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.

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial.

PubMed

Orozco-Beltran, Domingo; Ruescas-Escolano, Esther; Navarro-Palazón, Ana Isabel; Cordero, Alberto; Gaubert-Tortosa, María; Navarro-Perez, Jorge; Carratalá-Munuera, Concepción; Pertusa-Martínez, Salvador; Soler-Bahilo, Enrique; Brotons-Muntó, Francisco; Bort-Cubero, Jose; Nuñez-Martinez, Miguel Angel; Bertomeu-Martinez, Vicente; Gil-Guillen, Vicente Francisco

2013-08-02

To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. Experimental study. Randomized clinical trial. Follow-up period: one year. primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. NCT01826929.

Evaluation of the effect of Spiritual care on patients with generalized anxiety and depression: a randomized controlled study.

PubMed

Sankhe, A; Dalal, K; Save, D; Sarve, P

2017-12-01

The present study was conducted to assess the effect of spiritual care in patients with depression, anxiety or both in a randomized controlled design. The participants were randomized either to receive spiritual care or not and Hamilton anxiety rating scale-A (HAM-A), Hamilton depression rating scale-D (HAM-D), WHO-quality of life-Brief (WHOQOL-BREF) and Functional assessment of chronic illness therapy - Spiritual well-being (FACIT-Sp) were assessed before therapy and two follow-ups at 3 and 6 week. However, with regard to the spiritual care therapy group, statistically significant differences were observed in both HAM-A and HAM-D scales between the baseline and visit 2 (p < 0.001), thus significantly reducing symptoms of anxiety and depression, respectively. No statistically significant differences were observed for any of the scales during the follow-up periods for the control group of participants. When the scores were compared between the study groups, HAM-A, HAM-D and FACIT-Sp 12 scores were significantly lower in the interventional group as compared to the control group at both third and sixth weeks. This suggests a significant improvement in symptoms of anxiety and depression in the spiritual care therapy group than the control group; however, large randomized controlled trials with robust design are needed to confirm the same.

Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

PubMed

Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

2018-05-01

Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p < 0.01) and less often received consultations (0% vs. 27%; p = 0.04). Home patients were more physically active (median minutes, 209 vs. 78; p < 0.01), with a trend toward more sleep. No adverse events occurred in home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p < 0.01) lower, with trends toward less use of home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Chen, Jyun-Hong; Ou, Huang-Tz; Lin, Tzu-Chieh; Lai, Edward Chia-Cheng; Kao, Yea-Huei Yang

2016-02-01

Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider. To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes. A 421-bed district hospital in Nantou City, Taiwan. We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann–Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P < 0.05. The change in the mean HbA1c level from the baseline to the next level within 6 months after recruiting. Nonparametric data (Mann–Whitney test) showed that the mean HbA1c level significantly decreased (0.83 %) after 6 months for the intervention group compared with an increase of 0.43 % for the control group (P ≤ 0.001). Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups. The pharmacist intervention program provided pharmaceutical services that improved long-term, safe control of blood sugar levels for ambulatory elderly patients with diabetes and did not increase medical expenses.

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…

Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

PubMed

Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

2014-08-01

Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

Use of Video to Facilitate End-of-Life Discussions With Patients With Cancer: A Randomized Controlled Trial

PubMed Central

El-Jawahri, Areej; Podgurski, Lisa M.; Eichler, April F.; Plotkin, Scott R.; Temel, Jennifer S.; Mitchell, Susan L.; Chang, Yuchiao; Barry, Michael J.; Volandes, Angelo E.

2010-01-01

Purpose To determine whether the use of a goals-of-care video to supplement a verbal description can improve end-of-life decision making for patients with cancer. Methods Fifty participants with malignant glioma were randomly assigned to either a verbal narrative of goals-of-care options at the end of life (control), or a video after the same verbal narrative (intervention) in this randomized controlled trial. The video depicts three levels of medical care: life-prolonging care (cardiopulmonary resuscitation [CPR], ventilation), basic care (hospitalization, no CPR), and comfort care (symptom relief). The primary study outcome was participants' preferences for end-of-life care. The secondary outcome was participants' uncertainty regarding decision making (score range, 3 to 15; higher score indicating less uncertainty). Participants' comfort level with the video was also measured. Results Fifty participants were randomly assigned to either the verbal narrative (n = 27) or video (n = 23). After the verbal description, 25.9% of participants preferred life-prolonging care, 51.9% basic care, and 22.2% comfort care. In the video arm, no participants preferred life-prolonging care, 4.4% preferred basic care, 91.3% preferred comfort care, and 4.4% were uncertain (P < .0001). The mean uncertainty score was higher in the video group than in the verbal group (13.7 v 11.5, respectively; P < .002). In the intervention arm, 82.6% of participants reported being very comfortable watching the video. Conclusion Compared with participants who only heard a verbal description, participants who viewed a goals-of-care video were more likely to prefer comfort care and avoid CPR, and were more certain of their end-of-life decision making. Participants reported feeling comfortable watching the video. PMID:19949010

A randomized controlled trial of an activity specific exercise program for individuals with Alzheimer disease in long-term care settings.

PubMed

Roach, Kathryn E; Tappen, Ruth M; Kirk-Sanchez, Neva; Williams, Christine L; Loewenstein, David

2011-01-01

To determine whether an activity specific exercise program could improve ability to perform basic mobility activities in long-term care residents with Alzheimer disease (AD). Randomized, controlled, single-blinded clinical trial. Residents of 7 long-term care facilities. Eighty-two long-term care residents with mild to severe AD. An activity specific exercise program was compared to a walking program and to an attention control. Ability to perform bed mobility and transfers was assessed using the subscales of the Acute Care Index of Function; functional mobility was measured using the 6-Minute Walk test. Subjects receiving the activity specific exercise program improved in ability to perform transfers, whereas subjects in the other 2 groups declined.

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.

Children diagnosed with type 1 diabetes: a randomized controlled trial comparing hospital versus home-based care.

PubMed

Tiberg, Irén; Katarina, Steen Carlsson; Carlsson, Annelie; Hallström, Inger

2012-10-01

  To compare two different regimens for children diagnosed with type 1 diabetes: hospital-based care or hospital-based home care (HBHC), referring to specialist care in a home-based setting.   The trial took place in Sweden with a randomized controlled design and included 60 children, aged 3-15 years. After 2-3 days with hospital-based care, children were randomized to either continued hospital-based care or to HBHC for 6 days. The primary outcome was the child's metabolic control after 2 years. Secondary outcomes were set to evaluate the family and child situation as well as the healthcare services. This article presents data 6 months after diagnosis.   Results showed equivalence between groups in terms of metabolic control, insulin dose, parents' employment and working hours as well as parents' and significant others' absence from work related to the child's diabetes. Parents in the HBHC were more satisfied with the received health care and showed less subsequent healthcare resource use. The level of risk for the family's psychosocial distress assessed at diagnosis was associated with the subsequent use of resources, but not with metabolic control.   HBHC was found to be an equally safe and effective way of providing care as hospital-based care at the onset of type 1 diabetes for children who are medically stable. © 2012 The Author(s)/Acta Paediatrica © 2012 Foundation Acta Paediatrica.

Implementation and Randomized Controlled Trial Evaluation of Universal Postnatal Nurse Home Visiting

PubMed Central

Goodman, W. Benjamin; Murphy, Robert A.; O’Donnell, Karen; Sato, Jeannine; Guptill, Susan

2014-01-01

Objectives. We evaluated whether a brief, universal, postnatal nurse home-visiting intervention can be implemented with high penetration and fidelity, prevent emergency health care services, and promote positive parenting by infant age 6 months. Methods. Durham Connects is a manualized 4- to 7-session program to assess family needs and connect parents with community resources to improve infant health and well-being. All 4777 resident births in Durham, North Carolina, between July 1, 2009, and December 31, 2010, were randomly assigned to intervention and control conditions. A random, representative subset of 549 families received blinded interviews for impact evaluation. Results. Of all families, 80% initiated participation; adherence was 84%. Hospital records indicated that Durham Connects infants had 59% fewer infant emergency medical care episodes than did control infants. Durham Connects mothers reported fewer infant emergency care episodes and more community connections, more positive parenting behaviors, participation in higher quality out-of-home child care, and lower rates of anxiety than control mothers. Blinded observers reported higher quality home environments for Durham Connects than for control families. Conclusions. A brief universal home-visiting program implemented with high penetration and fidelity can lower costly emergency medical care and improve family outcomes. PMID:24354833

Installing the Communities that Care Prevention System: Implementation Progress and Fidelity in a Randomized Controlled Trial

ERIC Educational Resources Information Center

Quinby, Rose K.; Hanson, Koren; Brooke-Weiss, Blair; Arthur, Michael W.; Hawkins, J. David; Fagan, Abigail A.

2008-01-01

This article describes the degree to which high fidelity implementation of the Communities That Care (CTC) prevention operating system was reached during the first 18 months of intervention in 12 communities in the Community Youth Development Study, a 5-year group randomized controlled trial designed to test the efficacy of the CTC system. CTC…

Outcomes of a Telehealth Intervention for Homebound Older Adults with Heart or Chronic Respiratory Failure: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Gellis, Zvi D.; Kenaley, Bonnie; McGinty, Jean; Bardelli, Ellen; Davitt, Joan; Ten Have, Thomas

2012-01-01

Purpose: Telehealth care is emerging as a viable intervention model to treat complex chronic conditions, such as heart failure (HF) and chronic obstructive pulmonary disease (COPD), and to engage older adults in self-care disease management. Design and Methods: We report on a randomized controlled trial examining the impact of a multifaceted…

Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

ERIC Educational Resources Information Center

Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

2010-01-01

This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

Impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes: Randomized controlled trial.

PubMed

Wishah, Ruba A; Al-Khawaldeh, Omar A; Albsoul, Abla M

2015-01-01

The primary aim of this study was to evaluate the impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes patients in Jordan. A randomized controlled clinical trial was conducted on 106 patients with uncontrolled type 2 diabetes seeking care in the diabetes clinics at Jordan University Hospital. Patients were randomly allocated into control and intervention group. The intervention group patients received pharmaceutical care interventions developed by the clinical pharmacist in collaboration with the physician while the control group patients received usual care without clinical pharmacist's input. Fasting blood glucose and HbA1c were measured at the baseline, at three months, and six months intervals for both intervention and control groups. After the six months follow-up, mean of HbA1c and FBS of the patients in the intervention group decreased significantly compared to the control group patients (P<0.05). Also, the results indicated that mean scores of patients' knowledge about medications, knowledge about diabetes and adherence to medications and diabetes self-care activities of the patients in the intervention group increased significantly compared to the control group (P<0.05). This study demonstrated an improvement in HbA1c, FBS, and lipid profile, in addition to self-reported medication adherence, diabetes knowledge, and diabetes self-care activities in patients with type 2 diabetes who received pharmaceutical care interventions. The results suggest the benefits of integrating clinical pharmacist services in multidisciplinary healthcare team and diabetes management in Jordan. Copyright © 2014 Diabetes India. Published by Elsevier Ltd. All rights reserved.

The life in sight application study (LISA): design of a randomized controlled trial to assess the role of an assisted structured reflection on life events and ultimate life goals to improve quality of life of cancer patients

PubMed Central

2013-01-01

Background It is widely recognized that spiritual care plays an important role in physical and psychosocial well-being of cancer patients, but there is little evidence based research on the effects of spiritual care. We will conduct a randomized controlled trial on spiritual care using a brief structured interview scheme supported by an e-application. The aim is to examine whether an assisted reflection on life events and ultimate life goals can improve quality of life of cancer patients. Methods/Design Based on the findings of our previous research, we have developed a brief interview model that allows spiritual counsellors to explore, explicate and discuss life events and ultimate life goals with cancer patients. To support the interview, we created an e-application for a PC or tablet. To examine whether this assisted reflection improves quality of life we will conduct a randomized trial. Patients with advanced cancer not amenable to curative treatment options will be randomized to either the intervention or the control group. The intervention group will have two consultations with a spiritual counsellor using the interview scheme supported by the e-application. The control group will receive care as usual. At baseline and one and three months after randomization all patients fill out questionnaires regarding quality of life, spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health care consumption. Discussion Having insight into one’s ultimate life goals may help integrating a life event such as cancer into one’s life story. This is the first randomized controlled trial to evaluate the role of an assisted structured reflection on ultimate life goals to improve patients’ quality of life and spiritual well being. The intervention is brief and based on concepts and skills that spiritual counsellors are familiar with, it can be easily implemented in routine patient care and incorporated in guidelines on spiritual care. Trial registration The study is registered at ClinicalTrials.gov: NCT01830075 PMID:23889978

Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Bipolar I disorder (BD-I) is a chronic mental illness characterized by the presence of one or more manic episodes, or both depressive and manic episodes, usually separated by asymptomatic intervals. Pharmacists can contribute to the management of BD-I, mainly with the use of effective and safe drugs, and improve the patient’s life quality through pharmaceutical care. Some studies have shown the effect of pharmaceutical care in the achievement of therapeutic goals in different illnesses; however, to our knowledge, there is a lack of randomized controlled trials designed to assess the effect of pharmacist intervention in patients with BD. The aim of this study is to assess the effectiveness of the Dader Method for pharmaceutical care in patients with BD-I. Methods/design Randomized, controlled, prospective, single-center clinical trial with duration of 12 months will be performed to compare the effect of Dader Method of pharmaceutical care with the usual care process of patients in a psychiatric clinic. Patients diagnosed with BD-I aged between 18 and 65 years who have been discharged or referred from outpatients service of the San Juan de Dios Clinic (Antioquia, Colombia) will be included. Patients will be randomized into the intervention group who will receive pharmaceutical care provided by pharmacists working in collaboration with psychiatrists, or into the control group who will receive usual care and verbal-written counseling regarding BD. Study outcomes will be assessed at baseline and at 3, 6, 9, and 12 months after randomization. The primary outcome will be to measure the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits. Effectiveness, safety, adherence, and quality of life will be assessed as secondary outcomes. Statistical analyses will be performed using two-tailed McNemar tests, Pearson chi-square tests, and Student’s t-tests; a P value <0.05 will be considered as statistically significant. Discussion As far as we know, this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with BD-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals, solution of drug-related problems, and adherence. Trial registration Registration number NCT01750255 on August 6, 2012. First patient randomized on 24 November 2011. PMID:24885673

PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

PubMed

Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

2017-04-01

Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization prior to recruitment feasible with 100% participation of facilities randomized to the intervention arm. Critical regulatory issues included minimal risk determination, waiver of informed consent, and determination that nursing home providers were not engaged in human subjects research. Intervention training and implementation were initiated on 5 January 2016 using corporate infrastructures for new program roll-out guided by standardized training elements designed by the research team. Video Status Reports in facilities' electronic medical records permitted "real-time" adherence monitoring and corrective actions. The Centers for Medicare and Medicaid Services Virtual Research Data Center allowed for rapid outcomes ascertainment. Conclusion We must rigorously evaluate interventions to deliver more patient-focused care to an increasingly frail nursing home population. Video decision support is a practical approach to improve advance care planning. PRagmatic trial Of Video Education in Nursing homes has the potential to promote goal-directed care among millions of older Americans in nursing homes and establish a methodology for future pragmatic randomized controlled trials in this complex healthcare setting.

Control treatments in biologics trials of rheumatoid arthritis were often not deemed acceptable in the context of care.

PubMed

Estellat, Candice; Tubach, Florence; Seror, Raphaèle; Alfaiate, Toni; Hajage, David; De Rycke, Yann; Ravaud, Philippe

2016-01-01

Control treatments in randomized controlled trials (RCTs) should not deliberately disadvantage patients. The objectives of the study were to compare (1) willingness to include vs. (2) willingness to prescribe control treatment among physicians randomized to assess, respectively, either (1) enrollment in a trial or (2) appropriateness of control treatment in a care context for the same fictional patient. Physicians were authors of articles about rheumatoid arthritis (RA), involved in RA patient care, and used to enrolling patients in trials. The outcomes were willingness to give control treatment: trial enrollment or control-treatment appropriateness in care context. We derived three case vignettes of fictional standard eligible patients for each of 30 RCTs assessing biologics in RA. Physicians were randomly allocated to the "trial" or "care" arm. For each of the 90 fictional patients, physicians assigned to the trial arm were asked if they would enroll the patient in the RCT the patient was derived from. For the same 90 fictional patients, physicians assigned to the care arm were asked if the control treatment of the RCT was appropriate in a context of usual care. Of the 1,779 physicians invited to participate, 151 were randomized. Half of the fictional patients {41/90; 45% [95% confidence interval (CI): 37%, 53%]} would be enrolled in the RCT although the control-arm treatment of the RCT was not considered appropriate for them in the context of care. This rate differed by type of comparator [55% for non-head-to-head RCTs vs. 6% for head-to-head RCTs; adjusted odds ratio (aOR), 23.9 (95% CI: 5.5, 92.7)] and duration of trial control treatment [56% for ≤24 weeks and 15% for >24 weeks; aOR, 10.7 (95% CI: 2.8, 63.9)] but not patient RA activity [aOR, 2.5 (95% CI: 1.0, 6.6)]. The limitation of this study was that physicians gave their opinion on fictional patients with only RA. Control treatments in RCTs of biologics in RA are often deemed not acceptable in the context of usual care, especially those for non-head-to-head RCTs. These findings raise ethical concerns and challenge the choice of the comparator in RCTs. Copyright © 2016 Elsevier Inc. All rights reserved.

Substance Use and Delinquency among Middle School Girls in Foster Care: A Three-Year Follow-Up of a Randomized Controlled Trial

ERIC Educational Resources Information Center

Kim, Hyoun K.; Leve, Leslie D.

2011-01-01

Objective: The present study evaluated the efficacy of the Middle School Success intervention (MSS) for reducing substance use and delinquency among girls in foster care, using a randomized controlled trial design. The program was designed to fill a service gap during the summer prior to the middle school transition and to prevent delinquency,…

Optimizing the Primary Prevention of Type-2 Diabetes in Primary Health Care

ClinicalTrials.gov

2017-08-18

Interprofessional Relations; Primary Health Care/Organization & Administration; Diabetes Mellitus, Type 2/Prevention & Control; Primary Prevention/Methods; Risk Reduction Behavior; Randomized Controlled Trial; Life Style

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

A Randomized Controlled Trial of a Citywide Emergency Department Care Coordination Program to Reduce Prescription Opioid Related ED Visits

PubMed Central

Paulozzi, Leonard J.; Howell, Donelle; McPherson, Sterling; Murphy, Sean M.; Grohs, Becky; Marsh, Linda; Lederhos, Crystal; Roll, Jon

2017-01-01

Background Increasing prescription overdose deaths have demonstrated the need for safer ED prescribing practices for patients who are frequent ED users. Objectives We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients. Methods We conducted a multi-site randomized controlled trial (RCT) across all EDs in a metropolitan area. 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual. Results The intervention arm experienced a 34% decrease (IRR = 0.66, p < 0.001; 95% CI: 0.57 – 0.78) in ED visits and an 80% decrease (OR = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers. Conclusion This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. PMID:27624507

A Randomized Controlled Trial of a Citywide Emergency Department Care Coordination Program to Reduce Prescription Opioid Related Emergency Department Visits.

PubMed

Neven, Darin; Paulozzi, Leonard; Howell, Donelle; McPherson, Sterling; Murphy, Sean M; Grohs, Becky; Marsh, Linda; Lederhos, Crystal; Roll, John

2016-11-01

Increasing prescription overdose deaths have demonstrated the need for safer emergency department (ED) prescribing practices for patients who are frequent ED users. We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients. We conducted a multisite randomized controlled trial (RCT) across all EDs in a metropolitan area; 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual. The intervention arm experienced a 34% decrease (incident rate ratios = 0.66, p < 0.001; 95% confidence interval 0.57-0.78) in ED visits and an 80% decrease (odds ratio = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers, respectively. This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

A pilot randomized, controlled trial of the effectiveness of a psychoeducational intervention on family caregivers of patients with advanced cancer.

PubMed

Leow, Mabel; Chan, Sally; Chan, Moon

2015-03-01

To evaluate the effectiveness of a psychoeducational intervention, the Caring for the Caregiver Programme (CCP).
 A pilot randomized, controlled trial, two-group pretest, and repeated post-tests.
 Four home hospice organizations and an outpatient clinic in Singapore.
 80 caregivers were randomized into experimental and standard care groups.
 Outcomes were measured at baseline, week 4, and week 8 after the intervention. The standard care group received routine home hospice care, and the intervention group received the CCP in addition to routine care.
 Quality of life (QOL), social support, stress and depression, self-efficacy in self-care, closeness with the patient, rewards, and knowledge.
 Compared to the standard care group, the intervention group reported significantly higher QOL, social support satisfaction and number of supported people, closeness with the patient, self-efficacy in self-care, rewards of caregiving, and knowledge, and lower stress and depression. 
 The CCP had positive effects on family caregivers of patients with advanced cancer. 
 A psychoeducational intervention potentially could help caregivers cope with the demands of caregiving. 


Knowledge translation interventions for critically ill patients: a systematic review*.

PubMed

Sinuff, Tasnim; Muscedere, John; Adhikari, Neill K J; Stelfox, Henry T; Dodek, Peter; Heyland, Daren K; Rubenfeld, Gordon D; Cook, Deborah J; Pinto, Ruxandra; Manoharan, Venika; Currie, Jan; Cahill, Naomi; Friedrich, Jan O; Amaral, Andre; Piquette, Dominique; Scales, Damon C; Dhanani, Sonny; Garland, Allan

2013-11-01

We systematically reviewed ICU-based knowledge translation studies to assess the impact of knowledge translation interventions on processes and outcomes of care. We searched electronic databases (to July, 2010) without language restrictions and hand-searched reference lists of relevant studies and reviews. Two reviewers independently identified randomized controlled trials and observational studies comparing any ICU-based knowledge translation intervention (e.g., protocols, guidelines, and audit and feedback) to management without a knowledge translation intervention. We focused on clinical topics that were addressed in greater than or equal to five studies. Pairs of reviewers abstracted data on the clinical topic, knowledge translation intervention(s), process of care measures, and patient outcomes. For each individual or combination of knowledge translation intervention(s) addressed in greater than or equal to three studies, we summarized each study using median risk ratio for dichotomous and standardized mean difference for continuous process measures. We used random-effects models. Anticipating a small number of randomized controlled trials, our primary meta-analyses included randomized controlled trials and observational studies. In separate sensitivity analyses, we excluded randomized controlled trials and collapsed protocols, guidelines, and bundles into one category of intervention. We conducted meta-analyses for clinical outcomes (ICU and hospital mortality, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay) related to interventions that were associated with improvements in processes of care. From 11,742 publications, we included 119 investigations (seven randomized controlled trials, 112 observational studies) on nine clinical topics. Interventions that included protocols with or without education improved continuous process measures (seven observational studies and one randomized controlled trial; standardized mean difference [95% CI]: 0.26 [0.1, 0.42]; p = 0.001 and four observational studies and one randomized controlled trial; 0.83 [0.37, 1.29]; p = 0.0004, respectively). Heterogeneity among studies within topics ranged from low to extreme. The exclusion of randomized controlled trials did not change our results. Single-intervention and lower-quality studies had higher standardized mean differences compared to multiple-intervention and higher-quality studies (p = 0.013 and 0.016, respectively). There were no associated improvements in clinical outcomes. Knowledge translation interventions in the ICU that include protocols with or without education are associated with the greatest improvements in processes of critical care.

Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

PubMed

Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

2017-08-01

This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

A Cluster Randomized Controlled Trial Testing the Effectiveness of Houvast: A Strengths-Based Intervention for Homeless Young Adults

ERIC Educational Resources Information Center

Krabbenborg, Manon A. M.; Boersma, Sandra N.; van der Veld, William M.; van Hulst, Bente; Vollebergh, Wilma A. M.; Wolf, Judith R. L. M.

2017-01-01

Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended.…

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

Effects of a Psychological Intervention in a Primary Health Care Center for Caregivers of Dependent Relatives: A Randomized Trial

ERIC Educational Resources Information Center

Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis

2013-01-01

Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…

Randomized Controlled Trial of Problem-Solving Therapy for Minor Depression in Home Care

ERIC Educational Resources Information Center

Gellis, Zvi D.; McGinty, Jean; Tierney, Lynda; Jordan, Cindy; Burton, Jean; Misener, Elizabeth

2008-01-01

Objective: Data are presented from a pilot research program initiated to develop, refine, and test the outcomes of problem-solving therapy that targets the needs of older adults with minor depression in home care settings. Method: A pilot randomized clinical trial compares the impact of problem-solving therapy for home care to treatment as usual…

The efficacy of gum chewing in reducing postoperative ileus: a multisite randomized controlled trial.

