Community-dwelling people aged 60 and older (N = 3,092). A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care. Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living (ADLs), 8 instrumental activities of daily living (IADLs), one mobility item (range 0-15)); higher scores indicate greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality. The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval (CI) = 1.77-1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80-1.96; control group, 2.03, 95% CI = 1.92-2.13; P = .03). No differences in quality of life were observed. Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more-robust results. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Collaborative care for depression in European countries: a systematic review and meta-analysis.

PubMed

Sighinolfi, Cecilia; Nespeca, Claudia; Menchetti, Marco; Levantesi, Paolo; Belvederi Murri, Martino; Berardi, Domenico

2014-10-01

This is a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the effectiveness of collaborative care compared to Primary Care Physician's (PCP's) usual care in the treatment of depression, focusing on European countries. A systematic review of English and non-English articles, from inception to March 2014, was performed using database PubMed, British Nursing Index and Archive, Ovid Medline (R), PsychINFO, Books@Ovid, PsycARTICLES Full Text, EMBASE Classic+Embase, DARE (Database of Abstract of Reviews of Effectiveness) and the Cochrane Library electronic database. Search term included depression, collaborative care, physician family and allied health professional. RCTs comparing collaborative care to usual care for depression in primary care were included. Titles and abstracts were independently examined by two reviewers, who extracted from the included trials information on participants' characteristics, type of intervention, features of collaborative care and type of outcome measure. The 17 papers included, regarding 15 RCTs, involved 3240 participants. Primary analyses showed that collaborative care models were associated with greater improvement in depression outcomes in the short term, within 3 months (standardized mean difference (SMD) -0.19, 95% CI=-0.33; -0.05; p=0.006), medium term, between 4 and 11 months (SMD -0.24, 95% CI=-0.39; -0.09; p=0.001) and medium-long term, from 12 months and over (SMD -0.21, 95% CI=-0.37; -0.04; p=0.01), compared to usual care. The present review, specifically focusing on European countries, shows that collaborative care is more effective than treatment as usual in improving depression outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

Randomised controlled feasibility trial of a web-based weight management intervention with nurse support for obese patients in primary care

PubMed Central

2014-01-01

Background There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity. Automated web-based interventions might provide a solution, but evidence suggests that they may be ineffective without additional human support. The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care, comparing different levels of nurse support, to determine the optimal combination of web-based and personal support to be tested in a full trial. Methods This was an individually randomised four arm parallel non-blinded trial, recruiting obese patients in primary care. Following online registration, patients were randomly allocated by the automated intervention to either usual care, the web-based intervention only, or the web-based intervention with either basic nurse support (3 sessions in 3 months) or regular nurse support (7 sessions in 6 months). The main outcome measure (intended as the primary outcome for the main trial) was weight loss in kg at 12 months. As this was a feasibility trial no statistical analyses were carried out, but we present means, confidence intervals and effect sizes for weight loss in each group, uptake and retention, and completion of intervention components and outcome measures. Results All randomised patients were included in the weight loss analyses (using Last Observation Carried Forward). At 12 months mean weight loss was: usual care group (n = 43) 2.44 kg; web-based only group (n = 45) 2.30 kg; basic nurse support group (n = 44) 4.31 kg; regular nurse support group (n = 47) 2.50 kg. Intervention effect sizes compared with usual care were: d = 0.01 web-based; d = 0.34 basic nurse support; d = 0.02 regular nurse support. Two practices deviated from protocol by providing considerable weight management support to their usual care patients. Conclusions This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care, and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context. Trial registration Current Controlled Trials ISRCTN31685626. PMID:24886516

Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial.

PubMed

O'Brien, Claire; Bray, Emma P; Bryan, Stirling; Greenfield, Sheila M; Haque, M Sayeed; Hobbs, F D Richard; Jones, Miren I; Jowett, Sue; Kaambwa, Billingsley; Little, Paul; Mant, Jonathan; Penaloza, Cristina; Schwartz, Claire; Shackleford, Helen; Varghese, Jinu; Williams, Bryan; McManus, Richard J

2013-03-23

Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care. The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes. The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond. ISRCTN87171227.

Effect of integrated care for sick listed patients with chronic low back pain: economic evaluation alongside a randomised controlled trial.

PubMed

Lambeek, Ludeke C; Bosmans, Judith E; Van Royen, Barend J; Van Tulder, Maurits W; Van Mechelen, Willem; Anema, Johannes R

2010-11-30

To evaluate the cost effectiveness, cost utility, and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain. Economic evaluation alongside a randomised controlled trial with 12 months' follow-up. Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals) in the Netherlands, 2005-9. 134 adults aged 18-65 sick listed because of chronic low back pain: 66 were randomised to integrated care and 68 to usual care. Integrated care consisted of a workplace intervention based on participatory ergonomics, with involvement of a supervisor, and a graded activity programme based on cognitive behavioural principles. Usual care was provided by general practitioners and occupational physicians according to Dutch guidelines. The primary outcome was duration until sustainable return to work. The secondary outcome was quality adjusted life years (QALYs), measured using EuroQol. Total costs in the integrated care group (£13 165, SD £13 600) were significantly lower than in the usual care group (£18 475, SD £13 616). Cost effectiveness planes and acceptability curves showed that integrated care was cost effective compared with usual care for return to work and QALYs gained. The cost-benefit analyses showed that every £1 invested in integrated care would return an estimated £26. The net societal benefit of integrated care compared with usual care was £5744. Implementation of an integrated care programme for patients sick listed with chronic low back pain has a large potential to significantly reduce societal costs, increase effectiveness of care, improve quality of life, and improve function on a broad scale. Integrated care therefore has large gains for patients and society as well as for employers.

Patient navigation for breast and colorectal cancer treatment: a randomized trial.

PubMed

Fiscella, Kevin; Whitley, Elizabeth; Hendren, Samantha; Raich, Peter; Humiston, Sharon; Winters, Paul; Jean-Pierre, Pascal; Valverde, Patricia; Thorland, William; Epstein, Ronald

2012-10-01

There is limited high-quality evidence about the impact of patient navigation (PN) on outcomes for patients with diagnosed cancer. We pooled data from two sites from the national Patient Navigation Research Program. Patients (n = 438) with newly diagnosed breast (n = 353) or colorectal cancer (n = 85) were randomized to PN or usual care. Trained lay navigators met with patients randomized to PN to help them assess treatment barriers and identify resources to overcome barriers. We used intent-to-treat analysis to assess time to completion of primary treatment, psychologic distress (impact of events scale), and satisfaction (patient satisfaction with cancer-related care) within 3 months after initiation of cancer treatment. The sample was predominantly middle-aged (mean age = 57) and female (90%); 44% were race-ethnic minorities (44%), 46% reported lower education levels, 18% were uninsured, and 9% reported a non-English primary language. The randomized groups were comparable in baseline characteristics. Primary analysis showed no statistically significant group differences in time to completion of primary cancer treatment, satisfaction with cancer-related care, or psychologic distress. Subgroup analysis showed that socially disadvantaged patients (i.e., uninsured, low English proficiency, and non-English primary language) who received PN reported higher satisfaction than those receiving usual care (all P < 0.05). Navigated patients living alone reported greater distress than those receiving usual care. Although the primary analysis showed no overall benefit, the subgroup analysis suggests that PN may improve satisfaction with care for certain disadvantaged individuals. PN for cancer patients may not necessarily reduce treatment time nor distress. 2012 AACR

Adult community health-promoting interventions in primary health care: A systematic review.

PubMed

March, Sebastià; Torres, Elena; Ramos, María; Ripoll, Joana; García, Atanasio; Bulilete, Oana; Medina, David; Vidal, Clara; Cabeza, Elena; Llull, Micaela; Zabaleta-del-Olmo, Edurne; Aranda, José Manuel; Sastre, Silvia; Llobera, Joan

2015-07-01

To examine evidence on the effectiveness of health-promoting community interventions carried out in primary health care. Systematic review of originals and systematic reviews of health-promoting community interventions with the participation of primary health care. A working definition of community activities was used in the inclusion criteria. Databases searched up to 2013: PUBMED, EMBASE, CINHAL, Web of SCIENCE, IBECS, IME, and PSICODOC. No restrictions on year of publication or design. Articles were reviewed by separate researchers to identify risks of bias. Fifty-one articles published between 1966 and 2013 were included: 11 systematic reviews and 40 originals that described 39 community interventions. There is evidence on the effectiveness of community interventions in reducing cardiovascular risk factors, encouraging physical exercise, preventing falls and improving self-care among chronic patients compared with usual individual care. The effectiveness of some interventions increases when the community is involved in their development. Most assessments show positive results despite design limitations. The community approach may be more effective than the individual in usual preventive interventions in primary care. There is a lack of evidence on many community interventions in primary care and further research is needed. Copyright © 2015 Elsevier Inc. All rights reserved.

Primary care ... where?

PubMed

Adcock, G B

1999-07-01

Corporate-based nurse managed centers are not the national norm. More prevalent is the use of an occupational health or physician-directed medical model of care. The author describes how a 14-year-old primary care center at a North Carolina computer software company is just "business as usual" when viewed in the context of the company's philosophy, goals, and culture. Included are considerations for nurse practitioners interested in the successful transplantation of this primary care model to other settings.

Effect of Primary Care Intervention on Breastfeeding Duration and Intensity

PubMed Central

Stuebe, Alison; Barnett, Josephine; Labbok, Miriam H.; Fletcher, Jason; Bernstein, Peter S.

2014-01-01

Objectives. We determined the effectiveness of primary care–based, and pre- and postnatal interventions to increase breastfeeding. Methods. We conducted 2 trials at obstetrics and gynecology practices in the Bronx, New York, from 2008 to 2011. The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study (PAIRINGS) had 2 arms: usual care versus pre- and postnatal visits with a lactation consultant (LC) and electronically prompted guidance from prenatal care providers (EP). The Best Infant Nutrition for Good Outcomes (BINGO) study had 4 arms: usual care, LC alone, EP alone, or LC+EP. Results. In BINGO at 3 months, high intensity was greater for the LC+EP (odds ratio [OR] = 2.72; 95% confidence interval [CI] = 1.08, 6.84) and LC (OR = 3.22; 95% CI = 1.14, 9.09) groups versus usual care, but not for the EP group alone. In PAIRINGS at 3 months, intervention rates exceeded usual care (OR = 2.86; 95% CI = 1.21, 6.76); the number needed to treat to prevent 1 dyad from nonexclusive breastfeeding at 3 months was 10.3 (95% CI = 5.6, 50.7). Conclusions. LCs integrated into routine care alone and combined with EP guidance from prenatal care providers increased breastfeeding intensity at 3 months postpartum. PMID:24354834

The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial.

PubMed

Sitnikova, Kate; Leone, Stephanie S; Zonneveld, Lyonne N L; van Marwijk, Harm W J; Bosmans, Judith E; van der Wouden, Johannes C; van der Horst, Henriëtte E

2017-05-03

Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care. In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P. We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care. Dutch Trial Registry, identifier: NTR4686 , Registered on 14 July 2014.

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction.

PubMed

Lowrie, Richard; Mair, Frances S; Greenlaw, Nicola; Forsyth, Paul; Jhund, Pardeep S; McConnachie, Alex; Rae, Brian; McMurray, John J V

2012-02-01

Meta-analysis of small trials suggests that pharmacist-led collaborative review and revision of medical treatment may improve outcomes in heart failure. We studied patients with left ventricular systolic dysfunction in a cluster-randomized controlled, event driven, trial in primary care. We allocated 87 practices (1090 patients) to pharmacist intervention and 87 practices (1074 patients) to usual care. The intervention was delivered by non-specialist pharmacists working with family doctors to optimize medical treatment. The primary outcome was a composite of death or hospital admission for worsening heart failure. This trial is registered, number ISRCTN70118765. The median follow-up was 4.7 years. At baseline, 86% of patients in both groups were treated with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. In patients not receiving one or other of these medications, or receiving less than the recommended dose, treatment was started, or the dose increased, in 33.1% of patients in the intervention group and in 18.5% of the usual care group [odds ratio (OR) 2.26, 95% CI 1.64-3.10; P< 0.001]. At baseline, 62% of each group were treated with a β-blocker and the proportions starting or having an increase in the dose were 17.9% in the intervention group and 11.1% in the usual care group (OR 1.76, 95% CI 1.31-2.35; P< 0.001). The primary outcome occurred in 35.8% of patients in the intervention group and 35.4% in the usual care group (hazard ratio 0.97, 95% CI 0.83-1.14; P = 0.72). There was no difference in any secondary outcome. A low-intensity, pharmacist-led collaborative intervention in primary care resulted in modest improvements in prescribing of disease-modifying medications but did not improve clinical outcomes in a population that was relatively well treated at baseline.

Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial

PubMed Central

Littlewood, Elizabeth; Hewitt, Catherine; Brierley, Gwen; Tharmanathan, Puvan; Araya, Ricardo; Barkham, Michael; Bower, Peter; Cooper, Cindy; Gask, Linda; Kessler, David; Lester, Helen; Lovell, Karina; Parry, Glenys; Richards, David A; Andersen, Phil; Brabyn, Sally; Knowles, Sarah; Shepherd, Charles; Tallon, Debbie; White, David

2015-01-01

Study question How effective is supported computerised cognitive behaviour therapy (cCBT) as an adjunct to usual primary care for adults with depression? Methods This was a pragmatic, multicentre, three arm, parallel randomised controlled trial with simple randomisation. Treatment allocation was not blinded. Participants were adults with symptoms of depression (score ≥10 on nine item patient health questionnaire, PHQ-9) who were randomised to receive a commercially produced cCBT programme (“Beating the Blues”) or a free to use cCBT programme (MoodGYM) in addition to usual GP care. Participants were supported and encouraged to complete the programme via weekly telephone calls. Control participants were offered usual GP care, with no constraints on the range of treatments that could be accessed. The primary outcome was severity of depression assessed with the PHQ-9 at four months. Secondary outcomes included health related quality of life (measured by SF-36) and psychological wellbeing (measured by CORE-OM) at four, 12, and 24 months and depression at 12 and 24 months. Study answer and limitations Participants offered commercial or free to use cCBT experienced no additional improvement in depression compared with usual GP care at four months (odds ratio 1.19 (95% confidence interval 0.75 to 1.88) for Beating the Blues v usual GP care; 0.98 (0.62 to 1.56) for MoodGYM v usual GP care). There was no evidence of an overall difference between either programme compared with usual GP care (0.99 (0.57 to 1.70) and 0.68 (0.42 to 1.10), respectively) at any time point. Commercially provided cCBT conferred no additional benefit over free to use cCBT or usual GP care at any follow-up point. Uptake and use of cCBT was low, despite regular telephone support. Nearly a quarter of participants (24%) had dropped out by four months. The study did not have enough power to detect small differences so these cannot be ruled out. Findings cannot be generalised to cCBT offered with a much higher level of guidance and support. What this study adds Supported cCBT does not substantially improve depression outcomes compared with usual GP care alone. In this study, neither a commercially available nor free to use computerised CBT intervention was superior to usual GP care. Funding, competing interests, data sharing Commissioned and funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project No 06/43/05). The authors have no competing interests. Requests for patient level data will be considered by the REEACT trial management group Trial registration Current Controlled Trials ISRCTN91947481. PMID:26559241

Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the alliance study.

PubMed

Koren, Michael J; Hunninghake, Donald B

2004-11-02

This study sought to determine if an aggressive, focused low-density lipoprotein cholesterol (LDL-C)-lowering strategy was superior to usual care for coronary heart disease (CHD) patients enrolled in health maintenance organization or Veterans Administration settings. Statin therapy benefits are well established. No prospective, randomized studies have tested strategies to optimize these benefits in a "real-world" setting. A total of 2,442 CHD patients with hyperlipidemia were randomized to either an aggressive treatment arm using atorvastatin or usual care and followed for 51.5 months on average. Atorvastatin-group patients were titrated to LDL-C goals of <80 mg/dl (2.1 mmol/l) or a maximum atorvastatin dose of 80 mg/day. Usual-care patients received any treatment deemed appropriate by their regular physicians. End point assessments were complete in 958 atorvastatin-group and 941 usual-care patients. Partial assessments occurred in 259 patients in the atorvastatin group and 284 patients in the usual care group who did not complete four years of study participation because of adverse events, withdrawn consent, or follow-up loss. The primary efficacy parameter was time to first cardiovascular event. A total of 289 (23.7%) patients in the atorvastatin group compared with 333 (27.7%) patients in the usual care group experienced a primary outcome (hazard ratio, 0.83; 95% confidence interval 0.71 to 0.97, p = 0.02). This reduction in morbidity was largely due to fewer non-fatal myocardial infarctions (4.3% vs. 7.7%, p = 0.0002). Levels of LDL-C were reduced more (34.3% vs. 23.3%, p < 0.0001) and National Cholesterol Education Program goals (LDL-C <100 mg/dl) more likely met at end-of-study visits (72.4% vs. 40.0%) in patients receiving atorvastatin compared with those receiving usual care. An aggressive, focused statin therapy management strategy outperformed usual care in health maintenance organization and Veterans Administration clinic patients with CHD.

Cost-effectiveness of cognitive-behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: economic evaluation of the CoBalT Trial.

PubMed

Hollinghurst, Sandra; Carroll, Fran E; Abel, Anna; Campbell, John; Garland, Anne; Jerrom, Bill; Kessler, David; Kuyken, Willem; Morrison, Jill; Ridgway, Nicola; Thomas, Laura; Turner, Katrina; Williams, Chris; Peters, Tim J; Lewis, Glyn; Wiles, Nicola

2014-01-01

Depression is expensive to treat, but providing ineffective treatment is more expensive. Such is the case for many patients who do not respond to antidepressant medication. To assess the cost-effectiveness of cognitive-behavioural therapy (CBT) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone. Economic evaluation at 12 months alongside a randomised controlled trial. Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider, patients and society, with a range of outcomes. Cost-utility analysis comparing health and social care costs with quality-adjusted life-years (QALYs). The mean cost of CBT per participant was £910. The difference in QALY gain between the groups was 0.057, equivalent to 21 days a year of good health. The incremental cost-effectiveness ratio was £14 911 (representing a 74% probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of £20 000 per QALY). Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups. The addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants. Primary care physicians should therefore be encouraged to refer such individuals for CBT.

Physicians, the Affordable Care Act, and primary care: disruptive change or business as usual?

PubMed

Jacobson, Peter D; Jazowski, Shelley A

2011-08-01

The Patient Protection and Affordable Care Act 1 (ACA) presages disruptive change in primary care delivery. With expanded access to primary care for millions of new patients, physicians and policymakers face increased pressure to solve the perennial shortage of primary care practitioners. Despite the controversy surrounding its enactment, the ACA should motivate organized medicine to take the lead in shaping new strategies for meeting the nation's primary care needs. In this commentary, we argue that physicians should take the lead in developing policies to address the primary care shortage. First, physicians and medical professional organizations should abandon their long-standing opposition to non-physician practitioners (NPPs) as primary care providers. Second, physicians should re-imagine how primary care is delivered, including shifting routine care to NPPs while retaining responsibility for complex patients and oversight of the new primary care arrangements. Third, the ACA's focus on wellness and prevention creates opportunities for physicians to integrate population health into primary care practice.

Effectiveness of certified diabetes educators following pre-approved protocols to redesign diabetes care delivery in primary care: Results of the REMEDIES 4D trial.

PubMed

Zgibor, Janice C; Maloney, Maura A; Malmi, Markku; Fabio, Anthony; Kuo, Shihchen; Solano, Francis X; Tilves, Debra; Tu, Lichuan; Davidson, Mayer B

2018-01-01

To evaluate changes in HbA1c, blood pressure, and LDLc levels in participants from practices where certified diabetes educators (CDEs) implemented standardized protocols to intensify treatment compared with those receiving usual care. This clustered, randomized, clinical trial was implemented in community-based primary care practices. Fifteen primary care practices and 240 patients with type 2 diabetes were randomized to the intervention (n=175) or usual care (n=65). Participants had uncontrolled HbA1c, blood pressure, or LDLc. The one-year intervention included CDEs implementing pre-approved protocols to intensify treatment. Diabetes self-management education was also provided in both study groups. The population was 50.8% male with a mean age of 61years. The HbA1c in the intervention group decreased from 8.8% to 7.8%, (p=0.001) while the HbA1c in the usual care group increased slightly from 8.2% to 8.3%. There was also a significant difference in HbA1c between the two groups (p=0.004). There was not a significant difference between groups for systolic blood pressure (SBP) or LDLc at the end of the intervention. Those in the intervention group were more likely to have glucose-lowering medications intensified and were more likely to have their HbA1c (35% vs 15%), SBP (80% vs 77%) and HbA1c, SBP, and LDLc at goal (11% vs 1.5%) compared with the usual care group. There was no significant difference in intensification of blood pressure or cholesterol medication. Findings suggest that CDEs following standardized protocols in primary care is feasible and can effectively intensify treatment and improve glycemic control. Copyright © 2017 Elsevier Inc. All rights reserved.

Increasing the Screening and Counseling of Adolescents for Risky Health Behaviors: A Primary Care Intervention

ERIC Educational Resources Information Center

Ozer, Elizabeth M.; Adams, Sally H.; Lustig, Julie L.; Gee, Scott; Garber, Andrea K.; Gardner, Linda Rieder; Rehbein, Michael; Addison, Louise; Irwin, Charles E., Jr.

2005-01-01

Objective: To determine whether a systems intervention for primary care providers resulted in increased preventive screening and counseling of adolescent patients, compared with the usual standard of care. Methods: The intervention was conducted in 2 out-patient pediatric clinics; 2 other pediatric clinics in the same health maintenance…

Integrated collaborative care for major depression comorbid with a poor prognosis cancer (SMaRT Oncology-3): a multicentre randomised controlled trial in patients with lung cancer.

PubMed

Walker, Jane; Hansen, Christian Holm; Martin, Paul; Symeonides, Stefan; Gourley, Charlie; Wall, Lucy; Weller, David; Murray, Gordon; Sharpe, Michael

2014-09-01

The management of depression in patients with poor prognosis cancers, such as lung cancer, creates specific challenges. We aimed to assess the efficacy of an integrated treatment programme for major depression in patients with lung cancer compared with usual care. Symptom Management Research Trials (SMaRT) Oncology-3 is a parallel-group, multicentre, randomised controlled trial. We enrolled patients with lung cancer and major depression from three cancer centres and their associated clinics in Scotland, UK. Participants were randomly assigned in a 1:1 ratio to the depression care for people with lung cancer treatment programme or usual care by a database software algorithm that used stratification (by trial centre) and minimisation (by age, sex, and cancer type) with allocation concealment. Depression care for people with lung cancer is a manualised, multicomponent collaborative care treatment that is systematically delivered by a team of cancer nurses and psychiatrists in collaboration with primary care physicians. Usual care is provided by primary care physicians. The primary outcome was depression severity (on the Symptom Checklist Depression Scale [SCL-20], range 0-4) averaged over the patient's time in the trial (up to a maximum of 32 weeks). Trial statisticians and data collection staff were masked to treatment allocation, but patients and clinicians could not be masked to the allocations. Analyses were by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN75905964. 142 participants were recruited between Jan 5, 2009, and Sept 9, 2011; 68 were randomly allocated to depression care for people with lung cancer and 74 to usual care. 43 (30%) of 142 patients had died by 32 weeks, all of which were cancer-related deaths. No intervention-related serious adverse events occurred. 131 (92%) of 142 patients provided outcome data (59 in the depression care for people with lung cancer group and 72 in the usual care group) and were included in the intention-to-treat primary analysis. Average depression severity was significantly lower in patients allocated to depression care for people with lung cancer (mean score on the SCL-20 1·24 [SD 0·64]) than in those allocated to usual care (mean score 1·61 [SD 0·58]); difference -0·38 (95% CI -0·58 to -0·18); standardised mean difference -0·62 (95% CI -0·94 to -0·29). Self-rated depression improvement, anxiety, quality of life, role functioning, perceived quality of care, and proportion of patients achieving a 12-week treatment response were also significantly better in the depression care for people with lung cancer group than in the usual care group. Our findings suggest that major depression can be treated effectively in patients with a poor prognosis cancer; integrated depression care for people with lung cancer was substantially more efficacious than was usual care. Larger trials are now needed to estimate the effectiveness and cost-effectiveness of this care programme in this patient population, and further adaptation of the treatment will be necessary to address the unmet needs of patients with major depression and even shorter life expectancy. Cancer Research UK and Chief Scientist Office of the Scottish Government. Copyright © 2014 Elsevier Ltd. All rights reserved.

Outcomes of patients discharged from pharmacy-managed cardiovascular disease management.

PubMed

Olson, Kari L; Delate, Thomas; Rasmussen, Jon; Humphries, Tammy L; Merenich, John A

2009-08-01

To evaluate whether patients with coronary artery disease (CAD) discharged from the Clinical Pharmacy Cardiac Risk Service (CPCRS) would maintain their lipid goals with use of an electronic laboratory reminder system. A 2-year, randomized study at Kaiser Permanente Colorado. Patients with prior CAD (acute myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention) who had been enrolled in the CPCRS for at least 1 year and who had 2 consecutive low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol, and blood pressure readings at goal within 6 months before enrollment were randomized to remain in the CPCRS (CPCRS care) or to receive usual care from primary care physicians plus laboratory reminder letters (usual care). The primary outcome was maintenance of LDL-C goal at study end. The t test and chi(2) test of association were used to assess differences in mean and categorical values, respectively. A total of 421 patients (214 CPCRS care, 207 usual care) were randomized. Their mean age was 72 years; 74% were male. After 1.7 years of follow-up, the proportions of patients maintaining their LDL-C goal of <100 mg/dL were 91% and 93.1% in the CPCRS care and usual care groups, respectively (P = .46). The proportions maintaining their LDL-C goal of <70 mg/dL were 68.6% and 56.8% in the CPCRS care and usual care groups, respectively (P = .23). This study demonstrated that LDL-C measures can remain controlled in most patients discharged from a cardiac disease management program.

Early rehabilitation after total knee replacement surgery: a multicenter, noninferiority, randomized clinical trial comparing a home exercise program with usual outpatient care.

PubMed

Han, Annie S Y; Nairn, Lillias; Harmer, Alison R; Crosbie, Jack; March, Lyn; Parker, David; Crawford, Ross; Fransen, Marlene

2015-02-01

To determine, at 6 weeks postsurgery, if a monitored home exercise program (HEP) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement (TKR) surgery for osteoarthritis. We conducted a multicenter, randomized clinical trial. Patients ages 45-75 years were allocated at the time of hospital discharge to usual care rehabilitation (n = 196) or the HEP (n = 194). Outcomes assessed 6 weeks after surgery included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales, knee range of motion, and the 50-foot walk time. The upper bound of the 95% confidence interval (95% CI) mean difference favoring usual care was used to determine noninferiority. At 6 weeks after surgery there were no significant differences between usual care and HEP, respectively, for pain (7.4 and 7.2; 95% CI mean difference [MD] -0.7, 0.9), physical function (22.5 and 22.4; 95% CI MD -2.5, 2.6), knee flexion (96° and 97°; 95% CI MD -4°, 2°), knee extension (-7° and -6°; 95% CI MD -2°, 1°), or the 50-foot walk time (12.9 and 12.9 seconds; 95% CI MD -0.8, 0.7 seconds). At 6 weeks, 18 patients (9%) allocated to usual care and 11 (6%) to the HEP did not achieve 80° knee flexion. There was no difference between the treatment allocations in the number of hospital readmissions. The HEP was not inferior to usual care as an early rehabilitation protocol after primary TKR. Copyright © 2015 by the American College of Rheumatology.

Cost-effectiveness of computerized cognitive-behavioural therapy for the treatment of depression in primary care: findings from the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial.

PubMed

Duarte, A; Walker, S; Littlewood, E; Brabyn, S; Hewitt, C; Gilbody, S; Palmer, S

2017-07-01

Computerized cognitive-behavioural therapy (cCBT) forms a core component of stepped psychological care for depression. Existing evidence for cCBT has been informed by developer-led trials. This is the first study based on a large independent pragmatic trial to assess the cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care compared with usual GP care alone and to establish the differential cost-effectiveness of a free-to-use cCBT programme (MoodGYM) in comparison with a commercial programme (Beating the Blues) in primary care. Costs were estimated from a healthcare perspective and outcomes measured using quality-adjusted life years (QALYs) over 2 years. The incremental cost-effectiveness of each cCBT programme was compared with usual GP care. Uncertainty was estimated using probabilistic sensitivity analysis and scenario analyses were performed to assess the robustness of results. Neither cCBT programme was found to be cost-effective compared with usual GP care alone. At a £20 000 per QALY threshold, usual GP care alone had the highest probability of being cost-effective (0.55) followed by MoodGYM (0.42) and Beating the Blues (0.04). Usual GP care alone was also the cost-effective intervention in the majority of scenario analyses. However, the magnitude of the differences in costs and QALYs between all groups appeared minor (and non-significant). Technically supported cCBT programmes do not appear any more cost-effective than usual GP care alone. No cost-effective advantage of the commercially developed cCBT programme was evident compared with the free-to-use cCBT programme. Current UK practice recommendations for cCBT may need to be reconsidered in the light of the results.

Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial.

PubMed

McManus, Richard J; Mant, Jonathan; Franssen, Marloes; Nickless, Alecia; Schwartz, Claire; Hodgkinson, James; Bradburn, Peter; Farmer, Andrew; Grant, Sabrina; Greenfield, Sheila M; Heneghan, Carl; Jowett, Susan; Martin, Una; Milner, Siobhan; Monahan, Mark; Mort, Sam; Ogburn, Emma; Perera-Salazar, Rafael; Shah, Syed Ahmar; Yu, Ly-Mee; Tarassenko, Lionel; Hobbs, F D Richard

2018-03-10

Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care. This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366. 1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, -3·5 mm Hg [95% CI -5·8 to -1·2]; telemonitoring, -4·7 mm Hg [-7·0 to -2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference -1·2 mm Hg [95% CI -3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups. Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care. National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Centrally Assisted Collaborative Telecare for Posttraumatic Stress Disorder and Depression Among Military Personnel Attending Primary Care: A Randomized Clinical Trial.

PubMed

Engel, Charles C; Jaycox, Lisa H; Freed, Michael C; Bray, Robert M; Brambilla, Donald; Zatzick, Douglas; Litz, Brett; Tanielian, Terri; Novak, Laura A; Lane, Marian E; Belsher, Bradley E; Olmsted, Kristine L Rae; Evatt, Daniel P; Vandermaas-Peeler, Russ; Unützer, Jürgen; Katon, Wayne J

2016-07-01

It is often difficult for members of the US military to access high-quality care for posttraumatic stress disorder (PTSD) and depression. To determine effectiveness of a centrally assisted collaborative telecare (CACT) intervention for PTSD and depression in military primary care. The STEPS-UP study (Stepped Enhancement of PTSD Services Using Primary Care) is a randomized trial comparing CACT with usual integrated mental health care for PTSD or depression. Patients, mostly men in their 20s, were enrolled from 18 primary care clinics at 6 military installations from February 2012 to August 2013 with 12-month follow-up completed in October 2014. Randomization was to CACT (n = 332) or usual care (n = 334). The CACT patients received 12 months of stepped psychosocial and pharmacologic treatment with nurse telecare management of caseloads, symptoms, and treatment. Primary outcomes were severity scores on the PTSD Diagnostic Scale (PDS; scored 0-51) and Symptom Checklist depression items (SCL-20; scored 0-4). Secondary outcomes were somatic symptoms, pain severity, health-related function, and mental health service use. Of 666 patients, 81% were male and the mean (SD) age was 31.1 (7.7) years. The CACT and usual care patients had similar baseline mean (SD) PDS PTSD (29.4 [9.4] vs 28.9 [8.9]) and SCL-20 depression (2.1 [0.6] vs 2.0 [0.7]) scores. Compared with usual care, CACT patients reported significantly greater mean (SE) 12-month decrease in PDS PTSD scores (-6.07 [0.68] vs -3.54 [0.72]) and SCL-20 depression scores -0.56 [0.05] vs -0.31 [0.05]). In the CACT group, significantly more participants had 50% improvement at 12 months compared with usual care for both PTSD (73 [25%] vs 49 [17%]; relative risk, 1.6 [95% CI, 1.1-2.4]) and depression (86 [30%] vs 59 [21%]; relative risk, 1.7 [95% CI, 1.1-2.4]), with a number needed to treat for a 50% improvement of 12.5 (95% CI, 6.9-71.9) and 11.1 (95% CI, 6.2-50.5), respectively. The CACT patients had significant improvements in somatic symptoms (difference between mean 12-month Patient Health Questionnaire 15 changes, -1.37 [95% CI, -2.26 to -0.47]) and mental health-related functioning (difference between mean 12-month Short Form-12 Mental Component Summary changes, 3.17 [95% CI, 0.91 to 5.42]), as well as increases in telephone health contacts and appropriate medication use. Central assistance for collaborative telecare with stepped psychosocial management modestly improved outcomes of PTSD and depression among military personnel attending primary care. clinicaltrials.gov Identifier: NCT01492348.

Effectiveness of collaborative stepped care for anxiety disorders in primary care: a pragmatic cluster randomised controlled trial.

PubMed

Muntingh, Anna; van der Feltz-Cornelis, Christina; van Marwijk, Harm; Spinhoven, Philip; Assendelft, Willem; de Waal, Margot; Adèr, Herman; van Balkom, Anton

2014-01-01

Collaborative stepped care (CSC) may be an appropriate model to provide evidence-based treatment for anxiety disorders in primary care. In a cluster randomised controlled trial, the effectiveness of CSC compared to care as usual (CAU) for adults with panic disorder (PD) or generalised anxiety disorder (GAD) in primary care was evaluated. Thirty-one psychiatric nurses who provided their services to 43 primary care practices in the Netherlands were randomised to deliver CSC (16 psychiatric nurses, 23 practices) or CAU (15 psychiatric nurses, 20 practices). CSC was provided by the psychiatric nurses (care managers) in collaboration with the general practitioner and a consultant psychiatrist. The intervention consisted of 3 steps, namely guided self-help, cognitive behavioural therapy and antidepressants. Anxiety symptoms were measured with the Beck Anxiety Inventory (BAI) at baseline and after 3, 6, 9 and 12 months. We recruited 180 patients with a DSM-IV diagnosis of PD or GAD, of whom 114 received CSC and 66 received usual primary care. On the BAI, CSC was superior to CAU [difference in gain scores from baseline to 3 months: -5.11, 95% confidence interval (CI) -8.28 to -1.94; 6 months: -4.65, 95% CI -7.93 to -1.38; 9 months: -5.67, 95% CI -8.97 to -2.36; 12 months: -6.84, 95% CI -10.13 to -3.55]. CSC, with guided self-help as a first step, was more effective than CAU for primary care patients with PD or GAD.

Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial.

PubMed

Wiles, Nicola; Thomas, Laura; Abel, Anna; Ridgway, Nicola; Turner, Nicholas; Campbell, John; Garland, Anne; Hollinghurst, Sandra; Jerrom, Bill; Kessler, David; Kuyken, Willem; Morrison, Jill; Turner, Katrina; Williams, Chris; Peters, Tim; Lewis, Glyn

2013-02-02

Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone. This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611. Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001). Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population. National Institute for Health Research Health Technology Assessment. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial.

PubMed

Richards, David A; Bower, Peter; Chew-Graham, Carolyn; Gask, Linda; Lovell, Karina; Cape, John; Pilling, Stephen; Araya, Ricardo; Kessler, David; Barkham, Michael; Bland, J Martin; Gilbody, Simon; Green, Colin; Lewis, Glyn; Manning, Chris; Kontopantelis, Evangelos; Hill, Jacqueline J; Hughes-Morley, Adwoa; Russell, Abigail

2016-02-01

Collaborative care is effective for depression management in the USA. There is little UK evidence on its clinical effectiveness and cost-effectiveness. To determine the clinical effectiveness and cost-effectiveness of collaborative care compared with usual care in the management of patients with moderate to severe depression. Cluster randomised controlled trial. UK primary care practices (n = 51) in three UK primary care districts. A total of 581 adults aged ≥ 18 years in general practice with a current International Classification of Diseases, Tenth Edition depressive episode, excluding acutely suicidal people, those with psychosis, bipolar disorder or low mood associated with bereavement, those whose primary presentation was substance abuse and those receiving psychological treatment. Collaborative care: 14 weeks of 6-12 telephone contacts by care managers; mental health specialist supervision, including depression education, medication management, behavioural activation, relapse prevention and primary care liaison. Usual care was general practitioner standard practice. Blinded researchers collected depression [Patient Health Questionnaire-9 (PHQ-9)], anxiety (General Anxiety Disorder-7) and quality of life (European Quality of Life-5 Dimensions three-level version), Short Form questionnaire-36 items) outcomes at 4, 12 and 36 months, satisfaction (Client Satisfaction Questionnaire-8) outcomes at 4 months and treatment and service use costs at 12 months. In total, 276 and 305 participants were randomised to collaborative care and usual care respectively. Collaborative care participants had a mean depression score that was 1.33 PHQ-9 points lower [n = 230; 95% confidence interval (CI) 0.35 to 2.31; p = 0.009] than that of participants in usual care at 4 months and 1.36 PHQ-9 points lower (n = 275; 95% CI 0.07 to 2.64; p = 0.04) at 12 months after adjustment for baseline depression (effect size 0.28, 95% CI 0.01 to 0.52; odds ratio for recovery 1.88, 95% CI 1.28 to 2.75; number needed to treat 6.5). Quality of mental health but not physical health was significantly better for collaborative care at 4 months but not at 12 months. There was no difference for anxiety. Participants receiving collaborative care were significantly more satisfied with treatment. Differences between groups had disappeared at 36 months. Collaborative care had a mean cost of £272.50 per participant with similar health and social care service use between collaborative care and usual care. Collaborative care offered a mean incremental gain of 0.02 (95% CI -0.02 to 0.06) quality-adjusted life-years (QALYs) over 12 months at a mean incremental cost of £270.72 (95% CI -£202.98 to £886.04) and had an estimated mean cost per QALY of £14,248, which is below current UK willingness-to-pay thresholds. Sensitivity analyses including informal care costs indicated that collaborative care is expected to be less costly and more effective. The amount of participant behavioural activation was the only effect mediator. Collaborative care improves depression up to 12 months after initiation of the intervention, is preferred by patients over usual care, offers health gains at a relatively low cost, is cost-effective compared with usual care and is mediated by patient activation. Supervision was by expert clinicians and of short duration and more intensive therapy may have improved outcomes. In addition, one participant requiring inpatient treatment incurred very significant costs and substantially inflated our cost per QALY estimate. Future work should test enhanced intervention content not collaborative care per se. Current Controlled Trials ISRCTN32829227. This project was funded by the Medical Research Council (MRC) (G0701013) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.

Dissemination of Cognitive Therapy for Panic Disorder in Primary Care

PubMed Central

Grey, Nick; Salkovskis, Paul; Quigley, Alexandra; Clark, David M.; Ehlers, Anke

2011-01-01

This study investigated whether brief training in cognitive therapy for panic disorder (Clark et al., 1994) can improve the outcomes that primary care therapists obtain with their patients. Seven primary care therapists treated 36 patients meeting DSM-IV (APA, 1994) criteria for panic disorder with or without agoraphobia in general practice surgeries. Outcomes for the cohort of patients whom the therapists treated with their usual methods (treatment-as-usual) before the training (N = 12) were compared with those obtained with similar patients treated by the same therapists after brief training and ongoing supervision in cognitive therapy (CT) for panic disorder (N = 24). Treatment-as-usual led to significant improvements in panic severity, general anxiety, and depression. However, only a small proportion (17% of the intent-to-treat sample) became panic free and there was no improvement in agoraphobic avoidance. Patients treated with CT achieved significantly better outcomes on all measures of panic attacks, including panic-free rate (54%, intent-to-treat), and showed significantly greater improvements in agoraphobic avoidance and patient-rated general anxiety. In conclusion, cognitive therapy for panic disorder can be successfully disseminated in primary care with a brief therapist training and supervision programme that leads to significant improvements in patient outcomes. PMID:22661906

Implementing collaborative primary care for depression and posttraumatic stress disorder: design and sample for a randomized trial in the U.S. military health system.

PubMed

Engel, Charles C; Bray, Robert M; Jaycox, Lisa H; Freed, Michael C; Zatzick, Doug; Lane, Marian E; Brambilla, Donald; Rae Olmsted, Kristine; Vandermaas-Peeler, Russ; Litz, Brett; Tanielian, Terri; Belsher, Bradley E; Evatt, Daniel P; Novak, Laura A; Unützer, Jürgen; Katon, Wayne J

2014-11-01

War-related trauma, posttraumatic stress disorder (PTSD), depression and suicide are common in US military members. Often, those affected do not seek treatment due to stigma and barriers to care. When care is sought, it often fails to meet quality standards. A randomized trial is assessing whether collaborative primary care improves quality and outcomes of PTSD and depression care in the US military health system. The aim of this study is to describe the design and sample for a randomized effectiveness trial of collaborative care for PTSD and depression in military members attending primary care. The STEPS-UP Trial (STepped Enhancement of PTSD Services Using Primary Care) is a 6 installation (18 clinic) randomized effectiveness trial in the US military health system. Study rationale, design, enrollment and sample characteristics are summarized. Military members attending primary care with suspected PTSD, depression or both were referred to care management and recruited for the trial (2592), and 1041 gave permission to contact for research participation. Of those, 666 (64%) met eligibility criteria, completed baseline assessments, and were randomized to 12 months of usual collaborative primary care versus STEPS-UP collaborative care. Implementation was locally managed for usual collaborative care and centrally managed for STEPS-UP. Research reassessments occurred at 3-, 6-, and 12-months. Baseline characteristics were similar across the two intervention groups. STEPS-UP will be the first large scale randomized effectiveness trial completed in the US military health system, assessing how an implementation model affects collaborative care impact on mental health outcomes. It promises lessons for health system change. Copyright © 2014 Elsevier Inc. All rights reserved.

Reducing Clinical Inertia in Hypertension Treatment: a Pragmatic Randomized Controlled Trial

PubMed Central

Huebschmann, Amy G.; Mizrahi, Trina; Soenksen, Alyssa; Beaty, Brenda L.; Denberg, Thomas D.

2012-01-01

Clinical inertia is a major contributor to poor blood pressure (BP) control. We tested the effectiveness of an intervention targeting physician, patient, and office system factors with regard to outcomes of clinical inertia and BP control. We randomized 591 adult primary care patients with elevated BP (mean systolic BP ≥140 or mean diastolic BP ≥90 mm Hg) to intervention or usual care. An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused primary care clinic visits, and furnished providers with treatment decision support. The intervention reduced clinical inertia (−29% vs. −11%, p=0.001). Nonetheless, ΔBP did not differ between intervention and usual care (−10.1/−4.1 vs. −9.1/−4.5 mm Hg, p = 0.50 and 0.71 for systolic and diastolic BP, respectively). Future primary care-focused interventions might benefit from the use of specific medication titration protocols, treatment adherence support, and more sustained patient follow-up visits. PMID:22533659

Cost-Effectiveness Analysis: Risk Stratification of Nonalcoholic Fatty Liver Disease (NAFLD) by the Primary Care Physician Using the NAFLD Fibrosis Score.

PubMed

Tapper, Elliot B; Hunink, M G Myriam; Afdhal, Nezam H; Lai, Michelle; Sengupta, Neil

2016-01-01

The complications of Nonalcoholic Fatty Liver Disease (NAFLD) are dependent on the presence of advanced fibrosis. Given the high prevalence of NAFLD in the US, the optimal evaluation of NAFLD likely involves triage by a primary care physician (PCP) with advanced disease managed by gastroenterologists. We compared the cost-effectiveness of fibrosis risk-assessment strategies in a cohort of 10,000 simulated American patients with NAFLD performed in either PCP or referral clinics using a decision analytical microsimulation state-transition model. The strategies included use of vibration-controlled transient elastography (VCTE), the NAFLD fibrosis score (NFS), combination testing with NFS and VCTE, and liver biopsy (usual care by a specialist only). NFS and VCTE performance was obtained from a prospective cohort of 164 patients with NAFLD. Outcomes included cost per quality adjusted life year (QALY) and correct classification of fibrosis. Risk-stratification by the PCP using the NFS alone costs $5,985 per QALY while usual care costs $7,229/QALY. In the microsimulation, at a willingness-to-pay threshold of $100,000, the NFS alone in PCP clinic was the most cost-effective strategy in 94.2% of samples, followed by combination NFS/VCTE in the PCP clinic (5.6%) and usual care in 0.2%. The NFS based strategies yield the best biopsy-correct classification ratios (3.5) while the NFS/VCTE and usual care strategies yield more correct-classifications of advanced fibrosis at the cost of 3 and 37 additional biopsies per classification. Risk-stratification of patients with NAFLD primary care clinic is a cost-effective strategy that should be formally explored in clinical practice.

Early detection versus primary prevention in the PLCO flexible sigmoidoscopy screening trial: Which has the greatest impact on mortality?

PubMed

Doroudi, Maryam; Schoen, Robert E; Pinsky, Paul F

2017-12-15

Screening for colorectal cancer (CRC) with flexible sigmoidoscopy (FS) has been shown to reduce CRC mortality. The current study examined whether the observed mortality reduction was due primarily to the prevention of incident CRC via removal of adenomatous polyps or to the early detection of cancer and improved survival. The Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial randomized 154,900 men and women aged 55 to 74 years. Individuals underwent FS screening at baseline and at 3 or 5 years versus usual care. CRC-specific survival was analyzed using Kaplan-Meier curves and proportional hazards modeling. The authors estimated the percentage of CRC deaths averted by early detection versus primary prevention using a model that applied intervention arm survival rates to CRC cases in the usual-care arm and vice versa. A total of 1008 cases of CRC in the intervention arm and 1291 cases of CRC in the usual-care arm were observed. Through 13 years of follow-up, there was no significant difference noted between the trial arms with regard to CRC-specific survival for all CRC (68% in the intervention arm vs 65% in the usual-care arm; P =.16) or proximal CRC (68% vs 62%, respectively; P = .11) cases; however, survival in distal CRC cases was found to be higher in the intervention arm compared with the usual-care arm (77% vs 66%; P<.0001). Within each arm, symptom-detected cases had significantly worse survival compared with screen-detected cases. Overall, approximately 29% to 35% of averted CRC deaths were estimated to be due to early detection and 65% to 71% were estimated to be due to primary prevention. CRC-specific survival was similar across arms in the PLCO trial, suggesting a limited role for early detection in preventing CRC deaths. Modeling suggested that approximately two-thirds of avoided deaths were due to primary prevention. Future CRC screening guidelines should emphasize primary prevention via the identification and removal of precursor lesions. Cancer 2017;123:4815-22. © 2017 American Cancer Society. © 2017 American Cancer Society.

Evaluating and Managing Acute Low Back Pain in the Primary Care Setting

PubMed Central

Atlas, Steven J; Deyo, Richard A

2001-01-01

Acute low back pain is a common reason for patient calls or visits to a primary care clinician. Despite a large differential diagnosis, the precise etiology is rarely identified, although musculoligamentous processes are usually suspected. For most patients, back symptoms are nonspecific, meaning that there is no evidence for radicular symptoms or underlying systemic disease. Because episodes of acute, nonspecific low back pain are usually self-limited, many patients treat themselves without contacting their primary care clinician. When patients do call or schedule a visit, evaluation and management by primary care clinicians is appropriate. The history and physical examination usually provide clues to the rare but potentially serious causes of low back pain, as well as to identify patients at risk for prolonged recovery. Diagnostic testing, including plain x-rays, is often unnecessary during the initial evaluation. For patients with acute, nonspecific low back pain, the primary emphasis of treatment should be conservative care, time, reassurance, and education. Current recommendations focus on activity as tolerated (though not active exercise while pain is severe) and minimal if any bed rest. Referral for physical treatments is most appropriate for patients whose symptoms are not improving over 2 to 4 weeks. Specialty referral should be considered for patients with a progressive neurologic deficit, failure of conservative therapy, or an uncertain or serious diagnosis. The prognosis for most patients is good, although recurrence is common. Thus, educating patients about the natural history of acute low back pain and how to prevent future episodes can help ensure reasonable expectations. PMID:11251764

Associations of family characteristics with perceptions of care among parents of children with autism.

PubMed

Sobotka, S A; Francis, A; Vander Ploeg Booth, K

2016-01-01

Although autism spectrum disorder (ASD) is an increasingly common chronic disability, primary care provider (PCPs) report deficits in providing primary care for children with ASD, and parents report lapses in receipt of medical home services. In this study, we describe parental experiences with specific medical home components for their children with ASD. We analysed data from all children within the National Survey of Children with Special Health Care Needs database with ASD and a usual place for care (n = 2859). We evaluated the receipt of core medical home components: accessible, comprehensive, coordinated, family centred and compassionate and culturally sensitive care. Children were mean age 10.1 years, and respondents were 75% mothers and 95% reported having a primary care provider (PCP). Seventy-one percent reported care to be usually comprehensive, over three-fourths of respondents reported care to be family centred and compassionate and 87% reported care to be culturally sensitive. Of the parents who reported a need for care coordination (n = 1049), only 14% of parents reported usually getting the help they needed. More educated, English-speaking, non-Hispanic White mothers of older children supported by private insurance were more likely to report never getting as much help coordinating care as desired. Coordination with education services are especially important for children with ASD, yet 27% of parents reported dissatisfaction with PCPs' communication with schools or early intervention. Although parents report a high level of access to PCPs and places for care as well as receiving most core components of the medical home, care coordination activities are lacking for children with ASD. More resourced families are particularly likely to report unmet needs. © 2015 John Wiley & Sons Ltd.

Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack)

PubMed Central

Geraghty, Adam W A; Stanford, Rosie; Stuart, Beth; Little, Paul; Roberts, Lisa C; Foster, Nadine E; Hill, Jonathan C; Hay, Elaine M; Turner, David; Malakan, Wansida; Leigh, Linda; Yardley, Lucy

2018-01-01

Objective To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. Design and setting A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. Participants Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness. Interventions The ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance. Outcomes The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up. Results Primary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%. Conclusions This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP. Trial registration number ISRCTN31034004; Results. PMID:29525768

Cost-effectiveness analysis of a collaborative care programme for depression in primary care.

PubMed

Aragonès, Enric; López-Cortacans, Germán; Sánchez-Iriso, Eduardo; Piñol, Josep-Lluís; Caballero, Antonia; Salvador-Carulla, Luis; Cabasés, Juan

2014-04-01

Collaborative care programmes lead to better outcomes in the management of depression. A programme of this nature has demonstrated its effectiveness in primary care in Spain. Our objective was to evaluate the cost-effectiveness of this programme compared to usual care. A bottom-up cost-effectiveness analysis was conducted within a randomized controlled trial (2007-2010). The intervention consisted of a collaborative care programme with clinical, educational and organizational procedures. Outcomes were monitored over a 12 months period. Primary outcomes were incremental cost-effectiveness ratios (ICER): mean differences in costs divided by quality-adjusted life years (QALY) and mean differences in costs divided by depression-free days (DFD). Analyses were performed from a healthcare system perspective (considering healthcare costs) and from a society perspective (including healthcare costs plus loss of productivity costs). Three hundred and thirty-eight adult patients with major depression were assessed at baseline. Only patients with complete data were included in the primary analysis (166 in the intervention group and 126 in the control group). From a healthcare perspective, the average incremental cost of the programme compared to usual care was €182.53 (p<0.001). Incremental effectiveness was 0.045 QALY (p=0.017) and 40.09 DFD (p=0.011). ICERs were €4,056/QALY and €4.55/DFD. These estimates and their uncertainty are graphically represented in the cost-effectiveness plane. The amount of 13.6% of patients with incomplete data may have introduced a bias. Available data about non-healthcare costs were limited, although they may represent most of the total cost of depression. The intervention yields better outcomes than usual care with a modest increase in costs, resulting in favourable ICERs. This supports the recommendation for its implementation. Copyright © 2014 Elsevier B.V. All rights reserved.

Reducing suicidal ideation and depressive symptoms in depressed older primary care patients: a randomized controlled trial.

PubMed

Bruce, Martha L; Ten Have, Thomas R; Reynolds, Charles F; Katz, Ira I; Schulberg, Herbert C; Mulsant, Benoit H; Brown, Gregory K; McAvay, Gail J; Pearson, Jane L; Alexopoulos, George S

2004-03-03

Suicide rates are highest in late life; the majority of older adults who die by suicide have seen a primary care physician in preceding months. Depression is the strongest risk factor for late-life suicide and for suicide's precursor, suicidal ideation. To determine the effect of a primary care intervention on suicidal ideation and depression in older patients. Randomized controlled trial known as PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 20 primary care practices in New York City, Philadelphia, and Pittsburgh regions, May 1999 through August 2001. Two-stage, age-stratified (60-74, > or =75 years) depression screening of randomly sampled patients; enrollment included patients who screened positive and a random sample of screened negative patients. This analysis included patients with a depression diagnosis (N = 598). Treatment guidelines tailored for the elderly with care management compared with usual care. Assessment of suicidal ideation and depression severity at baseline, 4 months, 8 months, and 12 months. Rates of suicidal ideation declined faster (P =.01) in intervention patients compared with usual care patients; at 4 months, in the intervention group, raw rates of suicidal ideation declined 12.9% points (29.4% to 16.5%) compared with 3.0% points (20.1% to 17.1% in usual care [P =.01]). Among patients reporting suicidal ideation, resolution of ideation was faster among intervention patients (P =.03); differences peaked at 8 months (70.7% vs 43.9% resolution; P =.005). Intervention patients had a more favorable course of depression in both degree and speed of symptom reduction; group difference peaked at 4 months. The effects on depression were not significant among patients with minor depression unless suicidal ideation was present. Evidence of the intervention's effectiveness in community-based primary care with a heterogeneous sample of depressed patients introduces new challenges related to its sustainability and dissemination. The intervention's effectiveness in reducing suicidal ideation, regardless of depression severity, reinforces its role as a prevention strategy to reduce risk factors for suicide in late life.

Cost-effectiveness of a transitional pharmaceutical care program for patients discharged from the hospital

PubMed Central

van der Knaap, Ronald; Bouhannouch, Fatiha; Borgsteede, Sander D.; Janssen, Marjo J. A.; Siegert, Carl E. H.; Egberts, Toine C. G.; van den Bemt, Patricia M. L. A.; van Wier, Marieke F.; Bosmans, Judith E.

2017-01-01

Background To improve continuity of care at hospital admission and discharge and to decrease medication errors pharmaceutical care programs are developed. This study aims to determine the cost-effectiveness of the COACH program in comparison with usual care from a societal perspective. Methods A controlled clinical trial was performed at the Internal Medicine department of a general teaching hospital. All admitted patients using at least one prescription drug were included. The COACH program consisted of medication reconciliation, patient counselling at discharge, and communication to healthcare providers in primary care. The primary outcome was the proportion of patients with an unplanned rehospitalisation within three months after discharge. Also, the number of quality-adjusted life-years (QALYs) was assessed. Cost data were collected using cost diaries. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios between the groups was estimated by bootstrapping. Results In the COACH program, 168 patients were included and in usual care 151 patients. There was no significant difference in the proportion of patients with unplanned rehospitalisations (mean difference 0.17%, 95% CI -8.85;8.51), and in QALYs (mean difference -0.0085, 95% CI -0.0170;0.0001). Total costs for the COACH program were non-significantly lower than usual care (-€1160, 95% CI -3168;847). Cost-effectiveness planes showed that the program was not cost-effective compared with usual care for unplanned rehospitalisations and QALYs gained. Conclusion The COACH program was not cost-effective in comparison with usual care. Future studies should focus on high risk patients and include other outcomes (e.g. adverse drug events) as this may increase the chances of a cost-effective intervention. Dutch trial register NTR1519 PMID:28445474

Long-term cost-effectiveness of collaborative care (vs usual care) for people with depression and comorbid diabetes or cardiovascular disease: a Markov model informed by the COINCIDE randomised controlled trial

PubMed Central

Camacho, Elizabeth M; Ntais, Dionysios; Coventry, Peter; Bower, Peter; Lovell, Karina; Chew-Graham, Carolyn; Baguley, Clare; Gask, Linda; Dickens, Chris; Davies, Linda M

2016-01-01

Objectives To evaluate the long-term cost-effectiveness of collaborative care (vs usual care) for treating depression in patients with diabetes and/or coronary heart disease (CHD). Setting 36 primary care general practices in North West England. Participants 387 participants completed baseline assessment (collaborative care: 191; usual care: 196) and full or partial 4-month follow-up data were captured for 350 (collaborative care: 170; usual care: 180). 62% of participants were male, 14% were non-white. Participants were aged ≥18 years, listed on a Quality and Outcomes Framework register for CHD and/or type 1 or 2 diabetes mellitus, with persistent depressive symptoms. Patients with psychosis or type I/II bipolar disorder, actively suicidal, in receipt of services for substance misuse, or already in receipt of psychological therapy for depression were excluded. Intervention Collaborative care consisted of evidence-based low-intensity psychological treatments, delivered over 3 months and case management by a practice nurse and a Psychological Well Being Practitioner. Outcome measures As planned, the primary measure of cost-effectiveness was the incremental cost-effectiveness ratio (cost per quality-adjusted life year (QALY)). A Markov model was constructed to extrapolate the trial results from short-term to long-term (24 months). Results The mean cost per participant of collaborative care was £317 (95% CI 284 to 350). Over 24 months, it was estimated that collaborative care was associated with greater healthcare usage costs (net cost £674 (95% CI −30 953 to 38 853)) and QALYs (net QALY gain 0.04 (95% CI −0.46 to 0.54)) than usual care, resulting in a cost per QALY gained of £16 123, and a likelihood of being cost-effective of 0.54 (willingness to pay threshold of £20 000). Conclusions Collaborative care is a potentially cost-effective long-term treatment for depression in patients with comorbid physical and mental illness. The estimated cost per QALY gained was below the threshold recommended by English decision-makers. Further, long-term primary research is needed to address uncertainty associated with estimates of cost-effectiveness. Trial registration number ISRCTN80309252; Post-results. PMID:27855101

The Costs and Cost-effectiveness of Collaborative Care for Adolescents With Depression in Primary Care Settings: A Randomized Clinical Trial.

PubMed

Wright, Davene R; Haaland, Wren L; Ludman, Evette; McCauley, Elizabeth; Lindenbaum, Jeffrey; Richardson, Laura P

2016-11-01

Depression is one of the most common adolescent chronic health conditions and can lead to increased health care use. Collaborative care models have been shown to be effective in improving adolescent depressive symptoms, but there are few data on the effect of such a model on costs. To evaluate the costs and cost-effectiveness of a collaborative care model for treatment of adolescent major depressive disorder in primary care settings. This randomized clinical trial was conducted between April 1, 2010, and April 30, 2013, at 9 primary care clinics in the Group Health system in Washington State. Participants were adolescents (age range, 13-17 years) with depression who participated in the Reaching Out to Adolescents in Distress (ROAD) collaborative care intervention trial. A 12-month collaborative care intervention included an initial in-person engagement session, delivery of evidence-based treatments, and regular follow-up by master's level clinicians. Youth in the usual care control condition received depression screening results and could access mental health services and obtain medications through Group Health. Cost outcomes included intervention costs and per capita health plan costs, calculated from the payer perspective using administrative records. The primary effectiveness outcome was the difference in quality-adjusted life-years (QALYs) between groups from baseline to 12 months. The QALYs were calculated using Child Depression Rating Scale-Revised scores measured during the clinical trial. Cost and QALYs were used to calculate an incremental cost-effectiveness ratio. Of those screened, 105 youths met criteria for entry into the study, and 101 were randomized to the intervention (n = 50) and usual care (n = 51) groups. Overall health plan costs were not significantly different between the intervention ($5161; 95% CI, $3564-$7070) and usual care ($5752; 95% CI, $3814-$7952) groups. Intervention delivery cost an additional $1475 (95% CI, $1230-$1695) per person. The intervention group had a mean daily utility value of 0.78 (95% CI, 0.75-0.80) vs 0.73 (95% CI, 0.71-0.76) for the usual care group. The net mean difference in effectiveness was 0.04 (95% CI, 0.02-0.09) QALY at $883 above usual care. The mean incremental cost-effectiveness ratio was $18 239 (95% CI, dominant to $24 408) per QALY gained, with dominant indicating that the intervention resulted in both a net cost savings and a net increase in QALYs. Collaborative care for adolescent depression appears to be cost-effective, with 95% CIs far below the strictest willingness-to-pay thresholds. These findings support the use of collaborative care interventions to treat depression among adolescent youth. clinicaltrials.gov Identifier: NCT01140464.

Effectiveness of Cognitive-Behavioral Treatment for Panic Disorder versus Treatment as Usual in a Managed Care Setting

ERIC Educational Resources Information Center

Addis, Michael E.; Hatgis, Christina; Krasnow, Aaron D.; Jacob, Karen; Bourne, Leslie; Mansfield, Abigail

2004-01-01

Eighty clients enrolled in a managed care health plan who identified panic disorder as their primary presenting problem were randomly assigned to treatment by a therapist recently trained in a manual-based empirically supported psychotherapy (M. G. Craske, E. Meadows, & D. H. Barlow, 1994) or a therapist conducting treatment as usual (TAU).…

Primary Care Providers' Views regarding Assessing and Treating Suicidal Patients

ERIC Educational Resources Information Center

Graham, Ryan D.; Rudd, M. David; Bryan, Craig J.

2011-01-01

Primary care providers (PCPs) usually do not explore patient suicidality during routine visits. Factors that predict PCP attitudes toward the assessment and treatment of suicidality were examined via an online survey of 195 practicing PCPs affiliated with medical schools in the United States. PCPs who perceived themselves as competent to work with…

Baseline Obesity Status Modifies Effectiveness of Adapted Diabetes Prevention Program Lifestyle Interventions for Weight Management in Primary Care

PubMed Central

Azar, Kristen M. J.; Xiao, Lan; Ma, Jun

2013-01-01

Objective. To examine whether baseline obesity severity modifies the effects of two different, primary care-based, technology-enhanced lifestyle interventions among overweight or obese adults with prediabetes and/or metabolic syndrome. Patients and Methods. We compared mean differences in changes from baseline to 15 months in clinical measures of general and central obesity among participants randomized to usual care alone (n = 81) or usual care plus a coach-led group (n = 79) or self-directed individual (n = 81) intervention, stratified by baseline body mass index (BMI) category. Results. Participants with baseline BMI 35+ had greater reductions in mean BMI, body weight (as percentage change), and waist circumference in the coach-led group intervention, compared to usual care and the self-directed individual intervention (P < 0.05 for all). In contrast, the self-directed intervention was more effective than usual care only among participants with baseline BMIs between 25 ≤ 35. Mean weight loss exceeded 5% in the coach-led intervention regardless of baseline BMI category, but this was achieved only among self-directed intervention participants with baseline BMIs <35. Conclusions. Baseline BMI may influence behavioral weight-loss treatment effectiveness. Researchers and clinicians should take an individual's baseline BMI into account when developing or recommending lifestyle focused treatment strategy. This trial is registered with ClinicalTrials.gov NCT00842426. PMID:24369008

Depression care management for adults older than 60 years in primary care clinics in urban China: a cluster-randomised trial.

PubMed

Chen, Shulin; Conwell, Yeates; He, Jin; Lu, Naiji; Wu, Jiayan

2015-04-01

China's national health policy classifies depression as a chronic disease that should be managed in primary care settings. In some high-income countries use of chronic disease management principles and primary care-based collaborative-care models have improved outcomes for late-life depression; however, this approach has not yet been tested in China. We aimed to assess whether use of a collaborative-care depression care management (DCM) intervention could improve outcomes for Chinese adults with depression aged 60 years and older. Between Jan 17, 2011, [corrected] and Nov 30, 2013, we did a cluster-randomised trial in patients from primary care centre clinics in Shangcheng district of Hangzhou city in eastern China. We randomly assigned (1:1) clinics to either DCM (involving training for physicians in use of treatment guidelines, training for primary care nurses to function as care managers, and consultation with psychiatrists as support) or to give enhanced care as usual to all eligible patients aged 60 years and older with major depressive disorder. Clinics were chosen randomly for inclusion from all primary care clinics in the district by computer algorithm and then randomly allocated depression care interventions remotely by computer algorithm. Physicians, study personnel, and patients were not masked to clinic assignment. Our primary outcome was difference in Hamilton Depression Rating Scale (HAMD) score using data for clusters at baseline and 3, 6, and 12 month follow-up in a mixed-effects model of the intention-to-treat population. We originally aimed to analyse outcomes at 24 months, however the difference between groups at 12 months was large and funding was insufficient to continue to 24 months, therefore we decided to end the trial at 12 months. This trial is registered with ClinicalTrials.gov, number NCT01287494. Of 34 primary care clinics in Shangcheng district, 16 were randomly chosen. We randomly assigned eight clinics to the DCM intervention (164 patients enrolled) and eight primary care clinics to enhanced care as usual (162 patients). There were no major differences in baseline demographic and clinical variables between the groups of patients for each intervention. Over the 12 months, patients in clinics assigned to DCM had a significantly greater reduction in HAMD score than did those in practices assigned to enhanced care as usual (estimated between group difference -6·5 [95% CI -7·1 to -5·9]; Cohen's d 0·8 [95% CI 0·8-0·9]; p<0·0001). The intercluster correlation for change in HAMD total score was 0·07 (95% CI 0·06-0·08). There were no study-related adverse events in either group. Clinical outcomes of Chinese adults older than 60 years who had major depression were improved when their primary care clinic used DCM. Primary care-based collaborative management of depression is promising to address this pressing public health need in China. National Institutes of Health, Program for New Century Excellent Talents in Universities of China, Ministry of Education, China. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Stage Matched Physical Activity Intervention in Military Primary Care

DTIC Science & Technology

2000-05-26

usually offered as tertiary prevention ; i.e. prevention directed toward minimizing residual disability from existing diseases and helping the...through effective behavior modification is not usually offered as primary prevention (Pender, 1996). Little is being done to assist relatively...program has ended (Belisle, Roskies, & Levesque, 1987; Harris, Caspersen, DeFriese, & Estes, 1989). One of the three criteria used by the US Preventive

Telemonitoring and/or self-monitoring of blood pressure in hypertension (TASMINH4): protocol for a randomised controlled trial.

PubMed

Franssen, Marloes; Farmer, Andrew; Grant, Sabrina; Greenfield, Sheila; Heneghan, Carl; Hobbs, Richard; Hodgkinson, James; Jowett, Susan; Mant, Jonathan; Martin, Una; Milner, Siobhan; Monahan, Mark; Ogburn, Emma; Perera-Salazar, Rafael; Schwartz, Claire; Yu, Ly-Mee; McManus, Richard J

2017-02-13

Self-monitoring of hypertension is associated with lower systolic blood pressure (SBP). However, evidence for the use of self-monitoring to titrate antihypertensive medication by physicians is equivocal. Furthermore, there is some evidence for the efficacy of telemonitoring in the management of hypertension but it is not clear what this adds over and above self-monitoring. This trial aims to evaluate whether GP led antihypertensive titration using self-monitoring results in lower SBP compared to usual care and whether telemonitoring adds anything to self-monitoring alone. This will be a pragmatic primary care based, unblinded, randomised controlled trial of self-monitoring of BP with or without telemonitoring compared to usual care. Eligible patients will have poorly controlled hypertension (>140/90 mmHg) and will be recruited from primary care. Participants will be individually randomised to either usual care, self-monitoring alone, or self-monitoring with telemonitoring. The primary outcome of the trial will be difference in clinic SBP between intervention and control groups at 12 months adjusted for baseline SBP, gender, BP target and practice. At least 1110 patients will be sufficient to detect a difference in SBP between self-monitoring with or without telemonitoring and usual care of 5 mmHg with 90% power with an adjusted alpha of 0.017 (2-sided) to adjust for all three pairwise comparisons. Other outcomes will include adherence of anti-hypertensive medication, lifestyle behaviours, health-related quality of life, and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative sub study will gain insights into the views, experiences and decision making processes of patients and health care professionals focusing on the acceptability of self-monitoring and telemonitoring in the routine management of hypertension. The results of the trial will be directly applicable to primary care in the UK. If successful, self-monitoring of BP in people with hypertension would be applicable to hundreds of thousands of individuals in the UK. ISRCTN 83571366 . Registered 17 July 2014.

Translating the Diabetes Prevention Program Lifestyle Intervention for Weight Loss into Primary Care: A Randomized Trial

PubMed Central

Ma, Jun; Yank, Veronica; Xiao, Lan; Lavori, Philip W.; Wilson, Sandra R.; Rosas, Lisa G.; Stafford, Randall S.

2013-01-01

Background The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes among high risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care. Methods We evaluated two adapted DPP lifestyle interventions among overweight/obese adults who were recruited from one primary care clinic and had prediabetes and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n=79), (2) a self-directed DVD intervention (n=81), or (3) usual care (n=81). During a 3-month intensive intervention phase, the DPP-based behavioral weight loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely–through secure email within an electronic health record system and the American Heart Association Heart360 Web site for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) from baseline to 15 months. Results At baseline, participants had a mean (±SD) age of 52.9±10.6 years and mean BMI 32.0±5.4 kg/m2 with 47% female, 78% Non-Hispanic white, and 17% Asian/Pacific Islander. At month 15, the mean (±SE) change in BMI from baseline was −2.2±0.3 kg/m2 in the coach-led group (vs. −0.9±0.3 kg/m2 in the usual care group, P<0.001) and −1.6±0.3 kg/m2 in the self-directed group (P=0.02 vs. usual care). The percentages of participants who achieved the 7% DPP-based weight loss goal were 37.0% (P=0.003) and 35.9% (P=0.004) in the coach-led and self-directed groups, respectively, versus 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose. Conclusions Proven effective in a primary care setting, the two DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact. Trial Registration Clinicaltrials.gov identifier: NCT00842426 PMID:23229846

Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice.

PubMed

Vestbo, Jørgen; Leather, David; Diar Bakerly, Nawar; New, John; Gibson, J Martin; McCorkindale, Sheila; Collier, Susan; Crawford, Jodie; Frith, Lucy; Harvey, Catherine; Svedsater, Henrik; Woodcock, Ashley

2016-09-29

Evidence for the management of chronic obstructive pulmonary disease (COPD) comes from closely monitored efficacy trials involving groups of patients who were selected on the basis of restricted entry criteria. There is a need for randomized trials to be conducted in conditions that are closer to usual clinical practice. In a controlled effectiveness trial conducted in 75 general practices, we randomly assigned 2799 patients with COPD to a once-daily inhaled combination of fluticasone furoate at a dose of 100 μg and vilanterol at a dose of 25 μg (the fluticasone furoate-vilanterol group) or to usual care (the usual-care group). The primary outcome was the rate of moderate or severe exacerbations among patients who had had an exacerbation within 1 year before the trial. Secondary outcomes were the rates of primary care contact (contact with a general practitioner, nurse, or other health care professional) and secondary care contact (inpatient admission, outpatient visit with a specialist, or visit to the emergency department), modification of the initial trial treatment for COPD, and the rate of exacerbations among patients who had had an exacerbation within 3 years before the trial, as assessed in a time-to-event analysis. The rate of moderate or severe exacerbations was significantly lower, by 8.4% (95% confidence interval, 1.1 to 15.2), with fluticasone furoate-vilanterol therapy than with usual care (P=0.02). There was no significant difference in the annual rate of COPD-related contacts to primary or secondary care. There were no significant between-group differences in the rates of the first moderate or severe exacerbation and the first severe exacerbation in the time-to-event analyses. There were no excess serious adverse events of pneumonia in the fluticasone furoate-vilanterol group. The numbers of other serious adverse events were similar in the two groups. In patients with COPD and a history of exacerbations, a once-daily treatment regimen of combined fluticasone furoate and vilanterol was associated with a lower rate of exacerbations than usual care, without a greater risk of serious adverse events. (Funded by GlaxoSmithKline; Salford Lung Study ClinicalTrials.gov number, NCT01551758 .).

Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial.

PubMed

Bekelman, David B; Plomondon, Mary E; Carey, Evan P; Sullivan, Mark D; Nelson, Karin M; Hattler, Brack; McBryde, Connor F; Lehmann, Kenneth G; Gianola, Katherine; Heidenreich, Paul A; Rumsfeld, John S

2015-05-01

Heart failure (HF) has a major effect on patients' health status, including their symptom burden, functional status, and health-related quality of life. To determine the effectiveness of a collaborative care patient-centered disease management (PCDM) intervention to improve the health status of patients with HF. The Patient-Centered Disease Management (PCDM) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF. A population-based sample of 392 patients with an HF diagnosis from 4 Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of less than 60 (heavy symptom burden and impaired functional status and quality of life) were enrolled between May 2009 and June 2011. The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator, cardiologist, psychiatrist, and primary care physician; home telemonitoring and patient self-management support; and screening and treatment for comorbid depression. The primary outcome was change in the KCCQ overall summary score at 1 year (a 5-point change is clinically significant). Mortality, hospitalization, and depressive symptoms (Patient Health Questionnaire 9) were secondary outcomes. There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention (n=187) vs usual care (n=197); baseline mean KCCQ overall summary scores were 37.9 vs 36.9 (P=.48). There was significant improvement in the KCCQ overall summary scores in both groups after 1 year (mean change, 13.5 points in each group), with no significant difference between groups (P=.97). The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using 3-month, 6-month, and 12-month data (P=.74). Among secondary outcomes, there were significantly fewer deaths at 1 year in the intervention arm (8 of 187 [4.3%]) than in the usual care arm (19 of 197 [9.6%]) (P = .04). Among those who screened positive for depression, there was a greater improvement in the Patient Health Questionnaire 9 scores after 1 year in the intervention arm than in the usual care arm (2.1 points lower, P=.01). There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm (29.4% vs 29.9%, P=.87). This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care. clinicaltrials.gov Identifier: NCT00461513.

Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial.

PubMed

Margolis, Karen L; Kerby, Tessa J; Asche, Stephen E; Bergdall, Anna R; Maciosek, Michael V; O'Connor, Patrick J; Sperl-Hillen, JoAnn M

2012-07-01

Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. The Home Blood Pressure Telemonitoring and Case Management to Control Hypertension study (HyperLink) is a cluster-randomized trial designed to determine whether an intervention that combines home BP telemonitoring with pharmacist case management improves BP control compared to usual care at 6 and 12 months in patients with uncontrolled hypertension. Secondary outcomes are maintenance of BP control at 18 months, patient satisfaction with their health care, and costs of care. HyperLink enrolled 450 hypertensive patients with uncontrolled BP from 16 primary care clinics. Eight clinics were randomized to provide usual care (UC) to their patients (n=222) and 8 were randomized to provide the telemonitoring intervention (TI) (n=228). TI patients received home BP telemonitors that internally store and electronically transmit BP data to a secure database. Pharmacist case managers adjust antihypertensive therapy based on the home BP data under a collaborative practice agreement with the clinics' primary care teams. The length of the intervention is 12 months, with follow-up to 18 months to determine the durability of the intervention. We will test in a real primary care setting whether combining BP telemonitoring and pharmacist case management can achieve and maintain high rates of BP control compared to usual care. Copyright © 2012 Elsevier Inc. All rights reserved.

Enhancing Shared Decision Making Through Carefully Designed Interventions That Target Patient And Provider Behavior.

PubMed

Tai-Seale, Ming; Elwyn, Glyn; Wilson, Caroline J; Stults, Cheryl; Dillon, Ellis C; Li, Martina; Chuang, Judith; Meehan, Amy; Frosch, Dominick L

2016-04-01

Patient-provider communication and shared decision making are essential for primary care delivery and are vital contributors to patient experience and health outcomes. To alleviate communication shortfalls, we designed a novel, multidimensional intervention aimed at nudging both patients and primary care providers to communicate more openly. The intervention was tested against an existing intervention, which focused mainly on changing patients' behaviors, in four primary care clinics involving 26 primary care providers and 300 patients. Study results suggest that compared to usual care, both the novel and existing interventions were associated with better patient reports of how well primary care providers engaged them in shared decision making. Future research should build on the work in this pilot to rigorously examine the comparative effectiveness and scalability of these interventions to improve shared decision making at the point of care. Project HOPE—The People-to-People Health Foundation, Inc.

Effects of a long-term lifestyle intervention program with Mediterranean diet and exercise for the management of patients with metabolic syndrome in a primary care setting.

PubMed

Gomez-Huelgas, R; Jansen-Chaparro, S; Baca-Osorio, A J; Mancera-Romero, J; Tinahones, F J; Bernal-López, M R

2015-06-01

The impact of a lifestyle intervention (LSI) program for the long-term management of subjects with metabolic syndrome in a primary care setting is not known. This 3-year prospective controlled trial randomized adult subjects with metabolic syndrome to receive intensive LSI or to usual care in a community health centre in Malaga, Spain. LSI subjects received instruction on Mediterranean diet and a regular aerobic exercise program by their primary care professionals. Primary outcome included changes from baseline on different components of metabolic syndrome (abdominal circumference, blood pressure, HDL-cholesterol, fasting plasma glucose and triglycerides). Among the 2,492 subjects screened, 601 subjects with metabolic syndrome (24.1%) were randomized to LSI (n = 298) or to usual care (n = 303); of them, a 77% and a 58%, respectively, completed the study. At the end of the study period, LSI resulted in significant differences vs. usual care in abdominal circumference (-0.4 ± 6 cm vs. + 2.1 ± 6.7 cm, p < 0.001), systolic blood pressure (-5.5 ± 15 mmHg vs. -0.6 ± 19 mmHg, p = 0.004), diastolic blood pressure (-4.6 ± 10 mmHg vs. -0.2 ± 13 mmHg, p < 0.001) and HDL-cholesterol (+4 ± 12 mg/dL vs. + 2 ± 12 mg/dL, p = 0.05); however, there were no differences in fasting plasma glucose and triglyceride concentration (-4 ± 35 mg/dl vs. -1 ± 32 mg/dl, p = 0.43 and -0.4 ± 83 mg/dl vs. +6 ± 113 mg/dl, p = 0.28). Intensive LSI counseling provided by primary care professionals resulted in significant improvements in abdominal circumference, blood pressure and HDL-cholesterol but had limited effects on glucose and triglyceride levels in patients with metabolic syndrome. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Chronic disease management interventions for people with chronic kidney disease in primary care: a systematic review and meta-analysis.

PubMed

Galbraith, Lauren; Jacobs, Casey; Hemmelgarn, Brenda R; Donald, Maoliosa; Manns, Braden J; Jun, Min

2018-01-01

Primary care providers manage the majority of patients with chronic kidney disease (CKD), although the most effective chronic disease management (CDM) strategies for these patients are unknown. We assessed the efficacy of CDM interventions used by primary care providers managing patients with CKD. The Medline, Embase and Cochrane Central databases were systematically searched (inception to November 2014) for randomized controlled trials (RCTs) assessing education-based and computer-assisted CDM interventions targeting primary care providers managing patients with CKD in the community. The efficacy of CDM interventions was assessed using quality indicators [use of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), proteinuria measurement and achievement of blood pressure (BP) targets] and clinical outcomes (change in BP and glomerular filtration rate). Two independent reviewers evaluated studies for inclusion, quality and extracted data. Random effects models were used to estimate pooled odds ratios (ORs) and weighted mean differences for outcomes of interest. Five studies (188 clinics; 494 physicians; 42 852 patients with CKD) were included. Two studies compared computer-assisted intervention strategies with usual care, two studies compared education-based intervention strategies with computer-assisted intervention strategies and one study compared both these intervention strategies with usual care. Compared with usual care, computer-assisted CDM interventions did not increase the likelihood of ACEI/ARB use among patients with CKD {pooled OR 1.00 [95% confidence interval (CI) 0.83-1.21]; I2 = 0.0%}. Similarly, education-related CDM interventions did not increase the likelihood of ACEI/ARB use compared with computer-assisted CDM interventions [pooled OR 1.12 (95% CI 0.77-1.64); I2 = 0.0%]. Inconsistencies in reporting methods limited further pooling of data. To date, there have been very few randomized trials testing CDM interventions targeting primary care providers with the goal of improving care of people with CKD. Those conducted to date have shown minimal impact, suggesting that other strategies, or multifaceted interventions, may be required to enhance care for patients with CKD in the community. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Clinical and cost-effectiveness of computerised cognitive behavioural therapy for depression in primary care: Design of a randomised trial

PubMed Central

de Graaf, L Esther; Gerhards, Sylvia AH; Evers, Silvia MAA; Arntz, Arnoud; Riper, Heleen; Severens, Johan L; Widdershoven, Guy; Metsemakers, Job FM; Huibers, Marcus JH

2008-01-01

Background Major depression is a common mental health problem in the general population, associated with a substantial impact on quality of life and societal costs. However, many depressed patients in primary care do not receive the care they need. Reason for this is that pharmacotherapy is only effective in severely depressed patients and psychological treatments in primary care are scarce and costly. A more feasible treatment in primary care might be computerised cognitive behavioural therapy. This can be a self-help computer program based on the principles of cognitive behavioural therapy. Although previous studies suggest that computerised cognitive behavioural therapy is effective, more research is necessary. Therefore, the objective of the current study is to evaluate the (cost-) effectiveness of online computerised cognitive behavioural therapy for depression in primary care. Methods/Design In a randomised trial we will compare (a) computerised cognitive behavioural therapy with (b) treatment as usual by a GP, and (c) computerised cognitive behavioural therapy in combination with usual GP care. Three hundred mild to moderately depressed patients (aged 18–65) will be recruited in the general population by means of a large-scale Internet-based screening (N = 200,000). Patients will be randomly allocated to one of the three treatment groups. Primary outcome measure of the clinical evaluation is the severity of depression. Other outcomes include psychological distress, social functioning, and dysfunctional beliefs. The economic evaluation will be performed from a societal perspective, in which all costs will be related to clinical effectiveness and health-related quality of life. All outcome assessments will take place on the Internet at baseline, two, three, six, nine, and twelve months. Costs are measured on a monthly basis. A time horizon of one year will be used without long-term extrapolation of either costs or quality of life. Discussion Although computerised cognitive behavioural therapy is a promising treatment for depression in primary care, more research is needed. The effectiveness of online computerised cognitive behavioural therapy without support remains to be evaluated as well as the effects of computerised cognitive behavioural therapy in combination with usual GP care. Economic evaluation is also needed. Methodological strengths and weaknesses are discussed. Trial registration The study has been registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre (ISRCTN47481236). PMID:18590518

Impact of a Primary Care CKD Registry in a US Public Safety-Net Health Care Delivery System: A Pragmatic Randomized Trial.

PubMed

Tuot, Delphine S; McCulloch, Charles E; Velasquez, Alexandra; Schillinger, Dean; Hsu, Chi-Yuan; Handley, Margaret; Powe, Neil R

2018-04-23

Many individuals with chronic kidney disease (CKD) do not receive guideline-concordant care. We examined the impact of a team-based primary care CKD registry on clinical measures and processes of care among patients with CKD cared for in a public safety-net health care delivery system. Pragmatic trial of a CKD registry versus a usual-care registry for 1 year. Primary care providers (PCPs) and their patients with CKD in a safety-net primary care setting in San Francisco. The CKD registry identified at point of care all patients with CKD, those with blood pressure (BP)>140/90mmHg, those without angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB) prescription, and those without albuminuria quantification in the past year. It also provided quarterly feedback pertinent to these metrics to promote "outreach" to patients with CKD. The usual-care registry provided point-of-care cancer screening and immunization data. Changes in systolic BP at 12 months (primary outcome), proportion of patients with BP control, prescription of ACE inhibitors/ARBs, quantification of albuminuria, severity of albuminuria, and estimated glomerular filtration rate. The patient population (n=746) had a mean age of 56.7±12.1 (standard deviation) years, was 53% women, and was diverse (8% non-Hispanic white, 35.7% black, 24.5% Hispanic, and 24.4% Asian). Randomization to the CKD registry (30 PCPs, 285 patients) versus the usual-care registry (49 PCPs, 461 patients) was associated with 2-fold greater odds of ACE inhibitor/ARB prescription (adjusted OR, 2.25; 95% CI, 1.45-3.49) and albuminuria quantification (adjusted OR, 2.44; 95% CI, 1.38-4.29) during the 1-year study period. Randomization to the CKD registry was not associated with changes in systolic BP, proportion of patients with uncontrolled BP, or degree of albuminuria or estimated glomerular filtration rate. Potential misclassification of CKD; missing baseline medication data; limited to study of a public safety-net health care system. A team-based safety-net primary care CKD registry did not improve BP parameters, but led to greater albuminuria quantification and more ACE inhibitor/ARB prescriptions after 1 year. Adoption of team-based CKD registries may represent an important step in translating evidence into practice for CKD management. Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Developing effective child psychiatry collaboration with primary care: leadership and management strategies.

PubMed

Sarvet, Barry D; Wegner, Lynn

2010-01-01

By working in collaboration with pediatric primary care providers, child and adolescent psychiatrists have the opportunity to address significant levels of unmet need for the majority of children and teenagers with serious mental health problems who have been unable to gain access to care. Effective collaboration with primary care represents a significant change from practice-as-usual for many child and adolescent psychiatrists. Implementation of progressive levels of collaborative practice, from the improvement of provider communication through the development of comprehensive collaborative systems, may be possible with sustained management efforts and application of process improvement methodology.

Cost-effectiveness of a program to prevent depression relapse in primary care.

PubMed

Simon, Gregory E; Von Korff, Michael; Ludman, Evette J; Katon, Wayne J; Rutter, Carolyn; Unützer, Jürgen; Lin, Elizabeth H B; Bush, Terry; Walker, Edward

2002-10-01

Evaluate the incremental cost-effectiveness of a depression relapse prevention program in primary care. Primary care patients initiating antidepressant treatment completed a standardized telephone assessment 6-8 weeks later. Those recovered from the current episode but at high risk for relapse (based on history of recurrent depression or dysthymia) were offered randomization to usual care or a relapse prevention intervention. The intervention included systematic patient education, two psychoeducational visits with a depression prevention specialist, shared decision-making regarding maintenance pharmacotherapy, and telephone and mail monitoring of medication adherence and depressive symptoms. Outcomes in both groups were assessed via blinded telephone assessments at 3, 6, 9, and 12 months and health plan claims and accounting data. Intervention patients experienced 13.9 additional depression-free days during a 12-month period (95% CI, -1.5 to 29.3). Incremental costs of the intervention were $273 (95% CI, $102 to $418) for depression treatment costs only and $160 (95% CI, -$173 to $512) for total outpatient costs. Incremental cost-effectiveness ratio was $24 per depression-free day (95% CI, -$59 to $496) for depression treatment costs only and $14 per depression-free day (95% CI, -$35 to $248) for total outpatient costs. A program to prevent depression relapse in primary care yields modest increases in days free of depression and modest increases in treatment costs. These modest differences reflect high rates of treatment in usual care. Along with other recent studies, these findings suggest that improved care of depression in primary care is a prudent investment of health care resources.

The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials.

PubMed

Patel, Vikram; Weobong, Benedict; Nadkarni, Abhijit; Weiss, Helen A; Anand, Arpita; Naik, Smita; Bhat, Bhargav; Pereira, Jesina; Araya, Ricardo; Dimidjian, Sona; Hollon, Steven D; King, Michael; McCambridge, Jim; McDaid, David; Murthy, Pratima; Velleman, Richard; Fairburn, Christopher G; Kirkwood, Betty

2014-04-02

The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India. This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat. These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors. Both trials are registered with the International Society for the Registration of Clinical Trials (Healthy Activity Programme registration number ISRCTN95149997; Counselling for Alcohol Problems registration number ISRCTN76465238).

The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials

PubMed Central

2014-01-01

Background The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India. Methods/design This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat. Discussion These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors. Trial registration Both trials are registered with the International Society for the Registration of Clinical Trials (Healthy Activity Programme registration number ISRCTN95149997; Counselling for Alcohol Problems registration number ISRCTN76465238). PMID:24690184

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.