PubMed

Forrester, David Anthony Tony; Doyle-Munoz, Janet; McTigue, Toni; D'Andrea, Stephanie; Natale-Ryan, Angela

2014-01-01

The purpose of this prospective, attention-controlled, randomized study was to determine whether postoperative gum chewing reduces the duration of postoperative ileus symptoms following elective open or laparoscopic sigmoid colectomy when compared with standard care or an attention-control intervention. Forty-seven subjects scheduled for either an open or laparoscopic colon resection participated in the study. Subjects were recruited preoperatively at the preadmission learning centers of the 2 acute care medical centers that comprised the study settings. Subjects were randomized to 3 groups: (1) standard postoperative care (n = 18); (2) standard care and a silicone-adhesive patch applied to the deltoid region of the upper arm as an attention control (n = 16); and (3) standard care and gum chewing (n = 13). Standard postoperative care included removal of the nasogastric tube, early ambulation, nothing by mouth with ice chips only until the first passage of flatus, and then advancement of diet until tolerance of solid food. No statistically significant differences were found among the 3 study groups for the 4 postoperative outcome variables measured: (1) first passage of flatus; (2) first bowel movement; (3) return of hunger; and (4) ability to tolerate solid food for one meal. Postoperative gum chewing was not found to be more effective than standard postoperative care or our attention-control intervention in reducing the duration of postoperative ileus symptoms, length of stay, or complications among patients following open/laparoscopic sigmoid colectomy.

An intervention that reduces stress in people who combine work with informal care: randomized controlled trial results.

PubMed

Boezeman, Edwin J; Nieuwenhuijsen, Karen; Sluiter, Judith K

2018-06-01

The aim of the research was to examine whether a role-focused self-help course intervention would decrease caregiver stress and distress, and functioning problems, among people who suffer stress because they combine paid work with informal care. A pre-registered (NTR 5528) randomized controlled design was applied (intervention vs. wait list control). Participants (n = 128) were people who had paid work and were suffering stress due to their involvement in informal care activities. Participants allocated to the intervention group (n = 65) received the role-focused self-help course. Control group members (n = 63) received this intervention after all measurements. Prior to the random allocation (pre-test), and 1 month (post-test 1) and 2 months (post-test 2) after allocation, all participants completed a questionnaire that measured their caregiver stress (primary outcome), distress, work functioning, negative care-to-work interference and negative care-to-social and personal life interference. Mixed model ANOVAs were used to test the effectiveness of the intervention. Two months after allocation, the intervention group participants had lower levels of caregiver stress and distress compared with the control group participants. The intervention did not directly resolve impaired work functioning or interference of care with work and social/personal life. The intervention decreases caregiver stress and distress in people who suffer stress because they combine paid work with informal caring. The intervention (Dutch version) can be downloaded at no cost from www.amc.nl/mantelzorgstress.

Population-Level Cost-Effectiveness of Implementing Evidence-Based Practices into Routine Care

PubMed Central

Fortney, John C; Pyne, Jeffrey M; Burgess, James F

2014-01-01

Objective The objective of this research was to apply a new methodology (population-level cost-effectiveness analysis) to determine the value of implementing an evidence-based practice in routine care. Data Sources/Study Setting Data are from sequentially conducted studies: a randomized controlled trial and an implementation trial of collaborative care for depression. Both trials were conducted in the same practice setting and population (primary care patients prescribed antidepressants). Study Design The study combined results from a randomized controlled trial and a pre-post-quasi-experimental implementation trial. Data Collection/Extraction Methods The randomized controlled trial collected quality-adjusted life years (QALYs) from survey and medication possession ratios (MPRs) from administrative data. The implementation trial collected MPRs and intervention costs from administrative data and implementation costs from survey. Principal Findings In the randomized controlled trial, MPRs were significantly correlated with QALYs (p = .03). In the implementation trial, patients at implementation sites had significantly higher MPRs (p = .01) than patients at control sites, and by extrapolation higher QALYs (0.00188). Total costs (implementation, intervention) were nonsignificantly higher ($63.76) at implementation sites. The incremental population-level cost-effectiveness ratio was $33,905.92/QALY (bootstrap interquartile range −$45,343.10/QALY to $99,260.90/QALY). Conclusions The methodology was feasible to operationalize and gave reasonable estimates of implementation value. PMID:25328029

The Effect of Self-Care Education on Emotional Intelligence and HbA1c level in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial.

PubMed

Tavakol Moghadam, Salma; Najafi, Seyed Saeed; Yektatalab, Shahrzad

2018-01-01

The role of Emotional Intelligence (EI) in glycemic control in type 2 Diabetes Mellitus (DM) has not been fully understood. The present study aimed to investigate the effect of self-care education on EI and hemoglobin glycosylated (HbA1c) in patients with type 2 diabetes. In this randomized controlled clinical trial, 48 patients with type 2 DM referred to Shahid Motahari Diabetes Center in 2015 were divided into an intervention and a control group using block randomization. The study data were collected using Bar-On questionnaire and blood testing immediately and two months after the intervention. The educational content was presented to the intervention group through 1-1:30-hour sessions held once a week for 8 continuous weeks. The control group, however, only received the clinic's routine cares. The results showed a significant difference in the mean level of HbA1c in the intervention group before and two months after the intervention (P=0.003). However, this difference was not significant in the control group. Moreover, the mean of EI was higher in the intervention group compared to the control group (P=0.08). Self-care education improved the HbA1c level and EI among the patients with type 2 DM. Therefore, it is recommended that health care providers, specially nurses, should train the diabetic patients for self-care, which can lead to better glycemic control. Trial Registration Number: IRCT201408188505N7.

The Effect of Self-Care Education on Emotional Intelligence and HbA1c level in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial

PubMed Central

Tavakol Moghadam, Salma; Najafi, Seyed Saeed; Yektatalab, Shahrzad

2018-01-01

ABSTRACT Background: The role of Emotional Intelligence (EI) in glycemic control in type 2 Diabetes Mellitus (DM) has not been fully understood. The present study aimed to investigate the effect of self-care education on EI and hemoglobin glycosylated (HbA1c) in patients with type 2 diabetes. Methods: In this randomized controlled clinical trial, 48 patients with type 2 DM referred to Shahid Motahari Diabetes Center in 2015 were divided into an intervention and a control group using block randomization. The study data were collected using Bar-On questionnaire and blood testing immediately and two months after the intervention. The educational content was presented to the intervention group through 1-1:30-hour sessions held once a week for 8 continuous weeks. The control group, however, only received the clinic’s routine cares. Results: The results showed a significant difference in the mean level of HbA1c in the intervention group before and two months after the intervention (P=0.003). However, this difference was not significant in the control group. Moreover, the mean of EI was higher in the intervention group compared to the control group (P=0.08). Conclusion: Self-care education improved the HbA1c level and EI among the patients with type 2 DM. Therefore, it is recommended that health care providers, specially nurses, should train the diabetic patients for self-care, which can lead to better glycemic control. Trial Registration Number: IRCT201408188505N7 PMID:29344534

A Randomized Controlled Trial of an Activity Specific Exercise Program for Individuals With Alzheimer Disease in Long-term Care Settings

PubMed Central

Roach, Kathryn E.; Tappen, Ruth M.; Kirk-Sanchez, Neva; Williams, Christine L.; Loewenstein, David

2011-01-01

Objective To determine whether an activity specific exercise program could improve ability to perform basic mobility activities in long-term care residents with Alzheimer disease (AD). Design Randomized, controlled, single-blinded clinical trial. Setting Residents of 7 long-term care facilities. Participants Eighty-two long-term care residents with mild to severe AD. Intervention An activity specific exercise program was compared to a walking program and to an attention control. Measurements Ability to perform bed mobility and transfers were assessed using the subscales of the Acute Care Index of Function; functional mobility was measured using the 6-Minute Walk test. Results Subjects receiving the activity specific exercise program improved in ability to perform transfers, whereas subjects in the other 2 groups declined. PMID:21937893

Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery.

PubMed

Adamina, Michel; Kehlet, Henrik; Tomlinson, George A; Senagore, Anthony J; Delaney, Conor P

2011-06-01

Health care systems provide care to increasingly complex and elderly patients. Colorectal surgery is a prime example, with high volumes of major procedures, significant morbidity, prolonged hospital stays, and unplanned readmissions. This situation is exacerbated by an exponential rise in costs that threatens the stability of health care systems. Enhanced recovery pathways (ERP) have been proposed as a means to reduce morbidity and improve effectiveness of care. We have reviewed the evidence supporting the implementation of ERP in clinical practice. Medline, Embase, and the Cochrane library were searched for randomized, controlled trials comparing ERP with traditional care in colorectal surgery. Systematic reviews and papers on ERP based on data published in major surgical and anesthesiology journals were critically reviewed by international contributors, experienced in the development and implementation of ERP. A random-effect Bayesian meta-analysis was performed, including 6 randomized, controlled trials totalizing 452 patients. For patients adhering to ERP, length of stay decreased by 2.5 days (95% credible interval [CrI] -3.92 to -1.11), whereas 30-day morbidity was halved (relative risk, 0.52; 95% CrI, 0.36-0.73) and readmission was not increased (relative risk, 0.59; 95% CrI, 0.14-1.43) when compared with patients undergoing traditional care. Adherence to ERP achieves a reproducible improvement in the quality of care by enabling standardization of health care processes. Thus, while accelerating recovery and safely reducing hospital stay, ERPs optimize utilization of health care resources. ERPs can and should be routinely used in care after colorectal and other major gastrointestinal procedures. Copyright © 2011 Mosby, Inc. All rights reserved.

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.

A randomized controlled study to evaluate the effect of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among type 2 diabetes patients: A consort compliant study protocol.

PubMed

Bukhsh, Allah; Nawaz, Muhammad Sarfraz; Ahmed, Hafiz Sajjad; Khan, Tahir Mehmood

2018-03-01

Diabetes self-care activities, like, healthy diet, regular exercise, self-monitoring of blood glucose, and rational use of medicines are considered to play a vital role in establishing euglycemia. Health literacy among type 2 diabetes mellitus (T2DM) patients in Pakistan is very low, which is the most likely cause for poor clinical outcomes. This study is designed to investigate the impact of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among T2DM patients in Pakistan. In this randomized controlled trail, effectiveness of a 6-month pharmacist-led educational intervention will be examined on glycemic control, diabetes self-care activities and disease knowledge of 80 adult T2DM patients (age >30 years) with poorly controlled T2DM (HbA1c> 7%), after randomizing them into intervention and control groups, at diabetes care clinic of Capital Hospital Islamabad, Pakistan. The primary outcome is change in patients' HbA1c, whereas, changes in self-care activities and patients' disease knowledge are the secondary outcomes. After baseline assessment of their self-care activities and disease knowledge by using validated Urdu versions of Diabetes Self-management Questionnaire (DSMQ) and Diabetes Knowledge Questionnaire (DKQ), respectively, interventional group patients will be supplemented with a face-to-face pharmacist-led educational intervention, whereas, the control group will receive usual care. Intervention arm patients will be educated successively at their first follow-up visit (12th week) and telephonically after every 4 weeks. All assessments will be made at baseline and end of trail for both intervention and control groups. Multivariate general linear model will be applied to analyze the effects of the intervention. Glycemic control in T2DM patients requires optimum self-care activities. This study is an attempt to improve self-care behaviors among poorly controlled T2DM patients who are at higher risk of diabetes-associated late complications.

Effects of Massage in Reducing the Pain and Anxiety of the Cardiac Surgery Critically Ill-a Randomized Controlled Trial.

PubMed

Boitor, Madalina; Martorella, Géraldine; Maheu, Christine; Laizner, Andréa Maria; Gélinas, Céline

2018-03-30

To evaluate the effectiveness of hand massage on the pain and anxiety of the cardiac surgery critically ill. A three-arm randomized controlled trial. This study was conducted in a medical-surgical intensive care unit in Canada. Adult patients who underwent elective cardiac surgery, who were able to speak French/English and to self-report symptoms, without a high risk of postoperative complications were eligible. Patients were randomly allocated to standard care plus either two 20-minute hand massages (experimental), two 20-minute hand holdings (active control), or two 20-minute rest periods (passive control/standard care). Pain intensity, pain unpleasantness, anxiety, muscle tension, and vital signs were evaluated before, after, and 30 minutes later for each intervention. From the 83 patients recruited, 60 were randomized (20 massage, 19 hand holding, 21 standard care). After controlling for baseline scores, the massage group reported significantly lower pain intensity, pain unpleasantness, and anxiety for the first data collection set compared with both hand holding and standard care (analysis of covariance, P < 0.02), with an average decrease of two points on a 0-10 scale. No statistically significant differences were noted between hand holding and standard care for any of the symptoms. Similar results were observed for the second data collection set (N = 43). Patients had decreased muscle tension post massage. Vital signs did not differ significantly between groups. Findings suggest that a 20-minute hand massage in addition to routine postoperative pain management can concomitantly reduce pain intensity, pain unpleasantness, and anxiety by two points on average on a 0-10 scale.

A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control.

PubMed

Carter, Barry L; Clarke, William; Ardery, Gail; Weber, Cynthia A; James, Paul A; Vander Weg, Mark; Chrischilles, Elizabeth A; Vaughn, Thomas; Egan, Brent M

2010-07-01

Numerous studies have demonstrated the value of team-based care to improve blood pressure (BP) control, but there is limited information on whether these models would be adopted in diverse populations. The purpose of this study was to evaluate whether a collaborative model between physicians and pharmacists can improve BP control in multiple primary care medical offices with diverse geographic and patient characteristics and whether long-term BP control can be sustained. This study is a randomized prospective trial in 27 primary care offices first stratified by the percentage of underrepresented minorities and the level of clinical pharmacy services within the office. Each office is then randomized to either a 9- or 24-month intervention or a control group. Patients will be enrolled in this study until 2012. The results of this study should provide information on whether this model can be implemented in large numbers of diverse offices, if it is effective in diverse populations, and whether BP control can be sustained long term. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00935077.

Patient navigation and financial incentives to promote smoking cessation in an underserved primary care population: A randomized controlled trial protocol.

PubMed

Quintiliani, Lisa M; Russinova, Zlatka L; Bloch, Philippe P; Truong, Ve; Xuan, Ziming; Pbert, Lori; Lasser, Karen E

2015-11-01

Despite the high risk of tobacco-related morbidity and mortality among low-income persons, few studies have connected low-income smokers to evidence-based treatments. We will examine a smoking cessation intervention integrated into primary care. To begin, we completed qualitative formative research to refine an intervention utilizing the services of a patient navigator trained to promote smoking cessation. Next, we will conduct a randomized controlled trial combining two interventions: patient navigation and financial incentives. The goal of the intervention is to promote smoking cessation among patients who receive primary care in a large urban safety-net hospital. Our intervention will encourage patients to utilize existing smoking cessation resources (e.g., quit lines, smoking cessation groups, discussing smoking cessation with their primary care providers). To test our intervention, we will conduct a randomized controlled trial, randomizing 352 patients to the intervention condition (patient navigation and financial incentives) or an enhanced traditional care control condition. We will perform follow-up at 6, 12, and 18 months following the start of the intervention. Evaluation of the intervention will target several implementation variables: reach (participation rate and representativeness), effectiveness (smoking cessation at 12 months [primary outcome]), unintended consequences (e.g., purchase of illicit substances with incentive money), adoption (use of intervention across primary care suites), implementation (delivery of intervention), and maintenance (smoking cessation after conclusion of intervention). Improving the implementation of smoking cessation interventions in primary care settings serving large underserved populations could have substantial public health impact, reducing cancer-related morbidity/mortality and associated health disparities. Copyright © 2015 Elsevier Inc. All rights reserved.

Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial.

PubMed

Khan, Sikandar; Biju, Ashok; Wang, Sophia; Gao, Sujuan; Irfan, Omar; Harrawood, Amanda; Martinez, Stephanie; Brewer, Emily; Perkins, Anthony; Unverzagt, Frederick W; Lasiter, Sue; Zarzaur, Ben; Rahman, Omar; Boustani, Malaz; Khan, Babar

2018-02-07

Patients admitted to intensive care units (ICU) with acute respiratory failure (ARF) face chronic complications that can impede return to normal daily function. A mobile, collaborative critical care model may enhance the recovery of ARF survivors. The Mobile Critical Care Recovery Program (m-CCRP) study is a two arm, randomized clinical trial. We will randomize 620 patients admitted to the ICU with acute respiratory failure requiring mechanical ventilation in a 1:1 ratio to one of two arms (310 patients per arm) - m-CCRP intervention versus attention control. Those in the intervention group will meet with a care coordinator after hospital discharge in predetermined intervals to aid in the recovery process. Baseline assessments and personalized goal setting will be used to develop an individualized care plan for each patient after discussion with an interdisciplinary team. The attention control arm will receive printed material and telephone reminders emphasizing mobility and management of chronic conditions. Duration of the intervention and follow-up is 12 months post-randomization. Our primary aim is to assess the efficacy of m-CCRP in improving the quality of life of ARF survivors at 12 months. Secondary aims of the study are to evaluate the efficacy of m-CCRP in improving function (cognitive, physical, and psychological) of ARF survivors and to determine the efficacy of m-CCRP in reducing acute healthcare utilization. The proposed randomized controlled trial will evaluate the efficacy of a collaborative critical care recovery program in accomplishing the Institute of Healthcare Improvement's triple aims of better health, better care, at lower cost. We have developed a collaborative critical care model to promote ARF survivors' recovery from the physical, psychological, and cognitive impacts of critical illness. In contrast to a single disease focus and clinic-based access, m-CCRP represents a comprehensive, accessible, mobile, ahead of the curve intervention, focused on the multiple aspects of the unique recovery needs of ARF survivors. NCT03053245 , clinicaltrials.gov, registered February 1, 2017.

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.

The Effects of Intrapartum Supportive Care on Fear of Delivery and Labor Outcomes: A Single-Blind Randomized Controlled Trial.

PubMed

İsbir, Gözde Gökçe; Serçekuş, Pinar

2017-04-01

Supportive care during labor, the primary role of intrapartum nurses and midwives, provides comfort to prepartum women and helps facilitate a positive labor experience. It has been argued that supportive care during labor reduces fear and anxiety as well as the resultant side effects. However, evidence supporting this argument is insufficient. The aim of this study was to assess the effects of intrapartum supportive care on fear of delivery and on the key parameters of the labor process. This study used a single-blind randomized controlled trial approach. Randomized block assignment was used to assign 72 participants to either the intervention group (n = 36) or the control group (n = 36). Three women in the intervention group and six in the control group were later excluded from the study because they received emergency cesarean delivery. The intervention group received continuous supportive care, and the control group received routine hospital care. No significant differences were identified between the two groups at baseline. The intervention group reported less fear of delivery during the active and transient phases of labor, higher perceived support and control during delivery, lower pain scores during the transient phase of labor, and a shorter delivery period than the control group (p < .05). However, no significant difference in the use of oxytocin during delivery between the two groups was reported. The results of this evidence-based study suggest that continuous support during labor has clinically meaningful benefits for women and that all women should receive this support throughout their labor and delivery process.

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.

Collaborative Care for Adolescents With Persistent Postconcussive Symptoms: A Randomized Trial

PubMed Central

Zatzick, Douglas; Stein, Elizabeth; Wang, Jin; Hilt, Robert; Rivara, Frederick P.

2016-01-01

BACKGROUND AND OBJECTIVES: Postconcussive and co-occurring psychological symptoms are not uncommon after sports-related concussion and are associated with functional impairment and societal costs. There is no evidence-based treatment targeting postconcussive symptoms in children and adolescents. The goal of this study was to test a collaborative care intervention model with embedded cognitive–behavioral therapy, care management, and psychopharmacological consultation. We hypothesized that patients in collaborative care would demonstrate greater reductions in postconcussive, depressive, and anxiety symptoms and improvement in functioning over the course of 6 months, compared with usual care control. METHODS: Patients aged 11 to 17 years with persistent symptoms ≥1 month after sports-related concussion were randomly assigned to receive collaborative care (n = 25) or care as usual (n = 24). Patients were assessed before randomization and after 1, 3, and 6 months. Groups were compared over time via linear mixed effects regression models. RESULTS: Adolescents assigned to collaborative care experienced clinically and statistically significant improvements in postconcussive symptoms in addition to functional gains at 6 months compared with controls. Six months after the baseline assessment, 13.0% of intervention patients and 41.7% of control patients reported high levels of postconcussive symptoms (P = .03), and 78% of intervention patients and 45.8% of control patients reported ≥50% reduction in depression symptoms (P = .02). No changes between groups were demonstrated in anxiety symptoms. CONCLUSIONS: Orchestrated efforts to systematically implement collaborative care treatment approaches for slow-to-recover adolescents may be useful given the reductions in postconcussive and co-occurring psychological symptoms in addition to improved quality of life. PMID:27624513

Electronic communications and home blood pressure monitoring (e-BP) study: design, delivery, and evaluation framework.

PubMed

Green, Beverly B; Ralston, James D; Fishman, Paul A; Catz, Sheryl L; Cook, Andrea; Carlson, Jim; Tyll, Lynda; Carrell, David; Thompson, Robert S

2008-05-01

Randomized controlled trials have provided unequivocal evidence that treatment of hypertension decreases mortality and major disability from cardiovascular disease; however, blood pressure remains inadequately treated in most affected individuals. This large gap continues despite the facts that more than 90% of adults with hypertension have health insurance, and hypertension is the leading cause of visits to the doctor. New approaches are needed to improve hypertension care. The Electronic Communications and Home Blood Pressure Monitoring (e-BP) study is a three-arm randomized controlled trial designed to determine whether care based on the Chronic Care Model and delivered over the Internet improves hypertension care. The primary study outcomes are systolic, diastolic, and blood pressure control; secondary outcomes are medication adherence, patient self-efficacy, satisfaction and quality of life, and healthcare utilization and costs. Hypertensive patients receiving care at Group Health medical centers are eligible if they have uncontrolled blood pressure on two screening visits and access to the Web and an e-mail address. Study participants are randomly assigned to three intervention groups: (a) usual care; (b) home blood pressure monitoring receipt and proficiency training on its use and the Group Health secure patient website (with secure e-mail access to their healthcare provider, access to a shared medical record, prescription refill and other services); or (c) this plus pharmacist care management (collaborative care management between the patient, the pharmacist, and the patient's physician via a secure patient website and the electronic medical record). We will determine whether a new model of patient-centered care that leverages Web communications, self-monitoring, and collaborative care management improves hypertension control. If this model proves successful and cost-effective, similar interventions could be used to improve the care of large numbers of patients with uncontrolled hypertension.

Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial.

PubMed

Green, Beverly B; Cook, Andrea J; Ralston, James D; Fishman, Paul A; Catz, Sheryl L; Carlson, James; Carrell, David; Tyll, Lynda; Larson, Eric B; Thompson, Robert S

2008-06-25

Treating hypertension decreases mortality and disability from cardiovascular disease, but most hypertension remains inadequately controlled. To determine if a new model of care that uses patient Web services, home blood pressure (BP) monitoring, and pharmacist-assisted care improves BP control. A 3-group randomized controlled trial, the Electronic Communications and Home Blood Pressure Monitoring study was based on the Chronic Care Model. The trial was conducted at an integrated group practice in Washington state, enrolling 778 participants aged 25 to 75 years with uncontrolled essential hypertension and Internet access. Care was delivered over a secure patient Web site from June 2005 to December 2007. Participants were randomly assigned to usual care, home BP monitoring and secure patient Web site training only, or home BP monitoring and secure patient Web site training plus pharmacist care management delivered through Web communications. Percentage of patients with controlled BP (<140/90 mm Hg) and changes in systolic and diastolic BP at 12 months. Of 778 patients, 730 (94%) completed the 1-year follow-up visit. Patients assigned to the home BP monitoring and Web training only group had a nonsignificant increase in the percentage of patients with controlled BP (<140/90 mm Hg) compared with usual care (36% [95% confidence interval {CI}, 30%-42%] vs 31% [95% CI, 25%-37%]; P = .21). Adding Web-based pharmacist care to home BP monitoring and Web training significantly increased the percentage of patients with controlled BP (56%; 95% CI, 49%-62%) compared with usual care (P < .001) and home BP monitoring and Web training only (P < .001). Systolic BP was decreased stepwise from usual care to home BP monitoring and Web training only to home BP monitoring and Web training plus pharmacist care. Diastolic BP was decreased only in the pharmacist care group compared with both the usual care and home BP monitoring and Web training only groups. Compared with usual care, the patients who had baseline systolic BP of 160 mm Hg or higher and received home BP monitoring and Web training plus pharmacist care had a greater net reduction in systolic BP (-13.2 mm Hg [95% CI, -19.2 to -7.1]; P < .001) and diastolic BP (-4.6 mm Hg [95% CI, -8.0 to -1.2]; P < .001), and improved BP control (relative risk, 3.32 [95% CI, 1.86 to 5.94]; P<.001). Pharmacist care management delivered through secure patient Web communications improved BP control in patients with hypertension. Trial Registration clinicaltrials.gov Identifier: NCT00158639.