PubMed

DeBar, Lynn; Benes, Lindsay; Bonifay, Allison; Deyo, Richard A; Elder, Charles R; Keefe, Francis J; Leo, Michael C; McMullen, Carmit; Mayhew, Meghan; Owen-Smith, Ashli; Smith, David H; Trinacty, Connie M; Vollmer, William M

2018-04-01

Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) – Protocol for a pragmatic cluster randomized trial

PubMed Central

DeBar, Lynn; Benes, Lindsay; Bonifay, Allison; Deyo, Richard A.; Elder, Charles R.; Keefe, Francis J.; Leo, Michael C.; McMullen, Carmit; Mayhew, Meghan; Owen-Smith, Ashli; Smith, David H.; Trinacty, Connie M.; Vollmer, William M.

2018-01-01

Background Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. Methods/design This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. Discussion This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592 PMID:29522897

Telehealth by an Interprofessional Team in Patients With CKD: A Randomized Controlled Trial.

PubMed

Ishani, Areef; Christopher, Juleen; Palmer, Deirdre; Otterness, Sara; Clothier, Barbara; Nugent, Sean; Nelson, David; Rosenberg, Mark E

2016-07-01

Telehealth and interprofessional case management are newer strategies of care within chronic disease management. We investigated whether an interprofessional team using telehealth was a feasible care delivery strategy and whether this strategy could affect health outcomes in patients with chronic kidney disease (CKD). Randomized clinical trial. Minneapolis Veterans Affairs Health Care System (VAHCS), St. Cloud VAHCS, and affiliated clinics March 2012 to November 2013 in patients with CKD (estimated glomerular filtration rate < 60mL/min/1.73m(2)). Patients were randomly assigned to receive an intervention (n=451) consisting of care by an interprofessional team (nephrologist, nurse practitioner, nurses, clinical pharmacy specialist, psychologist, social worker, and dietician) using a telehealth device (touch screen computer with peripherals) or to usual care (n=150). The primary end point was a composite of death, hospitalization, emergency department visits, or admission to skilled nursing facilities, compared to usual care. Baseline characteristics of the overall study group: mean age, 75.1±8.1 (SD) years; men, 98.5%; white, 97.3%; and mean estimated glomerular filtration rate, 37±9mL/min/1.73m(2). Telehealth and interprofessional care were successfully implemented with meaningful engagement with the care system. One year after randomization, 208 (46.2%) patients in the intervention group versus 70 (46.7%) in the usual-care group had the primary composite outcome (HR, 0.98; 95% CI, 0.75-1.29; P=0.9). There was no difference between groups for any component of the primary outcome: all-cause mortality (HR, 1.46; 95% CI, 0.42-5.11), hospitalization (HR, 1.15; 95% CI, 0.80-1.63), emergency department visits (HR, 0.92; 95% CI, 0.68-1.24), or nursing home admission (HR, 3.07; 95% CI, 0.71-13.24). Older population, mostly men, potentially underpowered/wide CIs. Telehealth by an interprofessional team is a feasible care delivery strategy in patients with CKD. There was no statistically significant evidence of superiority of this intervention on health outcomes compared to usual care. Published by Elsevier Inc.

Counselling for depression in primary care.

PubMed

Rowland, N; Bower, P; Mellor, C; Heywood, P; Godfrey, C

2001-01-01

There is wide clinician and patient support for counselling in primary care, particularly in the UK. This review examines the effectiveness and cost effectiveness of counselling for psychological and psychosocial problems in the primary care setting. To assess the effects of counselling in primary care by reviewing cost and outcome data for patients with psychological and psychosocial problems considered suitable for counselling. The search strategy included electronic searching of databases (including the CCDAN Register of RCTs and CCTs) along with handsearching of a specialist journal. Published and unpublished sources (clinical trials, books, dissertations, agency reports etc.) were searched, and their reference lists scanned. Contact was made with subject experts and CCDAN members. Randomised and controlled patient preference trials comparing counselling in primary care with usual general practitioner care for patients with psychological and psychosocial problems considered suitable for counselling. Trials completed before the end of April 1998 were included in the review. Trials were independently assessed by at least two reviewers for appropriateness of inclusion and methdological quality. Four trials, involving 678 participants, of whom 487 were followed up, were included. Data for psychological symptom levels (four trials) were pooled statistically. Patients receiving counselling had significantly better psychological symptom levels post intervention than patients receiving usual general practitioner care (standardised mean difference -0.30, 95% CI, (-0.49 to - 0.11). The effect remained statistically significant when the results from studies with less rigorous methodology were excluded in a sensitivity analysis. Patients who received counselling tended to be more satisfied with their treatment (three trials). Health service utilisation data were reported in all trials reviewed, but only one trial undertook a cost analysis. No clear cost advantage was associated with either counselling or usual general practice care. Patients who received counselling were more likely to have improved psychological symptom levels than those who did not receive counselling. Levels of satisfaction with counselling were high. There is limited information about the cost effectiveness of counselling, with one study reporting no clear cost advantage with either counselling or general practice care. The four trials included in this review were all pragmatic trials of counselling in primary care in the UK, which reflect the reality of clinical provision in this context. There were methdological weaknesses identified in the studies, which should be taken into account when considering the results. The evidence base will be extended by trials of counselling which are nearing completion.

Long-term cost-effectiveness of collaborative care (vs usual care) for people with depression and comorbid diabetes or cardiovascular disease: a Markov model informed by the COINCIDE randomised controlled trial.

PubMed

Camacho, Elizabeth M; Ntais, Dionysios; Coventry, Peter; Bower, Peter; Lovell, Karina; Chew-Graham, Carolyn; Baguley, Clare; Gask, Linda; Dickens, Chris; Davies, Linda M

2016-10-07

To evaluate the long-term cost-effectiveness of collaborative care (vs usual care) for treating depression in patients with diabetes and/or coronary heart disease (CHD). 36 primary care general practices in North West England. 387 participants completed baseline assessment (collaborative care: 191; usual care: 196) and full or partial 4-month follow-up data were captured for 350 (collaborative care: 170; usual care: 180). 62% of participants were male, 14% were non-white. Participants were aged ≥18 years, listed on a Quality and Outcomes Framework register for CHD and/or type 1 or 2 diabetes mellitus, with persistent depressive symptoms. Patients with psychosis or type I/II bipolar disorder, actively suicidal, in receipt of services for substance misuse, or already in receipt of psychological therapy for depression were excluded. Collaborative care consisted of evidence-based low-intensity psychological treatments, delivered over 3 months and case management by a practice nurse and a Psychological Well Being Practitioner. As planned, the primary measure of cost-effectiveness was the incremental cost-effectiveness ratio (cost per quality-adjusted life year (QALY)). A Markov model was constructed to extrapolate the trial results from short-term to long-term (24 months). The mean cost per participant of collaborative care was £317 (95% CI 284 to 350). Over 24 months, it was estimated that collaborative care was associated with greater healthcare usage costs (net cost £674 (95% CI -30 953 to 38 853)) and QALYs (net QALY gain 0.04 (95% CI -0.46 to 0.54)) than usual care, resulting in a cost per QALY gained of £16 123, and a likelihood of being cost-effective of 0.54 (willingness to pay threshold of £20 000). Collaborative care is a potentially cost-effective long-term treatment for depression in patients with comorbid physical and mental illness. The estimated cost per QALY gained was below the threshold recommended by English decision-makers. Further, long-term primary research is needed to address uncertainty associated with estimates of cost-effectiveness. ISRCTN80309252; Post-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Effectiveness and cost effectiveness of counselling in primary care.

PubMed

Bower, P; Rowland, N

2006-07-19

The prevalence of mental health and psychosocial problems in primary care is high. This review examines the clinical and cost-effectiveness of psychological therapies provided in primary care by counsellors. To assess the effectiveness and cost effectiveness of counselling in primary care by reviewing cost and outcome data in randomised controlled trials for patients with psychological and psychosocial problems considered suitable for counselling. To update the review, the following electronic databases were searched on 25-10-2005: MEDLINE, EMBASE, PsycLIT, CINAHL, the Cochrane Controlled Trials register and the Cochrane Collaboration Depression, Anxiety and Neurosis (CCDAN) trials registers. All controlled trials comparing counselling in primary care with other treatments for patients with psychological and psychosocial problems considered suitable for counselling. Trials completed before the end of June 2005 were included in the review. Data were extracted using a standardised data extraction sheet. Trials were rated for quality using CCDAN criteria, to assess the extent to which their design and conduct were likely to have prevented systematic error. Continuous measures of outcome were combined using standardised mean differences. An overall effect size was calculated for each outcome with 95% confidence intervals (CI). Continuous data from different measuring instruments were transformed into a standard effect size by dividing mean values by standard deviations. Sensitivity analyses were undertaken to test the robustness of the results. Economic analyses were summarised in narrative form. Eight trials were included in the review. The analysis found significantly greater clinical effectiveness in the counselling group compared with usual care in the short-term (standardised mean difference -0.28, 95% CI -0.43 to -0.13, n = 772, 6 trials) but not the long-term (standardised mean difference -0.09, 95% CI -0.27 to 0.10, n = 475, 4 trials). Levels of satisfaction with counselling were high. There was some evidence that the overall costs of counselling and usual care were similar. Counselling is associated with modest improvement in short-term outcome compared to usual care, but provides no additional advantages in the long-term. Patients are satisfied with counselling. Although some types of health care utilisation may be reduced, counselling does not seem to reduce overall healthcare costs.

Substantial improvement of primary cardiovascular prevention by a systematic score-based multimodal approach: A randomized trial: The PreFord-Study.

PubMed

Gysan, Detlef Bernd; Millentrup, Stefanie; Albus, Christian; Bjarnason-Wehrens, Birna; Latsch, Joachim; Gohlke, Helmut; Herold, Gerd; Wegscheider, Karl; Heming, Christian; Seyfarth, Melchior; Predel, Hans-Georg

2017-09-01

Trial design Prospective randomized multicentre interventional study. Methods Individual cardiovascular risk assessment in Ford Company, Germany employees ( n = 4.196), using the European Society of Cardiology-Systematic Coronary Risk Evaluation (ESC-SCORE) for classification into three risk groups. Subjects assigned to ESC high-risk group (ESC-SCORE ≥ 5%), without a history of cardiovascular disease were eligible for randomization to a multimodal 15-week intervention programme (INT) or to usual care and followed up for 36 months. Objectives Evaluation of the long-term effects of a risk-adjusted multimodal intervention in high-risk subjects. Primary endpoint: reduction of ESC-SCORE in INT versus usual care. Secondary endpoints: composite of fatal and non-fatal cardiovascular events and time to first cardiovascular event. intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT ( n = 224) or to usual care ( n = 223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p = 0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n = 11 vs. usual care: n = 27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25-1.03; p = 0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18-0.90; p = 0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.).

Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial.

PubMed

van der Heijden, Amber A W A; de Bruijne, Martine C; Feenstra, Talitha L; Dekker, Jacqueline M; Baan, Caroline A; Bosmans, Judith E; Bot, Sandra D M; Donker, Gé A; Nijpels, Giel

2014-06-25

The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€ 758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). Compared to usual care, managed care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. Current Controlled trials: ISRCTN66124817.

Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial

PubMed Central

2014-01-01

Background The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. Methods In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Results Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). Conclusions Compared to usual care, managed care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. Trial registration Current Controlled trials: ISRCTN66124817. PMID:24966055

An enriched medical home intervention using community health workers improves adherence to immunization schedules.

PubMed

Pati, Susmita; Ladowski, Kristi L; Wong, Angie T; Huang, Jiayu; Yang, Jie

2015-11-17

Disparities in childhood vaccination rates persist. To evaluate the impact of an enriched medical home intervention using community health workers on improving immunization adherence among young children. The intervention group received home visits from trained community health workers to support families in adhering to recommended care while the comparison group received usual care (i.e. no home visits/reminders). Immunization history and socio-demographic data were collected using medical records and a validated questionnaire. The doubly robust estimation of risk difference, which combines weighting via propensity score and outcome regression model, was used to compare immunization adherence rates between two groups. Primary care practices affiliated with a suburban tertiary care academic medical center serving a socioeconomically diverse population. The study sample included children ≤ 2 years of age at enrollment who crossed at least one age time point of 3, 7, 15, or 24 months during their 6 months post-enrollment period. The primary outcome was age-specific immunization up-to-date status defined by CDC guidelines. The primary predictor was participation in the intervention. The analysis included 201 children in the usual care group and 110 children in the intervention group. The usual care and intervention groups were divided into subgroups of newborn and infant/toddler to account for prior immunization history. After adjusting for differences in group characteristics, we found a significant absolute increase in the up-to-date immunization likelihood for both newborns (20.9%, p=0.01) and infants/toddlers (16.8%, p=0.01) receiving the intervention when compared to their peers receiving usual clinical care. Our findings demonstrate the positive impact of an enriched medical home intervention using community health worker home visitation on early childhood immunization up-to-date status. With further study, this model may provide a cost-effective approach to improving childhood vaccination rates, especially for vulnerable groups. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effects of co-occurring depression on treatment for anxiety disorders: analysis of outcomes from a large primary care effectiveness trial.

PubMed

Campbell-Sills, Laura; Sherbourne, Cathy D; Roy-Byrne, Peter; Craske, Michelle G; Sullivan, Greer; Bystritsky, Alexander; Lang, Ariel J; Chavira, Denise A; Rose, Raphael D; Shaw Welch, Stacy; Stein, Murray B

2012-12-01

Co-occurring depression is common in patients seeking treatment for anxiety; however, the literature on the effects of depression on anxiety treatment outcomes is inconclusive. The current study evaluated prescriptive and prognostic effects of depression on anxiety treatment outcomes in a large primary care sample. Data were analyzed from a randomized controlled effectiveness trial that compared coordinated anxiety learning and management (CALM) to usual care. The study enrolled 1,004 patients between June 2006 and April 2008. Patients were referred by their primary care provider and met DSM-IV criteria for generalized anxiety disorder, panic disorder, posttraumatic stress disorder, and/or social anxiety disorder. They were treated for approximately 3 to 12 months with CALM (computer-assisted cognitive-behavioral therapy, medication management, or their combination) or usual care. Outcomes were evaluated by blinded assessment at 6, 12, and 18 months. Effects of baseline major depressive disorder (MDD) on anxiety symptoms, anxiety-related disability, and response/remission rates were evaluated using statistical models accounting for baseline anxiety and patient demographics. MDD did not moderate the effects of CALM (relative to usual care) on anxiety symptoms, anxiety-related disability, or response/remission rates. Greater improvements in anxiety symptoms and anxiety-related disability were observed in depressed patients, regardless of treatment assignment (P values < .005). However, cross-sectionally depressed patients displayed higher anxiety symptom and anxiety-related disability scores at baseline and all subsequent assessments (P values < .001). Depressed patients also displayed lower remission rates at each follow-up (P values < .001). CALM had comparable advantages over usual care for patients with and without MDD. Depressed patients displayed more severe anxiety symptoms and anxiety-related disability at baseline, but their clinical improvement was substantial and larger in magnitude than that observed in the nondepressed patients. Results support the use of empirically supported interventions for anxiety disorders in patients with co-occurring depression. ClinicalTrials.gov identifier: NCT00347269. © Copyright 2012 Physicians Postgraduate Press, Inc.

Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

PubMed

Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J

2017-03-21

A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). 10 Duke University Health System community-based primary care clinics. 537 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. The study involved 1 health care network. Data on provider referrals were not collected. Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care. National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Emergency Department Coverage by Primary Care Physicians in a Rural Practice-Based Research Network: Incentives, Confidence, and Training

ERIC Educational Resources Information Center

Lew, Edward; Fagnan, Lyle J.; Mattek, Nora; Mahler, Jo; Lowe, Robert A.

2009-01-01

Context: In rural areas of the United States, emergency departments (EDs) are often staffed by primary care physicians, as contrasted to urban and suburban hospitals where ED coverage is usually provided by physicians who are residency-trained in emergency medicine. Purpose: This study examines the reasons and incentives for rural Oregon primary…

Health IT-assisted population-based preventive cancer screening: a cost analysis.

PubMed

Levy, Douglas E; Munshi, Vidit N; Ashburner, Jeffrey M; Zai, Adrian H; Grant, Richard W; Atlas, Steven J

2015-12-01

Novel health information technology (IT)-based strategies harnessing patient registry data seek to improve care at a population level. We analyzed costs from a randomized trial of 2 health IT strategies to improve cancer screening compared with usual care from the perspective of a primary care network. Monte Carlo simulations were used to compare costs across management strategies. We assessed the cost of the software, materials, and personnel for baseline usual care (BUC) compared with augmented usual care (AUC [ie, automated patient outreach]) and augmented usual care with physician input (AUCPI [ie, outreach mediated by physicians' knowledge of their patient panels]) over 1 year. AUC and AUCPI each reduced the time physicians spent on cancer screening by 6.5 minutes per half-day clinical session compared with BUC without changing cancer screening rates. Assuming the value of this time accrues to the network, total costs of cancer screening efforts over the study year were $3.83 million for AUC, $3.88 million for AUCPI, and $4.10 million for BUC. AUC was cost-saving relative to BUC in 87.1% of simulations. AUCPI was cost-saving relative to BUC in 82.5% of simulations. Ongoing per patient costs were lower for both AUC ($35.63) and AUCPI ($35.58) relative to BUC ($39.51). Over the course of the study year, the value of reduced physician time devoted to preventive cancer screening outweighed the costs of the interventions. Primary care networks considering similar interventions will need to capture adequate physician time savings to offset the costs of expanding IT infrastructure.

Integrating palliative care with usual care of diabetic foot wounds.

PubMed

Dunning, Trisha

2016-01-01

Palliative care is a philosophy and a system for deciding care and can be used alone or integrated with usual chronic disease care. Palliative care encompasses end-of-life care. Palliative care aims to enhance quality of life, optimize function and manage symptoms including early in the course of chronic diseases. The purposes of this article are to outline palliative care and discuss how it can be integrated with usual care of diabetic foot wounds. Many people with diabetes who have foot wounds also have other comorbidities and diabetes complications such as cardiovascular and renal disease and depression, which affect medicine and other treatment choices, functional status, surgical risk and quality of life. Two broad of diabetic foot disease exist: those likely to heal but who could still benefit from integrated palliative care such as managing pain and those where healing is unlikely where palliation can be the primary focus. People with diabetes can die suddenly, although the life course is usually long with periods of stable and unstable disease. Many health professionals are reluctant to discuss palliative care or suggest people to document their end-of-life care preferences. If such preferences are not documented, the person might not achieve their desired death or place of death and health professionals and families can be confronted with difficult decisions. Palliative care can be integrated with usual foot care and is associated with improved function, better quality of life and greater patient and family satisfaction. Copyright © 2016 John Wiley & Sons, Ltd.

Care manager to control cardiovascular risk factors in primary care: the Raffaello cluster randomized trial.

PubMed

Deales, A; Fratini, M; Romano, S; Rappelli, A; Penco, M; Perna, G Piero; Beccaceci, G; Borgia, R; Palumbo, W; Magi, M; Vespasiani, G; Bronzini, M; Musilli, A; Nocciolini, M; Mezzetti, A; Manzoli, L

2014-05-01

This cluster randomized trial evaluated the efficacy of a disease and care management (D&CM) model in cardiovascular (CVD) prevention in primary care. Eligible subjects had ≥ 1 among: blood pressure ≥ 140/90 mmHg; glycated hemoglobin ≥ 7%; LDL-cholesterol ≥ 160 or ≥ 100 mg/dL (primary or secondary prevention, respectively); BMI ≥ 30; current smoking. The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans. Control group was allocated to usual-care. The main outcome was the proportion of subjects achieving recommended clinical targets for ≥ 1 of uncontrolled CVD risk factors at 12-month. During 2008-2009 we enrolled 920 subjects in the Abruzzo/Marche regions, Italy. Following the exclusion of L'Aquila due to 2009 earthquake, final analyses included 762 subjects. The primary outcome was achieved by 39.1% (95%CI: 34.2-44.2) and 25.2% (95%CI: 20.9-29.9) of subjects in the intervention and usual-care group, respectively (p < 0.001). The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension, with no differences in hypercholesterolemia, smoking status and obesity. The D&CM intervention was effective in controlling cardiovascular risk factors, in particular hypertension and diabetes. Numbers needed to treat were small. Such intervention may deserve further consideration in clinical practice. ACTRN12611000813987. Copyright © 2013 Elsevier B.V. All rights reserved.

Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial.

PubMed

Bischoff, Erik W M A; Akkermans, Reinier; Bourbeau, Jean; van Weel, Chris; Vercoulen, Jan H; Schermer, Tjard R J

2012-11-28

To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients' management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice. 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial. 15 general practices in the eastern part of the Netherlands. Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded. A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients' own initiative). The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients' management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale. 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58). Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group. Clinical trials NCT00128765.

Randomized clinical trial of an intravenous hydromorphone titration protocol versus usual care for management of acute pain in older emergency department patients.

PubMed

Chang, Andrew K; Bijur, Polly E; Davitt, Michelle; Gallagher, E John

2013-09-01

Opioid titration is an effective strategy for treating pain; however, titration is generally impractical in the busy emergency department (ED) setting. Our objective was to test a rapid, two-step, hydromorphone titration protocol against usual care in older patients presenting to the ED with acute severe pain. This was a prospective, randomized clinical trial of patients 65 years of age and older presenting to an adult, urban, academic ED with acute severe pain. The study was registered at http://www.clinicaltrials.gov (NCT01429285). Patients randomized to the hydromorphone titration protocol initially received 0.5 mg intravenous hydromorphone. Patients randomized to usual care received any dose of any intravenous opioid. At 15 min, patients in both groups were asked, 'Do you want more pain medication?' Patients in the hydromorphone titration group who answered 'yes' received a second dose of 0.5 mg intravenous hydromorphone. Patients in the usual care group who answered 'yes' had their ED attending physician notified, who then could administer any (or no) additional medication. The primary efficacy outcome was satisfactory analgesia defined a priori as the patient declining additional analgesia at least once when asked at 15 or 60 min after administration of the initial opioid. Dose was calculated in morphine equivalent units (MEU: 1 mg hydromorphone = 7 mg morphine). The need for naloxone to reverse adverse opioid effects was the primary safety outcome. 83.0 % of 153 patients in the hydromorphone titration group achieved satisfactory analgesia compared with 82.5 % of 166 patients in the usual care group (p = 0.91). Patients in the hydromorphone titration group received lower mean initial doses of opioids at baseline than patients in the usual care group (3.5 MEU vs. 4.7 MEU, respectively; p ≤ 0.001) and lower total opioids through 60 min (5.3 MEU vs. 6.0 MEU; p = 0.03). No patient needed naloxone. Low-dose titration of intravenous hydromorphone in increments of 0.5 mg provides comparable analgesia to usual care with less opioid over 60 min.

Post-Hospital Discharge Care: A Retrospective Cohort Study Exploring the Value of Pharmacist-Enhanced Care and Describing Medication-Related Problems.

PubMed

Hawes, Emily M; Pinelli, Nicole R; Sanders, Kimberly A; Lipshutz, Andrew M; Tong, Gretchen; Sievers, Lauren S; Chao, Sarah; Gwynne, Mark

2018-01-01

BACKGROUND Medication-related problems occur at high rates during care transitions. Evidence suggests that pharmacists are well-suited to identify and resolve medication-related problems during hospital admission and at discharge. Additional evidence is needed to understand the impact of face-to-face pharmacist visits in primary care after discharge. The purpose of the study was to describe medication-related problems found during face-to-face pharmacist visits in a medical home after hospital discharge. METHODS A retrospective cohort study was conducted within an academic primary care center staffed by family medicine trained physicians that evaluated patients who attended a hospital follow-up visit with pharmacist-enhanced care (N = 86) versus usual care (N = 86). The primary objective was to describe medication-related problems identified by pharmacists using a modified individualized Medication Assessment and Planning tool for patients receiving pharmacist-enhanced care. Secondary analyses were also conducted to compare 30-day and 60-day hospital readmission and emergency department visit rates in those exposed to pharmacist-enhanced care versus those who were not. RESULTS At baseline, the mean hospitalizations in the prior year were 1.1 ± 1.7 (pharmacist-enhanced care) and 0.76 ± 1.2 (usual care), indicating a low initial readmission risk. Of patients receiving pharmacist-enhanced care, 97.7% were found to have at least 1 medication-related problem, with an average of 4.36 medication-related problems per patient. The 30-day readmission rate was lower, but not significantly different between groups (8.1% for pharmacist-enhanced care versus 12.8% for usual care; adjusted odds ratio (OR), 0.47; 95% confidence interval (CI), 0.16-1.36). LIMITATIONS Limitations include the retrospective cohort study design and small sample size. Medication-related problems were identified and collected prospectively during pharmacist visits. CONCLUSION Medication-related problems are ubiquitous after hospital discharge. Larger prospective studies will be needed to understand the potential value of pharmacist-enhanced care during hospital follow-up visits on readmission rates in low-risk patient populations receiving care within a primary care medical home. ©2018 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.

Intention to Discontinue Care Among Primary Care Patients

PubMed Central

Federman, Alex D; Cook, E Francis; Phillips, Russell S; Puopolo, Ann Louise; Haas, Jennifer S; Brennan, Troyen A; Burstin, Helen R

2001-01-01

BACKGROUND Specific elements of health care process and physician behavior have been shown to influence disenrollment decisions in HMOs, but not in outpatient settings caring for patients with diverse types of insurance coverage. OBJECTIVE To examine whether physician behavior and process of care affect patients' intention to return to their usual health care practice. DESIGN Cross-sectional patient survey and medical record review. SETTING Eleven academically affiliated primary care medicine practices in the Boston area. PATIENTS 2,782 patients with at least one visit in the preceding year. MEASUREMENT Unwillingness to return to the usual health care practice. RESULTS Of the 2,782 patients interviewed, 160 (5.8%) indicated they would not be willing to return. Two variables correlated significantly with unwillingness to return after adjustment for demographics, health status, health care utilization, satisfaction with physician's technical skill, site of care, and clustering of patients by provider: dissatisfaction with visit duration (odds ratio [OR], 3.2; 95% confidence interval [CI], 1.4 to 7.4) and patient reports that the physician did not listen to what the patient had to say (OR, 8.8; 95% CI, 2.5 to 30.7). In subgroup analysis, patients who were prescribed medications at their last visit but who did not receive an explanation of the purpose of the medication were more likely to be unwilling to return (OR, 4.9; 95% CI, 1.8 to 13.3). CONCLUSION Failure of physicians to acknowledge patient concerns, provide explanations of care, and spend sufficient time with patients may contribute to patients' decisions to discontinue care at their usual site of care. PMID:11679034

Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life.

PubMed

Lambeek, Ludeke C; van Mechelen, Willem; Knol, Dirk L; Loisel, Patrick; Anema, Johannes R

2010-03-16

To evaluate the effectiveness of an integrated care programme, combining a patient directed and a workplace directed intervention, for patients with chronic low back pain. Population based randomised controlled trial. Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals). 134 adults aged 18-65 sick listed for at least 12 weeks owing to low back pain. Patients were randomly assigned to usual care (n=68) or integrated care (n=66). Integrated care consisted of a workplace intervention based on participatory ergonomics, involving a supervisor, and a graded activity programme based on cognitive behavioural principles. The primary outcome was the duration of time off work (work disability) due to low back pain until full sustainable return to work. Secondary outcome measures were intensity of pain and functional status. The median duration until sustainable return to work was 88 days in the integrated care group compared with 208 days in the usual care group (P=0.003). Integrated care was effective on return to work (hazard ratio 1.9, 95% confidence interval 1.2 to 2.8, P=0.004). After 12 months, patients in the integrated care group improved significantly more on functional status compared with patients in the usual care group (P=0.01). Improvement of pain between the groups did not differ significantly. The integrated care programme substantially reduced disability due to chronic low back pain in private and working life. Trial registration Current Controlled Trials ISRCTN28478651.

Telemonitoring based service redesign for the management of uncontrolled hypertension: multicentre randomised controlled trial

PubMed Central

Hanley, Janet; Wild, Sarah; Pagliari, Claudia; Paterson, Mary; Lewis, Steff; Sheikh, Aziz; Krishan, Ashma; Stoddart, Andrew; Padfield, Paul

2013-01-01

Objective To determine if an intervention consisting of telemonitoring and supervision by usual primary care clinicians of home self measured blood pressure and optional patient decision support leads to clinically important reductions in daytime systolic and diastolic ambulatory blood pressure in patients with uncontrolled blood pressure. Design Multicentre randomised controlled trial. Setting 20 primary care practices in south east Scotland. Participants 401 people aged 29-95 years with uncontrolled blood pressure (mean daytime ambulatory measurement ≥135/85 mm Hg but ≤210/135 mm Hg). Intervention Self measurement and transmission of blood pressure readings to a secure website for review by the attending nurse or doctor and participant, with optional automated patient decision support by text or email for six months. Main outcome measures Blinded assessment of mean daytime systolic ambulatory blood pressure six months after randomisation. Results 200 participants were randomised to the intervention and 201 to usual care; primary outcome data were available for 90% of participants (182 and 177, respectively). The mean difference in daytime systolic ambulatory blood pressure adjusted for baseline and minimisation factors between intervention and usual care was 4.3 mm Hg (95% confidence interval 2.0 to 6.5; P=0.0002) and for daytime diastolic ambulatory blood pressure was 2.3 mm Hg (0.9 to 3.6; P=0.001), with higher values in the usual care group. The intervention was associated with a mean increase of one general practitioner (95% confidence interval 0.5 to 1.6; P=0.0002) and 0.6 (0.1 to 1.0; P=0.01) practice nurse consultations during the course of the study. Conclusions Supported self monitoring by telemonitoring is an effective method for achieving clinically important reductions in blood pressure in patients with uncontrolled hypertension in primary care settings. However, it was associated with increase in use of National Health Service resources. Further research is required to determine if the reduction in blood pressure is maintained in the longer term and if the intervention is cost effective. Trial registration Current Controlled Trials ISRCTN72614272. PMID:23709583

Systematic review of the effectiveness of primary care nursing.

PubMed

Keleher, Helen; Parker, Rhian; Abdulwadud, Omar; Francis, Karen

2009-02-01

This paper reports on a systematic review that sought to answer the research question: What is the impact of the primary and community care nurse on patient health outcomes compared with usual doctor-led care in primary care settings? A range of pertinent text-words with medical subject headings were combined and electronic databases were searched. Because of the volume of published articles, the search was restricted to studies with high-level evidence. Overall, 31 relevant studies were identified and included in the review. We found modest international evidence that nurses in primary care settings can provide effective care and achieve positive health outcomes for patients similar to that provided by doctors. Nurses are effective in care management and achieve good patient compliance. Nurses are also effective in a more diverse range of roles including chronic disease management, illness prevention and health promotion. Nevertheless, there is insufficient evidence about primary care nurses' roles and impact on patient health outcomes.

Effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: A pragmatic cluster randomized controlled trial.

PubMed

Pols, Alide D; van Dijk, Susan E; Bosmans, Judith E; Hoekstra, Trynke; van Marwijk, Harm W J; van Tulder, Maurits W; Adriaanse, Marcel C

2017-01-01

Given the public health significance of poorly treatable co-morbid major depressive disorders (MDD) among patients with type 2 diabetes mellitus (DM2) and coronary heart disease (CHD), we need to investigate whether strategies to prevent the development of major depression could reduce its burden of disease. We therefore evaluated the effectiveness of a stepped-care program for subthreshold depression in comparison with usual care in patients with DM2 and/or CHD. A cluster randomized controlled trial, with 27 primary care centers serving as clusters. A total of 236 DM2 and/or CHD patients with subthreshold depression (nine item Patient Health Questionnaire (PHQ-9) score ≥ 6, no current MDD according to DSM-IV criteria) were allocated to the intervention group (N = 96) or usual care group (n = 140). The stepped-care program was delivered by trained practice nurses during one year and consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to the general practitioner. The primary outcome was the 12-month cumulative incidence of MDD as measured with the Mini International Neuropsychiatric Interview (MINI). Secondary outcomes included severity of depression (measured by PHQ-9) at 3, 6, 9 and 12 months. Of 236 patients (mean age, 67,5 (SD 10) years; 54.7% men), 210 (89%) completed the MINI at 12 months. The cumulative incidence of MDD was 9 of 89 (10.1%) participants in the intervention group and 12 of 121 (9.9%) participants in the usual care group. We found no statistically significant overall effect of the intervention (OR = 1.21; 95% confidence interval (0.12 to 12.41)) and there were no statistically significant differences in the course or severity of depressive symptoms between the two groups. This study suggest that Step-Dep was not more effective in preventing MDD than usual care in a primary care population with DM2 and/or CHD and subthreshold depression.

Protocolized fluid therapy in brain-dead donors: The multi-center randomized MOnIToR trial

PubMed Central

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S.; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-01-01

BACKGROUND Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multi-center randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases organs transplanted. METHODS We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A “protocol-guided fluid therapy” algorithm targeting cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor and our primary analysis was intention-to-treat. Secondary analyses included: 1) modified intention-to-treat where only subjects able to receive the intervention were included, and 2) twelve-month survival in transplant recipients. The study was stopped early. RESULTS We enrolled 556 donors; 279 protocolized care, 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76% of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor, (95%CI: 3.14-3.63) with protocolized care, compared to usual care 3.29 (95%CI: 3.04-3.54) (mean difference, 0.1, 95%CI: -0.25 to 0.45; p=0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95%CI: 3.23-3.8) but was not statistically significant (mean difference, 0.23, 95%CI: -0.15-0.61; p=0.23). Among the 1430 recipients of organs from study subjects, with data available, 56 deaths (7.8%) occurred in the protocolized care arm and 56 (7.9%) in the usual care arm in the first year (Hazard Ratio: 0.97, p=0.86). CONCLUSIONS In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor. PMID:25583616

Multidisciplinary outpatient care program for patients with chronic low back pain: design of a randomized controlled trial and cost-effectiveness study [ISRCTN28478651].

PubMed

Lambeek, Ludeke C; Anema, Johannes R; van Royen, Barend J; Buijs, Peter C; Wuisman, Paul I; van Tulder, Maurits W; van Mechelen, Willem

2007-09-20

Chronic low back pain (LBP) is a major public and occupational health problem, which is associated with very high costs. Although medical costs for chronic LBP are high, most costs are related to productivity losses due to sick leave. In general, the prognosis for return to work (RTW) is good but a minority of patients will be absent long-term from work. Research shows that work related problems are associated with an increase in seeking medical care and sick leave. Usual medical care of patients is however, not specifically aimed at RTW. The objective is to present the design of a randomized controlled trial, i.e. the BRIDGE-study, evaluating the effectiveness in improving RTW and cost-effectiveness of a multidisciplinary outpatient care program situated in both primary and outpatient care setting compared with usual clinical medical care for patients with chronic LBP. The design is a randomized controlled trial with an economic evaluation alongside. The study population consists of patients with chronic LBP who are completely or partially sick listed and visit an outpatient clinic of one of the participating hospitals in Amsterdam (the Netherlands). Two interventions will be compared. 1. a multidisciplinary outpatient care program consisting of a workplace intervention based on participatory ergonomics, and a graded activity program using cognitive behavioural principles. 2. usual care provided by the medical specialist, the occupational physician, the patient's general practitioner and allied health professionals. The primary outcome measure is sick leave duration until full RTW. Sick leave duration is measured monthly by self-report during one year. Data on sick leave during one-year follow-up are also requested form the employers. Secondary outcome measures are pain intensity, functional status, pain coping, patient satisfaction and quality of life. Outcome measures are assessed before randomization and 3, 6, and 12 months later. All statistical analysis will be performed according to the intension-to-treat principle. Usual care of primary and outpatient health services isn't directly aimed at RTW, therefore it is desirable to look for care which is aimed at RTW. Research shows that several occupational interventions in primary care are aimed at RTW. They have shown a significant reduction of sick leave for employee with LBP. If a comparable reduction of sick leave duration of patients with chronic LBP of who attend an outpatient clinic can be achieved, such reductions will be obviously substantial for the Netherlands and will have a considerable impact.

Evaluation of a combined lifestyle intervention for overweight and obese patients in primary health care: a quasi-experimental design.

PubMed

Verberne, Lisa D M; Hendriks, Marike R C; Rutten, Geert M; Spronk, Inge; Savelberg, Hans H C M; Veenhof, Cindy; Nielen, Mark M J

2016-12-01

Combined lifestyle interventions (CLIs) are designed to reduce risk factors for lifestyle-related diseases through increasing physical activity and improvement of dietary behaviour. To evaluate the effects of a CLI for overweight and obese patients on lifestyle-related risk factors and health care consumption, in comparison to usual care. Data on anthropometric and metabolic measurements, morbidity, drugs prescriptions and general practitioner (GP) consultations were extracted from electronic health records (timeframe: July 2009-August 2013). Using a quasi-experimental design, health outcomes of 127 patients who participated in a 1-year CLI were compared to a group of 254 matched patients that received usual care. Baseline to post-intervention changes in health outcomes between intervention and comparison group were evaluated using mixed model analyses. Compared to baseline, both groups showed reductions in body mass index (BMI), blood pressure, total cholesterol and low density lipoprotein cholesterol in year post-intervention. For these outcome measures, no significant differences in changes were observed between intervention and comparison group. A significant improvement of 0.08 mmol/l in high density lipoprotein (HDL) cholesterol was observed for the intervention group above the comparison group (P < 0.01). No significant intergroup differences were shown in drugs prescriptions and number of GP consultations. A CLI for overweight and obese patients in primary health care resulted in similar effects on health outcomes compared to usual care. Only an improvement on HDL cholesterol was shown. This study indicates that implementation and evaluation of a lifestyle intervention in primary health care is challenging due to political and financial barriers. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Costs of exacerbations of chronic obstructive pulmonary disease in primary and secondary care in 2007--results of multicenter Polish study].

PubMed

Jahnz-Rózyk, Karina; Targowski, Tomasz; From, Sławomir

2009-03-01

Exacerbations are the key drivers of the costs of chronic obstructive pulmonary disease (COPD). This was the multicenter study of patients with COPD aimed at evaluating direct and indirect cost of exacerbations under usual clinical practice in primary and secondary care form societal perspective. It was observational, multicenter study with participation of 196 subjects with moderate or severe COPD, defined according to the current GOLD criteria. Patients presenting at the selected health care centres were included into the study in the sequential manner if they fulfilled the inclusion criteria. Exacerbations were divided into three different severity types according to Anthonisen N.R. classification. The management of exacerbations followed the usual clinical practice. The number of exacerbations was 3.8 (3.2-4.4) in hospitalised patients and 1.7 (1.4-1.9) in ambulatory treated patients (1EURO was 3.85 PLN in 2007). The average direct health-care cost per exacerbation was PLN 5548 (95% CI = 4543; 6502) and PLN 524.1 (95% CI = 443; 614) in secondary and primary care respectively. In secondary care, the drug acquisition and oxygen therapy cost represented 18.3% of total direct costs, diagnostic tests costs accounted for 14.5%, the other hospital care and post-discharge followup visit costs 67%. Costs varied considerably with the severity of COPD before the exacerbation as well as the duration of COPD. In primary care the cost structure was as follows: diagnostic tests and medical devices 47.5%, drug acquisition costs 41% and doctors visits 11.4%. The average indirect costs per exacerbation were PLN 127.78 and PLN 100.56, in secondary and primary respectively (n.s) Exacerbations of COPD are costly. Cost of exacerbation managed in secondary care is almost 10-fold higher than in primary care. Prevention of moderate-to-severe exacerbations, requiring hospitalization could be very cost-effective strategy.

Longer wait times affect future use of VHA primary care.

PubMed

Wong, Edwin S; Liu, Chuan-Fen; Hernandez, Susan E; Augustine, Matthew R; Nelson, Karin; Fihn, Stephan D; Hebert, Paul L

2017-07-29

Improving access to the Veterans Health Administration (VHA) is a high priority, particularly given statutory mandates of the Veterans Access, Choice and Accountability Act. This study examined whether patient-reported wait times for VHA appointments were associated with future reliance on VHA primary care services. This observational study examined 13,595 VHA patients dually enrolled in fee-for-service Medicare. Data sources included VHA administrative data, Medicare claims and the Survey of Healthcare Experiences of Patients (SHEP). Primary care use was defined as the number of face-to-face visits from VHA and Medicare in the 12 months following SHEP completion. VHA reliance was defined as the number of VHA visits divided by total visits (VHA+Medicare). Wait times were derived from SHEP responses measuring the usual number of days to a VHA appointment with patients' primary care provider for those seeking immediate care. We defined appointment wait times categorically: 0 days, 1day, 2-3 days, 4-7 days and >7 days. We used fractional logistic regression to examine the relationship between wait times and reliance. Mean VHA reliance was 88.1% (95% CI = 86.7% to 89.5%) for patients reporting 0day waits. Compared with these patients, reliance over the subsequent year was 1.4 (p = 0.041), 2.8 (p = 0.001) and 1.6 (p = 0.014) percentage points lower for patients waiting 2-3 days, 4-7 days and >7 days, respectively. Patients reporting longer usual wait times for immediate VHA care exhibited lower future reliance on VHA primary care. Longer wait times may reduce care continuity and impact cost shifting across two federal health programs. Copyright © 2017. Published by Elsevier Inc.

Effectiveness and cost effectiveness of counselling in primary care.

PubMed

Bower, P; Rowland, N; Mellor, C l; Heywood, P; Godfrey, C; Hardy, R

2002-01-01

Counsellors are prevalent in primary care settings. However, there are concerns about the clinical and cost-effectiveness of the treatments they provide, compared with alternatives such as usual care from the general practitioner, medication or other psychological therapies. To assess the effectiveness and cost effectiveness of counselling in primary care by reviewing cost and outcome data in randomised controlled trials, controlled clinical trials and controlled patient preference trials of counselling interventions in primary care, for patients with psychological and psychosocial problems considered suitable for counselling. The original search strategy included electronic searching of databases (including the CCDAN Register of RCTs and CCTs) along with handsearching of a specialist journal. Published and unpublished sources (clinical trials, books, dissertations, agency reports etc.) were searched, and their reference lists scanned to uncover further controlled trials. Contact was made with subject experts and CCDAN members in order to uncover further trials. For the updated review, searches were restricted to those databases judged to be high yield in the first version of the review: MEDLINE, EMBASE, PSYCLIT and CINAHL, the Cochrane Controlled Trials register and the CCDAN trials register. All controlled trials comparing counselling in primary care with other treatments for patients with psychological and psychosocial problems considered suitable for counselling. Trials completed before the end of June 2001 were included in the review. Data were extracted using a standardised data extraction sheet. The relevant data were entered into the Review Manager software. Trials were quality rated, using CCDAN criteria, to assess the extent to which their design and conduct were likely to have prevented systematic error. Continuous measures of outcome were combined using standardised mean differences. An overall effect size was calculated for each outcome with 95% confidence intervals. Continuous data from different measuring instruments were transformed into a standard effect size by dividing mean values by standard deviations. In view of the diversity of counselling services in primary care (the range of treatments, patients and practitioners) tests of heterogeneity were done to assess the feasibility of aggregating measures of outcome from trials. Sensitivity analyses were undertaken to test the robustness of the results. Seven trials were included in the review. The main analyses showed significantly greater clinical effectiveness in the counselling group compared with 'usual care' in the short-term (standardised mean difference -0.28, 95% CI -0.43 to -0.13, n=772, 6 trials) but not the long-term (standardised mean difference -0.09, 95% CI -0.27 to 0.10, n=475, 4 trials). Levels of satisfaction with counselling were high. Four studies reported similar total costs associated with counselling and usual care over the long-term. However, the economic analyses were likely to be underpowered. Counselling is associated with modest improvement in short-term outcome compared to 'usual care', but provides no additional advantages in the long-term. Patients are satisfied with counselling, and it may not be associated with increased costs.

Impact of a pharmacist-physician collaborative care model on patient outcomes and health services utilization.

PubMed

Matzke, Gary R; Moczygemba, Leticia R; Williams, Karen J; Czar, Michael J; Lee, William T

2018-05-22

The impact of a pharmacist-physician collaborative care model on patient outcomes and health services utilization is described. Six hospitals from the Carilion Clinic health system in southwest Virginia, along with 22 patient-centered medical home (PCMH) practices affiliated with Carilion Clinic, participated in this project. Eligibility criteria included documented diagnosis of 2 or more of the 7 targeted chronic conditions (congestive heart failure, hypertension, hyperlipidemia, diabetes mellitus, asthma, chronic obstructive pulmonary disease, and depression), prescriptions for 4 or more medications, and having a primary care physician in the Carilion Clinic health system. A total of 2,480 evaluable patients were included in both the collaborative care group and the usual care group. The primary clinical outcomes measured were the absolute change in values associated with diabetes mellitus, hypertension, and hyperlipidemia management from baseline within and between the collaborative care and usual care groups. Significant improvements ( p < 0.01) in glycosylated hemoglobin, blood pressure, low-density-lipoprotein cholesterol, and total cholesterol were observed in the collaborative care group compared with the usual care group. Hospitalizations declined significantly in the collaborative care group (23.4%), yielding an estimated cost savings of $2,619 per patient. The return on investment (net savings divided by program cost) was 504%. Inclusion of clinical pharmacists in this physician-pharmacist collaborative care-based PCMH model was associated with significant improvements in patients' medication-related clinical health outcomes and a reduction in hospitalizations. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients.

PubMed

Walker, Jane; Cassidy, Jim; Sharpe, Michael

2009-03-30

Depression Care for People with Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. In a 'proof of concept' trial (Symptom Management Research Trials in Oncology-1) Depression Care for People with Cancer improved depression more than usual care alone. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2 Trial) will test its effectiveness and cost-effectiveness in a 'real world' setting. A two arm parallel group multi-centre randomised controlled trial. TRIAL PROCEDURES: 500 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of cancer (of various types); an estimated life expectancy of twelve months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is 'treatment response' measured at 24 week outcome data collection. 'Treatment response' will be defined as a reduction of 50% or more in the patient's baseline depression score, measured using the 20-item Symptom Checklist (SCL-20D). Secondary outcomes include remission of major depressive disorder, depression severity and patients' self-rated improvement of depression. Current controlled trials ISRCTN40568538 TRIAL HYPOTHESES: (1) Depression Care for People with Cancer as a supplement to usual care will be more effective than usual care alone in achieving a 50% reduction in baseline SCL-20D score at 24 weeks. (2) Depression Care for People with Cancer as a supplement to usual care will cost more than usual care alone but will be more cost effective in achieving improvements in patients' depression and quality of life.

Randomized controlled trial of a health plan-level mood disorders psychosocial intervention for solo or small practices.

PubMed

Kilbourne, Amy M; Nord, Kristina M; Kyle, Julia; Van Poppelen, Celeste; Goodrich, David E; Kim, Hyungjin Myra; Eisenberg, Daniel; Un, Hyong; Bauer, Mark S

2014-01-01

Mood disorders represent the most expensive mental disorders for employer-based commercial health plans. Collaborative care models are effective in treating chronic physical and mental illnesses at little to no net healthcare cost, but to date have primarily been implemented by larger healthcare organizations in facility-based models. The majority of practices providing commercially insured care are far too small to implement such models. Health plan-level collaborative care treatment can address this unmet need. The goal of this study is to implement at the national commercial health plan level a collaborative care model to improve outcomes for persons with mood disorders. A randomized controlled trial of a collaborative care model versus usual care will be conducted among beneficiaries of a large national health plan from across the country seen by primary care or behavioral health practices. At discharge 344 patients identified by health plan claims as hospitalized for unipolar depression or bipolar disorder will be randomized to receive collaborative care (patient phone-based self-management support, care management, and guideline dissemination to practices delivered by a plan-level care manager) or usual care from their provider. Primary outcomes are changes in mood symptoms and mental health-related quality of life at 12 months. Secondary outcomes include rehospitalization, receipt of guideline-concordant care, and work productivity. This study will determine whether a collaborative care model for mood disorders delivered at the national health plan level improves outcomes compared to usual care, and will inform a business case for collaborative care models for these settings that can reach patients wherever they receive treatment. ClinicalTrials.gov Identifier: NCT02041962; registered January 3, 2014.

Does capitation matter? Impacts on access, use, and quality.

PubMed

Zuvekas, Samuel H; Hill, Steven C

2004-01-01

Provider capitation may constrain costs, but it also may reduce access and quality of care. We examine the impacts of capitating the usual source of care of enrollees in health maintenance organizations (HMOs). We account for the endogeneity of capitation and other characteristics using generalized methods of moments (GMM) estimation on a sample from the Medical Expenditure Panel Survey for 1996 and 1997. Being organized as a group/staff HMO generally has stronger impact on access and quality than capitation. Capitation by itself may increase access to consumers' usual sources of care, improve primary preventive care, and reduce coordination, but estimates with GMM were not statistically significant.

Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial.

PubMed

Kruis, Annemarije L; Boland, Melinde R S; Assendelft, Willem J J; Gussekloo, Jacobijn; Tsiachristas, Apostolos; Stijnen, Theo; Blom, Coert; Sont, Jacob K; Rutten-van Mölken, Maureen P H M; Chavannes, Niels H

2014-09-10

To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. 24 month, multicentre, pragmatic cluster randomised controlled trial 40 general practices in the western part of the Netherlands Patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. General practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines). The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes. Of a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference -0.01, 95% confidence interval -0.10 to 0.08; P=0.8). After 12 months, no differences were seen in secondary outcomes between groups, except for the PACIC domain "follow-up/coordination" (indicating improved integration of care) and proportion of physically active patients. Exacerbation rates as well as number of days in hospital did not differ between groups. After 24 months, no differences were seen in outcomes, except for the PACIC follow-up/coordination domain. In this pragmatic study, an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care, except improved level of integrated care and a self reported higher degree of daily activities. The contradictory findings to earlier positive studies could be explained by differences between interventions (provider versus patient targeted), selective reporting of positive trials, or little room for improvement in the already well developed Dutch healthcare system. Netherlands Trial Register NTR2268. © Kruis et al 2014.

Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial.

PubMed

Han, Ji Won; Son, Kyung Lak; Byun, Hye Jin; Ko, Ji Won; Kim, Kayoung; Hong, Jong Woo; Kim, Tae Hyun; Kim, Ki Woong

2017-06-06

Spaced retrieval training (SRT) is a nonpharmacological intervention for mild cognitive impairment (MCI) and dementia that trains the learning and retention of target information by recalling it over increasingly long intervals. We recently developed the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program as a convenient, self-administered tablet-based SRT program. We also demonstrated the utility of USMART for improving memory in individuals with MCI through an open-label uncontrolled trial. This study had an open-label, single-blind, randomized, controlled, two-period crossover design. Fifty patients with MCI were randomized into USMART-usual care and usual care-USMART treatment sequences. USMART was completed or usual care was provided biweekly over a 4-week treatment period with a 2-week washout period between treatment periods. Primary outcome measures included the Word List Memory Test, Word List Recall Test (WLRT), and Word List Recognition Test. Outcomes were measured at baseline, week 5, and week 11 by raters who were blinded to intervention type. An intention-to-treat analysis and linear mixed modeling were used. Of 50 randomized participants, 41 completed the study (18% dropout rate). The USMART group had larger improvements in WLRT score (effect size = 0.49, p = 0.031) than the usual care group. There were no significant differences in other primary or secondary measures between the USMART and usual care groups. Moreover, no USMART-related adverse events were reported. The 4-week USMART modestly improved information retrieval in older people with MCI, and was well accepted with minimal technical support. ClinicalTrials.gov NCT01688128 . Registered 12 September 2012.

Clinical effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: the CoBalT randomised controlled trial.

PubMed

Wiles, Nicola; Thomas, Laura; Abel, Anna; Barnes, Maria; Carroll, Fran; Ridgway, Nicola; Sherlock, Sofie; Turner, Nicholas; Button, Katherine; Odondi, Lang'o; Metcalfe, Chris; Owen-Smith, Amanda; Campbell, John; Garland, Anne; Hollinghurst, Sandra; Jerrom, Bill; Kessler, David; Kuyken, Willem; Morrison, Jill; Turner, Katrina; Williams, Chris; Peters, Tim; Lewis, Glyn

2014-05-01

Only one-third of patients with depression respond fully to treatment with antidepressant medication. However, there is little robust evidence to guide the management of those whose symptoms are 'treatment resistant'. The CoBalT trial examined the clinical effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment-resistant depression (TRD) compared with usual care alone. Pragmatic, multicentre individually randomised controlled trial with follow-up at 3, 6, 9 and 12 months. A subset took part in a qualitative study investigating views and experiences of CBT, reasons for completing/not completing therapy, and usual care for TRD. General practices in Bristol, Exeter and Glasgow, and surrounding areas. Patients aged 18-75 years who had TRD [on antidepressants for ≥ 6 weeks, had adhered to medication, Beck Depression Inventory, 2nd version (BDI-II) score of ≥ 14 and fulfilled the International Classification of Diseases and Related Health Problems, Tenth edition criteria for depression]. Individuals were excluded who (1) had bipolar disorder/psychosis or major alcohol/substance abuse problems; (2) were unable to complete the questionnaires; or (3) were pregnant, as were those currently receiving CBT/other psychotherapy/secondary care for depression, or who had received CBT in the past 3 years. Participants were randomised, using a computer-generated code, to usual care or CBT (12-18 sessions) in addition to usual care. The primary outcome was 'response', defined as ≥ 50% reduction in depressive symptoms (BDI-II score) at 6 months compared with baseline. Secondary outcomes included BDI-II score as a continuous variable, remission of symptoms (BDI-II score of < 10), quality of life, anxiety and antidepressant use at 6 and 12 months. Data on health and social care use, personal costs, and time off work were collected at 6 and 12 months. Costs from these three perspectives were reported using a cost-consequence analysis. A cost-utility analysis compared health and social care costs with quality adjusted life-years. A total of 469 patients were randomised (intervention: n = 234; usual care: n = 235), with 422 participants (90%) and 396 (84%) followed up at 6 and 12 months. Ninety-five participants (46.1%) in the intervention group met criteria for 'response' at 6 months compared with 46 (21.6%) in the usual-care group {odds ratio [OR] 3.26 [95% confidence interval (CI) 2.10 to 5.06], p < 0.001}. In repeated measures analyses using data from 6 and 12 months, the OR for 'response' was 2.89 (95% CI 2.03 to 4.10, p < 0.001) and for a secondary 'remission' outcome (BDI-II score of < 10) 2.74 (95% CI 1.82 to 4.13, p < 0.001). The mean cost of CBT per participant was £ 910, the incremental health and social care cost £ 850, the incremental QALY gain 0.057 and incremental cost-effectiveness ratio £ 14,911. Forty participants were interviewed. Patients described CBT as challenging but helping them to manage their depression; listed social, emotional and practical reasons for not completing treatment; and described usual care as mainly taking medication. Among patients who have not responded to antidepressants, augmenting usual care with CBT is effective in reducing depressive symptoms, and these effects, including outcomes reflecting remission, are maintained over 12 months. The intervention was cost-effective based on the National Institute for Health and Care Excellence threshold. Patients may experience CBT as difficult but effective. Further research should evaluate long-term effectiveness, as this would have major implications for the recommended treatment of depression. Current Controlled Trials ISRCTN38231611.

Collection of family health history for assessment of chronic disease risk in primary care.

PubMed

Powell, Karen P; Christianson, Carol A; Hahn, Susan E; Dave, Gaurav; Evans, Leslie R; Blanton, Susan H; Hauser, Elizabeth; Agbaje, Astrid; Orlando, Lori A; Ginsburg, Geoffrey S; Henrich, Vincent C

2013-01-01

Family health history can predict a patient's risk for common complex diseases. This project assessed the completeness of family health history data in medical charts and evaluated the utility of these data for performing risk assessments in primary care. Family health history data were collected and analyzed to determine the presence of quality indicators that are necessary for effective and accurate assessment of disease risk. More than 99% of the 390 paper charts analyzed contained information about family health history, which was usually scattered throughout the chart. Information on the health of the patient's parents was collected more often than information on the health of other relatives. Key information that was often not collected included age of disease onset, affected side of the family, and second-degree relatives affected. Less than 4% of patient charts included family health histories that were informative enough to accurately assess risk for common complex diseases. Limitations of this study include the small number of charts reviewed per provider, the fact that the sample consisted of primary care providers in a single geographic location, and the inability to assess ethnicity, consanguinity, and other indicators of the informativeness of family health history. The family health histories collected in primary care are usually not complete enough to assess the patient's risk for common complex diseases. This situation could be improved with use of tools that analyze the family health history information collected and provide risk-stratified decision support recommendations for primary care.

Effects of Structured Versus Usual Care on Renal Endpoint in Type 2 Diabetes: The SURE Study

PubMed Central

Chan, Juliana C.; So, Wing-Yee; Yeung, Chun-Yip; Ko, Gary T.; Lau, Ip-Tim; Tsang, Man-Wo; Lau, Kam-Piu; Siu, Sing-Chung; Li, June K.; Yeung, Vincent T.; Leung, Wilson Y.; Tong, Peter C.

2009-01-01

OBJECTIVE Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes. We hypothesized that structured care would reduce renal complications in type 2 diabetes. RESEARCH DESIGN AND METHODS A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150–350 μmol/l were randomly assigned to receive structured care (n = 104) or usual care (n = 101) for 2 years. The structured care group was managed according to a prespecified protocol with the following treatment goals: blood pressure <130/80 mmHg, A1C <7%, LDL cholesterol <2.6 mmol/l, triglyceride <2 mmol/l, and persistent treatment with renin-angiotensin blockers. The primary end point was death and/or renal end point (creatinine >500 μmol/l or dialysis). RESULTS Of these 205 patients (mean ± SD age 65 ± 7.2 years; disease duration 14 ± 7.9 years), the structured care group achieved better control than the usual care group (diastolic blood pressure 68 ± 12 vs. 71 ± 12 mmHg, respectively, P = 0.02; A1C 7.3 ± 1.3 vs. 8.0 ± 1.6%, P < 0.01). After adjustment for age, sex, and study sites, the structured care (23.1%, n = 24) and usual care (23.8%, n = 24; NS) groups had similar end points, but more patients in the structured care group attained ≥3 treatment goals (61%, n = 63, vs. 28%, n = 28; P < 0.001). Patients who attained ≥3 treatment targets (n = 91) had reduced risk of the primary end point (14 vs. 34; relative risk 0.43 [95% CI 0.21–0.86] compared with that of those who attained ≤2 targets (n = 114). CONCLUSIONS Attainment of multiple treatment targets reduced the renal end point and death in type 2 diabetes. In addition to protocol, audits and feedback are needed to improve outcomes. PMID:19460913

Effects of structured versus usual care on renal endpoint in type 2 diabetes: the SURE study: a randomized multicenter translational study.

PubMed

Chan, Juliana C; So, Wing-Yee; Yeung, Chun-Yip; Ko, Gary T; Lau, Ip-Tim; Tsang, Man-Wo; Lau, Kam-Piu; Siu, Sing-Chung; Li, June K; Yeung, Vincent T; Leung, Wilson Y; Tong, Peter C

2009-06-01

Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes. We hypothesized that structured care would reduce renal complications in type 2 diabetes. A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150-350 micromol/l were randomly assigned to receive structured care (n = 104) or usual care (n = 101) for 2 years. The structured care group was managed according to a prespecified protocol with the following treatment goals: blood pressure <130/80 mmHg, A1C <7%, LDL cholesterol <2.6 mmol/l, triglyceride <2 mmol/l, and persistent treatment with renin-angiotensin blockers. The primary end point was death and/or renal end point (creatinine >500 micromol/l or dialysis). Of these 205 patients (mean +/- SD age 65 +/- 7.2 years; disease duration 14 +/- 7.9 years), the structured care group achieved better control than the usual care group (diastolic blood pressure 68 +/- 12 vs. 71 +/- 12 mmHg, respectively, P = 0.02; A1C 7.3 +/- 1.3 vs. 8.0 +/- 1.6%, P < 0.01). After adjustment for age, sex, and study sites, the structured care (23.1%, n = 24) and usual care (23.8%, n = 24; NS) groups had similar end points, but more patients in the structured care group attained >or=3 treatment goals (61%, n = 63, vs. 28%, n = 28; P < 0.001). Patients who attained >or=3 treatment targets (n = 91) had reduced risk of the primary end point (14 vs. 34; relative risk 0.43 [95% CI 0.21-0.86] compared with that of those who attained

Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term randomised pragmatic trial in primary care.

PubMed

Kai, Joe; Middleton, Lee; Daniels, Jane; Pattison, Helen; Tryposkiadis, Konstantinos; Gupta, Janesh

2016-12-01

Heavy menstrual bleeding (HMB) is a common, chronic problem affecting women and health services. However, long-term evidence on treatment in primary care is lacking. To assess the effectiveness of commencing the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice. A pragmatic, multicentre, parallel, open-label, long term, randomised controlled trial in 63 primary care practices across the English Midlands. In total, 571 women aged 25-50 years, with HMB were randomised to LNG-IUS or usual medical treatment (tranexamic/mefenamic acid, combined oestrogen-progestogen, or progesterone alone). The primary outcome was the patient reported Menorrhagia Multi-Attribute Scale (MMAS, measuring effect of HMB on practical difficulties, social life, psychological and physical health, and work and family life; scores from 0 to 100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality of life, sexual activity, and safety. At 5 years post-randomisation, 424 (74%) women provided data. While the difference between LNG-IUS and usual treatment groups was not significant (3.9 points; 95% confidence interval = -0.6 to 8.3; P = 0.09), MMAS scores improved significantly in both groups from baseline (mean increase, 44.9 and 43.4 points, respectively; P<0.001 for both comparisons). Rates of surgical intervention were low in both groups (surgery-free survival was 80% and 77%; hazard ratio 0.90; 95% CI = 0.62 to 1.31; P = 0.6). There was no difference in generic quality of life, sexual activity scores, or serious adverse events. Large improvements in symptom relief across both groups show treatment for HMB can be successfully initiated with long-term benefit and with only modest need for surgery. © British Journal of General Practice 2016.

Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial.

PubMed

Schull, Michael J; Banda, Hastings; Kathyola, Damson; Fairall, Lara; Martiniuk, Alexandra; Burciul, Barry; Zwarenstein, Merrick; Sodhi, Sumeet; Thompson, Sandy; Joshua, Martias; Mondiwa, Martha; Bateman, Eric

2010-12-03

In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions). This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS), on staff retention and satisfaction, and quality of patient care. A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants) in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours), intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation. The PALM PLUS trial aims to address a key problem: strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care. The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention, as well as the quality of patient care, when compared to usual practice. Controlled Clinical Trials ISRCTN47805230.

Evaluation of a multicomponent programme for the management of musculoskeletal pain and depression in primary care: a cluster-randomised clinical trial (the DROP study).

PubMed

Aragonès, Enric; López-Cortacans, Germán; Caballero, Antonia; Piñol, Josep Ll; Sánchez-Rodríguez, Elisabet; Rambla, Concepció; Tomé-Pires, Catarina; Miró, Jordi

2016-03-16

Chronic musculoskeletal pain and depression are very common in primary care patients. Furthermore, they often appear as comorbid conditions, resulting in additive effect on adverse health outcomes. On the basis of previous studies, we hypothesise that depression and chronic musculoskeletal pain may benefit from an integrated management programme at primary care level. We expect positive effects on both physical and psychological distress of patients. To determine whether a new programme for an integrated approach to chronic musculoskeletal pain and depression leads to better outcomes than usual care. Cluster-randomised controlled trial involving two arms: a) control arm (usual care); and b) intervention arm, where patients participate in a programme for an integrated approach to the pain-depression dyad. Primary care centres in the province of Tarragona, Catalonia, Spain, Participants: We will recruit 330 patients aged 18-80 with moderate or severe musculoskeletal pain (Brief Pain Inventory, average pain subscale ≥5) for at least 3 months, and with criteria for major depression (DSM-IV). A multicomponent programme according to the chronic care model. The main components are care management, optimised antidepressant treatment, and a psychoeducational group action. Blind measurements: The patients will be monitored through blind telephone interviews held at 0, 3, 6 and 12 months. Severity of pain and depressive symptoms, pain and depression treatment response rates, and depression remission rates. The outcomes will be analysed on an intent-to-treat basis and the analysis units will be the individual patients. This analysis will consider the effect of the study design on any potential lack of independence between observations made within the same cluster. The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAP), Barcelona, (P14/142). This project strengthens and improves treatment approaches for a major comorbidity in primary care. The design of the intervention takes into account its applicability under typical primary care conditions, so that if the programme is found to be effective it will be feasible to apply it in a generalised manner. ClinicalTrials.gov: NCT02605278 ; Registered 28 September, 2015.

Effectiveness and cost effectiveness of counselling in primary care.

PubMed

Rowland, N; Bower, P; Mellor, C; Heywood, P; Godfrey, C

2001-01-01

There is wide clinician and patient support for counselling in primary care, particularly in the UK. This review examines the effectiveness and cost effectiveness of counselling for psychological and psychosocial problems in the primary care setting. To assess the effects of counselling in primary care by reviewing cost and outcome data for patients with psychological and psychosocial problems considered suitable for counselling. The search strategy included electronic searching of databases (including the CCDAN Register of RCTs and CCTs) along with handsearching of a specialist journal. Published and unpublished sources (clinical trials, books, dissertations, agency reports etc.) were searched, and their reference lists scanned. Contact was made with subject experts and CCDAN members. Randomised and controlled patient preference trials comparing counselling in primary care with usual general practitioner care for patients with psychological and psychosocial problems considered suitable for counselling. Trials completed before the end of April 1998 were included in the review. Trials were independently assessed by at least two reviewers for appropriateness of inclusion and methdological quality. Four trials, involving 678 participants, of whom 487 were followed up, were included. Data for psychological symptom levels (four trials) were pooled statistically. Patients receiving counselling had significantly better psychological symptom levels post intervention than patients receiving usual general practitioner care (standardised mean difference -0.30, 95% CI, (-0.49 to - 0.11). The effect remained statistically significant when the results from studies with less rigorous methodology were excluded in a sensitivity analysis. Patients who received counselling tended to be more satisfied with their treatment (three trials). Health service utilisation data were reported in all trials reviewed, but only one trial undertook a cost analysis. No clear cost advantage was associated with either counselling or usual general practice care. Patients who received counselling were more likely to have improved psychological symptom levels than those who did not receive counselling. Levels of satisfaction with counselling were high. There is limited information about the cost effectiveness of counselling, with one study reporting no clear cost advantage with either counselling or general practice care. The four trials included in this review were all pragmatic trials of counselling in primary care in the UK, which reflect the reality of clinical provision in this context. There were methdological weaknesses identified in the studies, which should be taken into account when considering the results. The evidence base will be extended by trials of counselling which are nearing completion.

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

PubMed

Obreli-Neto, Paulo Roque; Marusic, Srecko; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Renovato, Rogério Dias; Pilger, Diogo; Cuman, Roberto Kenji Nakamura; Pereira, Leonardo Régis Leira

2015-01-01

Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen. The mean ICER per QALY gained suggests a favorable cost-effectiveness.

Economic evaluation of a brief education, self-management and upper limb exercise training in people with rheumatoid arthritis (EXTRA) programme: a trial-based analysis.

PubMed

Manning, Victoria L; Kaambwa, Billingsley; Ratcliffe, Julie; Scott, David L; Choy, Ernest; Hurley, Michael V; Bearne, Lindsay M

2015-02-01

The aim of this study was to conduct a cost-utility analysis of the Education, Self-management and Upper Limb Exercise Training in People with RA (EXTRA) programme compared with usual care. A within-trial incremental cost-utility analysis was conducted with 108 participants randomized to either the EXTRA programme (n = 52) or usual care (n = 56). A health care perspective was assumed for the primary analysis with a 36 week follow-up. Resource use information was collected on interventions, medication, primary and secondary care contacts, private health care and social care costs. Quality-adjusted life years (QALYs) were calculated from the EuroQol five-dimension three-level (EQ-5D-3L) questionnaire responses at baseline, 12 and 36 weeks. Compared with usual care, total QALYs gained were higher in the EXTRA programme, leading to an increase of 0.0296 QALYs. The mean National Health Service (NHS) costs per participant were slightly higher in the EXTRA programme (by £82), resulting in an incremental cost-effectiveness ratio of £2770 per additional QALY gained. Thus the EXTRA programme was cost effective from an NHS perspective when assessed against the threshold of £20 000-£30 000/QALY gained. Overall, costs were lower in the EXTRA programme compared with usual care, suggesting it was the dominant treatment option from a societal perspective. At a willingness-to-pay of £20 000/QALY gained, there was a 65% probability that the EXTRA programme was the most cost-effective option. These results were robust to sensitivity analyses accounting for missing data, changing the cost perspective and removing cost outliers. The physiotherapist-led EXTRA programme represents a cost-effective use of resources compared with usual care and leads to lower health care costs and work absence. International Standard Randomized Controlled Trial Number Register; http://www.controlled-trials.com/isrctn/ (ISRCTN14268051). © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Comprehensive process model of clinical information interaction in primary care: results of a "best-fit" framework synthesis.

PubMed

Veinot, Tiffany C; Senteio, Charles R; Hanauer, David; Lowery, Julie C

2018-06-01

To describe a new, comprehensive process model of clinical information interaction in primary care (Clinical Information Interaction Model, or CIIM) based on a systematic synthesis of published research. We used the "best fit" framework synthesis approach. Searches were performed in PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Library and Information Science Abstracts, Library, Information Science and Technology Abstracts, and Engineering Village. Two authors reviewed articles according to inclusion and exclusion criteria. Data abstraction and content analysis of 443 published papers were used to create a model in which every element was supported by empirical research. The CIIM documents how primary care clinicians interact with information as they make point-of-care clinical decisions. The model highlights 3 major process components: (1) context, (2) activity (usual and contingent), and (3) influence. Usual activities include information processing, source-user interaction, information evaluation, selection of information, information use, clinical reasoning, and clinical decisions. Clinician characteristics, patient behaviors, and other professionals influence the process. The CIIM depicts the complete process of information interaction, enabling a grasp of relationships previously difficult to discern. The CIIM suggests potentially helpful functionality for clinical decision support systems (CDSSs) to support primary care, including a greater focus on information processing and use. The CIIM also documents the role of influence in clinical information interaction; influencers may affect the success of CDSS implementations. The CIIM offers a new framework for achieving CDSS workflow integration and new directions for CDSS design that can support the work of diverse primary care clinicians.

Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention.

PubMed

Salisbury, Chris; O'Cathain, Alicia; Edwards, Louisa; Thomas, Clare; Gaunt, Daisy; Hollinghurst, Sandra; Nicholl, Jon; Large, Shirley; Yardley, Lucy; Lewis, Glyn; Foster, Alexis; Garner, Katy; Horspool, Kimberley; Man, Mei-See; Rogers, Anne; Pope, Catherine; Dixon, Padraig; Montgomery, Alan A

2016-06-01

Many countries are exploring the potential of telehealth interventions to manage the rising number of people with chronic disorders. However, evidence of the effectiveness of telehealth is ambiguous. Based on an evidence-based conceptual framework, we developed an integrated telehealth service (the Healthlines Service) for chronic disorders and assessed its effectiveness in patients with depression. We aimed to compare the Healthlines Depression Service plus usual care with usual care alone. This study was a pragmatic, multicentre, randomised controlled trial with participants recruited from 43 general practices in three areas of England. To be eligible, participants needed to have access to the internet and email, a Patient Health Questionnaire 9 (PHQ-9) score of at least 10, and a confirmed diagnosis of depression. Participants were individually assigned (1:1) to either the Healthlines Depression Service plus usual care or usual care alone. Random assignment was done by use of a web-based automated randomisation system, stratified by site and minimised by practice and PHQ-9 score. Participants were aware of their allocation, but outcomes were analysed masked. The Healthlines Service consisted of regular telephone calls from non-clinical, trained health advisers who followed standardised scripts generated by interactive software. After an initial assessment and goal-setting telephone call, the advisers called each participant on six occasions over 4 months, and then made up to three more calls at intervals of roughly 2 months to provide reinforcement and to detect relapse. Advisers supported participants in the use of online resources (including computerised cognitive behavioural therapy) and sought to encourage healthier lifestyles, optimise medication, and improve treatment adherence. The primary outcome was the proportion of participants responding to the intervention (defined as PHQ-9 <10 and reduction in PHQ-9 of ≥5 points) at 4 months after randomisation. The primary analysis was based on the intention-to-treat principle without imputation and all serious adverse events were investigated. This trial is registered with Current Controlled Trials, number ISRCTN 14172341. Between July 24, 2012, and July 31, 2013, we recruited 609 participants, randomly assigning 307 to the Healthlines Service plus usual care and 302 to usual care. Primary outcome data were available for 525 (86%) participants. At 4 months, 68 (27%) of 255 individuals in the intervention group had a treatment response compared with 50 (19%) of 270 individuals in the usual care group (adjusted odds ratio 1·7, 95% CI 1·1-2·5, p=0·019). Compared with usual care alone, intervention participants reported improvements in anxiety, better access to support and advice, greater satisfaction with the support they received, and improvements in self-management and health literacy. During the trial, 70 adverse events were reported by participants, one of which was related to the intervention (increased anxiety from discussing depression) and was not serious. This telehealth service based on non-clinically trained health advisers supporting patients in use of internet resources was both acceptable and effective compared with usual care. Our results provide support for the development and assessment of similar interventions in other chronic disorders to expand care provision. National Institute for Health Research (NIHR). Copyright © 2016 Salisbury et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

PubMed

Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

2013-07-02

People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. ISRCTN62019087.

45 CFR 1356.71 - Federal review of the eligibility of children in foster care and the eligibility of foster care...

Code of Federal Regulations, 2010 CFR

2010-10-01

... by ACF statistical staff from the Adoption and Foster Care Analysis and Reporting System (AFCARS... primary review utilizing probability sampling methodologies. Usually, the chosen methodology will be simple random sampling, but other probability samples may be utilized, when necessary and appropriate. (3...

Gender-informed, psychoeducational programme for couples to prevent postnatal common mental disorders among primiparous women: cluster randomised controlled trial.

PubMed

Fisher, Jane; Rowe, Heather; Wynter, Karen; Tran, Thach; Lorgelly, Paula; Amir, Lisa H; Proimos, Jenny; Ranasinha, Sanjeeva; Hiscock, Harriet; Bayer, Jordana; Cann, Warren

2016-03-07

Interventions to prevent postpartum common mental disorders (PCMD) among unselected populations of women have had limited success. The aim was to determine whether What Were We Thinking (WWWT) a gender-informed, psychoeducational programme for couples and babies can prevent PCMD among primiparous women 6 months postpartum. Cluster-randomised controlled trial. 48 Maternal and Child Health Centres (MCHCs) from 6 Local Government Areas in Melbourne, Australia were allocated randomly to usual care (24) or usual care plus WWWT (24). English-speaking primiparous women receiving primary care at trial MCHCs were recruited to the intervention (204) and control (196) conditions. Of these, 187 (91.7%) and 177 (90.3%) provided complete data. WWWT is a manualised programme comprising primary care from a trained nurse, print materials and a face-to-face seminar. Data sources were standardised and study-specific measures collected in blinded computer-assisted telephone interviews at 6 and 26 weeks postpartum. The primary outcome was PCMD assessed by Composite International Diagnostic Interviews and Patient Health Questionnaire (PHQ) Depression and Generalised Anxiety Disorder modules. In intention-to-treat analyses the adjusted OR (AOR) of PCMD in the intervention compared to the usual care group was 0.78 (95% CI 0.38 to 1.63, ns), but mild to moderate anxiety symptoms (AOR 0.58, 95% CI 0.35 to 0.97) and poor self-rated health (AOR 0.46, 95% CI 0.22 to 0.97) were significantly lower. In a per protocol analysis, comparing the full (three component) intervention and usual care groups, the AOR of PCMD was 0.36, (95% CI 0.14 to 0.95). The WWWT seminar was appraised as salient, comprehensible and useful by >85% participants. No harms were detected. WWWT is readily integrated into primary care, enables inclusion of fathers and addresses modifiable risks for PCMD directly. The full intervention appears a promising programme for preventing PCMD, optimising family functioning, and as the first component of a stepped approach to mental healthcare. ACTRN12613000506796; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A Remote Collaborative Care Program for Patients with Depression Living in Rural Areas: Open-Label Trial

PubMed Central

Rojas, Graciela; Guajardo, Viviana; Castro, Ariel; Fritsch, Rosemarie; Moessner, Markus; Bauer, Stephanie

2018-01-01

Background In the treatment of depression, primary care teams have an essential role, but they are most effective when inserted into a collaborative care model for disease management. In rural areas, the shortage of specialized mental health resources may hamper management of depressed patients. Objective The aim was to test the feasibility, acceptability, and effectiveness of a remote collaborative care program for patients with depression living in rural areas. Methods In a nonrandomized, open-label (blinded outcome assessor), two-arm clinical trial, physicians from 15 rural community hospitals recruited 250 patients aged 18 to 70 years with a major depressive episode (DSM-IV criteria). Patients were assigned to the remote collaborative care program (n=111) or to usual care (n=139). The remote collaborative care program used Web-based shared clinical records between rural primary care teams and a specialized/centralized mental health team, telephone monitoring of patients, and remote supervision by psychiatrists through the Web-based shared clinical records and/or telephone. Depressive symptoms, health-related quality of life, service use, and patient satisfaction were measured 3 and 6 months after baseline assessment. Results Six-month follow-up assessments were completed by 84.4% (221/250) of patients. The remote collaborative care program achieved higher user satisfaction (odds ratio [OR] 1.94, 95% CI 1.25-3.00) and better treatment adherence rates (OR 1.81, 95% CI 1.02-3.19) at 6 months compared to usual care. There were no statically significant differences in depressive symptoms between the remote collaborative care program and usual care. Significant differences between groups in favor of remote collaborative care program were observed at 3 months for mental health-related quality of life (beta 3.11, 95% CI 0.19-6.02). Conclusions Higher rates of treatment adherence in the remote collaborative care program suggest that technology-assisted interventions may help rural primary care teams in the management of depressive patients. Future cost-effectiveness studies are needed. Trial Registration Clinicaltrials.gov NCT02200367; https://clinicaltrials.gov/ct2/show/NCT02200367 (Archived by WebCite at http://www.webcitation.org/6xtZ7OijZ) PMID:29712627

A Comparison of the Effects of 2 Types of Massage and Usual Care on Chronic Low Back Pain: A Randomized, Controlled Trial

PubMed Central

Cherkin, Daniel C.; Sherman, Karen J.; Kahn, Janet; Wellman, Robert; Cook, Andrea J.; Johnson, Eric; Erro, Janet; Delaney, Kristin; Deyo, Richard A.

2013-01-01

Background Few studies have evaluated the effectiveness of massage for back pain. Objective To evaluate the effectiveness of two types of massage for chronic back pain. Design Single-blind parallel group randomized controlled trial. Setting Integrated health care delivery system in Seattle area. Patients 401 persons 20 to 65 years of age with non-specific chronic low back pain. Interventions Ten treatments over 10 weeks of Structural Massage (intended to identify and alleviate musculoskeletal contributors to pain through focused soft-tissue manipulation) (n=132) or Relaxation Massage (intended to decrease pain and dysfunction by inducing relaxation) (n=136). Treatments provided by 27 experienced licensed massage therapists. Comparison group received continued usual care (n=133). Study presented as comparison of usual care with two types of massage. Measurements Primary outcomes were the Roland Disability Questionnaire (RDQ) and the Symptom Bothersomeness scale measured at 10 weeks. Outcomes also measured after 26 and 52 weeks. Results At 10 weeks, the massage groups had similar functional outcomes that were superior to those for usual care. The adjusted mean RDQ scores were 2.9 and 2.4 points lower for the relaxation and structural massage groups, respectively, compared to usual care (95% CIs: [1.8, 4.0] and [1.4, 3.5]). Adjusted mean symptom bothersomeness scores were 1.7 points and 1.4 points lower with relaxation and structural massage, respectively, versus usual care (95% CIs: [1.2, 2.2] and [0.8, 1.9]). The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks, but were small. Limitations Restricted to single site; therapists and patients not blinded to treatment. Conclusions This study confirms the results of smaller trials that massage is an effective treatment for chronic back pain with benefits lasting at least 6 months, and also finds no evidence of a clinically-meaningful difference in the effectiveness of two distinct types of massage. Primary Funding Source National Center for Complementary and Alternative Medicine PMID:21727288

[Post-traumatic stress disorders in medical practice: diagnostic and therapeutic guidelines in primary care].

PubMed

Miller, Nick; Lazignac, Coralie; Jecker, Fabien; Zürcher, Marili; Damsa, Cristian

2009-01-01

Posttraumatic stress disorder (PTSD) is a prevalent and disabling condition. The patients suffering from PTSD often consult primary care clinician for non-specific symptoms. The aim of this work is to find out useful clinical guidelines for diagnosis and therapy in primary care, starting from a literature review (1981-2009) and a preliminary observational study. 20 patients with PTSD had a specific trauma-focused psychotherapy, called "Trauma and Reintegration Psychotherapy (TRP)". This is a psychodynamic eclectic treatment combining Ericksonian Hypnosis and EMDR techniques. The results show a more important decrease of PTSD symptoms in patient's beneficiating of the TRP, than the average of the usual clinical studies. This could be linked to an early diagnosis made by the primary care general practitioners.

Effects of the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) on biomedical outcomes, observed cardiovascular events and cardiovascular risks in primary care: a longitudinal comparative study.

PubMed

Jiao, Fang Fang; Fung, Colman Siu Cheung; Wong, Carlos King Ho; Wan, Yuk Fai; Dai, Daisy; Kwok, Ruby; Lam, Cindy Lo Kuen

2014-08-21

To assess whether the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) led to improvements in biomedical outcomes, observed cardiovascular events and predicted cardiovascular risks after 12-month intervention in the primary care setting. A random sample of 1,248 people with diabetes enrolled to RAMP-DM for at least 12 months was selected and 1,248 people with diabetes under the usual primary care were matched by age, sex, and HbA1c level at baseline as the usual care group. Biomedical and cardiovascular outcomes were measured at baseline and at 12-month after the enrollment. Difference-in-differences approach was employed to measure the effect of RAMP-DM on the changes in biomedical outcomes, proportion of subjects reaching treatment targets, observed and predicted cardiovascular risks. Compared to the usual care group, RAMP-DM group had lower cardiovascular events incidence (1.21% vs 2.89%, P = 0.003), and net decrease in HbA1c (-0.20%, P < 0.01), SBP (-3.62 mmHg, P < 0.01) and 10-year cardiovascular disease (CVD) risks (total CVD risk, -2.06%, P < 0.01; coronary heart disease (CHD) risk, -1.43%, P < 0.01; stroke risk, -0.71%, P < 0.01). The RAMP-DM subjects witnessed significant rises in the proportion of reaching treatment targets of HbA1c, and SBP/DBP. After adjusting for confounding variables, the significance remained for HbA1c, predicted CHD and stroke risks. The RAMP-DM resulted in greater improvements in HbA1c and reduction in observed and predicted cardiovascular risks at 12 months follow-up, which indicated a risk-stratification multidisciplinary intervention was an effective strategy for managing Chinese people with diabetes in the primary care setting. ClinicalTrials.gov, NCT02034695.

Fall Prevention in a Primary Care Setting.

PubMed

Siegrist, Monika; Freiberger, Ellen; Geilhof, Barbara; Salb, Johannes; Hentschke, Christian; Landendoerfer, Peter; Linde, Klause; Halle, Martin; Blank, Wolfgang A

2016-05-27

Falls and fall-related injuries are common in community-dwelling elderly people. Effective multifactorial fall prevention programs in the primary care setting may be a promising approach to reduce the incidence rate of falls. In a cluster randomized trial in 33 general practices 378 people living independently and at high risk of falling (65 to 94 years old; 285 women) were allocated to either a 16 week exercise-based fall prevention program including muscle strengthening and challenging balance training exercises, combined with a 12 week home-based exercise program (222 participants), or to usual care (156 participants). The main outcome was number of falls over a period of 12 months. Secondary outcomes were the number of fall-related injuries, physical function (Timed-Up-and-Go-Test, TUG, Chair-Stand-Test, CST, modified Romberg Test), and fear of falling. In the intervention group (n=222 patients in 17 general practices) 291 falls occurred, compared to 367 falls in the usual care group (n=156 patients in 16 general practices). We observed a lower incidence rate for falls in the intervention group (incidence rate ratio/IRR: 0.54; 95% confidence interval (CI): [0.35; 0.84], p=0.007) and for fall-related injuries (IRR: 0.66; [0.42; 0.94], p=0.033). Additionally, patients in the intervention group showed significant improvements in secondary endpoints (TUG: -2.39 s, [-3.91; -0.87], p=0.014; mRomberg: 1.70 s, [0.35; 3.04], p=0.037; fear of falling: -2.28 points, [-3.87; -0.69], p=0.022) compared to usual care. A complex falls prevention program in a primary care setting was effective in reducing falls and fall-related injuries in community dwelling older adults at risk.

Effect of intensive structured care on individual blood pressure targets in primary care: multicentre randomised controlled trial.

PubMed

Stewart, Simon; Carrington, Melinda J; Swemmer, Carla H; Anderson, Craig; Kurstjens, Nicol P; Amerena, John; Brown, Alex; Burrell, Louise M; de Looze, Ferdinandus J; Harris, Mark; Hung, Joseph; Krum, Henry; Nelson, Mark; Schlaich, Markus; Stocks, Nigel P; Jennings, Garry L

2012-11-20

To determine the effectiveness of intensive structured care to optimise blood pressure control based on individual absolute risk targets in primary care. Pragmatic multicentre randomised controlled trial. General practices throughout Australia, except Northern Territory, 2009-11. Of 2185 patients from 119 general practices who were eligible for drug treatment for hypertension according to national guidelines 416 (19.0%) achieved their individual blood pressure target during a 28 day run-in period of monotherapy. After exclusions, 1562 participants not at target blood pressure (systolic 150 (SD 17) mm Hg, diastolic 88 (SD 11) mm Hg) were randomised (1:2 ratio) to usual care (n=524) or the intervention (n=1038). Computer assisted clinical profiling and risk target setting (all participants) with intensified follow-up and stepwise drug titration (initial angiotensin receptor blocker monotherapy or two forms of combination therapy using angiotensin receptor blockers) for those randomised to the intervention. The control group received usual care. The primary outcome was individual blood pressure target achieved at 26 weeks. Secondary outcomes were change in mean sitting systolic and diastolic blood pressure, absolute risk for cardiovascular disease within five years based on the Framingham risk score, and proportion and rate of adverse events. On an intention to treat basis, there was an 8.8% absolute difference in individual blood pressure target achieved at 26 weeks in favour of the intervention group compared with usual care group (358/988 (36.2%) v 138/504 (27.4%)): adjusted relative risk 1.28 (95% confidence interval 1.10 to 1.49, P=0.0013). There was also a 9.5% absolute difference in favour of the intervention group for achieving the classic blood pressure target of ≤ 140/90 mm Hg (627/988 (63.5%) v 272/504 (54.0%)): adjusted relative risk 1.18 (1.07 to 1.29, P<0.001). The intervention group achieved a mean adjusted reduction in systolic blood pressure of 13.2 mm Hg (95% confidence interval -12.3 to -14.2 mm Hg) and diastolic blood pressure of 7.7 mm Hg (-7.1 to -8.3 mm Hg) v 10.1 mm Hg (-8.8 to 11.3 mm Hg) and 5.5 mm Hg (-4.7 to -6.2 mm Hg) in the usual care group (P<0.001). Among 1141 participants in whom five year absolute cardiovascular risk scores were calculated from baseline to the 26 week follow-up, the reduction in risk scores was greater in the intervention group than usual care group (14.7% (SD 9.3%) to 10.9% (SD 8.0%); difference -3.7% (SD 4.5%) and 15.0% (SD 10.1%) to 12.4% (SD 9.4%); -2.6% (SD 4.5%): adjusted mean difference -1.13% (95% confidence interval -0.69% to -1.63%; P<0.001). Owing to adverse events 82 (7.9%) participants in the intervention group and 10 (1.9%) in the usual care group had their drug treatment modified. In a primary care setting intensive structured care resulted in higher levels of blood pressure control, with clinically lower blood pressure and absolute risk of future cardiovascular events overall and with more people achieving their target blood pressure. An important gap in treatment remains though and applying intensive management and achieving currently advocated risk based blood pressure targets is challenging.

Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial.

PubMed

Goertz, Christine M; Long, Cynthia R; Vining, Robert D; Pohlman, Katherine A; Kane, Bridget; Corber, Lance; Walter, Joan; Coulter, Ian

2016-02-09

Low back pain is highly prevalent and one of the most common causes of disability in U.S. armed forces personnel. Currently, no single therapeutic method has been established as a gold standard treatment for this increasingly prevalent condition. One commonly used treatment, which has demonstrated consistent positive outcomes in terms of pain and function within a civilian population is spinal manipulative therapy provided by doctors of chiropractic. Chiropractic care, delivered within a multidisciplinary framework in military healthcare settings, has the potential to help improve clinical outcomes for military personnel with low back pain. However, its effectiveness in a military setting has not been well established. The primary objective of this study is to evaluate changes in pain and disability in active duty service members with low back pain who are allocated to receive usual medical care plus chiropractic care versus treatment with usual medical care alone. This pragmatic comparative effectiveness trial will enroll 750 active duty service members with low back pain at three military treatment facilities within the United States (250 from each site) who will be allocated to receive usual medical care plus chiropractic care or usual medical care alone for 6 weeks. Primary outcomes will include the numerical rating scale for pain intensity and the Roland-Morris Disability Questionnaire at week 6. Patient reported outcomes of pain, disability, bothersomeness, and back pain function will be collected at 2, 4, 6, and 12 weeks from allocation. Because low back pain is one of the leading causes of disability among U.S. military personnel, it is important to find pragmatic and conservative treatments that will treat low back pain and preserve low back function so that military readiness is maintained. Thus, it is important to evaluate the effects of the addition of chiropractic care to usual medical care on low back pain and disability. The trial discussed in this article was registered in ClinicalTrials.gov with the NCT01692275 Date of registration: 6 September 2012.

The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial.

PubMed

Vickrey, Barbara G; Mittman, Brian S; Connor, Karen I; Pearson, Marjorie L; Della Penna, Richard D; Ganiats, Theodore G; Demonte, Robert W; Chodosh, Joshua; Cui, Xinping; Vassar, Stefanie; Duan, Naihua; Lee, Martin

2006-11-21

Adherence to dementia guidelines is poor despite evidence that some guideline recommendations can improve symptoms and delay institutionalization of patients. To test the effectiveness of a dementia guideline-based disease management program on quality of care and outcomes for patients with dementia. Clinic-level, cluster randomized, controlled trial. 3 health care organizations collaborating with 3 community agencies in southern California. 18 primary care clinics and 408 patients with dementia age 65 years or older paired with 408 informal caregivers. Disease management program led by care managers and provided to 238 patient-caregiver pairs at 9 intervention clinics for more than 12 months. Adherence to 23 guideline recommendations (primary outcome) and receipt of community resources and patient and caregiver health and quality-of-care measures (secondary outcomes). The mean percentage of per-patient guideline recommendations to which care was adherent was significantly higher in the intervention group than in the usual care group (63.9% vs. 32.9%, respectively; adjusted difference, 30.1% [95% CI, 25.2% to 34.9%]; P < 0.001). Participants who received the intervention had higher care quality on 21 of 23 guidelines (P < or = 0.013 for all), and higher proportions received community agency assistance (P < or = 0.03) than those who received usual care. Patient health-related quality of life, overall quality of patient care, caregiving quality, social support, and level of unmet caregiving assistance needs were better for participants in the intervention group than for those in the usual care group (P < 0.05 for all). Caregiver health-related quality of life did not differ between the 2 groups. Participants were well-educated, were predominantly white, had a usual source of care, and were not institutionalized. Generalizability to other patients and geographic regions is unknown. Also, costs of a care management program under fee-for-service reimbursement may impede adoption. A dementia guideline-based disease management program led to substantial improvements in quality of care for patients with dementia. Current Controlled Trials identifier: ISRCTN72577751.

Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial.

PubMed

Woodcock, Ashley; Vestbo, Jørgen; Bakerly, Nawar Diar; New, John; Gibson, J Martin; McCorkindale, Sheila; Jones, Rupert; Collier, Susan; Lay-Flurrie, James; Frith, Lucy; Jacques, Loretta; Fletcher, Joanne L; Harvey, Catherine; Svedsater, Henrik; Leather, David

2017-11-18

Evidence for management of asthma comes from closely monitored efficacy trials done in highly selected patient groups. There is a need for randomised trials that are closer to usual clinical practice. We did an open-label, randomised, controlled, two-arm effectiveness trial at 74 general practice clinics in Salford and South Manchester, UK. Patients aged 18 years or older with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy were randomly assigned to initiate treatment with a once-daily inhaled combination of either 100 μg or 200 μg fluticasone furoate with 25 μg vilanterol or optimised usual care and followed up for 12 months. The primary endpoint was the percentage of patients who achieved an asthma control test (ACT) score of 20 or greater or an increase in ACT score from baseline of 3 or greater at 24 weeks (termed responders), in patients with a baseline ACT score less than 20 (the primary effectiveness analysis population). All effectiveness analyses were done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT01706198. Between Nov 12, 2012, and Dec 16, 2016, 4725 patients were enrolled and 4233 randomly assigned to initiate treatment with fluticasone furoate and vilanterol (n=2114) or usual care (n=2119). 1207 patients (605 assigned to usual care, 602 to fluticasone furoate and vilanterol) had a baseline ACT score greater than or equal to 20 and were thus excluded from the primary effectiveness analysis population. At week 24, the odds of being a responder were higher for patients who initiated treatment with fluticasone furoate and vilanterol than for those on usual care (977 [71%] of 1373 in the fluticasone furoate and vilanterol group vs 784 [56%] of 1399 in the usual care group; odds ratio [OR] 2·00 [95% CI 1·70-2·34], p<0·0001). At week 24, the adjusted mean ACT score increased by 4·4 points from baseline in patients initiated with fluticasone furoate and vilanterol, compared with 2·8 points in the usual care group (difference 1·6 [95% CI 1·3-2·0], p<0·0001). This result was consistent for the duration of the study. Pneumonia was uncommon, with no differences between groups; there was no difference in other serious adverse events between the groups. In patients with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy, initiation of a once-daily treatment regimen of combined fluticasone furoate and vilanterol improved asthma control without increasing the risk of serious adverse events when compared with optimised usual care. GlaxoSmithKline. Copyright © 2017 Elsevier Ltd. All rights reserved.

Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol.

PubMed

Rosell-Murphy, Magdalena; Bonet-Simó, Josep M; Baena, Esther; Prieto, Gemma; Bellerino, Eva; Solé, Francesc; Rubio, Montserrat; Krier, Ilona; Torres, Pascuala; Mimoso, Sonia

2014-03-25

Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver.Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. CONTROLled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Primary Health Care network (9 PHCTs). Primary informal caregivers of patients receiving home health care from participating PHCTs. Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request.Data analysisDependent variables: Caregiver burden (short-form Zarit test), caregivers' social support (Medical Outcomes Study), and caregivers' reported quality of life (SF-12)INDEPENDENT VARIABLES: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test). If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice. Clinical trials registrar: NCT02065427.

Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol

PubMed Central

2014-01-01

Background Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver. Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. Methods/design Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs. Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. Intervention: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request. Data analysis Dependent variables: Caregiver burden (short-form Zarit test), caregivers’ social support (Medical Outcomes Study), and caregivers’ reported quality of life (SF-12) Independent variables: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test). Discussion If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice. Trial registration Clinical trials registrar: NCT02065427 PMID:24666438

Doctoring in Eastern Europe

PubMed Central

Wilde, Henry

1983-01-01

Health care in Eastern Europe has not achieved world standards nor the goals of planners of socialist societies. With luck, perseverance, bribes or good connections, it is possible to obtain good medical and surgical care in Eastern Europe for a major illness. Primary and even secondary care usually are substandard, however, and often completely unacceptable to most Western foreigners. The reasons for this are complex but mainly rooted in different attitudes of health workers towards their patients, poor physical plants, poor salary structures, inadequate advancement opportunities for health care workers, poor social status and professional recognition for nurses and almost complete isolation of the average primary care doctor from hospital medicine. PMID:6659504

Behavioural activation by mental health nurses for late-life depression in primary care: a randomized controlled trial.

PubMed

Janssen, Noortje; Huibers, Marcus J H; Lucassen, Peter; Voshaar, Richard Oude; van Marwijk, Harm; Bosmans, Judith; Pijnappels, Mirjam; Spijker, Jan; Hendriks, Gert-Jan

2017-06-26

Depressive symptoms are common in older adults. The effectiveness of pharmacological treatments and the availability of psychological treatments in primary care are limited. A behavioural approach to depression treatment might be beneficial to many older adults but such care is still largely unavailable. Behavioural Activation (BA) protocols are less complicated and more easy to train than other psychological therapies, making them very suitable for delivery by less specialised therapists. The recent introduction of the mental health nurse in primary care centres in the Netherlands has created major opportunities for improving the accessibility of psychological treatments for late-life depression in primary care. BA may thus address the needs of older patients while improving treatment outcome and lowering costs.The primary objective of this study is to compare the effectiveness and cost-effectiveness of BA in comparison with treatment as usual (TAU) for late-life depression in Dutch primary care. A secondary goal is to explore several potential mechanisms of change, as well as predictors and moderators of treatment outcome of BA for late-life depression. Cluster-randomised controlled multicentre trial with two parallel groups: a) behavioural activation, and b) treatment as usual, conducted in primary care centres with a follow-up of 52 weeks. The main inclusion criterion is a PHQ-9 score > 9. Patients are excluded from the trial in case of severe mental illness that requires specialized treatment, high suicide risk, drug and/or alcohol abuse, prior psychotherapy, change in dosage or type of prescribed antidepressants in the previous 12 weeks, or moderate to severe cognitive impairment. The intervention consists of 8 weekly 30-min BA sessions delivered by a trained mental health nurse. We expect BA to be an effective and cost-effective treatment for late-life depression compared to TAU. BA delivered by mental health nurses could increase the availability and accessibility of non-pharmacological treatments for late-life depression in primary care. This study is retrospectively registered in the Dutch Clinical Trial Register NTR6013 on August 25th 2016.

Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care: Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial.

PubMed

van Leeuwen, Karen M; Bosmans, Judith E; Jansen, Aaltje P D; Hoogendijk, Emiel O; Muntinga, Maaike E; van Hout, Hein P J; Nijpels, Giel; van der Horst, Henriette E; van Tulder, Maurits W

2015-12-01

To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. Primary care (35 practices) in two regions in the Netherlands. Community-dwelling older adults who were frail according to their primary care physicians and the Program on Research for Integrating Services for the Maintenance of Autonomy case-finding tool questionnaire (N = 1,147). The GCM consisted of the following components: a regularly scheduled in-home comprehensive geriatric assessment by a practice nurse followed by a customized care plan, management and training of practice nurses by a geriatric expert team, and coordination of care through community network meetings and multidisciplinary team consultations of individuals with complex care needs. Outcomes were measured every 6 months and included costs from a societal perspective, health-related quality of life (Medical Outcomes Study 12-item Short-Form Survey (SF-12) physical (PCS) and mental component summary (MCS) scales), functional limitations (Katz activities of daily living and instrumental activities of daily living), and quality-adjusted life years based on the EQ-5D. Multilevel regression models adjusted for time and baseline confounders showed no significant differences in costs ($356, 95% confidence interval = -$488-1,134) and outcomes between intervention and usual care phases. Cost-effectiveness acceptability curves showed that, for the SF-12 PCS and MCS, the probability of the intervention being cost-effective was 0.76 if decision-makers are willing to pay $30,000 per point improvement on the SF-12 scales (range 0-100). For all other outcomes the probability of the intervention being cost-effective was low. Because the GCM was not cost-effective compared to usual care after 24 months of follow-up, widespread implementation in its current form is not recommended. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

A clustered controlled trial of the implementation and effectiveness of a medical home to improve health care of people with serious mental illness: study protocol.

PubMed

Young, Alexander S; Cohen, Amy N; Chang, Evelyn T; Flynn, Anthony W P; Hamilton, Alison B; Oberman, Rebecca; Vinzon, Merlyn

2018-06-07

People with serious mental illness (SMI) die many years prematurely, with rates of premature mortality two to three times greater than the general population. Most premature deaths are due to "natural causes," especially cardiovascular disease and cancer. Often, people with SMI are not well engaged in primary care treatment and do not receive high-value preventative and medical services. There have been numerous efforts to improve this care, and few controlled trials, with inconsistent results. While people with SMI often do poorly with usual primary care arrangements, research suggests that integrated care and medical care management may improve treatment and outcomes, and reduce treatment costs. This hybrid implementation-effectiveness study is a prospective, cluster controlled trial of a medical home, the SMI Patient-Aligned Care Team (SMI PACT), to improve the healthcare of patients with SMI enrolled with the Veterans Health Administration. The SMI PACT team includes proactive medical nurse care management, and integrated mental health treatment through regular psychiatry consultation and a collaborative care model. Patients are recruited to receive primary care through SMI PACT based on having a serious mental illness that is manageable with treatment, and elevated risk for hospitalization or death. In a site-level prospective controlled trial, this project studies the effect, relative to usual care, of SMI PACT on provision of appropriate preventive and medical treatments, health-related quality of life, satisfaction with care, and medical and mental health treatment utilization and costs. Research includes mixed-methods formative evaluation of usual care and SMI PACT implementation to strengthen the intervention and assess barriers and facilitators. Investigators examine relationships among organizational context, intervention factors, and patient and clinician outcomes, and identify patient factors related to successful patient outcomes. This will be one of the first controlled trials of the implementation and effectiveness of a patient centered medical home for people with serious mental illness. It will provide information regarding the value of this strategy, and processes and tools for implementing this model in community healthcare settings. ClinicalTrials.gov, NCT01668355 . Registered August 20, 2012.

Measuring patient-centered medical home access and continuity in clinics with part-time clinicians.

PubMed

Rosland, Ann-Marie; Krein, Sarah L; Kim, Hyunglin Myra; Greenstone, Clinton L; Tremblay, Adam; Ratz, David; Saffar, Darcy; Kerr, Eve A

2015-05-01

Common patient-centered medical home (PCMH) performance measures value access to a single primary care provider (PCP), which may have unintended consequences for clinics that rely on part-time PCPs and team-based care. Retrospective analysis of 110,454 primary care visits from 2 Veterans Health Administration clinics from 2010 to 2012. Multi-level models examined associations between PCP availability in clinic, and performance on access and continuity measures. Patient experiences with access and continuity were compared using 2012 patient survey data (N = 2881). Patients of PCPs with fewer half-day clinic sessions per week were significantly less likely to get a requested same-day appointment with their usual PCP (predicted probability 17% for PCPs with 2 sessions/week, 20% for 5 sessions/week, and 26% for 10 sessions/week). Among requests that did not result in a same-day appointment with the usual PCP, there were no significant differences in same-day access to a different PCP, or access within 2 to 7 days with patients' usual PCP. Overall, patients had >92% continuity with their usual PCP at the hospital-based site regardless of PCP sessions/week. Patients of full-time PCPs reported timely appointments for urgent needs more often than patients of part-time PCPs (82% vs 71%; P < .01), but reported similar experiences with routine access and continuity. Part-time PCP performance appeared worse when using measures focused on same-day access to patients' usual PCP. However, clinic-level same-day access, same-week access to the usual PCP, and overall continuity were similar for patients of part-time and full-time PCPs. Measures of in-person access to a usual PCP do not capture alternate access approaches encouraged by PCMH, and often used by part-time providers, such as team-based or non-face-to-face care.

Cost-utility analysis of a multidisciplinary strategy to manage osteoarthritis of the knee: economic evaluation of a cluster randomized controlled trial study.

PubMed

Marra, Carlo A; Grubisic, Maja; Cibere, Jolanda; Grindrod, Kelly A; Woolcott, John C; Gastonguay, Louise; Esdaile, John M

2014-06-01

To determine if a pharmacist-initiated multidisciplinary strategy provides value for money compared to usual care in participants with previously undiagnosed knee osteoarthritis. Pharmacies were randomly allocated to provide either 1) usual care and a pamphlet or 2) intervention care, which consisted of education, pain medication management by a pharmacist, physiotherapy-guided exercise, and communication with the primary care physician. Costs and quality-adjusted life-years (QALYs) were determined for patients assigned to each treatment and incremental cost-effectiveness ratios (ICERs) were determined. From the Ministry of Health perspective, the average patient in the intervention group generated slightly higher costs compared with usual care. Similar findings were obtained when using the societal perspective. The intervention resulted in ICERs of $232 (95% confidence interval [95% CI] -1,530, 2,154) per QALY gained from the Ministry of Health perspective and $14,395 (95% CI 7,826, 23,132) per QALY gained from the societal perspective, compared with usual care. A pharmacist-initiated, multidisciplinary program was good value for money from both the societal and Ministry of Health perspectives. Copyright © 2014 by the American College of Rheumatology.

Comparison of group-based outpatient physiotherapy with usual care after total knee replacement: a feasibility study for a randomized controlled trial.

PubMed

Artz, Neil; Dixon, Samantha; Wylde, Vikki; Marques, Elsa; Beswick, Andrew D; Lenguerrand, Erik; Blom, Ashley W; Gooberman-Hill, Rachael

2017-04-01

To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. A feasibility study for a randomized controlled trial. One secondary-care hospital orthopaedic centre, Bristol, UK. A total of 46 participants undergoing primary total knee replacement. The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial.

Comparison of interactive voice response, patient mailing, and mailed registry to encourage screening for osteoporosis: a randomized controlled trial.

PubMed

Heyworth, L; Kleinman, K; Oddleifson, S; Bernstein, L; Frampton, J; Lehrer, M; Salvato, K; Weiss, T W; Simon, S R; Connelly, M

2014-05-01

Guidelines recommend screening for osteoporosis with bone mineral density (BMD) testing in menopausal women, particularly those with additional risk factors for fracture. Many eligible women remain unscreened. This randomized study demonstrates that a single outreach interactive voice response phone call improves rates of BMD screening among high-risk women age 50-64. Osteoporotic fractures are a major cause of disability and mortality. Guidelines recommend screening with BMD for menopausal women, particularly those with additional risk factors for fracture. However, many women remain unscreened. We examined whether telephonic interactive voice response (IVR) or patient mailing could increase rates of BMD testing in high risk, menopausal women. We studied 4,685 women age 50-64 years within a not-for-profit health plan in the United States. All women had risk factors for developing osteoporosis and no prior BMD testing or treatment for osteoporosis. Patients were randomly allocated to usual care, usual care plus IVR, or usual care plus mailed educational materials. To avoid contamination, patients within a single primary care physician practice were randomized to receive the same intervention. The primary endpoint was BMD testing at 12 months. Secondary outcomes included BMD testing at 6 months and medication use at 12 months. Mean age was 57 years. Baseline demographic and clinical characteristics were similar across the three study groups. In adjusted analyses, the incidence of BMD screening was 24.6% in the IVR group compared with 18.6% in the usual care group (P < 0.001). There was no difference between the patient mailing group and the usual care group (P = 0.3). In this large community-based randomized trial of high risk, menopausal women age 50-64, IVR, but not patient mailing, improved rates of BMD screening. IVR remains a viable strategy to incorporate in population screening interventions.

Outreach invitations for FIT and colonoscopy improve colorectal cancer screening rates: A randomized controlled trial in a safety-net health system.

PubMed

Singal, Amit G; Gupta, Samir; Tiro, Jasmin A; Skinner, Celette Sugg; McCallister, Katharine; Sanders, Joanne M; Bishop, Wendy Pechero; Agrawal, Deepak; Mayorga, Christian A; Ahn, Chul; Loewen, Adam C; Santini, Noel O; Halm, Ethan A

2016-02-01

The effectiveness of colorectal cancer (CRC) screening is limited by underuse, particularly among underserved populations. Among a racially diverse and socioeconomically disadvantaged cohort of patients, the authors compared the effectiveness of fecal immunochemical test (FIT) outreach and colonoscopy outreach to increase screening participation rates, compared with usual visit-based care. Patients aged 50 to 64 years who were not up-to-date with CRC screening but used primary care services in a large safety-net health system were randomly assigned to mailed FIT outreach (2400 patients), mailed colonoscopy outreach (2400 patients), or usual care with opportunistic visit-based screening (1199 patients). Patients who did not respond to outreach invitations within 2 weeks received follow-up telephone reminders. The primary outcome was CRC screening completion within 12 months after randomization. Baseline patient characteristics across the 3 groups were similar. Using intention-to-screen analysis, screening participation rates were higher for FIT outreach (58.8%) and colonoscopy outreach (42.4%) than usual care (29.6%) (P <.001 for both). Screening participation with FIT outreach was higher than that for colonoscopy outreach (P <.001). Among responders, FIT outreach had a higher percentage of patients who responded before reminders (59.0% vs 29.7%; P <.001). Nearly one-half of patients in the colonoscopy outreach group crossed over to complete FIT via usual care, whereas <5% of patients in the FIT outreach group underwent usual-care colonoscopy. Mailed outreach invitations appear to significantly increase CRC screening rates among underserved populations. In the current study, FIT-based outreach was found to be more effective than colonoscopy-based outreach to increase 1-time screening participation. Studies with longer follow-up are needed to compare the effectiveness of outreach strategies for promoting completion of the entire screening process. © 2015 American Cancer Society.

Expert patient self-management program versus usual care in bronchiectasis: a randomized controlled trial.

PubMed

Lavery, Katherine A; O'Neill, Brenda; Parker, Michael; Elborn, J Stuart; Bradley, Judy M

2011-08-01

To investigate the efficacy of a disease-specific Expert Patient Programme (EPP) compared with usual care in patients with bronchiectasis. Proof-of-concept randomized controlled trial. Regional respiratory center. Adult patients (N=64; age, >18y) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomographic scan. Patients were randomly assigned to an intervention (usual care plus EPP; n=32) or control group (usual care only; n=32). The primary outcome measure was the Chronic Disease Self-efficacy Scale (CDSS). Other outcome measures included the Revised Illness Perception Questionnaire (IPQ-R), the St Georges Respiratory Questionnaire, and standard EPP questionnaires. Data were collected at baseline, postintervention, and 3 and 6 months postintervention. This disease-specific EPP for patients with bronchiectasis significantly improved self-efficacy in 6 of 10 subscales (CDSS subscales: exercise regularly [P=.02]; get information about disease [P=.03]; obtain help from community, family, and friends [P=.06]; communicate with physician [P=.85]; manage disease in general [P=.05]; do chores [P=.04]; social/recreational activities [P=.03]; manage symptoms [P<.01]; manage shortness of breath [P=.08]; control/manage depression [P=.01]) compared with usual care. There was no improvement on IPQ-R score. Patients who received the intervention reported more symptoms and decreased quality of life between 3 and 6 months postintervention and an increase in some components of self reported health care use. Patients receiving the disease-specific EPP indicated they were satisfied with the intervention and learned new self-management techniques. There were no significant differences in lung function over time. This original study indicates that a disease-specific EPP results in short-term improvements in self-efficacy. Based on these positive preliminary findings, a larger adequately powered study is justified to investigate the efficacy of a disease-specific EPP in patients with bronchiectasis. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of 'PhysioDirect' telephone assessment and advice services for physiotherapy.

PubMed

Salisbury, C; Foster, N E; Hopper, C; Bishop, A; Hollinghurst, S; Coast, J; Kaur, S; Pearson, J; Franchini, A; Hall, J; Grove, S; Calnan, M; Busby, J; Montgomery, A A

2013-01-01

As a result of long delays for physiotherapy for musculoskeletal problems, several areas in the UK have introduced PhysioDirect services in which patients telephone a physiotherapist for initial assessment and treatment advice. However, there is no robust evidence about the effectiveness, cost-effectiveness or acceptability to patients of PhysioDirect. To investigate whether or not PhysioDirect is equally as clinically effective as and more cost-effective than usual care for patients with musculoskeletal (MSK) problems in primary care. Pragmatic randomised controlled trial to assess equivalence, incorporating economic evaluation and nested qualitative research. Patients were randomised in 2 : 1 ratio to PhysioDirect or usual care using a remote automated allocation system at the level of the individual, stratifying by physiotherapy site and minimising by sex, age group and site of MSK problem. For the economic analysis, cost consequences included NHS and patient costs, and the cost of lost production. Cost-effectiveness analysis was carried out from the perspective of the NHS. Interviews were conducted with patients, physiotherapists and their managers. Four community physiotherapy services in England. Adults referred by general practitioners or self-referred for physiotherapy for a MSK problem. Patients allocated to PhysioDirect were invited to telephone a senior physiotherapist for initial assessment and advice using a computerised template, followed by face-to-face care when necessary. Patients allocated to usual care were put on to a waiting list for face-to-face care. Primary outcome was the Short Form questionnaire-36 items, version 2 (SF-36v2) Physical Component Score (PCS) at 6 months after randomisation. Secondary outcomes included other measures of health outcome [Measure Yourself Medical Outcomes Profile, European Quality of Life-5 Dimensions (EuroQol health utility measure, EQ-5D), global improvement, response to treatment], wait for treatment, time lost from work and usual activities, patient satisfaction. Data were collected by postal questionnaires at baseline, 6 weeks and 6 months, and from routine records by researchers blind to allocation. A total of 1506 patients were allocated to PhysioDirect and 743 to usual care. Patients allocated to PhysioDirect had a shorter wait for treatment than those allocated to usual care [median 7 days vs 34 days; arm-time ratio 0.32, 95% confidence interval (CI) 0.29 to 0.35] and had fewer non-attended face-to-face appointments [incidence rate ratio 0.55 (95% CI 0.41 to 0.73)]. The primary outcome at 6 months' follow-up was equivalent between PhysioDirect and usual care [mean PCS 43.50 vs 44.18, adjusted difference in means -0.01 (95% CI -0.80 to 0.79)]. The secondary measures of health outcome all demonstrated equivalence at 6 months, with slightly greater improvement in the PhysioDirect arm at 6 weeks' follow-up. Patients were equally satisfied with access to care but slightly less satisfied overall with PhysioDirect compared with usual care. NHS costs (physiotherapy plus other relevant NHS costs) per patient were similar in the two arms [PhysioDirect £ 198.98 vs usual care £ 179.68, difference in means £ 19.30 (95% CI -£ 37.60 to £ 76.19)], while QALYs gained were also similar [difference in means 0.007 (95% CI -0.003 to 0.016)]. Incremental cost per QALY gained was £ 2889. The probability that PhysioDirect was cost-effective at a £ 20,000 willingness-to-pay threshold was 88%. These conclusions about cost-effectiveness were robust to sensitivity analyses. There was no evidence of difference between trial arms in cost to patients or value of lost production. No adverse events were detected. Providing physiotherapy via PhysioDirect is equally clinically effective compared with usual waiting list-based care, provides faster access to treatment, appears to be safe, and is broadly acceptable to patients. PhysioDirect is probably cost-effective compared with usual care.

Effect of an Education Programme for South Asians with Asthma and Their Clinicians: A Cluster Randomised Controlled Trial (OEDIPUS)

PubMed Central

Griffiths, Chris; Bremner, Stephen; Islam, Kamrul; Sohanpal, Ratna; Vidal, Debi-Lee; Dawson, Carolyn; Foster, Gillian; Ramsay, Jean; Feder, Gene; Taylor, Stephanie; Barnes, Neil; Choudhury, Aklak; Packe, Geoff; Bayliss, Elizabeth; Trathen, Duncan; Moss, Philip; Cook, Viv; Livingstone, Anna Eleri; Eldridge, Sandra

2016-01-01

Background People with asthma from ethnic minority groups experience significant morbidity. Culturally-specific interventions to reduce asthma morbidity are rare. We tested the hypothesis that a culturally-specific education programme, adapted from promising theory-based interventions developed in the USA, would reduce unscheduled care for South Asians with asthma in the UK. Methods A cluster randomised controlled trial, set in two east London boroughs. 105 of 107 eligible general practices were randomised to usual care or the education programme. Participants were south Asians with asthma aged 3 years and older with recent unscheduled care. The programme had two components: the Physician Asthma Care Education (PACE) programme and the Chronic Disease Self Management Programme (CDSMP), targeted at clinicians and patients with asthma respectively. Both were culturally adapted for south Asians with asthma. Specialist nurses, and primary care teams from intervention practices were trained using the PACE programme. South Asian participants attended an outpatient appointment; those registered with intervention practices received self-management training from PACE-trained specialist nurses, a follow-up appointment with PACE-trained primary care practices, and an invitation to attend the CDSMP. Patients from control practices received usual care. Primary outcome was unscheduled care. Findings 375 south Asians with asthma from 84 general practices took part, 183 registered with intervention practices and 192 with control practices. Primary outcome data were available for 358/375 (95.5%) of participants. The intervention had no effect on time to first unscheduled attendance for asthma (Adjusted Hazard Ratio AHR = 1.19 95% CI 0.92 to 1.53). Time to first review in primary care was reduced (AHR = 2.22, (1.67 to 2.95). Asthma-related quality of life and self-efficacy were improved at 3 months (adjusted mean difference -2.56, (-3.89 to -1.24); 0.44, (0.05 to 0.82) respectively. Conclusions A multi-component education programme adapted for south Asians with asthma did not reduce unscheduled care but did improve follow-up in primary care, self-efficacy and quality of life. More effective interventions are needed for south Asians with asthma. PMID:28030569

Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial.

PubMed

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-03-01

Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multicenter randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases the number of organs transplanted. We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A "protocol-guided fluid therapy" algorithm targeting the cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor, and our primary analysis was intention to treat. Secondary analyses included: (1) modified intention to treat where only subjects able to receive the intervention were included and (2) 12-month survival in transplant recipients. The study was stopped early. We enrolled 556 donors: 279 protocolized care and 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76 % of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor (95 % CI 3.14-3.63) with protocolized care compared to 3.29 usual care (95 % CI 3.04-3.54; mean difference, 0.1, 95 % CI -0.25 to 0.45; p = 0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95 % CI 3.23-3.8), but not statistically significantly (mean difference, 0.23, 95 % CI -0.15 to 0.61; p = 0.23). Among the 1,430 recipients of organs from study subjects with data available, 56 deaths (7.8 %) occurred in the protocolized care arm and 56 (7.9 %) in the usual care arm in the first year (hazard ratio: 0.97, p = 0.86). In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor.

CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea.

PubMed

McEvoy, R Doug; Antic, Nick A; Heeley, Emma; Luo, Yuanming; Ou, Qiong; Zhang, Xilong; Mediano, Olga; Chen, Rui; Drager, Luciano F; Liu, Zhihong; Chen, Guofang; Du, Baoliang; McArdle, Nigel; Mukherjee, Sutapa; Tripathi, Manjari; Billot, Laurent; Li, Qiang; Lorenzi-Filho, Geraldo; Barbe, Ferran; Redline, Susan; Wang, Jiguang; Arima, Hisatomi; Neal, Bruce; White, David P; Grunstein, Ron R; Zhong, Nanshan; Anderson, Craig S

2016-09-08

Obstructive sleep apnea is associated with an increased risk of cardiovascular events; whether treatment with continuous positive airway pressure (CPAP) prevents major cardiovascular events is uncertain. After a 1-week run-in period during which the participants used sham CPAP, we randomly assigned 2717 eligible adults between 45 and 75 years of age who had moderate-to-severe obstructive sleep apnea and coronary or cerebrovascular disease to receive CPAP treatment plus usual care (CPAP group) or usual care alone (usual-care group). The primary composite end point was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack. Secondary end points included other cardiovascular outcomes, health-related quality of life, snoring symptoms, daytime sleepiness, and mood. Most of the participants were men who had moderate-to-severe obstructive sleep apnea and minimal sleepiness. In the CPAP group, the mean duration of adherence to CPAP therapy was 3.3 hours per night, and the mean apnea-hypopnea index (the number of apnea or hypopnea events per hour of recording) decreased from 29.0 events per hour at baseline to 3.7 events per hour during follow-up. After a mean follow-up of 3.7 years, a primary end-point event had occurred in 229 participants in the CPAP group (17.0%) and in 207 participants in the usual-care group (15.4%) (hazard ratio with CPAP, 1.10; 95% confidence interval, 0.91 to 1.32; P=0.34). No significant effect on any individual or other composite cardiovascular end point was observed. CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood. Therapy with CPAP plus usual care, as compared with usual care alone, did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnea and established cardiovascular disease. (Funded by the National Health and Medical Research Council of Australia and others; SAVE ClinicalTrials.gov number, NCT00738179 ; Australian New Zealand Clinical Trials Registry number, ACTRN12608000409370 .).

STI in remote communities: improved and enhanced primary health care (STRIVE) study protocol: a cluster randomised controlled trial comparing ‘usual practice’ STI care to enhanced care in remote primary health care services in Australia

PubMed Central

2013-01-01

Background Despite two decades of interventions, rates of sexually transmissible infections (STI) in remote Australian Aboriginal communities remain unacceptably high. Routine notifications data from 2011 indicate rates of chlamydia and gonorrhoea among Aboriginal people in remote settings were 8 and 61 times higher respectively than in the non-Indigenous population. Methods/design STRIVE is a stepped-wedge cluster randomised trial designed to compare a sexual health quality improvement program (SHQIP) to usual STI clinical care delivered in remote primary health care services. The SHQIP is a multifaceted intervention comprising annual assessments of sexual health service delivery, implementation of a sexual health action plan, six-monthly clinical service activity data reports, regular feedback meetings with a regional coordinator, training and financial incentive payments. The trial clusters comprise either a single community or several communities grouped together based on geographic proximity and cultural ties. The primary outcomes are: prevalence of chlamydia, gonorrhoea and trichomonas in Aboriginal residents aged 16–34 years, and performance in clinical management of STIs based on best practice indicators. STRIVE will be conducted over five years comprising one and a half years of trial initiation and community consultation, three years of trial conditions, and a half year of data analysis. The trial was initiated in 68 remote Aboriginal health services in the Northern Territory, Queensland and Western Australia. Discussion STRIVE is the first cluster randomised trial in STI care in remote Aboriginal health services. The trial will provide evidence to inform future culturally appropriate STI clinical care and control strategies in communities with high STI rates. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12610000358044 PMID:24016143

Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial.

PubMed

Godycki-Cwirko, Maciek; Zakowska, Izabela; Kosiek, Katarzyna; Wensing, Michel; Krawczyk, Jaroslaw; Kowalczyk, Anna

2014-04-04

Chronic obstructive pulmonary disease (COPD) remains a major health problem, strongly related to smoking. Despite the publication of practice guidelines on prevention and treatment, not all patients with the disease receive the recommended healthcare, particularly with regard to smoking cessation advice where applicable. We have developed a tailored implementation strategy for enhancing general practitioners' adherence to the disease management guidelines. The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners' adherence to guidelines. A pragmatic two-arm cluster randomized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care. The study will involve 18 general practices (9 in the intervention group and 9 in the control group) in Poland, each with at least 80 identified (at the baseline) patients with diagnosed COPD. The nine control practices will provide usual care without any interventions. Tailored interventions to implement four recommendations will be delivered in the remaining nine practices. At follow-up after nine months, data will be collected for all 18 general practices. The primary outcome measure is physicians' adherence to all four recommendations: brief anti-smoking advice, dyspnea assessment, care checklist utilization and demonstration to patients of correct inhaler use. This measurement will be based on data extracted from identified patients' records. Additionally, we will survey and interview patients with chronic obstructive pulmonary disease about the process of care. The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care. This trial has been registered with Clinical Trials Protocol Registration System. NCT01893476.

Dancing for Parkinson Disease: A Randomized Trial of Irish Set Dancing Compared With Usual Care.

PubMed

Shanahan, Joanne; Morris, Meg E; Bhriain, Orfhlaith Ni; Volpe, Daniele; Lynch, Tim; Clifford, Amanda M

2017-09-01

To examine the feasibility of a randomized controlled study design and to explore the benefits of a set dancing intervention compared with usual care. Randomized controlled design, with participants randomized to Irish set dance classes or a usual care group. Community based. Individuals with idiopathic Parkinson disease (PD) (N=90). The dance group attended a 1.5-hour dancing class each week for 10 weeks and undertook a home dance program for 20 minutes, 3 times per week. The usual care group continued with their usual care and daily activities. The primary outcome was feasibility, determined by recruitment rates, success of randomization and allocation procedures, attrition, adherence, safety, willingness of participants to be randomized, resource availability, and cost. Secondary outcomes were motor function (motor section of the Unified Parkinson's Disease Rating Scale), quality of life (Parkinson's Disease Questionnaire-39), functional endurance (6-min walk test), and balance (mini-BESTest). Ninety participants were randomized (45 per group). There were no adverse effects or resource constraints. Although adherence to the dancing program was 93.5%, there was >40% attrition in each group. Postintervention, the dance group had greater nonsignificant gains in quality of life than the usual care group. There was a meaningful deterioration in endurance in the usual care group. There were no meaningful changes in other outcomes. The exit questionnaire showed participants enjoyed the classes and would like to continue participation. For people with mild to moderately severe PD, set dancing is feasible and enjoyable and may improve quality of life. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Oncologists' perspectives on post-cancer treatment communication and care coordination with primary care physicians.

PubMed

Klabunde, C N; Haggstrom, D; Kahn, K L; Gray, S W; Kim, B; Liu, B; Eisenstein, J; Keating, N L

2017-07-01

Post-treatment cancer care is often fragmented and of suboptimal quality. We explored factors that may affect cancer survivors' post-treatment care coordination, including oncologists' use of electronic technologies such as e-mail and integrated electronic health records (EHRs) to communicate with primary care physicians (PCPs). We used data from a survey (357 respondents; participation rate 52.9%) conducted in 2012-2013 among medical oncologists caring for patients in a large US study of cancer care delivery and outcomes. Oncologists reported their frequency and mode of communication with PCPs, and role in providing post-treatment care. Seventy-five per cent said that they directly communicated with PCPs about post-treatment status and care recommendations for all/most patients. Among those directly communicating with PCPs, 70% always/usually used written correspondence, while 36% always/usually used integrated EHRs; telephone and e-mail were less used. Eighty per cent reported co-managing with PCPs at least one post-treatment general medical care need. In multivariate-adjusted analyses, neither communication mode nor intensity were associated with co-managing survivors' care. Oncologists' reliance on written correspondence to communicate with PCPs may be a barrier to care coordination. We discuss new research directions for enhancing communication and care coordination between oncologists and PCPs, and to better meet the needs of cancer survivors post-treatment. © 2017 John Wiley & Sons Ltd.

Group patient visits for Parkinson disease: a randomized feasibility trial.

PubMed

Dorsey, E R; Deuel, L M; Beck, C A; Gardiner, I F; Scoglio, N J; Scott, J C; Marshall, F J; Biglan, K M

2011-05-03

Group patient visits are medical appointments shared among patients with a common medical condition. This care delivery method has demonstrated benefits for individuals with chronic conditions but has not been evaluated for Parkinson disease (PD). We conducted a 12-month, randomized trial of group patient visits vs usual (one-on-one) care for patients with PD. Visits were led by one of 3 study physicians, included patients and caregivers, and lasted approximately 90 minutes. Those receiving group visits had 4 sessions over 12 months. The primary outcome measure was feasibility as measured by the ability to recruit participants and by the proportion of participants who completed the study. The primary efficacy outcome was quality of life as measured by the PD Questionnaire-39. Thirty patients and 27 caregivers enrolled in the study. Thirteen of the 15 patients randomized to group patient visits and 14 of the 15 randomized to usual care completed the study. Quality of life measured 12 months after baseline between the 2 groups was not different (25.9 points for group patient visits vs 26.0 points for usual care; p = 0.99). Group patient visits may be a feasible means of providing care to individuals with PD and may offer an alternative or complementary method of care delivery for some patients and physicians. This study provides Class II evidence that group patient visits did not improve quality of life for individuals with PD over a 1-year period.

After-hours access to primary care practices linked with lower emergency department use and less unmet medical need.

PubMed

O'Malley, Ann S

2013-01-01

One goal of the Affordable Care Act is to improve patients' access to primary care and the coordination of that care. An important ingredient in achieving that goal is ensuring that patients have access to their primary care practice outside of regular business hours. This analysis of the 2010 Health Tracking Household Survey found that among people with a usual source of primary care, 40.2 percent reported that their practice offered extended hours, such as at night or on weekends. The analysis also found that one in five people who attempted after-hours contact with their primary care provider reported it was "very difficult" or "somewhat difficult" to reach a clinician. Those who reported less difficulty contacting a clinician after hours had significantly fewer emergency department visits (30.4 percent compared to 37.7 percent) and lower rates of unmet medical need (6.1 percent compared to 13.7 percent) than people who experienced more difficulty. The findings provide a valuable baseline on after-hours access, especially as patient-centered medical homes and accountable care organizations expand. Increasing support to primary care practices to offer or coordinate after-hours care may help reduce rates of emergency department use and unmet medical need.

Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials

PubMed Central

2012-01-01

Background Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care. Methods / Design One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed. Discussion Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings. Trial registration NCT01130740 (VA); NCT 01435109 (NIH) PMID:22530979

Generic care pathway for elderly patients in need of home care services after discharge from hospital: a cluster randomised controlled trial.

PubMed

Røsstad, Tove; Salvesen, Øyvind; Steinsbekk, Aslak; Grimsmo, Anders; Sletvold, Olav; Garåsen, Helge

2017-04-17

Improved discharge arrangements and targeted post-discharge follow-up can reduce the risk of adverse events after hospital discharge for elderly patients. Although more care is to shift from specialist to primary care, there are few studies on post-discharge interventions run by primary care. A generic care pathway, Patient Trajectory for Home-dwelling elders (PaTH) including discharge arrangements and follow-up by primary care, was developed and introduced in Central Norway Region in 2009, applying checklists at defined stages in the patient trajectory. In a previous paper, we found that PaTH had potential of improving follow-up in primary care. The aim of this study was to establish the effect of PaTH-compared to usual care-for elderly in need of home care services after discharge from hospital. We did an unblinded, cluster randomised controlled trial with 12 home care clusters. Outcomes were measured at the patient level during a 12-month follow-up period for the individual patient and analysed applying linear and logistic mixed models. Primary outcomes were readmissions within 30 days and functional level assessed by Nottingham extended ADL scale. Secondary outcomes were number and length of inpatient hospital care and nursing home care, days at home, consultations with the general practitioners (GPs), mortality and health related quality of life (SF-36). One-hundred and sixty-three patients were included in the PaTH group (six clusters), and 141 patients received care as usual (six clusters). We found no statistically significant differences between the groups for primary and secondary outcomes except for more consultations with the GPs in PaTH group (p = 0.04). Adherence to the intervention was insufficient as only 36% of the patients in the intervention group were assessed by at least three of the four main checklists in PaTH, but this improved over time. Lack of adherence to PaTH rendered the study inconclusive regarding the elderly's functional level, number of readmissions after hospital discharge, and health care utilisation except for more consultations with the GPs. A targeted exploration of prerequisites for implementation is recommended in the pre-trial phase of complex intervention studies. Clinical Trials.gov NCT01107119 , retrospectively registered 2010.04.18.

Changes in eating, physical activity and related behaviors in a primary care-based weight loss intervention.

PubMed

Volger, S; Wadden, T A; Sarwer, D B; Moore, R H; Chittams, J; Diewald, L K; Panigrahi, E; Berkowitz, R I; Schmitz, K; Vetter, M L

2013-08-01

To examine changes in eating behaviors and physical activity, as well as predictors of weight loss success, in obese adults who participated in a 2-year behavioral weight loss intervention conducted in a primary care setting. A longitudinal, randomized controlled, multisite trial. Three hundred ninety obese (body mass index, 30-50 kg m(-2)) adults, ≥ 21 years, in the Philadelphia region. Participants were assigned to one of three interventions: (1) Usual Care (quarterly primary care provider (PCP) visits that included education on diet and exercise); (2) Brief Lifestyle Counseling (quarterly PCP visits plus monthly lifestyle counseling (LC) sessions about behavioral weight control); or (3) Enhanced Brief LC (the previous intervention with a choice of meal replacements or weight loss medication). At month 24, participants in both Brief LC and Enhanced Brief LC reported significantly greater improvements in mean (± s.e.) dietary restraint than those in Usual Care (4.4 ± 0.5, 4.8 ± 0.5 and 2.8 ± 0.5, respectively; both P-values ≤ 0.016). The percentage of calories from fat, along with fruit and vegetable consumption, did not differ significantly among the three groups. At month 24, both the Brief LC and Enhanced Brief LC groups reported significantly greater increases than usual care in energy expenditure (kcal per week) from moderately vigorous activity (+593.4 ± 175.9, +415.4 ± 179.6 and -70.4 ± 185.5 kcal per week, respectively; both P-values ≤ 0.037). The strongest predictor of weight loss at month 6 (partial R(2)=33.4%, P<0.0001) and at month 24 (partial R(2)=19.3%, P<0.001) was food records completed during the first 6 months. Participants who achieved a 5% weight loss at month 6 had 4.7 times greater odds of maintaining a ≥ 5% weight loss at month 24. A behavioral weight loss intervention delivered in a primary care setting can result in significant weight loss, with corresponding improvements in eating restraint and energy expenditure. Moreover, completion of food records, along with weight loss at month 6, is a strong predictor of long-term weight loss.

Home and Online Management and Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension: a protocol for the randomised controlled HOME BP trial

PubMed Central

Morton, Katherine; Stuart, Beth; Raftery, James; Bradbury, Katherine; Yao, Guiqing Lily; Zhu, Shihua; Little, Paul; Yardley, Lucy

2016-01-01

Introduction Self-management of hypertension, including self-monitoring and antihypertensive medication titration, lowers blood pressure (BP) at 1 year compared to usual care. The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure (HOME BP) intervention for the self-management of hypertension in primary care. Methods and analysis The HOME BP trial will be a randomised controlled trial comparing BP self-management—consisting of the HOME BP online digital intervention with self-monitoring, lifestyle advice and antihypertensive drug titration—with usual care for people with uncontrolled essential hypertension. Eligible patients will be recruited from primary care and randomised to usual care or to self-management using HOME BP. The primary outcome will be the difference in mean systolic BP (mm Hg) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates. Secondary outcomes (also adjusted for baseline and covariates where appropriate) will be differences in mean BP at 6 months and diastolic BP at 12 months; patient enablement; quality of life, and economic analyses including all key resources associated with the intervention and related services, adopting a broad societal perspective to include NHS, social care and patient costs, considered within trial and modelled with a lifetime horizon. Medication beliefs, adherence and changes; self-efficacy; perceived side effects and lifestyle changes will be measured for process analyses. Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability, feasibility and adherence. Ethics and dissemination This study has received NHS ethical approval (REC reference 15/SC/0082). The findings from HOME BP will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, HOME BP will be directly applicable to UK primary care management of hypertension. Trial registration number ISRCTN13790648; pre-results. PMID:27821598

Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness.

PubMed

Abbott, J H; Robertson, M C; Chapple, C; Pinto, D; Wright, A A; Leon de la Barra, S; Baxter, G D; Theis, J-C; Campbell, A J

2013-04-01

To evaluate the clinical effectiveness of manual physiotherapy and/or exercise physiotherapy in addition to usual care for patients with osteoarthritis (OA) of the hip or knee. In this 2 × 2 factorial randomized controlled trial, 206 adults (mean age 66 years) who met the American College of Rheumatology criteria for hip or knee OA were randomly allocated to receive manual physiotherapy (n = 54), multi-modal exercise physiotherapy (n = 51), combined exercise and manual physiotherapy (n = 50), or no trial physiotherapy (n = 51). The primary outcome was change in the Western Ontario and McMaster osteoarthritis index (WOMAC) after 1 year. Secondary outcomes included physical performance tests. Outcome assessors were blinded to group allocation. Of 206 participants recruited, 193 (93.2%) were retained at follow-up. Mean (SD) baseline WOMAC score was 100.8 (53.8) on a scale of 0-240. Intention to treat analysis showed adjusted reductions in WOMAC scores at 1 year compared with the usual care group of 28.5 (95% confidence interval (CI) 9.2-47.8) for usual care plus manual therapy, 16.4 (-3.2 to 35.9) for usual care plus exercise therapy, and 14.5 (-5.2 to 34.1) for usual care plus combined exercise therapy and manual therapy. There was an antagonistic interaction between exercise therapy and manual therapy (P = 0.027). Physical performance test outcomes favoured the exercise therapy group. Manual physiotherapy provided benefits over usual care, that were sustained to 1 year. Exercise physiotherapy also provided physical performance benefits over usual care. There was no added benefit from a combination of the two therapies. Australian New Zealand Clinical Trials Registry ACTRN12608000130369. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Applying the Chronic Care Model to Homeless Veterans: Effect of a Population Approach to Primary Care on Utilization and Clinical Outcomes

PubMed Central

Buckel, Lauren; Bourgault, Claire; Blumen, Jonathan; Redihan, Stephen G.; Jiang, Lan; Friedmann, Peter

2010-01-01

Objectives. We compared a population-tailored approach to primary care for homeless veterans with a usual care approach. Methods. We conducted a retrospective prolective cohort study of homeless veterans enrolled in a population-tailored primary care clinic matched to a historical sample in general internal medicine clinics. Overall, 177 patients were enrolled: 79 in the Homeless-Oriented Primary Care Clinic and 98 in general internal medicine primary care. Results. Homeless-oriented primary care–enrolled patients had greater improvements in hypertension, diabetes, and lipid control, and primary care use was higher during the first 6 months (5.96 visits per person vs 1.63 for general internal medicine) but stabilized to comparable rates during the second 6 months (2.01 vs 1.31, respectively). Emergency department (ED) use was also higher (2.59 vs 1.89 visits), although with 40% lower odds for nonacute ED visits than for the general internal medicine group (95% confidence interval = 0.2, 0.8). Excluding substance abuse and mental health admissions, hospitalizations were reduced among the homeless veterans between the 2 periods (28.6% vs 10.8%; P < .01) compared with the general internal medicine group (48.2% vs 44.4%; P = .6; difference of differences, P < .01). Conclusions. Tailoring primary care to homeless veterans can decrease unnecessary ED use and medical admissions and improve chronic disease management. PMID:20966377

Motivational, reduction and usual care interventions for smokers who are not ready to quit: a randomized controlled trial.

PubMed

Klemperer, Elias M; Hughes, John R; Solomon, Laura J; Callas, Peter W; Fingar, James R

2017-01-01

To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. A parallel-group randomized controlled trial of brief motivational (n = 185), reduction (n = 186) or usual care (n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. United States. A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Among adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months. © 2016 Society for the Study of Addiction.

Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

PubMed Central

Feldman, Penny H; McDonald, Margaret V; Barrón, Yolanda; Gerber, Linda M; Peng, Timothy R

2016-01-01

Aim: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. Patients & methods: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. Results: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5–145.4 mmHg) among all study participants. Conclusion: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. Clinical Trial Registration: NCT00139490. PMID:26946952

Counselling for mental health and psychosocial problems in primary care.

PubMed

Bower, Peter; Knowles, Sarah; Coventry, Peter A; Rowland, Nancy

2011-09-07

The prevalence of mental health and psychosocial problems in primary care is high. Counselling is a potential treatment for these patients, but there is a lack of consensus over the effectiveness of this treatment in primary care. To assess the effectiveness and cost effectiveness of counselling for patients with mental health and psychosocial problems in primary care. To update the review, the following electronic databases were searched: the Cochrane Collaboration Depression, Anxiety and Neurosis (CCDAN) trials registers (to December 2010), MEDLINE, EMBASE, PsycINFO and the Cochrane Central Register of Controlled Trials (to May 2011). Randomised controlled trials of counselling for mental health and psychosocial problems in primary care. Data were extracted using a standardised data extraction sheet by two reviewers. Trials were rated for quality by two reviewers using Cochrane risk of bias criteria, to assess the extent to which their design and conduct were likely to have prevented systematic error. Continuous measures of outcome were combined using standardised mean differences. An overall effect size was calculated for each outcome with 95% confidence intervals (CI). Continuous data from different measuring instruments were transformed into a standard effect size by dividing mean values by standard deviations. Sensitivity analyses were undertaken to test the robustness of the results. Economic analyses were summarised in narrative form. There was no assessment of adverse events. Nine trials were included in the review, involving 1384 randomised participants. Studies varied in risk of bias, although two studies were identified as being at high risk of selection bias because of problems with concealment of allocation. All studies were from primary care in the United Kingdom and thus comparability was high. The analysis found significantly greater clinical effectiveness in the counselling group compared with usual care in terms of mental health outcomes in the short-term (standardised mean difference -0.28, 95% CI -0.43 to -0.13, n = 772, 6 trials) but not in the long-term (standardised mean difference -0.09, 95% CI -0.27 to 0.10, n = 475, 4 trials), nor on measures of social function (standardised mean difference -0.09, 95% CI -0.29 to 0.11, n = 386, 3 trials). Levels of satisfaction with counselling were high. There was some evidence that the overall costs of counselling and usual care were similar. There were limited comparisons between counselling and other psychological therapies, medication, or other psychosocial interventions. Counselling is associated with significantly greater clinical effectiveness in short-term mental health outcomes compared to usual care, but provides no additional advantages in the long-term. Participants were satisfied with counselling. Although some types of health care utilisation may be reduced, counselling does not seem to reduce overall healthcare costs. The generalisability of these findings to settings outside the United Kingdom is unclear.

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

PubMed Central

2013-01-01

Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. Discussion This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. Trial registration ISRCTN62019087 PMID:23819476

Having a usual source of care and its associated factors in Korean adults: a cross-sectional study of the 2012 Korea Health Panel Survey.

PubMed

An, Ah Reum; Kim, Kyoungwoo; Lee, Jae-Ho; Sung, Nak-Jin; Lee, Sang-Il; Hyun, Min Kyung

2016-11-29

Usual source of care (USC) is one of the hallmarks of primary care. We aimed to examine the status of having a USC and its patient-related sociodemographic factors among Korean adults. Data were obtained from the 2012 Korea Health Panel survey. Panel participants were selected for the study who were aged 18 years or older and who replied to questionnaire items on having a USC (n = 11,935). Of the participants, 21.5% had a usual place and 13.9% had a usual physician. Reasons for not having a USC were seldom being ill (66.1%), the preference to visit multiple medical institutions (27.9%), and others. The private community clinic was the most common type of usual place (57.0%). In patient-reported attributes of care provided by a usual physician, the percentages of positive responses for comprehensiveness and coordination were 67.2% and 34.5%, respectively. By institution type, primary care clinics showed the lowest percentage (32.8%) of positive responses for coordination. Adjusted odds ratios of having a usual physician were 3.77 (95% confidence interval, CI: 3.75-3.79) for those aged 65 years or older (vs. aged 18-34 years), 1.31 (CI: 1.30-1.31) for females (vs. males), 0.72 (CI: 0.72-0.73) for unmarried people (vs. married), 1.16 (CI: 1.16-1.16) for college graduates or higher (vs. elementary school graduate or less), 0.64 for the fifth quintile (vs. the first quintile) by household income, 1.53 (CI: 1.52-1.54) for Medical Aid (vs. employee health insurance) for type of health insurance, and 4.09 (CI: 4.08-4.10) for presence (vs. absence) of a chronic diseases. The proportion of Korean adults who have a USC is extremely low, the most influential factor of having a USC is having a chronic disease or not, and Korean patients experience much poorer health care coordination than do patients in other industrialized countries. The findings of this study will give insight to researchers and policy makers regarding the potential facilitators of and barriers to promoting having a USC in the general Korean public.

The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.

PubMed

Thompson, E A; Shaw, A; Nichol, J; Hollinghurst, S; Henderson, A J; Thompson, T; Sharp, D

2011-07-01

To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial. In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences. 226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process. A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Managing Depression Among Homeless Mothers: Pilot Testing an Adapted Collaborative Care Intervention.

PubMed

Weinreb, Linda; Upshur, Carole C; Fletcher-Blake, Debbian; Reed, George; Frisard, Christine

2016-01-01

Although depression is common among homeless mothers, little progress has been made in testing treatment strategies for this group. We describe pilot test results of an adapted collaborative care model for homeless mothers with depression. We conducted a pilot intervention study of mothers screening positive for depression in 2 randomly selected shelter-based primary care clinics in New York over 18 months in 2010-2012. Study participants completed a psychosocial, health, and mental health assessment at baseline, 3 months, and 6 months. One-third of women screened positive for depression (123 of 328 women). Sixty-seven women (63.2% of the eligible sample) enrolled in the intervention. At 6 months, compared to usual-care women, intervention group women were more likely to be receiving depression treatment (40.0% vs 5.9%, P = .01) and antidepressant medication (73.3% vs 5.9%, P = .001, respectively) and had more primary care physician and care manager visits at both 3 months (74.3% vs 53.3%, P = .009 and 91.4% vs 26.7%, P < .001, respectively) and 6 months (46.7% vs 23.5%, P = .003 and 70% vs 17.7%, P = .001, respectively). More women in the intervention group compared to usual-care women reported ≥ 50% improvement in depression symptoms at 6 months (30% vs 5.9%, P = .07). This pilot study found that implementing an adapted collaborative care intervention was feasible in a shelter-based primary care clinic and had promising results that require further testing. ClinicalTrials.gov identifier: NCT02723058.

Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk.

PubMed

Müller-Wieland, Dirk; Leiter, Lawrence A; Cariou, Bertrand; Letierce, Alexia; Colhoun, Helen M; Del Prato, Stefano; Henry, Robert R; Tinahones, Francisco J; Aurand, Lisa; Maroni, Jaman; Ray, Kausik K; Bujas-Bobanovic, Maja

2017-05-25

Type 2 diabetes mellitus (T2DM) is often associated with mixed dyslipidaemia, where non-high-density lipoprotein cholesterol (non-HDL-C) levels may more closely align with cardiovascular risk than low-density lipoprotein cholesterol (LDL-C). We describe the design and rationale of the ODYSSEY DM-DYSLIPIDEMIA study that assesses the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk with non-HDL-C inadequately controlled despite maximally tolerated statin therapy. For the first time, atherogenic cholesterol-lowering with a PCSK9 inhibitor will be assessed with non-HDL-C as the primary endpoint with usual care as the comparator. DM-DYSLIPIDEMIA is a Phase 3b/4, randomised, open-label, parallel group, multinational study that planned to enrol 420 individuals. Main inclusion criteria were T2DM and mixed dyslipidaemia (non-HDL-C ≥100 mg/dl [≥2.59 mmol/l], and triglycerides ≥150 and <500 mg/dl [≥1.70 and <5.65 mmol/l]) with documented atherosclerotic cardiovascular disease or ≥1 additional cardiovascular risk factor. Participants were randomised (2:1) to alirocumab 75 mg every 2 weeks (Q2W) or lipid-lowering usual care on top of maximally tolerated statin (or no statin if intolerant). If randomised to usual care, investigators were able to add their pre-specified choice of one of the following to the patient's current statin regimen: ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid, in accordance with local standard-of-care. Alirocumab-treated individuals with non-HDL-C ≥100 mg/dl at week 8 will undergo a blinded dose increase to 150 mg Q2W at week 12. The primary efficacy endpoint is non-HDL-C change from baseline to week 24 with alirocumab versus usual care; other lipid levels (including LDL-C), glycaemia-related measures, safety and tolerability will also be assessed. Alirocumab will be compared to fenofibrate in a secondary analysis. Recruitment completed with 413 individuals randomised in 14 countries worldwide. Results of this trial are expected in the second quarter of 2017. ODYSSEY DM-DYSLIPIDEMIA will provide information on the efficacy and safety of alirocumab versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk using non-HDL-C as the primary efficacy endpoint. Trial registration NCT02642159 (registered December 24, 2015).

A randomised controlled trial of a consumer-focused e-health strategy for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study protocol.

PubMed

Redfern, Julie; Usherwood, T; Harris, M F; Rodgers, A; Hayman, N; Panaretto, K; Chow, C; Lau, A Y S; Neubeck, L; Coorey, G; Hersch, F; Heeley, E; Patel, A; Jan, S; Zwar, N; Peiris, D

2014-01-31

Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk. In this project, we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice. Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Islander and non-indigenous adults, recruited through primary care, at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care. Randomised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk. The trial will be augmented by formal economic and process evaluations to assess acceptability, equity and cost-effectiveness of the intervention. The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management. The programme is electronically integrated with the primary care provider's software and will include interactive smart phone and Internet platforms. The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline-recommended blood pressure (BP) and cholesterol targets. Secondary outcomes include change in mean BP and fasting cholesterol levels, proportion meeting BP and cholesterol targets separately, self-efficacy, health literacy, self-reported point prevalence abstinence in smoking, body mass index and waist circumference, self-reported physical activity and self-reported medication adherence. Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences ACTRN12613000715774.

Cost-Effectiveness of Collaborative Care for the Treatment of Depressive Disorders in Primary Care: A Systematic Review

PubMed Central

Grochtdreis, Thomas; Brettschneider, Christian; Wegener, Annemarie; Watzke, Birgit; Riedel-Heller, Steffi; Härter, Martin; König, Hans-Helmut

2015-01-01

Background For the treatment of depressive disorders, the framework of collaborative care has been recommended, which showed improved outcomes in the primary care sector. Yet, an earlier literature review did not find sufficient evidence to draw robust conclusions on the cost-effectiveness of collaborative care. Purpose To systematically review studies on the cost-effectiveness of collaborative care, compared with usual care for the treatment of patients with depressive disorders in primary care. Methods A systematic literature search in major databases was conducted. Risk of bias was assessed using the Cochrane Collaboration’s tool. Methodological quality of the articles was assessed using the Consensus on Health Economic Criteria (CHEC) list. To ensure comparability across studies, cost data were inflated to the year 2012 using country-specific gross domestic product inflation rates, and were adjusted to international dollars using purchasing power parities (PPP). Results In total, 19 cost-effectiveness analyses were reviewed. The included studies had sample sizes between n = 65 to n = 1,801, and time horizons between six to 24 months. Between 42% and 89% of the CHEC quality criteria were fulfilled, and in only one study no risk of bias was identified. A societal perspective was used by five studies. Incremental costs per depression-free day ranged from dominance to US$PPP 64.89, and incremental costs per QALY from dominance to US$PPP 874,562. Conclusion Despite our review improved the comparability of study results, cost-effectiveness of collaborative care compared with usual care for the treatment of patients with depressive disorders in primary care is ambiguous depending on willingness to pay. A still considerable uncertainty, due to inconsistent methodological quality and results among included studies, suggests further cost-effectiveness analyses using QALYs as effect measures and a time horizon of at least 1 year. PMID:25993034

Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial

PubMed Central

Robling, Michael; Bekkers, Marie-Jet; Bell, Kerry; Butler, Christopher C; Cannings-John, Rebecca; Channon, Sue; Martin, Belen Corbacho; Gregory, John W; Hood, Kerry; Kemp, Alison; Kenkre, Joyce; Montgomery, Alan A; Moody, Gwenllian; Owen-Jones, Eleri; Pickett, Kate; Richardson, Gerry; Roberts, Zoë E S; Ronaldson, Sarah; Sanders, Julia; Stamuli, Eugena; Torgerson, David

2016-01-01

Summary Background Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth. Methods We did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866. Findings Between June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64–1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI −47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99–1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77–1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother–child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention. Interpretation Adding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge. Funding Department of Health Policy Research Programme. PMID:26474809

Primary Care, Self-rated Health, and Reductions in Social Disparities in Health

PubMed Central

Shi, Leiyu; Starfield, Barbara; Politzer, Robert; Regan, Jerri

2002-01-01

Objective To examine the extent to which good primary-care experience attenuates the adverse association of income inequality with self-reported health. Data Sources Data for the study were drawn from the Robert Wood Johnson Foundation sponsored 1996–1997 Community Tracking Study (CTS) Household Survey and state indicators of income inequality and primary care. Study Design Cross-sectional, mixed-level analysis on individuals with a primary-care physician as their usual source of care. The analyses were weighted to represent the civilian noninstitutionalized population of the continental United States. Data Collection/Extraction Methods Principal component factor analysis was used to explore the structure of the primary-care indicators and examine their construct validity. Income inequality for the state in which the community is located was measured by the Gini coefficient, calculated using income distribution data from the 1996 current population survey. Stratified analyses compared proportion of individuals reporting bad health and feeling depressed with those with good and bad primary-care experiences for each of the four income-inequality strata. A set of logistic regressions were performed to examine the relation between primary-care experience, income inequality, and self-rated health. Principal Findings Good primary-care experience, in particular enhanced accessibility and continuity, was associated with better self-reported health both generally and mentally. Good primary-care experience was able to reduce the adverse association of income inequality with general health although not with mental health, and was especially beneficial in areas with highest income inequality. Socioeconomic status attenuated, but did not eliminate, the effect of primary-care experience on health. In conclusion, good primary-care experience is associated not only with improved self-rated overall and mental health but also with reductions in disparities between more- and less-disadvantaged communities in ratings of overall health. PMID:12132594

Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial.

PubMed

Nicolaije, Kim A H; Ezendam, Nicole P M; Vos, M Caroline; Pijnenborg, Johanna M A; Boll, Dorry; Boss, Erik A; Hermans, Ralph H M; Engelhart, Karin C M; Haartsen, Joke E; Pijlman, Brenda M; van Loon-Baelemans, Ingrid E A M; Mertens, Helena J M M; Nolting, Willem E; van Beek, Johannes J; Roukema, Jan A; Zijlstra, Wobbe P; Kruitwagen, Roy F P M; van de Poll-Franse, Lonneke V

2015-11-01

This study was conducted to longitudinally assess the impact of an automatically generated survivorship care plan (SCP) on patient-reported outcomes in routine clinical practice. Primary outcomes were patient satisfaction with information and care. Secondary outcomes included illness perceptions and health care use. Twelve hospitals were randomly assigned to SCP care or usual care in a pragmatic, cluster randomized trial. Newly diagnosed patients with endometrial cancer completed questionnaires after diagnosis (n = 221; 75% response), 6 months (n = 158), and 12 months (n = 147). An SCP application was built in the Web-based ROGY (Registration System Oncological Gynecology). By clicking the SCP button, a patient-tailored SCP was generated. In the SCP care arm, 74% of patients received an SCP. They reported receiving more information about their treatment (mean [M] = 57, standard deviation [SD] = 20 v M = 47, SD = 24; P = .03), other services (M = 35, SD = 22 v M = 25, SD = 22; P = .03), and different places of care (M = 27, SD = 25 v M = 23, SD = 26; P = .04) than the usual care arm (scales, 0 to 100). However, there were no differences regarding satisfaction with information or care. Patients in the SCP care arm experienced more symptoms (M = 3.3, SD = 2.0 v M = 2.6, SD = 1.6; P = .03), were more concerned about their illness (M = 4.4, SD = 2.3 v M = 3.9, SD = 2.1; P = .03), were more affected emotionally (M = 4.0, SD = 2.2 v M = 3.7, SD = 2.2; P = .046), and reported more cancer-related contact with their primary care physician (M = 1.8, SD = 2.0 v M = 1.1, SD = 0.9; P = .003) than those in the usual care arm (scale, 1 to 10). These effects did not differ over time. The present trial showed no evidence of a benefit of SCPs on satisfaction with information and care. Furthermore, SCPs increased patients' concerns, emotional impact, experienced symptoms, and the amount of cancer-related contact with the primary care physician. Whether this may ultimately lead to more empowered patients should be investigated further. © 2015 by American Society of Clinical Oncology.

A Remote Collaborative Care Program for Patients with Depression Living in Rural Areas: Open-Label Trial.

PubMed

Rojas, Graciela; Guajardo, Viviana; Martínez, Pablo; Castro, Ariel; Fritsch, Rosemarie; Moessner, Markus; Bauer, Stephanie

2018-04-30

In the treatment of depression, primary care teams have an essential role, but they are most effective when inserted into a collaborative care model for disease management. In rural areas, the shortage of specialized mental health resources may hamper management of depressed patients. The aim was to test the feasibility, acceptability, and effectiveness of a remote collaborative care program for patients with depression living in rural areas. In a nonrandomized, open-label (blinded outcome assessor), two-arm clinical trial, physicians from 15 rural community hospitals recruited 250 patients aged 18 to 70 years with a major depressive episode (DSM-IV criteria). Patients were assigned to the remote collaborative care program (n=111) or to usual care (n=139). The remote collaborative care program used Web-based shared clinical records between rural primary care teams and a specialized/centralized mental health team, telephone monitoring of patients, and remote supervision by psychiatrists through the Web-based shared clinical records and/or telephone. Depressive symptoms, health-related quality of life, service use, and patient satisfaction were measured 3 and 6 months after baseline assessment. Six-month follow-up assessments were completed by 84.4% (221/250) of patients. The remote collaborative care program achieved higher user satisfaction (odds ratio [OR] 1.94, 95% CI 1.25-3.00) and better treatment adherence rates (OR 1.81, 95% CI 1.02-3.19) at 6 months compared to usual care. There were no statically significant differences in depressive symptoms between the remote collaborative care program and usual care. Significant differences between groups in favor of remote collaborative care program were observed at 3 months for mental health-related quality of life (beta 3.11, 95% CI 0.19-6.02). Higher rates of treatment adherence in the remote collaborative care program suggest that technology-assisted interventions may help rural primary care teams in the management of depressive patients. Future cost-effectiveness studies are needed. Clinicaltrials.gov NCT02200367; https://clinicaltrials.gov/ct2/show/NCT02200367 (Archived by WebCite at http://www.webcitation.org/6xtZ7OijZ). ©Graciela Rojas, Viviana Guajardo, Pablo Martínez, Ariel Castro, Rosemarie Fritsch, Markus Moessner, Stephanie Bauer. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 30.04.2018.

Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial.

PubMed

Hwang, Man-Suk; Heo, Kwang-Ho; Cho, Hyun-Woo; Shin, Byung-Cheul; Lee, Hyeon-Yeop; Heo, In; Kim, Nam-Kwen; Choi, Byung-Kwan; Son, Dong-Wuk; Hwang, Eui-Hyoung

2015-02-04

Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described. This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ≥50 mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100 mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8 weeks after treatment. Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences. This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Efficacy of community-based physiotherapy networks for patients with Parkinson's disease: a cluster-randomised trial.

PubMed

Munneke, Marten; Nijkrake, Maarten J; Keus, Samyra Hj; Kwakkel, Gert; Berendse, Henk W; Roos, Raymund Ac; Borm, George F; Adang, Eddy M; Overeem, Sebastiaan; Bloem, Bastiaan R

2010-01-01

Many patients with Parkinson's disease are treated with physiotherapy. We have developed a community-based professional network (ParkinsonNet) that involves training of a selected number of expert physiotherapists to work according to evidence-based recommendations, and structured referrals to these trained physiotherapists to increase the numbers of patients they treat. We aimed to assess the efficacy of this approach for improving health-care outcomes. Between February, 2005, and August, 2007, we did a cluster-randomised trial with 16 clusters (defined as community hospitals and their catchment area). Clusters were randomly allocated by use of a variance minimisation algorithm to ParkinsonNet care (n=8) or usual care (n=8). Patients were assessed at baseline and at 8, 16, and 24 weeks of follow-up. The primary outcome was a patient preference disability score, the patient-specific index score, at 16 weeks. Health secondary outcomes were functional mobility, mobility-related quality of life, and total societal costs over 24 weeks. Analysis was by intention to treat. This trial is registered, number NCT00330694. We included 699 patients. Baseline characteristics of the patients were comparable between the ParkinsonNet clusters (n=358) and usual-care clusters (n=341). The primary endpoint was similar for patients within the ParkinsonNet clusters (mean 47.7, SD 21.9) and control clusters (48.3, 22.4). Health secondary endpoints were also similar for patients in both study groups. Total costs over 24 weeks were lower in ParkinsonNet clusters compared with usual-care clusters (difference euro727; 95% CI 56-1399). Implementation of ParkinsonNet networks did not change health outcomes for patients living in ParkinsonNet clusters. However, health-care costs were reduced in ParkinsonNet clusters compared with usual-care clusters. ZonMw; Netherlands Organisation for Scientific Research; Dutch Parkinson's Disease Society; National Parkinson Foundation; Stichting Robuust. Copyright 2010 Elsevier Ltd. All rights reserved.

Emerging Role of the Army Family Physician in Primary Health Care Delivery.

DTIC Science & Technology

1976-12-13

practice in the civilian community and had handled a variety of primary care problems. They volunteered to come into the Army , joined training pro ...the end of the draft came and with it the reality that adequate numbers of General Medical Officers ( GMO ’s) were no longer available. The typical... GMO , a product of the draft, came into the Army at the end of his year of internship. He was usually assigned all the unpleasant and mundane duties that

Multidisciplinary care planning in the primary care management of completed stroke: a systematic review

PubMed Central

Mitchell, Geoffrey K; Brown, Robyn M; Erikssen, Lars; Tieman, Jennifer J

2008-01-01

Background Chronic disease management requires input from multiple health professionals, both specialist and primary care providers. This study sought to assess the impact of co-ordinated multidisciplinary care in primary care, represented by the delivery of formal care planning by primary care teams or shared across primary-secondary teams, on outcomes in stroke, relative to usual care. Methods A Systematic review of Medline, EMBASE, CINAHL (all 1990–2006), Cochrane Library (Issue 1 2006), and grey literature from web based searching of web sites listed in the CCOHA Health Technology Assessment List Analysis used narrative analysis of findings of randomised and non-randomised trials, and observational and qualitative studies of patients with completed stroke in the primary care setting where care planning was undertaken by 1) a multi-disciplinary primary care team or 2) through shared care by primary and secondary providers. Results One thousand and forty-five citations were retrieved. Eighteen papers were included for analysis. Most care planning took part in the context of multidisciplinary team care based in hospitals with outreach to community patients. Mortality rates are not impacted by multidisciplinary care planning. Functional outcomes of the studies were inconsistent. It is uncertain whether the active engagement of GPs and other primary care professionals in the multidisciplinary care planning contributed to the outcomes in the studies showing a positive effect. There may be process benefits from multidisciplinary care planning that includes primary care professionals and GPs. Few studies actually described the tasks and roles GPs fulfilled and whether this matched what was presumed to be provided. Conclusion While multidisciplinary care planning may not unequivocally improve the care of patients with completed stroke, there may be process benefits such as improved task allocation between providers. Further study on the impact of active GP involvement in multidisciplinary care planning is warranted. PMID:18681977

The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial.

PubMed

Cannell, John; Jovic, Emelyn; Rathjen, Amy; Lane, Kylie; Tyson, Anna M; Callisaya, Michele L; Smith, Stuart T; Ahuja, Kiran Dk; Bird, Marie-Louise

2018-02-01

To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Randomized controlled clinical trial. Two subacute hospital rehabilitation units in Australia. In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. Both groups received functional retraining and individualized programs for up to an hour, on weekdays for 8-40 sessions (dose matched). For the intervention group, this individualized program used motivating virtual reality rehabilitation and novel gesture controlled interactive motion capture software. For usual care, the individualized program was delivered in a group class on one unit and by rehabilitation assistant 1:1 on the other. Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. Participants (mean 22 days post-stroke) attended mean 14 sessions. Both groups improved (mean (95% confidence interval)) on primary outcome functional reach (usual care 3.3 (0.6 to 5.9), intervention 4.1 (-3.0 to 5.0) cm) with no difference between groups ( P = 0.69) on this or any secondary measures. No differences between the rehabilitation units were seen except in lateral reach (less affected side) ( P = 0.04). No adverse events were recorded during therapy. Interactive, motion capture rehabilitation for inpatients post stroke produced functional improvements that were similar to those achieved by usual care stroke rehabilitation, safely delivered by either a physical therapist or a rehabilitation assistant.

Does providing prescription information or services improve medication adherence among patients discharged from the emergency department? A randomized controlled trial.

PubMed

McCarthy, Melissa L; Ding, Ru; Roderer, Nancy K; Steinwachs, Donald M; Ortmann, Melinda J; Pham, Julius Cong; Bessman, Edward S; Kelen, Gabor D; Atha, Walter; Retezar, Rodica; Bessman, Sara C; Zeger, Scott L

2013-09-01

We determine whether prescription information or services improve the medication adherence of emergency department (ED) patients. Adult patients treated at one of 3 EDs between November 2010 and September 2011 and prescribed an antibiotic, central nervous system, gastrointestinal, cardiac, or respiratory drug at discharge were eligible. Subjects were randomly assigned to usual care or one of 3 prescription information or services intervention groups: (1) practical services to reduce barriers to prescription filling (practical prescription information or services); (2) consumer drug information from MedlinePlus (MedlinePlus prescription information or services); or (3) both services and information (combination prescription information or services). Self-reported medication adherence, measured by primary adherence (prescription filling) and persistence (receiving medicine as prescribed) rates, was determined during a telephone interview 1 week postdischarge. Of the 3,940 subjects enrolled and randomly allocated to treatment, 86% (N=3,386) completed the follow-up interview. Overall, primary adherence was 88% and persistence was 48%. Across the sites, primary adherence and persistence did not differ significantly between usual care and the prescription information or services groups. However, at site C, subjects who received the practical prescription information or services (odds ratio [OR]=2.4; 95% confidence interval [CI] 1.4 to 4.3) or combination prescription information or services (OR=1.8; 95% CI 1.1 to 3.1) were more likely to fill their prescription compared with usual care. Among subjects prescribed a drug that treats an underlying condition, subjects who received the practical prescription information or services were more likely to fill their prescription (OR=1.8; 95% CI 1.0 to 3.1) compared with subjects who received usual care. Prescription filling and receiving medications as prescribed was not meaningfully improved by offering patients patient-centered prescription information and services. Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer.

PubMed

Emery, Jon D; Jefford, Michael; King, Madeleine; Hayne, Dickon; Martin, Andrew; Doorey, Juanita; Hyatt, Amelia; Habgood, Emily; Lim, Tee; Hawks, Cynthia; Pirotta, Marie; Trevena, Lyndal; Schofield, Penelope

2017-03-01

To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer. Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use. A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91-554]). Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study.

PubMed

Martin-Lujan, Francisco; Piñol-Moreso, Josep L I; Martin-Vergara, Nuria; Basora-Gallisa, Josep; Pascual-Palacios, Irene; Sagarra-Alamo, Ramon; Llopis, Estefania Aparicio; Basora-Gallisa, Maria T; Pedret-Llaberia, Roser

2011-11-11

There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Multicentre randomized clinical trial with an intervention and a control group. 12 primary care centres in the province of Tarragona (Spain). 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Smoking cessation at 12 months. Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. ClinicalTrial.gov, number NCT01194596.

The impact of primary care on emergency department presentation and hospital admission with pneumonia: a case–control study of preschool-aged children

PubMed Central

Emery, Diane P; Milne, Tania; Gilchrist, Catherine A; Gibbons, Megan J; Robinson, Elizabeth; Coster, Gregor D; Forrest, Christopher B; Harnden, Anthony; Mant, David; Grant, Cameron C

2015-01-01

Background: In children, community-acquired pneumonia is a frequent cause of emergency department (ED) presentation and hospital admission. Quality primary care may prevent some of these hospital visits. Aims: The aim of this study was to identify primary care factors associated with ED presentation and hospital admission of preschool-aged children with community-acquired pneumonia. Methods: A case–control study was conducted by enrolling three groups: children presenting to the ED with pneumonia and admitted (n=326), or discharged home (n=179), and well-neighbourhood controls (n=351). Interviews with parents and primary care staff were conducted and health record review was performed. The association of primary care factors with ED presentation and hospital admission, controlling for available confounding factors, was determined using logistic regression. Results: Children were more likely to present to the ED with pneumonia if they did not have a usual general practitioner (GP) (odds ratio (OR)=2.50, 95% confidence interval (CI)=1.67–3.70), their GP worked ⩽20 h/week (OR=1.86, 95% CI=1.10–3.13) or their GP practice lacked an immunisation recall system (OR=5.44, 95% CI=2.26–13.09). Lower parent ratings for continuity (OR=1.63, 95% CI=1.01–2.62), communication (OR=2.01, 95% CI=1.29–3.14) and overall satisfaction (OR=2.16, 95% CI=1.34–3.47) increased the likelihood of ED presentation. Children were more likely to be admitted when antibiotics were prescribed in primary care (OR=2.50, 95% CI=1.43–4.55). Hospital admission was less likely if children did not have a usual GP (OR=0.22, 95% CI=0.11–0.40) or self-referred to the ED (OR=0.48, 95% CI=0.26–0.89). Conclusions: Accessible and continuous primary care is associated with a decreased likelihood of preschool-aged children with pneumonia presenting to the ED and an increased likelihood of hospital admission, implying more appropriate referral. Lower parental satisfaction is associated with an increased likelihood of ED presentation. PMID:25654661

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study

PubMed Central

2011-01-01

Background There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Methods Design Multicentre randomized clinical trial with an intervention and a control group. Setting 12 primary care centres in the province of Tarragona (Spain). Subjects of study 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Intervention Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Measurements Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Main variables Smoking cessation at 12 months. Analysis Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Expected results Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Discussion Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. Trial registration ClinicalTrial.gov, number NCT01194596. PMID:22078490

A Randomized Effectiveness Trial of Brief Cognitive-Behavioral Therapy for Depressed Adolescents Receiving Antidepressant Medication

ERIC Educational Resources Information Center

Clarke, Gregory; DeBar, Lynn; Lynch, Frances; Powell, James; Gale, John; O'Connor, Elizabeth; Ludman, Evette; Bush, Terry; Lin, Elizabeth H. B.; Von Korff, Michael; Hertert, Stephanie

2005-01-01

Objective: To test a collaborative-care, cognitive-behavioral therapy (CBT) program adjunctive to selective serotonin reuptake inhibitor (SSRI) treatment in HMO pediatric primary care. Method: A randomized effectiveness trial comparing a treatment-as-usual (TAU) control condition consisting primarily of SSRI medication delivered outside the…

Concurrent Validity of a Self-Reported Physical Activity “Vital Sign” Questionnaire With Adult Primary Care Patients

PubMed Central

Joy, Elizabeth A.; Gren, Lisa H.; Shaw, Janet M.

2016-01-01

Introduction No tool currently used by primary health care providers to assess physical activity has been evaluated for its ability to determine whether or not patients achieve recommended levels of activity. The purpose of this study was to assess concurrent validity of physical activity self-reported to the brief (<30 sec) Physical Activity “Vital Sign” questionnaire (PAVS) compared with responses to the lengthier (3–5 min), validated Modifiable Activity Questionnaire (MAQ). Methods Agreement between activity reported to the PAVS and MAQ by primary care patients at 2 clinics in 2014 was assessed by using percentages and κ coefficients. Agreement consisted of meeting or not meeting the 2008 Aerobic Physical Activity Guidelines for Americans (PA Guidelines) of the US Department of Health and Human Services. We compared self-reported usual minutes per week of moderate-to-vigorous physical activity among patients at a primary care clinic in 2014 who reported to PAVS and to MAQ by using Pearson correlation and Bland–Altman plots of agreement. Results Among 269 consenting patients who reported physical activity, PAVS results agreed with those of MAQ 89.6% of the time and demonstrated good agreement in identifying patients who did not meet PA Guidelines recommendations (κ = 0.55, ρ = 0.57; P < .001). Usual minutes per week of moderate-to-vigorous physical activity reported to PAVS had a high positive correlation with the same reported to MAQ (r = 0.71; P < .001). Conclusion PAVS may be a valid tool for identifying primary care patients who need counseling about physical activity. PAVS should be assessed further for agreement with repeated objective measures of physical activity in the patient population. PMID:26851335

A stepped-wedge evaluation of an initiative to spread the collaborative care model for depression in primary care.

PubMed

Solberg, Leif I; Crain, A Lauren; Maciosek, Michael V; Unützer, Jürgen; Ohnsorg, Kris A; Beck, Arne; Rubenstein, Lisa; Whitebird, Robin R; Rossom, Rebecca C; Pietruszewski, Pamela B; Crabtree, Benjamin F; Joslyn, Kenneth; Van de Ven, Andrew; Glasgow, Russell E

2015-09-01

Scale-up and spread of evidence-based practices is one of the most important challenges facing health care. We tested whether a statewide initiative, Depression Improvement Across Minnesota-Offering a New Direction (DIAMOND), to implement the collaborative care model for depression in 75 primary care clinics resulted in patient outcome improvements corresponding to those reported in randomized controlled trials. Health plans provided a new monthly payment to participating clinics after a 6-month intensive training program with ongoing data submission, networking, and consultation. Implementation was staggered, with 5 sequences of 10 to 40 clinics every 6 months. Payers provided weekly contact information for members from participating clinics who were filling antidepressant prescriptions, and we conducted baseline and 6-month surveys of 1,578 patients about their care and outcomes. There were 466 patients in DIAMOND clinics who received usual care before implementation (UCB), 559 who received usual care in DIAMOND clinics after implementation (UCA), 245 who received DIAMOND care after implementation (DCA), and 308 who received usual care in comparison clinics (UC). Patients who received DIAMOND care after implementation reported more collaborative care depression services than the 3 comparison groups (10.9 vs 6.4-6.7, on a scale of 0 of 14, where higher numbers indicate more services; P <.001) and more satisfaction with their care (4.0 vs 3.4 on a scale 1 to 5, in which higher scores indicate higher satisfaction; P ≤.001). Depression remission rates, however, were not significantly different among the 4 groups (36.4% DCA vs 35.8% UCB, 35.0% UCA, 33.9% UC; P = .94). Despite the incentive of a supporting payment change and intensive training and support for clinics volunteering to participate, no difference in depression outcomes was documented. Specific unmeasured actions present in trials but not present in these clinics may be critical for successful outcome improvement. © 2015 Annals of Family Medicine, Inc.

Study protocol: a multi-professional team intervention of physical activity referrals in primary care patients with cardiovascular risk factors—the Dalby lifestyle intervention cohort (DALICO) study

PubMed Central

2012-01-01

Background The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than physical activity prescription in usual care. The study targets patients with newly diagnosed hypertension and/or type 2 diabetes. Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose; physical fitness and anthropometric variables; mental health; health related quality of life; and cost-effectiveness. Methods/Design The study is designed as a long-term intervention. Three primary care centres are involved in the study, each constituting one of three treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR, 2) Control group A (CA): physical activity prescription in usual care and 3) Control group B: treatment as usual (retrospective data collection). The intervention is based on self-determination theory and follows the principles of motivational interviewing. The primary outcome, physical activity, is measured with the International Physical Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as health behaviours; health-related quality of life; motivation to change; mental health; demographics and socioeconomic characteristics are assessed with an electronic study questionnaire that submits all data to a patient database, which automatically provides feed-back to the health-care providers on the patients’ health status. Cost-effectiveness of the intervention is evaluated continuously and the intermediate outcomes of the intervention are extrapolated by economic modelling. Discussions By helping patients to overcome practical, social and cultural obstacles and increase their internal motivation for physical activity we aim to improve their physical health in a long-term perspective. The targeted patients belong to a patient category that is supposed to benefit from increased physical activity in terms of improved physiological values, mental status and quality of life, decreased risk of complications and maybe a decreased need of medication. PMID:22726659

Collaborative Interventions for Circulation and Depression (COINCIDE): study protocol for a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease

PubMed Central

2012-01-01

Background Depression is up to two to three times as common in people with long-term conditions. It negatively affects medical management of disease and self-care behaviors, and leads to poorer quality of life and high costs in primary care. Screening and treatment of depression is increasingly prioritized, but despite initiatives to improve access and quality of care, depression remains under-detected and under-treated, especially in people with long-term conditions. Collaborative care is known to positively affect the process and outcome of care for people with depression and long-term conditions, but its effectiveness outside the USA is still relatively unknown. Furthermore, collaborative care has yet to be tested in settings that resemble more naturalistic settings that include patient choice and the usual care providers. The aim of this study was to test the effectiveness of a collaborative-care intervention, for people with depression and diabetes/coronary heart disease in National Health Service (NHS) primary care, in which low-intensity psychological treatment services are delivered by the usual care provider - Increasing Access to Psychological Therapies (IAPT) services. The study also aimed to evaluate the cost-effectiveness of the intervention over 6 months, and to assess qualitatively the extent to which collaborative care was implemented in the intervention general practices. Methods This is a cluster randomized controlled trial of 30 general practices allocated to either collaborative care or usual care. Fifteen patients per practice will be recruited after a screening exercise to detect patients with recognized depression (≥10 on the nine-symptom Patient Health Questionnaire; PHQ-9). Patients in the collaborative-care arm with recognized depression will be offered a choice of evidence-based low-intensity psychological treatments based on cognitive and behavioral approaches. Patients will be case managed by psychological well-being practitioners employed by IAPT in partnership with a practice nurse and/or general practitioner. The primary outcome will be change in depressive symptoms at 6 months on the 90-item Symptoms Checklist (SCL-90). Secondary outcomes include change in health status, self-care behaviors, and self-efficacy. A qualitative process evaluation will be undertaken with patients and health practitioners to gauge the extent to which the collaborative-care model is implemented, and to explore sustainability beyond the clinical trial. Discussion COINCIDE will assess whether collaborative care can improve patient-centered outcomes, and evaluate access to and quality of care of co-morbid depression of varying intensity in people with diabetes/coronary heart disease. Additionally, by working with usual care providers such as IAPT, and by identifying and evaluating interventions that are effective and appropriate for routine use in the NHS, the COINCIDE trial offers opportunities to address translational gaps between research and implementation. Trial Registration Number ISRCTN80309252 Trial Status Open PMID:22906179

The contribution of dietitians to the primary health care workforce.