Medical yoga for patients with stress-related symptoms and diagnoses in primary health care: a randomized controlled trial.

PubMed

Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

2013-01-01

An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care.

Medical Yoga for Patients with Stress-Related Symptoms and Diagnoses in Primary Health Care: A Randomized Controlled Trial

PubMed Central

Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

2013-01-01

An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care. PMID:23533465

Should we educate care staff to improve the oral health and oral hygiene of people with intellectual disability in residential care? Real world lessons from a randomized controlled trial.

PubMed

Mac Giolla Phadraig, Caoimhin; Guerin, Suzanne; Nunn, June

2015-01-01

This study assessed the impact of a multitiered oral health educational program on the oral health and oral hygiene of people with intellectual disabilities (ID). In a controlled pretest, posttest trial, with cluster randomization, a pyramidal training program was delivered to residential staff who cared for a randomly allocated, purposively stratified intervention group of people with ID living in community care homes. A control group lived in centers where staff received no training. Clinical measures were carried out pre- and posttest. Difference in Modified Gingival Index (MGI) and Plaque Index (PI) was measured posttest using ANCOVA. Seventy-six participants took part, representing 49.0% of the invited sample (n = 155). Fourteen did not receive clinical examination. There was one dropout 6-9 months later. A 10.5% and 8.5% reduction in mean MGI and PI was evident at posttest but did not show statistically significant difference, when controlling for baseline covariates (p > 0.05, ANCOVA). Mean MGI and PI scores were not significantly different among people with ID whose care staff had and had not received oral health training. Limitations are discussed. The results indicate that this program failed to significantly improve oral health or oral hygiene, despite the intervention being "educationally" successful. More research is needed. © 2015 Special Care Dentistry Association and Wiley Periodicals, Inc.

Inspection of care: Findings from an innovative demonstration

PubMed Central

Morris, John N.; Sherwood, Clarence C.; Dreyer, Paul

1989-01-01

In this article, information is presented concerning the efficacy of a sample-based approach to completing inspection of care reviews of Medicaid-supported nursing home residents. Massachusetts nursing homes were randomly assigned to full (the control group) or sample (the experimental group) review conditions. The primary research focus was to determine whether the proportion of facilities found to be deficient (based on quality of care and level of care criteria) in the experimental sample was comparable to the proportion in the control sample. The findings supported such a hypothesis: Deficient facilities appear to be equally identifiable using the random or full-sampling protocols, and the process can be completed with a considerable savings of surveyor time. PMID:10313458

The cues and care randomized controlled trial of a neonatal intensive care unit intervention: effects on maternal psychological distress and mother-infant interaction.

PubMed

Zelkowitz, Phyllis; Feeley, Nancy; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

2011-10-01

This study tested the efficacy of a brief intervention (Cues program) with mothers of very low birth weight (VLBW <1500 g) infants. The primary hypothesis was that mothers in the Cues program would report lower levels of anxiety compared with mothers in the control group. Secondary hypotheses examined whether Cues mothers would report less stress, depression, and role restriction, and exhibit more sensitive interactive behavior, than control group mothers. A total of 121 mothers of VLBW infants were randomly assigned to either the experimental (Cues) intervention or an attention control (Care) condition. The Cues program combined training to reduce anxiety and enhance sensitivity. The control group received general information about infant care. Both programs were initiated during the neonatal intensive care unit stay. Maternal anxiety, stress, depression, and demographic variables were evaluated at baseline, prior to randomization. Postintervention outcomes were assessed during a home visit when the infant was ∼6 to 8 weeks of corrected age. Although mothers in the Cues group demonstrated greater knowledge of the content of the experimental intervention than mothers in the Care group, the groups did not differ in levels of anxiety, depression, and symptoms of posttraumatic stress. They were similar in their reports of parental role restrictions and stress related to the infant's appearance and behavior. Cues and Care group mothers were equally sensitive in interaction with their infants. Nonspecific attention was as effective as an early skill-based intervention in reducing maternal anxiety and enhancing sensitive behavior in mothers of VLBW infants.

TakeCARE, a Video Bystander Program to Help Prevent Sexual Violence on College Campuses: Results of Two Randomized, Controlled Trials

PubMed Central

Jouriles, Ernest N.; McDonald, Renee; Rosenfield, David; Levy, Nicole; Sargent, Kelli; Caiozzo, Christina; Grych, John H.

2015-01-01

Objective The present research reports on two randomized controlled trials evaluating TakeCARE, a video bystander program designed to help prevent sexual violence on college campuses. Method In Study 1, students were recruited from psychology courses at two universities. In Study 2, first-year students were recruited from a required course at one university. In both studies, students were randomly assigned to view one of two videos: TakeCARE or a control video on study skills. Just before viewing the videos, students completed measures of bystander behavior toward friends and ratings of self-efficacy for performing such behaviors. The efficacy measure was administered again after the video, and both the bystander behavior measure and the efficacy measure were administered at either one (Study 1) or two (Study 2) months later. Results In both studies, students who viewed TakeCARE, compared to students who viewed the control video, reported engaging in more bystander behavior toward friends and greater feelings of efficacy for performing such behavior. In Study 1, feelings of efficacy mediated effects of TakeCARE on bystander behavior; this result did not emerge in Study 2. Conclusions This research demonstrates that TakeCARE, a video bystander program, can positively influence bystander behavior toward friends. Given its potential to be easily distributed to an entire campus community, TakeCARE might be an effective addition to campus efforts to prevent sexual violence. PMID:27867694

Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

PubMed

Silverman, Michael J

2013-10-01

Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided. © 2013.

Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial.

PubMed

Ma, Jun; Yank, Veronica; Lv, Nan; Goldhaber-Fiebert, Jeremy D; Lewis, Megan A; Kramer, M Kaye; Snowden, Mark B; Rosas, Lisa G; Xiao, Lan; Blonstein, Andrea C

2015-07-01

Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n = 404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system's services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance(™)). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE's cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated-through a new model of accessible and integrative lifestyle medicine and mental health expertise-in primary care. Copyright © 2015 Elsevier Inc. All rights reserved.

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…

Improving Diabetes Care and Health Measures among Hispanics Using Community Health Workers: Results from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Babamoto, Kenneth S.; Sey, Kwa A.; Camilleri, Angela J.; Karlan, Vicki J.; Catalasan, Joana; Morisky, Donald E.

2009-01-01

The increasing prevalence of diabetes and obesity, growing health disparities, and shortage of bilingual and culturally trained health care professionals underscore the role of trained community health workers (CHWs) to provide economically sustainable and culturally relevant services. This prospective randomized design evaluated the relative…

Impact of oral care with versus without toothbrushing on the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis of randomized controlled trials

PubMed Central

2012-01-01

Introduction Ventilator-associated pneumonia (VAP) remains a common hazardous complication in mechanically ventilated patients and is associated with increased morbidity and mortality. We undertook a systematic review and meta-analysis of randomized controlled trials to assess the effect of toothbrushing as a component of oral care on the prevention of VAP in adult critically ill patients. Methods A systematic literature search of PubMed and Embase (up to April 2012) was conducted. Eligible studies were randomized controlled trials of mechanically ventilated adult patients receiving oral care with toothbrushing. Relative risks (RRs), weighted mean differences (WMDs), and 95% confidence intervals (CIs) were calculated and heterogeneity was assessed with the I2 test. Results Four studies with a total of 828 patients met the inclusion criteria. Toothbrushing did not significantly reduce the incidence of VAP (RR, 0.77; 95% CI, 0.50 to 1.21) and intensive care unit mortality (RR, 0.88; 95% CI, 0.70 to 1.10). Toothbrushing was not associated with a statistically significant reduction in duration of mechanical ventilation (WMD, -0.88 days; 95% CI, -2.58 to 0.82), length of intensive care unit stay (WMD, -1.48 days; 95% CI, -3.40 to 0.45), antibiotic-free day (WMD, -0.52 days; 95% CI, -2.82 to 1.79), or mechanical ventilation-free day (WMD, -0.43 days; 95% CI, -1.23 to 0.36). Conclusions Oral care with toothbrushing versus without toothbrushing does not significantly reduce the incidence of VAP and alter other important clinical outcomes in mechanically ventilated patients. However, the results should be interpreted cautiously since relevant evidence is still limited, although accumulating. Further large-scale, well-designed randomized controlled trials are urgently needed. PMID:23062250

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial.

PubMed

Malhotra, Chetna; Sim, David Kheng Leng; Jaufeerally, Fazlur; Vikas, Nivedita Nadkarni; Sim, Genevieve Wong Cheng; Tan, Boon Cheng; Ng, Clarice Shu Hwa; Tho, Pei Leng; Lim, Jingfen; Chuang, Claire Ya-Ting; Fong, Florence Hui Mei; Liu, Joy; Finkelstein, Eric A

2016-06-10

Despite the promise and popularity of advance care planning, there is insufficient evidence that advance care planning helps patients to meet their end-of-life care preferences, especially in Asian settings. Thus, the proposed study aims to assess whether patients with advanced heart failure who are receiving advance care planning have a greater likelihood of receiving end-of-life care consistent with their preferences compared to patients receiving usual care. Secondary objectives are to compare differences in health care expenditures, quality of life, anxiety and depression, understanding of own illness, participation in decision-making and concordance with their caregiver's preferences for end-of-life care, between patients with advanced heart failure receiving advance care planning and usual care. This is a two-arm randomized controlled trial of advance care planning versus usual care (control) conducted at two institutions in Singapore. Two hundred and eighty-two patients with advanced heart failure (n = 94 in the advance care planning arm; n = 188 in the control arm receiving usual care) will be recruited from these centers and followed for 1 year or until they die, whichever is earlier. Additionally, the study will include up to one caregiver per patient enrolled. If advance care planning is proven to be effective, the results will help to promote its uptake among health care providers and patients both within Singapore and in other countries. NCT02299180 . Registered on 18 November 2014.

Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

ERIC Educational Resources Information Center

Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

2012-01-01

The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

The effectiveness of wet-cupping for nonspecific low back pain in Iran: a randomized controlled trial.

PubMed

Farhadi, Khosro; Schwebel, David C; Saeb, Morteza; Choubsaz, Mansour; Mohammadi, Reza; Ahmadi, Alireza

2009-01-01

To determine the efficacy of wet-cupping for treating persistent nonspecific low back pain. Wet-cupping therapy is one of the oldest known medical techniques. It is still used in several contemporary societies. Very minimal empirical study has been conducted on its efficacy. Randomized controlled trial with two parallel groups. Patients in the experimental group were offered the option of referral to the wet-cupping service; all accepted that option. The control group received usual care. Medical clinic in Kermanshah, Iran. In total, 98 patients aged 17-68 years with nonspecific low back pain; 48 were randomly assigned to experimental group and 50 to the control group. Patients in the experimental group were prescribed a series of three staged wet-cupping treatments, placed at 3 days intervals (i.e., 0, 3, and 6 days). Patients in the control group received usual care from their general practitioner. Three outcomes assessed at baseline and again 3 months following intervention: the McGill Present Pain Index, Oswestry Pain Disability Index, and the Medication Quantification Scale. Wet-cupping care was associated with clinically significant improvement at 3-month follow-up. The experimental group who received wet-cupping care had significantly lower levels of pain intensity ([95% confidence interval (CI) 1.72-2.60] mean difference=2.17, p<0.01), pain-related disability (95% CI=11.18-18.82, means difference=14.99, p<0.01), and medication use (95% CI=3.60-9.50, mean difference=6.55, p<0.01) than the control group. The differences in all three measures were maintained after controlling for age, gender, and duration of lower back pain in regression models (p<0.01). Traditional wet-cupping care delivered in a primary care setting was safe and acceptable to patients with nonspecific low back pain. Wet-cupping care was significantly more effective in reducing bodily pain than usual care at 3-month follow-up.

A Pilot Randomized Controlled Trial of a Holistic Needs Assessment Questionnaire in a Supportive and Palliative Care Service.

PubMed

Ahmed, Nisar; Hughes, Philippa; Winslow, Michelle; Bath, Peter A; Collins, Karen; Noble, Bill

2015-11-01

At present, there is no widely used systematic evidence-based holistic approach to assessment of patients' supportive and palliative care needs. To determine whether the use of a holistic needs assessment questionnaire, Sheffield Profile for Assessment and Referral for Care (SPARC), will lead to improved health care outcomes for patients referred to a palliative care service. This was an open, pragmatic, randomized controlled trial. Patients (n = 182) referred to the palliative care service were randomized to receive SPARC at baseline (n = 87) or after a period of two weeks (waiting-list control n = 95). Primary outcome measure is the difference in score between Measure Yourself Concerns and Wellbeing (MYCAW) patient-nominated Concern 1 on the patient self-scoring visual analogue scale at baseline and the two-week follow-up. Secondary outcomes include difference in scores in the MYCAW, EuroQoL (EQ-5D), and Patient Enablement Instrument (PEI) scores at Weeks 2, 4, and 6. There was a significant association between change in MYCAW score and whether the patients were in the intervention or control group (χ(2)trend = 5.51; degrees of freedom = 1; P = 0.019). A higher proportion of patients in the control group had an improvement in MYCAW score from baseline to Week 2: control (34 of 70 [48.6%]) vs. intervention (19 of 66 [28.8%]). There were no significant differences (no detectable effect) between the control and intervention groups in the scores for EQ-5D and Patient Enablement Instrument at 2-, 4-, or 6-week follow-up. This trial result identifies a potential negative effect of SPARC in specialist palliative care services, raising questions that standardized holistic needs assessment questionnaires may be counterproductive if not integrated with a clinical assessment that informs the care plan. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

A focus group study to understand biases and confounders in a cluster randomized controlled trial on low back pain in primary care in Norway.

PubMed

Werner, Erik L; Løchting, Ida; Storheim, Kjersti; Grotle, Margreth

2018-05-22

Cluster randomized controlled trials are often used in research in primary care but creates challenges regarding biases and confounders. We recently presented a study on low back pain from primary care in Norway with equal effects in the intervention and the control group. In order to understand the specific mechanisms that may produce biases in a cluster randomized trial we conducted a focus group study among the participating health care providers. The aim of this study was to understand how the participating providers themselves influenced on the study and thereby possibly on the results of the cluster randomized controlled trial. The providers were invited to share their experiences from their participation in the COPE study, from recruitment of patients to accomplishment of either the intervention or control consultations. Six clinicians from the intervention group and four from the control group took part in the focus group interviews. The group discussions focused on feasibility of the study in primary care and particularly on identifying potential biases and confounders in the study. The audio-recorded interviews were transcribed verbatim and analyzed according to a systematic text condensation. The themes for the analysis emerged from the group discussions. A personal interest for back pain, logistic factors at the clinics and an assessment of the patients' capacity to accomplish the study prior to their recruitment was reported. The providers were allowed to provide additional therapy to the intervention and it turned out that some of these could be regarded as opposed to the messages of the intervention. The providers seemed to select different items from the educational package according to personal beliefs and their perception of the patients' acceptance. The study disclosed several potential biases to the COPE study which may have impacted on the study results. Awareness of these is highly important when planning and conducting a cluster randomized controlled trial. Procedures in the recruitment of both providers and patients seem to be key factors and the providers should be aware of their role in a scientific study in order to standardize the provision of the intervention.

Effects on readiness to change of an educational intervention on depressive disorders for general physicians in primary care based on a modified Prochaska model--a randomized controlled study.

PubMed

Shirazi, M; Zeinaloo, A A; Parikh, S V; Sadeghi, M; Taghva, A; Arbabi, M; Kashani, A Sabouri; Alaeddini, F; Lonka, K; Wahlström, R

2008-04-01

The Prochaska model of readiness to change has been proposed to be used in educational interventions to improve medical care. To evaluate the impact on readiness to change of an educational intervention on management of depressive disorders based on a modified version of the Prochaska model in comparison with a standard programme of continuing medical education (CME). This is a randomized controlled trial within primary care practices in southern Tehran, Iran. The participants included 192 general physicians working in primary care (GPs) were recruited after random selection and randomized to intervention (96) and control (96). Intervention consisted of interactive, learner-centred educational methods in large and small group settings depending on the GPs' stages of readiness to change. Change in stage of readiness to change measured by the modified version of the Prochaska questionnaire was the The final number of participants was 78 (81%) in the intervention arm and 81 (84%) in the control arm. Significantly (P < 0.01), more GPs (57/96 = 59% versus 12/96 = 12%) in the intervention group changed to higher stages of readiness to change. The intervention effect was 46% points (P < 0.001) and 50% points (P < 0.001) in the large and small group setting, respectively. Educational formats that suit different stages of learning can support primary care doctors to reach higher stages of behavioural change in the topic of depressive disorders. Our findings have practical implications for conducting CME programmes in Iran and are possibly also applicable in other parts of the world.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

PubMed

Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

The prompted optional randomization trial: a new design for comparative effectiveness research.

PubMed

Flory, James; Karlawish, Jason

2012-12-01

Randomized controlled trials are the gold standard for medical evidence because randomization provides the best-known protection against confounding of results. Randomization has practical and ethical problems that limit the number of trials that can be conducted, however. A different method for collecting clinical data retains the statistically useful properties of randomization without incurring its practical and ethical challenges. A computerized prompt introduces a random element into clinical decision-making that can be instantly overridden if it conflicts with optimal patient care. This creates a weak form of randomization that still eliminates the effect of all confounders, can be carried out without disturbing routine clinical care, and arguably will not require research-grade informed consent.

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.

Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military.

PubMed

Cigrang, Jeffrey A; Rauch, Sheila A; Mintz, Jim; Brundige, Antoinette R; Mitchell, Jennifer A; Najera, Elizabeth; Litz, Brett T; Young-McCaughan, Stacey; Roache, John D; Hembree, Elizabeth A; Goodie, Jeffrey L; Sonnek, Scott M; Peterson, Alan L

2017-12-01

Many military service members with PTSD do not receive evidence-based specialty behavioral health treatment because of perceived barriers and stigma. Behavioral health providers in primary care can deliver brief, effective treatments expanding access and reducing barriers and stigma. The purpose of this randomized clinical trial was to determine if a brief cognitive-behavior therapy delivered in primary care using the Primary Care Behavioral Health model would be effective at reducing PTSD and co-occurring symptoms. A total of 67 service members (50 men, 17 women) were randomized to receive a brief, trauma-focused intervention developed for the primary care setting called Prolonged Exposure for Primary Care (PE-PC) or a delayed treatment minimal contact control condition. Inclusion criteria were significant PTSD symptoms following military deployment, medication stability, and interest in receiving treatment for PTSD symptoms in primary care. Exclusion criteria were moderate or greater risk of suicide, severe brain injury, or alcohol/substance use at a level that required immediate treatment. Assessments were completed at baseline, posttreatment/postminimal contact control, and at 8-week and 6-month posttreatment follow-up points. Primary measures were the PTSD Symptom Scale-Interview and the PTSD Checklist-Stressor-Specific. PE-PC resulted in larger reduction in PTSD severity and general distress than the minimal contact control. Delayed treatment evidenced medium to large effects comparable to the immediate intervention group. Treatment benefits persisted through the 6-month follow-up of the study. PE-PC delivered in integrated primary care is effective for the treatment of PTSD and co-occurring symptoms and may help reduce barriers and stigma found in specialty care settings. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Research Aimed at Improving Both Mood and Weight (RAINBOW) in Primary Care: A Type 1 hybrid design randomized controlled trial

PubMed Central

Ma, Jun; Yank, Veronica; Lv, Nan; Goldhaber-Fiebert, Jeremy D.; Lewis, Megan A.; Kramer, M. Kaye; Snowden, Mark B.; Rosas, Lisa G.; Xiao, Lan; Blonstein, Andrea C.

2015-01-01

Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n=404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system’s services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance™). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE’s cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated—through a new model of accessible and integrative lifestyle medicine and mental health expertise—in primary care. PMID:26096714

The Seamless Transfer-of-Care Protocol: a randomized controlled trial assessing the efficacy of an electronic transfer-of-care communication tool.

PubMed

Okoniewska, Barbara M; Santana, Maria J; Holroyd-Leduc, Jayna; Flemons, Ward; O'Beirne, Maeve; White, Deborah; Clement, Fiona; Forster, Alan; Ghali, William A

2012-11-21

The transition between acute care and community care represents a vulnerable period in health care delivery. The vulnerability of this period has been attributed to changes to patients' medication regimens during hospitalization, failure to reconcile discrepancies between admission and discharge and the burdening of patients/families to take over care responsibilities at discharge and to relay important information to the primary care physician. Electronic communication platforms can provide an immediate link between acute care and community care physicians (and other community providers), designed to ensure consistent information transfer. This study examines whether a transfer-of-care (TOC) communication tool is efficacious and cost-effective for reducing hospital readmission, adverse events and adverse drug events as well as reducing death. A randomized controlled trial conducted on the Medical Teaching Unit of a Canadian tertiary care centre will evaluate the efficacy and cost-effectiveness of a TOC communication tool. Medical in-patients admitted to the unit will be considered for this study. Data will be collected upon admission, and a total of 1400 patients will be randomized. The control group's acute care stay will be summarized using a traditional dictated summary, while the intervention group will have a summary generated using the TOC communication tool. The primary outcome will be a composite, at 3 months, of death or readmission to any Alberta acute-care hospital. Secondary outcomes will be the occurrence of post-discharge adverse events and adverse drug events at 1 month post discharge. Patients with adverse outcomes will have their cases reviewed by two Royal College certified internists or College-certified family physicians, blinded to patients' group assignments, to determine the type, severity, preventability and ameliorability of all detected adverse outcomes. An accompanying economic evaluation will assess the cost per life saved, cost per readmission avoided and cost per QALY gained with the TOC communication tool compared to traditional dictation summaries. This paper outlines the study protocol for a randomized controlled trial evaluating an electronic transfer-of-care communication tool, with sufficient statistical power to assess the impact of the tool on the significant outcomes of post-discharge death or readmission. The study findings will inform health systems around the world on the potential benefits of such tools, and the value for money associated with their widespread implementation. ClinicalTrials.gov NCT01402609.

Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial

PubMed Central

2014-01-01

Background Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs. We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population. We also explored whether reductions in glycated hemoglobin (HbA1c) will be more marked in minority persons. Methods We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5% (≥58 mmol/mol). Participants were randomized to: 1) a Chronic Disease Self-Management Program (CDSMP; n = 101); 2) a diabetes self-care software on a personal digital assistant (PDA; n = 81); 3) a combination of interventions (CDSMP + PDA; n = 99); or 4) usual care (control; n = 95). Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice. The primary outcome was change in HbA1c from randomization to 12 months. Data were analyzed using a multilevel statistical model. Results Average baseline HbA1c in the CDSMP, PDA, CDSMP + PDA, and control arms were 9.4%, 9.3%, 9.2%, and 9.2%, respectively. HbA1c reductions at 12 months for the groups averaged 1.1%, 0.7%, 1.1%, and 0.7%, respectively and did not differ significantly from baseline based on the model (P = .771). Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts (P < .004), no other significant differences were observed in participants’ diabetes self-care activities. Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups. Conclusions Although behavioral and technological interventions can result in some modest improvements in glycemic control, these interventions did not fare significantly better than usual care in achieving glycemic control. More research is needed to understand how these interventions can be most effective in clinical practice. The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control. Trial registration Clinicaltrials.gov Identifier: NCT01221090. PMID:24450992

Effect of Mobile-health on maternal health care service utilization in Eastern Ethiopia: study protocol for a randomized controlled trial.

PubMed

Gelano, Tilayie Feto; Assefa, Nega; Bacha, Yadeta Dessie; Mahamed, Afendi Abdi; Roba, Kedir Teji; Hambisa, Mitiku Teshome

2018-02-12

Globally, the rapid development of mobile technology has created new ways of addressing public health challenges and shifted the paradigm of health care access and delivery. The primary aim of this study is to examine the effectiveness of Mobile-health on maternal health care service utilization in Eastern Ethiopia. Through, a cluster-randomized controlled trial, 640 participants will be selected based on their districts and respective health centers as the unit of randomization. All pregnant mothers who fulfill the inclusion criteria will be allocated to a mobile-phone-based intervention and existing standard of care or control with a 1:1 allocation ratio. The intervention consists of a series of 24 voice messages which will be sent every 2 weeks from the date of enrollment until the close-out time. The control group will receive existing standard of care without voice messages. Data related to outcome variables will be assessed at three phases of the data collection periods. The primary outcome measures will be the proportion of antenatal care visits and institutional delivery, whereas the secondary outcome measures will consist of the proportion of postnatal care visits and pregnancy outcomes. Risk ratios will be used to a measure the effect of intervention on the outcomes which will be estimated with 95% confidence interval and all the analyses will be done with consideration of clustering effect. This study should generate evidence on the effectiveness of mobile-phone-based voice messages for the early initiation of maternal health care service use and its uptake. It has been carefully designed with the assumption of obtaining higher levels of maternal health care service use among the treatment group as compared to the control. Pan African Clinical Trial Registry, www.panctr.org , ID: PACTR201704002216259 . Registered on 28 April 2017.