PubMed

Howatson, Alexandra; Wall, Clare R; Turner-Benny, Petrina

2015-12-01

Dietetic intervention is effective in the management of nutrition-related conditions and their comorbidities. New Zealand has an increasing need for primary and preventive health care to reduce the burden of non-communicable disease. To review the recent evidence of effectiveness of dietetic intervention in primary health care on health and wider economic outcomes. Health benefits and cost benefits of employing dietitians to perform nutrition intervention in the primary health care setting are evaluated in the areas of obesity in conjunction with diabetes and cardiovascular disease, and malnutrition in older adults. An electronic literature search of four scientific databases, websites of major dietetic associations and high-impact nutrition and dietetic journals was conducted. Randomised controlled trials and non-randomised studies conducted from 2000 to 2014 were included. Dietetic intervention demonstrates statistically and clinically significant impacts on health outcomes in the areas of obesity, cardiovascular disease, diabetes, and malnutrition in older adults, when compared to usual care. Dietitians working in primary health care can also have significant economic benefits, potentially saving the health care system NZ$5.50-$99 for every NZ$1 spent on dietetic intervention. New Zealand must look to new models of health care provision that are not only patient-centred but are also cost-effective. This review demonstrates that dietitians in primary health care can improve patients' health and quality of life. Increasing the number of dietitians working in primary health care has the potential to make quality nutrition care accessible and affordable for more New Zealanders.

Improving diabetes care among patients overdue for recommended testing: a randomized controlled trial of automated telephone outreach.

PubMed

Simon, Steven R; Trinacty, Connie Mah; Soumerai, Stephen B; Piette, John D; Meigs, James B; Shi, Ping; Ensroth, Arthur; Ross-Degnan, Dennis

2010-07-01

The study's objective was to assess the effects of automated telephone outreach with speech recognition (ATO-SR) on diabetes-related testing. We identified 1,200 health plan members who were overdue for diabetes-related testing and randomly allocated 600 to ATO-SR and 600 to usual care (no intervention). The intervention included three interactive calls encouraging recommended testing. The primary outcome was retinopathy testing, since this was the health plan's principal goal. Tests for glycemia, hyperlipidemia, and nephropathy were secondary outcomes. In total, 232 participants (39%) verbally responded to the calls. There was no difference between the intervention and the usual care groups in the primary outcome (adjusted hazard ratio 0.93 [95% CI 0.71-1.22]) and no effect of the intervention on any of the secondary outcomes. Fewer than 40% of the patients randomized to ATO-SR interacted verbally with the system. The intervention had no effect on the study's outcomes.

Patients' experiences of diabetes education teams integrated into primary care.

PubMed

Grohmann, Barbara; Espin, Sherry; Gucciardi, Enza

2017-02-01

To explore patients' perspectives on care received from diabetes education teams (a registered nurse and a registered dietitian) integrated into primary care. Qualitative study using semistructured, one-on-one interviews. Three diabetes education programs operating in 11 primary care sites in one region of Ontario. Twenty-three patients with diabetes. Purposeful sampling was used to recruit participants from each site for interviews. Educator teams invited patients with whom they had met at least once to participate in semistructured interviews. Data were analyzed using thematic analysis with NVivo 11 software. The diabetes education teams integrated into primary care exhibited many of the principles of person-centred care, as evidenced by the 2 overarching themes. The first is personalized care, with the subthemes care environment, shared decision making, and patient preference for one-on-one care. Participants described feeling included in partnerships with their health care providers, as they collaborated with physicians and diabetes educators to develop knowledge and set goals in the convenience and comfort of their usual primary care settings. Many participants also expressed a preference for one-on-one sessions. The second theme is patient-provider relationship, with the subthemes respect, supportive interaction, and facilitating patient engagement. Supportive environments created by the educators built trusting relationships, where patients expressed enhanced motivation to improve their self-care. Diabetes educators integrated into primary care can serve to enrich the experience of patients, provide key education to improve patient understanding, and support primary care physicians in providing timely and comprehensive clinical care. Diabetes patients appear to benefit from convenient access to interprofessional teams of educators in primary care to support diabetes self-management. Copyright© the College of Family Physicians of Canada.

Cost-effectiveness of prize-based incentives for stimulant abusers in outpatient psychosocial treatment programs.

PubMed

Olmstead, Todd A; Sindelar, Jody L; Petry, Nancy M

2007-03-16

To evaluate the cost-effectiveness of a prize-based intervention as an addition to usual care for stimulant abusers. This cost-effectiveness analysis is based on a randomized clinical trial implemented within the National Drug Abuse Treatment Clinical Trials Network. The trial was conducted at eight community-based outpatient psychosocial drug abuse treatment clinics. Four hundred and fifteen stimulant abusers were assigned to usual care (N=206) or usual care plus abstinence-based incentives (N=209) for 12 weeks. Participants randomized to the incentive condition earned the chance to draw for prizes for submitting substance negative samples; the number of draws earned increased with continuous abstinence time. Incremental cost-effectiveness ratios were estimated to compare prize-based incentives relative to usual care. The primary patient outcome was longest duration of confirmed stimulant abstinence (LDA). Unit costs were obtained via surveys administered at the eight participating clinics. Resource utilizations and patient outcomes were obtained from the clinical trial. Acceptability curves are presented to illustrate the uncertainty due to the sample and to provide policy relevant information. The incremental cost to lengthen the LDA by 1 week was 258 US dollars (95% confidence interval, 191-401 US dollars). Sensitivity analyses on several key parameters show that this value ranges from 163 to 269 US dollars. Compared with the usual care group, the incentive group had significantly longer LDAs and significantly higher costs.

Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial.

PubMed

Salvo, Vera; Kristeller, Jean; Marin, Jesus Montero; Sanudo, Adriana; Lourenço, Bárbara Hatzlhoffer; Schveitzer, Mariana Cabral; D'Almeida, Vania; Morillo, Héctor; Gimeno, Suely Godoy Agostinho; Garcia-Campayo, Javier; Demarzo, Marcelo

2018-05-11

Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing awareness of emotional and other triggers for overeating. The aim of the present study protocol is to evaluate and compare the feasibility and efficacy of two mindfulness-based interventions (MBIs) addressing overweight and obesity in primary care patients: a general programme called Mindfulness-Based Health Promotion and a targeted mindful eating protocol called Mindfulness-Based Eating Awareness Training. A randomised controlled trial will be conducted to compare treatment as usual separately in primary care with both programmes (health promotion and mindful eating) added to treatment as usual. Two hundred forty adult women with overweight and obesity will be enrolled. The primary outcome will be an assessment of improvement in eating behaviour. Secondary outcomes will be (1) biochemical control; (2) anthropometric parameters, body composition, dietary intake and basal metabolism; and (3) levels of mindfulness, stress, depression, self-compassion and anxiety. At the end of each intervention, a focus group will be held to assess the programme's impact on the participants' lives, diet and health. A feasibility study on access to benefits from and importance of MBIs at primary care facilities will be conducted among primary care health care professionals and participants. Monthly maintenance sessions lasting at least 1 hour will be offered, according to each protocol, during the 3-month follow-up periods. This clinical trial will result in more effective mindfulness-based interventions as a complementary treatment in primary care for people with overweight and obesity. If the findings of this study confirm the effectiveness of mindfulness programmes in this population, it will be possible to improve quality of life and health while optimising public resources and reaching a greater number of people. In addition, on the basis of the evaluation of the feasibility of implementing this intervention in primary care facilities, we expect to be able to suggest the intervention for incorporation into public policy. ClinicalTrials.gov, NCT02893150 . Registered retrospectively on 30 March 2017.

IMPACT OF GLUCOSE MANAGEMENT TEAM ON OUTCOMES OF HOSPITALIZARON IN PATIENTS WITH TYPE 2 DIABETES ADMITTED TO THE MEDICAL SERVICE.

PubMed

Wang, Yunjiao J; Seggelke, Stacey; Hawkins, R Matthew; Gibbs, Joanna; Lindsay, Mark; Hazlett, Ingrid; Low Wang, Cecilia C; Rasouli, Neda; Young, Kendra A; Draznin, Boris

2016-12-01

To improve glycemic control of hospitalized patients with diabetes and hyperglycemia, many medical centers have established dedicated glucose management teams (GMTs). However, the impact of these specialized teams on clinical outcomes has not been evaluated. We conducted a retrospective study of 440 patients with type 2 diabetes admitted to the medical service for cardiac or infection-related diagnosis. The primary endpoint was a composite outcome of several well-recognized markers of morbidity, consisting of: death during hospitalization, transfer to intensive care unit, initiation of enteral or parenteral nutrition, line infection, new in-hospital infection or infection lasting more than 20 days of hospitalization, deep venous thrombosis or pulmonary embolism, rise in plasma creatinine, and hospital re-admissions. Medical housestaff managed the glycemia in 79% of patients (usual care group), while the GMT managed the glycemia in 21% of patients (GMT group). The primary outcome was similar between cohorts (0.95 events per patient versus 0.99 events per patient in the GMT and usual care cohorts, respectively). For subanalysis, the subjects in both groups were stratified into those with average glycemia of <180 mg/dL versus those with glycemia >180 mg/dL. We found a significant beneficial impact of glycemic management by the GMT on the composite outcome in patients with average glycemia >180 mg/dL during their hospital stay. The number of patients who met primary outcome was significantly higher in the usual care group (40 of 83 patients, 48%) than in the GMT-treated cohort (8 of 33 patients, 25.7%) (P<.02). Our data suggest that GMTs may have an important role in managing difficult-to-control hyperglycemia in the inpatient setting. BG = blood glucose GMT = glucose management team HbA1c = hemoglobin A1c ICU = intensive care unit POC = point of care T2D = type 2 diabetes.

Diagnosis of penile fracture in primary care: a case report

PubMed Central

Akpinar, Ersin

2009-01-01

Introduction Penile fracture has been reported with sexual intercourse, masturbation, rolling over or falling on to the erect penis. Classically the history is with a sudden snap, pain, detumescence and a hematoma of the penis with deformity. Immediate surgical treatment is recommended. The patients may delay the admission due to fear and embarrassment or the condition may usually be underreported. Case presentation A 32-year-old man presented to primary care complaining of discoloration of penis without any significant history or symptom. Physical examination revealed swollen, ecchymotic, and deviated circumcised penis. Conclusion Although frequent and common diseases represent the majority of daily work, the primary care physician should be alert for possible unexpected history or symptom of a rare and often serious condition. PMID:19830047

Effectiveness of psychological treatments for depressive disorders in primary care: systematic review and meta-analysis.

PubMed

Linde, Klaus; Sigterman, Kirsten; Kriston, Levente; Rücker, Gerta; Jamil, Susanne; Meissner, Karin; Schneider, Antonius

2015-01-01

We performed a systematic review of the currently available evidence on whether psychological treatments are effective for treating depressed primary care patients in comparison with usual care or placebo, taking the type of therapy and its delivery mode into account. Randomized controlled trials comparing a psychological treatment with a usual care or a placebo control in adult, depressed, primary care patients were identified by searches in MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and PsycINFO up to December 2013. At least 2 reviewers extracted information from included studies and assessed the risk of bias. Random effects meta-analyses were performed using posttreatment depression scores as outcome. A total of 30 studies with 5,159 patients met the inclusion criteria. Compared with control, the effect (standardized mean difference) at completion of treatment was -0.30 (95% CI, -0.48 to -0.13) for face-to-face cognitive behavioral therapy (CBT), -0.14 (-0.40 to 0.12) for face-to-face problem-solving therapy, -0.24 (-0.47 to -0.02) for face-to-face interpersonal psychotherapy, -0.28 (-0.44 to -0.12) for other face-to-face psychological interventions, -0.43 (-0.62 to -0.24) for remote therapist-led CBT, -0.56 (-1.57 to 0.45) for remote therapist-led problem-solving therapy, -0.40 (-0.69 to -0.11) for guided self-help CBT, and -0.27 (-0.44 to -0.10) for no or minimal contact CBT. There is evidence that psychological treatments are effective in depressed primary care patients. For CBT approaches, substantial evidence suggests that interventions that are less resource intensive might have effects similar to more intense treatments. © 2015 Annals of Family Medicine, Inc.

Interdisciplinary model of care (RADICALS) for early detection and management of chronic obstructive pulmonary disease (COPD) in Australian primary care: study protocol for a cluster randomised controlled trial

PubMed Central

Liang, Jenifer; Abramson, Michael J; Zwar, Nicholas; Russell, Grant; Holland, Anne E; Bonevski, Billie; Mahal, Ajay; van Hecke, Benjamin; Phillips, Kirsten; Eustace, Paula; Paul, Eldho; Petrie, Kate; Wilson, Sally; George, Johnson

2017-01-01

Introduction Up to half of all smokers develop clinically significant chronic obstructive pulmonary disease (COPD). Gaps exist in the implementation and uptake of evidence-based guidelines for managing COPD in primary care. We describe the methodology of a cluster randomised controlled trial (cRCT) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aimed at reducing the burden of smoking and COPD in Australian primary care settings. Methods and analysis A cRCT is being undertaken to evaluate an interdisciplinary model of care (RADICALS — Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers). General practice clinics across Melbourne, Australia, are identified and randomised to the intervention group (RADICALS) or usual care. Patients who are current or ex-smokers, of at least 10 pack years, including those with an existing diagnosis of COPD, are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD. Handheld lung function devices are being used to facilitate case-finding. RADICALS includes individualised smoking cessation support, home-based pulmonary rehabilitation and home medicines review. Patients at control group sites receive usual care and Quitline referral, as appropriate. Follow-ups occur at 6 and 12 months from baseline to assess changes in quality of life, abstinence rates, health resource utilisation, symptom severity and lung function. The primary outcome is change in St George’s Respiratory Questionnaire score of patients with COPD at 6 months from baseline. Ethics and dissemination This project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee (CF14/1018 – 2014000433). Results of the study will be disseminated in peer-reviewed journals and research conferences. If the intervention is successful, the RADICALS programme could potentially be integrated into general practices across Australia and sustained over time. Trial registration number ACTRN12614001155684; Pre-results. PMID:28928190

Collaborative depression care among Latino patients in diabetes disease management, Los Angeles, 2011-2013.

PubMed

Wu, Brian; Jin, Haomiao; Vidyanti, Irene; Lee, Pey-Jiuan; Ell, Kathleen; Wu, Shinyi

2014-08-28

The prevalence of comorbid diabetes and depression is high, especially in low-income Hispanic or Latino patients. The complex mix of factors in safety-net care systems impedes the adoption of evidence-based collaborative depression care and results in persistent disparities in depression outcomes. The Diabetes-Depression Care-Management Adoption Trial examined whether the collaborative depression care model is an effective approach in safety-net clinics to improve clinical care outcomes of depression and diabetes. A sample of 964 patients with diabetes from 5 safety-net clinics were enrolled in a quasi-experimental study that included 2 arms: usual care, in which primary medical providers and staff translated and adopted evidence-based depression care; and supportive care, in which providers of a disease management program delivered protocol-driven depression care. Because the study design established individual treatment centers as separate arms, we calculated propensity scores that interpreted the probability of treatment assignment conditional on observed baseline characteristics. Primary outcomes were 5 depression care outcomes and 7 diabetes care measures. Regression models with propensity score covariate adjustment were applied to analyze 6-month outcomes. Compared with usual care, supportive care significantly decreased Patient Health Questionnaire-9 scores, reduced the number of patients with moderate or severe depression, improved depression remission, increased satisfaction in care for patients with emotional problems, and significantly reduced functional impairment. Implementing collaborative depression care in a diabetes disease management program is a scalable approach to improve depression outcomes and patient care satisfaction among patients with diabetes in a safety-net care system.

Collaborative Depression Care Among Latino Patients in Diabetes Disease Management, Los Angeles, 2011–2013

PubMed Central

Wu, Brian; Jin, Haomiao; Vidyanti, Irene; Lee, Pey-Jiuan; Ell, Kathleen

2014-01-01

Introduction The prevalence of comorbid diabetes and depression is high, especially in low-income Hispanic or Latino patients. The complex mix of factors in safety-net care systems impedes the adoption of evidence-based collaborative depression care and results in persistent disparities in depression outcomes. The Diabetes–Depression Care-Management Adoption Trial examined whether the collaborative depression care model is an effective approach in safety-net clinics to improve clinical care outcomes of depression and diabetes. Methods A sample of 964 patients with diabetes from 5 safety-net clinics were enrolled in a quasi-experimental study that included 2 arms: usual care, in which primary medical providers and staff translated and adopted evidence-based depression care; and supportive care, in which providers of a disease management program delivered protocol-driven depression care. Because the study design established individual treatment centers as separate arms, we calculated propensity scores that interpreted the probability of treatment assignment conditional on observed baseline characteristics. Primary outcomes were 5 depression care outcomes and 7 diabetes care measures. Regression models with propensity score covariate adjustment were applied to analyze 6-month outcomes. Results Compared with usual care, supportive care significantly decreased Patient Health Questionnaire-9 scores, reduced the number of patients with moderate or severe depression, improved depression remission, increased satisfaction in care for patients with emotional problems, and significantly reduced functional impairment. Conclusion Implementing collaborative depression care in a diabetes disease management program is a scalable approach to improve depression outcomes and patient care satisfaction among patients with diabetes in a safety-net care system. PMID:25167093

[Depression in adolescence treated at primary care centres: size of a hidden problem of general health].

PubMed

dos Santos Palazzo, L; Humberto Béria, J; Alonso-Fernández, F; Tomasi, E

2001-11-15

To investigate the prevalence of depression and its relationship to the reason for the consultation and to the medical diagnosis. Descriptive, cross-sectional design. Primary care units of a community in Brazil. Individuals between 13 and 19 years old, who attended 10 primary care units to consult with a non-psychiatric doctor between October 1997 and January 1998 (n = 463). The CET-DE (Alonso-Fernández, 1986) was used to measure depression, jointly with a questionnaire for evaluating social and demographic details and data pertinent to the consultation. Prevalence ran at 26.5% (95% CI: 22.6-30.4%). 99.2% cases of depression had not been identified. Complaints were spread over the somatic field (61.1%), or were sex-related (49.5%), mainly pregnancy (31.7%), especially among the cases of depression (p < 0.001). There were few psychiatric-social complaints (1.5%). Diagnoses often coincided with complaints: 59.9% somatic, 38.4% sex-related (pregnancy = 21.6%) and 1.7% psychiatric-social. Adolescent depression is common in primary care, but is not usually identified. The reason for this may be the kind of depression, which is usually light or focused on just one dimension of human vitality; the doctors tendency to centre his/her attention on the complaint without broadening the clinical spectrum; or even because the adolescent expresses his/her emotional problems poorly, which often contributes to the depression not being diagnosed.

Does occasional cannabis use impact anxiety and depression treatment outcomes?: Results from a randomized effectiveness trial.

PubMed

Bricker, Jonathan B; Russo, Joan; Stein, Murray B; Sherbourne, Cathy; Craske, Michelle; Schraufnagel, Trevor J; Roy-Byrne, Peter

2007-01-01

This study investigated the extent to which occasional cannabis use moderated anxiety and depression outcomes in the Collaborative Care for Anxiety and Panic (CCAP) study, a combined cognitive-behavioral therapy (CBT) and pharmacotherapy randomized effectiveness trial. Participants were 232 adults from six university-based primary care outpatient clinics in three West Coast cities randomized to receive either the CCAP intervention or the usual care condition. Results showed significant (P<.01) evidence of an interaction between treatment group (CCAP vs. usual care) and cannabis use status (monthly vs. less than monthly) for depressive symptoms, but not for panic disorder or social phobia symptoms (all P>.05). Monthly cannabis users' depressive symptoms improved in the CCAP intervention just as much as those who used cannabis less than monthly, whereas monthly users receiving usual care had significantly more depressive symptoms than those using less than monthly. A combined CBT and medication treatment intervention may be a promising approach for the treatment of depression among occasional cannabis users. (c) 2006 Wiley-Liss, Inc.

Physicians' satisfaction with a collaborative disease management program for late-life depression in primary care.

PubMed

Levine, Stuart; Unützer, Jürgen; Yip, Judy Y; Hoffing, Marc; Leung, Moon; Fan, Ming-Yu; Lin, Elizabeth H B; Grypma, Lydia; Katon, Wayne; Harpole, Linda H; Langston, Christopher A

2005-01-01

This study describes physicians' satisfaction with care for patients with depression before and after the implementation of a primary care-based collaborative care program. Project Improving Mood, Promoting Access to Collaborative Treatment for late-life depression (IMPACT) is a multisite, randomized controlled trial comparing a primary care-based collaborative disease management program for late-life depression with care as usual. A total of 450 primary care physicians at 18 participating clinics participated in a satisfaction survey before and 12 months after IMPACT initiation. The preintervention survey focused on physicians' satisfaction with current mental health resources and ability to provide depression care. The postintervention survey repeated these and added questions about physician's experience with the IMPACT collaborative care model. Before intervention, about half (54%) of the participating physicians were satisfied with resources to treat patients with depression. After intervention, more than 90% reported the intervention as helpful in treating patients with depression and 82% felt that the intervention improved patients' clinical outcomes. Participating physicians identified proactive patient follow-up and patient education as the most helpful components of the IMPACT model. Physicians perceived a substantial need for improving depression treatment in primary care. They were very satisfied with the IMPACT collaborative care model for treating depressed older adults and felt that similar care management models would also be helpful for treating other chronic medical illnesses.

Neighborhood Socioeconomic Status and Primary Health Care: Usual Points of Access and Temporal Trends in a Major US Urban Area.

PubMed

Hussein, Mustafa; Diez Roux, Ana V; Field, Robert I

2016-12-01

Neighborhood socioeconomic status (SES), an overall marker of neighborhood conditions, may determine residents' access to health care, independently of their own individual characteristics. It remains unclear, however, how the distinct settings where individuals seek care vary by neighborhood SES, particularly in US urban areas. With existing literature being relatively old, revealing how these associations might have changed in recent years is also timely in this US health care reform era. Using data on the Philadelphia region from 2002 to 2012, we performed multilevel analysis to examine the associations of neighborhood SES (measured as census tract median household income) with access to usual sources of primary care (physician offices, community health centers, and hospital outpatient clinics). We found no evidence that residence in a low-income (versus high-income) neighborhood was associated with poorer overall access. However, low-income neighborhood residence was associated with less reliance on physician offices [-4.40 percentage points; 95 % confidence intervals (CI) -5.80, -3.00] and greater reliance on the safety net provided by health centers [2.08; 95 % CI 1.42, 2.75] and outpatient clinics [1.61; 95 % CI 0.97, 2.26]. These patterns largely persisted over the 10 years investigated. These findings suggest that safety-net providers have continued to play an important role in ensuring access to primary care in urban, low-income communities, further underscoring the importance of supporting a strong safety net to ensure equitable access to care regardless of place of residence.

Post-fracture care: do we need to educate patients rather than doctors? The PREVOST randomized controlled trial.

PubMed

Merle, B; Chapurlat, R; Vignot, E; Thomas, T; Haesebaert, J; Schott, A-M

2017-05-01

We conducted a multicenter, randomized controlled trial to evaluate the impact of a population-based patient-centered post-fracture care program with a dedicated case manager, PREVention of OSTeoporosis (PREVOST), on appropriate post-fracture osteoporosis management. We showed that, compared to usual care, BMD investigation post-fracture was significantly improved (+20%) by our intervention program. Our study aims to evaluate the impact of a population-based patient-centered post-fracture care program, PREVOST, on appropriate post-fracture care. Multicenter, randomized controlled trial enrolling 436 women aged 50 to 85 years and attending a French hospital, for a low-energy fracture of the wrist or humerus. Randomization was stratified by age, hospital department, and site of fracture. The intervention was performed by a trained case manager who interacted only with the patients, with repeated oral and written information about fragility fractures and osteoporosis management, and prompting them to visit their primary care physicians. Control group received usual care. The primary outcome was the initiation of an appropriate post-fracture care defined by Bone Mineral Density (BMD) and/or anti-osteoporotic treatment prescription at 6 months. At 6 months, 53% of women in intervention group initiated a post-fracture care versus 33% for usual care (adjOR 2.35, 95%CI [1.58-3.50], p < 0.001). Post-fracture care was more frequent after wrist than humerus fracture (adjOR 1.93, 95%CI [1.14-3.30], p = 0.015) and decreased with age (adjOR for 10 years increase 0.76, 95%CI [0.61-0.96], p = 0.02). The intervention resulted in BMD prescription in 50% of patients (adjOR 2.10, 95%CI [1.41-3.11], p < 0.001) and in BMD performance in 41% of patients (adjOR 2.12, 95%CI [1.40-3.20], p < 0.001) versus 33 and 25% for usual care, respectively. Having performed a BMD increased treatment prescription; however, only 46% of women with a low BMD requiring a treatment according to the French guidelines received a prescription. A patient-centered care program with a dedicated case manager can significantly improve post-fracture BMD investigation.

Cost-effectiveness of quality improvement programs for patients with subthreshold depression or depressive disorder.

PubMed

Wells, Kenneth B; Schoenbaum, Michael; Duan, Naihua; Miranda, Jeanne; Tang, Lingqi; Sherbourne, Cathy

2007-10-01

This study explored the cost-effectiveness of quality-improvement interventions for depression in primary care, relative to usual care, among patients with subthreshold depression or depressive disorder. A total of 746 primary care patients in managed care organizations with 12-month depressive disorder and 502 with current depressive symptoms but no disorder (subthreshold depression) participated in a group-level randomized controlled trial initiated between June 1996 and March 1997. Matched clinics were randomly assigned to enhanced usual care or one of two quality improvement interventions that provided education to manage depression over time and resources to facilitate access to medication management or psychotherapy for six to 12 months. The cost-effectiveness ratio for the pooled intervention groups versus usual care was $2,028 for patients with subthreshold depression (95% confidence interval [CI]=-$17,225 to $21,282) and $53,716 for those with depressive disorder (CI=$14,194 to $93,238), by using a measure of quality-adjusted life years (QALY) based on the 12-Item Short Form Health Survey. Similar results were obtained when alternative QALY measures were used. Although precision was limited, even the upper limit of the 95% CIs suggests that such interventions are as cost-effective for patients with subthreshold depression as are many widely used medical therapies. Despite lack of evidence for efficacy of treatments for subthreshold depression, disease management programs that support clinical care decisions over time for patients with subthreshold depression or depressive disorder can yield cost-effectiveness ratios comparable to those of widely adopted medical therapies. Achieving greater certainty about average cost-effectiveness would require a much larger study.

Glucose control and medication adherence among veterans with diabetes and serious mental illness: does collocation of primary care and mental health care matter?

PubMed

Long, Judith A; Wang, Andrew; Medvedeva, Elina L; Eisen, Susan V; Gordon, Adam J; Kreyenbuhl, Julie; Marcus, Steven C

2014-08-01

Persons with serious mental illness (SMI) may benefit from collocation of medical and mental health healthcare professionals and services in attending to their chronic comorbid medical conditions. We evaluated and compared glucose control and diabetes medication adherence among patients with SMI who received collocated care to those not receiving collocated care (which we call usual care). We performed a cross-sectional, observational cohort study of 363 veteran patients with type 2 diabetes and SMI who received care from one of three Veterans Affairs medical facilities: two sites that provided both collocated and usual care and one site that provided only usual care. Through a survey, laboratory tests, and medical records, we assessed patient characteristics, glucose control as measured by a current HbA1c, and adherence to diabetes medication as measured by the medication possession ration (MPR) and self-report. In the sample, the mean HbA1c was 7.4% (57 mmol/mol), the mean MPR was 80%, and 51% reported perfect adherence to their diabetes medications. In both unadjusted and adjusted analyses, there were no differences in glucose control and medication adherence by collocation of care. Patients seen in collocated care tended to have better HbA1c levels (β = -0.149; P = 0.393) and MPR values (β = 0.34; P = 0.132) and worse self-reported adherence (odds ratio 0.71; P = 0.143), but these were not statistically significant. In a population of veterans with comorbid diabetes and SMI, patients on average had good glucose control and medication adherence regardless of where they received primary care. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial

PubMed Central

Fu, Steven S; van Ryn, Michelle; Nelson, David; Burgess, Diana J; Thomas, Janet L; Saul, Jessie; Clothier, Barbara; Nyman, John A; Hammett, Patrick; Joseph, Anne M

2016-01-01

Background Evidenced-based tobacco cessation treatments are underused, especially by socioeconomically disadvantaged smokers. This contributes to widening socioeconomic disparities in tobacco-related morbidity and mortality. Methods The Offering Proactive Treatment Intervention trial tested the effects of a proactive outreach tobacco treatment intervention on population-level smoking abstinence and tobacco treatment use among a population-based sample of socioeconomically disadvantaged smokers. Current smokers (n=2406), regardless of interest in quitting, who were enrolled in the Minnesota Health Care Programs, the state's publicly funded healthcare programmes for low-income populations, were randomly assigned to proactive outreach or usual care. The intervention comprised proactive outreach (tailored mailings and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive, telephone counselling). Usual care comprised access to a primary care physician, insurance coverage of Food and Drug Administration-approved smoking cessation medications, and the state's telephone quitline. The primary outcome was self-reported 6-month prolonged smoking abstinence at 1 year and was assessed by follow-up survey. Findings The proactive intervention group had a higher prolonged abstinence rate at 1 year than usual care (16.5% vs 12.1%, OR 1.47, 95% CI 1.12 to 1.93). The effect of the proactive intervention on prolonged abstinence persisted in selection models accounting for non-response. In analysis of secondary outcomes, use of evidence-based tobacco cessation treatments were significantly greater among proactive outreach participants compared with usual care, particularly combination counselling and medications (17.4% vs 3.6%, OR 5.69, 95% CI 3.85 to 8.40). Interpretation Population-based proactive tobacco treatment increases engagement in evidence-based treatment and is effective in long-term smoking cessation among socioeconomically disadvantaged smokers. Findings suggest that dissemination of population-based proactive treatment approaches is an effective strategy to reduce the prevalence of smoking and socioeconomic disparities in tobacco use. Trial registration number NCT01123967. PMID:26931362

Disorders of gender identity: what to do and who should do it?

PubMed

Barrett, James

2014-02-01

Transsexualism is not usually indicative of psychopathology. In carefully selected individuals, with multidisciplinary support, a change of social gender role and cross-sex hormone treatment greatly improves the psychological and social state. Sustained improvement merits gender reassignment surgery. The key is early referral with subsequent primary care cooperation in the treatment plan.

Attachment-Based Family Therapy for Adolescents with Suicidal Ideation: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Diamond, Guy S.; Wintersteen, Matthew B.; Brown, Gregory K.; Diamond, Gary M.; Gallop, Robert; Shelef, Karni; Levy, Suzanne

2010-01-01

Objective: To evaluate whether Attachment-Based Family Therapy (ABFT) is more effective than Enhanced Usual Care (EUC) for reducing suicidal ideation and depressive symptoms in adolescents. Method: This was a randomized controlled trial of suicidal adolescents between the ages of 12 and 17, identified in primary care and emergency departments. Of…

Reducing suicidal ideation in depressed older primary care patients.

PubMed

Unützer, Jürgen; Tang, Lingqi; Oishi, Sabine; Katon, Wayne; Williams, John W; Hunkeler, Enid; Hendrie, Hugh; Lin, Elizabeth H B; Levine, Stuart; Grypma, Lydia; Steffens, David C; Fields, Julie; Langston, Christopher

2006-10-01

To determine the effect of a primary care-based collaborative care program for depression on suicidal ideation in older adults. Randomized, controlled trial. Eighteen diverse primary care clinics. One thousand eight hundred one adults aged 60 and older with major depression or dysthymia. Participants randomized to collaborative care had access to a depression care manager who supported antidepressant medication management prescribed by their primary care physician and offered a course of Problem Solving Treatment in Primary Care for 12 months. Participants in the control arm received care as usual. Participants had independent assessments of depression and suicidal ideation at baseline and 3, 6, 12, 18, and 24 months. Depression was assessed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (SCID). Suicidal ideation was determined using the SCID and the Hopkins Symptoms Checklist. At baseline, 139 (15.3%) intervention subjects and 119 (13.3%) controls reported thoughts of suicide. Intervention subjects had significantly lower rates of suicidal ideation than controls at 6 months (7.5% vs 12.1%) and 12 months (9.8% vs 15.5%) and even after intervention resources were no longer available at 18 months (8.0% vs 13.3%) and 24 months (10.1% vs 13.9%). There were no completed suicides in either group. Information on suicide attempts or hospitalization for suicidal ideation was not available. Primary care-based collaborative care programs for depression represent one strategy to reduce suicidal ideation and potentially the risk of suicide in older primary care patients.

Do diabetes group visits lead to lower medical care charges?

PubMed

Clancy, Dawn E; Dismuke, Clara E; Magruder, Kathryn Marley; Simpson, Kit N; Bradford, David

2008-01-01

To evaluate whether attending diabetes group visits (GVs) leads to lower medical care charges for inadequately insured patients with type 2 diabetes mellitus (DM). Randomized controlled clinical trial. Data were abstracted from financial records for 186 patients with uncontrolled type 2 DM randomized to receive care in GVs or usual care for 12 months. Mann-Whitney tests for differences of means for outpatient visits (primary and specialty care), emergency department (ED) visits, and inpatient stays were performed. Separate charge models were developed for primary and specialty outpatient visits. Because GV adherence is potentially dependent on unobserved patient characteristics, treatment effect models of outpatient charges and specialty care visits were estimated using maximum likelihood methods. Mann-Whitney test results indicated that GV patients had reduced ED and total charges but more outpatient charges than usual care patients. Ordinary least squares estimations confirmed that GVs increased outpatient visit charges; however, controlling for endogeneity by estimating a treatment effect model of outpatient visit charges showed that GVs statistically significantly reduced outpatient charges (P <.001). Estimation of a separate treatment effect model of specialty care visits confirmed that GV effects on outpatient visit charges occurred via a reduction in specialty care visits. After controlling for endogeneity via estimation of a treatment effect model, GVs statistically significantly reduced outpatient visit charges. Estimation of a separate treatment effect model of specialty care visits indicated that GVs likely substitute for more expensive specialty care visits.

The pivotal role of primary care in meeting the health needs of people recently released from prison.

PubMed

Kinner, Stuart A; Young, Jesse T; Carroll, Megan

2015-12-01

Australia's prison population is growing at a rate well in excess of population growth. Indigenous Australians are over-represented by a factor of 13. Prisoners are a profoundly marginalised group characterised by complex health and social needs. Despite improvements in health during incarceration, poor health outcomes after release are common, and the net effect of incarceration is usually health depleting. Given the need for effective care coordination, primary care plays a pivotal role in meeting the health needs of this population. In this paper we review what is known about patterns of primary care utilisation in ex-prisoners, identify evidence-based strategies for increasing access to primary care in ex-prisoners, and consider how such contact may shape subsequent health service outcomes. Primary care is a necessary but not sufficient condition for effective post-release support. Positive outcomes may depend more on the quality than the quantity of care received. Given massive over-representation of Indigenous people in Australia's prisons, and compelling evidence of preventable morbidity and mortality after release from prison, effective models of care for this population are an important component of closing the gap in Indigenous life expectancy. © The Royal Australian and New Zealand College of Psychiatrists 2015.

Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

PubMed

Østerås, Nina; van Bodegom-Vos, Leti; Dziedzic, Krysia; Moseng, Tuva; Aas, Eline; Andreassen, Øyvor; Mdala, Ibrahim; Natvig, Bård; Røtterud, Jan Harald; Schjervheim, Unni-Berit; Vlieland, Thea Vliet; Hagen, Kåre Birger

2015-12-02

Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). The results from the present study will add to the current knowledge on tailored strategies, which aims to improve the uptake of evidence-based OA care recommendations and improve the quality of OA care in primary health care. The new knowledge can be used in national and international initiatives designed to improve the quality of OA care. ClinicalTrials.gov NCT02333656.

CASPER plus (CollAborative care in Screen-Positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial.

PubMed

Overend, Karen; Lewis, Helen; Bailey, Della; Bosanquet, Kate; Chew-Graham, Carolyn; Ekers, David; Gascoyne, Samantha; Hems, Deborah; Holmes, John; Keding, Ada; McMillan, Dean; Meer, Shaista; Meredith, Jodi; Mitchell, Natasha; Nutbrown, Sarah; Parrott, Steve; Richards, David; Traviss, Gemma; Trépel, Dominic; Woodhouse, Rebecca; Gilbody, Simon

2014-11-19

Depression accounts for the greatest disease burden of all mental health disorders, contributes heavily to healthcare costs, and by 2020 is set to become the second largest cause of global disability. Although 10% to 16% of people aged 65 years and over are likely to experience depressive symptoms, the condition is under-diagnosed and often inadequately treated in primary care. Later-life depression is associated with chronic illness and disability, cognitive impairment and social isolation. With a progressively ageing population it becomes increasingly important to refine strategies to identity and manage depression in older people. Currently, management may be limited to the prescription of antidepressants where there may be poor concordance; older people may lack awareness of psychosocial interventions and general practitioners may neglect to offer this treatment option. CASPER Plus is a multi-centre, randomised controlled trial of a collaborative care intervention for individuals aged 65 years and over experiencing moderate to severe depression. Selected practices in the North of England identify potentially eligible patients and invite them to participate in the study. A diagnostic interview is carried out and participants with major depressive disorder are randomised to either collaborative care or usual care. The recruitment target is 450 participants. The intervention, behavioural activation and medication management in a collaborative care framework, has been adapted to meet the complex needs of older people. It is delivered over eight to 10 weekly sessions by a case manager liaising with general practitioners. The trial aims to evaluate the clinical and cost effectiveness of collaborative care in addition to usual GP care versus usual GP care alone. The primary clinical outcome, depression severity, will be measured with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 4, 12 and 18 months. Cost effectiveness analysis will assess health-related quality of life using the SF-12 and EQ-5D and will examine cost-consequences of collaborative care. A qualitative process evaluation will be undertaken to explore acceptability, gauge the extent to which the intervention is implemented and to explore sustainability beyond the clinical trial. Results will add to existing evidence and a positive outcome may lead to the commissioning of this model of service in primary care. ISRCTN45842879 (24 July 2012).

Systems for the management of respiratory disease in primary care--an international series: United Kingdom.

PubMed

Worth, Allison; Pinnock, Hilary; Fletcher, Monica; Hoskins, Gaylor; Levy, Mark L; Sheikh, Aziz

2011-03-01

The UK National Health Service (NHS) is essentially publicly funded through general taxation. Challenges facing the NHS include the rise in prevalence of long-term conditions and financial pressures. NATIONAL POLICY TRENDS: Political devolution within the UK has led to variations in the way services are organised and delivered between the four nations. PRIMARY CARE RESPIRATORY SERVICES IN THE UK: Primary care is the first point of contact with services. Most respiratory conditions are managed here, including prevention, diagnosis, treatment and palliative care. Respiratory disease accounts for more primary care consultations than any other type of illness, with 24 million consultations annually. Equitable access to care is an ongoing challenge: telehealthcare is being tried as a possible solution for monitoring of asthma and COPD. REFERRAL AND ACCESS TO SPECIALIST CARE: Referrals for specialist advice are usually to a secondary care respiratory physician, though respiratory General Practitioners with a Special Interest (GPwSIs) are an option in some localities. Prevalence of asthma and COPD is high. Asthma services are predominantly nurse-led. Self-management strategies are widely promoted but poorly implemented. COPD is high on the policy agenda with a shift in focus to preventive lung health and longterm condition management.

The costs and benefits of enhanced depression care to employers.

PubMed

Wang, Philip S; Patrick, Amanda; Avorn, Jerry; Azocar, Francisca; Ludman, Evette; McCulloch, Joyce; Simon, Gregory; Kessler, Ronald

2006-12-01

Although outreach and enhanced treatment interventions improve depression outcomes, uptake has been poor in part because purchasers lack information on their return on investment. To estimate the costs and benefits of enhanced depression care for workers from the societal and employer-purchaser perspectives. Cost-effectiveness and cost-benefit analyses using state-transition Markov models. Simulated movements between health states were based on probabilities drawn from the clinical literature. Hypothetical cohort of 40-year-old workers. Intervention Enhanced depression care consisting of a depression screen and care management for those depressed vs usual care. Our base-case cost-effectiveness analysis was from the societal perspective; costs and quality-adjusted life-years were used to compute the incremental cost-effectiveness of the intervention relative to usual care. A secondary cost-benefit analysis from the employer's perspective tracked monetary costs and monetary benefits accruing to employers during a 5-year time horizon. From the societal perspective, screening and depression care management for workers result in an incremental cost-effectiveness ratio of $19 976 per quality-adjusted life-year relative to usual care. These results are consistent with recent primary care effectiveness trials and within the range for medical interventions usually covered by employer-sponsored insurance. From the employer's perspective, enhanced depression care yields a net cumulative benefit of $2895 after 5 years. In 1-way and probabilistic sensitivity analyses, these findings were robust to a variety of assumptions. If these results can be replicated in effectiveness trials directly assessing effects on work outcomes, they suggest that enhanced treatment quality programs for depression are cost-beneficial to purchasers.

Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial

PubMed Central

2014-01-01

Background Chronic obstructive pulmonary disease (COPD) remains a major health problem, strongly related to smoking. Despite the publication of practice guidelines on prevention and treatment, not all patients with the disease receive the recommended healthcare, particularly with regard to smoking cessation advice where applicable. We have developed a tailored implementation strategy for enhancing general practitioners’ adherence to the disease management guidelines. The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners’ adherence to guidelines. Methods/Design A pragmatic two-arm cluster randomized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care. The study will involve 18 general practices (9 in the intervention group and 9 in the control group) in Poland, each with at least 80 identified (at the baseline) patients with diagnosed COPD. The nine control practices will provide usual care without any interventions. Tailored interventions to implement four recommendations will be delivered in the remaining nine practices. At follow-up after nine months, data will be collected for all 18 general practices. The primary outcome measure is physicians’ adherence to all four recommendations: brief anti-smoking advice, dyspnea assessment, care checklist utilization and demonstration to patients of correct inhaler use. This measurement will be based on data extracted from identified patients’ records. Additionally, we will survey and interview patients with chronic obstructive pulmonary disease about the process of care. Discussion The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care. Trial registration This trial has been registered with Clinical Trials Protocol Registration System. Trial number: NCT01893476. PMID:24708623

Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure: HF-ACTION Randomized Controlled Trial

PubMed Central

O’Connor, Christopher M.; Whellan, David J.; Lee, Kerry L.; Keteyian, Steven J.; Cooper, Lawton S.; Ellis, Stephen J.; Leifer, Eric S.; Kraus, William E.; Kitzman, Dalane W.; Blumenthal, James A.; Rendall, David S.; Miller, Nancy Houston; Fleg, Jerome L.; Schulman, Kevin A.; McKelvie, Robert S.; Zannad, Faiez; Piña, Ileana L.

2010-01-01

Context Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes. Objective To test the efficacy and safety of exercise training among patients with heart failure. Design, Setting, and Patients Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months. Interventions Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone. Main Outcome Measures Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization. Results The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Etiology was ischemic in 51%. Median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 (65%) patients in the exercise group died or were hospitalized, compared with 796 (68%) in the usual care group (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.84–1.02; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 [16%] in the exercise group vs 198 [17%] in the usual care group; HR, 0.96; 95% CI, 0.79–1.17; P = .70), cardiovascular mortality or cardiovascular hospitalization (632 [55%] in the exercise group vs 677 [58%] in the usual care group; HR, 0.92; 95% CI, 0.83–1.03; P = .14), and cardiovascular mortality or heart failure hospitalization (344 [30%] in the exercise group vs 393 [34%] in the usual care group; HR, 0.87; 95% CI, 0.75–1.00; P = .06). In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics, the HRs were 0.89 (95% CI, 0.81–0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI, 0.82–1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI, 0.74–0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Other adverse events were similar between the groups. Conclusions In the protocol-specified primary analysis, exercise training resulted in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points. After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization. Trial Registration clinicaltrials.gov Identifier: NCT00047437 PMID:19351941

Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial

PubMed Central

Blakeman, Tom; Blickem, Christian; Kennedy, Anne; Reeves, David; Bower, Peter; Gaffney, Hannah; Gardner, Caroline; Lee, Victoria; Jariwala, Praksha; Dawson, Shoba; Mossabir, Rahena; Brooks, Helen; Richardson, Gerry; Spackman, Eldon; Vassilev, Ivaylo; Chew-Graham, Carolyn; Rogers, Anne

2014-01-01

Background Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. Methods and Findings In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. Conclusions An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention. Trial Registration Controlled-Trials.com ISRCTN45433299 PMID:25330169

The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial

PubMed Central

Cannell, John; Jovic, Emelyn; Rathjen, Amy; Lane, Kylie; Tyson, Anna M; Callisaya, Michele L; Smith, Stuart T; Ahuja, Kiran DK; Bird, Marie-Louise

2017-01-01

Objective: To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Design: Randomized controlled clinical trial. Setting: Two subacute hospital rehabilitation units in Australia. Participants: In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. Interventions: Both groups received functional retraining and individualized programs for up to an hour, on weekdays for 8–40 sessions (dose matched). For the intervention group, this individualized program used motivating virtual reality rehabilitation and novel gesture controlled interactive motion capture software. For usual care, the individualized program was delivered in a group class on one unit and by rehabilitation assistant 1:1 on the other. Main measures: Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. Results: Participants (mean 22 days post-stroke) attended mean 14 sessions. Both groups improved (mean (95% confidence interval)) on primary outcome functional reach (usual care 3.3 (0.6 to 5.9), intervention 4.1 (−3.0 to 5.0) cm) with no difference between groups (P = 0.69) on this or any secondary measures. No differences between the rehabilitation units were seen except in lateral reach (less affected side) (P = 0.04). No adverse events were recorded during therapy. Conclusion: Interactive, motion capture rehabilitation for inpatients post stroke produced functional improvements that were similar to those achieved by usual care stroke rehabilitation, safely delivered by either a physical therapist or a rehabilitation assistant. PMID:28719977

Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A Randomized Clinical Trial.

PubMed

Reuland, Daniel S; Brenner, Alison T; Hoffman, Richard; McWilliams, Andrew; Rhyne, Robert L; Getrich, Christina; Tapp, Hazel; Weaver, Mark A; Callan, Danelle; Cubillos, Laura; Urquieta de Hernandez, Brisa; Pignone, Michael P

2017-07-01

Colorectal cancer (CRC) screening is underused, especially among vulnerable populations. Decision aids and patient navigation are potentially complementary interventions for improving CRC screening rates, but their combined effect on screening completion is unknown. To determine the combined effect of a CRC screening decision aid and patient navigation compared with usual care on CRC screening completion. In this randomized clinical trial, data were collected from January 2014 to March 2016 at 2 community health center practices, 1 in North Carolina and 1 in New Mexico, serving vulnerable populations. Patients ages 50 to 75 years who had average CRC risk, spoke English or Spanish, were not current with recommended CRC screening, and were attending primary care visits were recruited and randomized 1:1 to intervention or control arms. Intervention participants viewed a CRC screening decision aid in English or Spanish immediately before their clinician encounter. The decision aid promoted screening and presented colonoscopy and fecal occult blood testing as screening options. After the clinician encounter, intervention patients received support for screening completion from a bilingual patient navigator. Control participants viewed a food safety video before the encounter and otherwise received usual care. The primary outcome was CRC screening completion within 6 months of the index study visit assessed by blinded medical record review. Characteristics of the 265 participants were as follows: their mean age was 58 years; 173 (65%) were female, 164 (62%) were Latino; 40 (15%) were white non-Latino; 61 (23%) were black or of mixed race; 191 (78%) had a household income of less than $20 000; 101 (38%) had low literacy; 75 (28%) were on Medicaid; and 91 (34%) were uninsured. Intervention participants were more likely to complete CRC screening within 6 months (68% vs 27%); adjusted-difference, 40 percentage points (95% CI, 29-51 percentage points). The intervention was more effective in women than in men (50 vs 21 percentage point increase, interaction P = .02). No effect modification was observed across other subgroups. A patient decision aid plus patient navigation increased the rate of CRC screening completion in compared with usual care invulnerable primary care patients. clinicaltrials.gov Identifier: NCT02054598.

Physician losses from Medicare and Medicaid discounts: How real are they?

PubMed Central

Cromwell, Jerry; Burstein, Philip

1985-01-01

Physicians' claims that extensive Medicare and Medicaid fee discounting imposes an inequitable burden on them are examined using survey data from the Health Care Financing Administration on 5,000 primary care physicians. A definite fee hierarchy is documented, with the physician's usual charge at the top and Medicare and Medicaid allowables at the bottom. Under usual, customary, and reasonable methods, physicians can use fees to maximize payment, and insurer attempts to control fees result in both sides participating in a revenue maximization-expenditure control game. Raising Medicare and Medicaid allowables to the physician's usual fee is shown to result in large windfall gains that are unnecessary and unjustified in terms of work effort, human capital investment, or eliciting an adequate supply of practitioners. PMID:10311339

Race, gender, and language concordance in the primary care setting.

PubMed

Martin, Brian C; Shi, Leiyu; Ward, Ryan D

2009-01-01

The purpose of this paper is to examine race, gender and language concordance in terms of importance to primary care. The 2003 Medical Expenditure Panel Survey Household Component (MEPS) was used. Four distinguishing primary care attributes and selected measures were operationalized primarily from a sample subset that identified a usual source of care (USC): accessibility to USC; interface between primary care and specialist services; treatment decisions; and preventive services received from the USC. Bivariate and multivariate results are reported. Adjusting for covariates, the following items remained statistically significant: race--choosing primary care physician as USC, USC having office hours, and going to USC for new health problems; gender--choosing primary care physician as USC and USC having office hours; and language--lack of difficulty contacting the USC after hours. However, these items appear to be isolated cases rather than indicators that concordance plays a key role in determining primary care quality. Language barriers/communication issues are the only areas where improvement appears warranted. While the study has strong accessibility and interpersonal relationship measures, service coordination and comprehensiveness indicators are limited. The analyses' cross-sectional nature also poses a problem in drawing causal relationships and conclusive findings. Finally, sample size limitations preclude stratified analyses across racial/ethnic groups, an important consideration as the relationships between concordance and quality may vary across groups. This study indicates that more research is needed in this area to determine future resource allocation and policy direction. The unique contribution of the study is to suggest that race and gender concordance may not accurately predict primary health care quality.

Effect of adding postoperative noninvasive ventilation to usual care to prevent pulmonary complications in patients undergoing coronary artery bypass grafting: a randomized controlled trial.

PubMed

Al Jaaly, Emad; Fiorentino, Francesca; Reeves, Barnaby C; Ind, Philip W; Angelini, Gianni D; Kemp, Scott; Shiner, Robert J

2013-10-01

We compared the efficacy of noninvasive ventilation with bilevel positive airway pressure added to usual care versus usual care alone in patients undergoing coronary artery bypass grafting. We performed a 2-group, parallel, randomized controlled trial. The primary outcome was time until fit for discharge. Secondary outcomes were partial pressure of carbon dioxide, forced expiratory volume in 1 second, atelectasis, adverse events, duration of intensive care stay, and actual postoperative stay. A total of 129 patients were randomly allocated to bilevel positive airway pressure (66) or usual care (63). Three patients allocated to bilevel positive airway pressure withdrew. The median duration of bilevel positive airway pressure was 16 hours (interquartile range, 11-19). The median duration of hospital stay until fit for discharge was 5 days for the bilevel positive airway pressure group (interquartile range, 4-6) and 6 days for the usual care group (interquartile range, 5-7; hazard ratio, 1.68; 95% confidence interval, 1.08-2.31; P = .019). There was no significant difference in duration of intensive care, actual postoperative stay, and mean percentage of predicted forced expiratory volume in 1 second on day 3. Mean partial pressure of carbon dioxide was significantly reduced 1 hour after bilevel positive airway pressure application, but there was no overall difference between the groups up to 24 hours. Basal atelectasis occurred in 15 patients (24%) in the usual care group and 2 patients (3%) in the bilevel positive airway pressure group. Overall, 30% of patients in the bilevel positive airway pressure group experienced an adverse event compared with 59% in the usual care group. Among patients undergoing elective coronary artery bypass grafting, the use of bilevel positive airway pressure at extubation reduced the recovery time. Supported by trained staff, more than 75% of all patients allocated to bilevel positive airway pressure tolerated it for more than 10 hours. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Improving quality of care and long-term health outcomes through continuity of care with the use of an electronic or paper patient-held portable health file (COMMUNICATE): study protocol for a randomized controlled trial.

PubMed

Lassere, Marissa Nichole; Baker, Sue; Parle, Andrew; Sara, Anthony; Johnson, Kent Robert

2015-06-04

The advantages of patient-held portable health files (PHF) and personal health records (PHR), paper or electronic, are said to include improved health-care provider continuity-of-care and patient empowerment in maintaining health. Top-down approaches are favored by public sector government and health managers. Bottom-up approaches include systems developed directly by health-care providers, consumers and industry, implemented locally on devices carried by patient-consumers or shared via web-based portals. These allow individuals to access, manage and share their health information, and that of others for whom they are authorized, in a private, secure and confidential environment. Few medical record technologies have been evaluated in randomized trials to determine whether there are important clinical benefits of these interventions. The COMMUNICATE trial will assess the acceptability and long-term clinical outcomes of an electronic and paper patient-held PHF. This is a 48-month, open-label pragmatic, superiority, parallel-group design randomized controlled trial. Subjects (n = 792) will be randomized in a 1:1:1 ratio to each of the trial arms: the electronic PHF added to usual care, the paper PHF added to usual care and usual care alone (no PHF). Inclusion criteria include those 60 years or older living independently in the community, but who have two or more chronic medical conditions that require prescription medication and regular care by at least three medical practitioners (general and specialist care). The primary objective is whether use of a PHF compared to usual care reduces a combined endpoint of deaths, overnight hospitalizations and blindly adjudicated serious out-of-hospital events. All primary analyses will be undertaken masked to randomized arm allocation using intention-to-treat principles. Secondary outcomes include quality of life and health literacy improvements. Lack of blinding creates potential for bias in trial conduct and ascertainment of clinical outcomes. Mechanisms are provided to reduce bias, including balanced study contact with all participants, a blinded adjudication committee determining which out-of-hospital events are serious and endpoints that are objective (overnight hospitalizations and mortality). The PRECIS tool provides a summary of the trial's design on the Pragmatic-Explanatory Continuum. Registered with Clinicaltrials.gov (identifier: NCT01082978) on 8 March 2010.

Design of the Coordinated Anxiety Learning and Management (CALM) Study: Innovations in Collaborative Care for Anxiety Disorders

PubMed Central

Sullivan, Greer; Craske, Michelle G; Sherbourne, Cathy; Edlund, Mark J; Rose, Raphael D; Golinelli, Daniela; Chavira, Denise A; Bystritsky, Alexander; Stein, Murray B; Roy-Byrne, Peter P

2007-01-01

Background: Despite a marked increase in persons seeking help for anxiety disorders, the care provided may not be evidence-based, especially when delivered by non-specialists. Since anxiety disorders are most often treated in primary care, quality improvement interventions are needed there. Research Design: A randomized controlled trial of a collaborative care effectiveness intervention for anxiety disorders. Subjects: Approximately 1040 adult primary care patients with one of four anxiety disorders (generalized anxiety disorder, panic disorder, posttraumatic stress disorder, or social anxiety disorder), recruited from four national sites. Intervention: Anxiety clinical specialists deliver education and behavioral activation to intervention patients and monitor their symptoms. Intervention patients choose cognitive behavioral therapy, anti-anxiety medications, or both, in a “stepped care” treatment that varies according to clinical need. Control patients receive usual care from their primary care clinician. CALM's innovations include the flexibility to treat any one of four anxiety disorders, co-occurring depression, and/or alcohol abuse; its use of on-site clinicians to conduct initial assessments, and its computer-assisted psychotherapy delivery. Evaluation: Anxiety symptoms, functioning, satisfaction with care, and health care utilization are assessed at 6-month intervals. Conclusion: CALM was designed for clinical effectiveness and easy dissemination in a variety of primary care settings. PMID:17888803

Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan.

PubMed

Jarab, Anan Sadeq; Alqudah, Salam Ghazi; Mukattash, Tareq Lewis; Shattat, Ghassan; Al-Qirim, Tariq

2012-09-01

Glycemic goals (hemoglobin A1c < 7%) are often not achieved in patients with type 2 diabetes despite the availability of many effective treatments and the documented benefits of glycemic control in the reduction of long-term microvascular and macrovascular complications. Several studies have established the important positive effects of pharmacist-led management on achieving glycemic control and other clinical outcomes in patients with diabetes. Diabetes prevalence and mortality are increasing rapidly in Jordan. Nevertheless, clinical pharmacists in Jordan do not typically provide pharmaceutical care; instead, the principal responsibilities of pharmacists in Jordan are dispensing and marketing of medical products to physicians. To assess the primary clinical outcome of glycemic control (A1c) and secondary outcomes, including blood pressure, lipid values, self-reported medication adherence, and self-care activities for patients with type 2 diabetes in an outpatient diabetes clinic randomly assigned to either usual care or a pharmacist-led pharmaceutical care intervention program. Patients with type 2 diabetes attending an outpatient diabetes clinic of a large teaching hospital were recruited over a 4-month period from January through April 2011 and randomly assigned to intervention and usual care groups using the Minim software technique. The intervention group at baseline received face-to-face objective-directed education from a clinical pharmacist about type 2 diabetes, prescription medications, and necessary lifestyle changes, followed by 8 weekly telephone follow-up calls to discuss and review the prescribed treatment plan and to resolve any patient concerns. The primary outcome measure was glycemic control (A1c), and secondary measures included systolic and diastolic blood pressure, complete lipid profile (i.e., total cholesterol, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], serum triglycerides), and self-reported medication adherence (4-item Morisky Scale) and self-care activities (Summary of Diabetes Self-Care Activities questionnaire). Data were collected at baseline and at 6 months follow-up. Changes from baseline to follow-up were calculated for biomarker values, and between-group differences in the change amounts were tested using the t test for independent samples. A P value of < 0.05 was considered statistically significant. A total of 77 of 85 patients (90.6%) randomly assigned to the intervention group and 79 of 86 patients (91.9%) assigned to usual care had baseline and 6-month follow-up values. Compared with baseline values, patients in the intervention group had a mean reduction of 0.8% in A1c versus a mean increase of 0.1% from baseline in the usual care group (P = 0.019). The intervention group compared with the usual care group had small but statistically significant improvements in the secondary measures of fasting blood glucose, systolic and diastolic blood pressure, total cholesterol, LDL-C, serum triglycerides, self-reported medication adherence, and self-care activities. Between-group differences in changes in the secondary measures of HDL-C and body mass index were not significant. Patients with type 2 diabetes who received pharmacist-led pharmaceutical care in an outpatient diabetes clinic experienced reduction in A1c at 6 months compared with essentially no change in the usual care group. Six of 8 secondary biomarkers were improved in the intervention group compared with usual care. Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved.

[Recommendations for the use of rapid diagnosis techniques in respiratory infections in primary care].

PubMed

Llor, Carles; Alkorta Gurrutxaga, Miriam; de la Flor I Bru, Josep; Bernárdez Carracedo, Sílvia; Cañada Merino, José Luis; Bárcena Caamaño, Mario; Serrano Martino, Carmen; Cots Yago, Josep Maria

Respiratory tract infections rank first as causes of adult and paediatric infectious morbidity in primary care in Spain. These infections are usually self-limiting and are mainly caused by viruses. However, a high percentage of unnecessary antibiotic prescription is reported. Point-of-care tests are biomedical tests, which can be used near the patient, without interference of a laboratory. The use of these tests, many of which have been recently developed, is rapidly increasing in general practice. Notwithstanding, we must mull over whether they always contribute to an effective and high-quality diagnostic process by primary care clinicians. We present a set of criteria that can be used by clinicians and discuss the pros and cons of the instruments available for the management of respiratory tract infections and how to use them appropriately. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Multistrategy childcare-based intervention to improve compliance with nutrition guidelines versus usual care in long day care services: a study protocol for a randomised controlled trial

PubMed Central

Seward, Kirsty; Finch, Meghan; Wiggers, John; Wyse, Rebecca; Jones, Jannah; Gillham, Karen; Yoong, Sze Lin

2016-01-01

Introduction Interventions to improve child diet are recommended as dietary patterns developed in childhood track into adulthood and influence the risk of chronic disease. For child health, childcare services are required to provide foods to children consistent with nutrition guidelines. Research suggests that foods and beverages provided by services to children are often inconsistent with nutrition guidelines. The primary aim of this study is to assess, relative to a usual care control group, the effectiveness of a multistrategy childcare-based intervention in improving compliance with nutrition guidelines in long day care services. Methods and analysis The study will employ a parallel group randomised controlled trial design. A sample of 58 long day care services that provide all meals (typically includes 1 main and 2 mid-meals) to children while they are in care, in the Hunter New England region of New South Wales, Australia, will be randomly allocated to a 6-month intervention to support implementation of nutrition guidelines or a usual care control group in a 1:1 ratio. The intervention was designed to overcome barriers to the implementation of nutrition guidelines assessed using the theoretical domains framework. Intervention strategies will include the provision of staff training and resources, audit and feedback, ongoing support and securing executive support. The primary outcome of the trial will be the change in the proportion of long day care services that have a 2-week menu compliant with childcare nutrition guidelines, measured by comprehensive menu assessments. As a secondary outcome, child dietary intake while in care will also be assessed. To assess the effectiveness of the intervention, the measures will be undertaken at baseline and ∼6 months postbaseline. Ethics and dissemination The study was approved by the Hunter New England Human Research Ethics Committee. Study findings will be disseminated widely through peer-reviewed publications. PMID:27301484

Factors Influencing Health Care Access in Rural Health Professional Shortage Areas

DTIC Science & Technology

1992-08-01

CRA&I DTIC TAB1 9 UnannouncedS~~Just f~jpn_ ..__" l• By Distribution /93- 04772 Avi adom a..,.Availability Codes Avail and orDist Special •~-0 1S𔄃...profession. Large group and staff-model Health Maintenance Rural Health 16 Organizations [HMOs) usually provide care at primary HMO sites ald employ NPs

Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial.

PubMed

Fritz, Julie M; Magel, John S; McFadden, Molly; Asche, Carl; Thackeray, Anne; Meier, Whitney; Brennan, Gerard

2015-10-13

Low back pain (LBP) is common in primary care. Guidelines recommend delaying referrals for physical therapy. To evaluate whether early physical therapy (manipulation and exercise) is more effective than usual care in improving disability for patients with LBP fitting a decision rule. Randomized clinical trial with 220 participants recruited between March 2011 and November 2013. Participants with no LBP treatment in the past 6 months, aged 18 through 60 years (mean age, 37.4 years [SD, 10.3]), an Oswestry Disability Index (ODI) score of 20 or higher, symptom duration less than 16 days, and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit. All participants received education. Early physical therapy (n = 108) consisted of 4 physical therapy sessions. Usual care (n = 112) involved no additional interventions during the first 4 weeks. Primary outcome was change in the ODI score (range: 0-100; higher scores indicate greater disability; minimum clinically important difference, 6 points) at 3 months. Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up, and change in pain intensity, Pain Catastrophizing Scale (PCS) score, fear-avoidance beliefs, quality of life, patient-reported success, and health care utilization at 4-week, 3-month, and 1-year follow-up. One-year follow-up was completed by 207 participants (94.1%). Using analysis of covariance, early physical therapy showed improvement relative to usual care in disability after 3 months (mean ODI score: early physical therapy group, 41.3 [95% CI, 38.7 to 44.0] at baseline to 6.6 [95% CI, 4.7 to 8.5] at 3 months; usual care group, 40.9 [95% CI, 38.6 to 43.1] at baseline to 9.8 [95% CI, 7.9 to 11.7] at 3 months; between-group difference, -3.2 [95% CI, -5.9 to -0.47], P = .02). A significant difference was found between groups for the ODI score after 4 weeks (between-group difference, -3.5 [95% CI, -6.8 to -0.08], P = .045]), but not at 1-year follow-up (between-group difference, -2.0 [95% CI, -5.0 to 1.0], P = .19). There was no improvement in pain intensity at 4-week, 3-month, or 1-year follow-up (between-group difference, -0.42 [95% CI, -0.90 to 0.02] at 4-week follow-up; -0.38 [95% CI, -0.84 to 0.09] at 3-month follow-up; and -0.17 [95% CI, -0.62 to 0.27] at 1-year follow-up). The PCS scores improved at 4 weeks and 3 months but not at 1-year follow-up (between-group difference, -2.7 [95% CI, -4.6 to -0.85] at 4-week follow-up; -2.2 [95% CI, -3.9 to -0.49] at 3-month follow-up; and -0.92 [95% CI, -2.7 to 0.61] at 1-year follow-up). There were no differences in health care utilization at any point. Among adults with recent-onset LBP, early physical therapy resulted in statistically significant improvement in disability, but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care. clinicaltrials.gov Identifier: NCT01726803.

Effectiveness of an interactive platform, and the ESC/HFA heartfailurematters.org website in patients with heart failure: design of the multicentre randomized e-Vita heart failure trial.

PubMed

Wagenaar, Kim P; Broekhuizen, Berna D L; Dickstein, Kenneth; Jaarsma, Tiny; Hoes, Arno W; Rutten, Frans H

2015-12-01

Electronic health support (e-health) may improve self-care of patients with heart failure (HF). We aim to assess whether an adjusted care pathway with replacement of routine consultations by e-health improves self-care as compared with usual care. In addition, we will determine whether the ESC/HFA (European Society of Cardiology/Heart Failure Association) website heartfailurematters.org (HFM website) improves self-care when added to usual care. Finally, we aim to evaluate the cost-effectiveness of these interventions. A three-arm parallel randomized trial will be conducted. Arm 1 consists of usual care; arm 2 consists of usual care plus the HFM website; and arm 3 is the adjusted care pathway with an interactive platform for disease management (e-Vita platform), with a link to the HFM website, which replaces routine consultations with HF nurses at the outpatient clinic. In total, 414 patients managed in 10 Dutch HF outpatient clinics or in general practice will be included and followed for 12 months. Participants are included if they have had an established diagnosis of HF for at least 3 months. The primary outcome is self-care as measured by the European Heart Failure Self-care Behaviour scale (EHFScB scale). Secondary outcomes are quality of life, cardiovascular- and HF-related mortality, hospitalization, and its duration as captured by hospital and general practitioner registries, use of and user satisfaction with the HFM website, and cost-effectiveness. This study will provide important prospective data on the impact and cost-effectiveness of an interactive platform for disease management and the HFM website. unique identifier: NCT01755988. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

Women’s Preferred Sources for Primary and Mental Health Care: Implications for Reproductive Health Providers

PubMed Central

Harris, Lisa H.; Dalton, Vanessa K.

2016-01-01

Purpose To describe women’s preferences for reproductive health providers as sources of primary and mental health care. Methods Secondary data analysis of the Women’s Health Care Experiences and Preferences Study, an internet survey conducted in September 2013 of 1,078 women aged 18–55 randomly sampled from a U.S. national probability panel. We estimated women’s preferred and usual sources of care (reproductive health providers, generalists, other) for various primary care and mental health care services using weighted statistics and multiple logistic regression. Main Findings Among women using healthcare in the past five years (n=981), 88% received primary and/or mental health care, including routine medical check-up (78%), urgent/acute (48%), chronic disease (27%), depression/anxiety (21%), stress (16%), and IPV (2%) visits. Of those, reproductive health providers were the source of check-up (14%), urgent/acute (3%), chronic disease (6%), depression/anxiety (6%), stress (11%), and intimate partner violence (3%) services. Preference for specific reproductive health-provided primary/mental health care services ranged from 7–20%. Among women having used primary/mental health care services (N=894), more women (1–17%) preferred than had received primary/mental health care from reproductive health providers. Nearly a quarter (22%) identified reproductive health providers as their single most preferred source of care. Contraceptive use was the strongest predictor of preference for reproductive health-provided primary/mental health care (Odds Ratios range 2.11–3.30). Conclusions Reproductive health providers are the sole source of healthcare for a substantial proportion of reproductive-aged women – the same groups at risk for unmet primary and mental health care needs. Findings have implications for reproductive health providers’ role in comprehensive women’s healthcare provision and potentially for informing patient-centered, integrated models of care in current health systems. PMID:27825589

Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and sample characteristics.

PubMed

Kroenke, Kurt; Krebs, Erin; Wu, Jingwei; Bair, Matthew J; Damush, Teresa; Chumbler, Neale; York, Tish; Weitlauf, Sharon; McCalley, Stephanie; Evans, Erica; Barnd, Jeffrey; Yu, Zhangsheng

2013-03-01

Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Although collaborative care interventions are well-established for conditions such as depression, fewer systems-based interventions have been tested for chronic pain. This paper describes the study design and baseline characteristics of the enrolled sample for the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial conducted in five primary care clinics. SCOPE has enrolled 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity and randomized them to either the stepped care intervention or usual care control group. Using a telemedicine collaborative care approach, the intervention couples automated symptom monitoring with a telephone-based, nurse care manager/physician pain specialist team to treat pain. The goal is to optimize analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects undergo comprehensive outcome assessments at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. The primary outcome is pain severity/disability, and secondary outcomes include pain beliefs and behaviors, psychological functioning, health-related quality of life and treatment satisfaction. Innovations of SCOPE include optimized analgesic management (including a stepped care approach, opioid risk stratification, and criteria-based medication adjustment), automated monitoring, and centralized care management that can cover multiple primary care practices. Published by Elsevier Inc.

Comparing Dutch case management care models for people with dementia and their caregivers: The design of the COMPAS study.

PubMed

MacNeil Vroomen, Janet; Van Mierlo, Lisa D; van de Ven, Peter M; Bosmans, Judith E; van den Dungen, Pim; Meiland, Franka J M; Dröes, Rose-Marie; Moll van Charante, Eric P; van der Horst, Henriëtte E; de Rooij, Sophia E; van Hout, Hein P J

2012-05-28

Dementia care in the Netherlands is shifting from fragmented, ad hoc care to more coordinated and personalised care. Case management contributes to this shift. The linkage model and a combination of intensive case management and joint agency care models were selected based on their emerging prominence in the Netherlands. It is unclear if these different forms of case management are more effective than usual care in improving or preserving the functioning and well-being at the patient and caregiver level and at the societal cost. The objective of this article is to describe the design of a study comparing these two case management care models against usual care. Clinical and cost outcomes are investigated while care processes and the facilitators and barriers for implementation of these models are considered. Mixed methods include a prospective, observational, controlled, cohort study among persons with dementia and their primary informal caregiver in regions of the Netherlands with and without case management including a qualitative process evaluation. Inclusion criteria for the cohort study are: community-dwelling individuals with a dementia diagnosis who are not terminally-ill or anticipate admission to a nursing home within 6 months and with an informal caregiver who speaks fluent Dutch. Person with dementia-informal caregiver dyads are followed for two years. The primary outcome measure is the Neuropsychiatric Inventory for the people with dementia and the General Health Questionnaire for their caregivers. Secondary outcomes include: quality of life and needs assessment in both persons with dementia and caregivers, activity of daily living, competence of care, and number of crises. Costs are measured from a societal perspective using cost diaries. Process indicators measure the quality of care from the participant's perspective. The qualitative study uses purposive sampling methods to ensure a wide variation of respondents. Semi-structured interviews with stakeholders based on the theoretical model of adaptive implementation are planned. This study provides relevant insights into care processes, description of two case management models along with clinical and economic data from persons with dementia and caregivers to clarify important differences in two case management care models compared to usual care.

Comparing Dutch Case management care models for people with dementia and their caregivers: The design of the COMPAS study

PubMed Central

2012-01-01

Background Dementia care in the Netherlands is shifting from fragmented, ad hoc care to more coordinated and personalised care. Case management contributes to this shift. The linkage model and a combination of intensive case management and joint agency care models were selected based on their emerging prominence in the Netherlands. It is unclear if these different forms of case management are more effective than usual care in improving or preserving the functioning and well-being at the patient and caregiver level and at the societal cost. The objective of this article is to describe the design of a study comparing these two case management care models against usual care. Clinical and cost outcomes are investigated while care processes and the facilitators and barriers for implementation of these models are considered. Design Mixed methods include a prospective, observational, controlled, cohort study among persons with dementia and their primary informal caregiver in regions of the Netherlands with and without case management including a qualitative process evaluation. Inclusion criteria for the cohort study are: community-dwelling individuals with a dementia diagnosis who are not terminally-ill or anticipate admission to a nursing home within 6 months and with an informal caregiver who speaks fluent Dutch. Person with dementia-informal caregiver dyads are followed for two years. The primary outcome measure is the Neuropsychiatric Inventory for the people with dementia and the General Health Questionnaire for their caregivers. Secondary outcomes include: quality of life and needs assessment in both persons with dementia and caregivers, activity of daily living, competence of care, and number of crises. Costs are measured from a societal perspective using cost diaries. Process indicators measure the quality of care from the participant’s perspective. The qualitative study uses purposive sampling methods to ensure a wide variation of respondents. Semi-structured interviews with stakeholders based on the theoretical model of adaptive implementation are planned. Discussion This study provides relevant insights into care processes, description of two case management models along with clinical and economic data from persons with dementia and caregivers to clarify important differences in two case management care models compared to usual care. PMID:22640695

Multidimensional Treatment Foster Care for Adolescents in English care: randomised trial and observational cohort evaluation.

PubMed

Green, J M; Biehal, N; Roberts, C; Dixon, J; Kay, C; Parry, E; Rothwell, J; Roby, A; Kapadia, D; Scott, S; Sinclair, I

2014-03-01

Children in care often have poor outcomes. There is a lack of evaluative research into intervention options. To examine the efficacy of Multidimensional Treatment Foster Care for Adolescents (MTFC-A) compared with usual care for young people at risk in foster care in England. A two-arm single (assessor) blinded randomised controlled trial (RCT) embedded within an observational quasi-experimental case-control study involving 219 young people aged 11-16 years (trial registration: ISRCTN 68038570). The primary outcome was the Child Global Assessment Scale (CGAS). Secondary outcomes were ratings of educational attendance, achievement and rate of offending. The MTFC-A group showed a non-significant improvement in CGAS outcome in both the randomised cohort (n = 34, adjusted mean difference 1.3, 95% CI -7.1 to 9.7, P = 0.75) and in the trimmed observational cohort (n = 185, adjusted mean difference 0.95, 95% CI -2.38 to 4.29, P = 0.57). No significant effects were seen in secondary outcomes. There was a possible differential effect of the intervention according to antisocial behaviour. There was no evidence that the use of MTFC-A resulted in better outcomes than usual care. The intervention may be more beneficial for young people with antisocial behaviour but less beneficial than usual treatment for those without.

Effectiveness of physiotherapy for seniors with recurrent headaches associated with neck pain and dysfunction: a randomized controlled trial.

PubMed

Uthaikhup, Sureeporn; Assapun, Jenjira; Watcharasaksilp, Kanokwan; Jull, Gwendolen

2017-01-01

A previous study demonstrated that in seniors, the presence of cervical musculoskeletal impairment was not specific to cervicogenic headache but was present in various recurrent headache types. Physiotherapy treatment is indicated in those seniors diagnosed with cervicogenic headache but could also be adjunct treatment for those with cervical musculoskeletal signs who are suspected of having transitional headaches. This study aimed to determine the effectiveness of a physiotherapy program for seniors with recurrent headaches associated with neck pain and cervical musculoskeletal dysfunction, irrespective of the headache classification. This is a prospective, stratified, randomized controlled trial with blinded outcome assessment. Sixty-five participants with recurrent headache, aged 50-75 years, were randomly assigned to either a physiotherapy (n=33) or a usual care group (n=32). The primary outcome was headache frequency. Secondary outcomes were headache intensity and duration, neck pain and disability, cervical range of motion, quality of life, participant satisfaction, and medication intake. Participants in the physiotherapy group received 14 treatment sessions. Participants in the usual care group continued with their usual care. Outcome measures were recorded at baseline, 11 weeks, 6 months, and 9 months. This study was funded by a government research fund of $6,850. No conflict of interest is declared. There was no loss to follow-up for the primary outcome measure. Compared with usual care, participants receiving physiotherapy reported significant reductions in headache frequency immediately after treatment (mean difference -1.6 days, 95% confidence interval [CI] -2.5 to -0.6), at 6-month follow-up (-1.7 days, 95% CI -2.6 to -0.8), and at 9-month follow-up (-2.4 days, 95% CI -3.2 to -1.5), and significant improvements in all secondary outcomes immediately posttreatment and at 6- and 9-month follow-ups, (p<.05 for all). No adverse events were reported. Physiotherapy treatment provided benefits over usual care for seniors with recurrent headache associated with neck pain and dysfunction. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparative Effectiveness of Fecal Immunochemical Test Outreach, Colonoscopy Outreach, and Usual Care for Boosting Colorectal Cancer Screening Among the Underserved

PubMed Central

Gupta, Samir; Halm, Ethan A.; Rockey, Don C.; Hammons, Marcia; Koch, Mark; Carter, Elizabeth; Valdez, Luisa; Tong, Liyue; Ahn, Chul; Kashner, Michael; Argenbright, Keith; Tiro, Jasmin; Geng, Zhuo; Pruitt, Sandi; Skinner, Celette Sugg

2017-01-01

IMPORTANCE Colorectal cancer (CRC) screening saves lives, but participation rates are low among underserved populations. Knowledge on effective approaches for screening the underserved, including best test type to offer, is limited. OBJECTIVE To determine (1) if organized mailed outreach boosts CRC screening compared with usual care and (2) if FIT is superior to colonoscopy outreach for CRC screening participation in an underserved population. DESIGN, SETTING, AND PARTICIPANTS We identified uninsured patients, not up to date with CRC screening, age 54 to 64 years, served by the John Peter Smith Health Network, Fort Worth and Tarrant County, Texas, a safety net health system. INTERVENTIONS Patients were assigned randomly to 1 of 3 groups. One group was assigned to fecal immunochemical test (FIT) outreach, consisting of mailed invitation to use and return an enclosed no-cost FIT (n = 1593). A second was assigned to colonoscopy outreach, consisting of mailed invitation to schedule a no-cost colonoscopy (n = 479). The third group was assigned to usual care, consisting of opportunistic primary care visit-based screening (n = 3898). In addition, FIT and colonoscopy outreach groups received telephone follow-up to promote test completion. MAIN OUTCOME MEASURES Screening participation in any CRC test within 1 year after randomization. RESULTS Mean patient age was 59 years; 64% of patients were women. The sample was 41% white, 24% black, 29% Hispanic, and 7% other race/ethnicity. Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P < .001 for both comparisons with usual care). Screening was significantly higher for FIT than for colonoscopy outreach (P < .001). In stratified analyses, screening was higher for FIT and colonoscopy outreach than for usual care, and higher for FIT than for colonoscopy outreach among whites, blacks, and Hispanics (P < .005 for all comparisons). Rates of CRC identification and advanced adenoma detection were 0.4% and 0.8% for FIT outreach, 0.4% and 1.3% for colonoscopy outreach, and 0.2% and 0.4% for usual care, respectively (P < .05 for colonoscopy vs usual care advanced adenoma comparison; P > .05 for all other comparisons). Eleven of 60 patients with abnormal FIT results did not complete colonoscopy. CONCLUSIONS AND REVELANCE Among underserved patients whose CRC screening was not up to date, mailed outreach invitations resulted in markedly higher CRC screening compared with usual care. Outreach was more effective with FIT than with colonoscopy invitation. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01191411 PMID:23921906

Economic Analysis of Primary Care-Based Physical Activity Counseling in Older Men: The VA-LIFE Trial

PubMed Central

Cowper, Patricia A; Peterson, Matthew J; Pieper, Carl F; Sloane, Richard J; Hall, Katherine S; McConnell, Eleanor S; Bosworth, Hayden B; Ekelund, Carola C; Pearson, Megan P; Morey, Miriam C

2016-01-01

BACKGROUND/OBJECTIVES To perform an economic evaluation of a primary care-based physical activity counseling intervention that improved physical activity levels and rapid gait speed in older veterans. DESIGN Secondary objective of randomized trial that assessed the effect of exercise counseling (relative to usual care) on physical performance, physical activity, function, disability and medical resource use and cost. SETTING Veterans Affairs Medical Center, Durham, North Carolina. PARTICIPANTS Male veterans aged ≥ 70 years (n=398). INTERVENTION An experienced health counselor provided baseline in-person exercise counseling, followed by telephone counseling at 2, 4, and 6 weeks, and monthly thereafter through one year. Each participant’s primary care physician provided initial endorsement of the intervention, followed by monthly automated telephone messages tailored to the patient. Individualized progress reports were mailed quarterly. MEASUREMENTS Intervention costs were assessed. Health care resource use and costs were estimated from enrollment through one year follow-up. The incremental cost of achieving clinically significant changes in major trial endpoints was calculated. RESULTS The total direct cost of the intervention per participant was $459, 85% of which was counselor effort. With overhead, program cost totaled $696 per participant. Medical costs during follow-up reached $10,418 with the intervention, versus $12,052 with usual care (difference = −$1,634 (95% confidence interval=−$4,683 to $1,416; p=0.29)). Expressed in terms of short-term clinical outcomes, the intervention cost $4,971 per additional patient reaching target exercise levels, or $4,640 per patient achieving a clinically significant change in rapid gait speed. CONCLUSION Improvements in physical activity and rapid gait speed in the physical activity counseling group were obtained at a cost that represents a small fraction of patients’ annual health care costs. PMID:28152170

Economic Analysis of Primary Care-Based Physical Activity Counseling in Older Men: The VA-LIFE Trial.

PubMed

Cowper, Patricia A; Peterson, Matthew J; Pieper, Carl F; Sloane, Richard J; Hall, Katherine S; McConnell, Eleanor S; Bosworth, Hayden B; Ekelund, Carola C; Pearson, Megan P; Morey, Miriam C

2017-03-01

To perform an economic evaluation of a primary care-based physical activity counseling intervention that improved physical activity levels and rapid gait speed in older veterans. Secondary objective of randomized trial that assessed the effect of exercise counseling (relative to usual care) on physical performance, physical activity, function, disability, and medical resource use and cost. Veterans Affairs Medical Center, Durham, North Carolina. Male veterans aged ≥70 years (n = 398). An experienced health counselor provided baseline in-person exercise counseling, followed by telephone counseling at 2, 4, and 6 weeks, and monthly thereafter through one year. Each participant's primary care physician provided initial endorsement of the intervention, followed by monthly automated telephone messages tailored to the patient. Individualized progress reports were mailed quarterly. Intervention costs were assessed. Health care resource use and costs were estimated from enrollment through one year follow-up. The incremental cost of achieving clinically significant changes in major trial endpoints was calculated. The total direct cost of the intervention per participant was $459, 85% of which was counselor effort. With overhead, program cost totaled $696 per participant. Medical costs during follow-up reached $10,418 with the intervention, versus $12,052 with usual care (difference = -$1,634 (95% confidence interval = -$4,683 to $1,416; P = .29)). Expressed in terms of short-term clinical outcomes, the intervention cost $4,971 per additional patient reaching target exercise levels, or $4,640 per patient achieving a clinically significant change in rapid gait speed. Improvements in physical activity and rapid gait speed in the physical activity counseling group were obtained at a cost that represents a small fraction of patients' annual health care costs. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

The cost-effectiveness of a family meetings intervention to prevent depression and anxiety in family caregivers of patients with dementia: a randomized trial.

PubMed

Joling, Karlijn J; Bosmans, Judith E; van Marwijk, Harm W J; van der Horst, Henriëtte E; Scheltens, Philip; MacNeil Vroomen, Janet L; van Hout, Hein P J

2013-09-22

Dementia imposes a heavy burden on health and social care systems as well as on family caregivers who provide a substantial portion of the care. Interventions that effectively support caregivers may prevent or delay patient institutionalization and hence be cost-effective. However, evidence about the cost-effectiveness of such interventions is scarce. The aim of this study was to evaluate the cost-effectiveness of a family meetings intervention for family caregivers of dementia patients in comparison with usual care over a period of 12 months. The economic evaluation was conducted from a societal perspective alongside a randomized trial of 192 primary caregivers with community-dwelling dementia patients. Outcome measures included the Quality Adjusted Life-Years (QALY) of caregivers and patients and the incidence of depression and anxiety disorders in caregivers. Missing cost and effect data were imputed using multiple imputations. Bootstrapping was used to estimate uncertainty around the cost-differences and the incremental cost-effectiveness ratio (ICER). The bootstrapped cost-effect pairs were plotted on a cost-effectiveness plane and used to estimate cost-effectiveness curves. No significant differences in costs and effects between the groups were found. At 12 months, total costs per patient and primary caregiver dyad were substantial: €77,832 for the intervention group and €75,201 for the usual care group (adjusted mean difference per dyad €4,149, 95% CI -13,371 to 21,956, ICER 157,534). The main cost driver was informal care (66% of total costs), followed by patients' day treatment and costs of hospital and long-term care facility admissions (23%). Based on the cost-effectiveness acceptability curves, the maximum probability that the intervention was considered cost-effective in comparison with usual care reached 0.4 for the outcome QALY per patient-caregiver dyad and 0.6 for the caregivers' incidence of depression and/or anxiety disorders regardless of the willingness to pay. The annual costs of caring for a person with dementia were substantial with informal care being by far the largest contributor to the total societal costs. Based on this study, family meetings cannot be considered a cost-effective intervention strategy in comparison with usual care. ISRCTN register, ISRCTN90163486.

Effect of an enhanced medical home on serious illness and cost of care among high-risk children with chronic illness: a randomized clinical trial.