High-Quality Foster Care Mitigates Callous-Unemotional Traits Following Early Deprivation in Boys: A Randomized Controlled Trial.

PubMed

Humphreys, Kathryn L; McGoron, Lucy; Sheridan, Margaret A; McLaughlin, Katie A; Fox, Nathan A; Nelson, Charles A; Zeanah, Charles H

2015-12-01

Callous-unemotional (CU) traits in childhood are a developmental precursor to psychopathy, yet the origins and etiology of CU traits are not known. We examined CU traits among 12-year-old children exposed to severe early deprivation and evaluated whether a high-quality foster care intervention mitigated the development of high levels of CU traits. Participants were from the Bucharest Early Intervention Project, a randomized controlled trial of foster care for children in institutions. Children were recruited from institutions in Bucharest, Romania, along with age- and sex-matched children who were never institutionalized. Children raised in institutional settings were randomized (mean age = 22 months) to either a foster care group (n = 68) or a care-as-usual group (n = 68). CU traits were assessed at age 12.75 years in available participants from the randomized trial (n = 95) and children who were never institutionalized (n = 50). Children who experienced institutional rearing as young children had significantly higher levels of CU traits in early adolescence compared to children who were never institutionalized. Intent-to-treat analysis indicated that, among boys, CU traits were significantly lower among those who received the foster care intervention compared to those randomized to care as usual. Caregiver responsiveness to distress, but not caregiver warmth, mediated the intervention effect on CU traits in boys. These findings provide the first evidence to date that psychosocial intervention can prevent the onset of CU traits. Although severe early deprivation predicted higher levels of CU traits, high-quality foster care that emphasized responsive caregiving reduced the impact of deprivation on CU trait development for boys. The Bucharest Early Intervention Project; http://clinicaltrials.gov; NCT00747396. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Health and loyalty promotion visits for new enrollees: results of a randomized controlled trial.

PubMed

Thompson, M; Gee, S; Larson, P; Kotz, K; Northrop, L

2001-01-01

Managed care needs effective and efficient ways to orient new members, enhance trust and loyalty, and offer prevention and self-care education and services. Recent adult enrollees of Kaiser Permanente (Northern California) were randomly assigned to one of three intervention conditions (n = 286) (individual visit with a physician, physician visit plus a visit with a health educator, a group visit of eight new members led by a physician and health educator) or a random control group (n = 278). Outcomes were gauged via pre- and post-visit questionnaires and a 20-min telephone survey at baseline and at a 6-month follow-up. Compared to controls, attendees of the three interventions had higher satisfaction, self-rated prevention knowledge, acceptance of health plan guidelines, and were more likely to plan to remain in the health plan. Group visit attendees stood out as experiencing the greatest benefits and were especially likely to report saving a telephone call or visit to their doctor by using a self-care handbook.

A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net HIV Clinic: The Connect4Care (C4C) Trial.

PubMed

Christopoulos, Katerina A; Riley, Elise D; Carrico, Adam W; Tulsky, Jacqueline; Moskowitz, Judith T; Dilworth, Samantha; Coffin, Lara S; Wilson, Leslie; Peretz, Jason Johnson; Hilton, Joan F

2018-02-21

Text messaging is a promising strategy to support HIV care engagement, but little is known about its efficacy in urban safety-net HIV clinic populations. We conducted a randomized controlled trial of a supportive and motivational text messaging intervention, Connect4Care (C4C), among viremic patients who had a history of poor retention or were new to clinic. Participants were randomized (stratified by new HIV diagnosis status) to receive one of the following for 12 months: 1) thrice-weekly intervention messages, plus texted primary care appointment reminders and a monthly text message requesting confirmation of study participation, or; 2) texted reminders and monthly messages alone. Viral load was assessed at 6 and 12 months. The primary outcome was virologic suppression (<200 copies/mL) at 12 months, estimated via repeated measures log-binomial regression, adjusted for new diagnosis status. The secondary outcome was retention in clinic care. Between August 2013-November 2015, 230 participants were randomized. Virologic suppression at 12 months was similar between intervention and control participants (48.8% vs. 45.8%), with negligible change from 6-month estimates, yielding RR 1.07 (95% CI: 0.82, 1.39). Suppression was higher in the newly diagnosed (78.3% vs. 45.3%). There were no intervention effects on the secondary outcome. Exploratory analyses suggested that patients with more responses to study text messages had better outcomes, regardless of arm. The C4C text messaging intervention did not significantly increase virologic suppression or retention in care. Response to text messages may be a useful way for providers to gauge risk for poor HIV outcomes. NCT01917994.

Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial.

PubMed

Ward, Dianne S; Vaughn, Amber E; Hales, Derek; Viera, Anthony J; Gizlice, Ziya; Bateman, Lori A; Grummon, Anna H; Arandia, Gabriela; Linnan, Laura A

2018-05-01

Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies. Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff. Centers are randomized (1:1) into the Healthy Lifestyles (intervention) or the Healthy Finances (attention control) program. Healthy Lifestyles is delivered over six months including a kick-off event and three 8-week health campaigns (magazines, goal setting, behavior monitoring, tailored feedback, prompts, center displays, director coaching). The primary outcome is minutes of moderate and vigorous physical activity (MVPA); secondary outcomes are health behaviors (diet, smoking, sleep, stress), physical assessments (body mass index (BMI), waist circumference, blood pressure, fitness), and workplace supports for health and safety. In total, 56 centers and 553 participants have been recruited and randomized. Participants are predominately female (96.7%) and either Non-Hispanic African American (51.6%) or Non-Hispanic White (36.7%). Most participants (63.4%) are obese. They accumulate 17.4 (±14.2) minutes/day of MVPA and consume 1.3 (±1.4) and 1.3 (±0.8) servings/day of fruits and vegetables, respectively. Also, 14.2% are smokers; they report 6.4 (±1.4) hours/night of sleep; and 34.9% are high risk for depression. Baseline data demonstrate several serious health risks, confirming the importance of workplace interventions in child care. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial

PubMed Central

Ward, Dianne S.; Vaughn, Amber E.; Hales, Derek; Viera, Anthony J.; Gizlice, Ziya; Bateman, Lori A.; Grummon, Anna H.; Arandia, Gabriela; Linnan, Laura A.

2018-01-01

Background Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies. Methods Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff. Centers are randomized (1:1) into the Healthy Lifestyles (intervention) or the Healthy Finances (attention control) program. Healthy Lifestyles is delivered over six months including a kick-off event and three 8-week health campaigns (magazines, goal setting, behavior monitoring, tailored feedback, prompts, center displays, director coaching). The primary outcome is minutes of moderate and vigorous physical activity (MVPA); secondary outcomes are health behaviors (diet, smoking, sleep, stress), physical assessments (body mass index (BMI), waist circumference, blood pressure, fitness), and workplace supports for health and safety. Results In total, 56 centers and 553 participants have been recruited and randomized. Participants are predominately female (96.7%) and either Non-Hispanic African American (51.6%) or Non-Hispanic White (36.7%). Most participants (63.4%) are obese. They accumulate 17.4 ( ± 14.2) minutes/day of MVPA and consume 1.3 ( ± 1.4) and 1.3 ( ± 0.8) servings/day of fruits and vegetables, respectively. Also, 14.2% are smokers; they report 6.4 ( ± 1.4) hours/night of sleep; and 34.9% are high risk for depression. Conclusions Baseline data demonstrate several serious health risks, confirming the importance of workplace interventions in child care. PMID:29501740

Effects of the TCARE® intervention on caregiver burden and depressive symptoms: preliminary findings from a randomized controlled study.

PubMed

Montgomery, Rhonda J V; Kwak, Jung; Kosloski, Karl; O'Connell Valuch, Katharine

2011-09-01

We examined the effects of a manualized care management protocol specifically designed for care managers working with caregivers, the Tailored Caregiver Assessment and Referral® (TCARE®) protocol, on caregiver identity discrepancy, burden, and depressive symptoms. Preliminary data from a longitudinal, randomized, controlled intervention study with 266 family caregivers served by 52 care managers in 4 states were analyzed using repeated measures random effects regression procedures. Caregivers in the intervention and control groups were repeatedly assessed for up to 9 months on caregiver identity discrepancy, 3 areas of caregiving burden-objective, relationship, and stress burdens; depression; and intention for nursing home placement. We found significant group by time interaction effects for caregiver identity discrepancy, relationship burden, stress burden, depression, and intention for nursing home placement. Caregivers in the intervention group experienced significant improvement on these measures, whereas caregivers in the control group worsened on these measures over time. The preliminary findings provide strong support for effectiveness of the TCARE® protocol on improving caregiver well-being and mental health outcomes.

Effects of the TCARE® Intervention on Caregiver Burden and Depressive Symptoms: Preliminary Findings From a Randomized Controlled Study

PubMed Central

Kwak, Jung; Kosloski, Karl; O’Connell Valuch, Katharine

2011-01-01

Objectives. We examined the effects of a manualized care management protocol specifically designed for care managers working with caregivers, the Tailored Caregiver Assessment and Referral® (TCARE®) protocol, on caregiver identity discrepancy, burden, and depressive symptoms. Methods. Preliminary data from a longitudinal, randomized, controlled intervention study with 266 family caregivers served by 52 care managers in 4 states were analyzed using repeated measures random effects regression procedures. Caregivers in the intervention and control groups were repeatedly assessed for up to 9 months on caregiver identity discrepancy, 3 areas of caregiving burden—objective, relationship, and stress burdens; depression; and intention for nursing home placement. Results. We found significant group by time interaction effects for caregiver identity discrepancy, relationship burden, stress burden, depression, and intention for nursing home placement. Caregivers in the intervention group experienced significant improvement on these measures, whereas caregivers in the control group worsened on these measures over time. Discussion. The preliminary findings provide strong support for effectiveness of the TCARE® protocol on improving caregiver well-being and mental health outcomes. PMID:21840840

Minimum intervention dentistry approach to managing early childhood caries: a randomized control trial.

PubMed

Arrow, Peter; Klobas, Elizabeth

2015-12-01

A pragmatic randomized control trial was undertaken to compare the minimum intervention dentistry (MID) approach, based on the atraumatic restorative treatment procedures (MID-ART: Test), against the standard care approach (Control) to treat early childhood caries in a primary care setting. Consenting parent/child dyads were allocated to the Test or Control group using stratified block randomization. Inclusion and exclusion criteria were applied. Participants were examined at baseline and at follow-up by two calibrated examiners blind to group allocation status (κ = 0.77), and parents completed a questionnaire at baseline and follow-up. Dental therapists trained in MID-ART provided treatment to the Test group and dentists treated the Control group using standard approaches. The primary outcome of interest was the number of children who were referred for specialist pediatric care. Secondary outcomes were the number of teeth treated, changes in child oral health-related quality of life and dental anxiety and parental perceptions of care received. Data were analyzed on an intention to treat basis; risk ratio for referral for specialist care, test of proportions, Wilcoxon rank test and logistic regression were used. Three hundred and seventy parents/carers were initially screened; 273 children were examined at baseline and 254 were randomized (Test = 127; Control = 127): mean age = 3.8 years, SD 0.90; 59% male, mean dmft = 4.9, SD 4.0. There was no statistically significant difference in age, sex, baseline caries experience or child oral health-related quality of life between the Test and Control group. At follow-up (mean interval 11.4 months, SD 3.1 months), 220 children were examined: Test = 115, Control = 105. Case-notes review of 231 children showed Test = 6 (5%) and Control = 53 (49%) were referred for specialist care, P < 0.0001. More teeth were filled in the Test group (mean = 2.93, SD 2.48) than in the Control group (mean = 1.54, SD 2.20), Wilcoxon's test, P < 0.0001. Logistic regression, after controlling for age and baseline caries experience, showed a higher risk of referral by allocation to control group, OR 32.6, 95% CI 10.8-98.4, P < 0.0001. The MID-ART approach reduced significantly the likelihood of referral for specialist care, and more children and teeth were provided with treatment. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

PubMed Central

Sgandurra, Giuseppina; Lorentzen, Jakob; Inguaggiato, Emanuela; Bartalena, Laura; Beani, Elena; Cecchi, Francesca; Dario, Paolo; Giampietri, Matteo; Greisen, Gorm; Herskind, Anna; Nielsen, Jens Bo; Rossi, Giuseppe; Cioni, Giovanni

2017-01-01

CareToy system is an innovative tele-rehabilitative tool, useful in providing intensive, individualized, home-based, family-centred Early Intervention (EI) in infants. Our aim was to evaluate, through a Randomized Clinical Trial (RCT) study, the effects of CareToy intervention on early motor and visual development in preterm infants. 41 preterm infants (range age: 3.0–5.9 months of corrected age) were enrolled and randomized into two groups, CareToy and Standard Care. 19 infants randomized in CareToy group performed a 4-week CareToy program, while 22 allocated to control group completed 4 weeks of Standard Care. Infant Motor Profile (IMP) was primary outcome measure, Alberta Infant Motor Scale (AIMS) and Teller Acuity Cards were secondary ones. Assessments were carried out at baseline (T0) and at the end of CareToy training or Standard Care period (T1). T1 was the primary endpoint. After RCT phase, 17 infants from control group carried out a 4-week CareToy program, while 18 infants from the CareToy group continued with Standard Care. At the end of this phase, infants were re-assessed at T2. In RCT phase, delta IMP total score and variation and performance sub-domains were significantly higher (P<0.050) in CareToy group if compared to Standard Care group. Similar results were found for Teller Acuity Cards, while no differences between groups were found for AIMS. No differences were found in any outcome measure results (T2-T0), between infants who started CareToy training before or after one month of standard care. This RCT study confirms the results of a previous pilot study, indicating that CareToy system can provide effective home-based EI. Trial Registration: This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183). PMID:28328946

Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial.

PubMed

Blaya, Joaquín A; Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

2011-01-01

To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of 'late' DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of 'late' DSTs (p=0.57) compared with the control. Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.

Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial

PubMed Central

Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

2010-01-01

Objective To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Methods Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. Results For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of ‘late’ DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of ‘late’ DSTs (p=0.57) compared with the control. Conclusions Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting. PMID:21113076

A Randomized, Controlled Trial of a Shared Panel Management Program for Small Practices.

PubMed

Bishop, Tara F; Ryan, Andrew M; Chen, Melinda A; Mendelsohn, Jayme; Gottlieb, Daniel; Shih, Sarah; Desai, Priya; Wolff, Elizabeth A; Casalino, Lawrence P

2016-10-01

To determine whether a shared panel management program was effective at improving quality of care for patients with uncontrolled chronic disease. Data were extracted from electronic health records. Randomized controlled trial of a panel management program initiated by New York City Department of Health and Mental Hygiene. Patients from 20 practices with an uncontrolled chronic disease and a lapse in care were assigned to the intervention (a phone call requesting that the patient schedule a physician appointment) or usual care. Outcomes were visits to physician practices, body mass index measurement, blood pressure measurement and control, use of antithrombotics, and low-density lipoprotein measurement and control. Panel managers were able to successfully speak with 1,676 patients (14.7 percent of the intervention group). There were no significant differences in outcomes between the intervention and usual care groups. Successfully contacted patients were more likely to have an office visit within 1 year of randomization (45.6 percent [95 percent CI: 22.8, 26.9] vs. 38.1 percent [95 percent CI: 36.8, 39.3]) and more likely to be on antithrombotics (24.4 percent [95 percent CI: 17.7, 31.0]) versus those in the usual care group (17.0 percent [95 percent CI: 13.9, 20.0]) but had no other difference in quality. A shared, low-intensity panel management program run by a city health department did not improve quality of care for patients with chronic illnesses and lapses in care. © Health Research and Educational Trust.

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.

Exercise as an adjunct to nicotine gum in treating tobacco dependence among women.

PubMed

Kinnunen, Taru; Leeman, Robert F; Korhonen, Tellervo; Quiles, Zandra N; Terwal, Donna M; Garvey, Arthur J; Hartley, Howard L

2008-04-01

This was the first randomized, controlled smoking cessation trial assessing the efficacy of an exercise intervention as an adjunct to nicotine gum therapy in comparison with both equal contact control and standard care control conditions. Sedentary female smokers aged 18-55 years were provided with nicotine gum treatment along with brief behavioral counseling and were randomized into one of these three behavioral adjunct conditions. In the "intent-to-treat" sample (N = 182), at end of treatment and at 1-year follow-up, there were clear, but nonsignificant, trends in univariate analyses in which the exercise and equal contact control conditions both had higher rates of abstinence than the standard care control. However, when adjusting for other predictors of relapse in a multiple logistic regression, both exercise and equal contact control showed an advantage over standard care control in avoiding early relapse (i.e., after 1 week). In a multivariate survival model adjusting for other predictors, the equal contact condition had a significantly lower likelihood of relapse compared with the standard care condition and there was a near significant trend in which exercise offered an advantage over standard care as well. While these findings suggest a slightly improved likelihood of abstinence with exercise compared with standard care, exercise did not differ from equal contact control in its efficacy. Potential explanations for these equivalent levels of efficacy and implications for the findings are discussed.

Effects of a Telehealth Care Coordination Intervention on Perceptions of Health Care by Caregivers of Children With Medical Complexity: A Randomized Controlled Trial.

PubMed

Looman, Wendy S; Antolick, Megan; Cady, Rhonda G; Lunos, Scott A; Garwick, Ann E; Finkelstein, Stanley M

2015-01-01

The purpose of this study was to evaluate the effect of advanced practice registered nurse (APRN) telehealth care coordination for children with medical complexity (CMC) on family caregiver perceptions of health care. Families with CMC ages 2 to 15 years (N = 148) were enrolled in a three-armed, 30-month randomized controlled trial to test the effects of adding an APRN telehealth care coordination intervention to an existing specialized medical home for CMC. Satisfaction with health care was measured using items from the Consumer Assessment of Healthcare Providers and Systems survey at baseline and after 1 and 2 years. The intervention was associated with higher ratings on measures of the child's provider, provider communication, overall health care, and care coordination adequacy, compared with control subjects. Higher levels of condition complexity were associated with higher ratings of overall health care in some analyses. APRN telehealth care coordination for CMC was effective in improving ratings of caregiver experiences with health care and providers. Additional research with CMC is needed to determine which children benefit most from high-intensity care coordination. Copyright © 2015 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Examining clinical supervision as a mechanism for changes in practice: a research protocol.

PubMed

Dilworth, Sophie; Higgins, Isabel; Parker, Vicki; Kelly, Brian; Turner, Jane

2014-02-01

This paper describes the research protocol for a study exploring if and how clinical supervision facilitates change in practice relating to psychosocial aspects of care for Health Professionals, who have been trained to deliver a psychosocial intervention to adults with cancer. There is a recognized need to implement care that is in line with clinical practice guidelines for the psychosocial care of adults with cancer. Clinical supervision is recommended as a means to support Health Professionals in providing the recommended psychosocial care. A qualitative design embedded within an experimental, stepped wedge randomized control trial. The study will use discourse analysis to analyse audio-recorded data collected in clinical supervision sessions that are being delivered as one element of a large randomized control trial. The sessions will be attended primarily by nurses, but including physiotherapists, radiation therapists, occupational therapists. The Health Professionals are participants in a randomized control trial designed to reduce anxiety and depression of distressed adults with cancer. The sessions will be facilitated by psychiatrists experienced in psycho-oncology and the provision of clinical supervision. The proposed research is designed specifically to facilitate exploration of the mechanisms by which clinical supervision enables Health Professionals to deliver a brief, tailored psychosocial intervention in the context of their everyday practice. This is the first study to use discourse analysis embedded within an experimental randomized control trial to explore the mechanisms of change generated within clinical supervision by analysing the discourse within the clinical supervision sessions. © 2013 John Wiley & Sons Ltd.

Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes

PubMed Central

DOWNS, Danielle Symons; DINALLO, Jennifer M.; BIRCH, Leann L.; PAUL, Ian M.; ULBRECHT, Jan S.

2017-01-01

Objectives Evaluate effects of a theoretically-based, semi-intensive (Face-to-Face; F2F) exercise intervention and minimum-contact (Home) exercise intervention to the standard care (Control) on exercise, its motivational determinants, blood glucose levels, and insulin use of pregnant women with gestational diabetes mellitus (GDM). Design Randomized control trial with two intervention arms and control (standard care). Method Participants (N=65) were randomized to a Control (standard prenatal care/GDM dietary counseling), Home (standard care + phone education/support + home exercise), or F2F (standard care + on-site education/support + guided exercise with instructor on 2 days/week) group from ~20 weeks gestation to delivery. Assessments of exercise and motivational determinants were obtained at baseline (20-weeks gestation) and follow-up (32-weeks gestation). Blood glucose levels (fasting/postprandial mg/dL) and insulin use were extrapolated from medical records. Results At the 32-week follow-up, the F2F group had significantly higher exercise min, pedometer steps/day, and motivational determinants (attitude, subjective norm, perceived control, intention) than controls (p’s < .05) and significantly higher exercise min and subjective norm than the Home group (p’s < .05); these effect sizes were medium-large (η2 = .11–.23). There was a medium effect (η2 = .13) on postprandial blood glucose at 36-weeks gestation with the F2F group having lower values than controls. Although not significant, the F2F group started insulin later (33 weeks gestation) than the Home (27 weeks) and Control (31 weeks) groups. Conclusion A theoretically-based, F2F exercise intervention has multiple health benefits and may be the necessary approach for promoting exercise motivation and behavior among GDM women. PMID:28428728

Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes.

PubMed

Downs, Danielle Symons; Dinallo, Jennifer M; Birch, Leann L; Paul, Ian M; Ulbrecht, Jan S

2017-05-01

Evaluate effects of a theoretically-based, semi-intensive (Face-to-Face; F2F) exercise intervention and minimum-contact (Home) exercise intervention to the standard care (Control) on exercise, its motivational determinants, blood glucose levels, and insulin use of pregnant women with gestational diabetes mellitus (GDM). Randomized control trial with two intervention arms and control (standard care). Participants ( N =65) were randomized to a Control (standard prenatal care/GDM dietary counseling), Home (standard care + phone education/support + home exercise), or F2F (standard care + on-site education/support + guided exercise with instructor on 2 days/week) group from ~20 weeks gestation to delivery. Assessments of exercise and motivational determinants were obtained at baseline (20-weeks gestation) and follow-up (32-weeks gestation). Blood glucose levels (fasting/postprandial mg/dL) and insulin use were extrapolated from medical records. At the 32-week follow-up, the F2F group had significantly higher exercise min, pedometer steps/day, and motivational determinants (attitude, subjective norm, perceived control, intention) than controls ( p 's < .05) and significantly higher exercise min and subjective norm than the Home group ( p 's < .05); these effect sizes were medium-large (η 2 = .11-.23). There was a medium effect (η 2 = .13) on postprandial blood glucose at 36-weeks gestation with the F2F group having lower values than controls. Although not significant, the F2F group started insulin later (33 weeks gestation) than the Home (27 weeks) and Control (31 weeks) groups. A theoretically-based, F2F exercise intervention has multiple health benefits and may be the necessary approach for promoting exercise motivation and behavior among GDM women.

Randomized controlled trial of care bundles with chlorhexidine dressing and advanced dressings to prevent catheter-related bloodstream infections in pediatric hematology-oncology patients.

PubMed

Gerçeker, Gülçin Özalp; Yardımcı, Figen; Aydınok, Yeşim

2017-06-01

To compare the effects of the care bundles including chlorhexidine dressing and advanced dressings on the catheter-related bloodstream infection (CRBSI) rates in pediatric hematology-oncology patients with central venous catheters (CVCs). Twenty-seven PHO patients were recruited to participate in a prospective, randomized study in Turkey. The researcher used care bundles with chlorhexidine dressing in the experimental group (n = 14), and care bundles with advanced dressings in the control group (n = 13). According to the study results, 28.6% of the patients in the experimental group had CRBSI, while this rate was 38.5% in the control group patients. The CRBSI rate in the experimental group was 3.9, and the control group had 4.4 per 1000 inpatient catheter days. There was no exit-site infection in the experimental group. However, the control group had 1.7 per 1000 inpatient catheter days. Even though there was no difference between the two groups in which the researcher implemented care bundles with chlorhexidine dressing and advanced dressings in terms of CRBSI development, there was reduction in the CRBSI rates thanks to the care bundle approach. It is possible to control the CRBSI rates using care bundles in pediatric hematology-oncology patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

Bacterial colonization patterns in daily chlorhexidine care at the exit site in peritoneal dialysis patients-A prospective, randomized controlled trial.

PubMed

Wang, Hsi-Hao; Hung, Shih-Yuan; Chang, Min-Yu; Lee, Yi-Che; Lin, Hsiu-Fang; Lin, Tsun-Mei; Yang, Su-Pen; Lin, Hsi-Hsun; Yang, Su-Ching; Wang, Jiun-Ling

2017-01-01

Bacterial colonization patterns in daily chlorhexidine care at the exit site in peritoneal dialysis (PD) patients were not known. We performed a prospective, randomized controlled trial enrolling 89 PD patients. After stratification by initial Staphylococcus aureus (SA) carrier status, patients were randomly assigned to receive daily 4% chlorhexidine care (intervention group) or normal saline (control group) at the exit site. Monthly, we cultured bacteria from the exit site and nasal swabs for 1 year. The SA colonization rates at exit site at 6 and 12 months were significantly lower in the intervention group than the control group (5.0% vs. 22.9%, p = 0.023 and 8.6% vs. 28.1%, p = 0.037 for 6 and 12 months, respectively). The Methicillin-resistant SA (MRSA) colonization rate at exit site at 6 months was similar (5.7% vs. 2.5%,p = 0.596) in control and intervention group, but significantly lower in the intervention group than the control group at exit site at 12months (0% vs. 12.5%, p = 0.047). The gram-negative bacilli (GNB) colonization rates were similar between the intervention and control groups at 6 and 12 months. Genotyping of all MRSA isolates showed ST (sequence type) 59 was the most predominant clone. In conclusion, chlorhexidine care at the exit site in PD patients may be a good strategy for SA and MRSA decolonization. ClinicalTrials.gov NCT02446158.

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

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.

A patient navigation intervention for drug-involved former prison inmates.

PubMed

Binswanger, Ingrid A; Whitley, Elizabeth; Haffey, Paul-Ryan; Mueller, Shane R; Min, Sung-Joon

2015-01-01

Former prison inmates experience high rates of hospitalizations and death during the transition from prison to the community, particularly from drug-related causes and early after release. The authors designed a randomized controlled trial (RCT) of patient navigation to reduce barriers to health care and hospitalizations for former prison inmates. Forty former prison inmates with a history of drug involvement were recruited and randomized within 15 days after prison release. Participants were randomized to receive 3 months of patient navigation (PN) with facilitated enrollment into an indigent care discount program (intervention) or facilitated enrollment into an indigent care discount program alone (control). Structured interviews were conducted at baseline, 3 months, and 6 months. Outcomes were measured as a change in self-reported barriers to care and as the rate of health service use per 100 person-days. The mean number of reported barriers to care was reduced at 3 and 6 months in both groups. At 6 months, the rate of emergency department/urgent care visits per 100 person-days since baseline was 1.1 among intervention participants and 0.5 among control participants (P = .04), whereas the rate of hospitalizations per 100 person-days was 0.2 in intervention participants and 0.6 in control participants (P = .04). Recruitment of former inmates into an RCT of patient navigation was highly feasible, but follow-up was limited by rearrests. Results suggest a significantly lower rate of hospitalizations among navigation participants, although the rate of emergency department/urgent care visits was not improved. Patient navigation is a promising, pragmatic intervention that may be effective at reducing high-cost health care utilization in former prison inmates.

Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

PubMed Central

Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

2011-01-01

Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

Kangaroo mother care for low birth weight infants: a randomized controlled trial.

PubMed

Suman, Rao P N; Udani, Rekha; Nanavati, Ruchi

2008-01-01

To compare the effect of Kangaroo mother care (KMC) and conventional methods of care (CMC) on growth in LBW babies (> 2000 g). Randomized controlled trial. Level III NICU of a teaching institution in western India. 206 neonates with birth weight < 2000 g. The subjects were randomized into two groups: the intervention group (KMC-103) received Kangaroo mother care. The control group (CMC: 103) received conventional care. Growth, as measured by average daily weight gain and by other anthropometrical parameters at 40 weeks postmenstrual age in preterm babies and at 2500 g in term SGA infants was assessed. The KMC babies had better average weight gain per day (KMC: 23.99 g vs CMC: 15.58 g, P< 0.0001). The weekly increments in head circumference (KMC: 0.75 cm vs CMC: 0.49 cm, P = 0.02) and length (KMC: 0.99 cm vs CMC: 0.7 cm, P = 0.008) were higher in the KMC group. A significantly higher number of babies in the CMC group suffered from hypothermia, hypoglycemia, and sepsis. There was no effect on time to discharge. More KMC babies were exclusively breastfed at the end of the study (98% vs 76%). KMC was acceptable to most mothers and families at home. Kangaroo mother care improves growth and reduces morbidities in low birth weight infants. It is simple, acceptable to mothers and can be continued at home.

Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda.

PubMed

Ruzagira, Eugene; Grosskurth, Heiner; Kamali, Anatoli; Baisley, Kathy

2017-10-01

The aim of this study was to determine whether counselling provided subsequent to HIV testing and referral for care increases linkage to care among HIV-positive persons identified through home-based HIV counselling and testing (HBHCT) in Masaka, Uganda. The study was an open-label cluster-randomized trial. 28 rural communities were randomly allocated (1:1) to intervention (HBHCT, referral and counselling at one and two months) or control (HBHCT and referral only). HIV-positive care-naïve adults (≥18 years) were enrolled. To conceal participants' HIV status, one HIV-negative person was recruited for every three HIV-positive participants. Primary outcomes were linkage to care (clinic-verified registration for care) status at six months, and time to linkage. Primary analyses were intention-to-treat using random effects logistic regression or Cox regression with shared frailty, as appropriate. Three hundred and two(intervention, n = 149; control, n = 153) HIV-positive participants were enrolled. Except for travel time to the nearest HIV clinic, baseline participant characteristics were generally balanced between trial arms. Retention was similar across trial arms (92% overall). One hundred and twenty-seven (42.1%) participants linked to care: 76 (51.0%) in the intervention arm versus 51 (33.3%) in the control arm [odds ratio = 2.18, 95% confidence interval (CI) = 1.26-3.78; p = 0.008)]. There was evidence of interaction between trial arm and follow-up time (p = 0.009). The probability of linkage to care, did not differ between arms in the first two months of follow-up, but was subsequently higher in the intervention arm versus the control arm [hazard ratio = 4.87, 95% CI = 1.79-13.27, p = 0.002]. Counselling substantially increases linkage to care among HIV-positive adults identified through HBHCT and may enhance efforts to increase antiretroviral therapy coverage in sub-Saharan Africa. © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

PubMed

Utz, Bettina; Assarag, Bouchra; Essolbi, Amina; Barkat, Amina; El Ansari, Nawal; Fakhir, Bouchra; Delamou, Alexandre; De Brouwere, Vincent

2017-06-19

Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up. We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers. In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and treatment delays. Implementation of a strategy that enables detection, management and follow-up of affected women at primary health care level is expected to positively impact on access to care and medical outcomes. The trial has been registered on clininicaltrials.gov ; identifier NCT02979756 ; retrospectively registered 22 November 2016.

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.

Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

PubMed

Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

2014-05-01

Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work. Copyright 2014, SLACK Incorporated.

Delivery strategies to optimize resource utilization and performance status for patients with advanced life-limiting illness: results from the "palliative care trial" [ISRCTN 81117481].

PubMed

Abernethy, Amy P; Currow, David C; Shelby-James, Tania; Rowett, Debra; May, Frank; Samsa, Gregory P; Hunt, Roger; Williams, Helena; Esterman, Adrian; Phillips, Paddy A

2013-03-01

Evidence-based approaches are needed to improve the delivery of specialized palliative care. The aim of this trial was to improve on current models of service provision. This 2×2×2 factorial cluster randomized controlled trial was conducted at an Australian community-based palliative care service, allowing three simultaneous comparative effectiveness studies. Participating patients were newly referred adults, experiencing pain, and who were expected to live >48 hours. Patients enrolled with their general practitioners (GPs) and were randomized three times: 1) individualized interdisciplinary case conference including their GP vs. control, 2) educational outreach visiting for GPs about pain management vs. control, and 3) structured educational visiting for patients/caregivers about pain management vs. control. The control condition was current palliative care. Outcomes included Australia-modified Karnofsky Performance Status (AKPS) and pain from 60 days after randomization and hospitalizations. There were 461 participants: mean age 71 years, 50% male, 91% with cancer, median survival 179 days, and median baseline AKPS 60. Only 47% of individuals randomized to the case conferencing intervention received it; based on a priori-defined analyses, 32% of participants were included in final analyses. Case conferencing reduced hospitalizations by 26% (least squares means hospitalizations per patient: case conference 1.26 [SE 0.10] vs. control 1.70 [SE 0.13], P=0.0069) and better maintained performance status (AKPS case conferences 57.3 [SE 1.5] vs. control 51.7 [SE 2.3], P=0.0368). Among patients with declining function (AKPS <70), case conferencing and patient/caregiver education better maintained performance status (AKPS case conferences 55.0 [SE 2.1] vs. control 46.5 [SE 2.9], P=0.0143; patient/caregiver education 54.7 [SE 2.8] vs. control 46.8 [SE 2.1], P=0.0206). Pain was unchanged. GP education did not change outcomes. A single case conference added to current specialized community-based palliative care reduced hospitalizations and better maintained performance status. Comparatively, patient/caregiver education was less effective; GP education was not effective. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Patient satisfaction with different interpreting methods: a randomized controlled trial.

PubMed

Gany, Francesca; Leng, Jennifer; Shapiro, Ephraim; Abramson, David; Motola, Ivette; Shield, David C; Changrani, Jyotsna

2007-11-01

Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction. 1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants. 541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p < 0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (beta 0.10, 95% CI 0.02-0.18, scale 0-1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p < 0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters. While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged approach to addressing language barriers in health care.

Patient Satisfaction with Different Interpreting Methods: A Randomized Controlled Trial

PubMed Central

Leng, Jennifer; Shapiro, Ephraim; Abramson, David; Motola, Ivette; Shield, David C.; Changrani, Jyotsna

2007-01-01

Background Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction. Methods 1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants. Results 541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p < 0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (β 0.10, 95% CI 0.02–0.18, scale 0–1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p < 0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters. Conclusions While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged approach to addressing language barriers in health care. PMID:17957417

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.

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. Methods The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Discussion Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to teach and reinforce use of proven self-management strategies. HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change. Trial Registration Current Controlled Trials ISRCTN34326236. PMID:22168530

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial.

PubMed

Ahmed, Sara; Bartlett, Susan J; Ernst, Pierre; Paré, Guy; Kanter, Maria; Perreault, Robert; Grad, Roland; Taylor, Laurel; Tamblyn, Robyn

2011-12-14

Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to teach and reinforce use of proven self-management strategies. HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change. Current Controlled Trials ISRCTN34326236.

Enhanced Medical Rehabilitation increases therapy intensity and engagement and improves functional outcomes in post-acute rehabilitation of older adults: a randomized controlled trial

PubMed Central

Lenze, Eric J.; Host, Helen H.; Hildebrand, Mary W.; Morrow-Howell, Nancy; Carpenter, Brian; Freedland, Kenneth E.; Baum, Carolyn A.; Dixon, David; Doré, Peter; Wendleton, Leah; Binder, Ellen F.

2012-01-01

Objectives For millions of disabled older adults each year, post-acute care in skilled nursing facilities (SNFs) is a brief window of opportunity to regain enough function to return home and live independently. Too often this goal is not achieved, possibly due to therapy that is inadequately intense or engaging. This study tested Enhanced Medical Rehabilitation, an intervention designed to increase patient engagement in, and intensity of, daily physical and occupational therapy sessions in post-acute care rehabilitation. Design Randomized controlled trial of Enhanced Medical Rehabilitation versus standard-of-care rehabilitation. Setting Post-acute care unit of a skilled nursing facility in St Louis, MO. Participants 26 older adults admitted from a hospital for post-acute rehabilitation. Intervention Based on models of motivation and behavior change, Enhanced Medical Rehabilitation is a set of behavioral skills for physical and occupational therapists (PT/OT) that increase patient engagement and intensity, with the goal of improving functional outcome, through: (1) a patient-directed, interactive approach, (2) increased rehabilitation intensity, and (3) frequent feedback to patients on their effort and progress. Measurements Therapy intensity: assessment of patient active time in therapy sessions. Therapy engagement: Rehabilitation Participation Scale. Functional and performance outcomes: Barthel Index, gait speed, and six-minute walk. Results Participants randomized to Enhanced Medical Rehabilitation had higher intensity therapy and were more engaged in their rehabilitation sessions; they had more improvement in gait speed (improving from 0.08 to 0.38 meter/sec vs. 0.08 to 0.22 in standard of care,p=0.003) and six-minute walk (from 73 to 266 feet vs. 40 to 94 feet in standard of care, p=0.026), with a trend for better improvement of Barthel Index (+43 points vs. 26 points in standard of care, p=0.087), compared to participants randomized to standard-of-care rehabilitation. Conclusion Higher intensity and patient engagement in the post-acute rehabilitation setting is achievable, with resultant better functional outcomes for older adults. Findings should be confirmed in a larger randomized controlled trial. PMID:22863663

Small Cash Incentives Can Encourage Primary Care Visits By Low-Income People With New Health Care Coverage.

PubMed

Bradley, Cathy J; Neumark, David

2017-08-01

In a randomized controlled trial, we studied low-income adults newly covered by a primary care program to determine whether a cash incentive could encourage them to make an initial visit to a primary care provider. Subjects were randomly assigned to one of four groups: three groups whose members received $10 to complete a baseline survey during an interview and who were randomized to incentives of $50, $25, or $0 to visit their assigned primary care provider within six months after enrolling in the study; and a nonincentivized control group not contacted by the research team. Subjects in the $50 and $25 incentive groups were more likely to see a primary care provider (77 percent and 74 percent, respectively), compared to subjects in the $0 incentive group (68 percent). The effects of the intervention were about twice as large when we compared the proportions of subjects in the $50 and $25 incentive groups who visited their providers and the proportion in the nonincentivized group (61 percent). Cash incentive programs may steer newly covered low-income patients toward primary care, which could result in improved health outcomes and lower costs. Project HOPE—The People-to-People Health Foundation, Inc.

Targeted versus tailored multimedia patient engagement to enhance depression recognition and treatment in primary care: randomized controlled trial protocol for the AMEP2 study

PubMed Central

2013-01-01

Background Depression in primary care is common, yet this costly and disabling condition remains underdiagnosed and undertreated. Persisting gaps in the primary care of depression are due in part to patients’ reluctance to bring depressive symptoms to the attention of their primary care clinician and, when depression is diagnosed, to accept initial treatment for the condition. Both targeted and tailored communication strategies offer promise for fomenting discussion and reducing barriers to appropriate initial treatment of depression. Methods/design The Activating Messages to Enhance Primary Care Practice (AMEP2) Study is a stratified randomized controlled trial comparing two computerized multimedia patient interventions --- one targeted (to patient gender and income level) and one tailored (to level of depressive symptoms, visit agenda, treatment preferences, depression causal attributions, communication self-efficacy and stigma)--- and an attention control. AMEP2 consists of two linked sub-studies, one focusing on patients with significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] scores ≥ 5), the other on patients with few or no depressive symptoms (PHQ-9 < 5). The first sub-study examined effectiveness of the interventions; key outcomes included delivery of components of initial depression care (antidepressant prescription or mental health referral). The second sub-study tracked potential hazards (clinical distraction and overtreatment). A telephone interview screening procedure assessed patients for eligibility and oversampled patients with significant depressive symptoms. Sampled, consenting patients used computers to answer survey questions, be randomized, and view assigned interventions just before scheduled primary care office visits. Patient surveys were also collected immediately post-visit and 12 weeks later. Physicians completed brief reporting forms after each patient’s index visit. Additional data were obtained from medical record abstraction and visit audio recordings. Of 6,191 patients assessed, 867 were randomized and included in analysis, with 559 in the first sub-study and 308 in the second. Discussion Based on formative research, we developed two novel multimedia programs for encouraging patients to discuss depressive symptoms with their primary care clinicians. Our computer-based enrollment and randomization procedures ensured that randomization was fully concealed and data missingness minimized. Analyses will focus on the interventions’ potential benefits among depressed persons, and the potential hazards among the non-depressed. Trial registration ClinicialTrials.gov Identifier: http://NCT01144104 PMID:23594572

Evaluation of a nurse-led dementia education and knowledge translation programme in primary care: A cluster randomized controlled trial.

PubMed

Wang, Yao; Xiao, Lily Dongxia; Ullah, Shahid; He, Guo-Ping; De Bellis, Anita

2017-02-01

The lack of dementia education programmes for health professionals in primary care is one of the major factors contributing to the unmet demand for dementia care services. To determine the effectiveness of a nurse-led dementia education and knowledge translation programme for health professionals in primary care; participants' satisfaction with the programme; and to understand participants' perceptions of and experiences in the programme. A cluster randomized controlled trial was used as the main methodology to evaluate health professionals' knowledge, attitudes and care approach. Focus groups were used at the end of the project to understand health professionals' perceptions of and experiences in the programme. Fourteen community health service centres in a province in China participated in the study. Seven centres were randomly assigned to the intervention or control group respectively and 85 health professionals in each group completed the programme. A train-the-trainer model was used to implement a dementia education and knowledge translation programme. Outcome variables were measured at baseline, on the completion of the programme and at 3-month follow-up. A mixed effect linear regression model was applied to compare the significant differences of outcome measures over time between the two groups. Focus groups were guided by four semi-structured questions and analysed using content analysis. Findings revealed significant effects of the education and knowledge translation programme on participants' knowledge, attitudes and a person-centred care approach. Focus groups confirmed that the programme had a positive impact on dementia care practice. A dementia education and knowledge translation programme for health professionals in primary care has positive effects on their knowledge, attitudes, care approach and care practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of a cognitive behavioural self-help manual for reducing depression: a randomized controlled trial.

PubMed

Songprakun, W; McCann, T V

2012-09-01

The prevalence of depression is increasing in Thailand. We used a randomized controlled trial to examine the effectiveness of a self-help programme in reducing depression in people with depression in Chiang Mai Province in Thailand. Fifty-six individuals diagnosed with moderate depression participated. They were assigned randomly to an intervention (n= 27) or control (n= 29) group. The intervention group were given a self-help manual along with standard care and treatment, while the control group continued to receive standard care and treatment. Both groups were also given a short weekly telephone call. The findings showed statistically significant differences between the groups, and within the intervention group, in their depression levels. Between baseline and post-test, a sharp decrease in depression was evident in the intervention group, whereas the level of depression increased in the control group. Between post-test and follow-up, a decrease was apparent in depression in both groups. However, the intervention group showed a much lower level of depression than the control group. The results support the use of bibliotherapy as an adjunct to mental health nurses' and other professionals' work in caring for people with moderate depression in the community. http://www.ANZCTR.org.au/ACTRN12611000905965.aspx. © 2012 Blackwell Publishing.

Decreasing Inappropriate Use of Antibiotics in Primary Care in Four Countries in South America—Cluster Randomized Controlled Trial

PubMed Central

Urbiztondo, Inés; Caballero, Lidia; Suarez, Miguel Angel; Olinisky, Monica

2017-01-01

High antibiotic prescribing and antimicrobial resistance in patients attending primary care have been reported in South America. Very few interventions targeting general practitioners (GPs) to decrease inappropriate antibiotic prescribing have been investigated in this region. This study assessed the effectiveness of online feedback on reducing antibiotic prescribing in patients with suspected respiratory tract infections (RTIs) attending primary care. The aim was to reduce antibiotic prescribing in patients with acute bronchitis and acute otitis media. Both are RTIs for which antibiotics have a very limited effect. A cluster randomized two-arm control trial was implemented. Healthcare centres from Bolivia, Argentina, Paraguay and Uruguay participating in the quality improvement program HAPPY AUDIT were randomly allocated to either intervention or control group. During ten consecutive weeks, GPs in the intervention group received evidence-based online feedback on the management of suspected RTIs. In patients with acute bronchitis, the intervention reduced the antibiotic prescribing rate from 71.6% to 56% (control group from 61.2% to 52%). In patients with acute otitis media, the intervention reduced the antibiotic prescribing from 94.8% to 86.2% (no change in the control group). In all RTIs, the intervention reduced antibiotic prescribing rate from 37.4% to 28.1% (control group from 29% to 27.2%). Online evidence-based feedback is effective for reducing antibiotic prescribing in patients with RTIs attending primary care in South America. PMID:29240687

The effectiveness of high-intensity versus low-intensity back schools in an occupational setting: a pragmatic randomized controlled trial.

PubMed

Heymans, Martijn W; de Vet, Henrica C W; Bongers, Paulien M; Knol, Dirk L; Koes, Bart W; van Mechelen, Willem

2006-05-01

Randomized controlled trial. To compare high- and low-intensity back schools with usual care in occupational health care. The content and intensity of back schools vary widely and the methodologic quality of randomized controlled trials is generally weak. Until now, no back school has proven to be superior for workers sick-listed because of subacute nonspecific low back pain. Workers (n = 299) sick-listed for a period of 3 to 6 weeks because of nonspecific low back pain were recruited by the occupational physician and randomly assigned to a high-intensity back school, a low-intensity back school, or care as usual. Outcome measures were days until return to work, total days of sick-leave, pain, functional status, kinesiophobia, and perceived recovery and were assessed at baseline and at 3 and 6 months of follow-up. Principal analyses were performed according to the intention-to-treat principle. We randomly allocated 299 workers. Workers in the low-intensity back school returned to work faster compared with usual care and the high-intensity back school, with hazard ratios of 1.4 (P = 0.06) and 1.3 (P = 0.09), respectively. The comparison between high-intensity back school and usual care resulted in a hazard ratio of 1.0 (P = 0.83). The median number of sick-leave days was 68, 75, and 85 in the low-intensity back school, usual care, and high-intensity back school, respectively. Beneficial effects on functional status and kinesiophobia were found at 3 months in favor of the low-intensity back school. No substantial differences on pain and perceived recovery were found between groups. The low-intensity back school was most effective in reducing work absence, functional disability, and kinesiophobia, and more workers in this group scored a higher perceived recovery during the 6-month follow-up.

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.

Effects of an Updated Preventive Home Visit Program Based on a Systematic Structured Assessment of Care Needs for Ambulatory Frail Older Adults in Japan: A Randomized Controlled Trial.

PubMed

Kono, Ayumi; Izumi, Kyoko; Yoshiyuki, Noriko; Kanaya, Yukiko; Rubenstein, Laurence Z

2016-12-01

The aim of this randomized controlled trial was to determine the effects on functional parameters of an updated preventive home visit program for frail older adults in the Japanese Long-term Care Insurance (LTCI) system. The program included home visits by nurses or care managers every 3 months for 24 months, with a systematic assessment of care needs to prevent functional decline. Eligible participants (N = 360) were randomly assigned to the visit (VG: n = 179) or control group (CG: n = 181). Functional parameters were gathered via mail questionnaires at baseline and at 12- and 24-month follow-ups. Care-need levels in the LTCI were obtained at 12-, 24-, and 36-month follow-ups and the utilization of the LTCI service through 36 months. Participants in VG were significantly more likely to maintain their activities of daily living (ADL) functioning (p = .0113) and less likely to increase care-needs level, compared with CG participants, over 24 months. A generalized linear model showed that the estimate of the effect on increase in care-needs level (ie, functional decline) was -0.53 (p = .042) over 36 months. These results suggest that the updated preventive home visit program could be effective for the prevention of ADL and care-needs deterioration, and these effects could continue up to 1 year after program completion. © The Author 2016. 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.

Multimodal manual therapy vs. pharmacological care for management of tension type headache: A meta-analysis of randomized trials.