PubMed

Mosquera, Ricardo A; Avritscher, Elenir B C; Samuels, Cheryl L; Harris, Tomika S; Pedroza, Claudia; Evans, Patricia; Navarro, Fernando; Wootton, Susan H; Pacheco, Susan; Clifton, Guy; Moody, Shade; Franzini, Luisa; Zupancic, John; Tyson, Jon E

Patient-centered medical homes have not been shown to reduce adverse outcomes or costs in adults or children with chronic illness. To assess whether an enhanced medical home providing comprehensive care prevents serious illness (death, intensive care unit [ICU] admission, or hospital stay >7 days) and/or reduces costs among children with chronic illness. Randomized clinical trial of high-risk children with chronic illness (≥3 emergency department visits, ≥2 hospitalizations, or ≥1 pediatric ICU admissions during previous year, and >50% estimated risk for hospitalization) treated at a high-risk clinic at the University of Texas, Houston, and randomized to comprehensive care (n = 105) or usual care (n = 96). Enrollment was between March 2011 and February 2013 (when predefined stopping rules for benefit were met) and outcome evaluations continued through August 31, 2013. Comprehensive care included treatment from primary care clinicians and specialists in the same clinic with multiple features to promote prompt effective care. Usual care was provided locally in private offices or faculty-supervised clinics without modification. Primary outcome: children with a serious illness (death, ICU admission, or hospital stay >7 days), costs (health system perspective). Secondary outcomes: individual serious illnesses, medical services, Medicaid payments, and medical school revenues and costs. In an intent-to-treat analysis, comprehensive care decreased both the rate of children with a serious illness (10 per 100 child-years vs 22 for usual care; rate ratio [RR], 0.45 [95% CI, 0.28-0.73]), and total hospital and clinic costs ($16,523 vs $26,781 per child-year, respectively; cost ratio, 0.58 [95% CI, 0.38-0.88]). In analyses of net monetary benefit, the probability that comprehensive care was cost neutral or cost saving was 97%. Comprehensive care reduced (per 100 child-years) serious illnesses (16 vs 44 for usual care; RR, 0.33 [95% CI, 0.17-0.66]), emergency department visits (90 vs 190; RR, 0.48 [95% CI, 0.34-0.67]), hospitalizations (69 vs 131; RR, 0.51 [95% CI, 0.33-0.77]), pediatric ICU admissions (9 vs 26; RR, 0.35 [95% CI, 0.18-0.70]), and number of days in a hospital (276 vs 635; RR, 0.36 [95% CI, 0.19-0.67]). Medicaid payments were reduced by $6243 (95% CI, $1302-$11,678) per child-year. Medical school losses (costs minus revenues) increased by $6018 (95% CI, $5506-$6629) per child-year. Among high-risk children with chronic illness, an enhanced medical home that provided comprehensive care to promote prompt effective care vs usual care reduced serious illnesses and costs. These findings from a single site of selected patients with a limited number of clinicians require study in larger, broader populations before conclusions about generalizability to other settings can be reached. clinicaltrials.gov Identifier: NCT02128776.

Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN)

PubMed Central

Thompson, Tom P; Callaghan, Lynne; Hazeldine, Emma; Quinn, Cath; Walker, Samantha; Byng, Richard; Wallace, Gary; Creanor, Siobhan; Green, Colin; Hawton, Annie; Annison, Jill; Sinclair, Julia; Senior, Jane; Taylor, Adrian H

2018-01-01

Introduction People with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK. Methods and analysis A multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial. Ethics and dissemination The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants. Trial registration numbers ISRCTN80475744; Pre-results. PMID:29866736

Quality of life in Chinese patients with schizophrenia treated in primary care.

PubMed

Li, Yan; Hou, Cai-Lan; Ma, Xin-Rong; Zhong, Bao-Liang; Zang, Yu; Jia, Fu-Jun; Lin, Yong-Qiang; Lai, Kelly Y C; Chiu, Helen F K; Ungvari, Gabor S; Hall, Brian J; Cai, Mei-Ying; Ng, Chee H; Xiang, Yu-Tao

2017-08-01

In China, maintenance treatment for clinically stable patients with schizophrenia is usually provided by primary care physicians. This study examined the quality of life (QOL) in patients with schizophrenia treated in primary care and explored the demographic and clinical characteristics associated with QOL. Altogether, 612 patients with schizophrenia treated in 22 randomly selected primary care services in China formed the study sample. QOL, psychotic and depressive symptoms, extra-pyramidal symptoms and insight were assessed using standardized instruments. Data analyses were conducted with the one sample t-test and multiple linear regression analyses. Compared with the normative data for the Chinese general population, significantly lower scores in physical and mental QOL domains were found in the patient group. Older age, being unemployed, major medical conditions, no smoking, more severe depressive and negative symptoms, more frequent insomnia, and suicidality were independently associated with poor physical QOL. Male gender, more severe depressive and anxiety symptoms, more frequent insomnia, and suicidality were independently associated with poor mental QOL. Patients with schizophrenia treated in primary care had lower level of QOL in comparison with general population. Effective measures need to be implemented to improve their QOL. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

A practice-based intervention to improve primary care for falls, urinary incontinence, and dementia.

PubMed

Wenger, Neil S; Roth, Carol P; Shekelle, Paul G; Young, Roy T; Solomon, David H; Kamberg, Caren J; Chang, John T; Louie, Rachel; Higashi, Takahiro; MacLean, Catherine H; Adams, John; Min, Lillian C; Ransohoff, Kurt; Hoffing, Marc; Reuben, David B

2009-03-01

To determine whether a practice-based intervention can improve care for falls, urinary incontinence, and cognitive impairment. Controlled trial. Two community medical groups. Community-dwelling patients (357 at intervention sites and 287 at control sites) aged 75 and older identified as having difficulty with falls, incontinence, or cognitive impairment. Intervention and control practices received condition case-finding, but only intervention practices received a multicomponent practice-change intervention. Percentage of quality indicators satisfied measured using a 13-month medical record abstraction. Before the intervention, the quality of care was the same in intervention and control groups. Screening tripled the number of patients identified as needing care for falls, incontinence, or cognitive impairment. During the intervention, overall care for the three conditions was better in the intervention than the control group (41%, 95% confidence interval (CI)=35-46% vs 25%, 95% CI=20-30%, P<.001). Intervention group patients received better care for falls (44% vs 23%, P<.001) and incontinence (37% vs 22%, P<.001) but not for cognitive impairment (44% vs 41%, P=.67) than control group patients. The intervention was more effective for conditions identified by screening than for conditions identified through usual care. A practice-based intervention integrated into usual clinical care can improve primary care for falls and urinary incontinence, although even with the intervention, less than half of the recommended care for these conditions was provided. More-intensive interventions, such as embedding intervention components into an electronic medical record, will be needed to adequately improve care for falls and incontinence.

Improving family medicine resident training in dementia care: an experiential learning opportunity in Primary Care Collaborative Memory Clinics.

PubMed

Lee, Linda; Weston, W Wayne; Hillier, Loretta; Archibald, Douglas; Lee, Joseph

2018-06-21

Family physicians often find themselves inadequately prepared to manage dementia. This article describes the curriculum for a resident training intervention in Primary Care Collaborative Memory Clinics (PCCMC), outlines its underlying educational principles, and examines its impact on residents' ability to provide dementia care. PCCMCs are family physician-led interprofessional clinic teams that provide evidence-informed comprehensive assessment and management of memory concerns. Within PCCMCs residents learn to apply a structured approach to assessment, diagnosis, and management; training consists of a tutorial covering various topics related to dementia followed by work-based learning within the clinic. Significantly more residents who trained in PCCMCs (sample = 98), as compared to those in usual training programs (sample = 35), reported positive changes in knowledge, ability, and confidence in ability to assess and manage memory problems. The PCCMC training intervention for family medicine residents provides a significant opportunity for residents to learn about best clinical practices and interprofessional care needed for optimal dementia care integrated within primary care practice.

Patient satisfaction is biased by renovations to the interior of a primary care office: a pretest-posttest assessment.

PubMed

Tièche, Raphaël; da Costa, Bruno R; Streit, Sven

2016-08-11

Measuring quality of care is essential to improve primary care. Quality of primary care for patients is usually assessed by patient satisfaction questionnaires. However, patients may not be able to judge quality of care without also reflecting their perception of the environment. We determined the effect that redesigning a primary care office had on patient satisfaction. We hypothesized that renovating the interior would make patients more satisfied with the quality of medical care. We performed a Pretest-Posttest analysis in a recently renovated single-practice primary care office in Grenchen, Switzerland. Before and after renovation, we distributed a questionnaire to assess patient satisfaction in four domains. We chose a Likert scale (1 = very poor to 6 = very good), and 12 quality indicators, and included two consecutive samples of patients presenting at the primary care office before (n = 153) and after (n = 153) interior design renovation. Response rate was high (overall 85 %). The sample was similar to the enlisted patient collective, but the sample population was older (60 years) than the collective (52 years). Patient satisfaction was higher for all domains after the office was renovated (p < 0.01-0.001). Results did not change when we included potential confounders in the multivariable model (p < 0.01). Renovating the interior of a primary care office was associated with improved patient satisfaction, including satisfaction in domains otherwise unchanged. Physician skills and patient satisfaction sometimes depend on surrounding factors that may bias the ability of patients to assess the quality of medical care. These biases should be taken into account when quality assessment instruments are designed for patients.

[Centralization of health services in primary care in summer: Patients and professionals view during two consecutive years].

PubMed

Giménez, N; Martínez, J M; Clanchet, T

2015-01-01

The Spanish primary health care, gateway and pillar of the Health Care System has his resources increasingly constrained by current crisis. To know the opinion of users and professionals on two primary care centers which centralized in August 2011 and 2012 the attendance of seven primary care centers. Two questionnaires were designed: a telephone survey of a random sample of users and a self-completed questionnaire for health care professionals. The variables were scored on a scale of 1-10 (low to high). Cronbach's coefficient α>0,84. 1293 people responded (836 users and 357 professionals). Users rated, in 2011, the satisfaction with 6.7 points in August and 7.3 points the rest of the year (P<.001). And, in 2012, with 7.7 points in August and 8.1 points the rest of the year (P<.001). Health care professionals, rated their satisfaction with 6.8 points in 2011 and 7.3 points in 2012. The waiting time was the only variable best scores in August that the rest of the year. The perception of the solution given in consultation did not change. Satisfaction, marking, care and treatment were highest rated in the regular center than in the reference center (P<.001). The centralization of primary health care during periods of reduced demand could reduce costs while maintaining quality. The experience of centralizing primary care services during August was perceived as acceptable and improved over time. Users showed a slight, but significant, preference for their usual primary care center. Copyright © 2014 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

Aquatic Exercise Therapy for People With Parkinson Disease: A Randomized Controlled Trial.

PubMed

Carroll, Louise M; Volpe, Daniele; Morris, Meg E; Saunders, Jean; Clifford, Amanda M

2017-04-01

To evaluate the effects of aquatic exercise therapy on gait variability and disability compared with usual care for people with Parkinson disease (PD). Single-blind randomized controlled trial. Community-based hydrotherapy pool. Individuals with PD (Hoehn-Yahr stages I-III) (N=21). Participants were randomly assigned to either an aquatic exercise therapy group (45min, twice a week for 6wk) or a group that received usual care. The primary outcome measure was gait variability as measured using a motion capture system. Secondary outcomes were quality of life measured on the Parkinson's Disease Questionnaire-39 and freezing of gait and motor disability quantified by the Unified Parkinson's Disease Rating Scale. Feasibility was evaluated by measuring safety, adverse events, and participant satisfaction. People in the aquatic therapy group and usual care group showed similar small improvements in gait variability. The aquatic therapy group showed greater improvements in disability than the usual care group (P<.01). No differences between groups or over time were identified for freezing of gait or quality of life. Aquatic therapy sessions were safe and enjoyable with no adverse events. Aquatic therapy appears feasible and safe for some people in the early stages of PD. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Who's keeping the code? Compliance with the international code for the marketing of breast-milk substitutes in Greater Glasgow.

PubMed

McInnes, Rhona J; Wright, Charlotte; Haq, Shogufta; McGranachan, Margaret

2007-07-01

To evaluate compliance with the World Health Organization's International Code of Marketing of Breast-milk Substitutes in primary care, after the introduction of strict local infant feeding guidelines. An audit form was sent to all community-based health professionals with an infant feeding remit. Walking tours were conducted in a random sample of community care facilities. Greater Glasgow Primary Care Division. (1) Primary-care staff with an infant feeding remit; (2) community health-care facilities. Contact with manufacturers of breast-milk substitutes (BMS) and BMS company personnel, free samples or incentives, and advertising of BMS. Contact with company personnel was minimal, usually unsolicited and was mainly to provide product information. Free samples of BMS or feeding equipment were rare but childcare or parenting literature was more prevalent. Staff voiced concerns about the lack of relevant information for bottle-feeding mothers and the need to support the mother's feeding choice. One-third of facilities were still displaying materials non-compliant with the Code, with the most common materials being weight conversion charts and posters. Contact between personnel from primary care and BMS companies was minimal and generally unsolicited. The presence of materials from BMS companies in health-care premises was more common. Due to the high level of bottle-feeding in Glasgow, primary-care staff stated a need for information about BMS.

An evaluation of primary care led dementia diagnostic services in Bristol.

PubMed

Dodd, Emily; Cheston, Richard; Fear, Tina; Brown, Ellie; Fox, Chris; Morley, Clare; Jefferies, Rosalyn; Gray, Richard

2014-11-29

Typically people who go to see their GP with a memory problem will be initially assessed and those patients who seem to be at risk will be referred onto a memory clinic. The demographic forces mean that memory services will need to expand to meet demand. An alternative may be to expand the role of primary care in dementia diagnosis and care. The aim of this study was to contrast patient, family member and professional experience of primary and secondary (usual) care led memory services. A qualitative, participatory study. A topic guide was developed by the peer and professional panels. Data were collected through peer led interviews of people with dementia, their family members and health professionals. Eleven (21%) of the 53 GP practices in Bristol offered primary care led dementia services. Three professional panels were held and were attended by 9 professionals; nine carers but no patients were involved in the three peer panels. These panels identified four main themes: GPs rarely make independent dementia diagnosis; GPs and memory nurses work together; patients and carers generally experience a high quality diagnostic service; an absence of post diagnostic support. Evidence relating to these themes was collected through a total of 46 participants took part; 23 (50%) in primary care and 23 (50%) in the memory service. Patients and carers were generally satisfied with either primary or secondary care led approaches to dementia diagnosis. Their major concern, shared with many health care professionals, was a lack of post diagnostic support.

A service evaluation of self-referral to military mental health teams

PubMed Central

Kennedy, I.; Jones, N.; Sharpley, J.; Greenberg, N.

2016-01-01

Background The UK military runs a comprehensive mental health service ordinarily accessed via primary care referrals. Aims To evaluate the feasibility of self-referral to mental health services within a military environment. Methods Three pilot sites were identified; one from each service (Royal Navy, Army, Air Force). Socio-demographic information included age, rank, service and career duration. Clinical data included prior contact with general practitioner (GP), provisional diagnosis and assessment outcome. Results Of the 57 self-referrals, 69% (n = 39) had not previously accessed primary care for their current difficulties. After their mental health assessment, 47 (82%) were found to have a formal mental health problem and 41 (72%) were offered a further mental health clinician appointment. The data compared favourably with a large military mental health department that reported 87% of primary care referrals had a formal mental health condition. Conclusions The majority of self-referrals had formal mental health conditions for which they had not previously sought help from primary care; most were offered further clinical input. This supports the view that self-referral may be a useful option to encourage military personnel to seek professional care over and above the usual route of accessing care through their GP. PMID:27121634

The effect of the Family Health Strategy on usual source of care in Brazil: data from the 2013 National Health Survey (PNS 2013).

PubMed

Dourado, Inês; Medina, Maria Guadalupe; Aquino, Rosana

2016-11-17

A usual source of care (USC) has been conceptualized as having a health provider or place available for patients to consult when sick or in need of medical care. Having a USC is a means to achieve longitudinality of care with Primary Health Care (PHC) providers. Brazil has made enormous progress in PHC and thus provides an important opportunity to investigate USC in a middle-income country context. This study uses data from a nationally representative household survey, the 2013 National Health Survey (n = 62,986), to describe the prevalence of having a USC in Brazil and to investigate to what extent the Family Health Strategy (FHS) has contributed to USC prevalence. Analyses include descriptive, bivariate and multivariable Poisson regression. Show very high rates of people reporting any type of USC (74.4 %) and more than one third reporting PHC as their USC. Household enrolment in the FHS was positively associated with having any USC (PR:1.09; 95 % CI: 1.07-1.12) and a stronger association with having PHC as the regular source of care (PR:1.63;95 % CI:1.54-1.73). FHS enrolment was negatively associated with reporting emergency/urgent care facilities as one's USC (PR: 0.67; 95 % CI: 0.59-0.76). The association between the more consolidated FHS with having a USC was strongest in the poorest regions of the country (North, Northeast and Central-West). Having PHC as one's USC showed a positive dose-response relationship with the FHS in all regions, especially in the Central-West. Our results have important implications for the health care model in Brazil and in other countries, especially those seeking to base their national health systems more strongly on primary health care. The study suggests expanding primary health care can increase the establishment of a USC which can help assure better monitoring of chronic conditions and attention to patient needs.

Study protocol for iQuit in Practice: a randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care.

PubMed

Sutton, Stephen; Smith, Susan; Jamison, James; Boase, Sue; Mason, Dan; Prevost, A Toby; Brimicombe, James; Sloan, Melanie; Gilbert, Hazel; Naughton, Felix

2013-04-10

Primary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker's mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone. The design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking. This trial will focus on acceptability, feasibility and short-term effectiveness. The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness. ISRCTN56702353.

Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial.

PubMed

Sciurba, Frank C; Criner, Gerard J; Strange, Charlie; Shah, Pallav L; Michaud, Gaetane; Connolly, Timothy A; Deslée, Gaëtan; Tillis, William P; Delage, Antoine; Marquette, Charles-Hugo; Krishna, Ganesh; Kalhan, Ravi; Ferguson, J Scott; Jantz, Michael; Maldonado, Fabien; McKenna, Robert; Majid, Adnan; Rai, Navdeep; Gay, Steven; Dransfield, Mark T; Angel, Luis; Maxfield, Roger; Herth, Felix J F; Wahidi, Momen M; Mehta, Atul; Slebos, Dirk-Jan

Preliminary clinical trials have demonstrated that endobronchial coils compress emphysematous lung tissue and may improve lung function, exercise tolerance, and symptoms in patients with emphysema and severe lung hyperinflation. To determine the effectiveness and safety of endobronchial coil treatment. Randomized clinical trial conducted among 315 patients with emphysema and severe air trapping recruited from 21 North American and 5 European sites from December 2012 through November 2015. Participants were randomly assigned to continue usual care alone (guideline based, including pulmonary rehabilitation and bronchodilators; n = 157) vs usual care plus bilateral coil treatment (n = 158) involving 2 sequential procedures 4 months apart in which 10 to 14 coils were bronchoscopically placed in a single lobe of each lung. The primary effectiveness outcome was difference in absolute change in 6-minute-walk distance between baseline and 12 months (minimal clinically important difference [MCID], 25 m). Secondary end points included the difference between groups in 6-minute walk distance responder rate, absolute change in quality of life using the St George's Respiratory Questionnaire (MCID, 4) and change in forced expiratory volume in the first second (FEV1; MCID, 10%). The primary safety analysis compared the proportion of participants experiencing at least 1 of 7 prespecified major complications. Among 315 participants (mean age, 64 years; 52% women), 90% completed the 12-month follow-up. Median change in 6-minute walk distance at 12 months was 10.3 m with coil treatment vs -7.6 m with usual care, with a between-group difference of 14.6 m (Hodges-Lehmann 97.5% CI, 0.4 m to ∞; 1-sided P = .02). Improvement of at least 25 m occurred in 40.0% of patients in the coil group vs 26.9% with usual care (odds ratio, 1.8 [97.5% CI, 1.1 to ∞]; unadjusted between-group difference, 11.8% [97.5% CI, 1.0% to ∞]; 1-sided P = .01). The between-group difference in median change in FEV1 was 7.0% (97.5% CI, 3.4% to ∞; 1-sided P < .001), and the between-group St George's Respiratory Questionnaire score improved -8.9 points (97.5% CI, -∞ to -6.3 points; 1-sided P < .001), each favoring the coil group. Major complications (including pneumonia requiring hospitalization and other potentially life-threatening or fatal events) occurred in 34.8% of coil participants vs 19.1% of usual care (P = .002). Other serious adverse events including pneumonia (20% coil vs 4.5% usual care) and pneumothorax (9.7% vs 0.6%, respectively) occurred more frequently in the coil group. Among patients with emphysema and severe hyperinflation treated for 12 months, the use of endobronchial coils compared with usual care resulted in an improvement in median exercise tolerance that was modest and of uncertain clinical importance, with a higher likelihood of major complications. Further follow-up is needed to assess long-term effects on health outcomes. clinicaltrials.gov Identifier: NCT01608490.

ICARUSS, the Integrated Care for the Reduction of Secondary Stroke trial: rationale and design of a randomized controlled trial of a multimodal intervention to prevent recurrent stroke in patients with a recent cerebrovascular event, ACTRN = 12611000264987.

PubMed

Joubert, J; Davis, S M; Hankey, G J; Levi, C; Olver, J; Gonzales, G; Donnan, G A

2015-07-01

The majority of strokes, both ischaemic and haemorrhagic, are attributable to a relatively small number of risk factors which are readily manageable in primary care setting. Implementation of best-practice recommendations for risk factor management is calculated to reduce stroke recurrence by around 80%. However, risk factor management in stroke survivors has generally been poor at primary care level. A model of care that supports long-term effective risk factor management is needed. To determine whether the model of Integrated Care for the Reduction of Recurrent Stroke (ICARUSS) will, through promotion of implementation of best-practice recommendations for risk factor management reduce the combined incidence of stroke, myocardial infarction and vascular death in patients with recent stroke or transient ischaemic attack (TIA) of the brain or eye. A prospective, Australian, multicentre, randomized controlled trial. Academic stroke units in Melbourne, Perth and the John Hunter Hospital, New South Wales. 1000 stroke survivors recruited as from March 2007 with a recent (<3 months) stroke (ischaemic or haemorrhagic) or a TIA (brain or eye). Randomization and data collection are performed by means of a central computer generated telephone system (IVRS). Exposure to the ICARUSS model of integrated care or usual care. The composite of stroke, MI or death from any vascular cause, whichever occurs first. Risk factor management in the community, depression, quality of life, disability and dementia. With 1000 patients followed up for a median of one-year, with a recurrence rate of 7-10% per year in patients exposed to usual care, the study will have at least 80% power to detect a significant reduction in primary end-points The ICARUSS study aims to recruit and follow up patients between 2007 and 2013 and demonstrate the effectiveness of exposure to the ICARUSS model in stroke survivors to reduce recurrent stroke or vascular events and promote the implementation of best practice risk factor management at primary care level. © 2015 World Stroke Organization.

Interdisciplinary model of care (RADICALS) for early detection and management of chronic obstructive pulmonary disease (COPD) in Australian primary care: study protocol for a cluster randomised controlled trial.

PubMed

Liang, Jenifer; Abramson, Michael J; Zwar, Nicholas; Russell, Grant; Holland, Anne E; Bonevski, Billie; Mahal, Ajay; Hecke, Benjamin van; Phillips, Kirsten; Eustace, Paula; Paul, Eldho; Petrie, Kate; Wilson, Sally; George, Johnson

2017-09-18

Up to half of all smokers develop clinically significant chronic obstructive pulmonary disease (COPD). Gaps exist in the implementation and uptake of evidence-based guidelines for managing COPD in primary care. We describe the methodology of a cluster randomised controlled trial (cRCT) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aimed at reducing the burden of smoking and COPD in Australian primary care settings. A cRCT is being undertaken to evaluate an interdisciplinary model of care (RADICALS - Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers). General practice clinics across Melbourne, Australia, are identified and randomised to the intervention group (RADICALS) or usual care. Patients who are current or ex-smokers, of at least 10 pack years, including those with an existing diagnosis of COPD, are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD. Handheld lung function devices are being used to facilitate case-finding. RADICALS includes individualised smoking cessation support, home-based pulmonary rehabilitation and home medicines review. Patients at control group sites receive usual care and Quitline referral, as appropriate. Follow-ups occur at 6 and 12 months from baseline to assess changes in quality of life, abstinence rates, health resource utilisation, symptom severity and lung function. The primary outcome is change in St George's Respiratory Questionnaire score of patients with COPD at 6 months from baseline. This project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee (CF14/1018 - 2014000433). Results of the study will be disseminated in peer-reviewed journals and research conferences. If the intervention is successful, the RADICALS programme could potentially be integrated into general practices across Australia and sustained over time. ACTRN12614001155684; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes

PubMed Central

2012-01-01

Background While strong and consistent evidence supports the role of lifestyle modification in the prevention and management of type 2 diabetes (T2DM), the best strategies for program implementation to support lifestyle modification within primary care remain to be determined. The objective of the study is to evaluate the implementation of an evidence-based self- management program for patients with T2DM within a newly established primary care network (PCN) environment. Method Using a non-randomized design, participants (total N = 110 per group) will be consecutively allocated in bi-monthly blocks to either a 6-month self-management program lead by an Exercise Specialist or to usual care. Our primary outcome is self-reported physical activity and pedometer steps. Discussion The present study will assess whether a diabetes self-management program lead by an Exercise Specialist provided within a newly emerging model of primary care and linked to available community-based resources, can lead to positive changes in self-management behaviours for adults with T2DM. Ultimately, our work will serve as a platform upon which an emerging model of primary care can incorporate effective and efficient chronic disease management practices that are sustainable through partnerships with local community partners. Clinical Trials Registration ClinicalTrials.gov identifier: NCT00991380 PMID:22712881

Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial.

PubMed

Achey, Meredith A; Beck, Christopher A; Beran, Denise B; Boyd, Cynthia M; Schmidt, Peter N; Willis, Allison W; Riggare, Sara S; Simone, Richard B; Biglan, Kevin M; Dorsey, E Ray

2014-11-27

Interest in improving care for the growing number of individuals with chronic conditions is rising. However, access to care is limited by distance, disability, and distribution of doctors. Small-scale studies in Parkinson disease, a prototypical chronic condition, have suggested that delivering care using video house calls is feasible, offers similar clinical outcomes to in-person care, and reduces travel burden. We are conducting a randomized comparative effectiveness study (Connect.Parkinson) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist. Recruitment is completed centrally using online advertisements and emails and by contacting physicians, support groups, and allied health professionals. Efforts target areas with a high proportion of individuals not receiving care from neurologists. Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year. Participants receive educational materials, then are randomized in a 1:1 ratio to continue their usual care (control arm) or usual care and specialty care delivered virtually (intervention arm). Care partners are surveyed about their time and travel burden and their perceived caregiver burden. Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months. All study activities are completed remotely.The primary outcomes are: (1) feasibility, as measured by the proportion of visits completed, and (2) quality of life, as measured by the 39-item Parkinson's Disease Questionnaire. Secondary outcomes include measures of clinical benefit, quality of care, time and travel burden, and caregiver burden. Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease. The trial may serve as a model for increasing access and delivering patient-centered care at home for individuals with chronic conditions. This trial was registered on clinicaltrials.gov on January 8, 2014 [NCT02038959].

Long-term cost effectiveness of cardiac secondary prevention in primary care in the Republic of Ireland and Northern Ireland.

PubMed

Gillespie, Paddy; Murphy, Edel; Smith, Susan M; Cupples, Margaret E; Byrne, Molly; Murphy, Andrew W

2017-04-01

While cardiac secondary prevention in primary care is established practice, little is known about its long-term cost effectiveness. This study examines the cost effectiveness of a secondary prevention intervention in primary care in the Republic of Ireland and Northern Ireland over 6 years. An economic evaluation, based on a cluster randomised controlled trial of 903 patients with heart disease, was conducted 4.5 years after the intervention ceased to be delivered. Patients originally randomised to the control received usual practice while those randomised to the intervention received a tailored care package over the 1.5-year delivery period. Data on healthcare costs and quality adjusted life expectancy were used to undertake incremental cost utility analysis. Multilevel regression was used to estimate mean cost effectiveness and uncertainty was examined using cost effectiveness acceptability curves. At 6 years, there was a divergence in the results across jurisdictions. While the probability of the intervention being cost effective in the Republic of Ireland was 0.434, 0.232, 0.180, 0.150, 0.115 and 0.098 at selected threshold values of €5000, €15,000, €20,000, €25,000, €35,000 and €45,000, respectively, all equivalent probabilities for Northern Ireland equalled 1.000. Our findings suggest that the intervention in its current format is likely to be more cost effective than usual general practice care in Northern Ireland, but this is not the case in the Republic of Ireland.

Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City.

PubMed

Martínez-Andrade, Gloria Oliva; Cespedes, Elizabeth M; Rifas-Shiman, Sheryl L; Romero-Quechol, Guillermina; González-Unzaga, Marco Aurelio; Benítez-Trejo, María Amalia; Flores-Huerta, Samuel; Horan, Chrissy; Haines, Jess; Taveras, Elsie M; Pérez-Cuevas, Ricardo; Gillman, Matthew W

2014-03-20

Mexico has the highest adult overweight and obesity prevalence in the Americas; 23.8% of children <5 years old are at risk for overweight and 9.7% are already overweight or obese. Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social (IMSS) clinics. We randomized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care. We recruited 306 parent-child pairs: 168 intervention, 138 usual care. Children were 2-5 years old with WHO body mass index (BMI) z-score 0-3. We measured children's height and weight and parents reported children's diet and physical activity at baseline and 3 and 6-month follow-up. We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values. 93 (55%) intervention and 96 (70%) usual care families completed 3 and 6-month follow-up. At 3 months, intervention v. usual care children increased vegetables by 6.3 servings/week (95% CI, 1.8, 10.8). In stratified analyses, intervention participants with high program adherence (5-6 sessions) decreased snacks and screen time and increased vegetables v. usual care. No further effects on behavioral outcomes or BMI were observed. Transportation time and expenses were barriers to adherence. 90% of parents who completed the post-intervention survey were satisfied with the program. Although satisfaction was high among participants, barriers to participation and retention included transportation cost and time. In intention to treat analyses, we found intervention effects on vegetable intake, but not other behaviors or BMI. ClinicalTrials.gov NCT01539070.Comisión Nacional de Investigación Científica del IMSS: 2009-785-120.

Dexmedetomidine Use in Critically-Ill Children with Acute Respiratory Failure

PubMed Central

Grant, Mary Jo C.; Schneider, James B.; Asaro, Lisa A.; Dodson, Brenda L.; Hall, Brent A.; Simone, Shari L.; Cowl, Allison S.; Munkwitz, Michele M.; Wypij, David; Curley, Martha A.Q.

2016-01-01

Objective Care of critically-ill children includes sedation but current therapies are suboptimal. To describe dexmedetomidine (DEX) use in children supported on mechanical ventilation for acute respiratory failure. Design Secondary analysis of data from the RESTORE clinical trial. Setting Thirty-one pediatric ICUs. Patients Data from 2449 children; 2 weeks to 17 years old. Interventions Sedation practices were unrestrained in the usual care arm. Patients were categorized as receiving dexmedetomidine as a primary sedative (DEXp), secondary sedative (DEXs), periextubation agent (DEXe), or never prescribed. DEX exposure and sedation and clinical profiles are described. Measurements and Main Results Of 1224 usual care patients, 596 (49%) received DEX. DEXp patients (N=138; 11%) were less critically ill (PRISM III-12 score median 6 [IQR 3–11]) and when compared to all other cohorts, experienced more episodic agitation. In the intervention group, time in sedation target improved from 28% to 50% within one day of initiating DEXp. DEXs usual care patients (N=280; 23%) included more children with severe PARDS or organ failure. DEXs patients experienced more inadequate pain (22% vs 11%) and sedation (31% vs 16%) events. DEXe patients (N=178; 15%) were those known to not tolerate an awake, intubated state and experienced a shorter ventilator weaning process (2.1 vs 2.3 days). Conclusions Our data support the use of dexmedetomidine as a primary agent in low criticality patients offering the benefit of rapid achievement of targeted sedation levels. Dexmedetomidine as a secondary agent does not appear to add benefit. The use of dexmedetomidine to facilitate extubation in children intolerant of an awake, intubated state may abbreviate ventilator weaning. These data support a broader armamentarium of pediatric critical care sedation. PMID:27654816

Levonorgestrel intrauterine system versus medical therapy for menorrhagia.

PubMed

Gupta, Janesh; Kai, Joe; Middleton, Lee; Pattison, Helen; Gray, Richard; Daniels, Jane

2013-01-10

Menorrhagia is a common problem, yet evidence to inform decisions about therapy is limited. In a pragmatic, multicenter, randomized trial, we compared the levonorgestrel-releasing intrauterine system (levonorgestrel-IUS) with usual medical treatment in women with menorrhagia who presented to their primary care providers. We randomly assigned 571 women with menorrhagia to treatment with levonorgestrel-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined estrogen-progestogen, or progesterone alone). The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) (ranging from 0 to 100, with lower scores indicating greater severity), assessed over a 2-year period. Secondary outcomes included general quality-of-life and sexual-activity scores and surgical intervention. MMAS scores improved from baseline to 6 months in both the levonorgestrel-IUS group and the usual-treatment group (mean increase, 32.7 and 21.4 points, respectively; P<0.001 for both comparisons). The improvements were maintained over a 2-year period but were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group (mean between-group difference, 13.4 points; 95% confidence interval, 9.9 to 16.9; P<0.001). Improvements in all MMAS domains (practical difficulties, social life, family life, work and daily routine, psychological well-being, and physical health) were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group, and this was also true for seven of the eight quality-of-life domains. At 2 years, more of the women were still using the levonorgestrel-IUS than were undergoing the usual medical treatment (64% vs. 38%, P<0.001). There were no significant between-group differences in the rates of surgical intervention or sexual-activity scores. There were no significant differences in serious adverse events between groups. In women with menorrhagia who presented to primary care providers, the levonorgestrel-IUS was more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life. (Funded by the National Institute of Health Research Health Technology Assessment Programme; ECLIPSE Controlled-Trials.com number, ISRCTN86566246.).

Health administrative data can be used to define a shared care typology for people with HIV.

PubMed

Kendall, Claire E; Younger, Jaime; Manuel, Douglas G; Hogg, William; Glazier, Richard H; Taljaard, Monica

2015-11-01

Building on an existing theoretical shared primary care/specialist care framework to (1) develop a unique typology of care for people living with human immunodeficiency virus (HIV) in Ontario, (2) assess sensitivity of the typology by varying typology definitions, and (3) describe characteristics of typology categories. Retrospective population-based observational study from April 1, 2009, to March 31, 2012. A total of 13,480 eligible patients with HIV and receiving publicly funded health care in Ontario. We derived a typology of care by linking patients to usual family physicians and to HIV specialists with five possible patterns of care. Patient and physician characteristics and outpatient visits for HIV-related and non-HIV-related care were used to assess the robustness and characteristics of the typology. Five possible patterns of care were described as low engagement (8.6%), exclusively primary care (52.7%), family physician-dominated comanagement (10.0%), specialist-dominated comanagement (30.5%), and exclusively specialist care (5.2%). Sensitivity analyses demonstrated robustness of typology assignments. Visit patterns varied in ways that conform to typology assignments. We anticipate this typology can be used to assess the impact of care patterns on the quality of primary care for people living with HIV. Copyright © 2015 Elsevier Inc. All rights reserved.

Are brief interventions to increase physical activity cost-effective? A systematic review

PubMed Central

GC, Vijay; Suhrcke, Marc; Hardeman, Wendy; Sutton, Stephen

2016-01-01

Objective To determine whether brief interventions promoting physical activity are cost-effective in primary care or community settings. Design Systematic review of economic evaluations. Methods and data sources We searched MEDLINE, EMBASE, PsycINFO, CINAHL, EconLit, SPORTDiscus, PEDro, the Cochrane library, National Health Service Economic Evaluation Database and the Cost-Effectiveness Analysis Registry up to 20 August 2014. Web of Knowledge was used for cross-reference search. We included studies investigating the cost-effectiveness of brief interventions, as defined by National Institute for Health and Care Excellence, promoting physical activity in primary care or the community. Methodological quality was assessed using Drummond's checklist for economic evaluations. Data were extracted from individual studies fulfilling selection criteria using a standardised pro forma. Comparisons of cost-effectiveness and cost-utility ratios were made between studies. Results Of 1840 identified publications, 13 studies fulfilled the inclusion criteria describing 14 brief interventions. Studies varied widely in the methods used, such as the perspective of economic analysis, intervention effects and outcome measures. The incremental cost of moving an inactive person to an active state, estimated for eight studies, ranged from £96 to £986. The cost-utility was estimated in nine studies compared with usual care and varied from £57 to £14 002 per quality-adjusted life year; dominant to £6500 per disability-adjusted life year; and £15 873 per life years gained. Conclusions Brief interventions promoting physical activity in primary care and the community are likely to be inexpensive compared with usual care. Given the commonly accepted thresholds, they appear to be cost-effective on the whole, although there is notable variation between studies. PMID:26438429

Protocol for a randomised controlled trial evaluating the effects of providing essential medicines at no charge: the Carefully seLected and Easily Accessible at No Charge Medicines (CLEAN Meds) trial.

PubMed

Persaud, Nav; Lee, Taehoon; Ahmad, Haroon; Li, Winny; Taglione, Michael Sergio; Rajakulasingam, Yathavan; Umali, Norman; Boozary, Andrew; Glazier, Richard H; Gomes, Tara; Hwang, Stephen W; Jüni, Peter; Law, Michael; Mamdani, Muhammad M; Manns, Braden; Martin, Danielle; Morgan, Steve; Oh, Paul; Pinto, Andrew David; Shah, Baiju R; Sullivan, Frank M; Thorpe, Kevin E; Tu, Karen; Laupacis, Andreas

2017-06-12

Cost-related non-adherence to medicines is common in low-income, middle-income and high-income countries such as Canada. Medicine non-adherence is associated with poor health outcomes and increased mortality. This randomised trial will test the impact of a carefully selected list of essential medicines at no charge (compared with usual medicine access) in primary care patients reporting cost-related non-adherence. This is an open-label, parallel two-arm, superiority, individually randomised controlled trial conducted in three primary care sites (one urban, two rural) in Ontario, Canada, that was codesigned by a community guidance panel. Adult patients (≥18 years) who report cost-related non-adherence to medicines are eligible to participate in the study. Participants will be randomised to receive free and convenient access to a carefully selected list of 125 essential medicines (based on the WHO's Model List of Essential Medicines) or usual means of medicine access. Care for patients in both groups will otherwise be unchanged. The primary outcome of this trial is adherence to appropriately prescribed medicines. Secondary outcomes include medicine adherence, appropriate prescribing, blood pressure, haemoglobin A1c, low-density lipoprotein cholesterol, patient-oriented outcomes and healthcare costs. All participants will be followed for at least 12 months. Ethics approval was obtained in all three participating sites. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal and discussed with members of the public and decision makers. NCT02744963. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Multi-faceted implementation strategy to increase use of a clinical guideline for the diagnosis of deep venous thrombosis in primary care.

PubMed

Kingma, Anna E C; van Stel, Henk F; Oudega, Ruud; Moons, Karel G M; Geersing, Geert-Jan

2017-08-01

A clinical decision rule (CDR), combined with a negative D-dimer test, can safely rule out deep venous thrombosis (DVT) in primary care. This strategy is recommended by guidelines, yet uptake by GPs is low. To evaluate a multi-faceted implementation strategy aimed at increased use of the guideline recommended CDR plus D-dimer test in primary care patients with suspected DVT. This multi-faceted implementation strategy consisted of educational outreach visits, financial reimbursements and periodical newsletters. 217 Dutch GPs (implementation group) received this strategy and included patients. Effectiveness was measured through the following patient-level outcomes: (i) proportion of non-referred patients, (ii) proportion of missed DVT cases within this group and (iii) the proportion of patients in whom the guideline was applied incorrectly. Implementation outcomes ('acceptability', 'feasibility', 'fidelity' and 'sustainability') were assessed with an online questionnaire. Patient-level outcomes were compared with those of patients included by 450 GPs, uninformed about the study's purposes providing information about usual care. 336 (54%) of 619 analyzable implementation group patients were not referred, missing 6 [1.8% (95% confidence interval 0.7% to 3.9%)] DVT cases. Incorrect guideline use was observed in 199 patients (32%). Self-reported acceptability, feasibility and expected sustainability were high. Guideline use increased from 42% to an expected continuation of use of 91%. Only 32 usual care GPs included 62 patients, making formal comparison unreliable. This multi-faceted implementation strategy safely reduced patient referral to secondary care, despite frequently incorrect application of the guideline and resulted in high acceptability, feasibility and expected sustainability. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial.

PubMed

Gensichen, Jochen; Hiller, Thomas S; Breitbart, Jörg; Teismann, Tobias; Brettschneider, Christian; Schumacher, Ulrike; Piwtorak, Alexander; König, Hans-Helmut; Hoyer, Heike; Schneider, Nico; Schelle, Mercedes; Blank, Wolfgang; Thiel, Paul; Wensing, Michel; Margraf, Jürgen

2014-04-06

Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness. This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs. Current Controlled Trials [http://ISCRTN64669297].

Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial

PubMed Central

2014-01-01

Background Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness. Methods/Design This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs. Trial registration Current Controlled Trials [http://ISCRTN64669297] PMID:24708672

Blended care vs. usual care in the treatment of depressive symptoms and disorders in general practice [BLENDING]: study protocol of a non-inferiority randomized trial.

PubMed

Massoudi, Btissame; Blanker, Marco H; van Valen, Evelien; Wouters, Hans; Bockting, Claudi L H; Burger, Huibert

2017-06-13

The majority of patients with depressive disorders are treated by general practitioners (GPs) and are prescribed antidepressant medication. Patients prefer psychological treatments but they are under-used, mainly due to time constraints and limited accessibility. A promising approach to deliver psychological treatment is blended care, i.e. guided online treatment. However, the cost-effectiveness of blended care formatted as an online psychological treatment supported by the patients' own GP or general practice mental health worker (MHW) in routine primary care is unknown. We aim to demonstrate non-inferiority of blended care compared with usual care in patients with depressive symptoms or a depressive disorder in general practice. Additionally, we will explore the real-time course over the day of emotions and affect, and events within individuals during treatment. This is a pragmatic non-inferiority trial including 300 patients with depressive symptoms, recruited by collaborating GPs and MHWs. After inclusion, participants are randomized to either blended care or usual care in routine general practice. Blended care consists of the 'Act and Feel' treatment: an eight-week web-based program based on behavioral activation with integrated monitoring of depressive symptomatology and automatized feedback. GPs or their MHWs coach the participants through regular face-to-face or telephonic consultations with at least three sessions. Depressive symptomatology, health status, functional impairment, treatment satisfaction, daily activities and resource use are assessed during a follow-up period of 12 months. During treatment, real-time fluctuations in emotions and affect, and daily events will be rated using ecological momentary assessment. The primary outcome is the reduction of depressive symptoms from baseline to three months follow-up. We will conduct intention-to-treat analyses and supplementary per-protocol analyses. This trial will show whether blended care might be an appropriate treatment strategy for patients with depressive symptoms and depressive disorder in general practice. Netherlands Trial Register: NTR4757; 25 August 2014. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4757 . (Archived by WebCite® at http://www.webcitation.org/6mnXNMGef ).

Improving the quality of depression and pain care in multiple sclerosis using collaborative care: The MS-care trial protocol.

PubMed

Ehde, Dawn M; Alschuler, Kevin N; Sullivan, Mark D; Molton, Ivan P; Ciol, Marcia A; Bombardier, Charles H; Curran, Mary C; Gertz, Kevin J; Wundes, Annette; Fann, Jesse R

2018-01-01

Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care, which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting. We describe a 16-week randomized controlled trial comparing the MS Care collaborative care intervention to usual care in an outpatient MS specialty center. Eligible participants with chronic pain of at least moderate intensity (≥3/10) and/or major depressive disorder are randomly assigned to MS Care or usual care. MS Care utilizes a care manager to implement and coordinate guideline-based medical and behavioral treatments with the patient, clinic providers, and pain/depression treatment experts. We will compare outcomes at post-treatment and 6-month follow up. We hypothesize that participants randomly assigned to MS Care will demonstrate significantly greater control of both pain and depression at post-treatment (primary endpoint) relative to those assigned to usual care. Secondary analyses will examine quality of care, patient satisfaction, adherence to MS care, and quality of life. Study findings will aid patients, clinicians, healthcare system leaders, and policy makers in making decisions about effective care for pain and depression in MS healthcare systems. (PCORI- IH-1304-6379; clinicaltrials.gov: NCT02137044). This trial is registered at ClinicalTrials.gov, protocol NCT02137044. Copyright © 2017 Elsevier Inc. All rights reserved.

Patients' experiences with navigation for cancer care.

PubMed

Carroll, Jennifer K; Humiston, Sharon G; Meldrum, Sean C; Salamone, Charcy M; Jean-Pierre, Pascal; Epstein, Ronald M; Fiscella, Kevin

2010-08-01

We examined how navigation, defined as the assessment and alleviation of barriers to adequate health care, influences patients' perspectives on the quality of their cancer care. We conducted post-study patient interviews from a randomized controlled trial (usual care vs. patient navigation services) from cancer diagnosis through treatment completion. Patients were recruited from 11 primary care, hospital and community oncology practices in New York. We interviewed patients about their expectations and experience of patient navigation or, for non-navigated patients, other sources of assistance. Thirty-five patients newly diagnosed with breast or colorectal cancer. Valued aspects of navigation included emotional support, assistance with information needs and problem-solving, and logistical coordination of cancer care. Unmet cancer care needs expressed by patients randomized to usual care consisted of lack of assistance or support with childcare, household responsibilities, coordination of care, and emotional support. Cancer patients value navigation. Instrumental benefits were the most important expectations for navigation from navigated and non-navigated patients. Navigated patients received emotional support and assistance with information needs, problem-solving, and logistical aspects of cancer care coordination. Navigation services may help improve cancer care outcomes important to patients by addressing fragmented, confusing, uncoordinated, or inefficient care. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Patients' Experiences with Navigation for Cancer Care

PubMed Central

Carroll, Jennifer K.; Humiston, Sharon G.; Meldrum, Sean C.; Salamone, Charcy M.; Jean-Pierre, Pascal; Epstein, Ronald M.; Fiscella, Kevin

2010-01-01

Objective We examined how navigation, defined as the assessment and alleviation of barriers to adequate health care, influences patients' perspectives on the quality of their cancer care. Methods We conducted post-study patient interviews from a randomized controlled trial (usual care vs. patient navigation services) from cancer diagnosis through treatment completion. Patients were recruited from 11 primary care, hospital and community oncology practices in New York. We interviewed patients about their expectations and experience of patient navigation or, for non-navigated patients, other sources of assistance. Results Thirty-five patients newly diagnosed with breast or colorectal cancer. Valued aspects of navigation included emotional support, assistance with information needs and problem-solving, and logistical coordination of cancer care. Unmet cancer care needs expressed by patients randomized to usual care consisted of lack of assistance or support with childcare, household responsibilities, coordination of care, and emotional support. Conclusion Cancer patients value navigation. Instrumental benefits were the most important expectations for navigation from navigated and non-navigated patients. Navigated patients received emotional support and assistance with information needs, problem-solving, and logistical aspects of cancer care coordination. Practice Implications Navigation services may help improve cancer care outcomes important to patients by addressing fragmented, confusing, uncoordinated, or inefficient care. PMID:20006459

Design of a multicentre randomized controlled trial to evaluate the effectiveness of a tailored clinical support intervention to enhance return to work for gastrointestinal cancer patients.

PubMed

Zaman, AnneClaire G N M; Tytgat, Kristien M A J; Klinkenbijl, Jean H G; Frings-Dresen, Monique H W; de Boer, Angela G E M

2016-05-10

Gastrointestinal (GI) cancer is frequently diagnosed in people of working age, and many GI cancer patients experience work-related problems. Although these patients often experience difficulties returning to work, supportive work-related interventions are lacking. We have therefore developed a tailored work-related support intervention for GI cancer patients, and we aim to evaluate its cost-effectiveness compared with the usual care provided. If this intervention proves effective, it can be implemented in practice to support GI cancer patients after diagnosis and to help them return to work. We designed a multicentre randomized controlled trial with a follow-up of twelve months. The study population (N = 310) will include individuals aged 18-63 years diagnosed with a primary GI cancer and employed at the time of diagnosis. The participants will be randomized to the intervention or to usual care. 'Usual care' is defined as psychosocial care in which work-related issues are not discussed. The intervention group will receive tailored work-related support consisting of three face-to-face meetings of approximately 30 min each. Based on the severity of their work-related problems, the intervention group will be divided into groups receiving three types of support (A, B or C). A different supportive healthcare professional will be available for each group: an oncological nurse (A), an oncological occupational physician (B) and a multidisciplinary team (C) that includes an oncological nurse, oncological occupational physician and treating oncologist/physician. The primary outcome measure is return to work (RTW), defined as the time to a partial or full RTW. The secondary outcomes are work ability, work limitations, quality of life, and direct and indirect costs. The hypothesis is that tailored work-related support for GI cancer patients is more effective than usual care in terms of the RTW. The intervention is innovative in that it combines oncological and occupational care in a clinical setting, early in the cancer treatment process. METC protocol number NL51444.018.14/Netherlands Trial Register number NTR5022 . Registered 6 March 2015.

Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial.

PubMed

Fu, Steven S; van Ryn, Michelle; Nelson, David; Burgess, Diana J; Thomas, Janet L; Saul, Jessie; Clothier, Barbara; Nyman, John A; Hammett, Patrick; Joseph, Anne M

2016-05-01

Evidenced-based tobacco cessation treatments are underused, especially by socioeconomically disadvantaged smokers. This contributes to widening socioeconomic disparities in tobacco-related morbidity and mortality. The Offering Proactive Treatment Intervention trial tested the effects of a proactive outreach tobacco treatment intervention on population-level smoking abstinence and tobacco treatment use among a population-based sample of socioeconomically disadvantaged smokers. Current smokers (n=2406), regardless of interest in quitting, who were enrolled in the Minnesota Health Care Programs, the state's publicly funded healthcare programmes for low-income populations, were randomly assigned to proactive outreach or usual care. The intervention comprised proactive outreach (tailored mailings and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive, telephone counselling). Usual care comprised access to a primary care physician, insurance coverage of Food and Drug Administration-approved smoking cessation medications, and the state's telephone quitline. The primary outcome was self-reported 6-month prolonged smoking abstinence at 1 year and was assessed by follow-up survey. The proactive intervention group had a higher prolonged abstinence rate at 1 year than usual care (16.5% vs 12.1%, OR 1.47, 95% CI 1.12 to 1.93). The effect of the proactive intervention on prolonged abstinence persisted in selection models accounting for non-response. In analysis of secondary outcomes, use of evidence-based tobacco cessation treatments were significantly greater among proactive outreach participants compared with usual care, particularly combination counselling and medications (17.4% vs 3.6%, OR 5.69, 95% CI 3.85 to 8.40). Population-based proactive tobacco treatment increases engagement in evidence-based treatment and is effective in long-term smoking cessation among socioeconomically disadvantaged smokers. Findings suggest that dissemination of population-based proactive treatment approaches is an effective strategy to reduce the prevalence of smoking and socioeconomic disparities in tobacco use. NCT01123967. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Missing an opportunity: the embedded nature of weight management in primary care

PubMed Central

Osunlana, A. M.; Ogunleye, A. A.; Sharma, A. M.; Campbell‐Scherer, D.

2015-01-01

Summary The 5As Team study was designed to create, implement and evaluate a flexible intervention to improve the quality and quantity of weight management visits in primary care. The objective of this portion of the study was to explore how primary care providers incorporate weight management in their practice. 5AsT is a randomized controlled trial (RCT) on the implementation of a 6‐month 5 As Team (5AsT) intervention designed to operationalize the 5As of obesity management in primary care. Data for the qualitative portion of the study presented here included semi‐structured interviews with 29 multidisciplinary team providers and field notes of intervention sessions. Thematic analysis was undertaken. A key pattern that emerged from the data was that healthcare providers usually do not address obesity as a primary focus for a visit. Rather, obesity is embedded in a wide range of primary care encounters for other conditions. Implications were it can take extra time to discuss weight, it can be inappropriate to bring up weight as a topic, and treating risk factors and root causes of obesity have indirect benefits to patient weight management. Our findings have implications for obesity treatment approaches and tools that assume a discreet weight management visit. The embedded nature of obesity management in primary care can be harnessed to leverage multiple opportunities for asking and assessing root causes of obesity, and working longitudinally towards individual health goals. PMID:26303812

Randomized Trial of Family Therapy versus Non-Family Treatment for Adolescent Behavior Problems in Usual Care

PubMed Central

Hogue, Aaron; Dauber, Sarah; Henderson, Craig E.; Bobek, Molly; Johnson, Candace; Lichvar, Emily; Morgenstern, Jon

2014-01-01

Objective A major focus of implementation science is discovering whether evidence-based approaches can be delivered with fidelity and potency in routine practice. This randomized trial compared usual care family therapy (UC-FT), implemented without a treatment manual or extramural support as the standard-of-care approach in a community clinic, to non-family treatment (UC-Other) for adolescent conduct and substance use disorders. Method The study recruited 205 adolescents (mean age 15.7 years; 52% male; 59% Hispanic American, 21% African American) from a community referral network, enrolling 63% for primary mental health problems and 37% for primary substance use problems. Clients were randomly assigned to either the UC-FT site or one of five UC-Other sites. Implementation data confirmed that UC-FT showed adherence to the family therapy approach and differentiation from UC-Other. Follow-ups were completed at 3, 6, and 12 months post-baseline. Results There was no between-group difference in treatment attendance. Both conditions demonstrated improvements in externalizing, internalizing, and delinquency symptoms. However, UC-FT produced greater reductions in youth-reported externalizing and internalizing among the whole sample, in delinquency among substance-using youth, and in alcohol and drug use among substance-using youth. The degree to which UC-FT outperformed UC-Other was consistent with effect sizes from controlled trials of manualized family therapy models. Conclusions Non-manualized family therapy can be effective for adolescent behavior problems within diverse populations in usual care, and it may be superior to non-family alternatives. PMID:25496283

The utilization of video-conference shared medical appointments in rural diabetes care.

PubMed

Tokuda, Lisa; Lorenzo, Lenora; Theriault, Andre; Taveira, Tracey H; Marquis, Lynn; Head, Helene; Edelman, David; Kirsh, Susan R; Aron, David C; Wu, Wen-Chih

2016-09-01

To explore whether Video-Shared Medical Appointments (video-SMA), where group education and medication titration were provided remotely through video-conferencing technology would improve diabetes outcomes in remote rural settings. We conducted a pilot where a team of a clinical pharmacist and a nurse practitioner from Honolulu VA hospital remotely delivered video-SMA in diabetes to Guam. Patients with diabetes and HbA1c ≥7% were enrolled into the study during 2013-2014. Six groups of 4-6 subjects attended 4 weekly sessions, followed by 2 bi-monthly booster video-SMA sessions for 5 months. Patients with HbA1c ≥7% that had primary care visits during the study period but not referred/recruited for video-SMA were selected as usual-care comparators. We compared changes from baseline in HbA1c, blood-pressure, and lipid levels using mixed-effect modeling between video-SMA and usual care groups. We also analyzed emergency department (ED) visits and hospitalizations. Focus groups were conducted to understand patient's perceptions. Thirty-one patients received video-SMA and charts of 69 subjects were abstracted as usual-care. After 5 months, there was a significant decline in HbA1c in video-SMA vs. usual-care (9.1±1.9 to 8.3±1.8 vs. 8.6±1.4 to 8.7±1.6, P=0.03). No significant change in blood-pressure or lipid levels was found between the groups. Patients in the video-SMA group had significantly lower rates of ED visits (3.2% vs. 17.4%, P=0.01) than usual-care but similar hospitalization rates. Focus groups suggested patient satisfaction with video-SMA and increase in self-efficacy in diabetes self-care. Video-SMA is feasible, well-perceived and has the potential to improve diabetes outcomes in a rural setting. Published by Elsevier Ireland Ltd.

A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

PubMed Central

Cherkin, Daniel C.; Sherman, Karen J.; Avins, Andrew L.; Erro, Janet H.; Ichikawa, Laura; Barlow, William E.; Delaney, Kristin; Hawkes, Rene; Hamilton, Luisa; Pressman, Alice; Khalsa, Partap S.; Deyo, Richard A.

2009-01-01

Background Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. Methods 638 adults with chronic mechanical low back pain were randomized to: individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland Disability score, range: 0 to 23) and symptom bothersomeness (0 to 10 scale). Outcomes were assessed at baseline and after 8, 26 and 52 weeks. Results At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P<0.001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs. 39%, P<0.0001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P<0.0001). After one year, participants in the treatment groups were more likely than those receiving usual care group to experience clinically meaningful improvements in dysfunction (59% to 65% versus 50%, respectively, P=0.02) but not in symptoms (P>0.05). Conclusions Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture’s purported mechanisms of action. It remains unclear whether acupuncture, or our simulated method of acupuncture, provide physiologically important stimulation or represent placebo or non-specific effects. PMID:19433697

Health coaching by medical assistants to improve control of diabetes, hypertension, and hyperlipidemia in low-income patients: a randomized controlled trial.

PubMed

Willard-Grace, Rachel; Chen, Ellen H; Hessler, Danielle; DeVore, Denise; Prado, Camille; Bodenheimer, Thomas; Thom, David H

2015-03-01

Health coaching by medical assistants could be a financially viable model for providing self-management support in primary care if its effectiveness were demonstrated. We investigated whether in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care. We conducted a 12-month randomized controlled trial of 441 patients at 2 safety net primary care clinics in San Francisco, California. The primary outcome was a composite measure of being at or below goal at 12 months for at least 1 of 3 uncontrolled conditions at baseline as defined by hemoglobin A1c, systolic blood pressure, and low-density lipoprotein (LDL) cholesterol. Secondary outcomes were meeting all 3 goals and meeting individual goals. Data were analyzed using χ(2) tests and linear regression models. Participants in the coaching arm were more likely to achieve both the primary composite measure of 1 of the clinical goals (46.4% vs 34.3%, P = .02) and the secondary composite measure of reaching all clinical goals (34.0% vs 24.7%, P = .05). Almost twice as many coached patients achieved the hemoglobin A1c goal (48.6% vs 27.6%, P = .01). At the larger study site, coached patients were more likely to achieve the LDL cholesterol goal (41.8% vs 25.4%, P = .04). The proportion of patients meeting the systolic blood pressure goal did not differ significantly. Medical assistants serving as in-clinic health coaches improved control of hemoglobin A1c and LDL levels, but not blood pressure, compared with usual care. Our results highlight the need to understand the relationship between patients' clinical conditions, interventions, and the contextual features of implementation. © 2015 Annals of Family Medicine, Inc.

Rationale and design of a pilot study examining Acceptance and Commitment Therapy for persistent pain in an integrated primary care clinic.

PubMed

Kanzler, Kathryn E; Robinson, Patricia J; McGeary, Donald D; Mintz, Jim; Potter, Jennifer Sharpe; Muñante, Mariana; Lopez, Eliot J; Dougherty, Donald M; Hale, Willie J; Velligan, Dawn I

2018-03-01

Most of the 100 million Americans with persistent pain are treated in primary care clinics, but evidence-based psychosocial approaches targeting pain-related disability are not usually provided in these settings. This manuscript describes the rationale and methods for a protocol to pilot test the feasibility and effectiveness of Acceptance and Commitment Therapy (ACT), an evidence-based psychological treatment for persistent pain, delivered by a Behavioral Health Consultant in primary care. Eligible patients are identified through electronic health record registries and invited to participate via secure messaging, letters and a follow-up phone call. Participants are also recruited with advertising and clinician referral. Patients agreeing to participate are consented and complete initial assessments, with a target of 60 participants. Randomization is stratified based on pain severity with participants assigned to either ACT or Enhanced Treatment as Usual (E-TAU). ACT participants receive one standardized Behavioral Health Consultation visit followed by three ACT-based group visits and one group booster visit. All patients attend six assessment visits, during which the E-TAU patients are provided with educational pain management handouts based on standard cognitive behavioral treatment of pain. The study aims to determine feasibility and effectiveness of brief ACT for persistent pain delivered by an integrated behavioral health clinician in primary care from pre- to post-treatment, and to examine mechanisms of change in ACT participants. This study, in a "real-world" setting, will lay groundwork for a larger trial. If effective, it could improve treatment methods and quality of life for patients with persistent pain using a scalable approach. Copyright © 2018 Elsevier Inc. All rights reserved.

Health Coaching by Medical Assistants to Improve Control of Diabetes, Hypertension, and Hyperlipidemia in Low-Income Patients: A Randomized Controlled Trial

PubMed Central

Willard-Grace, Rachel; Chen, Ellen H.; Hessler, Danielle; DeVore, Denise; Prado, Camille; Bodenheimer, Thomas; Thom, David H.

2015-01-01

PURPOSE Health coaching by medical assistants could be a financially viable model for providing self-management support in primary care if its effectiveness were demonstrated. We investigated whether in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care. METHODS We conducted a 12-month randomized controlled trial of 441 patients at 2 safety net primary care clinics in San Francisco, California. The primary outcome was a composite measure of being at or below goal at 12 months for at least 1 of 3 uncontrolled conditions at baseline as defined by hemoglobin A1c, systolic blood pressure, and low-density lipoprotein (LDL) cholesterol. Secondary outcomes were meeting all 3 goals and meeting individual goals. Data were analyzed using χ2 tests and linear regression models. RESULTS Participants in the coaching arm were more likely to achieve both the primary composite measure of 1 of the clinical goals (46.4% vs 34.3%, P = .02) and the secondary composite measure of reaching all clinical goals (34.0% vs 24.7%, P = .05). Almost twice as many coached patients achieved the hemoglobin A1c goal (48.6% vs 27.6%, P = .01). At the larger study site, coached patients were more likely to achieve the LDL cholesterol goal (41.8% vs 25.4%, P = .04). The proportion of patients meeting the systolic blood pressure goal did not differ significantly. CONCLUSIONS Medical assistants serving as in-clinic health coaches improved control of hemoglobin A1c and LDL levels, but not blood pressure, compared with usual care. Our results highlight the need to understand the relationship between patients’ clinical conditions, interventions, and the contextual features of implementation. PMID:25755034

Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial.

PubMed

Dziedzic, K S; Healey, E L; Porcheret, M; Afolabi, E K; Lewis, M; Morden, A; Jinks, C; McHugh, G A; Ryan, S; Finney, A; Main, C; Edwards, J J; Paskins, Z; Pushpa-Rajah, A; Hay, E M

2018-01-01

To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. ISRCTN06984617. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Effectiveness and cost-effectiveness of a self-management training for patients with chronic and treatment resistant anxiety or depressive disorders: design of a multicenter randomized controlled trial.

PubMed

Zoun, Maringa H H; Koekkoek, Bauke; Sinnema, Henny; Muntingh, Anna D T; van Balkom, Anton J L M; Schene, Aart H; Smit, Filip; Spijker, Jan

2016-07-07

Many patients with anxiety or depressive disorders achieve no remission of their symptoms after evidence-based treatment algorithms. They develop a chronic course of the disorder. Current care for these patients usually consists of long-term supportive contacts with a community psychiatric nurse and pharmacological management by a psychiatrist. Data on the effectiveness of these treatments is lacking. A psychosocial rehabilitation approach, where self-management is an increasingly important part, could be more suitable. It focuses on the restoration of functioning and enhancement of patients' autonomy and responsibility. Treatment with this focus, followed by referral to primary care, may be more (cost-)effective. A multicenter randomized controlled trial is designed for twelve participating specialized outpatient mental health services in the Netherlands. Patients with chronic and treatment resistant anxiety or depressive disorders, currently receiving supportive care in specialized outpatient mental health care, are asked to participate. After inclusion, patients receive the baseline questionnaire and are randomized to the intervention group or the usual care control group. The intervention focuses on rehabilitation and self-management and is provided by a trained community psychiatric nurse, followed by referral to primary care. Measurements take place at 6, 12, and 18 months after baseline. This study evaluates both the effectiveness (on quality of life, symptom severity, and empowerment), and cost-effectiveness of the intervention compared to usual care. In addition, a questionnaire is designed to get insight in which self-management strategies patients use to manage their disorder, and in the experiences of patients with the change of care setting. In this study we evaluate the effectiveness and cost-effectiveness of a self-management intervention for patients with chronic and treatment resistant anxiety or depressive disorders in specialized outpatient mental health care. The results of this study may provide a first 'proof-of-concept' in this under-researched but important field, and might be relevant for a large group of patients in the context of a transition of the Dutch health care system. Netherlands Trial Register: NTR3335 , registered 7 March 2012.

Antihypertensive drugs for elderly patients: a cross- sectional study

PubMed Central

Lim, Ka Keat; Sivasampu, Sheamini; Khoo, Ee Ming

2015-01-01

INTRODUCTION As the population ages, the prevalence of hypertension also increases. Although primary care is usually the patient’s first point of contact for healthcare, little is known about the management of hypertension among elderly patients at the primary care level. This study aimed to determine the antihypertensive prescription trend for elderly patients, the predictors of antihypertensive use and any inappropriate prescribing practices in both public and private primary care settings. METHODS Data on patient demographics, diagnosis, prescription pattern, payment mode and follow-up was extracted from a cross-sectional study involving 122 public primary care clinics and 652 private primary care clinics in Malaysia. Encounters with hypertensive patients aged ≥ 60 years were included. RESULTS A total of 1,017 antihypertensive medications were prescribed – calcium channel blockers (27.1%), beta blockers (25.5%), diuretics (23.3%), angiotensin-converting enzyme inhibitors (14.9%) and angiotensin receptor blockers (6.3%). Out of the 614 patient encounters, 53.1% of the patients were prescribed monotherapy, 31.6% were prescribed dual therapy, 12.2% triple therapy, 2.8% quadruple therapy and 0.3% quintuple therapy. Type of primary care clinic and payment mode were significant predictors for the prescription of combination therapy and fixed-dose combination therapy, respectively. Four types of inappropriate prescriptions were identified. CONCLUSION Calcium channel blockers were the most common antihypertensive drug prescribed and more than half of the elderly patients were on monotherapy. Antihypertensive drug prescription was found to be associated with the type of primary care clinic and the payment mode, suggesting that prescription is influenced by the cost of the drug. PMID:25597751

Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial

PubMed Central

Neal, Richard D; Barham, Allan; Bongard, Emily; Edwards, Rhiannon Tudor; Fitzgibbon, Jim; Griffiths, Gareth; Hamilton, Willie; Hood, Kerenza; Nelson, Annmarie; Parker, David; Porter, Cath; Prout, Hayley; Roberts, Kirsty; Rogers, Trevor; Thomas-Jones, Emma; Tod, Angela; Yeo, Seow Tien; Hurt, Chris N

2017-01-01

Background: Achieving earlier stage diagnosis is one option for improving lung cancer outcomes in the United Kingdom. Patients with lung cancer typically present with symptoms to general practitioners several times before referral or investigation. Methods: We undertook a mixed methods feasibility individually randomised controlled trial (the ELCID trial) to assess the feasibility and inform the design of a definitive, fully powered, UK-wide, Phase III trial of lowering the threshold for urgent investigation of suspected lung cancer. Patients over 60, with a smoking history, presenting with new chest symptoms to primary care, were eligible to be randomised to intervention (urgent chest X-ray) or usual care. Results: The trial design and materials were acceptable to GPs and patients. We randomised 255 patients from 22 practices, although the proportion of eligible patients who participated was lower than expected. Survey responses (89%), and the fidelity of the intervention (82% patients X-rayed within 3 weeks) were good. There was slightly higher anxiety and depression in the control arm in participants aged >75. Three patients (1.2%) were diagnosed with lung cancer. Conclusions: We have demonstrated the feasibility of individually randomising patients at higher risk of lung cancer, to a trial offering urgent investigation or usual care. PMID:28072761

Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve adherence to colorectal cancer screening among patients cared for in a community health center.

PubMed

Baker, David W; Brown, Tiffany; Buchanan, David R; Weil, Jordan; Cameron, Kenzie A; Ranalli, Lauren; Ferreira, M Rosario; Stephens, Quinn; Balsley, Kate; Goldman, Shira N; Wolf, Michael S

2013-04-29

Colorectal cancer (CRC) is common and leads to significant morbidity and mortality. Although screening with fecal occult blood testing (FOBT) or endoscopy has been shown to decrease CRC mortality, screening rates remain suboptimal. Screening rates are particularly low for people with low incomes and members of underrepresented minority groups. FOBT should be done annually to detect CRC early and to reduce CRC mortality, but this often does not occur. This paper describes the design of a multifaceted intervention to increase long-term adherence to FOBT among poor, predominantly Latino patients, and the design of a randomized controlled trial (RCT) to test the efficacy of this intervention compared to usual care. In this RCT, patients who are due for repeat FOBT are identified in the electronic health record (EHR) and randomized to receive either usual care or a multifaceted intervention. The usual care group includes multiple point-of-care interventions (e.g., standing orders, EHR reminders), performance measurement, and financial incentives to improve CRC screening rates. The intervention augments usual care through mailed CRC screening test kits, low literacy patient education materials, automated phone and text message reminders, in-person follow up calls from a CRC Screening Coordinator, and communication of results to patients along with a reminder card highlighting when the patient is next due for screening. The primary outcome is completion of FOBT within 6 months of becoming due. The main goal of the study is to determine the comparative effectiveness of the intervention compared to usual care. Additionally, we want to assess whether or not it is possible to achieve high rates of adherence to CRC screening with annual FOBT, which is necessary for reducing CRC mortality. The intervention relies on technology that is increasingly widespread and declining in cost, including EHR systems, automated phone and text messaging, and FOBTs for CRC screening. We took this approach to ensure generalizability and allow us to rapidly disseminate the intervention through networks of community health centers (CHCs) if the RCT shows the intervention to be superior to usual care. ClinicalTrials.gov NCT01453894.

Tailoring Outreach Efforts to Increase Primary Care Use Among Homeless Veterans: Results of a Randomized Controlled Trial.

PubMed

O'Toole, Thomas P; Johnson, Erin E; Borgia, Matthew L; Rose, Jennifer

2015-07-01

Homeless individuals often have significant unmet health care needs that are critical to helping them leave homelessness. However, engaging them in primary and mental health care services is often elusive and difficult to achieve. We aimed to increase health-seeking behavior and receipt of health care among homeless Veterans. This was a multi-center, prospective, community-based, two-by-two randomized controlled trial of homeless Veterans. Homeless Veterans not receiving primary care participated in the study. An outreach intervention that included a personal health assessment and brief intervention (PHA/BI), and/or a clinic orientation (CO) was implemented. We measured receipt of primary care within 4 weeks of study enrollment. Overall, 185 homeless Veterans were enrolled: the average age was 48.6 years (SD 10.8), 94.6% were male, 43.0% were from a minority population, 12.0% were unsheltered, 25.5% were staying in a dusk-to-dawn emergency shelter, 26.1% were in transitional housing, while 27.7% were in an unstable, doubled-up arrangement. At one month, 77.3% of the PHA/BI plus CO group accessed primary care and by 6 months, 88.7% had been seen in primary care. This was followed by the CO-only group, 50.0% of whom accessed care in the first 4 weeks, the PHI/BI-only arm at 41.0% and the Usual Care arm at 30.6%. Chi-squared tests by group were significant (p < 0.001) at both 4 weeks and 6 months. There was no difference in attitudes about care at baseline and 6 months or in use patterns once enrolled in care. Our findings suggest that treatment-resistant/avoidant homeless Veterans can be effectively engaged in primary and other clinical care services through a relatively low intensity, targeted and tailored outreach effort.

Managing multimorbidity in primary care in patients with chronic respiratory conditions.

PubMed

Morrison, Deborah; Agur, Karolina; Mercer, Stewart; Eiras, Andreia; González-Montalvo, Juan I; Gruffydd-Jones, Kevin

2016-09-15

The term multimorbidity is usually defined as the coexistence of two or more chronic conditions within an individual, whereas the term comorbidity traditionally describes patients with an index condition and one or more additional conditions. Multimorbidity of chronic conditions markedly worsens outcomes in patients, increases treatment burden and increases health service costs. Although patients with chronic respiratory disease often have physical comorbidities, they also commonly experience psychological problems such as depression and anxiety. Multimorbidity is associated with increased health-care utilisation and specifically with an increased number of prescription drugs in individuals with multiple chronic conditions such as chronic obstructive pulmonary disease. This npj Primary Care Respiratory Medicine Education Section case study involves a patient in a primary care consultation presenting several common diseases prevalent in people of this age. The patient takes nine different drugs at this moment, one or more pills for each condition, which amounts to polypharmacy. The problems related with polypharmacy recommend that a routine medication review by primary care physicians be performed to reduce the risk of adverse effects of polypharmacy among those with multiple chronic conditions. The primary care physician has the challenging role of integrating all of the clinical problems affecting the patient and reviewing all medicaments (including over-the-counter medications) taken by the patient at any point in time, and has the has the key to prevent the unwanted consequences of polypharmacy. Multimorbid chronic disease management can be achieved with the use of care planning, unified disease templates, use of information technology with appointment reminders and with the help of the wider primary care and community teams.

An economic evaluation of a self-management programme of activity, coping and education for patients with chronic obstructive pulmonary disease.

PubMed

Dritsaki, Melina; Johnson-Warrington, Vicki; Mitchell, Katy; Singh, Sally; Rees, Karen

2016-02-01

The aim was to undertake a cost-utility analysis of a self-management programme of activity, coping and education (SPACE) for chronic obstructive pulmonary disease (COPD). The analysis was conducted alongside a six-month randomized controlled trial in 30 primary care settings. The economic analysis used data from 184 patients with confirmed diagnosis of COPD, forced expiratory volume in one second/forced vital capacity ratio <0.7 and with grade 2-5 on the Medical Research Council dyspnoea scale. Participants received either a self-management programme consisting of an education manual (SPACE for COPD) and consultation or usual care. Six-month costs were estimated from the National Health Service and Personal Social Services perspective and quality-adjusted life years (QALYs) were calculated based on patient responses at baseline and six months.The mean difference in costs between usual care and SPACE FOR COPD programme was -£27.18 (95% confidence interval (CI); -£122.59 to £68.25) while mean difference in QALYs was -0.10 (95% CI; -0.17 to -0.02). The results suggest that the intervention is more costly and more effective than usual care. The probability of the intervention being cost-effective was 97% at a threshold of £20,000/QALY gained. We conclude that the SPACE FOR COPD programme is cost-effective compared to usual care. © The Author(s) 2015.

Cost effectiveness of a pragmatic exercise intervention (EXIMS) for people with multiple sclerosis: economic evaluation of a randomised controlled trial.

PubMed

Tosh, J; Dixon, S; Carter, A; Daley, A; Petty, J; Roalfe, A; Sharrack, B; Saxton, J M

2014-07-01

Exercise is a safe, non-pharmacological adjunctive treatment for people with multiple sclerosis but cost-effective approaches to implementing exercise within health care settings are needed. The objective of this paper is to assess the cost effectiveness of a pragmatic exercise intervention in conjunction with usual care compared to usual care only in people with mild to moderate multiple sclerosis. A cost-utility analysis of a pragmatic randomised controlled trial over nine months of follow-up was conducted. A total of 120 people with multiple sclerosis were randomised (1:1) to the intervention or usual care. Exercising participants received 18 supervised and 18 home exercise sessions over 12 weeks. The primary outcome for the cost utility analysis was the incremental cost per quality-adjusted life year (QALY) gained, calculated using utilities measured by the EQ-5D questionnaire. The incremental cost per QALY of the intervention was £10,137 per QALY gained compared to usual care. The probability of being cost effective at a £20,000 per QALY threshold was 0.75, rising to 0.78 at a £30,000 per QALY threshold. The pragmatic exercise intervention is highly likely to be cost effective at current established thresholds, and there is scope for it to be tailored to particular sub-groups of patients or services to reduce its cost impact. © The Author(s) 2013.

Do Pediatricians Ask About Adverse Childhood Experiences in Pediatric Primary Care?

PubMed

Kerker, Bonnie D; Storfer-Isser, Amy; Szilagyi, Moira; Stein, Ruth E K; Garner, Andrew S; O'Connor, Karen G; Hoagwood, Kimberly E; Horwitz, Sarah M

2016-03-01

The stress associated with adverse childhood experiences (ACEs) has immediate and long-lasting effects. The objectives of this study were to examine 1) how often pediatricians ask patients' families about ACEs, 2) how familiar pediatricians are with the original ACE study, and 3) physician/practice characteristics, physicians' mental health training, and physicians' attitudes/beliefs that are associated with asking about ACEs. Data were collected from 302 nontrainee pediatricians exclusively practicing general pediatrics who completed the 2013 American Academy of Pediatrics Periodic Survey. Pediatricians indicated whether they usually, sometimes, or never inquired about or screened for 7 ACEs. Sample weights were used to reduce nonresponse bias. Weighted descriptive and logistic regression analyses were conducted. Only 4% of pediatricians usually asked about all 7 ACEs; 32% did not usually ask about any. Less than 11% of pediatricians reported being very or somewhat familiar with the ACE study. Pediatricians who screened/inquired about ACEs usually asked about maternal depression (46%) and parental separation/divorce (42%). Multivariable analyses showed that pediatricians had more than twice the odds of usually asking about ACEs if they disagreed that they have little effect on influencing positive parenting skills, disagreed that screening for social emotional risk factors within the family is beyond the scope of pediatricians, or were very interested in receiving further education on managing/treating mental health problems in children and adolescents. Few pediatricians ask about all ACEs. Pediatric training that emphasizes the importance of social/emotional risk factors may increase the identification of ACEs in pediatric primary care. Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

The impact of a lay counselor led collaborative care intervention for common mental disorders in public and private primary care: a qualitative evaluation nested in the MANAS trial in Goa, India.

PubMed

Shinde, Sachin; Andrew, Gracy; Bangash, Omer; Cohen, Alex; Kirkwood, Betty; Patel, Vikram

2013-07-01

The MANAS trial evaluated the effectiveness of a lay counselor led collaborative stepped care intervention for Common Mental Disorders (CMD) in public and private sector primary care settings in Goa, India. This paper describes the qualitative findings of the experience of the intervention and its impact on health and psychosocial outcomes. Twenty four primary care facilities (12 public and private each) were randomized to provide either collaborative stepped care (CSC) or enhanced usual care (EUC) to adults who screen positive for CMDs. Participants were sampled purposively based on two criteria: gender and, in the CSC arm, adherence with the intervention. The qualitative study component involved two semi-structured interviews with participants of both arms (N = 115); the first interview within 2 months of recruitment and the second 6-8 months after recruitment. Data were collected between September 2007 and November 2009. More participants in the CSC than EUC arm reported relief from symptoms and an improvement in social functioning and positive impact on work and activities of daily life. The CSC participants attributed their improvement both to medication received from the doctors and the strategies suggested by the lay Health Counselors (HC). However, two key differences were observed in the results for the two types of facilities. First, the CSC participants in the public sector clinics were more likely to consider the HCs to be an important component of providing care who served as a link between patient and the doctor, provided them skills on stress management and helped in adherence to medication. Second, in the private sector, doctors performed roles similar to those of the HCs and participants in both arms placed much faith in the doctor who acted as a confidante and was perceived to understand the participant's health and context intimately. Lay counselors working in a CSC model have a positive effect on symptomatic relief, social functioning and satisfaction with care in patients with CMD attending primary care clinics although the impact, compared with usual care, is greater in the public sector. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

How common is multiple general practice attendance in Australia?

PubMed

Wright, Michael; Hall, Jane; van Gool, Kees; Haas, Marion

2018-05-01

Australians can seek general practice care from multiple general practitioners (GPs) in multiple locations. This provides high levels of patient choice but may reduce continuity of care. The aim of this study was to estimate the prevalence of attendance at multiple general practices in Australia, and identify patient characteristics associated with multiple practice attendances. A cross-sectional survey of 2477 Australian adults was conducted online in July 2013. Respondents reported whether they had attended more than one general practice in the past year, and whether they had a usual general practice and GP. Demographic information, health service use and practice characteristics were also obtained from the survey. Over one-quarter of the sample reported attending more than one practice in the previous year. Multiple practice attendance is less common with increasing age, and less likely for survey respondents from regional Australia, compared with respondents from metropolitan areas. Multiple practice attenders are just as likely as single practice attenders to have a usual GP. A significant proportion of general practice care is delivered away from usual practices. This may have implications for health policy, in terms of continuity and quality of primary care.

The use of instrumented gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomised controlled trial protocol.

PubMed

Rasmussen, Helle Mätzke; Pedersen, Niels Wisbech; Overgaard, Søren; Hansen, Lars Kjaersgaard; Dunkhase-Heinl, Ulrike; Petkov, Yanko; Engell, Vilhelm; Baker, Richard; Holsgaard-Larsen, Anders

2015-12-07

Children with cerebral palsy (CP) often have an altered gait. Orthopaedic surgery, spasticity management, physical therapy and orthotics are used to improve the gait. Interventions are individually tailored and are planned on the basis of clinical examinations and standardised measurements to assess walking ('care as usual'). However, these measurements do not describe features in the gait that reflect underlying neuro-musculoskeletal impairments. This can be done with 3-dimensional instrumented gait analysis (IGA). The aim of this study is to test the hypothesis that improvements in gait following individually tailored interventions when IGA is used are superior to those following 'care as usual'. A prospective, single blind, randomised, parallel group study will be conducted. Children aged 5 to 8 years with spastic CP, classified at Gross Motor Function Classification System levels I or II, will be included. The interventions under investigation are: 1) individually tailored interdisciplinary interventions based on the use of IGA, and 2) 'care as usual'. The primary outcome is gait measured by the Gait Deviation Index. Secondary outcome measures are: walking performance (1-min walk test) and patient-reported outcomes of functional mobility (Pediatric Evaluation of Disability Inventory), health-related quality of life (The Pediatric Quality of Life Inventory Cerebral Palsy Module) and overall health, pain and participation (The Pediatric Outcome Data Collection Instrument). The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks; however, exclusively for the patient-reported outcomes. To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention based on the use of IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA. ClinicalTrials.gov NCT02160457 . Registered June 2, 2014.

A cluster randomised controlled trial of a brief couple-focused psychoeducational intervention to prevent common postnatal mental disorders among women: study protocol.

PubMed

Rowe, Heather; Wynter, Karen; Lorgelly, Paula; Amir, Lisa H; Ranasinha, Sanjeeva; Proimos, Jenny; Cann, Warren; Hiscock, Harriet; Bayer, Jordana; Burns, Joanna; Ride, Jemimah; Bobevski, Irene; Fisher, Jane

2014-09-23

Postnatal common mental disorders among women are an important public health problem internationally. Interventions to prevent postnatal depression have had limited success. What Were We Thinking (WWWT) is a structured, gender-informed, psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health. This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and cost-effectiveness of WWWT when implemented in usual primary care. 48 maternal and child health (MCH) centres from six diverse Local Government Areas, in Victoria, Australia are randomly allocated to the intervention group (usual care plus WWWT) or the control group (usual care). The required sample size is 184 women in each group. English-speaking primiparous women receiving postpartum healthcare in participating MCH centres complete two computer-assisted telephone interviews: baseline at 4 weeks and outcome at 6 months postpartum. Women attending intervention MCH centres are invited to attend WWWT in addition to usual care. The primary outcome is meeting Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for major depressive episode; generalised anxiety disorder; panic disorder with or without agoraphobia, agoraphobia with or without panic, social phobia, adult separation anxiety or adjustment disorder with depressed mood, anxiety or mixed depressed mood and anxiety within the past 30 days at 6 months postpartum. Secondary outcomes are self-rated general and emotional health, infant sleep problems, method of infant feeding, quality of mother-infant relationship and intimate partner relationship, and healthcare costs and outcomes. Approval to conduct the study has been granted. A comprehensive dissemination plan has been devised. Australian New Zealand Clinical Trials Registry ACTRN12613000506796. UTN: U1111-1125-8208. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial

PubMed Central

Lauche, Romy; Spitzer, Julia; Schwahn, Barbara; Ostermann, Thomas; Bernardy, Kathrin; Cramer, Holger; Dobos, Gustav; Langhorst, Jost

2016-01-01

This study aimed to test the efficacy of cupping therapy to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome. Participants were randomly assigned to cupping therapy, sham or usual care. Cupping was administered five times at twice weekly intervals on the upper and lower back. The primary outcome measure was pain intensity at day 18. Secondary outcomes included functional disability, quality of life, fatigue and sleep quality as well as pressure pain sensitivity, satisfaction and safety at day 18 and 6 months. Altogether 141 patients were included in this study (139 females, 55.8 ± 9.1 years). After 18 days patients reported significant less pain after cupping compared to usual care (difference −12.4; 95% CI: −18.9; −5.9, p < 0.001) but not compared to sham (difference −3.0; 95% CI: −9.9, 3.9, p = 0.396). Further effects were found for quality of life compared to usual care. Patients were mildly satisfied with cupping and sham cupping; and only minor side effects were observed. Despite cupping therapy being more effective than usual care to improve pain intensity and quality of life, effects of cupping therapy were small and comparable to those of a sham treatment, and as such cupping cannot be recommended for fibromyalgia at the current time. PMID:27853272

Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial.

PubMed

Lauche, Romy; Spitzer, Julia; Schwahn, Barbara; Ostermann, Thomas; Bernardy, Kathrin; Cramer, Holger; Dobos, Gustav; Langhorst, Jost

2016-11-17

This study aimed to test the efficacy of cupping therapy to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome. Participants were randomly assigned to cupping therapy, sham or usual care. Cupping was administered five times at twice weekly intervals on the upper and lower back. The primary outcome measure was pain intensity at day 18. Secondary outcomes included functional disability, quality of life, fatigue and sleep quality as well as pressure pain sensitivity, satisfaction and safety at day 18 and 6 months. Altogether 141 patients were included in this study (139 females, 55.8 ± 9.1 years). After 18 days patients reported significant less pain after cupping compared to usual care (difference -12.4; 95% CI: -18.9; -5.9, p < 0.001) but not compared to sham (difference -3.0; 95% CI: -9.9, 3.9, p = 0.396). Further effects were found for quality of life compared to usual care. Patients were mildly satisfied with cupping and sham cupping; and only minor side effects were observed. Despite cupping therapy being more effective than usual care to improve pain intensity and quality of life, effects of cupping therapy were small and comparable to those of a sham treatment, and as such cupping cannot be recommended for fibromyalgia at the current time.

Method‐of‐use study of naltrexone sustained release (SR)/bupropion SR on body weight in individuals with obesity

PubMed Central

Shan, Kevin; Walsh, Brandon; Gilder, Kye; Fujioka, Ken

2016-01-01

Objective This study assessed the effects of 32 mg naltrexone sustained release (SR)/360 mg bupropion SR (NB) on body weight in adults with obesity, with comprehensive lifestyle intervention (CLI), for 78 weeks. Methods In this phase 3b, randomized, open‐label, controlled study, subjects received NB + CLI or usual care (standard diet/exercise advice) for 26 weeks. NB subjects not achieving 5% weight loss at week 16 were discontinued, as indicated by product labeling. After week 26, usual care subjects began NB + CLI. Assessments continued through week 78. The primary end point was percent change in weight from baseline to week 26 in the per protocol population. Other end points included percentage of subjects achieving ≥5%, ≥10%, and ≥15% weight loss, percent change in weight at week 78, and adverse events (AEs) necessitating study medication discontinuation. Results NB + CLI subjects lost significantly more weight than usual care subjects at week 26 (8.52% difference; P < 0.0001). Weight loss persisted through 78 weeks. In total, 20.7% of subjects discontinued medication for AEs, including 7.0% for nausea. Conclusions Treatment with NB, used as indicated by prescribing information and with CLI, significantly improved weight loss over usual care alone. NB‐facilitated weight loss was sustained for 78 weeks and was deemed safe and well tolerated. PMID:28026920

Design of the POINT study: Pharmacotherapy Optimisation through Integration of a Non-dispensing pharmacist in a primary care Team (POINT).

PubMed

Hazen, Ankie C M; Sloeserwij, Vivianne M; Zwart, Dorien L M; de Bont, Antoinette A; Bouvy, Marcel L; de Gier, Johan J; de Wit, Niek J; Leendertse, Anne J

2015-07-02

In the Netherlands, 5.6 % of acute hospital admissions are medication-related. Almost half of these admissions are potentially preventable. Reviewing medication in patients at risk in primary care might prevent these hospital admissions. At present, implementation of medication reviews in primary care is suboptimal: pharmacists lack access to patient information, pharmacists are short of clinical knowledge and skills, and working processes of pharmacists (focus on dispensing) and general practitioners (focus on clinical practice) match poorly. Integration of the pharmacist in the primary health care team might improve pharmaceutical care outcomes. The aim of this study is to evaluate the effect of integration of a non-dispensing pharmacist in general practice on the safety of pharmacotherapy in the Netherlands. The POINT study is a non-randomised controlled intervention study with pre-post comparison in an integrated primary care setting. We compare three different models of pharmaceutical care provision in primary care: 1) a non-dispensing pharmacist as an integral member of a primary care team, 2) a pharmacist in a community pharmacy with a predefined training in performing medication reviews and 3) a pharmacist in a community pharmacy (care as usual). In all models, GPs remain accountable for individual medication prescription. In the first model, ten non-dispensing clinical pharmacists are posted in ten primary care practices (including 5 - 10 000 patients each) for a period of 15 months. These non-dispensing pharmacists perform patient consultations, including medication reviews, and share responsibility for the pharmaceutical care provided in the practice. The two other groups consist of ten primary care practices with collaborating pharmacists. The main outcome measurement is the number of medication-related hospital admissions during follow-up. Secondary outcome measurements are potential medication errors, drug burden index and costs. Parallel to this study, a qualitative study is conducted to evaluate the feasibility of introducing a NDP in general practice. As the POINT study is a large-scale intervention study, it should provide evidence as to whether integration of a non-dispensing clinical pharmacist in primary care will result in safer pharmacotherapy. The qualitative study also generates knowledge on the optimal implementation of this model in primary care. Results are expected in 2016. NTR4389 , The Netherlands National Trial Register, 07-01-2014.