PubMed

Mesa-Jiménez, Juan A; Lozano-López, Cristina; Angulo-Díaz-Parreño, Santiago; Rodríguez-Fernández, Ángel L; De-la-Hoz-Aizpurua, Jose L; Fernández-de-Las-Peñas, Cesar

2015-12-01

Manual therapies are generally requested by patients with tension type headache. To compare the efficacy of multimodal manual therapy vs. pharmacological care for the management of tension type headache pain by conducting a meta-analysis of randomized controlled trials. PubMed, MEDLINE, EMBASE, AMED, CINAHL, EBSCO, Cochrane Database of Systematic Reviews, Cochrane Collaboration Trials Register, PEDro and SCOPUS were searched from their inception until June 2014. All randomized controlled trials comparing any manual therapy vs. medication care for treating tension type headache adults were included. Data were extracted and methodological quality assessed independently by two reviewers. We pooled headache frequency as the main outcome and also intensity and duration. The weighted mean difference between manual therapy and pharmacological care was used to determine effect sizes. Five randomized controlled trials met our inclusion criteria and were included in the meta-analysis. Pooled analyses found that manual therapies were more effective than pharmacological care in reducing frequency (weighted mean difference -0.8036, 95% confidence interval -1.66 to -0.44; three trials), intensity (weighted mean difference -0.5974, 95% confidence interval -0.8875 to -0.3073; five trials) and duration (weighted mean difference -0.5558, 95% confidence interval -0.9124 to -0.1992; three trials) of the headache immediately after treatment. No differences were found at longer follow-up for headache intensity (weighted mean difference -0.3498, 95% confidence interval -1.106 to 0.407; three trials). Manual therapies were associated with moderate effectiveness at short term, but similar effectiveness at longer follow-up for reducing headache frequency, intensity and duration in tension type headache than pharmacological medical drug care. However, due to the heterogeneity of the interventions, these results should be considered with caution at this stage. © International Headache Society 2015.

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

PubMed

Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

2013-11-01

To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

Evaluation of a "Just-in-Time" Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial.

PubMed

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p < 0.01), osteoporosis knowledge (p = 0.04), activation (p < 0.01), dietary self-efficacy (p = 0.06), and osteoporosis care satisfaction (p < 0.01). Compared with PAADRN intervention participants (n = 39), nurse consultation participants had improved dietary self-efficacy (p = 0.07) and osteoporosis care satisfaction (p = 0.05). No significant improvements in osteoporosis-related outcomes were achieved vs PAADRN controls (n = 70). "Just-in-time" nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care.

Prevention Service System Transformation Using "Communities That Care"

ERIC Educational Resources Information Center

Brown, Eric C.; Hawkins, J. David; Arthur, Michael W.; Briney, John S.; Fagan, Abigail A.

2011-01-01

This study examines prevention system transformation as part of a community-randomized controlled trial of Communities That Care (CTC). Using data from surveys of community leaders, we examine differences between CTC and control communities 4.5 years after CTC implementation. Significantly higher levels of adopting a science-based approach to…

A coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's community hypertension care: study protocol for a randomized controlled trial.

PubMed

Xu, Lei; Fang, Wei-Yi; Zhu, Fu; Zhang, Hong-Guang; Liu, Kai

2017-05-25

Hypertension is a major risk factor for cardiovascular disease, and its control rate has remained low worldwide. Studies have found that telemonitoring blood pressure (BP) helped control hypertension in randomized controlled trials. However, little is known about its effect in a structured primary care model in which primary care physicians (PCPs) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions. This study aims to identify the effects of a coordinated PCP-cardiologist model that applies telemedicine tools to facilitate community hypertension control in China. Patients with hypertension receiving care at four community healthcare centers that are academically affiliated to Shanghai Chest Hospital, Shanghai JiaoTong University are eligible if they have had uncontrolled BP in the previous 3 months and access to mobile Internet. Study subjects are randomly assigned to three interventional groups: (1) usual care; (2) home-based BP telemonitor with embedded Global System for Mobile Communications (GSM) module and unlimited data plan, an app to access personal healthcare record and receive personalized lifestyle coaching contents, and proficiency training of their use; or (3) this plus coordinated PCP-cardiologist care in which PCPs and cardiologists share data via a secure CareLinker website to determine interventional approaches. The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes are changes of diastolic blood pressure, HbA1C, blood lipids, and medication adherence measured by the eight-item Morisky Medication Adherence Scale. This study will determine whether a coordinated PCP-Cardiologist Telemedicine Model that incorporates the latest telemedicine technologies will improve hypertension care. Success of the model would help streamline the present community healthcare processes and impact a greater number of patients with uncontrolled hypertension. ClinicalTrials.gov, NCT02919033 . Registered on 23 September 2016.

A randomized, controlled trial to increase discussion of breast cancer in primary care.

PubMed

Kaplan, Celia P; Livaudais-Toman, Jennifer; Tice, Jeffrey A; Kerlikowske, Karla; Gregorich, Steven E; Pérez-Stable, Eliseo J; Pasick, Rena J; Chen, Alice; Quinn, Jessica; Karliner, Leah S

2014-07-01

Assessment and discussion of individual risk for breast cancer within the primary care setting are crucial to discussion of risk reduction and timely referral. We conducted a randomized controlled trial of a multiethnic, multilingual sample of women ages 40 to 74 years from two primary care practices (one academic, one safety net) to test a breast cancer risk assessment and education intervention. Patients were randomly assigned to control or intervention group. All patients completed a baseline telephone survey and risk assessment (via telephone for controls, via tablet computer in clinic waiting room before visit for intervention). Intervention (BreastCARE) patients and their physicians received an individualized risk report to discuss during the visit. One-week follow-up telephone surveys with all patients assessed patient-physician discussion of family cancer history, personal breast cancer risk, high-risk clinics, and genetic counseling/testing. A total of 655 control and 580 intervention women completed the risk assessment and follow-up interview; 25% were high-risk by family history, Gail, or Breast Cancer Surveillance Consortium risk models. BreastCARE increased discussions of family cancer history [OR, 1.54; 95% confidence interval (CI), 1.25-1.91], personal breast cancer risk (OR, 4.15; 95% CI, 3.02-5.70), high-risk clinics (OR, 3.84; 95% CI, 2.13-6.95), and genetic counseling/testing (OR, 2.22; 95% CI, 1.34-3.68). Among high-risk women, all intervention effects were stronger. An intervention combining an easy-to-use, quick risk assessment tool with patient-centered risk reports at the point of care can successfully promote discussion of breast cancer risk reduction between patients and primary care physicians, particularly for high-risk women. Next steps include scaling and dissemination of BreastCARE with integration into electronic medical record systems. ©2014 American Association for Cancer Research.

A Randomized, Controlled Trial to Increase Discussion of Breast Cancer in Primary Care

PubMed Central

Kaplan, Celia P.; Livaudais-Toman, Jennifer; Tice, Jeffrey A.; Kerlikowske, Karla; Gregorich, Steven E.; Pérez-Stable, Eliseo J.; Pasick, Rena J.; Chen, Alice; Quinn, Jessica; Karliner, Leah S.

2014-01-01

Background Assessment and discussion of individual risk for breast cancer within the primary care setting are crucial to discussion of risk reduction and timely referral. Methods We conducted a randomized controlled trial of a multiethnic, multilingual sample of women ages 40 to 74 years from two primary care practices (one academic, one safety net) to test a breast cancer risk assessment and education intervention. Patients were randomly assigned to control or intervention group. All patients completed a baseline telephone survey and risk assessment (via telephone for controls, via tablet computer in clinic waiting room before visit for intervention). Intervention (BreastCARE) patients and their physicians received an individualized risk report to discuss during the visit. One-week follow-up telephone surveys with all patients assessed patient–physician discussion of family cancer history, personal breast cancer risk, high-risk clinics, and genetic counseling/testing. Results A total of 655 control and 580 intervention women completed the risk assessment and follow-up interview; 25% were high-risk by family history, Gail, or Breast Cancer Surveillance Consortium risk models. BreastCARE increased discussions of family cancer history [OR, 1.54; 95% confidence interval (CI), 1.25–1.91], personal breast cancer risk (OR, 4.15; 95% CI, 3.02–5.70), high-risk clinics (OR, 3.84; 95% CI, 2.13–6.95), and genetic counseling/testing (OR, 2.22; 95% CI, 1.34–3.68). Among high-risk women, all intervention effects were stronger. Conclusions An intervention combining an easy-to-use, quick risk assessment tool with patient-centered risk reports at the point of care can successfully promote discussion of breast cancer risk reduction between patients and primary care physicians, particularly for high-risk women. Impact Next steps include scaling and dissemination of BreastCARE with integration into electronic medical record systems. PMID:24762560

Web-based consultation between general practitioners and nephrologists: a cluster randomized controlled trial.

PubMed

van Gelder, Vincent A; Scherpbier-de Haan, Nynke D; van Berkel, Saskia; Akkermans, Reinier P; de Grauw, Inge S; Adang, Eddy M; Assendelft, Pim J; de Grauw, Wim J C; Biermans, Marion C J; Wetzels, Jack F M

2017-08-01

Consultation of a nephrologist is important in aligning care for patients with chronic kidney disease (CKD) at the primary-secondary care interface. However, current consultation methods come with practical difficulties that can lead to postponed consultation or patient referral instead. This study aimed to investigate whether a web-based consultation platform, telenephrology, led to a lower referral rate of indicated patients. Furthermore, we assessed consultation rate, quality of care, costs and general practitioner (GPs') experiences with telenephrology. Cluster randomized controlled trial with 47 general practices in the Netherlands was randomized to access to telenephrology or to enhanced usual care. A total of 3004 CKD patients aged 18 years or older who were under primary care were included (intervention group n = 1277, control group n = 1727) and 2693 completed the trial. All practices participated in a CKD management course and were given an overview of their CKD patients. The referral rates amounted to 2.3% (n = 29) in the intervention group and 3.0% (n = 52) in the control group, which was a non-significant difference, OR 0.61; 95% CI 0.31 to 1.23. The intervention group's consultation rate was 6.3% (n = 81) against 5.0% (n = 87) (OR 2.00; 95% CI 0.75-5.33). We found no difference in quality of care or costs. The majority of GPs had a positive opinion about telenephrology. The data in our study do not allow for conclusions on the effect of telenephrology on the rate of patient referrals and provider-to-provider consultations, compared to conventional methods. It was positively evaluated by GPs and was non-inferior in terms of quality of care and costs. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Reduced mortality: the unexpected impact of a telephone-based care management intervention for older adults in managed care.

PubMed

Alkema, Gretchen E; Wilber, Kathleen H; Shannon, George R; Allen, Douglas

2007-08-01

This analysis evaluated mortality over 24 months for Medicare managed care members who participated in the Care Advocate Program (CA Program) designed to link those with high health care utilization to home- and community-based services. Secondary data from the CA Program, part of the California HealthCare Foundation's Elders in Managed Care Initiative. Randomized-control trial in which participants (N=781) were randomly assigned to intent-to-treat (ITT) and control groups. ITT group received telephonic social care management and 12 months of follow-up. Various multivariate analyses were used to evaluate mortality risk throughout multiple study periods controlling for sociodemographic characteristics, health status, and health care utilization. Older adults (65+) enrolled in a Medicare managed care plan who had high health care utilization in the previous year. ITT group had a significantly lower odds of mortality throughout the study (OR=0.55; p=.005) and during the care management intervention (OR=0.45; p=.006), whereas differential risk in the postintervention period was not statistically significant. Other significant predictors of mortality were age, gender, three chronic conditions (cancer, heart disease, and kidney disease), and emergency room utilization. Findings suggest that the care advocate model of social care management affected mortality while the program was in progress, but not after completion of the intervention phase. Key model elements accounted for the findings, which include individualized targeting, assessment, and monitoring; consumer choice, control, and participant self-management; and bridging medical and social service delivery systems through direct linkages and communication.

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.

Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial.

PubMed

Lund, Stine; Rasch, Vibeke; Hemed, Maryam; Boas, Ida Marie; Said, Azzah; Said, Khadija; Makundu, Mkoko Hassan; Nielsen, Birgitte Bruun

2014-03-26

Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse. We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting. This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality. Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74). Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings. ClinicalTrials.gov NCT01821222; http://www.clinicaltrials.gov/ct2/show/NCT01821222 (Archived by WebCite at http://www.webcitation.org/6NqxnxYn0).

A novel behavioral intervention in adolescents with type 1 diabetes mellitus improves glycemic control: preliminary results from a pilot randomized control trial.

PubMed

Maranda, Louise; Lau, May; Stewart, Sunita M; Gupta, Olga T

2015-04-01

The purpose of this study was to develop and pilot-test an innovative behavioral intervention in adolescents with type 1 diabetes mellitus (T1DM) incorporating structured care of a pet to improve glycemic control. Twenty-eight adolescents with A1C > 8.5% (69 mmol/mol) were randomly assigned to either the intervention group (care of a Betta splendens pet fish) or the control group (usual care). Adolescents in the intervention group were given instructions to associate daily and weekly fish care duties with diabetes self-management tasks, including blood glucose testing and parent-adolescent communication. After 3 months, the participants in the intervention group exhibited a statistically significant decrease in A1C level (-0.5%) compared with their peers in the control group, who had an increase in A1C level (0.8%) (P = .04). The younger adolescents (10-13 years of age) demonstrated a greater response to the intervention, which was statistically significant (-1.5% vs 0.6%, P = .04), compared with the older adolescents (14-17 years of age). Structured care of a pet fish can improve glycemic control in adolescents with T1DM, likely by providing cues to perform diabetes self-management behaviors. © 2015 The Author(s).

Nasal Continuous Positive Airway Pressure in Bronchiolitis: A Randomized Controlled Trial.

PubMed

Lal, Sandeep Narayan; Kaur, Jaspreet; Anthwal, Pooja; Goyal, Kanika; Bahl, Pinky; Puliyel, Jacob M

2018-01-15

To evaluate the efficacy of nasal continuous positive airway pressure (nCPAP) in decreasing respiratory distress in bronchiolitis. Randomized controlled trial. Tertiary-care hospital in New Delhi, India. Participants: 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. The outcome was assessed after 60 minutes. If nCPAP was not tolerated or the distress increased, the infant was switched to standard care. Analysis was done on intention-to-treat basis. Change in respiratory rate, Silverman-Anderson score and a Modified Pediatric Society of New Zealand Severity Score. 14 out of 32 in nCPAP group and 5 out of 35 in standard care group had change in respiratory rate ≥10 (P=0.008). The mean (SD) change in respiratory rate [8.0 (5.8) vs 5.1 (4.0), P=0.02] in Silverman-Anderson score [0.78 (0.87) vs 0.39 (0.73), P=0.029] and in Modified Pediatric Society of New Zealand Severity Score [2.5 (3.01) vs. 1.08 (1.3), P=0.012] were significantly different in the nCPAP and standard care groups, respectively. nCPAP helped reduce respiratory distress significantly compared to standard care.

Continued smoking abstinence in diabetic patients in primary care: a cluster randomized controlled multicenter study.

PubMed

Pérez-Tortosa, Santiago; Roig, Lydia; Manresa, Josep M; Martin-Cantera, Carlos; Puigdomènech, Elisa; Roura, Pilar; Armengol, Angelina; Advani, Mamta

2015-01-01

To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change (TTM) in diabetic smokers attending primary care. A cluster randomized controlled clinical trial was designed in which the unit of randomization (intervention vs. usual care) was the primary care team. An intensive, individualized intervention using motivational interview and therapies and medications adapted to the patient's stage of change was delivered. The duration of the study was 1 year. A total of 722 people with diabetes who were smokers (345 in the intervention group and 377 in the control group) completed the study. After 1 year, continued abstinence was recorded in 90 (26.1%) patients in the intervention group and in 67 (17.8%) controls (p=0.007). In patients with smoking abstinence, there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls (21.2% vs. 13.7%, p=0.024). When the precontemplation stage was taken as reference (OR=1.0), preparation/action stage at baseline showed a protective effect, decreasing 3.41 times odds of continuing smoking (OR=0.293 95% CI 0.179-0.479, p<0.001). Contemplation stage at baseline also showed a protective effect, decreasing the odds of continuing smoking (OR=0.518, 95% CI 0.318-0.845, p=0.008). An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective, with a smoking cessation rate of 26.1% after 1 year. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A randomized, controlled trial of bright light therapy for agitated behaviors in dementia patients residing in long-term care.

PubMed

Lyketsos, C G; Lindell Veiel, L; Baker, A; Steele, C

1999-07-01

Agitated behaviors are common in dementia patients residing in chronic care settings. Their occurrence may be associated with lack of adequate exposure to sunlight and with circadian rhythm disturbances. Prior research has suggested that bright light therapy (BLT) may reduce agitated behaviors in dementia patients. The aim of this study was to test the efficacy of BLT in a randomized, controlled, crossover clinical trial. Fifteen patients with dementia and agitated behaviors residing in a chronic care facility were randomized in a crossover design to morning BLT for 1 hour per day or to a control condition with dim light exposure. Patients were treated in either condition for 4 weeks, followed by 1 week on no treatment, prior to being crossed over to the other condition. Eight out of 15 patients completed the entire study. The rest completed at least 2 weeks of study. Patients randomized to the BLT condition exhibited a statistically significant improvement in nocturnal sleep from a mean of 6.4 hours/night to 8.1 hours/night 4 weeks later (p<0.05). The sleep of patients in the control condition did not improve significantly. There were no other significant differences between baseline and follow-up, nor between BLT and control treated patients on the other outcome measures, which included the Behavioral Pathology in Alzheimer Disease scale (Behave-AD) and the Cornell Scale for Depression in Dementia. Patients with dementia in chronic care who exhibit agitated behaviors sleep more hours at night when administered morning BLT. However, BLT does not lead to improvements in agitated behaviors in institutionalized patients with dementia with non-disturbed sleep-wake cycles. Copyright 1999 John Wiley & Sons, Ltd.

A randomized controlled trial of a Return-to-Work Coordinator model of care in a general hospital to facilitate return to work of injured workers.

PubMed

Tan, Heidi Siew Khoon; Yeo, Doreen Sai Ching; Giam, Joanna Yu Ting; Cheong, Florence Wai Fong; Chan, Kay Fei

2016-04-07

Return-to-work (RTW) programmes for injured workers have been prevalent in Western countries with established work injury management policies for decades. In recent years, more Asian countries have started to develop RTW programmes in the absence of work injury management policies. However, few studies have evaluated the effectiveness of RTW programmes in Asia. Return-to-work coordination has been found to be an important facilitator in RTW programmes. This study seeks to determine the effectiveness of a Return-to-work coordinator (RTWC) model of care in facilitating early RTW for injured workers in Singapore. A randomized controlled trial was used. 160 injured workers in a general hospital were randomly allocated to either control (receive usual hospital standard care) or intervention (assigned a RTWC) group. The RTWC closely supported RTW arrangements and proactively liaised with employers and healthcare professionals on RTW solutions for the injured workers. At three months post injury, workers in the intervention group RTW 10 days earlier than the control group, with a higher proportion of workers in the intervention group returning to modified jobs. There were no significant differences in the quality of life measures between the two groups. The addition of a RTWC into the hospital model of care is effective in facilitating early RTW for injured workers. This could be a potential model of care for injured workers in Asian countries where work injury management policies are not yet established.

The Aged Residential Care Healthcare Utilization Study (ARCHUS): a multidisciplinary, cluster randomized controlled trial designed to reduce acute avoidable hospitalizations from long-term care facilities.

PubMed

Connolly, Martin J; Boyd, Michal; Broad, Joanna B; Kerse, Ngaire; Lumley, Thomas; Whitehead, Noeline; Foster, Susan

2015-01-01

To assess effect of a complex, multidisciplinary intervention aimed at reducing avoidable acute hospitalization of residents of residential aged care (RAC) facilities. Cluster randomized controlled trial. RAC facilities with higher than expected hospitalizations in Auckland, New Zealand, were recruited and randomized to intervention or control. A total of 1998 residents of 18 intervention facilities and 18 control facilities. A facility-based complex intervention of 9 months' duration. The intervention comprised gerontology nurse specialist (GNS)-led staff education, facility bench-marking, GNS resident review, and multidisciplinary (geriatrician, primary-care physician, pharmacist, GNS, and facility nurse) discussion of residents selected using standard criteria. Primary end point was avoidable hospitalizations. Secondary end points were all acute admissions, mortality, and acute bed-days. Follow-up was for a total of 14 months. The intervention did not affect main study end points: number of acute avoidable hospital admissions (RR 1.07; 95% CI 0.85-1.36; P = .59) or mortality (RR 1.11; 95% CI 0.76-1.61; P = .62). This multidisciplinary intervention, packaging selected case review, and staff education had no overall impact on acute hospital admissions or mortality. This may have considerable implications for resourcing in the acute and RAC sectors in the face of population aging. Australian and New Zealand Clinical Trials Registry (ACTRN12611000187943). Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Primary care quality: community health center and health maintenance organization.

PubMed

Shi, Leiyu; Starfield, Barbara; Xu, Jiahong; Politzer, Robert; Regan, Jerrilyn

2003-08-01

This study compares the primary health care quality of community health centers (CHCs) and health maintenance organizations (HMOs) in South Carolina to elucidate the quality of CHC performance relative to mainstream settings such as the HMO. Mail surveys were used to obtain data from 350 randomly selected HMO users. Surveys with follow-up interviews were conducted to obtain data from 540 randomly selected CHC users. A validated adult primary care assessment tool was used in both surveys. Multivariate analyses were performed to assess the association of health care setting (HMO versus CHC) with primary care quality while controlling for sociodemographic and health care characteristics. After controlling for sociodemographic and health care use measures, CHC patients demonstrated higher scores in several primary care domains (ongoing care, coordination of service, comprehensiveness, and community orientation) as well as total primary care performance. Users of CHC are more likely than HMO users to rate their primary health care provider as good, except in the area of ease of first contact. The positive rating of the CHC is particularly impressive after taking into account that many CHC users have characteristics associated with poorer ratings of care.

The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review.

PubMed

Demarzo, Marcelo M P; Montero-Marin, Jesús; Cuijpers, Pim; Zabaleta-del-Olmo, Edurne; Mahtani, Kamal R; Vellinga, Akke; Vicens, Caterina; López-del-Hoyo, Yolanda; García-Campayo, Javier

2015-11-01

Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients. We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models. The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I(2) = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I(2) = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I(2) = 0; P >.05). Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care. © 2015 Annals of Family Medicine, Inc.

Measurement, Education and Tracking in Integrated Care (METRIC): use of a culturally adapted education tool versus standard education to increase engagement in depression treatment among Hispanic patients: study protocol for a randomized control trial.

PubMed

Sanchez, Katherine; Eghaneyan, Brittany H; Killian, Michael O; Cabassa, Leopoldo; Trivedi, Madhukar H

2017-08-03

Significant mental health disparities exist for Hispanic populations, especially with regard to depression treatment. Stigma and poor communication between patients and their providers result in low use of antidepressant medications and early treatment withdrawal. Cultural factors which influence treatment decisions among Hispanics include fears about the addictive and harmful properties of antidepressants, worries about taking too many pills, and the stigma attached to taking medications. Primary care settings often are the gateway to identifying undiagnosed or untreated mental health disorders, particularly for people with co-morbid physical health conditions. Hispanics, in particular, are more likely to receive mental healthcare in primary care settings. Recent recommendations from the U.S. Preventive Services Task Force are that primary care providers screen adult patients for depression only if systems are in place to ensure adequate treatment and follow-up. We are conducting a randomized controlled trial among 150 depressed adult Hispanics in a primary care safety net setting, testing the effectiveness of a culturally appropriate depression education intervention to reduce stigma and increase uptake in depression treatment among Hispanics, and implement a Measurement-Based Integrated Care (MBIC) model with collaborative, multidisciplinary treatment and culturally tailored care management strategies. This study protocol represents the first randomized control trial of the culturally adapted depression education fotonovela, Secret Feelings, among Hispanics in a primary care setting. The education intervention will be implemented after diagnosis using an innovative screening technology and enrolled in measurement-based integrated care for the treatment of depression, which will help build the evidence around cultural adaptations in treatment to reduce mental health disparities. ClinicalTrials.gov, NCT02702596. Registered on 20 March 2016.