The effect of a telephone-based cognitive behavioral therapy on quality of life: a randomized controlled trial.

PubMed

Ngai, Fei-Wan; Wong, Paul Wai-Ching; Chung, Ka-Fai; Leung, Kwok-Yin

2017-06-01

Health-related quality of life (HRQoL) has emerged as a major public health concern in perinatal care. The purpose of this study was to examine the effect of telephone-based cognitive behavioral therapy (T-CBT) on HRQoL among Chinese mothers at risk of postnatal depression at 6 weeks and 6 months postpartum. A multi-center randomized controlled trial was conducted at the postnatal units of three regional hospitals. Three hundred and ninety-seven women at risk of postnatal depression were recruited and were randomly assigned to the T-CBT (n = 197) or usual care (n = 200). Assessment was conducted at baseline, 6 weeks and 6 months postpartum for HRQoL. Women in the T-CBT experienced greater improvement in the physical component of HRQoL from baseline to 6 weeks and 6 months postpartum than the usual care group. At 6 months postpartum, the T-CBT group also experienced better HRQoL in the mental component of HRQoL than the usual care group. The T-CBT appears to be feasible and effective in improving HRQoL in women at risk of postnatal depression in the primary care practice.

Determinants of childhood mortality in slums of Karachi, Pakistan.

PubMed

D'souza, R M; Bryant, J H

1999-01-01

Pakistan has an infant mortality rate (IMR) of 90.5/1000 live births, and the country's child mortality level of 117.5 is worse than in other South Asian countries. Rapid population growth combined with rural-to-urban migration has led to the creation of urban slums in which morbidity levels are usually higher than in rural populations. A study was conducted in January 1993 in 6 slums of Karachi where the Aga Khan University has operated primary health care programs since 1985. Researchers recorded the deaths of 347 children under age 5 years old due to diarrhea and acute respiratory infections (ARI) during 1989-93. 235 mothers of these children were interviewed. The following are discussed as risk factors for under-5 child mortality: the use of traditional healers, poor nutritional status, incomplete or no immunization, the quick change of healers, inappropriate child care arrangements, mother's literacy, who decides about outside treatment, short birth interval, bottle feeding, and nuclear family structure. Maternal autonomy, appropriate health-seeking behavior, and child-rearing processes identified in the study point to the need for intervention strategies which go beyond the usual primary health care initiatives and involve communities in developing social support systems for mothers.

Cost-effectiveness of a multicomponent primary care program targeting frail elderly people.

PubMed

Ruikes, Franca G H; Adang, Eddy M; Assendelft, Willem J J; Schers, Henk J; Koopmans, Raymond T C M; Zuidema, Sytse U

2018-05-16

Over the last 20 years, integrated care programs for frail elderly people aimed to prevent functional dependence and reduce hospitalization and institutionalization. However, results have been inconsistent and merely modest. To date, evidence on the cost-effectiveness of these programs is scarce. We evaluated the cost-effectiveness of the CareWell program, a multicomponent integrated care program for frail elderly people. Economic evaluation from a healthcare perspective embedded in a cluster controlled trial of 12 months in 12 general practices in (the region of) Nijmegen. Two hundred and four frail elderly from 6 general practices in the intervention group received care according to the CareWell program, consisting of multidisciplinary team meetings, proactive care planning, case management, and medication reviews; 165 frail elderly from 6 general practices in the control group received usual care. In cost-effectiveness analyses, we related costs to daily functioning (Katz-15 change score i.e. follow up score minus baseline score) and quality adjusted life years (EQ-5D-3 L). Adjusted mean costs directly related to the intervention were €456 per person. Adjusted mean total costs, i.e. intervention costs plus healthcare utilization costs, were €1583 (95% CI -4647 to 1481) higher in the intervention group than in the control group. Incremental Net Monetary Benefits did not show significant differences between groups, but on average tended to favour usual care. The CareWell primary program was not cost-effective after 12 months. From a cost-effectiveness perspective, widespread implementation of the program in its current form cannot be recommended. The study was registered in the ClinicalTrials.govProtocol Registration System: ( NCT01499797 ; December 26, 2011). Retrospectively registered.

Late-life depression in the primary care setting: Challenges, collaborative care, and prevention

PubMed Central

Hall, Charles A.; Reynolds, Charles F.

2014-01-01

Late-life depression is highly prevalent worldwide. In addition to being a debilitating illness, it is a risk factor for excess morbidity and mortality. Older adults with depression are at risk for dementia, coronary heart disease, stroke, cancer and suicide. Individuals with late-life depression often have significant medical comorbidity and, poor treatment adherence. Furthermore, psychosocial considerations such as gender, ethnicity, stigma and bereavement are necessary to understand the full context of late-life depression. The fact that most older adults seek treatment for depression in primary care settings led to the development of collaborative care interventions for depression. These interventions have consistently demonstrated clinically meaningful effectiveness in the treatment of late-life depression. We describe three pivotal studies detailing the management of depression in primary care settings in both high and low-income countries. Beyond effectively treating depression, collaborative care models address additional challenges associated with late-life depression. Although depression treatment interventions are effective compared to usual care, they exhibit relatively low remission rates and small to medium effect sizes. Several studies have demonstrated that depression prevention is possible and most effective in at-risk older adults. Given the relatively modest effects of treatment in averting years lived with disability, preventing late-life depression at the primary care level should be highly prioritized as a matter of health policy. PMID:24996484

Impact of primary care depression intervention on employment and workplace conflict outcomes: is value added?

PubMed

Smith, Jeffrey L; Rost, Kathryn M; Nutting, Paul A; Libby, Anne M; Elliott, Carl E; Pyne, Jeffrey M

2002-03-01

Depression causes significant functional impairment in sufferers and often leads to adverse employment outcomes for working individuals. Recovery from depression has been associated with better employment outcomes at one year. The study s goals were to assess a primary care depression intervention s impact on subsequent employment and workplace conflict outcomes in employed patients with depression. In 1996-1997, the study enrolled 262 employed patients with depression from twelve primary care practices located across ten U.S. states; 219 (84%) of the patients were followed at one year. Intent-to-treat analyses assessing intervention effects on subsequent employment and workplace conflict were conducted using logistic regression models controlling for individual clinical and sociodemographic characteristics, job classification and local employment conditions. To meet criteria for subsequent employment, persons working full-time at baseline had to report they were working full-time at follow-up and persons working part-time at baseline had to report working part-/full-time at follow-up. Workplace conflict was measured by asking patients employed at follow-up whether, in the past year, they had arguments or other difficulties with people at work . Findings showed that 92.1% of intervention patients met criteria for subsequent employment at one year, versus 82.0% of usual care patients (c2=4.42, p=.04). Intervention patients were less likely than usual care patients to report workplace conflict in the year following baseline (8.1% vs. 18.9%, respectively; c2=4.11; p=.04). The intervention s effect on subsequent employment was not mediated by its effect on workplace conflict. The intervention significantly improved employment outcomes and reduced workplace conflict in depressed, employed persons at one year. Economic implications for employers related to reduced turnover costs, for workers related to retained earnings, and for governments related to reduced unemployment expenditures and increased tax receipts may be considerable. Although similar primary care depression interventions have been shown to produce comparable effects on subsequent employment at one year, replications in larger samples of depressed, employed patients in different economic climates may be necessary to increase the generalizability and precision of estimates. Primary care interventions that enhance depression treatment and improve clinical outcomes can contribute meaningful added value to society by improving employment and workplace outcomes. Federal/state governments may realize economic benefits from reduced unemployment expenditures and increased tax receipts should primary care depression interventions that improve employment outcomes be broadly disseminated. Policy initiatives to increase the dissemination of such interventions may be an innovative approach for improving labor force participation by depressed individuals. Formal cost-benefit analyses are needed to explore whether economic benefits to societal stakeholders from these and other labor outcomes equal or exceed the incremental costs of disseminating similar primary care interventions nationally. Researchers in other nations may wish to consider investigating the impact primary care depression interventions might have on employment and workplace outcomes in their countries.

Reducing barriers to mental health and social services for Iraq and Afghanistan veterans: outcomes of an integrated primary care clinic.

PubMed

Seal, Karen H; Cohen, Greg; Bertenthal, Daniel; Cohen, Beth E; Maguen, Shira; Daley, Aaron

2011-10-01

Despite high rates of post-deployment psychosocial problems in Iraq and Afghanistan veterans, mental health and social services are under-utilized. To evaluate whether a Department of Veterans Affairs (VA) integrated care (IC) clinic (established in April 2007), offering an initial three-part primary care, mental health and social services visit, improved psychosocial services utilization in Iraq and Afghanistan veterans compared to usual care (UC), a standard primary care visit with referral for psychosocial services as needed. Retrospective cohort study using VA administrative data. Five hundred and twenty-six Iraq and Afghanistan veterans initiating primary care at a VA medical center between April 1, 2005 and April 31, 2009. Multivariable models compared the independent effects of primary care clinic type (IC versus UC) on mental health and social services utilization outcomes. After 2007, compared to UC, veterans presenting to the IC primary care clinic were significantly more likely to have had a within-30-day mental health evaluation (92% versus 59%, p < 0.001) and social services evaluation [77% (IC) versus 56% (UC), p < 0.001]. This exceeded background system-wide increases in mental health services utilization that occurred in the UC Clinic after 2007 compared to before 2007. In particular, female veterans, younger veterans, and those with positive mental health screens were independently more likely to have had mental health and social service evaluations if seen in the IC versus UC clinic. Among veterans who screened positive for  ≥ 1 mental health disorder(s), there was a median of 1 follow-up specialty mental health visit within the first year in both clinics. Among Iraq and Afghanistan veterans new to primary care, an integrated primary care visit further improved the likelihood of an initial mental health and social services evaluation over background increases, but did not improve retention in specialty mental health services.

Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study.

PubMed

Brueckmann, B; Sasaki, N; Grobara, P; Li, M K; Woo, T; de Bie, J; Maktabi, M; Lee, J; Kwo, J; Pino, R; Sabouri, A S; McGovern, F; Staehr-Rye, A K; Eikermann, M

2015-11-01

This study aimed to investigate whether reversal of rocuronium-induced neuromuscular blockade with sugammadex reduced the incidence of residual blockade and facilitated operating room discharge readiness. Adult patients undergoing abdominal surgery received rocuronium, followed by randomized allocation to sugammadex (2 or 4 mg kg(-1)) or usual care (neostigmine/glycopyrrolate, dosing per usual care practice) for reversal of neuromuscular blockade. Timing of reversal agent administration was based on the providers' clinical judgement. Primary endpoint was the presence of residual neuromuscular blockade at PACU admission, defined as a train-of-four (TOF) ratio <0.9, using TOF-Watch® SX. Key secondary endpoint was time between reversal agent administration and operating room discharge-readiness; analysed with analysis of covariance. Of 154 patients randomized, 150 had a TOF value measured at PACU entry. Zero out of 74 sugammadex patients and 33 out of 76 (43.4%) usual care patients had TOF-Watch SX-assessed residual neuromuscular blockade at PACU admission (odds ratio 0.0, 95% CI [0-0.06], P<0.0001). Of these 33 usual care patients, 2 also had clinical evidence of partial paralysis. Time between reversal agent administration and operating room discharge-readiness was shorter for sugammadex vs usual care (14.7 vs. 18.6 min respectively; P=0.02). After abdominal surgery, sugammadex reversal eliminated residual neuromuscular blockade in the PACU, and shortened the time from start of study medication administration to the time the patient was ready for discharge from the operating room. Clinicaltrials.gov:NCT01479764. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention.

PubMed

Farquharson, Barbara; Johnston, Marie; Smith, Karen; Williams, Brian; Treweek, Shaun; Dombrowski, Stephan U; Dougall, Nadine; Abhyankar, Purva; Grindle, Mark

2017-05-01

To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text + visual and text-only) with usual care. Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for acute coronary syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions. A three-arm web-based, parallel randomized controlled trial of a theory-based intervention. The intervention comprises 12 behaviour change techniques systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n = 177 participants who have experienced acute coronary syndrome in the previous 6 months from a National Health Service Hospital. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care, ii) usual care plus text-only behaviour change technique-based intervention or iii) usual care plus text + visual behaviour change technique-based intervention. The primary outcome will be the change in intention to phone an ambulance immediately with symptoms of acute coronary syndrome ≥15-minute duration, assessed using two randomized series of eight scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care). Funding granted January 2014. Positive results changing intentions would lead to a randomized controlled trial of the behaviour change intervention in clinical practice, assessing patient delay in the event of actual symptoms. Registered at ClinicalTrials.gov: NCT02820103. © 2016 John Wiley & Sons Ltd.

Exploring patients' treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets.

PubMed

Turner, Katrina M; Percival, John; Kessler, David; Donovan, Jenny

2017-06-15

The way in which pragmatic trials are designed suggests that there are differences between the experiences of participants randomised to usual care and intervention arms. These potential differences relate not only to which treatment participants receive but also how they access and engage with their allocated treatment. Such differences could affect trial results. The aim of this study was to assess whether such differences exist and, if they do, to consider their implications for the design of future trials. Interview transcripts were sampled from data sets gathered during three qualitative studies, all of which had been nested within large, primary care depression trials. Each study had explored trial participants' views and experiences of treatments received following randomisation. Transcripts from 37 participants were purposefully sampled, 20 of which were from interviews held with individuals allocated to receive usual GP care. Data were analysed thematically. There was evidence of differences between trial arms across all three data sets. Intervention participants were willing and able to engage with the treatment to which they had been allocated. Randomisation had led to them embarking upon a clear treatment pathway and receiving care in a context where they felt comfortable discussing their mental health and had sufficient time to do so. Intervention participants also had continuity with and confidence in the practitioners they saw. A few usual-care participants talked about having continuity with and confidence in their GPs. However, most of the usual-care participants reported a reluctance to consult GPs about mental health, difficulties in securing treatment appointments, and little or no changes in care following randomisation. Additionally, most reported a lack of continuity of care and a lack confidence in the treatment available to them. There are important differences between usual-care and intervention arms that go beyond treatment received, and they relate to how participants experience accessing and engaging with their allocated care. As these differences could affect trial results, researchers may want to measure or reduce them in order to fully appreciate or control for the range of factors that might affect treatment outcomes.

Telephone outreach to increase colon cancer screening in medicaid managed care organizations: a randomized controlled trial.

PubMed

Dietrich, Allen J; Tobin, Jonathan N; Robinson, Christina M; Cassells, Andrea; Greene, Mary Ann; Dunn, Van H; Falkenstern, Kimberly M; De Leon, Rosanna; Beach, Michael L

2013-01-01

Health Plans are uniquely positioned to deliver outreach to members. We explored whether telephone outreach, delivered by Medicaid managed care organization (MMCO) staff, could increase colorectal cancer (CRC) screening among publicly insured urban women, potentially reducing disparities. We conducted an 18-month randomized clinical trial in 3 MMCOs in New York City in 2008-2010, randomizing 2,240 MMCO-insured women, aged 50 to 63 years, who received care at a participating practice and were overdue for CRC screening. MMCO outreach staff provided cancer screening telephone support, educating patients and helping overcome barriers. The primary outcome was the number of women screened for CRC during the 18-month intervention, assessed using claims. MMCO staff reached 60% of women in the intervention arm by telephone. Although significantly more women in the intervention (36.7%) than in the usual care (30.6%) arm received CRC screening (odds ratio [OR] = 1.32; 95% CI, 1.08-1.62), increases varied from 1.1% to 13.7% across the participating MMCOs, and the overall increase was driven by increases at 1 MMCO. In an as-treated comparison, 41.8% of women in the intervention arm who were reached by telephone received CRC screening compared with 26.8% of women in the usual care arm who were not contacted during the study (OR = 1.84; 95% CI, 1.38, 2.44); 7 women needed to be reached by telephone for 1 to become screened. The telephone outreach intervention delivered by MMCO staff increased CRC screening by 6% more than usual care among randomized women, and by 15.1% more than usual care among previously overdue women reached by the intervention. Our research-based intervention was successfully translated to the health plan arena, with variable effects in the participating MMCOs.

Interprofessional stroke rehabilitation for stroke survivors using home care.

PubMed

Markle-Reid, Maureen; Orridge, Camille; Weir, Robin; Browne, Gina; Gafni, Amiram; Lewis, Mary; Walsh, Marian; Levy, Charissa; Daub, Stacey; Brien, Heather; Roberts, Jacqueline; Thabane, Lehana

2011-03-01

To compare a specialized interprofessional team approach to community-based stroke rehabilitation with usual home care for stroke survivors using home care services. Randomized controlled trial of 101 community-living stroke survivors (<18 months post-stroke) using home care services. Subjects were randomized to intervention (n=52) or control (n=49) groups. The intervention was a 12-month specialized, evidence-based rehabilitation strategy involving an interprofessional team. The primary outcome was change in health-related quality of life and functioning (SF-36) from baseline to 12 months. Secondary outcomes were number of strokes during the 12-month follow-up, and changes in community reintegration (RNLI), perceived social support (PRQ85-Part 2), anxiety and depressive symptoms (Kessler-10), cognitive function (SPMSQ), and costs of use of health services from baseline to 12 months. A total of 82 subjects completed the 12-month follow-up. Compared with the usual care group, stroke survivors in the intervention group showed clinically important (although not statistically significant) greater improvements from baseline in mean SF-36 physical functioning score (5.87, 95% CI -3.98 to 15.7; p=0.24) and social functioning score (9.03, CI-7.50 to 25.6; p=0.28). The groups did not differ for any of the secondary effectiveness outcomes. There was a higher total per-person costs of use of health services in the intervention group compared to usual home care although the difference was not statistically significant (p=0.76). A 12-month specialized, interprofessional team is a feasible and acceptable approach to community-based stroke rehabilitation that produced greater improvements in quality of life compared to usual home care. Clinicaltrials.gov identifier: NCT00463229.

Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

PubMed

Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

2015-06-01

Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1.15-4.53]) and CDS + coaching arm (adjusted odds ratio, 2.60 [95% CI, 1.25-5.41]) and higher use of HEDIS codes for nutrition or physical activity counseling (CDS arm, 45%; CDS + coaching arm, 25%; P < .001 compared with usual care arm). An intervention that included computerized CDS for pediatric clinicians and support for self-guided behavior change for families resulted in improved childhood BMI. Both interventions improved the quality of care for childhood obesity. clinicaltrials.gov Identifier: NCT01537510.

An open cluster-randomized, 18-month trial to compare the effectiveness of educational outreach visits with usual guideline dissemination to improve family physician prescribing

PubMed Central

2014-01-01

Background The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs, acid suppressive therapy, and antiplatelets. However, their effectiveness in changing actual practice is unknown. Methods The study will compare the effectiveness of educational outreach visits regarding the improvement of compliance with clinical guidelines in primary care against usual dissemination strategies. A cost-benefit analysis will also be conducted. We will carry out a parallel, open, superiority, randomized trial directed to primary care physicians. Physicians will be recruited and allocated at a cluster-level (primary care unit) by minimization. Data will be analyzed at the physician level. Primary care units will be eligible if they use electronic prescribing and have at least four physicians willing to participate. Physicians in intervention units will be offered individual educational outreach visits (one for each guideline) at their workplace during a six-month period. Physicians in the control group will be offered a single unrelated group training session. Primary outcomes will be the proportion of cyclooxygenase-2 inhibitors prescribed in the anti-inflammatory class, and the proportion of omeprazole in the proton pump inhibitors class at 18 months post-intervention. Prescription data will be collected from the regional pharmacy claims database. We estimated a sample size of 110 physicians in each group, corresponding to 19 clusters with a mean size of 6 physicians. Outcome collection and data analysis will be blinded to allocation, but due to the nature of the intervention, physicians and detailers cannot be blinded. Discussion This trial will attempt to address unresolved issues in the literature, namely, long term persistence of effect, the importance of sequential visits in an outreach program, and cost issues. If successful, this trial may be the cornerstone for deploying large scale educational outreach programs within the Portuguese National Health Service. Trial registration ClinicalTrials.gov number NCT01984034. PMID:24423370

A personalized intervention to prevent depression in primary care: cost-effectiveness study nested into a clustered randomized trial.

PubMed

Fernández, Anna; Mendive, Juan M; Conejo-Cerón, Sonia; Moreno-Peral, Patricia; King, Michael; Nazareth, Irwin; Martín-Pérez, Carlos; Fernández-Alonso, Carmen; Rodríguez-Bayón, Antonina; Aiarzaguena, Jose Maria; Montón-Franco, Carmen; Serrano-Blanco, Antoni; Ibañez-Casas, Inmaculada; Rodríguez-Sánchez, Emiliano; Salvador-Carulla, Luis; Garay, Paola Bully; Ballesta-Rodríguez, María Isabel; LaFuente, Pilar; Del Mar Muñoz-García, María; Mínguez-Gonzalo, Pilar; Araujo, Luz; Palao, Diego; Gómez, María Cruz; Zubiaga, Fernando; Navas-Campaña, Desirée; Aranda-Regules, Jose Manuel; Rodriguez-Morejón, Alberto; de Dios Luna, Juan; Bellón, Juan Ángel

2018-02-23

Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care. Cost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months. With a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results. Compared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated. ClinicalTrials.gov, NCT01151982. Registered on June 29, 2010.

Effectiveness and cost-effectiveness of implementing HIV testing in primary care in East London: protocol for an interrupted time series analysis.

PubMed

Leber, Werner; Beresford, Lee; Nightingale, Claire; Barbosa, Estela Capelas; Morris, Stephen; El-Shogri, Farah; McMullen, Heather; Boomla, Kambiz; Delpech, Valerie; Brown, Alison; Hutchinson, Jane; Apea, Vanessa; Symonds, Merle; Gilliham, Samantha; Creighton, Sarah; Shahmanesh, Maryam; Fulop, Naomi; Estcourt, Claudia; Anderson, Jane; Figueroa, Jose; Griffiths, Chris

2017-12-14

HIV remains underdiagnosed. Guidelines recommend routine HIV testing in primary care, but evidence on implementing testing is lacking. In a previous study, the Rapid HIV Assessment 2 (RHIVA2) cluster randomised controlled trial, we showed that providing training and rapid point-of-care HIV testing at general practice registration (RHIVA2 intervention) in Hackney led to cost-effective, increased and earlier diagnosis of HIV. However, interventions effective in a trial context may be less so when implemented in routine practice. We describe the protocol for an MRC phase IV implementation programme, evaluating the impact of rolling out the RHIVA2 intervention in a post-trial setting. We will use a longitudinal study to examine if the post-trial implementation in Hackney practices is effective and cost-effective, and a cross-sectional study to compare Hackney with two adjacent boroughs providing usual primary care (Newham) and an enhanced service promoting HIV testing in primary care (Tower Hamlets). Service evaluation using interrupted time series and cost-effectiveness analyses. We will include all general practices in three contiguous high HIV prevalence East London boroughs. All adults aged 16 and above registered with the practices will be included. The interventions to be examined are: a post-trial RHIVA2 implementation programme (including practice-based education and training, external quality assurance, incentive payments for rapid HIV testing and incorporation of rapid HIV testing in the sexual health Local Enhanced Service) in Hackney; the general practice sexual health Network Improved Service in Tower Hamlets and usual care in Newham. Coprimary outcomes are rates of HIV testing and new HIV diagnoses. The chair of the Camden and Islington NHS Research Ethics Committee, London, has endorsed this programme as an evaluation of routine care. Study results will be published in peer-reviewed journals and reported to commissioners. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

PubMed

Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

2014-02-24

The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. ClinicalTrials.gov identifier NCT01232764.

Behavior medicine specialist.

PubMed

Tuso, Phillip

2014-01-01

Total Health is a vision for the future and a strategy to prevent preventable disease, save lives, and make health care more affordable. Total Health means health of mind (behavior health) and health of body (physical health). To achieve Total Health we need healthy people in healthy communities. A behavior medicine specialist is a psychologist who works in the medical home with the primary care physician instead of in the Mental Health Department with a psychiatrist. The key to achieving Total Health will be to transform our current health care system from a focus on treating disease to a focus on preventing disease. This transformation will require complex behavior change interventions and services not usually provided in the medical home. The behavior medicine specialist will bring the knowledge and experience used to treat mental illness into the medical home to help the primary care physician improve the care of all patients in the medical home. The behavior medicine specialist will help improve outcomes in synergy with the primary care physician by universal screening of high-risk diseases, stepped care protocols, and efficient use of all resources available to care for patients in the medical home (health education classes, wellness coaches, and online social networking lifestyle management programs). These interventions should increase patient satisfaction, increase access to specialty care (psychiatry), and help us achieve Total Health.

Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study.

PubMed

Douglas, Pamela S; Pontone, Gianluca; Hlatky, Mark A; Patel, Manesh R; Norgaard, Bjarne L; Byrne, Robert A; Curzen, Nick; Purcell, Ian; Gutberlet, Matthias; Rioufol, Gilles; Hink, Ulrich; Schuchlenz, Herwig Walter; Feuchtner, Gudrun; Gilard, Martine; Andreini, Daniele; Jensen, Jesper M; Hadamitzky, Martin; Chiswell, Karen; Cyr, Derek; Wilk, Alan; Wang, Furong; Rogers, Campbell; De Bruyne, Bernard

2015-12-14

In symptomatic patients with suspected coronary artery disease (CAD), computed tomographic angiography (CTA) improves patient selection for invasive coronary angiography (ICA) compared with functional testing. The impact of measuring fractional flow reserve by CTA (FFRCT) is unknown. At 11 sites, 584 patients with new onset chest pain were prospectively assigned to receive either usual testing (n = 287) or CTA/FFR(CT) (n = 297). Test interpretation and care decisions were made by the clinical care team. The primary endpoint was the percentage of those with planned ICA in whom no significant obstructive CAD (no stenosis ≥50% by core laboratory quantitative analysis or invasive FFR < 0.80) was found at ICA within 90 days. Secondary endpoints including death, myocardial infarction, and unplanned revascularization were independently and blindly adjudicated. Subjects averaged 61 ± 11 years of age, 40% were female, and the mean pre-test probability of obstructive CAD was 49 ± 17%. Among those with intended ICA (FFR(CT)-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFR(CT) arm and 137 (73%) in the usual care arm (risk difference 61%, 95% confidence interval 53-69, P< 0.0001), with similar mean cumulative radiation exposure (9.9 vs. 9.4 mSv, P = 0.20). Invasive coronary angiography was cancelled in 61% after receiving CTA/FFR(CT) results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFR(CT)) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFR(CT) arms. Computed tomographic angiography/fractional flow reserve by CTA was a feasible and safe alternative to ICA and was associated with a significantly lower rate of invasive angiography showing no obstructive CAD. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Integration of HIV Care with Primary Health Care Services: Effect on Patient Satisfaction and Stigma in Rural Kenya

PubMed Central

Odeny, Thomas A.; Penner, Jeremy; Lewis-Kulzer, Jayne; Leslie, Hannah H.; Shade, Starley B.; Adero, Walter; Kioko, Jackson; Cohen, Craig R.; Bukusi, Elizabeth A.

2013-01-01

HIV departments within Kenyan health facilities are usually better staffed and equipped than departments offering non-HIV services. Integration of HIV services into primary care may address this issue of skewed resource allocation. Between 2008 and 2010, we piloted a system of integrating HIV services into primary care in rural Kenya. Before integration, we conducted a survey among returning adults ≥18-year old attending the HIV clinic. We then integrated HIV and primary care services. Three and twelve months after integration, we administered the same questionnaires to a sample of returning adults attending the integrated clinic. Changes in patient responses were assessed using truncated linear regression and logistic regression. At 12 months after integration, respondents were more likely to be satisfied with reception services (adjusted odds ratio, aOR 2.71, 95% CI 1.32–5.56), HIV education (aOR 3.28, 95% CI 1.92–6.83), and wait time (aOR 1.97 95% CI 1.03–3.76). Men's comfort with receiving care at an integrated clinic did not change (aOR = 0.46 95% CI 0.06–3.86). Women were more likely to express discomfort after integration (aOR 3.37 95% CI 1.33–8.52). Integration of HIV services into primary care services was associated with significant increases in patient satisfaction in certain domains, with no negative effect on satisfaction. PMID:23738055

Foot examinations of diabetes patients by primary health care nurses in Auckland, New Zealand.

PubMed

Daly, Barbara; Arroll, Bruce; Sheridan, Nicolette; Kenealy, Timothy; Stewart, Alistair; Scragg, Robert

2014-07-01

To identify factors associated with patients receiving foot examinations by primary health care nurses. A cross-sectional survey of 287 randomly sampled primary health care nurses, from a total of 1091 in Auckland, completed a postal self-administered questionnaire and telephone interview. Biographical and diabetes management details were collected for 265 diabetes patients consulted by the nurses on a randomly selected day. A response rate of 86% was achieved. Nurses examined patient's feet in 46% of consultations. Controlling for demographic variables, foot examinations were associated with age, odds ratio (1.25, 95% CI 0.57-2.74) for patients aged 51-65 years and >66 years (2.50, 1.08-5.75) compared with those ≤50 years, consultations by district compared with practice nurses (14.23, 95% CI 3.82-53.05), special programme consultations compared with usual follow-up consults (8.81, 95% CI 2.99-25.93) and length of consultation (1.89, 0.72-4.97) for 15-30 min and (4.45, 95% CI 1.48-13.41) >30 min compared with consultations ≤15 min, or for wound care (2.58, 1.01-6.61). Diabetes foot examinations by primary health care nurses varies greatly, and are associated with characteristics of the patient (age, need for wound care) and the consultation (district nurses, diabetes programme and duration). Copyright © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Prevalence of Intimate Partner Violence among Women Veterans who Utilize Veterans Health Administration Primary Care.

PubMed

Kimerling, Rachel; Iverson, Katherine M; Dichter, Melissa E; Rodriguez, Allison L; Wong, Ava; Pavao, Joanne

2016-08-01

The objectives of this study were to identify the prevalence of past-year intimate partner violence (IPV) among women Veterans utilizing Veterans Health Administration (VHA) primary care, and to document associated demographic, military, and primary care characteristics. This was a retrospective cohort design, where participants completed a telephone survey in 2012 (84% participation rate); responses were linked to VHA administrative data for utilization in the year prior to the survey. A national stratified random sample of 6,287 women Veteran VHA primary care users participated in the study. Past-year IPV was assessed using the HARK screening tool. Self-report items and scales assessed demographic and military characteristics. Primary care characteristics were assessed via self-report and VHA administrative data. The prevalence of past-year IPV among women Veterans was 18.5% (se = 0.5%), with higher rates (22.2% - 25.5%) among women up to age 55. Other demographic correlates included indicators of economic hardship, lesbian or bisexual orientation, and being a parent/guardian of a child less than 18 years old. Military correlates included service during Vietnam to post-Vietnam eras, less than 10 years of service, and experiences of Military Sexual Trauma (MST). Most (77.3%, se = 1.2%) women who experienced IPV identified a VHA provider as their usual provider. Compared with women who did not report past-year IPV, women who reported IPV had more primary care visits, yet experienced lower continuity of care across providers. The high prevalence of past-year IPV among women beyond childbearing years, the majority of whom primarily rely on VHA as a source of health care, reinforces the importance of screening all women for IPV in VHA primary care settings. Key considerations for service implementation include sensitivity with respect to sexual orientation, race/ethnicity, and other aspects of diversity, as well as care coordination and linkages with social services and MST-related care.

Surgical vs Nonoperative Treatment for Lumbar Disk Herniation

PubMed Central

Weinstein, James N.; Lurie, Jon D.; Tosteson, Tor D.; Skinner, Jonathan S.; Hanscom, Brett; Tosteson, Anna N. A.; Herkowitz, Harry; Fischgrund, Jeffrey; Cammisa, Frank P.; Albert, Todd; Deyo, Richard A.

2008-01-01

Context For patients with lumbar disk herniation, the Spine Patient Outcomes Research Trial (SPORT) randomized trial intent-to-treat analysis showed small but not statistically significant differences in favor of diskectomy compared with usual care. However, the large numbers of patients who crossed over between assigned groups precluded any conclusions about the comparative effectiveness of operative therapy vs usual care. Objective To compare the treatment effects of diskectomy and usual care. Design, Setting, and Patients Prospective observational cohort of surgical candidates with imaging-confirmed lumbar intervertebral disk herniation who were treated at 13 spine clinics in 11 US states and who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003. Interventions Standard open diskectomy vs usual nonoperative care. Main Outcome Measures Changes from baseline in the Medical Outcomes Study Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons/MODEMS version). Results Of the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care. At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain (mean change: surgery, 40.9 vs nonoperative care, 26.0; treatment effect, 14.8; 95% confidence interval, 10.8-18.9), physical function (mean change: surgery, 40.7 vs nonoperative care, 25.3; treatment effect, 15.4; 95% CI, 11.6-19.2), and Oswestry Disability Index (mean change: surgery, −36.1 vs nonoperative care, −20.9; treatment effect, −15.2; 95% CI, −18.5. to −11.8). These differences narrowed somewhat at 2 years: bodily pain (mean change: surgery, 42.6 vs nonoperative care, 32.4; treatment effect, 10.2; 95% CI, 5.9-14.5), physical function (mean change: surgery, 43.9 vs nonoperavtive care 31.9; treatment effect, 12.0; 95% CI; 7.9-16.1), and Oswestry Disability Index (mean change: surgery −37.6 vs nonoperative care −24.2; treatment effect, −13.4; 95% CI, −17.0 to −9.7). Conclusions Patients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups. Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously. Trial Registration clinicaltrials.gov Identifier: NCT00000410 PMID:17119141

Pedometer-Based Internet-Mediated Intervention For Adults With Chronic Low Back Pain: Randomized Controlled Trial

PubMed Central

Kadri, Reema; Hughes, Maria; Kerr, Eve A; Piette, John D; Holleman, Rob; Kim, Hyungjin Myra; Richardson, Caroline R

2013-01-01

Background Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program. Objective The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability. Methods A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points. Results Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant. Conclusions Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements. Trial Registration ClinicalTrials.gov NCT00694018; http://clinicaltrials.gov/ct2/show/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E). PMID:23969029

Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN).

PubMed

Thompson, Tom P; Callaghan, Lynne; Hazeldine, Emma; Quinn, Cath; Walker, Samantha; Byng, Richard; Wallace, Gary; Creanor, Siobhan; Green, Colin; Hawton, Annie; Annison, Jill; Sinclair, Julia; Senior, Jane; Taylor, Adrian H

2018-06-04

People with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK. A multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial. The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants. ISRCTN80475744; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Reducing falls after hospital discharge: a protocol for a randomised controlled trial evaluating an individualised multimodal falls education programme for older adults.

PubMed

Hill, Anne-Marie; Etherton-Beer, Christopher; McPhail, Steven M; Morris, Meg E; Flicker, Leon; Shorr, Ronald; Bulsara, Max; Lee, Den-Ching; Francis-Coad, Jacqueline; Waldron, Nicholas; Boudville, Amanda; Haines, Terry

2017-02-02

Older adults frequently fall after discharge from hospital. Older people may have low self-perceived risk of falls and poor knowledge about falls prevention. The primary aim of the study is to evaluate the effect of providing tailored falls prevention education in addition to usual care on falls rates in older people after discharge from hospital compared to providing a social intervention in addition to usual care. The 'Back to My Best' study is a multisite, single blind, parallel-group randomised controlled trial with blinded outcome assessment and intention-to-treat analysis, adhering to CONSORT guidelines. Patients (n=390) (aged 60 years or older; score more than 7/10 on the Abbreviated Mental Test Score; discharged to community settings) from aged care rehabilitation wards in three hospitals will be recruited and randomly assigned to one of two groups. Participants allocated to the control group shall receive usual care plus a social visit. Participants allocated to the experimental group shall receive usual care and a falls prevention programme incorporating a video, workbook and individualised follow-up from an expert health professional to foster capability and motivation to engage in falls prevention strategies. The primary outcome is falls rates in the first 6 months after discharge, analysed using negative binomial regression with adjustment for participant's length of observation in the study. Secondary outcomes are injurious falls rates, the proportion of people who become fallers, functional status and health-related quality of life. Healthcare resource use will be captured from four sources for 6 months after discharge. The study is powered to detect a 30% relative reduction in the rate of falls (negative binomial incidence ratio 0.70) for a control rate of 0.80 falls per person over 6 months. Results will be presented in peer-reviewed journals and at conferences worldwide. This study is approved by hospital and university Human Research Ethics Committees. ACTRN12615000784516. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Reducing falls after hospital discharge: a protocol for a randomised controlled trial evaluating an individualised multimodal falls education programme for older adults

PubMed Central

Hill, Anne-Marie; Etherton-Beer, Christopher; McPhail, Steven M; Morris, Meg E; Flicker, Leon; Bulsara, Max; Lee, Den-Ching; Francis-Coad, Jacqueline; Waldron, Nicholas; Boudville, Amanda; Haines, Terry

2017-01-01

Introduction Older adults frequently fall after discharge from hospital. Older people may have low self-perceived risk of falls and poor knowledge about falls prevention. The primary aim of the study is to evaluate the effect of providing tailored falls prevention education in addition to usual care on falls rates in older people after discharge from hospital compared to providing a social intervention in addition to usual care. Methods and analyses The ‘Back to My Best’ study is a multisite, single blind, parallel-group randomised controlled trial with blinded outcome assessment and intention-to-treat analysis, adhering to CONSORT guidelines. Patients (n=390) (aged 60 years or older; score more than 7/10 on the Abbreviated Mental Test Score; discharged to community settings) from aged care rehabilitation wards in three hospitals will be recruited and randomly assigned to one of two groups. Participants allocated to the control group shall receive usual care plus a social visit. Participants allocated to the experimental group shall receive usual care and a falls prevention programme incorporating a video, workbook and individualised follow-up from an expert health professional to foster capability and motivation to engage in falls prevention strategies. The primary outcome is falls rates in the first 6 months after discharge, analysed using negative binomial regression with adjustment for participant's length of observation in the study. Secondary outcomes are injurious falls rates, the proportion of people who become fallers, functional status and health-related quality of life. Healthcare resource use will be captured from four sources for 6 months after discharge. The study is powered to detect a 30% relative reduction in the rate of falls (negative binomial incidence ratio 0.70) for a control rate of 0.80 falls per person over 6 months. Ethics and dissemination Results will be presented in peer-reviewed journals and at conferences worldwide. This study is approved by hospital and university Human Research Ethics Committees. Trial registration number ACTRN12615000784516. PMID:28153933

Promoting self-management in diabetes: efficacy of a collaborative care approach.

PubMed

Sieber, William; Newsome, Alita; Lillie, Dustin

2012-12-01

Diabetes is a leading cause of death and is estimated to cost the United States 90 billion dollars annually. Increasing patient self-management skills has been shown to improve outcomes in patients with Type II diabetes. Promotion of shared decision-making between patient and provider is a core element of collaborative care and is especially well suited for increasing patient self-management. Research trials to date have been limited in demonstrating how self-management promotion can be fully integrated into primary care practices. Demonstration of the impact of this approach is needed. This study involves 22 randomly assigned physicians across three family medicine clinics to either provide usual care or work with a part-time collaborative care therapist in their clinic serving as an outreach health coach for their diabetic patients. Each outreach health coach met with each physician in the intervention group to identify patients most in need of intervention, sent identified patients a video on diabetes management, and called to encourage video viewing and discuss any patient-perceived barriers to self-management. Initial markers of patient activation in self-management, patients' video-viewing behavior, and health care encounters in the subsequent 6 months were compared between groups. Results showed that patients targeted by an outreach health coach were more likely to view the video, be seen by their primary care physician (PCP) within 6 months, and have disease-relevant laboratory tests performed than patients receiving usual care from their PCP (p < .05). This approach, linking PCPs with collaborative care staff, is viewed as expanding the engagement of PCPs with the collaborative team for superior patient health outcomes.

The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features.

PubMed

Losina, Elena; Collins, Jamie E; Daigle, Meghan E; Donnell-Fink, Laurel A; Prokopetz, Julian J Z; Strnad, Doris; Lerner, Vladislav; Rome, Benjamin N; Ghazinouri, Roya; Skoniecki, Debra J; Katz, Jeffrey N; Wright, John

2013-10-12

Utilization of total knee arthroplasty is increasing rapidly. A substantial number of total knee arthroplasty recipients have persistent pain after surgery. Our objective was to design a randomized controlled trial to establish the efficacy of a motivational-interviewing-based telephone intervention aimed at improving patient outcomes and satisfaction following total knee arthroplasty. The study was conducted at Brigham and Women's Hospital in Boston, Massachusetts. The study focused on individuals 40 years or older with a primary diagnosis of osteoarthritis who were scheduled for total knee arthroplasty. The study compared two management strategies over the first six months postoperatively: 1) enhanced postoperative care with frequent follow-up by a care navigator; 2) usual postoperative care. Those who were randomized into the enhanced postoperative care arm received ten calls from a trained non-clinician care navigator over the first six postoperative months. The navigator used motivational interviewing techniques to engage patients in discussions related to their rehabilitation goals, including patient's plans for and confidence in achieving those goals. Patients in the usual care arm received standard postoperative management and received no navigator phone calls. Patients in both arms were assessed at baseline, three months, and six months postoperatively. The primary outcome of the study was improvement in function as measured by the difference in Western Ontario and McMaster Universities Osteoarthritis Index function score between preoperative (baseline) status and six months postoperatively. Data were collected to identify factors that may be related to total knee arthroplasty outcomes, including preoperative pain, pain catastrophizing, self-efficacy, and depression. A formal economic analysis is also planned to determine the cost-effectiveness of the care navigator as a component of total knee arthroplasty care. ClinicalTrials.gov NCT01540851.

Implementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT): protocol of a randomised, controlled trial.

PubMed

Rebbeck, Trudy; Leaver, Andrew; Bandong, Aila Nica; Kenardy, Justin; Refshauge, Kathryn; Connelly, Luke; Cameron, Ian; Mitchell, Geoffrey; Willcock, Simon; Ritchie, Carrie; Jagnoor, Jagnoor; Sterling, Michele

2016-04-01

Whiplash-associated disorders (WAD) are a huge worldwide health and economic burden. The propensity towards developing into chronic, disabling conditions drives the rise in health and economic costs associated with treatment, productivity loss and compulsory third party insurance claims. Current treatments fail to address the well-documented heterogeneity of WAD and often result in poor outcomes. A novel approach is to evaluate whether the care provided according to the estimated risk of poor prognosis improves health outcomes while remaining cost-effective. (1) Does a guideline-based clinical pathway of care improve health outcomes after whiplash injury compared to usual care? (2) Does risk of recovery have a differential effect on health outcomes for the clinical pathway of care? (3) Is the clinical pathway of care intervention cost-effective? (4) What are the variations in professional practice between usual care and the clinical pathway of care? Multi-centre, randomised, controlled trial conducted over two Australian states: Queensland and New South Wales. 236 people with WAD (grade I-III, within 6 weeks of injury) and their primary healthcare providers. A clinical pathway of care, with care matched to the predicted risk of poor recovery. Participants at low risk of ongoing pain and disability (hence, predicted to fully recover) will receive up to three sessions of guideline-based advice and exercise with their primary healthcare provider. Participants at medium/high risk of developing ongoing pain and disability will be referred to a specialist (defined as a practitioner with expertise in whiplash) who will conduct a more in-depth physical and psychological assessment. As a result, the specialist will liaise with the original primary healthcare provider and determine one of three further pathways of care. Usual care provided by the primary healthcare provider that is based on clinical judgment. Primary (global rating of change and neck-related disability) and secondary (self-efficacy, pain intensity, general health and disability and psychological health) outcomes will be collected using validated scales. Direct (eg, professional care, transportation costs, time spent for care, co-payments) and indirect (eg, lost economic productivity) costs will be obtained through an electronic cost diary. Health and cost outcomes will be assessed at baseline, 3, 6 and 12 months after randomisation. Professional practice outcomes will be evaluated through questionnaires completed by healthcare providers and their patients at 3 months. Potential participants (patients) will be identified through emergency departments, primary health clinics and advertisements. Eligible participants will complete baseline assessments and will be categorised into low or medium/high risk of poor recovery using a clinical prediction rule. After this assessment, participants will be randomly allocated to either a control group (n=118) or intervention group (n=118), stratified by risk subgroup and treatment site. The participants' nominated primary healthcare providers will be informed of their involvement in the trial. Consent will be obtained from the primary healthcare providers to participate and to obtain information about professional practice. Participants in the intervention group will additionally have access to an interactive website that provides information about whiplash and recovery relative to their risk category. Analysis will be conducted on an intention-to-treat basis. Outcomes will be analysed independently through cross-sectional analyses using generalised linear models methods, with an appropriate link function, to test for an intervention effect, adjusted for the baseline values. The risk category will be tested for its association with treatment effect by adding risk group to the regression equation. Cost-effectiveness will be calculated using utility weights and the resulting measure will be cost per quality-adjusted life year (QALY) saved. Professional practice outcomes will be analysed using descriptive statistics. This research is significant as it will be the first study to address the heterogeneity of whiplash by implementing a clinical pathway of care that matches evidence-based interventions to projected risk of poor recovery. The results of this trial have the potential to change clinical practice for WAD, thereby maximising treatment effects, improving patient outcomes, reducing costs and maintaining the compulsory third party system. Copyright © 2016. Published by Elsevier B.V.

Improving Care for Depression in Obstetrics and Gynecology: A Randomized Controlled Trial

PubMed Central

Melville, Jennifer L.; Reed, Susan D.; Russo, Joan; Croicu, Carmen A.; Ludman, Evette; LaRocco-Cockburn, Anna; Katon, Wayne

2014-01-01

OBJECTIVE To evaluate an evidence-based collaborative depression care intervention adapted to obstetrics and gynecology clinics compared with usual care. METHODS Two-site randomized controlled trial included screen-positive women (Patient Health Questionnaire-9 of at least 10) who then met criteria for major depression, dysthymia or both (Mini-International Neuropsychiatric Interview). Women were randomized to 12-months of collaborative depression management or usual care; 6, 12 and 18-month outcomes were compared. The primary outcomes were change from baseline to 12-months on depression symptoms and functional status. Secondary outcomes included at least 50% decrease and remission in depressive symptoms, global improvement, treatment satisfaction, and quality of care. RESULTS Participants were on average 39 years old, 44% were non-white and 56% had posttraumatic stress disorder. Intervention (n= 102) compared to usual care (n=103) patients had greater improvement in depressive symptoms at 12 months (P< .001) and 18 months (P=.004). The intervention group compared with usual care had improved functioning over 18 months (P< .05), were more likely to have an at least 50% decrease in depressive symptoms at 12 months (relative risk [RR]=1.74, 95% confidence interval [CI] 1.11–2.73), greater likelihood of at least 4 specialty mental health visits (6 month RR=2.70, 95% CI1.73–4.20; 12 month RR=2.53, 95% CI 1.63–3.94), adequate dose of antidepressant (6-month RR=1.64, 95% CI 1.03–2.60; 12-month RR=1.71, 95%CI 1.08 2.73), and greater satisfaction with care (6-month RR=1.70, 95% CI 1.19–2.44; 12-month RR=2.26, 95% CI 1.52–3.36). CONCLUSION Collaborative depression care adapted to women’s health settings improved depressive and functional outcomes and quality of depression care. PMID:24807320

A new model of exercise referral scheme in primary care: is the effect on adherence to physical activity sustainable in the long term? A 15-month randomised controlled trial.

PubMed

Martín-Borràs, Carme; Giné-Garriga, Maria; Puig-Ribera, Anna; Martín, Carlos; Solà, Mercè; Cuesta-Vargas, Antonio I

2018-03-03

Studies had not yet overcome the most relevant barriers to physical activity (PA) adherence. An exercise referral scheme (ERS) with mechanisms to promote social support might enhance adherence to PA in the long term. A randomised controlled trial in 10 primary care centres in Spain. To assess the effectiveness of a primary care-based ERS linked to municipal resources and enhancing social support and social participation in establishing adherence to PA among adults over a 15-month period. 422 insufficiently active participants suffering from at least one chronic condition were included. 220 patients (69.5 (8.4) years; 136 women) were randomly allocated to the intervention group (IG) and 202 (68.2 (8.9) years; 121 women) to the control group (CG). The IG went through a 12-week standardised ERS linked to community resources and with inclusion of mechanisms to enhance social support. The CG received usual care from their primary care practice. The main outcome measure was self-report PA with the International Physical Activity Questionnaire and secondary outcomes included stages of change and social support to PA practice. Participant-level data were collected via questionnaires at baseline, and at months 3, 9 and 15. The study statistician and research assessors were blinded to group allocation. Compared with usual care, follow-up data at month 15 for the ERS group showed a significant increase of self-reported PA (IG: 1373±1845 metabolic equivalents (MET) min/week, n=195; CG: 919±1454 MET min/week, n=144; P=0.009). Higher adherence (in terms of a more active stage of change) was associated with higher PA level at baseline and with social support. Prescription from ordinary primary care centres staff yielded adherence to PA practice in the long term. An innovative ERS linked to community resources and enhancing social support had shown to be sustainable in the long term. NCT00714831; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The state of primary care in the United States of America and lessons for primary care groups in the United Kingdom.

PubMed

Koperski, M

2000-04-01

The health care system of the United States of America (USA) is lavishly funded and those with adequate insurance usually receive excellent attention. However, the system is fragmented and inequitable. Health workers often find it difficult to separate vocational roles from business roles. Care tends to focus on the acute rather than the chronic, on 'episodes of illness' rather than 'person-centred' care, on short-term fixes rather than long-term approaches, on scientific/technical solutions rather than discourse or the 'art of healing', and on individual health rather than population health. The majority of US doctors are trained in the 'hightech' hospital paradigm and there is no equivalent of the United Kingdom (UK) general practitioner (GP), who lies at the hub of a primary health care team (PHCT) and who is charged with taking a long-term view, co-ordinating health care for individual patients, and acting as patient advocate without major conflicting financial incentives. However, primary care groups/trusts (PCGs) could learn from US management and training techniques, case management, NHS Direct equivalents, and the effects of poorly developed PHCTs. PCGs could develop the UK's own version of utilisation management. A cash-limited, unified budget within an underfunded National Health Service poses threats to general practice. In both the USA and the UK, primary care is a prominent tool in new attempts at cost control. PCGs offer the opportunity of better integration with public health and social services, but threaten GPs' role as independent advocates by giving them a rationing role. Managed care has forced a similar role onto our US counterparts with consequent public displeasure and professional disillusion. UK GPs will have to steer a careful course if they are to avoid a similar fate.

Barriers to managing child and adolescent mental health problems: a systematic review of primary care practitioners' perceptions.

PubMed

O'Brien, Doireann; Harvey, Kate; Howse, Jessica; Reardon, Tessa; Creswell, Cathy

2016-10-01

Mental health problems are common and typically have an early onset. Effective treatments for mental health problems in childhood and adolescence are available, yet only a minority of children who are affected access them. This is of serious concern, considering the far-reaching and long-term negative consequences of such problems. Primary care is usually the first port of call for concerned parents so it is important to understand how primary care practitioners manage child and adolescent mental health problems and the barriers they face. To ascertain primary care practitioners' perceptions of the barriers that prevent effective management of child and adolescent mental health problems. A systematic review of qualitative and quantitative literature in a primary care setting. A database search of peer-reviewed articles using PsycINFO, MEDLINE(®), Embase, and Web of Science, from inception (earliest 1806) until October 2014, was conducted. Additional studies were identified through hand searches and forward-citation searches. Studies needed to have at least one search term in four categories: primary care, childhood/adolescence, mental health, and barriers. A total of 4151 articles were identified, of which 43 were included (30 quantitative studies and 13 qualitative studies). The majority of the barriers related to identification, management, and/or referral. Considerable barriers included a lack of providers and resources, extensive waiting lists, and financial restrictions. The identification of a broad range of significant barriers highlights the need to strengthen the ability to deal with these common difficulties in primary care. There is a particular need for tools and training to aid accurate identification and management, and for more efficient access to specialist services. © British Journal of General Practice 2016.

Barriers to managing child and adolescent mental health problems: a systematic review of primary care practitioners’ perceptions

PubMed Central

O’Brien, Doireann; Harvey, Kate; Howse, Jessica; Reardon, Tessa; Creswell, Cathy

2016-01-01

Background Mental health problems are common and typically have an early onset. Effective treatments for mental health problems in childhood and adolescence are available, yet only a minority of children who are affected access them. This is of serious concern, considering the far-reaching and long-term negative consequences of such problems. Primary care is usually the first port of call for concerned parents so it is important to understand how primary care practitioners manage child and adolescent mental health problems and the barriers they face. Aim To ascertain primary care practitioners’ perceptions of the barriers that prevent effective management of child and adolescent mental health problems. Design and setting A systematic review of qualitative and quantitative literature in a primary care setting. Method A database search of peer-reviewed articles using PsycINFO, MEDLINE®, Embase, and Web of Science, from inception (earliest 1806) until October 2014, was conducted. Additional studies were identified through hand searches and forward-citation searches. Studies needed to have at least one search term in four categories: primary care, childhood/adolescence, mental health, and barriers. Results A total of 4151 articles were identified, of which 43 were included (30 quantitative studies and 13 qualitative studies). The majority of the barriers related to identification, management, and/or referral. Considerable barriers included a lack of providers and resources, extensive waiting lists, and financial restrictions. Conclusion The identification of a broad range of significant barriers highlights the need to strengthen the ability to deal with these common difficulties in primary care. There is a particular need for tools and training to aid accurate identification and management, and for more efficient access to specialist services. PMID:27621291

Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial.

PubMed

Fu, Steven S; van Ryn, Michelle; Sherman, Scott E; Burgess, Diana J; Noorbaloochi, Siamak; Clothier, Barbara; Taylor, Brent C; Schlede, Carolyn M; Burke, Randy S; Joseph, Anne M

2014-05-01

Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive. Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy. To assess the effect of a proactive, population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates (ie, abstinence among all smokers including those who use and do not use treatment) compared with usual care among a diverse population of current smokers. The Veterans Victory Over Tobacco Study, a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years. A total of 6400 current smokers, identified using the Department of Veterans Affairs (VA) electronic medical record, were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention. Current smokers were randomized to usual care or proactive care. Proactive care combined (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or in-person). Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services. The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization. A total of 5123 participants were included in the primary analysis. The follow-up survey response rate was 66%. The population-level, 6-month prolonged smoking abstinence rate at 1 year was 13.5% for proactive care compared with 10.9% for usual care (P = .02). Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence (odds ratio [OR], 1.27 [95% CI, 1.03-1.57]). In analyses accounting for nonresponse using likelihood-based not-missing-at-random models, the effect of proactive care on 6-month prolonged abstinence persisted (OR, 1.33 [95% CI, 1.17-1.51]). Proactive, population-based tobacco cessation care using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates. clinicaltrials.gov Identifier: NCT00608426.

A randomized trial of protocol-based care for early septic shock.

PubMed

Yealy, Donald M; Kellum, John A; Huang, David T; Barnato, Amber E; Weissfeld, Lisa A; Pike, Francis; Terndrup, Thomas; Wang, Henry E; Hou, Peter C; LoVecchio, Frank; Filbin, Michael R; Shapiro, Nathan I; Angus, Derek C

2014-05-01

In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary. In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support. We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support. In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).

[Comparing case management care models for people with dementia and their caregivers: the design of the COMPAS study].

PubMed

van Hout, H P J; Macneil Vroomen, J L; Van Mierlo, L D; Meiland, F J M; Moll van Charante, E P; Joling, K J; van den Dungen, P; Dröes, R M; van der Horst, H E; de Rooij, S E J A

2014-04-01

Dementia care in The Netherlands is shifting from fragmented, ad hoc care to more coordinated and personalized care. Case management contributes to this shift. The linkage model and a combination of intensive case management and joint agency care models were selected based on their emerging prominence in The Netherlands. It is unclear if these different forms of case management are more effective than usual care in improving or preserving the functioning and well-being at the patient and caregiver level and at the societal cost. The objective of this article is to describe the design of a study comparing these two case management care models against usual care. Clinical and cost outcomes are investigated while care processes and the facilitators and barriers for implementation of these models are considered. Mixed methods include a prospective, observational, controlled, cohort study among persons with dementia and their primary informal caregiver in regions of The Netherlands with and without case management including a qualitative process evaluation. Community-dwelling individuals with a dementia diagnosis with an informal caregiver are included. The primary outcome measure is the Neuropsychiatric Inventory for the people with dementia and the General Health Questionnaire for their caregivers. Costs are measured from a societal perspective. Semi-structured interviews with stakeholders based on the theoretical model of adaptive implementation are planned. 521 pairs of persons with dementia and their primary informal caregiver were included and are followed over two years. In the linked model substantially more impeding factors for implementation were identified compared with the model. This article describes the design of an evaluation study of two case management models along with clinical and economic data from persons with dementia and caregivers. The impeding and facilitating factors differed substantially between the two models. Further results on cost-effectiveness are expected by the beginning of 2015. This is a Dutch adaptation of MacNeil Vroomen et al., Comparing Dutch case management care models for people with dementia and their caregivers: The design of the COMPAS study.

Care management for low-risk patients with heart failure: a randomized, controlled trial.

PubMed

DeBusk, Robert Frank; Miller, Nancy Houston; Parker, Kathleen Marie; Bandura, Albert; Kraemer, Helena Chmura; Cher, Daniel Joseph; West, Jeffrey Alan; Fowler, Michael Bruce; Greenwald, George

2004-10-19

Nurse care management programs for patients with chronic illness have been shown to be safe and effective. To determine whether a telephone-mediated nurse care management program for heart failure reduced the rate of rehospitalization for heart failure and for all causes over a 1-year period. Randomized, controlled trial of usual care with nurse management versus usual care alone in patients hospitalized for heart failure from May 1998 through October 2001. 5 northern California hospitals in a large health maintenance organization. Of 2786 patients screened, 462 met clinical criteria for heart failure and were randomly assigned (228 to intervention and 234 to usual care). Nurse care management provided structured telephone surveillance and treatment for heart failure and coordination of patients' care with primary care physicians. Time to first rehospitalization for heart failure or for any cause and time to a combined end point of first rehospitalization, emergency department visit, or death. At 1 year, half of the patients had been rehospitalized at least once and 11% had died. Only one third of rehospitalizations were for heart failure. The rate of first rehospitalization for heart failure was similar in both groups (proportional hazard, 0.85 [95% CI, 0.46 to 1.57]). The rate of all-cause rehospitalization was similar (proportional hazard, 0.98 [CI, 0.76 to 1.27]). The findings of this study, conducted in a single health care system, may not be generalizable to other health care systems. The overall effect of the intervention was minor. Among patients with heart failure at low risk on the basis of sociodemographic and medical attributes, nurse care management did not statistically significantly reduce rehospitalizations for heart failure or for any cause. Such programs may be less effective for patients at low risk than those at high risk.

Feasibility of a multifaceted educational strategy for strengthening rural primary health care.

PubMed

Reyes-Morales, Hortensia; Gómez-Bernal, Enrique; Gutiérrez-Alba, Gaudencio; Aguilar-Ye, Arturo; Ruiz-Larios, José Arturo; Alonso-Núñez, Gabriel de Jesús

2017-01-01

To evaluate the feasibility and acceptability of a comprehensive educational strategy designed to improve care quality in rural areas of Mexico. A demonstration study was performed in 18 public rural health centers in Mexico, including an educational intervention that consists of the following steps: Development of the strategy; Selection and training of instructors (specialist physicians from the referral hospital and multidisciplinary field teams); Implementation of the strategy among health care teams for six priority causes of visit, through workshops, individual tutorials, and round-table case-review sessions. Feasibility and acceptability were evaluated using checklists, direct observation, questionnaires and in-depth interviews with key players. Despite some organizational barriers, the strategy was perceived as worthy by the participants because of the personalized tutorials and the improved integration of health teams within their usual professional practice. The educational strategy proved to be acceptable; its feasibility for usual care conditions will depend on the improvement of organizational processes at rural facilities.

Effectiveness and costs of specialised physiotherapy given via ParkinsonNet: a retrospective analysis of medical claims data.

PubMed

Ypinga, Jan H L; de Vries, Nienke M; Boonen, Lieke H H M; Koolman, Xander; Munneke, Marten; Zwinderman, Aeilko H; Bloem, Bastiaan R

2018-02-01

Parkinson's disease is a complex condition that is best managed by specialised professionals. Trials show that specialised allied health interventions are cost-effective, as compared with usual care. We aimed to study the long-term benefits of specialised physiotherapy using the ParkinsonNet approach in real-world practice. We did an observational study, retrospectively analysing a database of health insurance claims that included a representative population of Dutch patients with Parkinson's disease, who were followed for up to 3 years (Jan 1, 2013, to Dec 31, 2015). Eligibility criteria included having both a diagnosis of Parkinson's disease and having received physiotherapy for the disease. Allocation to specialised or usual care physiotherapy was based on the choices of patients and referring physicians. We used a mixed-effects model to compare health-care use and outcomes between patients treated by specialised or usual care physiotherapists. The primary outcome was the percentage of patients with a Parkinson's disease-related complication (ie, visit or admission to hospital because of fracture, other orthopaedic injuries, or pneumonia) adjusted for baseline variables. We compared physiotherapist caseload, the number of physiotherapy sessions, physiotherapy costs, and total health-care costs (including hospital care, but excluding community care, long-term care, and informal care) between the groups, and used a Cox's proportional hazard model for survival time to establish whether mortality was influenced by treatment by a specialised physiotherapist. We analysed 2129 patients (4649 observations) receiving specialised physiotherapy and 2252 patients (5353 observations) receiving usual care physiotherapy. Significantly fewer patients treated by a specialised physiotherapist had a Parkinson's disease-related complication (n=368 [17%]) than patients treated by a usual care physiotherapist (n=480 [21%]; odds ratio 0·67, 95% CI 0·56-0·81, p<0·0001). The annual caseload of patients per therapist was significantly higher for specialised physiotherapists (mean 3·89 patients per therapist [SD 3·91]) than usual care physiotherapists (1·48 [1·24]). Patients who saw specialised physiotherapists received fewer treatment sessions (mean 33·72 [SD 26·70]) than usual care physiotherapists (47·97 [32·11]). Consequently, expenditure was lower for specialised than usual care physiotherapists, both for direct costs (mean €933 [SD 843] vs €1329 [1021]; annual difference €395, 95% CI 358-432, p<0·0001) and total health-care expenditure (€2056 [3272] vs €2586 [3756]; €530, 391-669, p<0·0001). Mortality risk was lower for patients receiving specialised physiotherapy (134 [6%]) compared with patients receiving usual care physiotherapy (205 [9%], p=0·001) before correction for baseline variables, although Cox's survival model showed no significant difference between the two (hazard ratio 0·86, 95% CI 0·69-1·07, p=0·195). These results confirm the findings from controlled trials, and offer evidence that specialised physiotherapy as delivered through ParkinsonNet is associated with fewer Parkinson's disease-related complications and lower costs in real-world practice. Neurologists can facilitate specialised physiotherapy by specific referral to such experts. None. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial.

PubMed

Bekelman, David B; Allen, Larry A; McBryde, Connor F; Hattler, Brack; Fairclough, Diane L; Havranek, Edward P; Turvey, Carolyn; Meek, Paula M

2018-04-01

Many patients with chronic heart failure experience reduced health status despite receiving conventional therapy. To determine whether a symptom and psychosocial collaborative care intervention improves heart failure-specific health status, depression, and symptom burden in patients with heart failure. A single-blind, 2-arm, multisite randomized clinical trial was conducted at Veterans Affairs, academic, and safety-net health systems in Colorado among outpatients with symptomatic heart failure and reduced health status recruited between August 2012 and April 2015. Data from all participants were included regardless of level of participation, using an intent-to-treat approach. Patients were randomized 1:1 to receive the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) intervention or usual care. The CASA intervention included collaborative symptom care provided by a nurse and psychosocial care provided by a social worker, both of whom worked with the patients' primary care clinicians and were supervised by a study primary care clinician, cardiologist, and palliative care physician. The primary outcome was patient-reported heart failure-specific health status, measured by difference in change scores on the Kansas City Cardiomyopathy Questionnaire (range, 0-100) at 6 months. Secondary outcomes included depression (measured by the 9-item Patient Health Questionnaire), anxiety (measured by the 7-item Generalized Anxiety Disorder Questionnaire), overall symptom distress (measured by the General Symptom Distress Scale), specific symptoms (pain, fatigue, and shortness of breath), number of hospitalizations, and mortality. Of 314 patients randomized (157 to intervention arm and 157 to control arm), there were 67 women and 247 men, mean (SD) age was 65.5 (11.4) years, and 178 (56.7%) had reduced ejection fraction. At 6 months, the mean Kansas City Cardiomyopathy Questionnaire score improved 5.5 points in the intervention arm and 2.9 points in the control arm (difference, 2.6; 95% CI, -1.3 to 6.6; P = .19). Among secondary outcomes, depressive symptoms and fatigue improved at 6 months with CASA (effect size of -0.29 [95% CI, -0.53 to -0.04] for depressive symptoms and -0.30 [95% CI, -0.55 to -0.06] for fatigue; P = .02 for both). There were no significant changes in overall symptom distress, pain, shortness of breath, or number of hospitalizations. Mortality at 12 months was similar in both arms (10 patients died receiving CASA, and 13 patients died receiving usual care; P = .52). This multisite randomized clinical trial of the CASA intervention did not demonstrate improved heart failure-specific health status. Secondary outcomes of depression and fatigue, both difficult symptoms to treat in heart failure, improved. clinicaltrials.gov Identifier: NCT01739686.

UK GPs' and practice nurses' views of continuity of care for patients with type 2 diabetes.

PubMed

Alazri, Mohammed H; Heywood, Philip; Neal, Richard D; Leese, Brenda

2007-04-01

Continuity of care is widely regarded as a core value of primary care. Type 2 diabetes is a common chronic disease with major health, social and economic impacts. Primary health care professionals in many countries are involved in the management of patients with type 2 diabetes, but their perspectives on continuity remain neglected in research. To explore UK GPs' and nurses' experiences of continuity of care for patients with type 2 diabetes in primary care settings. Semi-structured individual interviews were conducted with 16 GPs and 18 practice nurses who manage patients with type 2 diabetes recruited from 20 practices with various organizational structures in Leeds, UK. Three types of continuities were identified: relational continuity from the same health care professional, team continuity from a group of health care professionals and cross-boundary continuity across primary-secondary care settings. Relational continuity was influenced by the quality of the patient-health care professional relationship, policy of the National Health Service (NHS) in the UK (new General Medical Services contract), walk-in centres, the behaviour of receptionists and the structure and systems of the practice. Team and cross-boundary continuities were influenced by the relationship between team members and by effective communication. Relational continuity contributed to more 'personal care', but the usual health care professional might know less about diabetes. Team continuity was important in providing 'physical care', but patients could be confused by conflicting advice from different professionals. Cross-boundary continuity helps to provide 'expert advice', but is dependent upon effective communication. GPs and practice nurses dealing with patients with type 2 diabetes identified three types of continuities, each influenced by several factors. Relational continuity deals better with psychosocial care while team continuity promotes better physical care; therefore, imposing one type of continuity may inhibit good diabetic care. Cross-boundary continuity between primary and secondary care is fundamental to contemporary diabetic services and ways should be found to achieve more effective communication.

[Doctor shopping: the difficult-to-manage patient].

PubMed

de Zwaan, Martina; Müller, Astrid

2006-08-01

Medically unexplained symptoms and bodily dysfunctions are the single most prevalent class of symptoms in primary care. Differences in opinion as to the cause of the illness between the patients and the health care professionals make somatoform disorders a challenge for the patient-doctor relationship, and frequently produce negative feelings in health care professionals. The patients are usually reluctant to consider psychosocial aspects of their illness to be a factor. Early recognition of patients with somatization tendencies would be beneficial so that more effective treatment could begin sooner and unnecessary treatment be avoided. In order not to reinforce the patient's symptomatology, physicians should schedule appointments in a time contingent rather than a symptom contingent manner. Repetition of different tests should be avoided despite patients' demands in order not to further exacerbate the disorder. In many patients, psychotherapy should be recommended, although motivational work should already be initiated at the primary care stage.

Very high volume hemofiltration with the Cascade system in septic shock patients.

PubMed

Quenot, Jean-Pierre; Binquet, Christine; Vinsonneau, Christophe; Barbar, Saber-David; Vinault, Sandrine; Deckert, Valerie; Lemaire, Stéphanie; Hassain, Ali Ait; Bruyère, Rémi; Souweine, Bertrand; Lagrost, Laurent; Adrie, Christophe

2015-12-01

We compared hemodynamic and biological effects of the Cascade system, which uses very high volume hemofiltration (HVHF) (120 mL kg(-1) h(-1)), with those of usual care in patients with septic shock. Multicenter, prospective, randomized, open-label trial in three intensive care units (ICU). Adults with septic shock with administration of epinephrine/norepinephrine were eligible. Patients were randomized to usual care plus HVHF (Cascade group), or usual care alone (control group). Primary end point was the number of catecholamine-free days up to 28 days after randomization. Secondary end points were number of days free of mechanical ventilation, renal replacement therapy (RRT) or ICU up to 90 days, and 7-, 28-, and 90-day mortality. We included 60 patients (29 Cascade, 31 usual care). Baseline characteristics were comparable. Median number of catecholamine-free days was 22 [IQR 11-23] vs 20 [0-25] for Cascade vs control; there was no significant difference even after adjustment. There was no significant difference in number of mechanical ventilation-free days or ICU requirement. Median number of RRT-free days was 85 [46-90] vs 74 [0-90] for Cascade vs control groups, p = 0.42. By multivariate analysis, the number of RRT-free days was significantly higher in the Cascade group (up to 25 days higher after adjustment). There was no difference in mortality at 7, 28, or 90 days. Very HVHF using the Cascade system can safely be used in patients presenting with septic shock, but it was not associated with a reduction in the need for catecholamines during the first 28 days.

Cost-Effectiveness Analysis of Interventions to Reduce Risk of Aspiration in Elderly Cancer Survivors Residing in Skilled Nursing Facilities.

PubMed

Mantravadi, S

2017-04-01

Aspiration can occur in patients of any age group, but it can be prevented. The primary population at risk is made up of survivors of cancer because of their increased risk of mucositis, mucosal atrophy, and dysphagia associated with chemotherapy, radiotherapy, and the disease process itself. The rate of incidence of aspiration cannot be quantified, because minor cases of aspiration often go unreported. Sequelae ensuing from aspirations can include pneumonia, end-stage kidney disease, dialysis, and death. Analyses of cost, decision-tree modeling, and cost effectiveness were performed to compare a hypothetical, interventional model based on best practices with usual (standard) care. A societal perspective was used as the economic view point. Direct costs, caregiver time, and market values for wages were estimated for the 2 interventions. Effectiveness values for the cost-effectiveness and decision-tree analyses were obtained from the literature. The incremental-cost-effectiveness ratio was calculated and used to compare the intervention with usual care. The interventional method was more costly but more effective than usual care. A sensitivity analysis considered the uncertainty of event probability (aspiration vs no aspiration). The interventional protocol for aspiration reduction continued to be more cost effective than usual care. Aspiration takes a financial toll on all facets of health care, including on nurses, skilled nursing facilities, patients, their families, and insurers, among others. Implementing guidelines that describe best practices for aspiration appears to be a cost-effective strategy for reducing aspirations among cancer survivors - especially elderly patients - who live in skilled nursing facilities.

The influence of primary health care professionals in encouraging exercise and physical activity uptake among White and South Asian older adults: experiences of young older adults.

PubMed

Horne, Maria; Skelton, Dawn; Speed, Shaun; Todd, Chris

2010-01-01

To explore the influence of primary health care professionals in increasing exercise and physical activity among 60-70-year-old White and South Asian community dwellers. Fifteen focus groups and 40 in-depth interviews with community dwelling White and South Asian 60-70-year olds. The sample was selected to include people with very different experiences of participation and non-participation in exercise and physical activity. Data were analysed using framework analysis. Primary health care professionals' advice and support was found to be a motivator to the initiation of exercise and physical activity. However, this was usually in relation to advice on weight reduction, cardiac conditions and mobility issues, but not generally to improve or increase activity levels. An underlying attitude of genuine interest and empathy was valued and shaped decisions about initiating and/or increasing activity levels. Primary health care professionals should be encouraged to show interest and empathy with older people about the positive benefits of exercise and physical activity to them individually. This advice needs to be tailored to the older adult's symptoms. Primary health care professionals need to be able to provide specific advice as to the quantity (frequency, duration, intensity and type) of exercise or physical activity to undertake. Practitioners need to listen to their patients' needs, show empathy and avoid ageism during consultations.

A randomized controlled trial of the effect of intrapartum intravenous fluid management on breastfed newborn weight loss.

PubMed

Watson, Jo; Hodnett, Ellen; Armson, B Anthony; Davies, Barbara; Watt-Watson, Judy

2012-01-01

To determine the effect of conservative versus usual intrapartum intravenous (IV) fluid management for low-risk women receiving epidural analgesia on weight loss in breastfed newborns. A randomized controlled trial. A tertiary perinatal center in a large urban setting. Women experiencing uncomplicated pregnancies who planned to have epidural analgesia and to breastfeed. Healthy pregnant women were randomized to receive an IV epidural preload volume of <500 mLs continuing at an hourly rate of 75-100 mL/h (conservative care) or an epidural preload volume of ≥500 mLs and an hourly rate >125 mL/h (usual care). The primary study outcome was breastfed newborn weight loss >7% prior to hospital discharge. Secondary study outcomes included breastfeeding exclusivity, referral to outpatient breastfeeding clinic support, and delayed discharge. Other outcomes were admission to the neonatal intensive care unit and cord blood pH <7.25. Two hundred women participated (100 in the conservative care and 100 in the usual care groups). Forty-eight of 100 infants in the usual care group and 44 of the 100 infants in the conservative care group lost >7% of their birth weight prior to discharge, p < 0.52 RR 0.92 [0.68-1.24]. A policy of restricted IV fluids did not affect newborn weight loss. Women and their care providers should be reassured that the volumes of IV fluid <2500 mLs are unlikely to have a clinically meaningful effect on breastfed newborn weight loss >7%. Exploratory analyses suggest that breastfed newborn weight loss increases when intrapartum volumes infused are >2500 mLs. Care providers are encouraged to consider volumes of IV fluid infused intrapartum as a factor that may have contributed to early newborn weight loss in the first 48 h of life. © 2012 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Cost-effectiveness of integrated COPD care: the RECODE cluster randomised trial.

PubMed

Boland, Melinde R S; Kruis, Annemarije L; Tsiachristas, Apostolos; Assendelft, Willem J J; Gussekloo, Jacobijn; Blom, Coert M G; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H

2015-11-01

To investigate the cost-effectiveness of a chronic obstructive pulmonary disease (COPD) disease management (COPD-DM) programme in primary care, called RECODE, compared to usual care. A 2-year cluster-randomised controlled trial. 40 general practices in the western part of the Netherlands. 1086 patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. A multidisciplinary team of caregivers was trained in motivational interviewing, setting up individual care plans, exacerbation management, implementing clinical guidelines and redesigning the care process. In addition, clinical decision-making was supported by feedback reports provided by an ICT programme. We investigated the impact on health outcomes (quality-adjusted life years (QALYs), Clinical COPD Questionnaire, St. George's Respiratory Questionnaire and exacerbations) and costs (healthcare and societal perspective). The intervention costs were €324 per patient. Excluding these costs, the intervention group had €584 (95% CI €86 to €1046) higher healthcare costs than did the usual care group and €645 (95% CI €28 to €1190) higher costs from the societal perspective. Health outcomes were similar in both groups, except for 0.04 (95% CI -0.07 to -0.01) less QALYs in the intervention group. This integrated care programme for patients with COPD that mainly included professionally directed interventions was not cost-effective in primary care. Netherlands Trial Register NTR2268. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Evaluating the role of clinical pharmacists in pre-procedural anticoagulation management.

PubMed

Kataruka, Akash; Renner, Elizabeth; Barnes, Geoffrey D

2018-02-01

While physicians are typically responsible for managing perioperative warfarin, clinic pharmacists may improve pre-procedural decision-making. We assessed the impact of pharmacist-driven care for chronic warfarin-treated patients undergoing outpatient right heart catheterization (RHC). 200 warfarin patients who underwent RHC between January 2012 and September 2015 were analyzed. Pharmacist-care (n = 79) was compared to the usual care model (n = 121). The primary outcome was a composite of (1) documentation of anticoagulation plan, (2) holding warfarin at least 5 days prior to procedure, (3) guideline-congruent low molecular weight heparin (LMWH) bridging, and (4) correct LMWH dosing if bridging deemed necessary. Chi-squared test performed to assess the role of pharmacist. A multivariable logistic regression analysis was performed to the composite endpoint, adjusted for the month of procedure. Compared to the usual care model, pharmacist-driven care (OR 4.69, 95% CI 1.73-12.71, p = 0.002) and date of the procedure (OR 1.06/month, 95% CI 1.01-1.10, p = 0.011) were independently associated with the primary composite outcome. Of the individual outcome components, pharmacist-driven care was only associated with documentation (96.2% vs. 67.8%, OR 9.19, 95% CI 2.19-38.62, p = 0.002). Remaining components including hold warfarin for at least 5 days, appropriate bridging and correct LMWH dosing were not significantly associated with pharmacist-care. Pharmacist-care is associated with better guideline-based anticoagulation management, but this was primarily driven by improved documentation. The impact of pharmacist managed peri-procedural anticoagulation on clinical outcomes remains unknown.

Cost-effectiveness of integrated COPD care: the RECODE cluster randomised trial

PubMed Central

Boland, Melinde R S; Kruis, Annemarije L; Tsiachristas, Apostolos; Assendelft, Willem J J; Gussekloo, Jacobijn; Blom, Coert M G; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H

2015-01-01

Objectives To investigate the cost-effectiveness of a chronic obstructive pulmonary disease (COPD) disease management (COPD-DM) programme in primary care, called RECODE, compared to usual care. Design A 2-year cluster-randomised controlled trial. Setting 40 general practices in the western part of the Netherlands. Participants 1086 patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. Interventions A multidisciplinary team of caregivers was trained in motivational interviewing, setting up individual care plans, exacerbation management, implementing clinical guidelines and redesigning the care process. In addition, clinical decision-making was supported by feedback reports provided by an ICT programme. Main outcome measures We investigated the impact on health outcomes (quality-adjusted life years (QALYs), Clinical COPD Questionnaire, St. George's Respiratory Questionnaire and exacerbations) and costs (healthcare and societal perspective). Results The intervention costs were €324 per patient. Excluding these costs, the intervention group had €584 (95% CI €86 to €1046) higher healthcare costs than did the usual care group and €645 (95% CI €28 to €1190) higher costs from the societal perspective. Health outcomes were similar in both groups, except for 0.04 (95% CI −0.07 to −0.01) less QALYs in the intervention group. Conclusions This integrated care programme for patients with COPD that mainly included professionally directed interventions was not cost-effective in primary care. Trial registration number Netherlands Trial Register NTR2268. PMID:26525419

A structured tool to improve clinical outcomes of Type 2 diabetes mellitus patients: A randomised controlled trial.

PubMed

Ayadurai, Shamala; Sunderland, V Bruce; Tee, Lisa Bg; Md Said, Siti Norlina; Hattingh, H Laetitia

2018-06-07

A review of pharmacist diabetes intervention studies revealed lack of structured process in providing diabetes care which consequently produced varied results from increased to minimal improvements. This study aimed to determine the effectiveness of a structured clinical guidelines tool, the Simpler™ tool, in the delivery of diabetes care. The primary outcome was significant improvement in HbA1c (glycated haemoglobin). Secondary outcomes were improved lipid profiles and blood pressure (BP). A 6-month, parallel, multi-centre, two arms, randomised controlled trial involving 14 pharmacists at seven primary care clinics was conducted in Johor, Malaysia. Pharmacists without prior specialised diabetes training were trained to use the tool. Patients were randomised within each centre to: 1) Simpler™ care (SC), receiving care from pharmacists who applied the tool (n=55); 2) Usual care (UC), receiving usual care and dispensing services (n=69). SC reduced HbA1c significantly by 1.59% (95%CI: -2.2, -0.9) compared to 0.25% (95%CI: -0.62, 0.11), (P=<0.001) in UC. In addition, SC patients had significantly improved systolic BP: (-6.28 mmHg (95%CI: -10.5, 2.0), p=0.005). The proportion of patients who reached the Malaysian guideline treatment goals were significantly more in the SC arm (14.3% vs 1.5% for HbA1c, p=0.020; 80% vs 42% for systolic BP, p=0.001; 60.5% vs 40.4% for LDL cholesterol, p=0.046). Use of the Simpler™ tool facilitated delivery of comprehensive evidence-based diabetes management and significantly improved clinical outcomes. The Simpler™ tool supported pharmacists in providing enhanced structured diabetes care. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Case Management in Primary Care for Frequent Users of Health Care Services: A Mixed Methods Study.

PubMed

Hudon, Catherine; Chouinard, Maud-Christine; Dubois, Marie-France; Roberge, Pasquale; Loignon, Christine; Tchouaket, Éric; Lambert, Mireille; Hudon, Émilie; Diadiou, Fatoumata; Bouliane, Danielle

2018-05-01

This study aimed to evaluate the effects of the V1SAGES case management intervention (Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support) for frequent users of health care services with chronic disease and complex care needs on psychological distress and patient activation. We used a 2-phase sequential mixed methods design. The first phase was a pragmatic randomized controlled trial with intention-to-treat analysis that measured the effects of the intervention compared with usual care on psychological distress and patient activation before and after 6 months. The second phase had a qualitative descriptive design and entailed thematic analysis of in-depth interviews (25 patients, 6 case management nurses, 9 health managers) and focus groups (8 patients' spouses, 21 family physicians) to understand stakeholders' perceived effects of the intervention on patients. A total of 247 patients were randomized into the intervention group (n = 126) or the control group (n = 121). Compared with usual care, the intervention reduced psychological distress (odds ratio = 0.43; 95% CI, 0.19-0.95, P = .04), but did not have any significant effect on patient activation ( P = .43). Qualitative results suggested that patients and their spouses benefitted from the case management intervention, gaining a sense of security, and stakeholders noted better patient self-management of health. Together, our study's quantitative and qualitative results suggest that case management reduces psychological distress, making patients and caregivers feel more secure, whereas impact on self-management is unclear. Case management is a promising avenue to improve outcomes among frequent users of health care with complex needs. © 2018 Annals of Family Medicine, Inc.

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure.

PubMed

Kim, Yoon-Nyun; Shin, Dong Gu; Park, Sungha; Lee, Chang Hee

2015-07-01

The effectiveness of remote patient monitoring and physician care for the treatment of hypertension has not been demonstrated in a randomized clinical trial. The objective of this study was to evaluate the effectiveness of remote patient monitoring with or without remote physician care in reducing office blood pressure in patients with hypertension. A total of 374 hypertensive patients over 20 years of age were randomized into the following three groups: group (1) control, the patients received usual clinical care with home BP monitoring; group (2) the patients were remotely monitored and received office follow-up; and group (3) the patients received remote monitoring without physician office care using the remote monitoring device. For each group, in-office follow-up care was scheduled every 8 weeks for 24 weeks. The primary end point was the difference in sitting SBP at the 24-week follow-up. No difference between the three groups was observed in the primary end point (adjusted mean sitting SBP was as follows: group 1: -8.9±15.5 mm Hg, group 2: -11.3±15.9 mm Hg, group 3: -11.6±19.8 mm Hg, (NS). Significant differences in achieving the target BP at the 24th week of follow-up were observed between groups 1 and 2. The subjects over 55-years old had a significant decrease in the adjusted mean sitting SBP in groups 2 and 3 compared with that of the control group. Remote monitoring alone or remote monitoring coupled with remote physician care was as efficacious as the usual office care for reducing blood pressure with comparable safety and efficacy in hypertensive patients.

Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City

PubMed Central

2014-01-01

Background Mexico has the highest adult overweight and obesity prevalence in the Americas; 23.8% of children <5 years old are at risk for overweight and 9.7% are already overweight or obese. Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social (IMSS) clinics. Methods We randomized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care. We recruited 306 parent-child pairs: 168 intervention, 138 usual care. Children were 2-5 years old with WHO body mass index (BMI) z-score 0-3. We measured children’s height and weight and parents reported children’s diet and physical activity at baseline and 3 and 6-month follow-up. We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values. Results 93 (55%) intervention and 96 (70%) usual care families completed 3 and 6-month follow-up. At 3 months, intervention v. usual care children increased vegetables by 6.3 servings/week (95% CI, 1.8, 10.8). In stratified analyses, intervention participants with high program adherence (5-6 sessions) decreased snacks and screen time and increased vegetables v. usual care. No further effects on behavioral outcomes or BMI were observed. Transportation time and expenses were barriers to adherence. 90% of parents who completed the post-intervention survey were satisfied with the program. Conclusions Although satisfaction was high among participants, barriers to participation and retention included transportation cost and time. In intention to treat analyses, we found intervention effects on vegetable intake, but not other behaviors or BMI. Trial registration ClinicalTrials.gov NCT01539070. Comisión Nacional de Investigación Científica del IMSS: 2009-785-120. PMID:24649831

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

PubMed

Shin, Byung-Cheul; Kim, Me-Riong; Cho, Jae-Heung; Jung, Jae-Young; Kim, Koh-Woon; Lee, Jun-Hwan; Nam, Kibong; Lee, Min Ho; Hwang, Eui-Hyoung; Heo, Kwang-Ho; Kim, Namkwen; Ha, In-Hyuk

2017-01-17

While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Cost-Effectiveness of a Community Pharmacist Intervention in Patients with Depression: A Randomized Controlled Trial (PRODEFAR Study)

PubMed Central

Rubio-Valera, Maria; Bosmans, Judith; Fernández, Ana; Peñarrubia-María, Maite; March, Marian; Travé, Pere; Bellón, Juan A.; Serrano-Blanco, Antoni

2013-01-01

Background Non-adherence to antidepressants generates higher costs for the treatment of depression. Little is known about the cost-effectiveness of pharmacist's interventions aimed at improving adherence to antidepressants. The study aimed to evaluate the cost-effectiveness of a community pharmacist intervention in comparison with usual care in depressed patients initiating treatment with antidepressants in primary care. Methods Patients were recruited by general practitioners and randomized to community pharmacist intervention (87) that received an educational intervention and usual care (92). Adherence to antidepressants, clinical symptoms, Quality-Adjusted Life-Years (QALYs), use of healthcare services and productivity losses were measured at baseline, 3 and 6 months. Results There were no significant differences between groups in costs or effects. From a societal perspective, the incremental cost-effectiveness ratio (ICER) for the community pharmacist intervention compared with usual care was €1,866 for extra adherent patient and €9,872 per extra QALY. In terms of remission of depressive symptoms, the usual care dominated the community pharmacist intervention. If willingness to pay (WTP) is €30,000 per extra adherent patient, remission of symptoms or QALYs, the probability of the community pharmacist intervention being cost-effective was 0.71, 0.46 and 0.75, respectively (societal perspective). From a healthcare perspective, the probability of the community pharmacist intervention being cost-effective in terms of adherence, QALYs and remission was of 0.71, 0.76 and 0.46, respectively, if WTP is €30,000. Conclusion A brief community pharmacist intervention addressed to depressed patients initiating antidepressant treatment showed a probability of being cost-effective of 0.71 and 0.75 in terms of improvement of adherence and QALYs, respectively, when compared to usual care. Regular implementation of the community pharmacist intervention is not recommended. Trial Registration ClinicalTrials.gov NCT00794196 PMID:23950967

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial.

PubMed

Moe, Rikke Helene; Grotle, Margreth; Kjeken, Ingvild; Olsen, Inge Christoffer; Mowinckel, Petter; Haavardsholm, Espen A; Hagen, Kåre Birger; Kvien, Tore K; Uhlig, Till

2016-02-01

Osteoarthritis (OA) is one of the leading causes of pain and disability. Given the constraint in the provision of care, there is a need to develop and assess effectiveness of new treatment models. The objective was to compare satisfaction with and effectiveness of a new integrated multidisciplinary outpatient program with usual care in an outpatient clinic for patients with OA. Patients with clinical OA referred to a rheumatology outpatient clinic were randomized to a 3.5-h multidisciplinary group-based educational program followed by individual consultations, or to usual care. The primary outcome was satisfaction with the health service evaluated on a numerical rating scale (0 = extremely unsatisfied, 10 = extremely satisfied) after 4 months. Secondary outcomes included health-related quality of life measures. Of 391 patients, 86.4% (n = 338) were women, and mean age was 61.2 (SD 8.0) years. At 4 months, patients who received integrated multidisciplinary care were significantly more satisfied with the health service compared with controls, with a mean difference of -1.05 (95% CI -1.68 to -0.43, p < 0.001). Among secondary outcomes, only self-efficacy with other symptoms scale (10-100) improved significantly in the multidisciplinary group compared with controls at 4 months (3.59, 95% CI 0.69-6.5, p = 0.02). At 12 months, the Australian/Canadian Hand Osteoarthritis Index pain (0-10) and fatigue scores (0-10) were slightly worse in the multidisciplinary group with differences of 0.38 (95% CI 0.06-0.71, p = 0.02) and 0.55 (95% CI 0.02-1.07, p = 0.04), respectively. Patients receiving an integrated multidisciplinary care model were more satisfied with healthcare than those receiving usual care, whereas there were no clinically relevant improvements in health outcomes.

Effect of a peer support service on breast-feeding continuation in the UK: a randomised controlled trial.

PubMed

Jolly, Kate; Ingram, Lucy; Freemantle, Nick; Khan, Khalid; Chambers, Jacky; Hamburger, Ros; Brown, Julia; Dennis, Cindy-Lee; Macarthur, Christine

2012-12-01

to assess the effectiveness of a peer support worker (PSW) service on breast-feeding continuation. cluster randomised controlled trial (ISRCTN16126175). Primary Care Trust, UK serving a multi-ethnic, socio-economically disadvantaged population. 2,724 women giving birth following antenatal care from 66 clinics: 33 clinics (1,267 women) randomised to the PSW service and 33 clinics (1,457 women) to usual care. 848 women consented to additional follow-up by questionnaire at 6 months. PSW service provided in the antenatal and postnatal period. any and exclusive breast feeding at 10-14 days obtained from routine computerised records and at 6 weeks and 6 months from a questionnaire. follow-up: 94% at 10-14 days, 67.5% at 6 months. There was no difference in any breast feeding at 10-14 days between intervention and usual care, odds ratio (OR) 1.07 (95% CI 0.87-1.31, p=0.54). Proportion of women reporting any breast feeding in the intervention group at 6 weeks was 62.7% and 64.5% in the usual care group OR 0.93 (95% CI 0.64-1.35); and at 6 months was 34.3% and 38.9%, respectively, OR 1.06 (95% CI 0.71-1.58). universal antenatal peer support and postnatal peer support for women who initiated breast feeding did not improve breast-feeding rates up to 6 months in this UK population. with high levels of professional support part of usual maternity care it may not be possible for low intensity peer support to produce additional benefit. More intensive or targeted programmes might be effective, but should have concurrent high quality evaluation. Copyright © 2011 Elsevier Ltd. All rights reserved.

Perceived social support mediates anxiety and depressive symptom changes following primary care intervention.

PubMed

Dour, Halina J; Wiley, Joshua F; Roy-Byrne, Peter; Stein, Murray B; Sullivan, Greer; Sherbourne, Cathy D; Bystritsky, Alexander; Rose, Raphael D; Craske, Michelle G

2014-05-01

The current study tested whether perceived social support serves as a mediator of anxiety and depressive symptom change following evidence-based anxiety treatment in the primary care setting. Gender, age, and race were tested as moderators. Data were obtained from 1004 adult patients (age M = 43, SD = 13; 71% female; 56% White, 20% Hispanic, 12% Black) who participated in a randomized effectiveness trial (coordinated anxiety learning and management [CALM] study) comparing evidence-based intervention (cognitive-behavioral therapy and/or psychopharmacology) to usual care in the primary care setting. Patients were assessed with a battery of questionnaires at baseline, as well as at 6, 12, and 18 months following baseline. Measures utilized in the mediation analyses included the Abbreviated Medical Outcomes (MOS) Social Support Survey, the Brief Symptom Index (BSI)-Somatic and Anxiety subscales, and the Patient Health Questionnaire (PHQ-9). There was a mediating effect over time of perceived social support on symptom change following treatment, with stronger effects for 18-month depression than anxiety. None of the mediating pathways were moderated by gender, age, or race. Perceived social support may be central to anxiety and depressive symptom changes over time with evidence-based intervention in the primary care setting. These findings possibly have important implications for development of anxiety interventions. © 2013 Wiley Periodicals, Inc.

Web-based weight loss in primary care: a randomized controlled trial.

PubMed

Bennett, Gary G; Herring, Sharon J; Puleo, Elaine; Stein, Evelyn K; Emmons, Karen M; Gillman, Matthew W

2010-02-01

Evidence is lacking regarding effective and sustainable weight loss approaches for use in the primary care setting. We conducted a 12-week randomized controlled trial to evaluate the short-term efficacy of a web-based weight loss intervention among 101 primary care patients with obesity and hypertension. Patients had access to a comprehensive website that used a moderate-intensity weight loss approach designed specifically for web-based implementation. Patients also participated in four (two in-person and two telephonic) counseling sessions with a health coach. Intent-to-treat analysis showed greater weight loss at 3 months (-2.56 kg; 95% CI -3.60, -1.53) among intervention participants (-2.28 +/- 3.21 kg), relative to usual care (0.28 +/- 1.87 kg). Similar findings were observed among intervention completers (-3.05 kg; 95% CI -4.24, -1.85). High rates of participant retention (84%) and website utilization were observed, with the greatest weight loss found among those with a high frequency of website logins (quartile 4 vs. 1: -4.16 kg; 95% CI -1.47, -6.84). The intervention's approach promoted moderate weight loss at 12 weeks, though greater weight loss was observed among those with higher levels of website utilization. Efficacious web-based weight loss interventions can be successfully offered in the primary care setting.

Mindfulness-Based Cognitive Therapy in Advanced Prostate Cancer: A Randomized Controlled Trial.

PubMed

Chambers, Suzanne K; Occhipinti, Stefano; Foley, Elizabeth; Clutton, Samantha; Legg, Melissa; Berry, Martin; Stockler, Martin R; Frydenberg, Mark; Gardiner, Robert A; Lepore, Stephen J; Davis, Ian D; Smith, David P

2017-01-20

Purpose Advanced prostate cancer (PC) is associated with substantial psychosocial morbidity. We sought to determine whether mindfulness-based cognitive therapy (MBCT) reduces distress in men with advanced PC. Methods Men with advanced PC (proven metastatic and/or castration-resistant biochemical progression) were randomly assigned to an 8-week, group-based MBCT intervention delivered by telephone (n = 94) or to minimally enhanced usual care (n = 95). Primary intervention outcomes were psychological distress, cancer-specific distress, and prostate-specific antigen anxiety. Mindfulness skills were assessed as potential mediators of effect. Participants were assessed at baseline and were followed up at 3, 6, and 9 months. Main statistical analyses were conducted on the basis of intention to treat. Results Fourteen MBCT groups were conducted in the intervention arm. Facilitator adherence ratings were high (> 93%). Using random-effects mixed-regression models, intention-to-treat analyses indicated no significant changes in intervention outcomes or in engagement with mindfulness for men in MBCT compared with those receiving minimally enhanced usual care. Per-protocol analyses also found no differences between arms in outcomes or engagement, with the exception of the mindfulness skill of observing, which increased over time for men in MBCT compared with usual care ( P = .032). Conclusion MBCT in this format was not more effective than minimally enhanced usual care in reducing distress in men with advanced PC. Future intervention research for these men should consider approaches that map more closely to masculinity.

The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

PubMed

Darlow, Ben; Stanley, James; Dean, Sarah; Abbott, J Haxby; Garrett, Sue; Mathieson, Fiona; Dowell, Anthony

2017-10-17

Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care. This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted. In the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care. Australian New Zealand Clinical Trials Registry, ACTRN12616000888460 . Registered on 6 July 2016.

The effect of improving primary care depression management on employee absenteeism and productivity. A randomized trial.

PubMed

Rost, Kathryn; Smith, Jeffrey L; Dickinson, Miriam

2004-12-01

To test whether an intervention to improve primary care depression management significantly improves productivity at work and absenteeism over 2 years. Twelve community primary care practices recruiting depressed primary care patients identified in a previsit screening. Practices were stratified by depression treatment patterns before randomization to enhanced or usual care. After delivering brief training, enhanced care clinicians provided improved depression management over 24 months. The research team evaluated productivity and absenteeism at baseline, 6, 12, 18, and 24 months in 326 patients who reported full-or part-time work at one or more completed waves. Employed patients in the enhanced care condition reported 6.1% greater productivity and 22.8% less absenteeism over 2 years. Consistent with its impact on depression severity and emotional role functioning, intervention effects were more observable in consistently employed subjects where the intervention improved productivity by 8.2% over 2 years at an estimated annual value of US 1982 dollars per depressed full-time equivalent and reduced absenteeism by 28.4% or 12.3 days over 2 years at an estimated annual value of US 619 dollars per depressed full-time equivalent. This trial, which is the first to our knowledge to demonstrate that improving the quality of care for any chronic disease has positive consequences for productivity and absenteeism, encourages formal cost-benefit research to assess the potential return-on-investment employers of stable workforces can realize from using their purchasing power to encourage better depression treatment for their employees.

Automated Risk Assessment for Stroke in Atrial Fibrillation (AURAS-AF)--an automated software system to promote anticoagulation and reduce stroke risk: study protocol for a cluster randomised controlled trial.

PubMed

Holt, Tim A; Fitzmaurice, David A; Marshall, Tom; Fay, Matthew; Qureshi, Nadeem; Dalton, Andrew R H; Hobbs, F D Richard; Lasserson, Daniel S; Kearley, Karen; Hislop, Jenny; Jin, Jing

2013-11-13

Patients with atrial fibrillation (AF) are at significantly increased risk of stroke. Oral anticoagulants (OACs) substantially reduce this risk, with gains seen across the spectrum of baseline risk. Despite the benefit to patients, OAC prescribing remains suboptimal in the United Kingdom (UK). We will investigate whether an automated software system, operating within primary care electronic medical records, can improve the management of AF by identifying patients eligible for OAC therapy and increasing uptake of this treatment. We will conduct a cluster randomised controlled trial, involving general practices using the Egton Medical Information Systems (EMIS) Web clinical system. We will randomise practices to use an electronic software tool or to continue with usual care. The tool will a) produce (and continually refresh) a list of patients with AF who are eligible for OAC therapy--practices will invite these patients to discuss therapy at the start of the trial--and b) generate electronic screen reminders in the medical records of those eligible, appearing throughout the trial. The software will run for 6 months in 23 intervention practices. A total of 23 control practices will manage their AF register in line with the usual care offered. The primary outcome is change in proportion of eligible patients with AF who have been prescribed OAC therapy after six months. Secondary outcomes are incidence of stroke, transient ischaemic attack, other major thromboembolism, major haemorrhage and reports of inappropriate OAC prescribing in the data collection sample--those deemed eligible for OACs. We will conduct a process evaluation in parallel with the randomised trial. We will use qualitative methods to examine patient and practitioner views of the intervention and its impact on primary care practice, including its time implications. AURAS-AF will investigate whether a simple intervention, using electronic primary care records, can improve OAC uptake in a high risk group for stroke. Given previous concerns about safety, especially surrounding inappropriate prescribing, we will also examine whether electronic reminders safely impact care in this clinical area. http://ISRCTN 55722437.

Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomized trial (OPTI-SCRIPT study protocol).

PubMed

Clyne, Barbara; Bradley, Marie C; Smith, Susan M; Hughes, Carmel M; Motterlini, Nicola; Clear, Daniel; McDonnell, Ronan; Williams, David; Fahey, Tom

2013-03-13

Potentially inappropriate prescribing in older people is common in primary care and can result in increased morbidity, adverse drug events, hospitalizations and mortality. In Ireland, 36% of those aged 70 years or over received at least one potentially inappropriate medication, with an associated expenditure of over €45 million.The main objective of this study is to determine the effectiveness and acceptability of a complex, multifaceted intervention in reducing the level of potentially inappropriate prescribing in primary care. This study is a pragmatic cluster randomized controlled trial, conducted in primary care (OPTI-SCRIPT trial), involving 22 practices (clusters) and 220 patients. Practices will be allocated to intervention or control arms using minimization, with intervention participants receiving a complex multifaceted intervention incorporating academic detailing, medicines review with web-based pharmaceutical treatment algorithms that provide recommended alternative treatment options, and tailored patient information leaflets. Control practices will deliver usual care and receive simple patient-level feedback on potentially inappropriate prescribing. Routinely collected national prescribing data will also be analyzed for nonparticipating practices, acting as a contemporary national control. The primary outcomes are the proportion of participant patients with potentially inappropriate prescribing and the mean number of potentially inappropriate prescriptions per patient. In addition, economic and qualitative evaluations will be conducted. This study will establish the effectiveness of a multifaceted intervention in reducing potentially inappropriate prescribing in older people in Irish primary care that is generalizable to countries with similar prescribing challenges. Current controlled trials ISRCTN41694007.

Primary Care Provider Perceptions of the Effectiveness of Two Self-Management Support Programs for Vulnerable Patients with Diabetes

PubMed Central

Ratanawongsa, Neda; Bhandari, Vijay K; Handley, Margaret; Rundall, Thomas; Hammer, Hali; Schillinger, Dean

2012-01-01

Background Primary care providers (PCPs) in safety net settings face barriers to optimizing care for patients with diabetes. We conducted this study to assess PCPs' perspectives on the effectiveness of two language-concordant diabetes self-management support programs. Methods One year postintervention, we surveyed PCPs whose patients with diabetes participated in a three-arm multiclinic randomized controlled trial comparing usual care (UC), weekly automated telephone self-management (ATSM) support with nurse care management, and monthly group medical visits (GMVs). We compared PCP perspectives on patient activation to create and achieve goals, quality of care, and barriers to care using regression models accounting for within-PCP clustering. Results Of 113 eligible PCPs caring for 330 enrolled patients, 87 PCPs (77%) responded to surveys about 245 (74%) enrolled patients. Intervention patients were more likely to be perceived by PCPs as activated to create and achieve goals for chronic care when compared with UC patients (standardized effect size, ATSM vs UC, +0.41, p = 0.01; GMV vs UC, +0.31, p = 0.05). Primary care providers rated quality of care as higher for patients exposed to ATSM compared to UC (odds ratio 3.6, p < 0.01). Compared with GMV patients, ATSM patients were more likely to be perceived by PCPs as overcoming barriers related to limited English proficiency (82% ATSM vs 44% GMV, p = 0.01) and managing medications (80% ATSM vs 53% GMV, p = 0.01). Conclusions Primary care providers perceived that patients receiving ATSM support had overcome barriers, participated more actively, and received higher quality diabetes care. These views of clinician stakeholders lend additional evidence for the potential to upscale ATSM more broadly to support PCPs in their care of diverse, multilinguistic populations. PMID:22401329

The safety climate in primary care (SAP-C) study: study protocol for a randomised controlled feasibility study.

PubMed

Lydon, Sinéad; Cupples, Margaret E; Hart, Nigel; Murphy, Andrew W; Faherty, Aileen; O'Connor, Paul

2016-01-01

Research on patient safety has focused largely on secondary care settings, and there is a dearth of knowledge relating to safety culture or climate, and safety climate improvement strategies, in the context of primary care. This is problematic given the high rates of usage of primary care services and the myriad of opportunities for clinical errors daily. The current research programme aimed to assess the effectiveness of an intervention derived from the Scottish Patient Safety Programme in Primary Care. The intervention consists of safety climate measurement and feedback and patient chart audit using the trigger review method. The purpose of this paper is to describe the background to this research and to present the methodology of this feasibility study in preparation for a future definitive RCT. The SAP-C study is a feasibility study employing a randomised controlled pretest-posttest design that will be conducted in 10 general practices in the Republic of Ireland and Northern Ireland. Five practices will receive the safety climate intervention over a 9-month period. The five practices in the control group will continue care as usual but will complete the GP-SafeQuest safety climate questionnaire at baseline (month 1) and at the terminus of the intervention (month 9). The outcomes of the study include process evaluation metrics (i.e. rates of participant recruitment and retention, rates of completion of safety climate measures, qualitative data regarding participants' perceptions of the intervention's potential efficacy, acceptability, and sustainability), patient safety culture in intervention and control group practices at posttest, and instances of undetected patient harm identified through patient chart audit using the trigger review method. The planned study investigates an intervention to improve safety climate in Irish primary care settings. The resulting data may inform our knowledge of the frequency of undetected patient safety incidents in primary care, may contribute to improved patient safety practices in primary care settings, and may inform future research on patient safety improvement initiatives.

Long-term effectiveness of a community-based model of care in Māori and Pacific patients with type 2 diabetes and chronic kidney disease: a 4-year follow up of the DElay Future End Stage Nephropathy due to Diabetes (DEFEND) study.

PubMed

Tan, J; Manley, P; Gamble, G; Collins, J; Bagg, W; Hotu, C; Braatvedt, G

2015-08-01

The Delay Future End Stage Nephropathy due to Diabetes study was a randomised controlled trial of Māori and Pacific patients with advanced diabetic nephropathy, comparing a community-based model of care with usual care. The intervention group achieved lower blood pressure (BP), proteinuria and less end-organ damage. After the intervention ended, all patients reverted to usual care, and were followed to review the sustainability of the intervention. A retrospective observation of 65 patients (aged 47-75 years) with type 2 diabetes, hypertension, chronic kidney disease 3/4 and proteinuria (>0.5 g/day) previously randomised to intervention/community care or usual care for 11-21 months. Follow up thereafter was until death, end-stage renal disease (ESRD) (estimated glomerular filtration rate (eGFR) ≤ 10 mL/min/1.73 m(2) )/dialysis or 1 February 2014. Primary end-points were death and ESRD/dialysis. Secondary outcomes were annualised glomerular filtration rate decline, non-fatal vascular events and hospitalisations. Median (interquartile ranges (IQR)) post-trial follow up was 49 (21-81) months and similar in both groups. The median (IQR) eGFR decline was -3.1 (-5.5, -2.3) and -5.5 (-7.1, -3.0) mL/min/year in the intervention and usual care groups respectively (P = 0.11). Similar number of deaths, renal and vascular events were observed in both groups. At the end of follow up, the number of prescribed antihypertensive medications was similar (3.4 ± 1.0 vs 3.3 ± 1.4; P = 0.78). There were fewer median (IQR) hospital days (8 (3, 18) vs 15.5 (6, 49) days, P = 0.03) in the intervention group. Short-term intensive BP control followed by usual care did not translate into reduction in long-term mortality or ESRD rates, but was associated with reduced hospitalisations. © 2015 Royal Australasian College of Physicians.

The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes’ Effects on Moms (GEM) Cluster Randomized Controlled Trial

PubMed Central

Hedderson, Monique M.; Brown, Susan D.; Albright, Cheryl L.; Ehrlich, Samantha F.; Tsai, Ai-Lin; Caan, Bette J.; Sternfeld, Barbara; Gordon, Nancy P.; Schmittdiel, Julie A.; Gunderson, Erica P.; Mevi, Ashley A.; Herman, William H.; Ching, Jenny; Crites, Yvonne; Quesenberry, Charles P.

2016-01-01

OBJECTIVE To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)–derived lifestyle intervention. RESEARCH DESIGN AND METHODS This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m2 or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m2; and pregravid to postpartum weight change. RESULTS On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference −0.64 kg [95% CI −1.13, −0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]). CONCLUSIONS A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity. PMID:26657945

The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster Randomized Controlled Trial.

PubMed

Ferrara, Assiamira; Hedderson, Monique M; Brown, Susan D; Albright, Cheryl L; Ehrlich, Samantha F; Tsai, Ai-Lin; Caan, Bette J; Sternfeld, Barbara; Gordon, Nancy P; Schmittdiel, Julie A; Gunderson, Erica P; Mevi, Ashley A; Herman, William H; Ching, Jenny; Crites, Yvonne; Quesenberry, Charles P

2016-01-01

To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)-derived lifestyle intervention. This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m(2) or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m(2); and pregravid to postpartum weight change. On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference -0.64 kg [95% CI -1.13, -0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]). A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Robot-assisted therapy for long-term upper-limb impairment after stroke.

PubMed

Lo, Albert C; Guarino, Peter D; Richards, Lorie G; Haselkorn, Jodie K; Wittenberg, George F; Federman, Daniel G; Ringer, Robert J; Wagner, Todd H; Krebs, Hermano I; Volpe, Bruce T; Bever, Christopher T; Bravata, Dawn M; Duncan, Pamela W; Corn, Barbara H; Maffucci, Alysia D; Nadeau, Stephen E; Conroy, Susan S; Powell, Janet M; Huang, Grant D; Peduzzi, Peter

2010-05-13

Effective rehabilitative therapies are needed for patients with long-term deficits after stroke. In this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks. At 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported. In patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.) 2010 Massachusetts Medical Society

THE COST-EFFECTIVENESS OF COGNITIVE BEHAVIOR THERAPY FOR BORDERLINE PERSONALITY DISORDER: RESULTS FROM THE BOSCOT TRIAL

PubMed Central

Palmer, Stephen; Davidson, Kate; Tyrer, Peter; Gumley, Andrew; Tata, Philip; Norrie, John; Murray, Heather; Seivewright, Helen

2007-01-01

Borderline personality disorder places a significant burden on healthcare providers and other agencies. This study evaluated the cost-effectiveness of cognitive behavior therapy plus treatment as usual compared to treatment as usual alone for patients with borderline personality disorder. The economic analysis was conducted alongside a multi-center, randomized controlled trial. The costs of primary and secondary healthcare utilization, alongside the wider economic costs, were estimated from medical records and patient self-report. The primary outcome measure used was the quality-adjusted life year (QALY), assessed using EuroQol. On average, total costs per patient in the cognitive behavior therapy group were lower than patients receiving usual care alone (−£689), although this group also reported a lower quality of life (−0.11 QALYs). These differences were small and did not approach conventional levels of statistical significance. The use of cognitive therapy for borderline personality disorder does not appear to demonstrate any significant cost-effective advantage based on the results of this study. PMID:17032159

Reducing Medical Admissions into Hospital through Optimising Medicines (REMAIN HOME) Study: protocol for a stepped-wedge, cluster-randomised trial

PubMed Central

Foot, Holly; Freeman, Christopher; Hemming, Karla; Scott, Ian; Coombes, Ian D; Williams, Ian D; Connelly, Luke; Whitty, Jennifer A; Sturman, Nancy; Kirsa, Sue; Nicholson, Caroline; Russell, Grant; Kirkpatrick, Carl; Cottrell, Neil

2017-01-01

Introduction A model of general practitioner (GP) and pharmacist collaboration in primary care may be an effective strategy to reduce medication-related problems and provide better support to patients after discharge. The aim of this study is to investigate whether a model of structured pharmacist and GP care reduces hospital readmissions in high-risk patients. Methods and analysis This protocol details a stepped-wedge, cluster-randomised trial that will recruit participants over 9 months with a 12-month follow-up. There will be 14 clusters each representing a different general practice medical centre. A total of 2240 participants will be recruited from hospital who attend an enrolled medical centre, take five or more long-term medicines or whose reason for admission was related to heart failure or chronic obstructive pulmonary disease. The intervention is a multifaceted service, involving a pharmacist integrated into a medical centre to assist patients after hospitalisation. Participants will meet with the practice pharmacist and their GP after discharge to review and reconcile their medicines and discuss changes made in hospital. The pharmacist will follow-up with the participant and liaise with other health professionals involved in the participant’s care. The control will be usual care, which usually involves a patient self-organising a visit to their GP after hospital discharge. The primary outcome is the rate of unplanned, all-cause hospital readmissions over 12 months, which will be analysed using a mixed effects Poisson regression model with a random effect for cluster and a fixed effect to account for any temporal trend. A cost analysis will be undertaken to compare the healthcare costs associated with the intervention to those of usual care. Ethics and dissemination The study has received ethical approval (HREC/16/QRBW/410). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders. Trial registration number ACTRN12616001627448 PMID:28408545

Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study).

PubMed

Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos

2011-09-01

To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Stepped care for depression and anxiety in visually impaired older adults: multicentre randomised controlled trial.

PubMed

van der Aa, Hilde P A; van Rens, Ger H M B; Comijs, Hannie C; Margrain, Tom H; Gallindo-Garre, Francisca; Twisk, Jos W R; van Nispen, Ruth M A

2015-11-23

Is stepped care compared with usual care effective in preventing the onset of major depressive, dysthymic, and anxiety disorders in older people with visual impairment (caused mainly by age related eye disease) and subthreshold depression and/or anxiety? 265 people aged ≥50 were randomly assigned to a stepped care programme plus usual care (n=131) or usual care only (n=134). Supervised occupational therapists, social workers, and psychologists from low vision rehabilitation organisations delivered the stepped care programme, which comprised watchful waiting, guided self help based on cognitive behavioural therapy, problem solving treatment, and referral to a general practitioner. The primary outcome was the 24 month cumulative incidence (seven measurements) of major depressive dysthymic and/or anxiety disorders (panic disorder, agoraphobia, social phobia, and generalised anxiety disorder). Secondary outcomes were change in symptoms of depression and anxiety, vision related quality of life, health related quality of life, and adaptation to vision loss over time up to 24 months' follow-up. 62 participants (46%) in the usual care group and 38 participants (29%) from the stepped care group developed a disorder. The intervention was associated with a significantly reduced incidence (relative risk 0.63, 95% confidence interval 0.45 to 0.87; P=0.01), even if time to the event was taken into account (adjusted hazard ratio 0.57, 0.35 to 0.93; P=0.02). The number needed to treat was 5.8 (3.5 to 17.3). The dropout rate was fairly high (34.3%), but rates were not significantly different for the two groups, indicating that the intervention was as acceptable as usual care. Participants who volunteered and were selected for this study might not be representative of visually impaired older adults in general (responders were significantly younger than non-responders), thereby reducing the generalisability of the outcomes. Stepped care seems to be a promising way to deal with depression and anxiety in visually impaired older adults. This approach could lead to standardised strategies for the screening, monitoring, treatment, and referral of visually impaired older adults with depression and anxiety. Funded by ZonMw InZicht, the Dutch Organisation for Health Research and Development-InSight Society. There are no competing interests. Full dataset and statistical code are available from the corresponding author.Study registration www.trialregister.nl NTR3296. © van der Aa et al 2015.

Effectiveness of Nurse-Practitioner-Delivered Brief Motivational Intervention for Young Adult Alcohol and Drug Use in Primary Care in South Africa: A Randomized Clinical Trial

PubMed Central

Mertens, Jennifer R.; Ward, Catherine L.; Bresick, Graham F.; Broder, Tina; Weisner, Constance M.

2014-01-01

Aims: To assess the effectiveness of brief motivational intervention for alcohol and drug use in young adult primary care patients in a low-income population and country. Methods: A randomized controlled trial in a public-sector clinic in Delft, a township in the Western Cape, South Africa recruited 403 patients who were randomized to either single-session, nurse practitioner-delivered Brief Motivational Intervention plus referral list or usual care plus referral list, and followed up at 3 months. Results: Although rates of at-risk alcohol use and drug use did not differ by treatment arm at follow-up, patients assigned to the Brief Motivational Intervention had significantly reduced scores on ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) for alcohol—the most prevalent substance. Conclusion: Brief Motivational Intervention may be effective at reducing at-risk alcohol use in the short term among low-income young adult primary care patients; additional research is needed to examine long-term outcomes. PMID:24899076

A service evaluation of self-referral to military mental health teams.

PubMed

Kennedy, I; Whybrow, D; Jones, N; Sharpley, J; Greenberg, N

2016-07-01

The UK military runs a comprehensive mental health service ordinarily accessed via primary care referrals. To evaluate the feasibility of self-referral to mental health services within a military environment. Three pilot sites were identified; one from each service (Royal Navy, Army, Air Force). Socio-demographic information included age, rank, service and career duration. Clinical data included prior contact with general practitioner (GP), provisional diagnosis and assessment outcome. Of the 57 self-referrals, 69% (n = 39) had not previously accessed primary care for their current difficulties. After their mental health assessment, 47 (82%) were found to have a formal mental health problem and 41 (72%) were offered a further mental health clinician appointment. The data compared favourably with a large military mental health department that reported 87% of primary care referrals had a formal mental health condition. The majority of self-referrals had formal mental health conditions for which they had not previously sought help from primary care; most were offered further clinical input. This supports the view that self-referral may be a useful option to encourage military personnel to seek professional care over and above the usual route of accessing care through their GP. © The Author 2016. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Assessment of a primary care-based telemonitoring intervention for home care patients with heart failure and chronic lung disease. The TELBIL study

PubMed Central

2011-01-01

Background Telemonitoring technology offers one of the most promising alternatives for the provision of health care services at the patient's home. The primary aim of this study is to evaluate the impact of a primary care-based telemonitoring intervention on the frequency of hospital admissions. Methods/design A primary care-based randomised controlled trial will be carried out to assess the impact of a telemonitoring intervention aimed at home care patients with heart failure (HF) and/or chronic lung disease (CLD). The results will be compared with those obtained with standard health care practice. The duration of the study will be of one year. Sixty patients will be recruited for the study. In-home patients, diagnosed with HF and/or CLD, aged 14 or above and with two or more hospital admissions in the previous year will be eligible. For the intervention group, telemonitoring will consist of daily patient self-measurements of respiratory-rate, heart-rate, blood pressure, oxygen saturation, weight and body temperature. Additionally, the patients will complete a qualitative symptom questionnaire daily using the telemonitoring system. Routine telephone contacts will be conducted every fortnight and additional telephone contacts will be carried out if the data received at the primary care centre are out of the established limits. The control group will receive usual care. The primary outcome measure is the number of hospital admissions due to any cause that occurred in a period of 12 months post-randomisation. The secondary outcome measures are: duration of hospital stay, hospital admissions due to HF or CLD, mortality rate, use of health care resources, quality of life, cost-effectiveness, compliance and patient and health care professional satisfaction with the new technology. Discussion The results of this study will shed some light on the effects of telemonitoring for the follow-up and management of chronic patients from a primary care setting. The study may contribute to enhance the understanding of alternative modes of health care provision for medically unstable elderly patients, who bear a high degree of physical and functional deterioration. Trial Registration ISRCTN: ISRCTN89041993 PMID:21385401

Effectiveness of Psychological and Educational Interventions to Prevent Depression in Primary Care: A Systematic Review and Meta-Analysis.

PubMed

Conejo-Cerón, Sonia; Moreno-Peral, Patricia; Rodríguez-Morejón, Alberto; Motrico, Emma; Navas-Campaña, Desirée; Rigabert, Alina; Martín-Pérez, Carlos; Rodríguez-Bayón, Antonina; Ballesta-Rodríguez, María Isabel; Luna, Juan de Dios; García-Campayo, Javier; Roca, Miquel; Bellón, Juan Ángel

2017-05-01

Although evidence exists for the efficacy of psychosocial interventions to prevent the onset of depression, little is known about its prevention in primary care. We aimed to evaluate the effectiveness of psychological and educational interventions to prevent depression in primary care. We conducted a systematic review and meta-analysis of relevant randomized controlled trials (RCTs) examining the effect of psychological and educational interventions to prevent depression in nondepressed primary care attendees. We searched MEDLINE, PsycINFO, Web of Science, OpenGrey Repository, Cochrane Central Register of Controlled Trials, and other sources up to May 2016. At least 2 reviewers independently evaluated the eligibility criteria, extracted data, and assessed the risk of bias. We calculated standardized mean differences (SMD) using random-effects models. We selected 14 studies (7,365 patients) that met the inclusion criteria, 13 of which were valid to perform a meta-analysis. Most of the interventions had a cognitive-behavioral orientation, and in only 4 RCTs were the intervention clinicians primary care staff. The pooled SMD was -0.163 (95%CI, -0.256 to -0.070; P = .001). The risk of bias and the heterogeneity (I 2 = 20.6%) were low, and there was no evidence of publication bias. Meta-regression detected no association between SMD and follow-up times or SMD and risk of bias. Subgroup analysis suggested greater effectiveness when the RCTs used care as usual as the comparator compared with those using placebo. Psychological and educational interventions to prevent depression had a modest though statistically significant preventive effect in primary care. Further RCTs using placebo or active comparators are needed. © 2017 Annals of Family Medicine, Inc.

Effectiveness of Psychological and Educational Interventions to Prevent Depression in Primary Care: A Systematic Review and Meta-Analysis

PubMed Central

Conejo-Cerón, Sonia; Moreno-Peral, Patricia; Rodríguez-Morejón, Alberto; Motrico, Emma; Navas-Campaña, Desirée; Rigabert, Alina; Martín-Pérez, Carlos; Rodríguez-Bayón, Antonina; Ballesta-Rodríguez, María Isabel; Luna, Juan de Dios; García-Campayo, Javier; Roca, Miquel; Bellón, Juan Ángel

2017-01-01

PURPOSE Although evidence exists for the efficacy of psychosocial interventions to prevent the onset of depression, little is known about its prevention in primary care. We aimed to evaluate the effectiveness of psychological and educational interventions to prevent depression in primary care. METHODS We conducted a systematic review and meta-analysis of relevant randomized controlled trials (RCTs) examining the effect of psychological and educational interventions to prevent depression in nondepressed primary care attendees. We searched MEDLINE, PsycINFO, Web of Science, OpenGrey Repository, Cochrane Central Register of Controlled Trials, and other sources up to May 2016. At least 2 reviewers independently evaluated the eligibility criteria, extracted data, and assessed the risk of bias. We calculated standardized mean differences (SMD) using random-effects models. RESULTS We selected 14 studies (7,365 patients) that met the inclusion criteria, 13 of which were valid to perform a meta-analysis. Most of the interventions had a cognitive-behavioral orientation, and in only 4 RCTs were the intervention clinicians primary care staff. The pooled SMD was −0.163 (95%CI, −0.256 to −0.070; P = .001). The risk of bias and the heterogeneity (I2 = 20.6%) were low, and there was no evidence of publication bias. Meta-regression detected no association between SMD and follow-up times or SMD and risk of bias. Subgroup analysis suggested greater effectiveness when the RCTs used care as usual as the comparator compared with those using placebo. CONCLUSIONS Psychological and educational interventions to prevent depression had a modest though statistically significant preventive effect in primary care. Further RCTs using placebo or active comparators are needed. PMID:28483893

Efficacy of a Chronic Care-Based Intervention on Secondary Stroke Prevention Among Vulnerable Stroke Survivors: A Randomized Controlled Trial.

PubMed

Cheng, Eric M; Cunningham, William E; Towfighi, Amytis; Sanossian, Nerses; Bryg, Robert J; Anderson, Thomas L; Barry, Frances; Douglas, Susan M; Hudson, Lillie; Ayala-Rivera, Monica; Guterman, Jeffrey J; Gross-Schulman, Sandra; Beanes, Sylvia; Jones, Andrea S; Liu, Honghu; Vickrey, Barbara G

2018-01-01

Disparities of care among stroke survivors are well documented. Effective interventions to improve recurrent stroke preventative care in vulnerable populations are lacking. In a randomized controlled trial, we tested the efficacy of components of a chronic care model-based intervention versus usual care among 404 subjects having an ischemic stroke or transient ischemic attack within 90 days of enrollment and receiving care within the Los Angeles public healthcare system. Subjects had baseline systolic blood pressure (SBP) ≥120 mm Hg. The intervention included a nurse practitioner/physician assistant care manager, group clinics, self-management support, report cards, decision support, and ongoing care coordination. Outcomes were collected at 3, 8, and 12 months, analyzed as intention-to-treat, and used repeated-measures mixed-effects models. Change in SBP was the primary outcome. Low-density lipoprotein reduction, antithrombotic medication use, smoking cessation, and physical activity were secondary outcomes. Average age was 57 years; 18% were of black race; 69% were of Hispanic ethnicity. Mean baseline SBP was 150 mm Hg in both arms. SBP decreased to 17 mm Hg in the intervention arm and 14 mm Hg in the usual care arm; the between-arm difference was not significant (-3.6 mm Hg; 95% confidence interval, -9.2 to 2.2). Among secondary outcomes, the only significant difference was that persons in the intervention arm were more likely to lower their low-density lipoprotein <100 md/dL (2.0 odds ratio; 95% confidence interval, 1.1-3.5). This intervention did not improve SBP control beyond that attained in usual care among vulnerable stroke survivors. A community-centered component could strengthen the intervention impact. URL: https://clinicaltrials.gov. Unique identifier: NCT00861081. © 2017 American Heart Association, Inc.

Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial

PubMed Central

Little, Paul; Stuart, Beth; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Rabago, David; Richards-Hall, Samantha; Williamson, Ian; Yao, Guiqing; Raftery, James; Zhu, Shihua; Moore, Michael

2016-01-01

Background: Systematic reviews support nasal saline irrigation for chronic or recurrent sinus symptoms, but trials have been small and few in primary care settings. Steam inhalation has also been proposed, but supporting evidence is lacking. We investigated whether brief pragmatic interventions to encourage use of nasal irrigation or steam inhalation would be effective in relieving sinus symptoms. Methods: We conducted a pragmatic randomized controlled trial involving adults (age 18–65 yr) from 72 primary care practices in the United Kingdom who had a history of chronic or recurrent sinusitis and reported a “moderate to severe” impact of sinus symptoms on their quality of life. Participants were recruited between Feb. 11, 2009, and June 30, 2014, and randomly assigned to 1 of 4 advice strategies: usual care, daily nasal saline irrigation supported by a demonstration video, daily steam inhalation, or combined treatment with both interventions. The primary outcome measure was the Rhinosinusitis Disability Index (RSDI). Patients were followed up at 3 and 6 months. We imputed missing data using multiple imputation methods. Results: Of the 961 patients who consented, 871 returned baseline questionnaires (210 usual care, 219 nasal irrigation, 232 steam inhalation and 210 combined treatment). A total of 671 (77.0%) of the 871 participants reported RSDI scores at 3 months. Patients’ RSDI scores improved more with nasal irrigation than without nasal irrigation by 3 months (crude change −7.42 v. −5.23; estimated adjusted mean difference between groups −2.51, 95% confidence interval −4.65 to −0.37). By 6 months, significantly more patients maintained a 10-point clinically important improvement in the RSDI score with nasal irrigation (44.1% v. 36.6%); fewer used over-the-counter medications (59.4% v. 68.0%) or intended to consult a doctor in future episodes. Steam inhalation reduced headache but had no significant effect on other outcomes. The proportion of participants who had adverse effects was the same in both intervention groups. Interpretation: Advice to use steam inhalation for chronic or recurrent sinus symptoms in primary care was not effective. A similar strategy to use nasal irrigation was less effective than prior evidence suggested, but it provided some symptomatic benefit. Trial registration: ISRCTN, no. 88204146. PMID:27431306

Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial.

PubMed

Little, Paul; Stuart, Beth; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Rabago, David; Richards-Hall, Samantha; Williamson, Ian; Yao, Guiqing; Raftery, James; Zhu, Shihua; Moore, Michael

2016-09-20

Systematic reviews support nasal saline irrigation for chronic or recurrent sinus symptoms, but trials have been small and few in primary care settings. Steam inhalation has also been proposed, but supporting evidence is lacking. We investigated whether brief pragmatic interventions to encourage use of nasal irrigation or steam inhalation would be effective in relieving sinus symptoms. We conducted a pragmatic randomized controlled trial involving adults (age 18-65 yr) from 72 primary care practices in the United Kingdom who had a history of chronic or recurrent sinusitis and reported a "moderate to severe" impact of sinus symptoms on their quality of life. Participants were recruited between Feb. 11, 2009, and June 30, 2014, and randomly assigned to 1 of 4 advice strategies: usual care, daily nasal saline irrigation supported by a demonstration video, daily steam inhalation, or combined treatment with both interventions. The primary outcome measure was the Rhinosinusitis Disability Index (RSDI). Patients were followed up at 3 and 6 months. We imputed missing data using multiple imputation methods. Of the 961 patients who consented, 871 returned baseline questionnaires (210 usual care, 219 nasal irrigation, 232 steam inhalation and 210 combined treatment). A total of 671 (77.0%) of the 871 participants reported RSDI scores at 3 months. Patients' RSDI scores improved more with nasal irrigation than without nasal irrigation by 3 months (crude change -7.42 v. -5.23; estimated adjusted mean difference between groups -2.51, 95% confidence interval -4.65 to -0.37). By 6 months, significantly more patients maintained a 10-point clinically important improvement in the RSDI score with nasal irrigation (44.1% v. 36.6%); fewer used over-the-counter medications (59.4% v. 68.0%) or intended to consult a doctor in future episodes. Steam inhalation reduced headache but had no significant effect on other outcomes. The proportion of participants who had adverse effects was the same in both intervention groups. Advice to use steam inhalation for chronic or recurrent sinus symptoms in primary care was not effective. A similar strategy to use nasal irrigation was less effective than prior evidence suggested, but it provided some symptomatic benefit. ISRCTN, no. 88204146. © 2016 Canadian Medical Association or its licensors.

Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial

PubMed Central

Siriwardena, A Niroshan; Apekey, Tanefa; Tilling, Michelle; Harrison, Andrew; Dyas, Jane V; Middleton, Hugh C; Ørner, Roderick; Sach, Tracey; Dewey, Michael; Qureshi, Zubair M

2009-01-01

Background Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi) have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety. Methods and design This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity) and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs). Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours) to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing. Discussion Previous studies in adults have shown that psychological treatments for insomnia administered by specialist nurses to groups of patients can be effective within a primary care setting. This will be a pilot study to determine whether an educational intervention aimed at primary care teams to deliver problem focused therapy for insomnia can improve sleep management and outcomes for individual adult patients presenting to general practice. The study will also test procedures and collect information in preparation for a larger definitive cluster-randomised trial. The study is funded by The Health Foundation. Trial Registration ClinicalTrials.gov ID ISRCTN55001433 – PMID:19171070

Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial.

PubMed

Buys, Saundra S; Partridge, Edward; Black, Amanda; Johnson, Christine C; Lamerato, Lois; Isaacs, Claudine; Reding, Douglas J; Greenlee, Robert T; Yokochi, Lance A; Kessel, Bruce; Crawford, E David; Church, Timothy R; Andriole, Gerald L; Weissfeld, Joel L; Fouad, Mona N; Chia, David; O'Brien, Barbara; Ragard, Lawrence R; Clapp, Jonathan D; Rathmell, Joshua M; Riley, Thomas L; Hartge, Patricia; Pinsky, Paul F; Zhu, Claire S; Izmirlian, Grant; Kramer, Barnett S; Miller, Anthony B; Xu, Jian-Lun; Prorok, Philip C; Gohagan, John K; Berg, Christine D

2011-06-08

Screening for ovarian cancer with cancer antigen 125 (CA-125) and transvaginal ultrasound has an unknown effect on mortality. To evaluate the effect of screening for ovarian cancer on mortality in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Randomized controlled trial of 78,216 women aged 55 to 74 years assigned to undergo either annual screening (n = 39,105) or usual care (n = 39,111) at 10 screening centers across the United States between November 1993 and July 2001. Intervention The intervention group was offered annual screening with CA-125 for 6 years and transvaginal ultrasound for 4 years. Participants and their health care practitioners received the screening test results and managed evaluation of abnormal results. The usual care group was not offered annual screening with CA-125 for 6 years or transvaginal ultrasound but received their usual medical care. Participants were followed up for a maximum of 13 years (median [range], 12.4 years [10.9-13.0 years]) for cancer diagnoses and death until February 28, 2010. Mortality from ovarian cancer, including primary peritoneal and fallopian tube cancers. Secondary outcomes included ovarian cancer incidence and complications associated with screening examinations and diagnostic procedures. Ovarian cancer was diagnosed in 212 women (5.7 per 10,000 person-years) in the intervention group and 176 (4.7 per 10,000 person-years) in the usual care group (rate ratio [RR], 1.21; 95% confidence interval [CI], 0.99-1.48). There were 118 deaths caused by ovarian cancer (3.1 per 10,000 person-years) in the intervention group and 100 deaths (2.6 per 10,000 person-years) in the usual care group (mortality RR, 1.18; 95% CI, 0.82-1.71). Of 3285 women with false-positive results, 1080 underwent surgical follow-up; of whom, 163 women experienced at least 1 serious complication (15%). There were 2924 deaths due to other causes (excluding ovarian, colorectal, and lung cancer) (76.6 per 10,000 person-years) in the intervention group and 2914 deaths (76.2 per 10,000 person-years) in the usual care group (RR, 1.01; 95% CI, 0.96-1.06). Among women in the general US population, simultaneous screening with CA-125 and transvaginal ultrasound compared with usual care did not reduce ovarian cancer mortality. Diagnostic evaluation following a false-positive screening test result was associated with complications. Trial Registration clinicaltrials.gov Identifier: NCT00002540.

Disease management programme for secondary prevention of coronary heart disease and heart failure in primary care: a cluster randomised controlled trial.

PubMed

Khunti, Kamlesh; Stone, Margaret; Paul, Sanjoy; Baines, Jan; Gisborne, Louise; Farooqi, Azhar; Luan, Xiujie; Squire, Iain

2007-11-01

To evaluate the effect of a disease management programme for patients with coronary heart disease (CHD) and chronic heart failure (CHF) in primary care. A cluster randomised controlled trial of 1316 patients with CHD and CHF from 20 primary care practices in the UK was carried out. Care in the intervention practices was delivered by specialist nurses trained in the management of patients with CHD and CHF. Usual care was delivered by the primary healthcare team in the control practices. At follow up, significantly more patients with a history of myocardial infarction in the intervention group were prescribed a beta-blocker compared to the control group (adjusted OR 1.43, 95% CI 1.19 to 1.99). Significantly more patients with CHD in the intervention group had adequate management of their blood pressure (<140/85 mm Hg) (OR 1.61, 95% CI 1.22 to 2.13) and their cholesterol (<5 mmol/l) (OR 1.58, 95% CI 1.05 to 2.37) compared to those in the control group. Significantly more patients with an unconfirmed diagnosis of CHF had a diagnosis of left ventricular systolic dysfunction confirmed (OR 4.69, 95% CI 1.88 to 11.66) or excluded (OR 3.80, 95% CI 1.50 to 9.64) in the intervention group compared to the control group. There were significant improvements in some quality-of-life measures in patients with CHD in the intervention group. Disease management programmes can lead to improvements in the care of patients with CHD and presumed CHF in primary care.

Considerations for management of migraine symptoms in the primary care setting.

PubMed

Silberstein, Stephen D

2016-06-01

Migraine is a common disabling brain disorder that affects one in seven US citizens annually. The burden of migraine is substantial, both in economic terms and for individual patients and their close family members. Initial medical consultations for migraine are usually with a primary care physician (PCP), and it is predominantly managed in a primary care setting; therefore, PCPs need a thorough understanding of migraine and the treatment options. This review provides an overview of the prevalence, symptoms, burden, and diagnosis of migraine with a focus on adults. Important aspects of migraine management, such as medication overuse and chronic migraine, are highlighted and insight is provided into factors for consideration when prescribing acute/abortive treatment for migraine to ensure that individual patients receive optimal pharmaceutical management. The effects of associated symptoms, e.g. nausea/vomiting, on treatment efficacy are pertinent in migraine; however, many therapy options, including alternative delivery systems, are available, thus facilitating the selection of optimal treatment for an individual patient.

An exercise intervention to prevent falls in Parkinson’s: an economic evaluation

PubMed Central

2012-01-01

Background People with Parkinson’s (PwP) experience frequent and recurrent falls. As these falls may have devastating consequences, there is an urgent need to identify cost-effective interventions with the potential to reduce falls in PwP. The purpose of this economic evaluation is to compare the costs and cost-effectiveness of a targeted exercise programme versus usual care for PwP who were at risk of falling. Methods One hundred and thirty participants were recruited through specialist clinics, primary care and Parkinson’s support groups and randomised to either an exercise intervention or usual care. Health and social care utilisation and health-related quality of life (EQ-5D) were assessed over the 20 weeks of the study (ten-week intervention period and ten-week follow up period), and these data were complete for 93 participants. Incremental cost per quality adjusted life year (QALY) was estimated. The uncertainty around costs and QALYs was represented using cost-effectiveness acceptability curves. Results The mean cost of the intervention was £76 per participant. Although in direction of favour of exercise intervention, there was no statistically significant differences between groups in total healthcare (−£128, 95% CI: -734 to 478), combined health and social care costs (£-35, 95% CI: -817 to 746) or QALYs (0.03, 95% CI: -0.02 to 0.03) at 20 weeks. Nevertheless, exploration of the uncertainty surrounding these estimates suggests there is more than 80% probability that the exercise intervention is a cost-effective strategy relative to usual care. Conclusion Whilst we found no difference between groups in total healthcare, total social care cost and QALYs, analyses indicate that there is high probability that the exercise intervention is cost-effective compared with usual care. These results require confirmation by larger trial-based economic evaluations and over the longer term. PMID:23176532

Behavioral Treatment for Weight Gain Prevention Among Black Women in Primary Care Practice

PubMed Central

Bennett, Gary G.; Foley, Perry; Levine, Erica; Whiteley, Jessica; Askew, Sandy; Steinberg, Dori M.; Batch, Bryan; Greaney, Mary L.; Miranda, Heather; Wroth, Thomas H.; Holder, Marni Gwyther; Emmons, Karen M.; Puleo, Elaine

2014-01-01

IMPORTANCE Few weight loss treatments produce clinically meaningful weight loss outcomes among black women, particularly in the primary care setting. New weight management strategies are necessary for this population. Weight gain prevention might be an effective treatment option, with particular benefits for overweight and class 1 obese black women. OBJECTIVE To compare changes in weight and cardiometabolic risk during a 12-month period among black women randomized to a primary care–based behavioral weight gain prevention intervention, relative to usual care. DESIGN, SETTING, AND PARTICIPANTS Two-arm randomized clinical trial (the Shape Program). We recruited patients from a 6-site community health center system. We randomized 194 overweight and class 1 obese (body mass index [calculated as weight in kilograms divided by height in meters squared], 25–34.9) premenopausal black women aged 25 to 44 years. Enrollment began on December 7, 2009; 12- and 18-month assessments were completed in February and October 2, 2012. INTERVENTIONS The medium-intensity intervention included tailored behavior change goals, weekly self-monitoring via interactive voice response, monthly counseling calls, tailored skills training materials, and a gym membership. MAIN OUTCOMES AND MEASURES Twelve-month change in weight and body mass index and maintenance of change at 18 months. RESULTS Participants had a mean age of 35.4 years, a mean weight of 81.1 kg, and a mean body mass index of 30.2 at baseline. Most were socioeconomically disadvantaged (79.7% with educational level less than a college degree; 74.3% reporting annual income <$30 000). The 12-month weight change was larger among intervention participants (mean [SD], −1.0 [0.5] kg), relative to usual care (0.5 [0.5] kg; mean difference, −1.4 kg [95%CI, −2.8 to −0.1 kg]; P = .04). At month 12, 62% of intervention participants were at or below their baseline weights compared with 45% of usual-care participants (P = .03). By 18 months, intervention participants maintained significantly larger changes in weight (mean difference, −1.7 kg; 95% CI, −3.3 to −0.2 kg). CONCLUSIONS AND RELEVANCE A medium-intensity primary care–based behavioral intervention demonstrated efficacy for weight gain prevention among socioeconomically disadvantaged black women. A “maintain, don’t gain” approach might be a useful alternative treatment for reducing obesity-associated disease risk among some premenopausal black women. PMID:23979005

Effectiveness of chronic care models for the management of type 2 diabetes mellitus in Europe: a systematic review and meta-analysis

PubMed Central

Bongaerts, Brenda W C; Müssig, Karsten; Wens, Johan; Lang, Caroline; Schwarz, Peter; Roden, Michael; Rathmann, Wolfgang

2017-01-01

Objectives We evaluated the effectiveness of European chronic care programmes for type 2 diabetes mellitus (characterised by integrative care and a multicomponent framework for enhancing healthcare delivery), compared with usual diabetes care. Design Systematic review and meta-analysis. Data sources MEDLINE, Embase, CENTRAL and CINAHL from January 2000 to July 2015. Eligibility criteria Randomised controlled trials focussing on (1) adults with type 2 diabetes, (2) multifaceted diabetes care interventions specifically designed for type 2 diabetes and delivered in primary or secondary care, targeting patient, physician and healthcare organisation and (3) usual diabetes care as the control intervention. Data extraction Study characteristics, characteristics of the intervention, data on baseline demographics and changes in patient outcomes. Data analysis Weighted mean differences in change in HbA1c and total cholesterol levels between intervention and control patients (95% CI) were estimated using a random-effects model. Results Eight cluster randomised controlled trials were identified for inclusion (9529 patients). One year of multifaceted care improved HbA1c levels in patients with screen-detected and newly diagnosed diabetes, but not in patients with prevalent diabetes, compared to usual diabetes care. Across all seven included trials, the weighted mean difference in HbA1c change was −0.07% (95% CI −0.10 to −0.04) (−0.8 mmol/mol (95% CI −1.1 to −0.4)); I2=21%. The findings for total cholesterol, LDL-cholesterol and blood pressure were similar to HbA1c, albeit statistical heterogeneity between studies was considerably larger. Compared to usual care, multifaceted care did not significantly change quality of life of the diabetes patient. Finally, measured for screen-detected diabetes only, the risk of macrovascular and mircovascular complications at follow-up was not significantly different between intervention and control patients. Conclusions Effects of European multifaceted diabetes care patient outcomes are only small. Improvements are somewhat larger for screen-detected and newly diagnosed diabetes patients than for patients with prevalent diabetes. PMID:28320788

Effectiveness of chronic care models for the management of type 2 diabetes mellitus in Europe: a systematic review and meta-analysis.

PubMed

Bongaerts, Brenda W C; Müssig, Karsten; Wens, Johan; Lang, Caroline; Schwarz, Peter; Roden, Michael; Rathmann, Wolfgang

2017-03-20

We evaluated the effectiveness of European chronic care programmes for type 2 diabetes mellitus (characterised by integrative care and a multicomponent framework for enhancing healthcare delivery), compared with usual diabetes care. Systematic review and meta-analysis. MEDLINE, Embase, CENTRAL and CINAHL from January 2000 to July 2015. Randomised controlled trials focussing on (1) adults with type 2 diabetes, (2) multifaceted diabetes care interventions specifically designed for type 2 diabetes and delivered in primary or secondary care, targeting patient, physician and healthcare organisation and (3) usual diabetes care as the control intervention. Study characteristics, characteristics of the intervention, data on baseline demographics and changes in patient outcomes. Weighted mean differences in change in HbA1c and total cholesterol levels between intervention and control patients (95% CI) were estimated using a random-effects model. Eight cluster randomised controlled trials were identified for inclusion (9529 patients). One year of multifaceted care improved HbA1c levels in patients with screen-detected and newly diagnosed diabetes, but not in patients with prevalent diabetes, compared to usual diabetes care. Across all seven included trials, the weighted mean difference in HbA1c change was -0.07% (95% CI -0.10 to -0.04) (-0.8 mmol/mol (95% CI -1.1 to -0.4)); I 2 =21%. The findings for total cholesterol, LDL-cholesterol and blood pressure were similar to HbA1c, albeit statistical heterogeneity between studies was considerably larger. Compared to usual care, multifaceted care did not significantly change quality of life of the diabetes patient. Finally, measured for screen-detected diabetes only, the risk of macrovascular and mircovascular complications at follow-up was not significantly different between intervention and control patients. Effects of European multifaceted diabetes care patient outcomes are only small. Improvements are somewhat larger for screen-detected and newly diagnosed diabetes patients than for patients with prevalent diabetes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Managing leg ulceration in intravenous drug users.

PubMed

Geraghty, Jemell

2015-09-01

Chronic venous leg ulceration is a long-term condition commonly associated with lower-limb injecting and chronic venous hypertension caused by collapsed veins, incompetent valves, deep vein thrombosis and reflux. It is not usually a medical emergency, but intravenous (IV) drug users with leg ulcers can attend emergency departments (EDs) with a different primary complaint such as pain or because they cannot access local primary care or voluntary services. Leg ulceration might then be identified during history taking, so it is important that ED nurses know how to assess and manage these wounds. This article explains how to assess and manage chronic venous leg ulcers in patients with a history of IV drug use, and highlights the importance of referral to specialist services when required, and to local primary care or voluntary services, before discharge to prevent admission and re-attendance.

The management of diagnosed heart failure in older people in primary care.

PubMed

Jones, Nicholas R; Hobbs, F D Richard; Taylor, Clare J

2017-12-01

Heart failure (HF) is a common condition affecting predominantly older people. Symptoms include breathlessness and fatigue, and can significantly reduce quality of life. HF rarely occurs in isolation, with most patients having several co-existing diseases requiring multiple medications. There is a large evidence base for treatment of HF with reduced ejection fraction, or HFrEF; however, many of the trials did not include older people with multimorbidity so their findings should be applied to this group with some caution. The evidence for treatment of HF with preserved ejection fraction, or HFpEF, is much less well established in all age groups. Older people with HF are usually managed in primary care with input from specialist HF teams when needed. General practitioners are trained to take a generalist approach, which allows them to deliver holistic, person-centred care. The wider multidisciplinary team is also important during the patient's HF journey, with a particular need to consider palliative care towards the end of life. This article summarises the important aspects of HF management in older people from the perspective of primary care. Copyright © 2017 Elsevier B.V. All rights reserved.

Clinically relevant diagnostic research in primary care: the example of B-type natriuretic peptides in the detection of heart failure.

PubMed

Kelder, Johannes C; Rutten, Frans H; Hoes, Arno W

2009-02-01

With the emergence of novel diagnostic tests, e.g. point-of-care tests, clinically relevant empirical evidence is needed to assess whether such a test should be used in daily practice. With the example of the value of B-type natriuretic peptides (BNP) in the diagnostic assessment of suspected heart failure, we will discuss the major methodological issues crucial in diagnostic research; most notably the choice of the study population and the data analysis with a multivariable approach. BNP have been studied extensively in the emergency care setting, and also several studies in the primary care are available. The usefulness of this test when applied in combination with other readily available tests is still not adequately addressed in the relevant patient domain, i.e. those who are clinically suspected of heart failure by their GP. Future diagnostic research in primary care should be targeted much more at answering the clinically relevant question 'Is it useful to add this (new) test to the other tests I usually perform, including history taking and physical examination, in patients I suspect of having a certain disease'.

Access to Preventive Health Care for Cancer Survivors

PubMed Central

Yabroff, K. Robin; Short, Pamela Farley; Machlin, Steven; Dowling, Emily; Rozjabek, Heather; Li, Chunyu; McNeel, Timothy; Ekwueme, Donatus U.; Virgo, Katherine S.

2013-01-01

Background Access to healthcare, particularly effective primary and secondary preventive care, is critical for cancer survivors, in order to minimize the adverse sequelae of cancer and its treatment. Purpose The goal of the study was to evaluate the association between cancer survivorship and access to primary and preventive health care. Methods Cancer survivors (n=4960) and individuals without a cancer history (n=64,431) aged ≥18 years, from the 2008–2010 Medical Expenditure Panel Survey (MEPS), were evaluated. Multiple measures of access and preventive services use were compared. The association between cancer survivorship and access and preventive services was evaluated with multivariate logistic regression models, stratified by age group (18–64 years and ≥65 years), controlling for the effects of age, gender, race/ethnicity, education, marital status, and comorbidities. Data were analyzed in 2013. Results Cancer survivors aged ≥65 years had equivalent or greater access and preventive services use than individuals without a cancer history, in adjusted analyses. However, among those aged 18–64 years with private health insurance, cancer survivors were more likely than other individuals to have a usual source of care and to use preventive services, whereas uninsured or publicly insured cancer survivors were generally less likely to have a usual source of care and to use preventive services than were uninsured or publicly insured adults without a cancer history. Conclusions Although access and preventive care use in cancer survivors is generally equivalent or greater compared to that of other individuals, disparities for uninsured and publicly insured cancer survivors aged 18–64 years suggest that improvements in survivor care are needed. PMID:23953357

Effectiveness of the Engagement and Counseling for Latinos (ECLA) Intervention in Low-Income Latinos

PubMed Central

Ludman, Evette; Kafali, Nilay; Lapatin, Sheri; Vila, Doriliz; Shrout, Patrick E.; Keefe, Kristen; Cook, Benjamin; Ault, Andrea; Li, Xinliang; Bauer, Amy; Epelbaum, Claudia; Alcantara, Carmela; Pineda, Tulia Inés Guerra; Tejera, Gloria Gonzalez; Suarez, Gloria; Leon, Karla; Lessios, Anna S.; Ramirez, Rafael R; Canino, Glorisa

2014-01-01

Background Persistent disparities in access and quality of mental health care for Latinos indicate a need for evidence-based, culturally adapted and outside-the-clinic-walls treatments. Objective Evaluate treatment effectiveness of telephone (ECLA –T) or face-to-face (ECLA-F) delivery of a 6–8 session cognitive behavioral therapy and care-management intervention for low-income Latinos, as compared to usual care for depression. Design Multi-site randomized controlled trial. Setting Eight community health clinics in Boston, Massachusetts and San Juan, Puerto Rico. Participants 257 Latino patients recruited from primary care between May 2011 and September 2012. Main Outcome Measures The primary outcome was severity of depression, assessed with the Patient Health Questionnaire-9 (PHQ-9) and the Hopkins Symptom Checklist-20 (HSCL-20). The secondary outcome was functioning over the previous 30 days, measured using the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). Results Both telephone and face-to-face versions of the ECLA were more effective than usual care. The effect sizes of both intervention conditions on PHQ-9 were moderate when combined data from both sites are analyzed (.56 and .64 for face-to-face and telephone, respectively). Similarly, effect sizes of ECLA-F and ECLA-T on the HSCL were quite large in the Boston site (.64 and .73. respectively) but not in Puerto Rico (.10 and .03). Conclusions and Relevance The intervention appears to help Latino patients reduce depressive symptoms and improve functioning. Of particular importance is the higher treatment initiation for the telephone vs. face-to-face intervention (89.7% vs. 78.8%), which suggests that telephone-based care may improve access and quality of care. PMID:25310525

Having a Physician Rather than a Place as a Usual Source of Care Would Be Better - from 2012 Korea Health Panel Data.

PubMed

Kim, Kyeong Min; Jeon, Hyunsoo; Lee, Jae Ho

2017-01-01

A usual source of care (USC) in primary care improves health care quality and can result in improved health. However, current research about the type of USC (place only vs. physician with a place) is insufficient as an evidence to support the value of primary care. We analyzed data from the 2012 Korea Health Panel survey of adults aged 18 years or older (n = 11,873) who reported whether having a USC or not to compare the effects by type of USC on medical care use and out-of-pocket costs. Descriptive analysis showed significant differences in the distributions of sociodemographic and health status factors except frequency of outpatient visit by type of USC. Adjusted odds ratios (ORs) of having a physician with a place compared to not having a USC were 4.05 for age 65 ≥ years (vs. < 35 years), 1.33 for females (vs. males), 0.63 for the fifth (highest) quintile (vs. the first) of household income, 1.62 for medical aid (vs. employee) health insurance, and 4.46 for having a chronic disease (vs. not). For those having a physician with a place (vs. only a place) as a USC, adjusted ORs of hospital admission and emergency room (ER) visit were 0.77 and 0.71 with out-of-pocket costs not significantly high. Those having a physician with a place (vs. only a place) as a USC included more patients with chronic diseases, but they had fewer hospital admissions and ER visits. When designing a plan for health care reform in Korea, promoting having a physician rather than a place as a USC would be a better policy.

Having a Physician Rather than a Place as a Usual Source of Care Would Be Better - from 2012 Korea Health Panel Data

PubMed Central

2017-01-01

A usual source of care (USC) in primary care improves health care quality and can result in improved health. However, current research about the type of USC (place only vs. physician with a place) is insufficient as an evidence to support the value of primary care. We analyzed data from the 2012 Korea Health Panel survey of adults aged 18 years or older (n = 11,873) who reported whether having a USC or not to compare the effects by type of USC on medical care use and out-of-pocket costs. Descriptive analysis showed significant differences in the distributions of sociodemographic and health status factors except frequency of outpatient visit by type of USC. Adjusted odds ratios (ORs) of having a physician with a place compared to not having a USC were 4.05 for age 65 ≥ years (vs. < 35 years), 1.33 for females (vs. males), 0.63 for the fifth (highest) quintile (vs. the first) of household income, 1.62 for medical aid (vs. employee) health insurance, and 4.46 for having a chronic disease (vs. not). For those having a physician with a place (vs. only a place) as a USC, adjusted ORs of hospital admission and emergency room (ER) visit were 0.77 and 0.71 with out-of-pocket costs not significantly high. Those having a physician with a place (vs. only a place) as a USC included more patients with chronic diseases, but they had fewer hospital admissions and ER visits. When designing a plan for health care reform in Korea, promoting having a physician rather than a place as a USC would be a better policy. PMID:27914125

Impact of Computerized Decision Support on Blood Pressure Management and Control: A Randomized Controlled Trial

PubMed Central

Sequist, Thomas D.; Ayanian, John Z.; Shaykevich, Shimon; Fairchild, David G.; Orav, E. John; Bates, David W.

2008-01-01

BACKGROUND We conducted a cluster randomized controlled trial to examine the effectiveness of computerized decision support (CDS) designed to improve hypertension care and outcomes in a racially diverse sample of primary care patients. METHODS We randomized 2,027 adult patients receiving hypertension care in 14 primary care practices to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group. We assessed prescribing of guideline-recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients’ race/ethnicity using interaction terms. MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42% at baseline and 46% at the outcome visit with no significant differences between groups. After adjustment for patients’ demographic and clinical characteristics, number of prior visits, and levels of baseline blood pressure control, there were no differences between intervention groups in the odds of outcome blood pressure control. The use of CDS to providers significantly improved Joint National Committee (JNC) guideline adherent medication prescribing compared to usual care (7% versus 5%, P < 0.001); the effects of the intervention remained after multivariable adjustment (odds ratio [OR] 1.39 [CI, 1.13–1.72]) and the effects of the intervention did not differ by patients’ race and ethnicity. CONCLUSIONS CDS improved appropriate medication prescribing with no improvement in disparities in care and overall blood pressure control. Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed. PMID:18373141

Depressive symptom deterioration among predominantly Hispanic diabetes patients in safety net care.

PubMed

Ell, Kathleen; Katon, Wayne; Lee, Pey-Jiuan; Kapetanovic, Suad; Guterman, Jeffrey; Xie, Bin; Chou, Chih-Ping

2012-01-01

This study examines clinical predictors of symptom deterioration (relapse/recurrence) at the completion of a clinical intervention trial of depressed, low-income, predominantly Hispanic diabetes patients who were randomized to socio-culturally adapted collaborative depression treatment or usual care and who no longer met clinically significant depression criteria at 12 months post-trial baseline. A sub-cohort of 193 diabetes patients with major depression symptoms at baseline, who were randomized to a 12-month collaborative care intervention (INT) (problem-solving therapy and/or pharmacotherapy, telephone symptom monitoring/relapse prevention, behavioral activation and patient navigation support) or enhanced usual care (EUC), and who did not meet major depression criteria at 12 months were subsequently observed over 18 to 24 months. Post-trial depression symptom deterioration was similar between INT (35.2%) and EUC (35.3%) groups. Among the combined groups, significant predictors of symptom deterioration were baseline history of previous depression and/or dysthymia (odds ratio [OR] = 2.66), 12-month PHQ-9 score (OR = 1.22), antidepressant treatment receipt during the initial 12-months (OR = 2.38), 12-month diabetes symptoms (OR = 2.27), and new ICD-9 medical diagnoses in the initial 12 months (OR = 1.11) (R2 = 27%; max-rescaled R2 = 37%; likelihood ratio test, χ2 = 59.79, df = 5, P < 0.0001). Among predominantly Hispanic diabetes patients in community safety net primary care clinics whose depression had improved over 1 year, more than one-third experienced symptom deterioration over the following year. A primary care management depression care protocol that includes ongoing depression symptom monitoring, antidepressant adherence, and diabetes and co-morbid illness monitoring plus depression medication adjustment and behavioral activation may reduce and/or effectively treat depression symptom deterioration. Copyright © 2012 The Academy of Psychosomatic Medicine. All rights reserved.

[Non-randomised trial of an educational intervention based on cognitive-behavioural principles for patients with chronic low back pain attended in Primary Care Physiotherapy].

PubMed

Díaz-Cerrillo, Juan Luis; Rondón-Ramos, Antonio; Pérez-González, Rita; Clavero-Cano, Susana

2016-01-01

To assess the influence of an educational intervention in reducing «fear-avoidance» (FA) and «pain catastrophising» (CAT) in a population with unspecific chronic low back pain (UCLBP), attending physiotherapy in Primary Health Care. A pragmatic quasi-experimental study was conducted in Health Centres of a Costa del Sol Health District. Quasi-experimental study. Primary Health Care physiotherapy Back Schools in Health Centres of a Costa del Sol Health District. The selection criteria were: UCLBP; 18-65years; understanding of the Spanish language; absence of parallel educational interventions; absence of red flags; not showing cognitive impairment or fibromyalgia; absence of thoracic-lumbar surgery, and exercise tolerance. The control group received the usual Back Schools program. The experimental group also received a written document for home reading, plus the subsequent sharing, clarifying doubts, and beliefs and goals restructuring during the development of the sessions. Both interventions lasted about 280minutes (7 sessions×40min). The main variables included FA and CAT. Pain and disability were also assessed. Some «demographic» and «related disorder» variables were considered in the analysis. Statistically significant differences were observed in the experimental group versus control, in the variation of FA -14 (-25.5; 0) vs -4 (-13; 0) (P=.009), and CAT -9 (-18; -4) vs -4,5 (-8.25; 0) (P=.000), were observed. Also differences in disability (P=.046), but not in pain (P=.280). These results should be considered in light of possible limits imposed by the study. Its pragmatic nature would allow a potential transfer to usual care. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Incremental cost-effectiveness of pharmacotherapy and two brief cognitive-behavioral therapies compared with usual care for panic disorder and noncardiac chest pain.

PubMed

Poirier-Bisson, Joannie; Marchand, André; Pelland, Marie-Eve; Lessard, Marie-Josée; Dupuis, Gilles; Fleet, Richard; Roberge, Pasquale

2013-09-01

The aim of this study was to assess the incremental cost-effectiveness ratios (ICERs) of two brief cognitive-behavioral therapy (CBT)-based interventions and a pharmacological treatment, compared with usual care, initiated in the emergency department (ED) for individuals with panic disorder (PD) with a chief complaint of noncardiac chest pain. A total of 69 patients were followed up to 6 months. The primary outcome variables were direct and indirect costs of treatment and PD severity. Panic management (PM) had an ICER of $124.05, per the Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, severity score change (95% confidence interval [CI], $54.63-$314.57), compared with pharmacotherapy (paroxetine), with an ICER of $213.90 (95% CI, $133.51-$394.94), and brief CBT, with an ICER of $309.31 (95% CI, $151.27-$548.28). The pharmacological and CBT interventions were associated with a greater clinical improvement compared with usual care at posttest. PM presented a superior ICER, suggesting that it may be a promising treatment option to implement in EDs.

Usual source of care and the quality of medical care experiences: a cross-sectional survey of patients from a Taiwanese community.

PubMed

Tsai, Jenna; Shi, Leiyu; Yu, Wei-Lung; Lebrun, Lydie A

2010-07-01

This study used a recent patient survey to examine the relationship between having a usual source of care (USC) and the quality of ambulatory medical care experiences in Taiwan, where there is universal health insurance coverage. The study design was a cross-sectional survey of 879 patients in Taichung County, Taiwan. Children and adults visiting hospital-based physicians were included. Quality of care was measured using items from the Primary Care Assessment Tool (PCAT), representing 7 ambulatory medical care domains: first contact (ie, access and utilization), longitudinality (ie, ongoing care), coordination (ie, referrals and information systems), comprehensiveness (ie, services available and provided), family centeredness, community orientation, and cultural competence. USC was defined based on responses to 3 survey items from the PCAT. Having a USC was significantly associated with higher quality of medical care experiences. Specifically, having a USC was associated with improved accessibility and utilization, ongoing care, coordination of referrals, and healthcare providers' family centeredness and cultural competence. However, having a USC was not strongly related with comprehensiveness of services, coordination of information systems, or healthcare providers' community orientation. In a region with universal health insurance, patients with a USC reported higher quality of medical care experiences compared with those without a USC. Beyond the provision of health insurance coverage, efforts to improve quality of care should include policies promoting USC.

Primary care challenges of an obscure case of "Alice in Wonderland" syndrome in a patient with severe malaria in a resource-constrained setting: a case report.

PubMed

Kadia, Benjamin Momo; Ekabe, Cyril Jabea; Agborndip, Ettamba

2017-12-22

"Alice in Wonderland" syndrome (AIWS) is a rare neurological abnormality characterized by distortions of visual perceptions, body schema and experience of time. AIWS has been reported in patients with various infections such as infectious mononucleosis, H1N1 influenza, Cytomegalovirus encephalitis, and typhoid encephalopathy. However, AIWS occurring in a patient with severe malaria is less familiar and could pose serious primary care challenges in a low-income context. A 9-year-old male of black African ethnicity was brought by his parents to our primary care hospital because for 2 days he had been experiencing intermittent sudden perceptions of his parents' heads and objects around him either "shrinking" or "expanding". The visual perceptions were usually brief and resolved spontaneously. One week prior to the onset of the visual problem, he had developed an intermittent high grade fever that was associated with other severe constitutional symptoms. Based on the historical and clinical data that were acquired, severe malaria was suspected and this was confirmed by hyperparasitaemia on blood film analysis. The patient was treated with quinine for 10 days. Apart from a single episode of generalized tonic-clonic seizures that was observed on the first day of treatment, the overall clinical progress was good. The visual illusions completely resolved and no further abnormalities were recorded during 3 months of follow-up. Symptoms of AIWS usually resolve spontaneously or after treatment of an underlying cause. In our case, the successful treatment of severe malaria coincided with a complete regression of AIWS whose aetiology was poorly-elucidated given the resource constraints. In any case, the good outcome of our patient aligns with previous reports on acute AIWS that highlight a limited need for excessive investigation and treatment modalities which are, in passing, predominantly unaffordable in resource-limited primary care settings.

The limits of market-based reforms in the NHS: the case of alternative providers in primary care.

PubMed

Coleman, Anna; Checkland, Kath; McDermott, Imelda; Harrison, Stephen

2013-01-01

Historically, primary medical care in the UK has been delivered by general practitioners who are independent contractors, operating under a contract, which until 2004 was subject to little performance management. In keeping with the wider political impetus to introduce markets and competition into the NHS, reforms were introduced to allow new providers to bid for contracts to provide primary care services in England. These contracts known as 'Alternative Provider Medical Services', were encouraged by two centrally-driven rounds of procurement (2007/8 and 2008/9). This research investigated the commissioning and operation of such Alternative Providers of Primary Care (APPCs). Two qualitative case studies were undertaken in purposively sampled English Primary Care Trusts (PCTs) and their associated APPCs over 14 months (2009-10). We observed 65 hours of meetings, conducted 23 interviews with PCT and practice staff, and gathered relevant associated documentation. We found that the procurement and contracting process was costly and time-consuming. Extensive local consultation was undertaken, and there was considerable opposition in some areas. Many APPCs struggled to build up their patient list sizes, whilst over-performing on walk-in contracts. Contracting for APPCs was 'transactional', in marked contrast to the 'relational' contracting usually found in the NHS, with APPCs subject to tight performance management. These complicated and costly processes contrast to those experienced by traditionally owned GP partnerships. However, managers reported that the perception of competition had led existing practices to improve their services. The Coalition Government elected in 2010 is committed to 'Any Qualified Provider' of secondary care, and some commentators argue that this should also be applied to primary care. Our research suggests that, if this is to happen, a debate is needed about the operation of a market in primary care provision, including the trade-offs between transparent processes, fair procurement, performance assurance and cost.

The limits of market-based reforms in the NHS: the case of alternative providers in primary care

PubMed Central

2013-01-01

Background Historically, primary medical care in the UK has been delivered by general practitioners who are independent contractors, operating under a contract, which until 2004 was subject to little performance management. In keeping with the wider political impetus to introduce markets and competition into the NHS, reforms were introduced to allow new providers to bid for contracts to provide primary care services in England. These contracts known as ‘Alternative Provider Medical Services’, were encouraged by two centrally-driven rounds of procurement (2007/8 and 2008/9). This research investigated the commissioning and operation of such Alternative Providers of Primary Care (APPCs). Methods Two qualitative case studies were undertaken in purposively sampled English Primary Care Trusts (PCTs) and their associated APPCs over 14 months (2009-10). We observed 65 hours of meetings, conducted 23 interviews with PCT and practice staff, and gathered relevant associated documentation. Results and conclusions We found that the procurement and contracting process was costly and time-consuming. Extensive local consultation was undertaken, and there was considerable opposition in some areas. Many APPCs struggled to build up their patient list sizes, whilst over-performing on walk-in contracts. Contracting for APPCs was ‘transactional’, in marked contrast to the ‘relational’ contracting usually found in the NHS, with APPCs subject to tight performance management. These complicated and costly processes contrast to those experienced by traditionally owned GP partnerships. However, managers reported that the perception of competition had led existing practices to improve their services. The Coalition Government elected in 2010 is committed to ‘Any Qualified Provider’ of secondary care, and some commentators argue that this should also be applied to primary care. Our research suggests that, if this is to happen, a debate is needed about the operation of a market in primary care provision, including the trade-offs between transparent processes, fair procurement, performance assurance and cost. PMID:23735051

Implementing collaborative care for depression treatment in primary care: A cluster randomized evaluation of a quality improvement practice redesign

PubMed Central

2011-01-01

Background Meta-analyses show collaborative care models (CCMs) with nurse care management are effective for improving primary care for depression. This study aimed to develop CCM approaches that could be sustained and spread within Veterans Affairs (VA). Evidence-based quality improvement (EBQI) uses QI approaches within a research/clinical partnership to redesign care. The study used EBQI methods for CCM redesign, tested the effectiveness of the locally adapted model as implemented, and assessed the contextual factors shaping intervention effectiveness. Methods The study intervention is EBQI as applied to CCM implementation. The study uses a cluster randomized design as a formative evaluation tool to test and improve the effectiveness of the redesign process, with seven intervention and three non-intervention VA primary care practices in five different states. The primary study outcome is patient antidepressant use. The context evaluation is descriptive and uses subgroup analysis. The primary context evaluation measure is naturalistic primary care clinician (PCC) predilection to adopt CCM. For the randomized evaluation, trained telephone research interviewers enrolled consecutive primary care patients with major depression in the evaluation, referred enrolled patients in intervention practices to the implemented CCM, and re-surveyed at seven months. Results Interviewers enrolled 288 CCM site and 258 non-CCM site patients. Enrolled intervention site patients were more likely to receive appropriate antidepressant care (66% versus 43%, p = 0.01), but showed no significant difference in symptom improvement compared to usual care. In terms of context, only 40% of enrolled patients received complete care management per protocol. PCC predilection to adopt CCM had substantial effects on patient participation, with patients belonging to early adopter clinicians completing adequate care manager follow-up significantly more often than patients of clinicians with low predilection to adopt CCM (74% versus 48%%, p = 0.003). Conclusions Depression CCM designed and implemented by primary care practices using EBQI improved antidepressant initiation. Combining QI methods with a randomized evaluation proved challenging, but enabled new insights into the process of translating research-based CCM into practice. Future research on the effects of PCC attitudes and skills on CCM results, as well as on enhancing the link between improved antidepressant use and symptom outcomes, is needed. Trial Registration ClinicalTrials.gov: NCT00105820 PMID:22032247

Study protocol of EMPOWER participatory action research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care.

PubMed

Ramli, Anis S; Lakshmanan, Sharmila; Haniff, Jamaiyah; Selvarajah, Sharmini; Tong, Seng F; Bujang, Mohamad-Adam; Abdul-Razak, Suraya; Shafie, Asrul A; Lee, Verna K M; Abdul-Rahman, Thuhairah H; Daud, Maryam H; Ng, Kien K; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md-Yasin; Mat-Nasir, Nafiza; Miskan, Maizatullifah; Stanley-Ponniah, Jaya P; Ismail, Mastura; Chan, Chun W; Abdul-Rahman, Yong R; Chew, Boon-How; Low, Wilson H H

2014-09-13

Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol. A pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period. The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team, training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing. For type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving HbA1c < 6.5%. For hypertension without type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving blood pressure < 140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets for serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients' assessment of their chronic disease care and providers' perceptions, attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated. Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings. The evidence should instigate crucial primary care system change in Malaysia. ClinicalTrials.gov NCT01545401.

Medication Therapy Management after Hospitalization in CKD: A Randomized Clinical Trial.

PubMed

Tuttle, Katherine R; Alicic, Radica Z; Short, Robert A; Neumiller, Joshua J; Gates, Brian J; Daratha, Kenn B; Barbosa-Leiker, Celestina; McPherson, Sterling M; Chaytor, Naomi S; Dieter, Brad P; Setter, Stephen M; Corbett, Cynthia F

2018-02-07

CKD is characterized by remarkably high hospitalization and readmission rates. Our study aim was to test a medication therapy management intervention to reduce subsequent acute care utilization. The CKD Medication Intervention Trial was a single-blind (investigators), randomized clinical trial conducted at Providence Health Care in Spokane, Washington. Patients with CKD stages 3-5 not treated by dialysis who were hospitalized for acute illness were recruited. The intervention was designed to improve posthospitalization care by medication therapy management. A pharmacist delivered the intervention as a single home visit within 7 days of discharge. The intervention included these fundamental elements: comprehensive medication review, medication action plan, and a personal medication list. The primary outcome was a composite of acute care utilization (hospital readmissions and emergency department and urgent care visits) for 90 days after hospitalization. Baseline characteristics of participants ( n =141) included the following: age, 69±11 (mean±SD) years old; women, 48% (67 of 141); diabetes, 56% (79 of 141); hypertension, 83% (117 of 141); eGFR, 41±14 ml/min per 1.73 m 2 (serum creatinine-based Chronic Kidney Disease Epidemiology Collaboration equation); and urine albumin-to-creatinine ratio median, 43 mg/g (interquartile range, 8-528) creatinine. The most common primary diagnoses for hospitalization were the following: cardiovascular events, 36% (51 of 141); infections, 18% (26 of 141); and kidney diseases, 12% (17 of 141). The primary outcome occurred in 32 of 72 (44%) of the medication intervention group and 28 of 69 (41%) of those in usual care (log rank P =0.72). For only hospital readmission, the rate was 19 of 72 (26%) in the medication intervention group and 18 of 69 (26%) in the usual care group (log rank P =0.95). There was no between-group difference in achievement of guideline-based goals for use of renin-angiotensin system inhibition or for BP, hemoglobin, phosphorus, or parathyroid hormone. Acute care utilization after hospitalization was not reduced by a pharmacist-led medication therapy management intervention at the transition from hospital to home. Copyright © 2018 by the American Society of Nephrology.

A Randomized Trial of Acceptability and Effects of Values-Based Advance Care Planning in Outpatient Oncology: Person-Centered Oncologic Care and Choices (P-COCC).

PubMed

Epstein, Andrew S; O'Reilly, Eileen M; Shuk, Elyse; Romano, Danielle; Li, Yuelin; Breitbart, William; Volandes, Angelo E

2018-05-02

No standard advance care planning (ACP) process exists in oncology. We previously developed and validated the values questions for Person-Centered Oncologic Care and Choices (P-COCC), a novel ACP intervention combining a patient values interview with an informational care goals video. To pilot study acceptability, and, using randomization, explore potential utility of P-COCC. Eligibility included patients with advanced gastrointestinal cancer cared for at a comprehensive cancer center. Participants were randomized 2:2:1 to P-COCC vs. video alone vs. usual care. Validated assessments of wellbeing and decisional conflict were completed. Participants in the P-COCC arm also completed 3 Likert scales (was the intervention helpful, comfortable, and recommended to others); a positive score on at least 1 of 3 indicated acceptability. Patients were screened from 9/2014-11/2016; 151 were consented and randomized, 99 whom completed study measures (most common attrition reason: disease progression or death). The primary aim was met: Among 33 participants, P-COCC was acceptable to 32 (97%, 95%CI: 0.84-0.99, p<0.001). Mean distress scores (0-10) increased (0.43) in the P-COCC arm but decreased in the video alone (-0.04) and usual care (-0.21) arms (p=0.03 and 0.04, P-COCC versus video alone and usual care arms, respectively). There were no significant pre-post change scores on other measures of wellbeing (e.g., anxiety, depression, stress), or intergroup differences in decisional conflict. Our values-based ACP paradigm is acceptable but may increase distress in cancer outpatients. Further studies are investigating the underpinnings of these effects and ways to best support cancer patients in ACP. Copyright © 2018. Published by Elsevier Inc.

Cost-benefit and cost-savings analyses of antiarrhythmic medication monitoring.

PubMed

Snider, Melissa; Carnes, Cynthia; Grover, Janel; Davis, Rich; Kalbfleisch, Steven

2012-09-15

The economic impact of pharmacist-managed antiarrhythmic drug therapy monitoring on an academic medical center's electrophysiology (EP) program was investigated. Data were collected for the initial two years of patient visits (n = 816) to a pharmacist-run clinic for antiarrhythmic drug therapy monitoring. A retrospective cost analysis was conducted to assess the direct costs associated with three appointment models: (1) a clinic office visit only, (2) a clinic visit involving electrocardiography and basic laboratory tests, and (3) a clinic visit including pulmonary function testing and chest x-rays in addition to electrocardiography and laboratory testing. A subset of patient cases (n = 18) were included in a crossover analysis comparing pharmacist clinic care and usual care in an EP physician clinic. The primary endpoints were the cost benefits and cost savings associated with pharmacy-clinic care versus usual care. A secondary endpoint was improvement of overall EP program efficiency. The payer mix was 61.6% (n = 498) Medicare, 33.2% (n = 268) managed care, and 5.2% (n = 42) other. Positive contribution margins were demonstrated for all appointment models. The pharmacist-managed clinic also yielded cost savings by reducing overall patient care charges by 21% relative to usual care. By the second year, the pharmacy clinic improved EP program efficiency by scheduling an average of 24 patients per week, in effect freeing up one day per week of EP physician time to spend on other clinical activities. Pharmacist monitoring of antiarrhythmic drug therapy in an out-patient clinic provided cost benefits, cost savings, and improved overall EP program efficiency.

A target-driven collaborative care model for Major Depressive Disorder is effective in primary care in the Netherlands. A randomized clinical trial from the depression initiative.