Randomized controlled trial of Anticipatory and Preventive multidisciplinary Team Care

PubMed Central

Hogg, William; Lemelin, Jacques; Dahrouge, Simone; Liddy, Clare; Armstrong, Catherine Deri; Legault, Frances; Dalziel, Bill; Zhang, Wei

2009-01-01

ABSTRACT OBJECTIVE T o examine whether quality of care (QOC) improves when nurse practitioners and pharmacists work with family physicians in community practice and focus their work on patients who are 50 years of age and older and considered to be at risk of experiencing adverse health outcomes. DESIGN Randomized controlled trial. SETTING A family health network with 8 family physicians, 5 nurses, and 11 administrative personnel serving 10 000 patients in a rural area near Ottawa, Ont. PARTICIPANTS Patients 50 years of age and older at risk of experiencing adverse health outcomes (N = 241). INTERVENTIONS At-risk patients were randomly assigned to receive usual care from their family physicians or Anticipatory and Preventive Team Care (APTCare) from a collaborative team composed of their physicians, 1 of 3 nurse practitioners, and a pharmacist. MAIN OUTCOME MEASURES Quality of care for chronic disease management (CDM) for diabetes, coronary artery disease, congestive heart failure, and chronic obstructive pulmonary disease. RESULTS Controlling for baseline demographic characteristics, the APTCare approach improved CDM QOC by 9.2% (P < .001) compared with traditional care. The APTCare intervention also improved preventive care by 16.5% (P < .001). We did not observe significant differences in other secondary outcome measures (intermediate clinical outcomes, quality of life [Short-Form 36 and health-related quality of life scales], functional status [instrumental activities of daily living scale] and service usage). CONCLUSION Additional resources in the form of collaborative multidisciplinary care teams with intensive interventions in primary care can improve QOC for CDM in a population of older at-risk patients. The appropriateness of this intervention will depend on its cost-effectiveness. TRIAL REGISTRATION NUMBER NCT00238836 (CONSORT) PMID:20008582

The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review

PubMed Central

Demarzo, Marcelo M.P.; Montero-Marin, Jesús; Cuijpers, Pim; Zabaleta-del-Olmo, Edurne; Mahtani, Kamal R.; Vellinga, Akke; Vicens, Caterina; López-del-Hoyo, Yolanda; García-Campayo, Javier

2015-01-01

PURPOSE Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients. METHODS We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models. RESULTS The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I2 = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I2 = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I2 = 0; P >.05). CONCLUSIONS Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care. PMID:26553897

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

PubMed Central

2011-01-01

Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. Trial Registration http://www.clinicaltrials.gov NCT00302718 PMID:21967830

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

PubMed

Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

2015-07-01

Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol.

PubMed

Petersen, Laura A; Urech, Tracy; Simpson, Kate; Pietz, Kenneth; Hysong, Sylvia J; Profit, Jochen; Conrad, Douglas; Dudley, R Adams; Lutschg, Meghan Z; Petzel, Robert; Woodard, Lechauncy D

2011-10-03

Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. http://www.clinicaltrials.govNCT00302718.

Graded activity for low back pain in occupational health care: a randomized, controlled trial.

PubMed

Staal, J Bart; Hlobil, Hynek; Twisk, Jos W R; Smid, Tjabe; Köke, Albère J A; van Mechelen, Willem

2004-01-20

Low back pain is a common medical and social problem frequently associated with disability and absence from work. However, data on effective return to work after interventions for low back pain are scarce. To determine the effectiveness of a behavior-oriented graded activity program compared with usual care. Randomized, controlled trial. Occupational health services department of an airline company in the Netherlands. 134 workers who were absent from work because of low back pain were randomly assigned to either graded activity (n = 67) or usual care (n = 67). Graded activity, a physical exercise program based on operant-conditioning behavioral principles, to stimulate a rapid return to work. Outcomes were the number of days of absence from work because of low back pain, functional status (Roland Disability Questionnaire), and severity of pain (11-point numerical scale). The median number of days of absence from work over 6 months of follow-up was 58 days in the graded activity group and 87 days in the usual care group. From randomization onward, graded activity was effective after 50 days of absence from work (hazard ratio, 1.9 [95% CI, 1.2 to 3.2]; P = 0.009). The graded activity group was more effective in improving functional status and pain than the usual care group. The effects, however, were small and not statistically significant. Graded activity was more effective than usual care in reducing the number of days of absence from work because of low back pain.

Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy | Division of Cancer Prevention

Cancer.gov

RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It is not yet known whether standard care is more effective with or without acupressure wristbands in controlling acute and delayed nausea. PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

PubMed Central

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

2015-01-01

Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

Does telemedicine improve treatment outcomes for diabetes? A meta-analysis of results from 55 randomized controlled trials.

PubMed

Su, Dejun; Zhou, Junmin; Kelley, Megan S; Michaud, Tzeyu L; Siahpush, Mohammad; Kim, Jungyoon; Wilson, Fernando; Stimpson, Jim P; Pagán, José A

2016-06-01

To assess the overall effect of telemedicine on diabetes management and to identify features of telemedicine interventions that are associated with better diabetes management outcomes. Hedges's g was estimated as the summary measure of mean difference in HbA1c between patients with diabetes who went through telemedicine care and those who went through conventional, non-telemedicine care using a random-effects model. Q statistics were calculated to assess if the effect of telemedicine on diabetes management differs by types of diabetes, age groups of patients, duration of intervention, and primary telemedicine approaches used. The analysis included 55 randomized controlled trials with a total of 9258 patients with diabetes, out of which 4607 were randomized to telemedicine groups and 4651 to conventional, non-telemedicine care groups. The results favored telemedicine over conventional care (Hedges's g=-0.48, p<0.001) in diabetes management. The beneficial effect of telemedicine were more pronounced among patients with type 2 diabetes (Hedges's g=-0.63, p<0.001) than among those with type 1 diabetes (Hedges's g=-0.27, p=0.027) (Q=4.25, p=0.04). Compared to conventional care, telemedicine is more effective in improving treatment outcomes for diabetes patients, especially for those with type 2 diabetes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Protocol of an ongoing randomized controlled trial of care management for comorbid depression and hypertension: the Chinese Older Adult Collaborations in Health (COACH) study.

PubMed

Chen, Shulin; Conwell, Yeates; Xue, Jiang; Li, Lydia W; Tang, Wan; Bogner, Hillary R; Dong, Hengjin

2018-05-29

Depression and hypertension are common, costly, and destructive conditions among the rapidly aging population of China. The two disorders commonly coexist and are poorly recognized and inadequately treated, especially in rural areas. The Chinese Older Adult Collaborations in Health (COACH) Study is a cluster randomized controlled trial (RCT) designed to test the hypotheses that the COACH intervention, designed to manage comorbid depression and hypertension in older adult, rural Chinese primary care patients, will result in better treatment adherence and greater improvement in depressive symptoms and blood pressure control, and better quality of life, than enhanced Care-as-Usual (eCAU). Based on chronic disease management and collaborative care principles, the COACH model integrates the care provided by the older person's primary care provider (PCP) with that delivered by an Aging Worker (AW) from the village's Aging Association, supervised by a psychiatrist consultant. One hundred sixty villages, each of which is served by one PCP, will be randomly selected from two counties in Zhejiang Province and assigned to deliver eCAU or the COACH intervention. Approximately 2400 older adult residents from the selected villages who have both clinically significant depressive symptoms and a diagnosis of hypertension will be recruited into the study, randomized by the villages in which they live and receive primary care. After giving informed consent, they will undergo a baseline research evaluation; receive treatment for 12 months with the approach to which their village was assigned; and be re-evaluated at 3, 6, 9, and 12 months after entry. Depression and HTN control are the primary outcomes. Treatment received, health care utilization, and cost data will be obtained from the subjects' electronic medical records (EMR) and used to assess adherence to care recommendations and, in a preliminary manner, to establish cost and cost effectiveness of the intervention. The COACH intervention is designed to serve as a model for primary care-based management of common mental disorders that occur in tandem with common chronic conditions of later life. It leverages existing resources in rural settings, integrates social interventions with the medical model, and is consistent with the cultural context of rural life. ClinicalTrials.gov ID: NCT01938963 ; First posted: September 10, 2013.

[Realization of design regarding experimental research in the clinical real-world research].

PubMed

He, Q; Shi, J P

2018-04-10

Real world study (RWS), a further verification and supplement for explanatory randomized controlled trial to evaluate the effectiveness of intervention measures in real clinical environment, has increasingly become the focus in the field of research on medical and health care services. However, some people mistakenly equate real world study with observational research, and argue that intervention and randomization cannot be carried out in real world study. In fact, both observational and experimental design are the basic designs in real world study, while the latter usually refers to pragmatic randomized controlled trial and registry-based randomized controlled trial. Other nonrandomized controlled and adaptive designs can also be adopted in the RWS.

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

A Participatory Randomized Controlled Trial in Knowledge Translation (KT) to Promote the Adoption of Self-Monitoring of Blood Glucose for Type 2 Diabetes Mellitus Patients in An Urban District of Thailand.

PubMed

Suriyawongpaisal, Paibul; Tansirisithikul, Rassamee; Sakulpipat, Thida; Charoensuk, Phikul; Aekplakorn, Wichai

2016-02-01

To examine effectiveness of self-monitoring of blood glucose (SMBG) in glycemic control for poor control diabetes patients, and test whether the glycemic outcome for those with the 7-point SMBG was better than those with 5-point SMBG or usual care. Randomized-controlled trial (RCT) of patients with type 2 diabetes mellitus aged 30 years or older HbA1c > 7. Patients were randomly allocated to one of three groups; 7-point SMBG 5-point SBMG and control group. Differences in HbA1c at 6 months and baseline were compared among groups. A total of 191 patients with poor control of diabetes were included. Compared with baseline, at 6 months, average change in HbAlc among control, 7-point, and 5-point SMBG were -0.38, -0.87, and -0.99 (p = 0.04), respectively. The corresponding percentages of patients with reduced HbA1c were 57.1%, 77.6% and 75.5%, respectively (p = 0.03). Using different cut-off values for HbA1c (< 7 and < 7.5) resulted in different percentage distribution of T2DM patients among the 3 groups, yet the differences were not statistically significant. Reductions in body weight were observed in both SMBG groups but not in the control group. Using RCT on participatory basis, SMBG with individual dietary counseling was effective in short term. Further engagement with the provider team, the patients/care takers and the health care financing agency to integrate SMBG in the care protocol for poor control diabetes should be considered.

Implementation of client versus care-provider strategies to improve external cephalic version rates: a cluster randomized controlled trial.

PubMed

Vlemmix, Floortje; Rosman, Ageeth N; Rijnders, Marlies E; Beuckens, Antje; Opmeer, Brent C; Mol, Ben W J; Kok, Marjolein; Fleuren, Margot A H

2015-05-01

To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version. Cluster randomized controlled trial. Twenty-five clusters; hospitals and their referring midwifery practices randomly selected in the Netherlands. Singleton breech presentation from 32 weeks of gestation onwards. We randomized clusters to a client strategy (written information leaflets and decision aid), a care-provider strategy (1-day counseling course focused on knowledge and counseling skills), a combined client and care-provider strategy and care-as-usual strategy. We performed an intention-to-treat analysis. Rate of external cephalic version in various strategies. Secondary outcomes were the percentage of women counseled and opting for a version attempt. The overall implementation rate of external cephalic version was 72% (1169 of 1613 eligible clients) with a range between clusters of 8-95%. Neither the client strategy (OR 0.8, 95% CI 0.4-1.5) nor the care-provider strategy (OR 1.2, 95% CI 0.6-2.3) showed significant improvements. Results were comparable when we limited the analysis to those women who were actually offered intervention (OR 0.6, 95% CI 0.3-1.4 and OR 2.0, 95% CI 0.7-4.5). Neither a client nor a care-provider strategy improved the external cephalic version implementation rate for breech presentation, neither with regard to the number of version attempts offered nor the number of women accepting the procedure. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

PubMed Central

2011-01-01

Background Many newly screened people living with HIV (PLHIV) in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV) care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400) from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills), the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up) pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1). No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by community support agents had a significant effect on uptake of pre-ARV care and appears to be a cost-effective way to increase the prerequisites for timely ARV initiation. Trial registration The trial was registered by Current Controlled Trials Ltd C/OBioMed Central Ltd as ISRCTN94133652 and received financial support from Sida and logistical support from the European Commission. PMID:21794162

Population-centered Risk- and Evidence-based Dental Interprofessional Care Team (PREDICT): study protocol for a randomized controlled trial.

PubMed

Cunha-Cruz, Joana; Milgrom, Peter; Shirtcliff, R Michael; Bailit, Howard L; Huebner, Colleen E; Conrad, Douglas; Ludwig, Sharity; Mitchell, Melissa; Dysert, Jeanne; Allen, Gary; Scott, JoAnna; Mancl, Lloyd

2015-06-20

To improve the oral health of low-income children, innovations in dental delivery systems are needed, including community-based care, the use of expanded duty auxiliary dental personnel, capitation payments, and global budgets. This paper describes the protocol for PREDICT (Population-centered Risk- and Evidence-based Dental Interprofessional Care Team), an evaluation project to test the effectiveness of new delivery and payment systems for improving dental care and oral health. This is a parallel-group cluster randomized controlled trial. Fourteen rural Oregon counties with a publicly insured (Medicaid) population of 82,000 children (0 to 21 years old) and pregnant women served by a managed dental care organization are randomized into test and control counties. In the test intervention (PREDICT), allied dental personnel provide screening and preventive services in community settings and case managers serve as patient navigators to arrange referrals of children who need dentist services. The delivery system intervention is paired with a compensation system for high performance (pay-for-performance) with efficient performance monitoring. PREDICT focuses on the following: 1) identifying eligible children and gaining caregiver consent for services in community settings (for example, schools); 2) providing risk-based preventive and caries stabilization services efficiently at these settings; 3) providing curative care in dental clinics; and 4) incentivizing local delivery teams to meet performance benchmarks. In the control intervention, care is delivered in dental offices without performance incentives. The primary outcome is the prevalence of untreated dental caries. Other outcomes are related to process, structure and cost. Data are collected through patient and staff surveys, clinical examinations, and the review of health and administrative records. If effective, PREDICT is expected to substantially reduce disparities in dental care and oral health. PREDICT can be disseminated to other care organizations as publicly insured clients are increasingly served by large practice organizations. ClinicalTrials.gov NCT02312921 6 December 2014. The Robert Wood Johnson Foundation and Advantage Dental Services, LLC, are supporting the evaluation.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial.

PubMed

Goertz, Christine M; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Andresen, Andrew A; Jones, Mark E; Lyons, Kevin J; Hondras, Maria A; Killinger, Lisa Z; Wolinsky, Fredric D; Wallace, Robert B

2013-01-16

Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes. This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain.

The impact of health coaching on medication adherence in patients with poorly controlled diabetes, hypertension, and/or hyperlipidemia: a randomized controlled trial.

PubMed

Thom, David H; Willard-Grace, Rachel; Hessler, Danielle; DeVore, Denise; Prado, Camille; Bodenheimer, Thomas; Chen, Ellen

2015-01-01

Lack of concordance between medications listed in the medical record and taken by the patient contributes to poor outcomes. We sought to determine whether patients who received health coaching by medical assistants improved their medication concordance and adherence. This was a nonblinded, randomized, controlled, pragmatic intervention trial. English- or Spanish-speaking patients, age 18 to 75 years, with poorly controlled type 2 diabetes, hypertension, and/or hyperlipidemia were enrolled from 2 urban safety net clinics and randomized to receive 12 months of health coaching versus usual care. Outcomes included concordance between medications documented in the medical record and those reported by the patient and adherence based on the patient-reported number of days (of the last 7) on which patient took all prescribed medications. The proportion of medications completely concordant increased in the coached group versus the usual care group (difference in change, 10%; P = .05). The proportion of medications listed in the chart but not taken significantly decreased in the coached group compared with the usual care group (difference in change, 17%; P = .013). The mean number of adherent days increased in the coached but not in the usual care group (difference in change, 1.08; P < .001). Health coaching by medical assistants significantly increases medication concordance and adherence. © Copyright 2015 by the American Board of Family Medicine.

Randomized Controlled Trial Comparing Collagen/Oxidized Regenerated Cellulose/Silver to Standard of Care in the Management of Venous Leg Ulcers.

PubMed

Cullen, Breda M; Serena, Thomas E; Gibson, Molly C; Snyder, Robert J; Hanft, Jason R; Yaakov, Raphael A

2017-10-01

To assess healing outcomes in venous leg ulcers (VLUs) treated with a combination of collagen, oxidized regenerated cellulose, and silver in conjunction with standard of care (SOC; intervention group) compared with SOC alone (control group). Standard of care included ADAPTIC nonadhering dressing (Acelity, San Antonio, Texas) and compression. Randomized controlled trial that followed patients in 3 US facilities for 12 weeks or until complete healing. Forty-nine patients with VLUs were randomized to either the intervention group (n = 22) or the control group (n = 27). Wound healing over 12 weeks. Intent-to-treat analysis showed a mean percentage wound area reduction at 12 weeks of 85.6% (SD, 28.6%) for the intervention group and 72.5% (SD, 77.8%) for the control group. There was a higher healing rate in the intervention group compared with patients who received SOC only at both week 4 (23% vs 11%) and week 12 (64% vs 59%). There were no adverse events related to the study therapy. Although the results were not significant, there was a trend toward faster healing in the intervention group. The results of this study indicate that collagen/oxidized regenerated cellulose/silver is a suitable and safe adjunctive intervention for use with SOC to manage VLUs.

The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

PubMed Central

Zelkowitz, Phyllis; Feeley, Nancy; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

2008-01-01

Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues) in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues) intervention or to an attention control (Care) condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will provide important information on the efficacy of a brief, skills-based intervention to reduce anxiety and increase sensitivity in mothers of very low birthweight infants. A brief intervention of this nature may be more readily implemented as part of standard neonatal intensive care than broad-based, multi-component interventions. By intervening early, we aim to optimize developmental outcomes in these high risk infants. Trial Registration Current Controlled Trials ISRCTN00918472 The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants PMID:18822128

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.

Methods for a study of Anticipatory and Preventive multidisciplinary Team Care in a family practice.

PubMed

Dahrouge, Simone; Hogg, William; Lemelin, Jacques; Liddy, Clare; Legault, Frances

2010-02-01

BACKGROUND T o examine the methodology used to evaluate whether focusing the work of nurse practitioners and a pharmacist on frail and at-risk patients would improve the quality of care for such patients. Evaluation of methodology of a randomized controlled trial including analysis of quantitative and qualitative data over time and analysis of cost-effectiveness. A single practice in a rural area near Ottawa, Ont. A total of 241 frail patients, aged 50 years and older, at risk of experiencing adverse health outcomes. At-risk patients were randomly assigned to receive Anticipatory and Preventive Team Care (from their family physicians, 1 of 3 nurse practitioners, and a pharmacist) or usual care. The principal outcome for the study was the quality of care for chronic disease management. Secondary outcomes included other quality of care measures and evaluation of the program process and its cost-effectiveness. This article examines the effectiveness of the methodology used. Quantitative data from surveys, administrative databases, and medical records were supplemented with qualitative information from interviews, focus groups, work logs, and study notes. Three factors limit our ability to fully demonstrate the potential effects of this team structure. For reasons outside our control, the intervention duration was shorter than intended; the practice's physical layout did not facilitate interactions between the care providers; and contamination of the intervention effect into the control arm cannot be excluded. The study used a randomized design, relied on a multifaceted approach to evaluating its effects, and used several sources of data. TRIAL REGISTRATION NUMBER NCT00238836 (CONSORT).

Effect of aerobic exercise on peripheral nerve functions of population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, parallel group randomized controlled trial.

PubMed

Dixit, Snehil; Maiya, Arun G; Shastry, B A

2014-01-01

To evaluate the effect of moderate intensity aerobic exercise (40%-60% of Heart Rate Reserve (HRR)) on diabetic peripheral neuropathy. A parallel-group, randomized controlled trial was carried out in a tertiary health care setting, India. The study comprised of experimental (moderate intensity aerobic exercise and standard care) and control groups (standard care). Population with type 2 diabetes with clinical neuropathy, defined as a minimum score of seven on the Michigan Diabetic Neuropathy Score (MDNS), was randomly assigned to experimental and control groups by computer generated random number tables. RANOVA was used for data analysis (p<0.05 was significant). A total of 87 patients with DPN were evaluated in the study. After randomization there were 47 patients in the control group and 40 patients in the experimental group. A comparison of two groups using RANOVA for anthropometric measures showed an insignificant change at eight weeks. For distal peroneal nerve's conduction velocity there was a significant difference in two groups at eight weeks (p<0.05), Degrees of freedom (Df)=1, 62, F=5.14, and p=0.03. Sural sensory nerve at eight weeks showed a significant difference in two groups for conduction velocity, Df =1, 60, F=10.16, and p=0.00. Significant differences in mean scores of MDNS were also observed in the two groups at eight weeks (p value significant<0.05). Moderate intensity aerobic exercises can play a valuable role to disrupt the normal progression of DPN in type 2 diabetes. Copyright © 2014 Elsevier Inc. All rights reserved.

Comparison of the Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Therapy on the Upper Trapezius in Myofascial Pain Syndrome: A Randomized Controlled Study.

PubMed

Dissanayaka, Thusharika Dilrukshi; Pallegama, Ranjith Wasantha; Suraweera, Hilari Justus; Johnson, Mark I; Kariyawasam, Anula Padma

2016-09-01

The aim of this study was to compare the effectiveness of transcutaneous electrical nerve stimulation and interferential therapy (IFT) both in combination with hot pack, myofascial release, active range of motion exercise, and a home exercise program on myofascial pain syndrome patients with upper trapezius myofascial trigger point. A total of 105 patients with an upper trapezius myofascial trigger point were recruited to this single-blind randomized controlled trial. Following random allocation of patients to three groups, three therapeutic regimens-control-standard care (hot pack, active range of motion exercises, myofascial release, and a home exercise program with postural advice), transcutaneous electrical nerve stimulation-standard care and IFT-standard care-were administered eight times during 4 wks at regular intervals. Pain intensity and cervical range of motions (cervical extension, lateral flexion to the contralateral side, and rotation to the ipsilateral side) were measured at baseline, immediately after the first treatment, before the eighth treatment, and 1 wk after the eighth treatment. Immediate and short-term improvements were marked in the transcutaneous electrical nerve stimulation group (n = 35) compared with the IFT group (n = 35) and the control group (n = 35) with respect to pain intensity and cervical range of motions (P < 0.05). The IFT group showed significant improvement on these outcome measurements than the control group did (P < 0.05). Transcutaneous electrical nerve stimulation with standard care facilitates recovery better than IFT does in the same combination.

Testing a stepped care model for binge-eating disorder: a two-step randomized controlled trial.

PubMed

Tasca, Giorgio A; Koszycki, Diana; Brugnera, Agostino; Chyurlia, Livia; Hammond, Nicole; Francis, Kylie; Ritchie, Kerri; Ivanova, Iryna; Proulx, Genevieve; Wilson, Brian; Beaulac, Julie; Bissada, Hany; Beasley, Erin; Mcquaid, Nancy; Grenon, Renee; Fortin-Langelier, Benjamin; Compare, Angelo; Balfour, Louise

2018-05-24

A stepped care approach involves patients first receiving low-intensity treatment followed by higher intensity treatment. This two-step randomized controlled trial investigated the efficacy of a sequential stepped care approach for the psychological treatment of binge-eating disorder (BED). In the first step, all participants with BED (n = 135) received unguided self-help (USH) based on a cognitive-behavioral therapy model. In the second step, participants who remained in the trial were randomized either to 16 weeks of group psychodynamic-interpersonal psychotherapy (GPIP) (n = 39) or to a no-treatment control condition (n = 46). Outcomes were assessed for USH in step 1, and then for step 2 up to 6-months post-treatment using multilevel regression slope discontinuity models. In the first step, USH resulted in large and statistically significant reductions in the frequency of binge eating. Statistically significant moderate to large reductions in eating disorder cognitions were also noted. In the second step, there was no difference in change in frequency of binge eating between GPIP and the control condition. Compared with controls, GPIP resulted in significant and large improvement in attachment avoidance and interpersonal problems. The findings indicated that a second step of a stepped care approach did not significantly reduce binge-eating symptoms beyond the effects of USH alone. The study provided some evidence for the second step potentially to reduce factors known to maintain binge eating in the long run, such as attachment avoidance and interpersonal problems.

Web-based proactive system to improve breast cancer screening: a randomized controlled trial.

PubMed

Chaudhry, Rajeev; Scheitel, Sidna M; McMurtry, Erin K; Leutink, Dorinda J; Cabanela, Rosa L; Naessens, James M; Rahman, Ahmed S; Davis, Lynn A; Stroebel, Robert J

2007-03-26

Screening mammography is recommended for early detection of breast cancer but screening rates remain suboptimal. A primary care portal for a large academic primary practice was developed for all preventive services. Another Web-based system (PRECARES [PREventive CAre REminder System]) was developed for appointment secretaries to manage proactive breast cancer screening. Female patients aged 40 to 75 years were randomly assigned to a control group (usual care) and an intervention group. For the intervention group, 2 monthly letters inviting patients to undergo mammography were sent starting 3 months before they were due for annual screening, followed by a telephone call to nonresponding patients. A subgroup of women employees was further randomized to receive a reminder by either US mail or e-mail. Of the total eligible population of 6665 women identified as having consented to participate in research, 3339 were randomly assigned to the control group and 3326 to the intervention group. The screening rate for annual mammography was 64.3% for the intervention group and 55.3% for the control group (P <.001). There were no significant differences between the 2 groups for any of the other adult preventive services. For the employee subgroup, the screening rate was 57.5% for the control group, 68.1% for the US mail group, and 72.2% for the e-mail group (intervention vs control, P <.001; e-mail vs US mail; P = .24). The breast cancer screening rate improved significantly with the practice redesign of having appointment secretaries proactively manage breast cancer screening needs.