PubMed

Huijbregts, Klaas M L; de Jong, Fransina J; van Marwijk, Harm W J; Beekman, Aartjan T F; Adèr, Herman J; Hakkaart-van Roijen, Leona; Unützer, Jürgen; van der Feltz-Cornelis, Christina M

2013-04-25

Practice variation in the primary care treatment of depression may be considerable in the Netherlands, due to relatively small and unregulated practices. We adapted the collaborative care model for the treatment of Major Depressive Disorder (MDD) to accommodate existing practice variation and tested whether this had added value over Care as Usual (CAU). A cluster randomized controlled trial was conducted to compare an adapted target driven collaborative care model with Care as Usual (CAU). Randomization was at the level of 18 (sub)urban primary care centers. The care manager and GP were supported by a web-based tracking and decision aid system that advised targeted treatment actions to achieve rapid response and if possible remission, and that warned the consultant psychiatrist if such treatment advice was not followed up. Eligible patients had a score of 10 or higher on the PHQ9, and met diagnostic criteria for major depression at the subsequent MINI Neuropsychiatric interview. A total of 93 patients were identified by screening. They received either collaborative care (CC) or CAU. Another 56 patients received collaborative care after identification by the GP. The outcome measures were response to treatment (50% or greater reduction of the PHQ9-total score from baseline) at three, six, nine and twelve months, and remission (a score of 0-4 on the PHQ9 at follow-up). Treatment response and remission in CAU were low. Collaborative care was more effective on achieving treatment response than CAU at three months for the total group of patients who received collaborative care [OR 5.2 ((1.41-16.09), NNT 2] and at nine months [OR 5.6 ((1.40-22.58)), NNT 3]. The effect was not statistically significant at 6 and 12 months. A relatively high percentage of patients (36.5%) did not return one or more follow-up questionnaires. There was no evidence for selective non response. Our adapted target driven CC was considerably more effective than CAU for MDD in primary care in the Netherlands. The Numbers Needed To Treat (NNT) to achieve response in one additional patient were low (2-3), which suggest that introducing CC at a larger scale may be beneficial. The relatively large effects may be due to our focus on reducing practice variation through the introduction of easy to use web based tracking and decision aids. The findings are highly relevant for the application of the model in areas where practices tend to be small and for mixed healthcare systems such as in many countries in Europe. Dutch trial register ISRCTN15266438 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=820). Copyright © 2012 Elsevier B.V. All rights reserved.

Comparing counselling models for the hazardous use of alcohol at the Swedish National Alcohol Helpline: study protocol for a randomised controlled trial.

PubMed

Säfsten, Eleonor; Forsell, Yvonne; Ramstedt, Mats; Galanti, Maria Rosaria

2017-06-06

Hazardous and harmful consumption of alcohol is a leading cause of preventable disease and premature deaths. Modifying the amount and pattern of risky alcohol consumption conveys substantial benefits to individuals and to society at large. Telephone helplines provide a feasible alternative to face-to-face counselling in order to increase the reach of brief interventions aiming at modifying the hazardous and harmful use of alcohol. However, there is a lack of studies on the implementation and evaluation of population-based telephone services for the prevention and treatment of alcohol misuse. A randomised controlled trial was designed to compare a brief, structured intervention to usual care within the Swedish National Alcohol Helpline (SAH), concerning their effectiveness on decreasing the hazardous use of alcohol. Between May 2015 and December 2017, about 300 callers are to be individually randomised with a 1:1 ratio to a brief, structured intervention (n = 150) or to usual care (n = 150). The brief, structured intervention consists of the delivery of a self-help booklet followed by one proactive call from SAH counsellors to monitor and give feedback about the client's progression. Callers assigned to usual care receive telephone counselling according to existing practice, i.e., motivational interviewing in a tailored and client-driven combination of proactive and reactive calls. The primary outcome is defined as a change from a higher to a lower AUDIT risk-level category between baseline and follow-up. General linear modeling will be used to calculate risk ratios of the outcome events. The primary analysis will follow an intention-to-treat (ITT) approach. The trial is designed to evaluate the effectiveness in decreasing the hazardous and harmful consumption of alcohol of a brief, structured intervention compared to usual care when delivered at the SAH. The results of the study will be used locally to improve the effectiveness of the service provided at the SAH. Additionally, they will expand the evidence base about optimal counselling models in population-based telephone services for alcohol misuse prevention and treatment. ISRCNT.com, ID: ISRCTN13160878 . Retrospectively registered on 18 January 2016.

Efficacy of GP referral of insufficiently active patients for expert physical activity counseling: protocol for a pragmatic randomized trial (The NewCOACH trial).

PubMed

James, Erica L; Ewald, Ben; Johnson, Natalie; Brown, Wendy; Stacey, Fiona G; Mcelduff, Patrick; Booth, Angela; Yang, Fan; Hespe, Charlotte; Plotnikoff, Ronald C

2014-12-29

Physical inactivity is fourth in the list of risk factors for global mortality. General practitioners are well placed to offer physical activity counseling but insufficient time is a barrier. Although referral to an exercise specialist is an alternative, in Australia, these allied health professionals are only publicly funded to provide face-to-face counseling to patients who have an existing chronic illness. Accordingly, this trial aims to determine the efficacy of GP referral of insufficiently active patients (regardless of their chronic disease status) for physical activity counseling (either face-to-face or predominately via telephone) by exercise specialists, based on patients' objectively assessed physical activity levels, compared with usual care. If the trial is efficacious, the equivalence and cost-effectiveness of face-to-face counseling versus telephone counseling will be assessed. This three arm pragmatic randomized trial will involve the recruitment of 261 patients from primary care clinics in metropolitan and regional areas of New South Wales, Australia. Insufficiently active (less than 7000 steps/day) consenting adult patients will be randomly assigned to: 1) five face-to-face counseling sessions, 2) one face-to-face counseling session followed by four telephone calls, or 3) a generic mailed physical activity brochure (usual care). The interventions will operationalize social cognitive theory via a behavior change counseling framework. Participants will complete a survey and seven days of pedometry at baseline, and at three and 12 months post-randomization. The primary analyses will be based on intention-to-treat principles and will compare: (i) mean change in average daily step counts between baseline and 12 months for the combined intervention group (Group 1: face-to-face, and Group 2: telephone) and usual care (Group 3); (ii) step counts at 3 months post-randomization. Secondary outcomes include: self-reported physical activity, sedentary behavior, quality of life, and depression. If referral of primary care patients to exercise specialists increases physical activity, this process offers the prospect of systematically and sustainably reaching a large proportion of insufficiently active adults. If shown to be efficacious this trial provides evidence to expand public funding beyond those with a chronic disease and for delivery via telephone as well as face-to-face consultations. Australian New Zealand Clinical Trials Registry ACTRN12611000884909 .

RECODE: design and baseline results of a cluster randomized trial on cost-effectiveness of integrated COPD management in primary care.

PubMed

Kruis, Annemarije L; Boland, Melinde R S; Schoonvelde, Catharina H; Assendelft, Willem J J; Rutten-van Mölken, Maureen P M H; Gussekloo, Jacobijn; Tsiachristas, Apostolos; Chavannes, Niels H

2013-03-23

Favorable effects of formal pulmonary rehabilitation in selected moderate to severe COPD patients are well established. Few data are available on the effects and costs of integrated disease management (IDM) programs on quality of care and health status of COPD patients in primary care, representing a much larger group of COPD patients. Therefore, the RECODE trial assesses the long-term clinical and cost-effectiveness of IDM in primary care. RECODE is a cluster randomized trial with two years of follow-up, during which 40 clusters of primary care teams (including 1086 COPD patients) are randomized to IDM or usual care. The intervention started with a 2-day multidisciplinary course in which healthcare providers are trained as a team in essential components of effective COPD IDM in primary care. During the course, the team redesigns the care process and defines responsibilities of different caregivers. They are trained in how to use feedback on process and outcome data to guide implement guideline-driven integrated healthcare. Practice-tailored feedback reports are provided at baseline, and at 6 and 12 months. The team learns the details of an ICT program that supports recording of process and outcome measures. Afterwards, the team designs a time-contingent individual practice plan, agreeing on steps to be taken in order to integrate a COPD IDM program into daily practice. After 6 and 12 months, there is a refresher course for all teams simultaneously to enable them to learn from each other's experience. Health status of patients at 12 months is the primary outcome, measured by the Clinical COPD Questionnaire (CCQ). Secondary outcomes include effects on quality of care, disease-specific and generic health-related quality of life, COPD exacerbations, dyspnea, costs of healthcare utilization, and productivity loss. This article presents the protocol and baseline results of the RECODE trial. This study will allow to evaluate whether IDM implemented in primary care can positively influence quality of life and quality of care in mild to moderate COPD patients, thereby making the benefits of multidisciplinary rehabilitation applicable to a substantial part of the COPD population. Netherlands Trial Register (NTR): NTR2268.

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

PubMed

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs from participants in the PT-led primary care sites. If this pilot demonstrates feasibility, a fully powered trial will provide evidence that has the potential to transform primary care for back pain. The full trial will inform future service design, whether these models should be more widely implemented, and training agendas. ClinicalTrials.gov, NCT03320148 . Submitted for registration on 17 September 2017.

Effectiveness of early intensive therapy on β-cell preservation in type 1 diabetes.

PubMed

Buckingham, Bruce; Beck, Roy W; Ruedy, Katrina J; Cheng, Peiyao; Kollman, Craig; Weinzimer, Stuart A; DiMeglio, Linda A; Bremer, Andrew A; Slover, Robert; Tamborlane, William V

2013-12-01

To assess effectiveness of inpatient hybrid closed-loop control (HCLC) followed by outpatient sensor-augmented pump (SAP) therapy initiated within 7 days of diagnosis of type 1 diabetes on the preservation of β-cell function at 1 year. Sixty-eight individuals (mean age 13.3 ± 5.7 years; 35% female, 92% Caucasian) were randomized to HCLC followed by SAP therapy (intensive group; N = 48) or to the usual-care group treated with multiple daily injections or insulin pump therapy (N = 20). Primary outcome was C-peptide concentrations during mixed-meal tolerance tests at 12 months. Intensive-group participants initiated HCLC a median of 6 days after diagnosis for a median duration of 71.3 h, during which median participant mean glucose concentration was 140 mg/dL (interquartile range 134-153 mg/dL). During outpatient SAP, continuous glucose monitor (CGM) use decreased over time, and at 12 months, only 33% of intensive participants averaged sensor use ≥6 days/week. In the usual-care group, insulin pump and CGM use were initiated prior to 12 months by 15 and 5 participants, respectively. Mean HbA1c levels were similar in both groups throughout the study. At 12 months, the geometric mean (95% CI) of C-peptide area under the curve was 0.43 (0.34-0.52) pmol/mL in the intensive group and 0.52 (0.32-0.75) pmol/mL in the usual-care group (P = 0.49). Thirty-seven (79%) intensive and 16 (80%) usual-care participants had a peak C-peptide concentration ≥0.2 pmol/mL (P = 0.30). In new-onset type 1 diabetes, HCLC followed by SAP therapy did not provide benefit in preserving β-cell function compared with current standards of care.

Healthy Colon, Healthy Life

PubMed Central

Walsh, Judith M.E.; Salazar, Rene; Nguyen, Tung T.; Kaplan, Celia; Nguyen, Lamkieu; Hwang, Jimmy; McPhee, Stephen J.; Pasick, Rena J.

2014-01-01

Background Colorectal cancer (CRC) screening rates are increasing, but they are still low, particularly in ethnic minority groups. In many resource-poor settings, fecal occult blood test (FOBT) is the main screening option. Intervention Culturally tailored telephone counseling by community health advisors employed by a community-based organization, culturally tailored brochures, and customized FOBT kits. Design RCT. Participants were randomized to (1) basic intervention: culturally tailored brochure plus FOBT kit (n=765); (2) enhanced intervention: brochure, FOBT plus telephone counseling (n=768); or (3) usual care (n=256). Setting/participants Latino and Vietnamese primary care patients at a large public hospital. Main outcome measures Self-reported receipt of FOBT or any CRC screening at 1-year follow-up. Results 1358 individuals (718 Latinos and 640 Vietnamese) completed the follow-up survey. Self-reported FOBT screening rates increased by 7.8 % in the control group, by 15.1 % in the brochure group, and by 25.1 % in the brochure/telephone counseling group (p<0.01 for differences between each intervention and usual care and for the difference between brochure/telephone counseling and brochure alone). For any CRC screening, rates increased by 4.1 % in the usual care group, by 11.9 % in the FOBT/brochure group, and by 21.4 % in the brochure/telephone counseling group (p<0.01 for differences between each intervention and usual care and for the difference between the basic and the enhanced intervention). Conclusions An intervention that included culturally tailored brochures and tailored telephone counseling increased CRC screening in Latinos and the Vietnamese. Brochure and telephone counseling together had the greatest impact. Future research should address replication and dissemination of this model for Latinos and Vietnamese in other communities, and adaptation of the model for other groups. PMID:20547275

MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol

PubMed Central

Chow, Clara K; Thiagalingam, Aravinda; Rogers, Kris; Chalmers, John; Redfern, Julie

2017-01-01

Introduction The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. Methods and analysis Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. Ethics and dissemination Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. Trial registration number ACTRN12616000661471; Pre-results PMID:28993388

Effects of Telephone Counseling Intervention by Pharmacists (TelCIP) on Medication Adherence; Results of a Cluster Randomized Trial

PubMed Central

Kooij, Marcel J.; Heerdink, Eibert R.; van Dijk, Liset; van Geffen, Erica C. G.; Belitser, Svetlana V.; Bouvy, Marcel L.

2016-01-01

Objectives: To assess the effect of a pharmacist telephone counseling intervention on patients' medication adherence. Design: Pragmatic cluster randomized controlled trial. Setting: 53 Community pharmacies in The Netherlands. Participants: Patients ≥18 years initiating treatment with antidepressants, bisphosphonates, Renin-Angiotensin System (RAS)-inhibitors, or statins (lipid lowering drugs). Pharmacies in arm A provided the intervention for antidepressants and bisphosphonates and usual care for RAS-inhibitors and statins. Pharmacies in arm B provided the intervention for RAS-inhibitors and statins and usual care for antidepressants and bisphosphonates. Intervention: Intervention consisted of a telephone counseling intervention 7–21 days after the start of therapy. Counseling included assessment of practical and perceptual barriers and provision of information and motivation. Main outcome measure: Primary outcome was refill adherence measured over 1 year expressed as continuous outcome and dichotomous (refill rate≥80%). Secondary outcome was discontinuation within 1 year. Results: In the control arms 3627 patients were eligible and in the intervention arms 3094 patients. Of the latter, 1054 patients (34%) received the intervention. Intention to treat analysis showed no difference in adherence rates between the intervention and the usual care arm (74.7%, SD 37.5 respectively 74.5%, 37.9). More patients starting with RAS-inhibitors had a refill ratio ≥80% in the intervention arm compared to usual care (81.4 vs. 74.9% with odds ratio (OR) 1.43, 95%CI 1.11–1.99). Comparing patients with counseling to patients with usual care (per protocol analysis), adherence was statistically significant higher for patients starting with RAS-inhibitors, statins and bisphosphonates. Patients initiating antidepressants did not benefit from the intervention. Conclusions: Telephone counseling at start of therapy improved adherence in patients initiating RAS-inhibitors. The per protocol analysis indicated an improvement for lipid lowering drugs and bisphosphonates. No effect for on adherence in patients initiating antidepressants was found. The trial was registered at www.trialregister.nl under the identifier NTR3237. PMID:27625605

Educational video to improve CPAP use in patients with obstructive sleep apnoea at risk for poor adherence: a randomised controlled trial.

PubMed

Guralnick, Amy S; Balachandran, Jay S; Szutenbach, Shane; Adley, Kevin; Emami, Leila; Mohammadi, Meelad; Farnan, Jeanne M; Arora, Vineet M; Mokhlesi, Babak

2017-12-01

Suboptimal adherence to CPAP limits its clinical effectiveness in patients with obstructive sleep apnoea (OSA). Although rigorous behavioural interventions improve CPAP adherence, their labour-intensive nature has limited widespread implementation. Moreover, these interventions have not been tested in patients at risk of poor CPAP adherence. Our objective was to determine whether an educational video will improve CPAP adherence in patients at risk of poor CPAP adherence. Patients referred by clinicians without sleep medicine expertise to an urban sleep laboratory that serves predominantly minority population were randomised to view an educational video about OSA and CPAP therapy before the polysomnogram, or to usual care. The primary outcome was CPAP adherence during the first 30 days of therapy. Secondary outcomes were show rates to sleep clinic (attended appointment) and 30-day CPAP adherence after the sleep clinic visit date. A total of 212 patients met the eligibility criteria and were randomised to video education (n=99) or to usual care (n=113). There were no differences in CPAP adherence at 30 days (3.3, 95% CI 2.8 to 3.8 hours/day video education; vs 3.5, 95% CI 3.1 to 4.0 hours/day usual care; p=0.44) or during the 30 days after sleep clinic visit. Sleep clinic show rate was 54% in the video education group and 59% in the usual care group (p=0.41). CPAP adherence, however, significantly worsened in patients who did not show up to the sleep clinic. In patients at risk for poor CPAP adherence, an educational video did not improve CPAP adherence or show rates to sleep clinic compared with usual care. ClinicalTrials.gov Identifier: NCT02553694. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Prevalence of chronic pancreatitis: Results of a primary care physician-based population study.

PubMed

Capurso, Gabriele; Archibugi, Livia; Pasquali, Piera; Aceti, Alessandro; Balducci, Paolo; Bianchi, Patrizia; Buono, Francesco; Camerucci, Stefano; Cantarini, Rosanna; Centofanti, Sergio; Colantonio, Patrizia; Cremaschi, Riccarda; Crescenzi, Sergio; Di Mauro, Caterina; Di Renzi, Davide; Filabozzi, Andrea; Fiorillo, Alfonso; Giancaspro, Giuseppe; Giovannetti, Paola; Lanna, Giuseppe; Medori, Claudio; Merletti, Emilio; Nunnari, Enzo; Paris, Francesca; Pavone, Marco; Piacenti, Angela; Rossi, Almerindo; Scamuffa, Maria Cristina; Spinelli, Giovanni; Taborchi, Marco; Valente, Biagio; Villanova, Antonella; Chiriatti, Alberto; Delle Fave, Gianfranco

2017-05-01

Data on chronic pancreatitis prevalence are scanty and usually limited to hospital-based studies. Investigating chronic pancreatitis prevalence in primary care. Participating primary care physicians reported the prevalence of chronic pancreatitis among their registered patients, environmental factors and disease characteristics. The data were centrally reviewed and chronic pancreatitis cases defined according to M-ANNHEIM criteria for diagnosis and severity and TIGAR-O classification for etiology. Twenty-three primary care physicians participated in the study. According to their judgment, 51 of 36.401 patients had chronic pancreatitis. After reviewing each patient data, 11 turned out to have definite, 5 probable, 19 borderline and 16 uncertain disease. Prevalence was 30.2/100.000 for definite cases and 44.0/100.000 for definite plus probable cases. Of the 16 patients with definite/probable diagnosis, 8 were male, with mean age of 55.6 (±16.7). Four patients had alcoholic etiology, 5 post-acute/recurrent pancreatitis, 6 were deemed to be idiopathic. Four had pancreatic exocrine insufficiency, 10 were receiving pancreatic enzymes, and six had pain. Most patients had initial stage and non-severe disease. This is the first study investigating the prevalence of chronic pancreatitis in primary care. Results suggest that the prevalence in this context is higher than in hospital-based studies, with specific features, possibly representing an earlier disease stage. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Delivery of Brief Interventions for Heavy Drinking in Primary Care: Outcomes of the ODHIN 5-Country Cluster Randomized Trial

PubMed Central

Anderson, Peter; Coulton, Simon; Kaner, Eileen; Bendtsen, Preben; Kłoda, Karolina; Reynolds, Jillian; Segura, Lidia; Wojnar, Marcin; Mierzecki, Artur; Deluca, Paolo; Newbury-Birch, Dorothy; Parkinson, Kathryn; Okulicz-Kozaryn, Katarzyna; Drummond, Colin; Gual, Antoni

2017-01-01

PURPOSE We aimed to test whether 3 strategies—training and support, financial reimbursement, and an option to direct screen-positive patients to an Internet-based method of giving brief advice—have a longer-term effect on primary care clinicians’ delivery of screening and advice to heavy drinkers operationalized with the Alcohol Use Disorders Identification Test–Consumption (AUDIT-C) tool. METHODS We undertook a cluster randomized factorial trial with a 12-week implementation period in 120 primary health care units throughout Catalonia, England, Netherlands, Poland, and Sweden. Units were randomized to 8 groups: care as usual (control); training and support alone; financial reimbursement alone; electronic brief advice alone; paired combinations of these conditions; and all 3 combined. The primary outcome was the proportion of consulting adult patients (aged 18 years and older) receiving intervention—screening and, if screen-positive, advice—at 9 months. RESULTS Based on the factorial design, the ratio of the log of the proportion of patients given intervention at the 9-month follow-up was 1.39 (95% CI, 1.03–1.88) in units that received training and support as compared with units that did not. Neither financial reimbursement nor directing screen-positive patients to electronic brief advice led to a higher proportion of patients receiving intervention. CONCLUSIONS Training and support of primary health care units has a lasting, albeit small, impact on the proportion of adult patients given an alcohol intervention at 9 months. PMID:28694269

Telephone Outreach to Increase Colon Cancer Screening in Medicaid Managed Care Organizations: A Randomized Controlled Trial

PubMed Central

Dietrich, Allen J.; Tobin, Jonathan N.; Robinson, Christina M.; Cassells, Andrea; Greene, Mary Ann; Dunn, Van H.; Falkenstern, Kimberly M.; De Leon, Rosanna; Beach, Michael L.

2013-01-01

PURPOSE Health Plans are uniquely positioned to deliver outreach to members. We explored whether telephone outreach, delivered by Medicaid managed care organization (MMCO) staff, could increase colorectal cancer (CRC) screening among publicly insured urban women, potentially reducing disparities. METHODS We conducted an 18-month randomized clinical trial in 3 MMCOs in New York City in 2008–2010, randomizing 2,240 MMCO-insured women, aged 50 to 63 years, who received care at a participating practice and were overdue for CRC screening. MMCO outreach staff provided cancer screening telephone support, educating patients and helping overcome barriers. The primary outcome was the number of women screened for CRC during the 18-month intervention, assessed using claims. RESULTS MMCO staff reached 60% of women in the intervention arm by telephone. Although significantly more women in the intervention (36.7%) than in the usual care (30.6%) arm received CRC screening (odds ratio [OR] = 1.32; 95% CI, 1.08–1.62), increases varied from 1.1% to 13.7% across the participating MMCOs, and the overall increase was driven by increases at 1 MMCO. In an as-treated comparison, 41.8% of women in the intervention arm who were reached by telephone received CRC screening compared with 26.8% of women in the usual care arm who were not contacted during the study (OR = 1.84; 95% CI, 1.38, 2.44); 7 women needed to be reached by telephone for 1 to become screened. CONCLUSIONS The telephone outreach intervention delivered by MMCO staff increased CRC screening by 6% more than usual care among randomized women, and by 15.1% more than usual care among previously overdue women reached by the intervention. Our research-based intervention was successfully translated to the health plan arena, with variable effects in the participating MMCOs. PMID:23835819

Series: The research agenda for general practice/family medicine and primary health care in Europe. Part 4. Results: specific problem solving skills.

PubMed

Hummers-Pradier, Eva; Beyer, Martin; Chevallier, Patrick; Eilat-Tsanani, Sophia; Lionis, Christos; Peremans, Lieve; Petek, Davorina; Rurik, Imre; Soler, Jean Karl; Stoffers, Henri Ejh; Topsever, Pinar; Ungan, Mehmet; van Royen, Paul

2010-09-01

The 'Research Agenda for General Practice/Family Medicine and Primary Health Care in Europe' summarizes the evidence relating to the core competencies and characteristics of the Wonca Europe definition of GP/FM, and its implications for general practitioners/family doctors, researchers and policy makers. The European Journal of General Practice publishes a series of articles based on this document. The previous articles presented background, objectives, and methodology, as well results on 'primary care management' and 'community orientation' and the person-related core competencies of GP/FM. This article reflects on the general practitioner's 'specific problem solving skills'. These include decision making on diagnosis and therapy of specific diseases, accounting for the properties of primary care, but also research questions related to quality management and resource use, shared decision making, or professional education and development. Clinical research covers most specific diseases, but often lacks pragmatism and primary care relevance. Quality management is a stronghold of GP/FM research. Educational interventions can be effective when well designed for a specific setting and situation. However, their message that 'usual care' by general practitioners is insufficient may be problematic. GP and their patients need more research into diagnostic reasoning with a step-wise approach to increase predictive values in a setting characterized by uncertainty and low prevalence of specific diseases. Pragmatic comparative effectiveness studies of new and established drugs or non-pharmaceutical therapy are needed. Multi-morbidity and complexity should be addressed. Studies on therapy, communication strategies and educational interventions should consider impact on health and sustainability of effects.

Use of standard Webcam and Internet equipment for telepsychiatry treatment of depression among underserved Hispanics.

PubMed

Moreno, Francisco A; Chong, Jenny; Dumbauld, James; Humke, Michelle; Byreddy, Seenaiah

2012-12-01

Depression affects nearly one in five Americans at some time in their life, causing individual suffering and financial cost. The Internet has made it possible to deliver telemedicine care economically to areas and populations with limited access to specialist or culturally and linguistically congruent care. This study compared the effectiveness for Hispanic patients of depression treatment provided by a psychiatrist through Internet videoconferencing (Webcam intervention) and treatment as usual by a primary care provider. Adults (N=167) with a diagnosis of depression were recruited from a community clinic and were randomly assigned to treatment condition. Webcam participants met remotely each month with the psychiatrist, and treatment-as-usual patients received customary care from their primary care providers, all for six months. At baseline and three and six months, analyses of variance tested differences between conditions in scores on depression rating scales and quality-of-life and functional ability measures. All participants experienced an improvement in depression symptoms. Ratings on the Montgomery-Åsberg Depression Rating Scale by clinicians blind to treatment group and self-ratings on the nine-item Patient Health Questionnaire, Quality of Life Enjoyment and Satisfaction Questionnaire, and Sheehan Disability Scale showed a significant main effect of time. On all four measures, a significant interaction of time by intervention favoring the Webcam group was noted. Results suggest that telepsychiatry delivered through the Internet utilizing commercially available domestic Webcams and standard Internet and computer equipment is effective and acceptable. Use of this technology may help close the gap in access to culturally and linguistically congruent specialists.

Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control.

PubMed

Quinn, Charlene C; Gruber-Baldini, Ann L; Shardell, Michelle; Weed, Kelly; Clough, Suzanne S; Peeples, Malinda; Terrin, Michael; Bronich-Hall, Lauren; Barr, Erik; Lender, Dan

2009-07-01

National data find glycemic control is within target (A1c<7.0%) for 37% of patients with diabetes, and only 7% meet recommended glycemic, lipid, and blood pressure goals. To compare active interventions and usual care for glucose control in a randomized clinical trial (RCT) among persons with diabetes cared for by primary care physicians (PCPs) over the course of 1 year. Physician practices (n=36) in 4 geographic areas are randomly assigned to 1 of 4 study groups. The intervention is a diabetes communication system, using mobile phones and patient/physician portals to allow patient-specific treatment and communication. All physicians receive American Diabetes Association (ADA) Guidelines for diabetes care. Patients with poor diabetes control (A1c> or =7.5%) at baseline (n=260) are enrolled in study groups based on PCP randomization. All study patients receive blood glucose (BG) meters and a year's supply of testing materials. Patients in three treatment groups select one of two mobile phone models, receive one-year unlimited mobile phone data and service plan, register on the web-based individual patient portal and receive study treatment phone software based on study assignment. Control group patients receive usual care from their PCP. The primary outcome is mean change in A1c over a 12-month intervention period. Traditional methods of disease management have not achieved adequate control for BG and other conditions important to persons with diabetes. Tools to improve communication between patients and PCPs may improve patient outcomes and be satisfactory to patients and physicians. This RCT is ongoing.

Patient characteristics associated with hospitalisations for ambulatory care sensitive conditions in Victoria, Australia

PubMed Central

2012-01-01

Background Ambulatory Care Sensitive Conditions (ACSCs) are those for which hospitalisation is thought to be avoidable with the application of preventive care and early disease management, usually delivered in a primary care setting. ACSCs are used extensively as indicators of accessibility and effectiveness of primary health care. We examined the association between patient characteristics and hospitalisation for ACSCs in the adult and paediatric population in Victoria, Australia, 2003/04. Methods Hospital admissions data were merged with two area-level socioeconomic indexes: Index of Socio-Economic Disadvantage (IRSED) and Accessibility/Remoteness Index of Australia (ARIA). Univariate and multiple logistic regressions were performed for both adult (age 18+ years) and paediatric (age <18 years) groups, reporting odds ratios (OR) and 95% confidence intervals (CI) for a number of predictors of ACSCs admissions compared to non-ACSCs admissions. Results Predictors were much more strongly associated with ACSCs admissions compared to non-ACSCs admissions in the adult group than for the paediatric group with the exception of rurality. Significant adjusted ORs in the adult group were 1.06, 1.15, 1.13, 1.06 and 1.11 for sex, rurality, age, IRSED and ARIA variables, and 1.34, 1.04 and 1.09 in the paediatric group for rurality, IRSED and ARIA, respectively. Conclusions Disadvantaged paediatric and adult population experience more need of hospital care for ACSCs. Access barriers to primary care are plausible causes for the observed disparities. Understanding the characteristics of individuals experiencing access barriers to primary care will be useful for developing targeted interventions meeting the unique ambulatory needs of the population. PMID:23259969

The Effect of Improving Primary Care Depression Management on Employee Absenteeism and Productivity A Randomized Trial

PubMed Central

Rost, Kathryn; Smith, Jeffrey L.; Dickinson, Miriam

2005-01-01

Objective: To test whether an intervention to improve primary care depression management significantly improves productivity at work and absenteeism over 2 years. Setting and Subjects: Twelve community primary care practices recruiting depressed primary care patients identified in a previsit screening. Research Design: Practices were stratified by depression treatment patterns before randomization to enhanced or usual care. After delivering brief training, enhanced care clinicians provided improved depression management over 24 months. The research team evaluated productivity and absenteeism at baseline, 6, 12, 18, and 24 months in 326 patients who reported full-or part-time work at one or more completed waves. Results: Employed patients in the enhanced care condition reported 6.1% greater productivity and 22.8% less absenteeism over 2 years. Consistent with its impact on depression severity and emotional role functioning, intervention effects were more observable in consistently employed subjects where the intervention improved productivity by 8.2% over 2 years at an estimated annual value of $1982 per depressed full-time equivalent and reduced absenteeism by 28.4% or 12.3 days over 2 years at an estimated annual value of $619 per depressed full-time equivalent. Conclusions: This trial, which is the first to our knowledge to demonstrate that improving the quality of care for any chronic disease has positive consequences for productivity and absenteeism, encourages formal cost-benefit research to assess the potential return-on-investment employers of stable workforces can realize from using their purchasing power to encourage better depression treatment for their employees. PMID:15550800

Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) in primary care using total diet replacement products: a protocol for a randomised controlled trial.

PubMed

Jebb, Susan A; Astbury, Nerys M; Tearne, Sarah; Nickless, Alecia; Aveyard, Paul

2017-08-04

The global prevalence of obesity has risen significantly in recent decades. There is a pressing need to identify effective interventions to treat established obesity that can be delivered at scale. The aim of the Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) study is to determine the clinical effectiveness, feasibility and acceptability of referral to a low-energy total diet replacement programme compared with usual weight management interventions in primary care. The DROPLET trial is a randomised controlled trial comparing a low-energy total diet replacement programme with usual weight management interventions delivered in primary care. Eligible patients will be recruited through primary care registers and randomised to receive a behavioural support programme delivered by their practice nurse or a referral to a commercial provider offering an initial 810 kcal/d low-energy total diet replacement programme for 8 weeks, followed by gradual food reintroduction, along with weekly behavioural support for 24 weeks. The primary outcome is weight change at 12 months. The secondary outcomes are weight change at 3 and 6 months, the proportion of participants achieving 5% and 10% weight loss at 12 months, and change in fat mass, haemoglobin A1c, low-density lipoprotein cholesterol and systolic and diastolic blood pressure at 12 months. Data will be analysed on the basis of intention to treat. Qualitative interviews on a subsample of patients and healthcare providers will assess their experiences of the weight loss programmes and identify factors affecting acceptability and adherence. This study has been reviewed and approved by the National Health ServiceHealth Research Authority (HRA)Research Ethics Committee (Ref: SC/15/0337). The trial findings will be disseminated to academic and health professionals through presentations at meetings and peer-reviewed journals and to the public through the media. If the intervention is effective, the results will be communicated to policymakers and commissioners of weight management services. ISRCTN75092026. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Treatment of clozapine-associated obesity and diabetes with exenatide in adults with schizophrenia: A randomized controlled trial (CODEX).

PubMed

Siskind, Dan J; Russell, Anthony W; Gamble, Clare; Winckel, Karl; Mayfield, Karla; Hollingworth, Sam; Hickman, Ingrid; Siskind, Victor; Kisely, Steve

2018-04-01

Clozapine causes obesity and type 2 diabetes (T2DM). Glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide) can counter clozapine-associated GLP-1 dysregulation in animals, and may be beneficial in people on clozapine. This randomized, controlled, open-label, pilot trial evaluated weekly exenatide for weight loss among clozapine-treated obese adults with schizophrenia, with or without T2DM. A total of 28 outpatients were randomized to once-weekly extended-release subcutaneous exenatide or usual care for 24 weeks. The primary outcome was proportion of participants with >5% weight loss. All 28 participants completed the study; 3/14 in the exenatide group and 2/14 in the usual care group had T2DM. Six people on exenatide achieved >5% weight loss vs one receiving usual care (P = .029). Compared with usual care, participants on exenatide had greater mean weight loss (-5.29 vs -1.12 kg; P = .015) and body mass index reduction (-1.78 vs -0.39 kg/m 2 ; P = .019), and reduced fasting glucose (-0.34 vs 0.39 mmol/L; P = .036) and glycated haemoglobin levels (-0.21% vs 0.03%; P = .004). There were no significant differences in other metabolic syndrome components. Exenatide may be a promising therapeutic agent for glycaemic control and weight loss in clozapine-treated people with obesity, and could assist in reducing clozapine-associated cardio-metabolic morbidity and mortality. © 2017 John Wiley & Sons Ltd.

Interspecialty communication supported by health information technology associated with lower hospitalization rates for ambulatory care-sensitive conditions.

PubMed

O'Malley, Ann S; Reschovsky, James D; Saiontz-Martinez, Cynthia

2015-01-01

Practice tools such as health information technology (HIT) have the potential to support care processes, such as communication between health care providers, and influence care for "ambulatory care-sensitive conditions" (ACSCs). ACSCs are conditions for which good outpatient care can potentially prevent the need for hospitalization. To date, associations between such primary care practice capabilities and hospitalizations for ambulatory care-sensitive conditions have been primarily limited to smaller, local studies or unique delivery systems rather than nationally representative studies of primary care physicians in the United States. We analyzed a nationally representative sample of 1,819 primary care physicians who responded to the Center for Studying Health System Change's Physician Survey. We linked 3 years of Medicare claims (2007 to 2009) with these primary care physician survey respondents. This linkage resulted in the identification of 123,760 beneficiaries with one or more of 4 ambulatory care-sensitive chronic conditions (diabetes, chronic obstructive pulmonary disease, asthma, and congestive heart failure) for whom these physicians served as the usual provider. Key independent variables of interest were physicians' practice capabilities, including communication with specialists, use of care managers, participation in quality and performance measurement, use of patient registries, and HIT use. The dependent variable was a summary measure of ambulatory care-sensitive hospitalizations for one or more of these 4 conditions. Higher provider-reported levels of communication between primary care and specialist physicians were associated with lower rates of potentially avoidable hospitalizations. While there was no significant main effect between HIT use and ACSC hospitalizations, the associations between interspecialty communication and ACSC hospitalizations were magnified in the presence of higher HIT use. For example, patients in practices with both the highest level of interspecialty communication and the highest level of HIT use had lower odds of ambulatory care-sensitive hospitalizations than did those in practices with lower interspecialty communication and high HIT use (adjusted odds ratio, 0.70; 95% confidence limits, 0.59, 0.82). Greater primary care and specialist communication is associated with reduced hospitalizations for ambulatory care-sensitive conditions. This effect was magnified in the presence of higher provider-reported HIT use, suggesting that coordination of care with support from HIT is important in the treatment of ambulatory care-sensitive conditions. © Copyright 2015 by the American Board of Family Medicine.

The first multicenter, randomized, controlled trial of home telemonitoring for Japanese patients with heart failure: home telemonitoring study for patients with heart failure (HOMES-HF).

PubMed

Kotooka, Norihiko; Kitakaze, Masafumi; Nagashima, Kengo; Asaka, Machiko; Kinugasa, Yoshiharu; Nochioka, Kotaro; Mizuno, Atsushi; Nagatomo, Daisuke; Mine, Daigo; Yamada, Yoko; Kuratomi, Akiko; Okada, Norihiro; Fujimatsu, Daisuke; Kuwahata, So; Toyoda, Shigeru; Hirotani, Shin-Ichi; Komori, Takahiro; Eguchi, Kazuo; Kario, Kazuomi; Inomata, Takayuki; Sugi, Kaoru; Yamamoto, Kazuhiro; Tsutsui, Hiroyuki; Masuyama, Tohru; Shimokawa, Hiroaki; Momomura, Shin-Ichi; Seino, Yoshihiko; Sato, Yasunori; Inoue, Teruo; Node, Koichi

2018-02-15

Home telemonitoring is becoming more important to home medical care for patients with heart failure. Since there are no data on home telemonitoring for Japanese patients with heart failure, we investigated its effect on cardiovascular outcomes. The HOMES-HF study was the first multicenter, open-label, randomized, controlled trial (RCT) to elucidate the effectiveness of home telemonitoring of physiological data, such as body weight, blood pressure, and pulse rate, for Japanese patients with heart failure (UMIN Clinical Trials Registry 000006839). The primary end-point was a composite of all-cause death or rehospitalization due to worsening heart failure. We analyzed 181 recently hospitalized patients with heart failure who were randomly assigned to a telemonitoring group (n = 90) or a usual care group (n = 91). The mean follow-up period was 15 (range 0-31) months. There was no statistically significant difference in the primary end-point between groups [hazard ratio (HR), 0.95; 95% confidence interval (CI), 0.548-1.648; p = 0.572]. Home telemonitoring for Japanese patients with heart failure was feasible; however, beneficial effects in addition to those of usual care were not demonstrated. Further investigation of more patients with severe heart failure, participation of home medical care providers, and use of a more integrated home telemonitoring system emphasizing communication as well as monitoring of symptoms and physiological data are required.

Enhancing diabetes care by adding a pharmacist to the primary care team.

PubMed

Ip, Eric J; Shah, Bijal M; Yu, Junhua; Chan, James; Nguyen, Lynda T; Bhatt, Deempal C

2013-05-15

The impact of pharmacist interventions on short-term clinical markers and long-term cardiovascular risk in patients with type 2 diabetes is investigated. Selected health outcomes were retrospectively analyzed in 147 adults with type 2 diabetes whose care was managed by a team of providers including a pharmacist (the enhanced care group) and a matched sample of patients (n = 147) managed by a primary care physician only (the control group). All patients received services through the same health maintenance organization (HMO). The primary study endpoints were (1) the changes from baseline to 12-month follow-up in glycosylated hemoglobin (HbA(1c)), low-density lipoprotein cholesterol (LDL-C), and blood pressure (BP) values, (2) rates of attainment of HbA(1c), LDL-C and BP goals, and (3) changes from baseline in predicted 10-year risks of coronary heart disease (CHD) and stroke. During the 12-month study period, the mean HbA(1c) value was decreased from 9.5% to 6.9% in the enhanced care group and from 9.3% to 8.4% in the control group (p < 0.001); patients in the enhanced care group were significantly more likely to attain goals for HbA(1c) (odds ratio [OR], 3.9), LDL-C (OR, 2.0), and BP reduction (OR, 2.0) and three times more likely to attain all three goals (OR, 3.2). The estimated 10-year risk of CHD was decreased from 16.4% to 9.3% with enhanced care versus a reduction from 17.4% to 14.8% with usual care (p < 0.001). The addition of a pharmacist to an HMO primary care team improved short-term surrogate markers as well as long-term cardiovascular risk in adult patients with type 2 diabetes.

Study protocol for a comparative effectiveness trial of two models of perinatal integrated psychosocial assessment: the PIPA project.

PubMed

Reilly, Nicole; Black, Emma; Chambers, Georgina M; Schmied, Virginia; Matthey, Stephen; Farrell, Josephine; Kingston, Dawn; Bisits, Andrew; Austin, Marie-Paule

2017-07-20

Studies examining psychosocial and depression assessment programs in maternity settings have not adequately considered the context in which psychosocial assessment occurs or how broader components of integrated care, including clinician decision-making aids, may optimise program delivery and its cost-effectiveness. There is also limited evidence relating to the diagnostic accuracy of symptom-based screening measures used in this context. The Perinatal Integrated Psychosocial Assessment (PIPA) Project was developed to address these knowledge gaps. The primary aims of the PIPA Project are to examine the clinical- and cost-effectiveness of two alternative models of integrated psychosocial care during pregnancy: 'care as usual' (the SAFE START model) and an alternative model (the PIPA model). The acceptability and perceived benefit of each model of care from the perspective of both pregnant women and their healthcare providers will also be assessed. Our secondary aim is to examine the psychometric properties of a number of symptom-based screening tools for depression and anxiety when used in pregnancy. This is a comparative-effectiveness study comparing 'care as usual' to an alternative model sequentially over two 12-month periods. Data will be collected from women at Time 1 (initial antenatal psychosocial assessment), Time 2 (2-weeks after Time 1) and from clinicians at Time 3 for each condition. Primary aims will be evaluated using a between-groups design, and the secondary aim using a within group design. The PIPA Project will provide evidence relating to the clinical- and cost- effectiveness of psychosocial assessment integrated with electronic clinician decision making prompts, and referral options that are tailored to the woman's psychosocial risk, in the maternity care setting. It will also address research recommendations from the Australian (2011) and NICE (2015) Clinical Practice Guidelines. ACTRN12617000932369.

Economic evaluation of an intensive group training protocol compared with usual care physiotherapy in patients with chronic low back pain.

PubMed

van der Roer, Nicole; van Tulder, Maurits; van Mechelen, Willem; de Vet, Henrica

2008-02-15

Economic evaluation from a societal perspective conducted alongside a randomized controlled trial with a follow-up of 52 weeks. To evaluate the cost effectiveness and cost utility of an intensive group training protocol compared with usual care physiotherapy in patients with nonspecific chronic low back pain. The intensive group training protocol combines exercise therapy, back school, and behavioral principles. Two studies found a significant reduction in absenteeism for a graded activity program in occupational health care. This program has not yet been evaluated in a primary care physiotherapy setting. Participating physical therapists in primary care recruited 114 patients with chronic nonspecific low back pain. Eligible patients were randomized to either the protocol group or the guideline group. Outcome measures included functional status (Roland Morris Disability Questionnaire), pain intensity (11-point numerical rating scale), general perceived effect and quality of life (EuroQol-5D). Cost data were measured with cost diaries and included direct and indirect costs related to low back pain. After 52 weeks, the direct health care costs were significantly higher for patients in the protocol group, largely due to the costs of the intervention. The mean difference in total costs amounted to [Euro sign] 233 (95% confidence interval: [Euro sign] -2.185; [Euro sign] 2.764). The cost-effectiveness planes indicated no significant differences in cost effectiveness between the 2 groups. The results of this economic evaluation showed no difference in total costs between the protocol group and the guideline group. The differences in effects were small and not statistically significant. At present, national implementation of the protocol is not recommended.

Integrated Care in Prostate Cancer (ICARE-P): Nonrandomized Controlled Feasibility Study of Online Holistic Needs Assessment, Linking the Patient and the Health Care Team

PubMed Central

Dale, Jeremy; Roscoe, Julia; Hamborg, Thomas; Ahmedzai, Sam H; Arvanitis, Theodoros N; Badger, Douglas; James, Nicholas; Mendelsohn, Richard; Khan, Omar; Parashar, Deepak; Patel, Prashant

2017-01-01

Background The potential of technology to aid integration of care delivery systems is being explored in a range of contexts across a variety of conditions in the United Kingdom. Prostate cancer is the most common cancer in UK men. With a 10-year survival rate of 84%, there is a need to explore innovative methods of care that are integrated between primary health care providers and specialist teams in order to address long-term consequences of the disease and its treatment as well as to provide continued monitoring for recurrence. Objective Our aim was to test the feasibility of a randomized controlled trial to compare a model of prostate cancer continuing and follow-up care integration, underpinned by digital technology, with usual care in terms of clinical and cost-effectiveness, patient-reported outcomes, and experience. Methods A first phase of the study has included development of an online adaptive prostate specific Holistic Needs Assessment system (HNA), training for primary care-based nurses, training of an IT peer supporter, and interviews with health care professionals and men with prostate cancer to explore views of their care, experience of technology, and views of the proposed intervention. In Phase 2, men in the intervention arm will complete the HNA at home to help identify and articulate concerns and share them with their health care professionals, in both primary and specialist care. Participants in the control arm will receive usual care. Outcomes including quality of life and well-being, prostate-specific concerns, and patient enablement will be measured 3 times over a 9-month period. Results Findings from phase 1 indicated strong support for the intervention among men, including those who had had little experience of digital technology. Men expressed a range of views on ways that the online system might be used within a clinical pathway. Health care professionals gave valuable feedback on how the output of the assessment might be presented to encourage engagement and uptake by clinical teams. Recruitment to the second phase of the study, the feasibility trial, commenced March 2017. Conclusions To our knowledge, this study is the first in the United Kingdom to trial an online holistic needs assessment for men with prostate cancer, with data shared between patients and primary and secondary care providers. This study addresses recommendations in recent policy documents promoting the importance of data sharing and enhanced communication between care providers as a basis for care integration. We anticipate that this model of care will ultimately provide important benefits for both patients and the National Health Service. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 31380482; http://www.isrctn.com/ISRCTN31380482 (Archived by WebCite at http://www.webcitation.org/6s8I42u5N) PMID:28754653

Efficacy of nurse-led and general practitioner-led comprehensive geriatric assessment in primary care: protocol of a pragmatic three-arm cluster randomised controlled trial (CEpiA study)

PubMed Central

Ferrat, Emilie; Bastuji-Garin, Sylvie; Paillaud, Elena; Caillet, Philippe; Clerc, Pascal; Moscova, Laura; Gouja, Amel; Renard, Vincent; Attali, Claude; Breton, Julien Le; Audureau, Etienne

2018-01-01

Introduction Older patients raise therapeutic challenges, because they constitute a heterogeneous population with multimorbidity. To appraise this complexity, geriatricians have developed a multidimensional comprehensive geriatric assessment (CGA), which may be difficult to apply in primary care settings. Our primary objective was to compare the effect on morbimortality of usual care compared with two complex interventions combining educational seminars about CGA: a dedicated geriatric hotline for general practitioners (GPs) and CGA by trained nurses or GPs. Methods and analysis The Clinical Epidemiology and Ageing study is an open-label, pragmatic, multicentre, three-arm, cluster randomised controlled trial comparing two intervention groups and one control group. Patients must be 70 years or older with a long-term illness or with unscheduled hospitalisation in the past 3 months (750 patients planned). This study involves volunteering GPs practising in French primary care centres, with randomisation at the practice level. The multifaceted interventions for interventional arms comprise an educational interactive multiprofessional seminar for GPs and nurses, a geriatric hotline dedicated to GPs in case of difficulties and the performance of a CGA updated to primary care. The CGA is systematically performed by a nurse in arm 1 but is GP-led on a case-by-case basis in arm 2. The primary endpoint is a composite criterion comprising overall death, unscheduled hospitalisations, emergency admissions and institutionalisation within 12 months after inclusion. Intention-to-treat analysis will be performed using mixed-effects logistic regression models, with adjustment for potential confounders. Ethics and dissemination The protocol was approved by an appropriate ethics committee (CPP Ile-de-France IV, Paris, France, approval April 2015;15 664). This study is conducted according to principles of good clinical practice in the context of current care and will provide useful knowledge on the clinical benefits achievable by CGA in primary care. Trial registration number NCT02664454; Pre-results. PMID:29654038

Randomized controlled trial to improve primary care to prevent and manage childhood obesity: the High Five for Kids study.

PubMed

Taveras, Elsie M; Gortmaker, Steven L; Hohman, Katherine H; Horan, Christine M; Kleinman, Ken P; Mitchell, Kathleen; Price, Sarah; Prosser, Lisa A; Rifas-Shiman, Sheryl L; Gillman, Matthew W

2011-08-01

To examine the effectiveness of a primary care-based obesity intervention over the first year (6 intervention contacts) of a planned 2-year study. Cluster randomized controlled trial. Ten pediatric practices, 5 intervention and 5 usual care. Four hundred seventy-five children aged 2 to 6 years with body mass index (BMI) in the 95th percentile or higher or 85th to less than 95th percentile if at least 1 parent was overweight; 445 (93%) had 1-year outcomes. Intervention practices received primary care restructuring, and families received motivational interviewing by clinicians and educational modules targeting television viewing and fast food and sugar-sweetened beverage intake. Change in BMI and obesity-related behaviors from baseline to 1 year. Compared with usual care, intervention participants had a smaller, nonsignificant change in BMI (-0.21; 95% confidence interval [CI], -0.50 to 0.07; P = .15), greater decreases in television viewing (-0.36 h/d; 95% CI, -0.64 to -0.09; P = .01), and slightly greater decreases in fast food (-0.16 serving/wk; 95% CI, -0.33 to 0.01; P = .07) and sugar-sweetened beverage (-0.22 serving/d; 95% CI, -0.52 to 0.08; P = .15) intake. In post hoc analyses, we observed significant effects on BMI among girls (-0.38; 95% CI, -0.73 to -0.03; P = .03) but not boys (0.04; 95% CI, -0.55 to 0.63; P = .89) and among participants in households with annual incomes of $50 000 or less (-0.93; 95% CI, -1.60 to -0.25; P = .01) but not in higher-income households (0.02; 95% CI, -0.30 to 0.33; P = .92). After 1 year, the High Five for Kids intervention was effective in reducing television viewing but did not significantly reduce BMI.

Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of a Multifactorial Fall Injury Prevention Strategy: Design and Methods.

PubMed

Bhasin, Shalender; Gill, Thomas M; Reuben, David B; Latham, Nancy K; Gurwitz, Jerry H; Dykes, Patricia; McMahon, Siobhan; Storer, Thomas W; Duncan, Pamela W; Ganz, David A; Basaria, Shehzad; Miller, Michael E; Travison, Thomas G; Greene, Erich J; Dziura, James; Esserman, Denise; Allore, Heather; Carnie, Martha B; Fagan, Maureen; Hanson, Catherine; Baker, Dorothy; Greenspan, Susan L; Alexander, Neil; Ko, Fred; Siu, Albert L; Volpi, Elena; Wu, Albert W; Rich, Jeremy; Waring, Stephen C; Wallace, Robert; Casteel, Carri; Magaziner, Jay; Charpentier, Peter; Lu, Charles; Araujo, Katy; Rajeevan, Haseena; Margolis, Scott; Eder, Richard; McGloin, Joanne M; Skokos, Eleni; Wiggins, Jocelyn; Garber, Lawrence; Clauser, Steven B; Correa-De-Araujo, Rosaly; Peduzzi, Peter

2017-10-14

Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care. Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 healthcare systems across USA. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by healthcare system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a co-management model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (non-vertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control. Trial enrolled 5451 subjects in 20 months. Intervention and follow-up are ongoing. The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults. © The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Family perceptions of the usual source of care among children with asthma by race/ethnicity, language, and family income.

PubMed

Greek, April A; Kieckhefer, Gail M; Kim, Hyoshin; Joesch, Jutta M; Baydar, Nazli

2006-01-01

A usual source of care (USC) can serve as the foundation for good primary health care and is critical for children living with a chronic health condition. This study applies national data to the following objectives: (1) describe family reports of the presence and characteristics of the USC for children with asthma; (2) examine evidence of systematic differences in the USC for these children with asthma by race/ethnicity, English language proficiency in Hispanic respondents, and family income; and (3) conduct multivariate analysis adjusting for possible confounding factors to examine independent effects of race/ethnicity, language, and income. Data from the 1996-2000 Medical Expenditure Panel Survey (MEPS) were analyzed. Overall, 95% of children with asthma had a USC, with Spanish-speaking Hispanics least likely to report a USC (89%). There were significant differences in USC attributes by race/ethnicity, language, and income, with the largest differences by type of provider and accessibility. Hispanics with poor English language proficiency had the greatest accessibility barriers.

Reducing disability in community-dwelling frail older people: cost-effectiveness study alongside a cluster randomised controlled trial.

PubMed

Metzelthin, Silke F; van Rossum, Erik; Hendriks, Marike R C; De Witte, Luc P; Hobma, Sjoerd O; Sipers, Walther; Kempen, Gertrudis I J M

2015-05-01

although proactive primary care, including early detection and treatment of community-dwelling frail older people, is a part of the national healthcare policy in several countries, little is known about its cost-effectiveness. to evaluate the cost-effectiveness of a proactive primary care approach in community-dwelling frail older people. embedded in a cluster randomised trial among 12 Dutch general practitioner practices, an economic evaluation was performed from a societal perspective with a time horizon of 24 months. frail older people in the intervention group received an in-home assessment and interdisciplinary care based on a tailor-made treatment plan and regular evaluation and follow-up. Practices in the control group delivered usual care. The primary outcome for the cost-effectiveness and cost-utility analysis was disability and health-related quality of life, respectively. multilevel analyses among 346 frail older people showed no significant differences between the groups regarding disability and health-related quality of life at 24 months. People in the intervention group used, as expected, more primary care services, but there was no decline in more expensive hospital and long-term care. Total costs over 24 months tended to be higher in the intervention group than in the control group (€26,503 versus €20,550, P = 0.08). the intervention under study led to an increase in healthcare utilisation and related costs without providing any beneficial effects. This study adds to the scarce amount of evidence of the cost-effectiveness of proactive primary care in community-dwelling frail older people. Current Controlled Trials, ISRCTN 31954692. © The Author 2015. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

An institutional ethnography of chronic pain management in family medicine (COPE) study protocol.

PubMed

Webster, Fiona; Bhattacharyya, Onil; Davis, Aileen; Glazier, Rick; Katz, Joel; Krueger, Paul; Upshur, Ross; Yee, Albert; Wilson, Lynn

2015-11-05

Patients with chronic conditions and multiple comorbidities represent a growing challenge for health care globally. Improved coordination of care is considered essential for providing more effective and cost-efficient care for these patients with complex needs. Osteoarthritis is one of the most common and debilitating chronic conditions, is the most frequent cause of chronic pain yet osteoarthritis care is often poorly-coordinated. Primary care is usually the first contact for patients requiring relief from chronic pain. Our previous work suggests discordance between the policy goals of improving patient care and the experience of osteoarthritis patients. We plan to investigate the empirical context of the primary care setting by focusing on primary physicians' conceptualizations and performance of their work in treating complex patients with chronic pain. This will allow for an exploration of how primary health care is - or could be - integrated with other services that play an important role in health care delivery. Our study is an Institutional Ethnography of pain management in family medicine, to be carried out in three phases over 3 years from 2014/15 to 2018. Over the first year we will undertake approximately 80 key informant interviews with primary care physicians, other health care providers, policymakers and clinical experts. In the second year we will focus on mobilizing our networks from year one to assist in the collection of key texts which shape the current context of care. These texts will be analyzed by the research team. In the final year of the study we will focus on synthesizing our findings in order to map the social relations informing care. As is standard and optimal in qualitative research, analysis will be concurrent with data collection. Our study will allow us to identify how the work of coordinating care across multiple settings is accomplished, in practice as well as discursively and textually. Ultimately, we will identify links between everyday experience of care for patients with chronic pain, and broader discourses related to health care system inefficiencies, integration and patient-centred care. An expected outcome of this study will be the development of new, or augmentation of existing, models of care, that are based in the local realities of primary care practice.

Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care

PubMed Central

Slok, Annerika H M; Kotz, Daniel; van Breukelen, Gerard; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H; Kerstjens, Huib A M; van der Molen, Thys; Asijee, Guus M; Dekhuijzen, P N Richard; Holverda, Sebastiaan; Salomé, Philippe L; Goossens, Lucas M A; Twellaar, Mascha; in ‘t Veen, Johannes C C M; van Schayck, Onno C P

2016-01-01

Objective Assessing the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with chronic obstructive pulmonary disease (COPD) measured with the St. George's Respiratory Questionnaire (SGRQ), compared with usual care. Methods A pragmatic cluster randomised controlled trial, in 39 Dutch primary care practices and 17 hospitals, with 357 patients with COPD (postbronchodilator FEV1/FVC ratio <0.7) aged ≥40 years, who could understand and read the Dutch language. Healthcare providers were randomly assigned to the intervention or control group. The intervention group applied the ABC tool, which consists of a short validated questionnaire assessing the experienced burden of COPD, objective COPD parameter (eg, lung function) and a treatment algorithm including a visual display and treatment advice. The control group provided usual care. Researchers were blinded to group allocation during analyses. Primary outcome was the number of patients with a clinically relevant improvement in SGRQ score between baseline and 18-month follow-up. Secondary outcomes were the COPD Assessment Test (CAT) and the Patient Assessment of Chronic Illness Care (PACIC; a measurement of perceived quality of care). Results At 18-month follow-up, 34% of the 146 patients from 27 healthcare providers in the intervention group showed a clinically relevant improvement in the SGRQ, compared with 22% of the 148 patients from 29 healthcare providers in the control group (OR 1.85, 95% CI 1.08 to 3.16). No difference was found on the CAT (−0.26 points (scores ranging from 0 to 40); 95% CI −1.52 to 0.99). The PACIC showed a higher improvement in the intervention group (0.32 points (scores ranging from 1 to 5); 95% CI 0.14 to 0.50). Conclusions This study showed that use of the ABC tool may increase quality of life and perceived quality of care. Trial registration number NTR3788; Results. PMID:27401361

Getting better at chronic care in remote communities: study protocol for a pragmatic cluster randomised controlled of community based management.

PubMed

Schmidt, Barbara; Wenitong, Mark; Esterman, Adrian; Hoy, Wendy; Segal, Leonie; Taylor, Sean; Preece, Cilla; Sticpewich, Alex; McDermott, Robyn

2012-11-21

Prevalence and incidence of diabetes and other common comorbid conditions (hypertension, coronary heart disease, renal disease and chronic lung disease) are extremely high among Indigenous Australians. Recent measures to improve quality of preventive care in Indigenous community settings, while apparently successful at increasing screening and routine check-up rates, have shown only modest or little improvements in appropriate care such as the introduction of insulin and other scaled-up drug regimens in line with evidence-based guidelines, together with support for risk factor reduction. A new strategy is required to ensure high quality integrated family-centred care is available locally, with continuity and cultural safety, by community-based care coordinators with appropriate system supports. The trial design is open parallel cluster randomised controlled trial. The objective of this pragmatic trial is to test the effectiveness of a model of health service delivery that facilitates integrated community-based, intensive chronic condition management, compared with usual care, in rural and remote Indigenous primary health care services in north Queensland. Participants are Indigenous adults (aged 18-65 years) with poorly controlled diabetes (HbA1c>=8.5) and at least one other chronic condition. The intervention is to employ an Indigenous Health Worker to case manage the care of a maximum caseload of 30 participants. The Indigenous Health Workers receive intensive clinical training initially, and throughout the study, to ensure they are competent to coordinate care for people with chronic conditions. The Indigenous Health Workers, supported by the local primary health care (PHC) team and an Indigenous Clinical Support Team, will manage care, including coordinating access to multidisciplinary team care based on best practice standards. Allocation by cluster to the intervention and control groups is by simple randomisation after participant enrolment. Participants in the control group will receive usual care, and will be wait-listed to receive a revised model of the intervention informed by the data analysis. The primary outcome is reduction in HbA1c measured at 18 months. Implementation fidelity will be monitored and a qualitative investigation (methods to be determined) will aim to identify elements of the model which may influence health outcomes for Indigenous people with chronic conditions. This pragmatic trial will test a culturally-sound family-centred model of care with supported case management by IHWs to improve outcomes for people with complex chronic care needs. This trial is now in the intervention phase. Australian New Zealand Clinical Trials Registry ACTR12610000812099.

Effect of a Primary Care Walking Intervention with and without Nurse Support on Physical Activity Levels in 45- to 75-Year-Olds: The Pedometer And Consultation Evaluation (PACE-UP) Cluster Randomised Clinical Trial

PubMed Central

Harris, Tess; Iliffe, Steve; Whincup, Peter H.; Ekelund, Ulf; Furness, Cheryl; Anokye, Nana; Ibison, Judith; DeWilde, Steve; David, Lee; Dale, Rebecca; Cook, Derek G.

2017-01-01

Background Pedometers can increase walking and moderate-to-vigorous physical activity (MVPA) levels, but their effectiveness with or without support has not been rigorously evaluated. We assessed the effectiveness of a pedometer-based walking intervention in predominantly inactive adults, delivered by post or through primary care nurse-supported physical activity (PA) consultations. Methods and Findings A parallel three-arm cluster randomised trial was randomised by household, with 12-mo follow-up, in seven London, United Kingdom, primary care practices. Eleven thousand fifteen randomly selected patients aged 45–75 y without PA contraindications were invited. Five hundred forty-eight self-reporting achieving PA guidelines were excluded. One thousand twenty-three people from 922 households were randomised between 2012–2013 to one of the following groups: usual care (n = 338); postal pedometer intervention (n = 339); and nurse-supported pedometer intervention (n = 346). Of these, 956 participants (93%) provided outcome data (usual care n = 323, postal n = 312, nurse-supported n = 321). Both intervention groups received pedometers, 12-wk walking programmes, and PA diaries. The nurse group was offered three PA consultations. Primary and main secondary outcomes were changes from baseline to 12 mo in average daily step-counts and time in MVPA (in ≥10-min bouts), respectively, measured objectively by accelerometry. Only statisticians were masked to group. Analysis was by intention-to-treat. Average baseline daily step-count was 7,479 (standard deviation [s.d.] 2,671), and average time in MVPA bouts was 94 (s.d. 102) min/wk. At 12 mo, mean steps/d, with s.d. in parentheses, were as follows: control 7,246 (2,671); postal 8,010 (2,922); and nurse support 8,131 (3,228). PA increased in both intervention groups compared with the control group; additional steps/d were 642 for postal (95% CI 329–955) and 677 for nurse support (95% CI 365–989); additional MVPA in bouts (min/wk) were 33 for postal (95% CI 17–49) and 35 for nurse support (95% CI 19–51). There were no significant differences between the two interventions at 12 mo. The 10% (1,023/10,467) recruitment rate was a study limitation. Conclusions A primary care pedometer-based walking intervention in predominantly inactive 45- to 75-y-olds increased step-counts by about one-tenth and time in MVPA in bouts by about one-third. Nurse and postal delivery achieved similar 12-mo PA outcomes. A primary care pedometer intervention delivered by post or with minimal support could help address the public health physical inactivity challenge. Clinical Trial Registration isrctn.com ISRCTN98538934. PMID:28045890

Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial.

PubMed

Saitz, Richard; Cheng, Debbie M; Winter, Michael; Kim, Theresa W; Meli, Seville M; Allensworth-Davies, Don; Lloyd-Travaglini, Christine A; Samet, Jeffrey H

2013-09-18

People with substance dependence have health consequences, high health care utilization, and frequent comorbidity but often receive poor-quality care. Chronic care management (CCM) has been proposed as an approach to improve care and outcomes. To determine whether CCM for alcohol and other drug dependence improves substance use outcomes compared with usual primary care. The AHEAD study, a randomized trial conducted among 563 people with alcohol and other drug dependence at a Boston, Massachusetts, hospital-based primary care practice. Participants were recruited from September 2006 to September 2008 from a freestanding residential detoxification unit and referrals from an urban teaching hospital and advertisements; 95% completed 12-month follow-up. Participants were randomized to receive CCM (n=282) or no CCM (n=281). Chronic care management included longitudinal care coordinated with a primary care clinician; motivational enhancement therapy; relapse prevention counseling; and on-site medical, addiction, and psychiatric treatment, social work assistance, and referrals (including mutual help). The no CCM (control) group received a primary care appointment and a list of treatment resources including a telephone number to arrange counseling. The primary outcome was self-reported abstinence from opioids, stimulants, or heavy drinking. Biomarkers were secondary outcomes. There was no significant difference in abstinence from opioids, stimulants, or heavy drinking between the CCM (44%) and control (42%) groups (adjusted odds ratio, 0.84; 95% CI, 0.65-1.10; P=.21). No significant differences were found for secondary outcomes of addiction severity, health-related quality of life, or drug problems. No subgroup effects were found except among those with alcohol dependence, in whom CCM was associated with fewer alcohol problems (mean score, 10 vs 13; incidence rate ratio, 0.85; 95% CI, 0.72-1.00; P=.048). Among persons with alcohol and other drug dependence, CCM compared with a primary care appointment but no CCM did not increase self-reported abstinence over 12 months. Whether more intensive or longer-duration CCM is effective requires further investigation. clinicaltrials.gov Identifier: NCT00278447.

Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care.

PubMed

Sheppard, Lauren; Dewey, Helen; Bernhardt, Julie; Collier, Janice M; Ellery, Fiona; Churilov, Leonid; Tay-Teo, Kiu; Wu, Olivia; Moodie, Marj

2016-06-01

A key objective of A Very Early Rehabilitation Trial is to determine if the intervention, very early mobilisation following stroke, is cost-effective. Resource use data were collected to enable an economic evaluation to be undertaken and a plan for the main economic analyses was written prior to the completion of follow up data collection. To report methods used to collect resource use data, pre-specify the main economic evaluation analyses and report other intended exploratory analyses of resource use data. Recruitment to the trial has been completed. A total of 2,104 participants from 56 stroke units across three geographic regions participated in the trial. Resource use data were collected prospectively alongside the trial using standardised tools. The primary economic evaluation method is a cost-effectiveness analysis to compare resource use over 12 months with health outcomes of the intervention measured against a usual care comparator. A cost-utility analysis is also intended. The primary outcome in the cost-effectiveness analysis will be favourable outcome (modified Rankin Scale score 0-2) at 12 months. Cost-utility analysis will use health-related quality of life, reported as quality-adjusted life years gained over a 12 month period, as measured by the modified Rankin Scale and the Assessment of Quality of Life. Outcomes of the economic evaluation analysis will inform the cost-effectiveness of very early mobilisation following stroke when compared to usual care. The exploratory analysis will report patterns of resource use in the first year following stroke. © 2016 World Stroke Organization.

Effects of Dementia-Care Mapping on Residents and Staff of Care Homes: A Pragmatic Cluster-Randomised Controlled Trial

PubMed Central

van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M. M.; Donders, Rogier; Zuidema, Sytse U.; Koopmans, Raymond T. C. M.; Vernooij-Dassen, Myrra J. F. J.

2013-01-01

Background The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. Methods Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents’ neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. Results 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI −2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects. Conclusions Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. Trial Registration Dutch Trials Registry NTR2314. PMID:23844003

Effects of dementia-care mapping on residents and staff of care homes: a pragmatic cluster-randomised controlled trial.

PubMed

van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M M; Donders, Rogier; Zuidema, Sytse U; Koopmans, Raymond T C M; Vernooij-Dassen, Myrra J F J

2013-01-01

The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents' neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI -2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects. Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. Dutch Trials Registry NTR2314.

Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression.

PubMed

Gardiner, Paula; Lestoquoy, Anna Sophia; Gergen-Barnett, Katherine; Penti, Brian; White, Laura F; Saper, Robert; Fredman, Lisa; Stillman, Sarah; Lily Negash, N; Adelstein, Pamela; Brackup, Ivy; Farrell-Riley, Christine; Kabbara, Karim; Laird, Lance; Mitchell, Suzanne; Bickmore, Timothy; Shamekhi, Ameneh; Liebschutz, Jane M

2017-03-01

Given the public health crisis of opioid overprescribing for pain, there is a need for evidence-based non pharmacological treatment options that effectively reduce pain and depression. We aim to examine the effectiveness of the Integrative Medical Group Visits (IMGV) model in reducing chronic pain and depressive symptoms, as well as increasing pain self-management. This paper details the study design and implementation of an ongoing randomized controlled trial of the IMGV model as compared to primary care visits. The research aims to determine if the IMGV model is effective in achieving: a) a reduction in self-reported pain and depressive symptoms and 2) an improvement in the self-management of pain, through increasing pain self-efficacy and reducing use of self-reported pain medication. We intend to recruit 154 participants to be randomized in our intervention, the IMGV model (n=77) and to usual care (n=77). Usual care of chronic pain through pharmacological treatment has mixed evidence of efficacy and may not improve quality of life or functional status. We aim to conduct a randomized controlled trial to evaluate the effectiveness of the IMGV model as compared to usual care in reducing self-reported pain and depressive symptoms as well as increasing pain management skills. Copyright © 2016 Elsevier Inc. All rights reserved.

The Effect of Guided Care Teams on the Use of Health Services

PubMed Central

Boult, Chad; Reider, Lisa; Leff, Bruce; Frick, Kevin D.; Boyd, Cynthia M.; Wolff, Jennifer L.; Frey, Katherine; Karm, Lya; Wegener, Stephen T.; Mroz, Tracy; Scharfstein, Daniel O.

2015-01-01

Background The effect of interdisciplinary primary care teams on the use of health services by patients with multiple chronic conditions is uncertain. This study aimed to measure the effect of guided care teams on multimorbid older patients’ use of health services. Methods Eligible patients from 3 health care systems in the Baltimore, Maryland–Washington, DC, area were cluster-randomized to receive guided care or usual care for 20 months between November 1, 2006, and June 30, 2008. Eight services of a guided care nurse working in partnership with patients’ primary care physicians were provided: comprehensive assessment, evidence-based care planning, monthly monitoring of symptoms and adherence, transitional care, coordination of health care professionals, support for self-management, support for family caregivers, and enhanced access to community services. Outcome measures were frequency of use of emergency departments, hospitals, skilled nursing facilities, home health agencies, primary care physician services, and specialty physician services. Results The study included 850 older patients at high risk for using health care heavily in the future. The only statistically significant overall effect of guided care in the whole sample was a reduction in episodes of home health care (odds ratio, 0.70; 95% confidence interval, 0.53–0.93). In a preplanned analysis, guided care also reduced skilled nursing facility admissions (odds ratio, 0.53; 95% confidence interval,0.31–0.89) and days (0.48; 0.28–0.84) among Kaiser-Permanente patients. Conclusions Guided care reduces the use of home health care but has little effect on the use of other health services in the short run. Its positive effect on Kaiser-Permanente patients’ use of skilled nursing facilities and other health services is intriguing. Trial Registration clinicaltrials.gov Identifier: NCT00121940 PMID:21403043

Telehealth Applications to Enhance CKD Knowledge and Awareness Among Patients and Providers.

PubMed

Tuot, Delphine S; Boulware, L Ebony

2017-01-01

CKD affects 13% of the US adult population, causes excess mortality, and is associated with significant sociodemographic disparities. Optimal CKD management slows progression of disease and reduces cardiovascular-related outcomes. Resources for patients and primary care providers, major stakeholders in preventive CKD care, are critically needed to enhance understanding of the disease and to optimize CKD health, particularly because of the asymptomatic nature of kidney disease. Telehealth is defined as the use of electronic communication and telecommunications technology to support long-distance clinical health care, patient and professional health-related education, and public health and health administration. It provides new opportunities to enhance awareness and understanding among these important stakeholders. This review will examine the role of telehealth within existing educational theories, identify telehealth applications that can enhance CKD knowledge and behavior change among patients and primary care providers, and examine the advantages and disadvantages of telehealth vs usual modalities for education. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Treatment of obsessive compulsive disorder in a nationwide survey of office-based physician practice

PubMed Central

Patel, Sapana R; Humensky, Jennifer L; Olfson, Mark; Simpson, Helen Blair; Myers, Robert; Dixon, Lisa B.

2014-01-01

Objective To examine the treatment of obsessive compulsive disorder (OCD) in office-based physician practices. Methods Data from the 2003–2010 National Ambulatory Medical Care Survey, a nationally representative survey of visits to office-based physicians in the United States, were used to examine treatment of adult outpatient visits with a diagnosis of OCD. Results Most visits with a diagnosis of OCD (N=316) had been seen previously by the same physician (96%), usually a psychiatrist (86%), ≥6 times (56%) within the previous year. Most visits included psychotropic medications (84%), most commonly a serotonin reuptake inhibitor (69%) and less commonly included any psychotherapy (39%). Conclusions OCD is predominantly treated by psychiatrists using SRI medications, despite the prevalence of OCD and SRI prescribing practices in primary care. Given the potential shift in OCD treatment practice patterns after health care reform, future research on the treatment of OCD in primary care are warranted. PMID:24585056

A feasibility study of brain-targeted treatment for people with painful knee osteoarthritis in tertiary care.

PubMed

Harms, Anton; Heredia-Rizo, Alberto M; Moseley, G Lorimer; Hau, Raphael; Stanton, Tasha R

2018-06-11

To assess the feasibility and clinical impact of brain-targeted treatment (BT; aiming to target sensorimotor processing) in knee osteoarthritis patients attending tertiary care. Randomized replicated case series. The study involved three phases, each of 2 weeks duration: (1) no-treatment phase; (2) BT phase (left/right judgments and touch discrimination training); and (3) usual care (education, strengthening, and stretching training). Primary outcomes were: timely recruitment; number of participants completing the interventions; treatment compliance and barriers; follow-up rates; and treatment impact on pain and function. Fear-avoidance beliefs and clinical measures of cortical body representation (tactile acuity and left/right judgment performance) were secondary outcomes. A total of 5% (19/355) of all assessed patients were eligible to participate and of these, 58% (11/19) agreed to participate. Ten patients completed the study, and 9 were successfully followed up, with treatment compliance varying between interventions. Compliance was poor for the touch discrimination component of BT. No significant effects were observed for pain relief or knee function after any treatment. A positive impact of treatment was found for fear-avoidance beliefs (usual care vs. washout, p = 0.007; BT vs. washout, p = 0.029) and left/right judgment accuracy (usual care vs. washout; p = 0.006). Clear barriers were identified to implementing BT in tertiary care for knee osteoarthritis. Access to all available services (especially the use of interpreters), and treatment options that do not require additional assistance to perform (e.g., touch discrimination training) represent the main lessons learned.

The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial.

PubMed

Jeon, Yun-Hee; Simpson, Judy M; Chenoweth, Lynn; Cunich, Michelle; Kendig, Hal

2013-10-25

A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care--CLiAC) was developed to improve managers' leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster-level analysis. The overall costs and benefits of the program will also be assessed. The outcomes of the trial have the potential to inform actions to enhance leadership and management capabilities of the aged care workforce, address pressing issues about workforce shortages, and increase the quality of aged care services. Australian New Zealand Clinical Trials Registry (ACTRN12611001070921).

Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review.

PubMed

Pearse, Rupert M; Harrison, David A; MacDonald, Neil; Gillies, Michael A; Blunt, Mark; Ackland, Gareth; Grocott, Michael P W; Ahern, Aoife; Griggs, Kathryn; Scott, Rachael; Hinds, Charles; Rowan, Kathryn

2014-06-04

Small trials suggest that postoperative outcomes may be improved by the use of cardiac output monitoring to guide administration of intravenous fluid and inotropic drugs as part of a hemodynamic therapy algorithm. To evaluate the clinical effectiveness of a perioperative, cardiac output-guided hemodynamic therapy algorithm. OPTIMISE was a pragmatic, multicenter, randomized, observer-blinded trial of 734 high-risk patients aged 50 years or older undergoing major gastrointestinal surgery at 17 acute care hospitals in the United Kingdom. An updated systematic review and meta-analysis were also conducted including randomized trials published from 1966 to February 2014. Patients were randomly assigned to a cardiac output-guided hemodynamic therapy algorithm for intravenous fluid and inotrope (dopexamine) infusion during and 6 hours following surgery (n=368) or to usual care (n=366). The primary outcome was a composite of predefined 30-day moderate or major complications and mortality. Secondary outcomes were morbidity on day 7; infection, critical care-free days, and all-cause mortality at 30 days; all-cause mortality at 180 days; and length of hospital stay. Baseline patient characteristics, clinical care, and volumes of intravenous fluid were similar between groups. Care was nonadherent to the allocated treatment for less than 10% of patients in each group. The primary outcome occurred in 36.6% of intervention and 43.4% of usual care participants (relative risk [RR], 0.84 [95% CI, 0.71-1.01]; absolute risk reduction, 6.8% [95% CI, -0.3% to 13.9%]; P = .07). There was no significant difference between groups for any secondary outcomes. Five intervention patients (1.4%) experienced cardiovascular serious adverse events within 24 hours compared with none in the usual care group. Findings of the meta-analysis of 38 trials, including data from this study, suggest that the intervention is associated with fewer complications (intervention, 488/1548 [31.5%] vs control, 614/1476 [41.6%]; RR, 0.77 [95% CI, 0.71-0.83]) and a nonsignificant reduction in hospital, 28-day, or 30-day mortality (intervention, 159/3215 deaths [4.9%] vs control, 206/3160 deaths [6.5%]; RR, 0.82 [95% CI, 0.67-1.01]) and mortality at longest follow-up (intervention, 267/3215 deaths [8.3%] vs control, 327/3160 deaths [10.3%]; RR, 0.86 [95% CI, 0.74-1.00]). In a randomized trial of high-risk patients undergoing major gastrointestinal surgery, use of a cardiac output-guided hemodynamic therapy algorithm compared with usual care did not reduce a composite outcome of complications and 30-day mortality. However, inclusion of these data in an updated meta-analysis indicates that the intervention was associated with a reduction in complication rates. isrctn.org Identifier: ISRCTN04386758.

Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial.

PubMed

Labhardt, Niklaus D; Ringera, Isaac; Lejone, Thabo I; Klimkait, Thomas; Muhairwe, Josephine; Amstutz, Alain; Glass, Tracy R

2018-03-20

Home-based HIV testing is a frequently used strategy to increase awareness of HIV status in sub-Saharan Africa. However, with referral to health facilities, less than half of those who test HIV positive link to care and initiate antiretroviral therapy (ART). To determine whether offering same-day home-based ART to patients with HIV improves linkage to care and viral suppression in a rural, high-prevalence setting in sub-Saharan Africa. Open-label, 2-group, randomized clinical trial (February 22, 2016-September 17, 2017), involving 6 health care facilities in northern Lesotho. During home-based HIV testing in 6655 households from 60 rural villages and 17 urban areas, 278 individuals aged 18 years or older who tested HIV positive and were ART naive from 268 households consented and enrolled. Individuals from the same household were randomized into the same group. Participants were randomly assigned to be offered same-day home-based ART initiation (n = 138) and subsequent follow-up intervals of 1.5, 3, 6, 9, and 12 months after treatment initiation at the health facility or to receive usual care (n = 140) with referral to the nearest health facility for preparatory counseling followed by ART initiation and monthly follow-up visits thereafter. Primary end points were rates of linkage to care within 3 months (presenting at the health facility within 90 days after the home visit) and viral suppression at 12 months, defined as a viral load of less than 100 copies/mL from 11 through 14 months after enrollment. Among 278 randomized individuals (median age, 39 years [interquartile range, 28.0-52.0]; 180 women [65.7%]), 274 (98.6%) were included in the analysis (137 in the same-day group and 137 in the usual care group). In the same-day group, 134 (97.8%) indicated readiness to start ART that day and 2 (1.5%) within the next few days and were given a 1-month supply of ART. At 3 months, 68.6% (94) in same-day group vs 43.1% (59) in usual care group had linked to care (absolute difference, 25.6%; 95% CI, 13.8% to 36.3%; P < .001). At 12 months, 50.4% (69) in the same-day group vs 34.3% (47) in usual care group achieved viral suppression (absolute difference, 16.0%; 4.4%-27.2%; P = .007). Two deaths (1.5%) were reported in the same-day group, none in usual care group. Among adults in rural Lesotho, a setting of high HIV prevalence, offering same-day home-based ART initiation to individuals who tested positive during home-based HIV testing, compared with usual care and standard clinic referral, significantly increased linkage to care at 3 months and HIV viral suppression at 12 months. These findings support the practice of offering same-day ART initiation during home-based HIV testing. clinicaltrials.gov Identifier: NCT02692027.

Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial.

PubMed

Farmer, Andrew; Toms, Christy; Hardinge, Maxine; Williams, Veronika; Rutter, Heather; Tarassenko, Lionel

2014-01-08

The potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education. The EDGE (sElf management anD support proGrammE) for COPD is a multicentre, randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention (the EDGE platform) in improving quality of life in patients with moderate to very severe COPD compared with usual care. Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system. Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics. Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter. Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables. The primary outcome of quality of life is measured using the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) baseline, 6 and 12 months. Secondary outcome measures are recorded at these intervals in addition to 3 months. The Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the study will be disseminated through peer review publications and conference presentations. Current controlled trials ISRCTN40367841.

Workflow standardization of a novel team care model to improve chronic care: a quasi-experimental study.

PubMed

Panattoni, Laura; Hurlimann, Lily; Wilson, Caroline; Durbin, Meg; Tai-Seale, Ming

2017-04-19

Team-based chronic care models have not been widely adopted in community settings, partly due to their varying effectiveness in randomized control trials, implementation challenges, and concerns about physician acceptance. The Palo Alto Medical Foundation designed and implemented "Champion," a novel team-based model that includes new standard work (e.g. proactive patient outreach, pre-visit schedule grooming, depression screening, care planning, health coaching) to support patients' self-management of hypertension and diabetes. We investigated whether Champion improved clinical outcomes. We conducted a quasi-experimental study comparing the Champion clinic-level intervention (n = 38 physicians) with a usual care clinic (n = 37 physicians) in Northern California. The primary outcomes, blood pressure and glycohemoglobin (A1c), were analyzed using a piecewise linear growth curve model for patients exposed to a Champion physician visit (n = 3156) or usual care visit (n = 8034) in the two years prior and one year post implementation. Secondary outcomes were provider experience, compared at baseline and 12 months in both the intervention and usual care clinics using multi-level ordered logistic modeling, and electronic health record based fidelity measures. Compared to usual care, in the first 6 months after a Champion physician visit, diabetes patients aged 18-75 experienced an additional -1.13 mm Hg (95% CI: -2.23 to -0.04) decline in diastolic blood pressure and -0.47 (95% CI: -0.61 to -0.33) decline in A1c. There were no additional improvements in blood pressure or A1c 6 to 12 months post physician visit. At 12 months, Champion physicians reported improved experience with managing chronic care patients in 6 of 7 survey items (p < 0.05), but compared to usual, this difference was only statistically significant for one item (p < 0.05). Fidelity to standard work was uneven; depression screening was the most commonly documented element (85% of patients), while care plans were the least (30.8% of patients). Champion standard work improved glycemic control over the first 6 months and physicians' experience with managing chronic care; changes in blood pressure were not clinically meaningful. Our results suggest the need to understand the relationship between the intervention, the contextual features of implementation, and fidelity to further improve chronic disease outcomes. This study was retrospectively registered with the ISRCTN Registry on March 15, 2017 (ISRCTN11341906).

Stepped care for depression and anxiety in visually impaired older adults: multicentre randomised controlled trial

PubMed Central

van Rens, Ger H M B; Comijs, Hannie C; Margrain, Tom H; Gallindo-Garre, Francisca; Twisk, Jos W R; van Nispen, Ruth M A

2015-01-01

Study question Is stepped care compared with usual care effective in preventing the onset of major depressive, dysthymic, and anxiety disorders in older people with visual impairment (caused mainly by age related eye disease) and subthreshold depression and/or anxiety? Methods 265 people aged ≥50 were randomly assigned to a stepped care programme plus usual care (n=131) or usual care only (n=134). Supervised occupational therapists, social workers, and psychologists from low vision rehabilitation organisations delivered the stepped care programme, which comprised watchful waiting, guided self help based on cognitive behavioural therapy, problem solving treatment, and referral to a general practitioner. The primary outcome was the 24 month cumulative incidence (seven measurements) of major depressive dysthymic and/or anxiety disorders (panic disorder, agoraphobia, social phobia, and generalised anxiety disorder). Secondary outcomes were change in symptoms of depression and anxiety, vision related quality of life, health related quality of life, and adaptation to vision loss over time up to 24 months’ follow-up. Study answer and limitations 62 participants (46%) in the usual care group and 38 participants (29%) from the stepped care group developed a disorder. The intervention was associated with a significantly reduced incidence (relative risk 0.63, 95% confidence interval 0.45 to 0.87; P=0.01), even if time to the event was taken into account (adjusted hazard ratio 0.57, 0.35 to 0.93; P=0.02). The number needed to treat was 5.8 (3.5 to 17.3). The dropout rate was fairly high (34.3%), but rates were not significantly different for the two groups, indicating that the intervention was as acceptable as usual care. Participants who volunteered and were selected for this study might not be representative of visually impaired older adults in general (responders were significantly younger than non-responders), thereby reducing the generalisability of the outcomes. What this study adds Stepped care seems to be a promising way to deal with depression and anxiety in visually impaired older adults. This approach could lead to standardised strategies for the screening, monitoring, treatment, and referral of visually impaired older adults with depression and anxiety. Funding, competing interests, data sharing Funded by ZonMw InZicht, the Dutch Organisation for Health Research and Development-InSight Society. There are no competing interests. Full dataset and statistical code are available from the corresponding author. Study registration www.trialregister.nl NTR3296. PMID:26597263

Knowledge flow and exchange in interdisciplinary primary health care teams (PHCTs): an exploratory study

PubMed Central

Sibbald, Shannon L.; Wathen, C. Nadine; Kothari, Anita; Day, Adam M. B.

2013-01-01

Objective: Improving the process of evidence-based practice in primary health care requires an understanding of information exchange among colleagues. This study explored how clinically oriented research knowledge flows through multidisciplinary primary health care teams (PHCTs) and influences clinical decisions. Methods: This was an exploratory mixed-methods study with members of six PHCTs in Ontario, Canada. Quantitative data were collected using a questionnaire and analyzed with social network analysis (SNA) using UCINet. Qualitative data were collected using semi-structured interviews and analyzed with content analysis procedures using NVivo8. Results: It was found that obtaining research knowledge was perceived to be a shared responsibility among team members, whereas its application in patient care was seen as the responsibility of the team leader, usually the senior physician. PHCT members acknowledged the need for resources for information access, synthesis, interpretation, or management. Conclusion: Information sharing in interdisciplinary teams is a complex and multifaceted process. Specific interventions need to be improved such as formalizing modes of communication, better organizing knowledge-sharing activities, and improving the active use of allied health professionals. Despite movement toward team-based models, senior physicians are often gatekeepers of uptake of new evidence and changes in practice. PMID:23646028

Characteristics of physicians and patients who join team-based primary care practices: evidence from Quebec's Family Medicine Groups.

PubMed

Coyle, Natalie; Strumpf, Erin; Fiset-Laniel, Julie; Tousignant, Pierre; Roy, Yves

2014-06-01

New models of delivering primary care are being implemented in various countries. In Quebec, Family Medicine Groups (FMGs) are a team-based approach to enhance access to, and coordination of, care. We examined whether physicians' and patients' characteristics predicted their participation in this new model of primary care. Using provincial administrative data, we created a population cohort of Quebec's vulnerable patients. We collected data before the advent of FMGs on patients' demographic characteristics, chronic illnesses and health service use, and their physicians' demographics, and practice characteristics. Multivariate regression was used to identify key predictors of joining a FMG among both patients and physicians. Patients who eventually enrolled in a FMG were more likely to be female, reside outside of an urban region, have a lower SES status, have diabetes and congestive heart failure, visit the emergency department for ambulatory sensitive conditions and be hospitalized for any cause. They were also less likely to have hypertension, visit an ambulatory clinic and have a usual provider of care. Physicians who joined a FMG were less likely to be located in urban locations, had fewer years in medical practice, saw more patients in hospital, and had patients with lower morbidity. Physicians' practice characteristics and patients' health status and health care service use were important predictors of joining a FMG. To avoid basing policy decisions on tenuous evidence, policymakers and researchers should account for differential selection into team-based primary health care models. Copyright © 2014. Published by Elsevier Ireland Ltd.