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.

Randomized Controlled Trial of Abstinence and Safer Sex Intervention for Adolescents in Singapore: 6-Month Follow-Up

ERIC Educational Resources Information Center

Wong, Mee Lian; Ng, Junice Y. S.; Chan, Roy K. W.; Chio, Martin T. W.; Lim, Raymond B. T.; Koh, David

2017-01-01

We assessed the efficacy of an individual-based behavioral intervention on sexually transmitted infections' (STI) risk-reduction behaviors in Singapore. A randomized controlled trial of a behavioral intervention compared to usual care was conducted on sexually active heterosexual adolescents aged 16-19 years attending the only public STI clinic.…

The Palliative Care in Heart Failure (PAL-HF) Trial: Rationale and Design

PubMed Central

Mentz, Robert J.; Tulsky, James A.; Granger, Bradi B.; Anstrom, Kevin J.; Adams, Patricia A.; Dodson, Gwen C.; Fiuzat, Mona; Johnson, Kimberly S.; Patel, Chetan B.; Steinhauser, Karen E.; Taylor, Donald H.; O’Connor, Christopher M.; Rogers, Joseph G.

2014-01-01

Background The progressive nature of heart failure (HF) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management. Limited evidence exists from randomized, controlled trials supporting the use of interdisciplinary palliative care in HF. Methods The Palliative Care in Heart Failure trial (PAL-HF) is a prospective, controlled, unblinded, single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or re-hospitalization in the ensuing 6 months. The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief, attention to spiritual concerns and advanced care planning. The primary endpoint is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months. Secondary endpoints include changes in anxiety/depression, spiritual well-being, caregiver satisfaction, cost and resource utilization, and a composite of death, HF hospitalization and quality of life. Conclusions PAL-HF is a randomized, controlled clinical trial that will help evaluate the efficacy and cost-effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic endpoints. PMID:25440791

COACH trial: A randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: Rationale and design

PubMed Central

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-01-01

Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. PMID:21241828

COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

PubMed

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-05-01

Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

Does the patient-held record improve continuity and related outcomes in cancer care: a systematic review.

PubMed

Gysels, Marjolein; Richardson, Alison; Higginson, Irene J

2007-03-01

To assess the effectiveness of the patient-held record (PHR) in cancer care. Patients with cancer may receive care from different services resulting in gaps. A PHR could provide continuity and patient involvement in care. Relevant literature was identified through five electronic databases (Medline, Embase, Cinahl, CCTR and CDSR) and hand searches. Patient-held records in cancer care with the purpose of improving communication and information exchange between and within different levels of care and to promote continuity of care and patients' involvement in their own care. Data extraction recorded characteristics of intervention, type of study and factors that contributed to methodological quality of individual studies. Data were then contrasted by setting, objectives, population, study design, outcome measures and changes in outcome, including knowledge, satisfaction, anxiety and depression. Methodological quality of randomized control trials and non-experimental studies were assessed with separate standard grading scales. Seven randomized control trials and six non-experimental studies were identified. Evaluations of the PHR have reached equivocal findings. Randomized trials found an absence of effect, non-experimental evaluations shed light on the conditions for its successful use. Most patients welcomed introduction of a PHR. Main problems related to its suitability for different patient groups and the lack of agreement between patients and health professionals regarding its function. Further research is required to determine the conditions under which the PHR can realize its potential as a tool to promote continuity of care and patient participation.

A smartphone application to support recovery from alcoholism: A randomized controlled trial

PubMed Central

Gustafson, David H.; McTavish, Fiona M.; Chih, Ming-Yuan; Atwood, Amy K.; A. Johnson, Roberta; G. Boyle, Michael; S. Levy, Michael; Driscoll, Hilary; M. Chisholm, Steven; Dillenburg, Lisa; Isham, Andrew; Shah, Dhavan

2014-01-01

Importance: Patients leaving treatment for alcohol-use disorders (AUDs) are not typically offered evidence-based continuing care, although research suggests that continuing care is associated with better outcomes. A smartphone-based application could provide effective continuing care. Objective: To determine whether patients leaving residential treatment for AUDs with a smartphone application to support recovery have fewer risky drinking days than control-group patients. Design: An un-blinded randomized controlled trial. Patients were randomized to treatment as usual or treatment as usual plus a smartphone with A-CHESS, an application designed to improve continuing care for AUDs. “A-CHESS” stands for Addiction – Comprehensive Health Enhancement Support System. Setting: Three residential programs operated by one treatment organization in the Midwestern US and 2 residential programs operated by one organization in the Northeastern US. Participants: 349 patients who met the criteria for DSM-IV alcohol dependence when they entered residential treatment. 179 were randomized to the control group and 170 to the treatment group. Intervention: Treatment as usual varied across programs; none offered patients coordinated continuing care after discharge. A-CHESS provides monitoring, information, communication, and support services to patients, including ways for patients and counselors to stay in contact. The intervention lasted 8 months and the follow-up period lasted 4 months. Main Outcome Measure: Risky drinking days—the number of days during which a patient’s drinking in a 2-hour period exceeded, for men, 4 standard drinks and for women, 3 standard drinks. Patients were asked to report their risky drinking days in the previous 30 days on surveys taken 4, 8, and 12 months after discharge from residential treatment. Results: For the 8 months of the intervention and 4 months of follow-up, patients in the A-CHESS group reported significantly fewer risky drinking days than patients in the control group (M = 1.39 vs. 2.75, respectively; P = .003; 95% CI [.46, 2.27]). Conclusions and Relevance: The findings suggest that a multi-featured smartphone application may have significant benefit to patients in continuing care for AUDs. Trial registration: clinicaltrials.gov Identifier: NCT01003119 PMID:24671165

Effect of Facilitation of Local Maternal-and-Newborn Stakeholder Groups on Neonatal Mortality: Cluster-Randomized Controlled Trial

PubMed Central

Persson, Lars Åke; Nga, Nguyen T.; Målqvist, Mats; Thi Phuong Hoa, Dinh; Eriksson, Leif; Wallin, Lars; Selling, Katarina; Huy, Tran Q.; Duc, Duong M.; Tiep, Tran V.; Thi Thu Thuy, Vu; Ewald, Uwe

2013-01-01

Background Facilitation of local women's groups may reportedly reduce neonatal mortality. It is not known whether facilitation of groups composed of local health care staff and politicians can improve perinatal outcomes. We hypothesised that facilitation of local stakeholder groups would reduce neonatal mortality (primary outcome) and improve maternal, delivery, and newborn care indicators (secondary outcomes) in Quang Ninh province, Vietnam. Methods and Findings In a cluster-randomized design 44 communes were allocated to intervention and 46 to control. Laywomen facilitated monthly meetings during 3 years in groups composed of health care staff and key persons in the communes. A problem-solving approach was employed. Births and neonatal deaths were monitored, and interviews were performed in households of neonatal deaths and of randomly selected surviving infants. A latent period before effect is expected in this type of intervention, but this timeframe was not pre-specified. Neonatal mortality rate (NMR) from July 2008 to June 2011 was 16.5/1,000 (195 deaths per 11,818 live births) in the intervention communes and 18.4/1,000 (194 per 10,559 live births) in control communes (adjusted odds ratio [OR] 0.96 [95% CI 0.73–1.25]). There was a significant downward time trend of NMR in intervention communes (p = 0.003) but not in control communes (p = 0.184). No significant difference in NMR was observed during the first two years (July 2008 to June 2010) while the third year (July 2010 to June 2011) had significantly lower NMR in intervention arm: adjusted OR 0.51 (95% CI 0.30–0.89). Women in intervention communes more frequently attended antenatal care (adjusted OR 2.27 [95% CI 1.07–4.8]). Conclusions A randomized facilitation intervention with local stakeholder groups composed of primary care staff and local politicians working for three years with a perinatal problem-solving approach resulted in increased attendance to antenatal care and reduced neonatal mortality after a latent period. Trial registration Current Controlled Trials ISRCTN44599712 Please see later in the article for the Editors' Summary PMID:23690755

Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial).

PubMed

Spaic, Tamara; Mahon, Jeff L; Hramiak, Irene; Byers, Nicole; Evans, Keira; Robinson, Tracy; Lawson, Margaret L; Malcolm, Janine; Goldbloom, Ellen B; Clarson, Cheril L

2013-10-09

Transition from pediatric to adult diabetes care is a high risk period during which there is an increased rate of disengagement from care. Suboptimal transition has been associated with higher risks for acute and chronic diabetes-related complications. The period of emerging adulthood challenges current systems of healthcare delivery as many young adults with type 1 diabetes (T1D) default from diabetes care and are at risk for diabetes complications which are undetected and therefore untreated. Despite the importance of minimizing loss to follow-up there are no randomized control trials evaluating models of transition from pediatric to adult diabetes care. This is a multicentre randomized controlled trial. A minimum of 188 subjects with T1D aged between 17 and 20 years will be evaluated. Eligible subjects will be recruited from three pediatric care centres and randomly assigned in a 1:1 ratio to a structured transition program that will span 18 months or to receive standard diabetes care. The structured transition program is a multidisciplinary, complex intervention aiming to provide additional support in the transition period. A Transition Coordinator will provide transition support and will provide the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention to facilitate ongoing contact with the medical system as well as education and clinical support where appropriate. Subjects will be seen in the pediatric care setting for 6 months and will then be transferred to the adult care setting where they will be seen for one year. There will then be a one-year follow-up period for outcome assessment. The primary outcome is the proportion of subjects who fail to attend at least one outpatient adult diabetes specialist visit during the second year after transition to adult diabetes care. Secondary outcome measures include A1C frequency measurement and levels, diabetes related emergency room visits and hospital admissions, frequency of complication screening, and subject perception and satisfaction with care. This trial will determine if the support of a Transition Coordinator improves health outcomes for this at-risk population of young adults. NCT01351857.

Mediators of Treatment Effects in a Randomized Clinical Trial of Multisystemic Therapy-Health Care in Adolescents With Poorly Controlled Asthma: Disease Knowledge and Device Use Skills.

PubMed

Ellis, Deborah A; King, Pamela; Naar-King, Sylvie

2016-06-01

Determine whether Multisystemic Therapy-Health Care (MST-HC) improved asthma knowledge and controller device use skills among African-American youth with poorly controlled asthma and whether any improvements mediated changes in illness management. A randomized controlled trial was conducted with 170 adolescents with moderate to severe asthma. Families were randomized to MST-HC or attention control. Data were collected at baseline and 6 and 12 months after intervention completion. In linear mixed models, adolescents in the MST-HC group had increases in asthma knowledge; asthma knowledge was unchanged for attention control. Controller device use skills increased for adolescents in the MST-HC group, while skills declined for attention control. Both knowledge and skills mediated the relationship between intervention condition and changes in illness management. Tailored, home-based interventions that include knowledge and skills building components are one means by which illness management in African-American youth with poorly controlled asthma can be improved. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial

PubMed Central

2013-01-01

Background To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. Methods/design Experimental study. Randomized clinical trial. Follow-up period: one year. Study setting: primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. Intervention components: a) Organizational intervention on the patient/professional relationship. Centered on the Chronic Care Model, the Stanford Expert Patient Program and the Kaiser Permanente model: Teamwork, informed and active patient, decision making shared with the patient, recommendations based on clinical guidelines, single electronic medical history per patient that allows the use of indicators for risk monitoring and stratification. b) Formative strategy for professionals: 4 face-to-face training workshops (one every 3 months), monthly update clinical sessions, online tutorial by a cardiologist, availability through the intranet of the action protocol and related documents. Measurements: Blood pressure, blood glucose, HbA1c, lipid profile and smoking. Frequent health care visits. Number of hospitalizations related to vascular disease. Therapeutic compliance. Drug use. Discussion This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. Trial registration NCT01826929 PMID:23915267

Diabetes quality improvement in Department of Veterans Affairs Ambulatory Care Clinics: a group-randomized clinical trial.

PubMed

Reiber, Gayle E; Au, David; McDonell, Mary; Fihn, Stephan D

2004-05-01

To conduct a group-randomized clinical trial to determine whether regular feedback to primary care providers of synthesized information on patients' health, function, and satisfaction would demonstrate improved outcomes for their patients with diabetes. Patients in General Internal Medicine Clinics Department of Veterans Affairs (VA) Medical Centers were randomized into seven intervention or control firms. Patient self-reported information was collected by mail on general health, diabetes, and up to five other chronic conditions. Patients with diabetes received the Seattle Diabetes Questionnaire, the 36-item Medical Outcomes Study short form (SF-36), and a validated patient satisfaction questionnaire at regular intervals. Data from self-report, clinical, pharmacy, and laboratory sources were synthesized into patient-specific feedback reports that intervention providers received before patients' visits. The timely delivery to primary care providers of state-of-the-art patient-feedback reports that identified patient issues and areas for improvement did not result in significant improvements in patient outcomes between the intervention and control firms. Outcomes in diabetic patients whose providers received synthesized patient data before visits were no better than in those receiving care from control firms. Future studies may benefit from substantial involvement in patients discussing, problem solving, and goal setting in addition to use of timely synthesized patient data.

Does routine psychosocial screening improve referral to psychosocial care providers and patient-radiotherapist communication? A cluster randomized controlled trial.

PubMed

Braeken, Anna P B M; Lechner, Lilian; Eekers, Daniëlle B P; Houben, Ruud M A; van Gils, Francis C J M; Ambergen, Ton; Kempen, Gertrudis I J M

2013-11-01

This study tests whether using a screening instrument improves referral to psychosocial care providers (e.g. psychologist) and facilitates patient-radiotherapist communication. A cluster randomized controlled trial was used. Fourteen radiotherapists were randomly allocated to the experimental or control group and 568 of their patients received care in accordance with the group to which their radiotherapist was allocated. Patients in the experimental group were asked to complete a screening instrument before and at the end of the radiation treatment period. All patients were requested to complete questionnaires concerning patient-physician communication after the first consultation and concerning psychosocial care 3 and 12 months post-intervention. Patients who completed the screening instrument were referred to social workers at an earlier stage than patients who did not (P<0.01). No effects were observed for numbers of referred patients, or for improved patient-radiotherapist communication. Our results suggest that a simple screening procedure can be valuable for the timely treatment of psychosocial problems in patients. Future efforts should be directed at appropriate timing of screening and enhancing physicians' awareness regarding the importance of identifying, discussing and treating psychosocial problems in cancer patients. Psychosocial screening can be enhanced by effective radiotherapist-patient communication. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure.

PubMed

El-Jawahri, Areej; Paasche-Orlow, Michael K; Matlock, Dan; Stevenson, Lynne Warner; Lewis, Eldrin F; Stewart, Garrick; Semigran, Marc; Chang, Yuchiao; Parks, Kimberly; Walker-Corkery, Elizabeth S; Temel, Jennifer S; Bohossian, Hacho; Ooi, Henry; Mann, Eileen; Volandes, Angelo E

2016-07-05

Conversations about goals of care and cardiopulmonary resuscitation (CPR)/intubation for patients with advanced heart failure can be difficult. This study examined the impact of a video decision support tool and patient checklist on advance care planning for patients with heart failure. This was a multisite, randomized, controlled trial of a video-assisted intervention and advance care planning checklist versus a verbal description in 246 patients ≥64 years of age with heart failure and an estimated likelihood of death of >50% within 2 years. Intervention participants received a verbal description for goals of care (life-prolonging care, limited care, and comfort care) and CPR/intubation plus a 6-minute video depicting the 3 levels of care, CPR/intubation, and an advance care planning checklist. Control subjects received only the verbal description. The primary analysis compared the proportion of patients preferring comfort care between study arms immediately after the intervention. Secondary outcomes were CPR/intubation preferences and knowledge (6-item test; range, 0-6) after intervention. In the intervention group, 27 (22%) chose life-prolonging care, 31 (25%) chose limited care, 63 (51%) selected comfort care, and 2 (2%) were uncertain. In the control group, 50 (41%) chose life-prolonging care, 27 (22%) selected limited care, 37 (30%) chose comfort care, and 8 (7%) were uncertain (P<0.001). Intervention participants (compared with control subjects) were more likely to forgo CPR (68% versus 35%; P<0.001) and intubation (77% versus 48%; P<0.001) and had higher mean knowledge scores (4.1 versus 3.0; P<0.001). Patients with heart failure who viewed a video were more informed, more likely to select a focus on comfort, and less likely to desire CPR/intubation compared with patients receiving verbal information only. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01589120. © 2016 American Heart Association, Inc.

Effects of professional oral health care on elderly: randomized trial.

PubMed

Morino, T; Ookawa, K; Haruta, N; Hagiwara, Y; Seki, M

2014-11-01

To better understand the role of the professional oral health care for elderly in improving geriatric oral health, the effects of short-term professional oral health care (once per week for 1 month) on oral microbiological parameters were assessed. Parallel, open-labelled, randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka, Japan. Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention (17/34) and control (17/34) groups. The outcomes were changes in oral microbiological parameters (number of bacteria in unstimulated saliva; whole bacteria, Streptococcus, Fusobacterium and Prevotella: opportunistic pathogens detection: and index of oral hygiene evaluation [Dental Plaque Index, DPI]) within the intervention period. Each parameter was evaluated at before and after intervention period. Four elderly were lost from mortality (1), bone fracture (1), refused to participate (1) and multi-antibiotics usage (1). Finally, 30 elderly were analysed (14/intervention and 16/control). At baseline, no difference was found between the control and intervention groups. After the intervention period, the percentage of Streptococcus species increased significantly in the intervention group (Intervention, 86% [12/14]; Control, 50% [8/16]: Fisher's, right-tailed, P < 0.05). Moreover, DPI significantly improved in the intervention group (Intervention, 57% [8/14]; Control, 13% [2/16]: Fisher's, two-tailed, P < 0.05). The improvement in DPI extended for 3 months after intervention. None of side effects were reported. The short-term professional oral health care can improve oral conditions in the elderly. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Evaluation of a “Just-in-Time” Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial

PubMed Central

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Context Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. Objective To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Design Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Main Outcome Measures Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Results Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p < 0.01), osteoporosis knowledge (p = 0.04), activation (p < 0.01), dietary self-efficacy (p = 0.06), and osteoporosis care satisfaction (p < 0.01). Compared with PAADRN intervention participants (n = 39), nurse consultation participants had improved dietary self-efficacy (p = 0.07) and osteoporosis care satisfaction (p = 0.05). No significant improvements in osteoporosis-related outcomes were achieved vs PAADRN controls (n = 70). Conclusion “Just-in-time” nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care. PMID:28746019

Effects of music videos on sleep quality in middle-aged and older adults with chronic insomnia: a randomized controlled trial.

PubMed

Lai, Hui-Ling; Chang, En-Ting; Li, Yin-Ming; Huang, Chiung-Yu; Lee, Li-Hua; Wang, Hsiu-Mei

2015-05-01

Listening to soothing music has been used as a complementary therapy to improve sleep quality. However, there is no empirical evidence for the effects of music videos (MVs) on sleep quality in adults with insomnia as assessed by polysomnography (PSG). In this randomized crossover controlled trial, we compared the effects of a peaceful Buddhist MV intervention to a usual-care control condition before bedtime on subjective and objective sleep quality in middle-aged and older adults with chronic insomnia. The study was conducted in a hospital's sleep laboratory. We randomly assigned 38 subjects, aged 50-75 years, to an MV/usual-care sequence or a usual-care/MV sequence. After pretest data collection, testing was held on two consecutive nights, with subjects participating in one condition each night according to their assigned sequence. Each intervention lasted 30 min. Sleep was assessed using PSG and self-report questionnaires. After controlling for baseline data, sleep-onset latency was significantly shorter by approximately 2 min in the MV condition than in the usual-care condition (p = .002). The MV intervention had no significant effects relative to the usual care on any other sleep parameters assessed by PSG or self-reported sleep quality. These results suggest that an MV intervention may be effective in promoting sleep. However, the effectiveness of a Buddhist MV on sleep needs further study to develop a culturally specific insomnia intervention. Our findings also suggest that an MV intervention can serve as another option for health care providers to improve sleep onset in people with insomnia. © The Author(s) 2014.

A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

PubMed

Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

2014-09-01

To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

Community-Based Intervention to Improve Cardiometabolic Targets in Patients With Stroke: A Randomized Controlled Trial.

PubMed

Olaiya, Muideen T; Cadilhac, Dominique A; Kim, Joosup; Nelson, Mark R; Srikanth, Velandai K; Gerraty, Richard P; Bladin, Christopher F; Fitzgerald, Sharyn M; Phan, Thanh; Frayne, Judith; Thrift, Amanda G

2017-09-01

Many guidelines for secondary prevention of stroke focus on controlling cardiometabolic risk factors. We investigated the effectiveness of a management program for attaining cardiometabolic targets in survivors of stroke/transient ischemic attack. Randomized controlled trial of survivors of stroke/transient ischemic attack aged ≥18 years. General practices were randomized to usual care (control) or an intervention comprising specialist review of care plans and nurse education in addition to usual care. The outcome is attainment of pre-defined cardiometabolic targets based on Australian guidelines. Multivariable regression was undertaken to determine efficacy and identify factors associated with attaining targets. Overall, 283 subjects were randomized to the intervention and 280 to controls. Although we found no between-group difference in overall cardiometabolic targets achieved at 12 months, the intervention group more often achieved control of low-density lipoprotein cholesterol (odds ratio, 1.97; 95% confidence interval, 1.18-3.29) than controls. At 24 months, no between-group differences were observed. Medication adherence was ≥80% at follow-up, but uptake of lifestyle/behavioral habits was poor. Older age, being male, being married/living with partner, and having greater functional ability or a history of diabetes mellitus were associated with attaining targets. The intervention in this largely negative trial only had a detectable effect on attaining target for lipids but not for other factors at 12 months or any factor at 24 months. This limited effect may be attributable to inadequate uptake of behavioral/lifestyle interventions, highlighting the need for new or better approaches to achieve meaningful behavioral change. URL: http://www.clinicaltrials.gov. Unique identifier: ACTRN12608000166370. © 2017 American Heart Association, Inc.

A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection

PubMed Central

2016-01-01

BACKGROUND Data from studies in nonhuman primates suggest that the triple monoclonal antibody cocktail ZMapp is a promising immune-based treatment for Ebola virus disease (EVD). METHODS Beginning in March 2015, we conducted a randomized, controlled trial of ZMapp plus the current standard of care as compared with the current standard of care alone in patients with EVD that was diagnosed in West Africa by polymerase-chain-reaction (PCR) assay. Eligible patients of any age were randomly assigned in a 1:1 ratio to receive either the current standard of care or the current standard of care plus three intravenous infusions of ZMapp (50 mg per kilogram of body weight, administered every third day). Patients were stratified according to baseline PCR cycle-threshold value for the virus (≤22 vs. >22) and country of enrollment. Oral favipiravir was part of the current standard of care in Guinea. The primary end point was mortality at 28 days. RESULTS A total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea, and the United States. Of the 71 patients who could be evaluated, 21 died, representing an overall case fatality rate of 30%. Death occurred in 13 of 35 patients (37%) who received the current standard of care alone and in 8 of 36 patients (22%) who received the current standard of care plus ZMapp. The observed posterior probability that ZMapp plus the current standard of care was superior to the current standard of care alone was 91.2%, falling short of the prespecified threshold of 97.5%. Frequentist analyses yielded similar results (absolute difference in mortality with ZMapp, −15 percentage points; 95% confidence interval, −36 to 7). Baseline viral load was strongly predictive of both mortality and duration of hospitalization in all age groups. CONCLUSIONS In this randomized, controlled trial of a putative therapeutic agent for EVD, although the estimated effect of ZMapp appeared to be beneficial, the result did not meet the prespecified statistical threshold for efficacy. (Funded by the National Institute of Allergy and Infectious Diseases and others; PREVAIL II ClinicalTrials.gov number, NCT02363322.) PMID:27732819

Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial.

PubMed

Hermans, Michel P; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank; Vandenberghe, Hans; Brotons, Carlos

2013-11-01

To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. Primary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P < 0.001); 54.3 vs. 49.7% met the LDL cholesterol target (P = 0.006). Percentages of patients meeting all three targets increased during the study in both groups, with a statistically significant increase observed in the benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P < 0.001). In this prospective, randomized, controlled study, benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile.

The effect of integration of HIV care and treatment into antenatal care clinics on mother-to-child HIV transmission and maternal outcomes in Nyanza, Kenya: results from the SHAIP cluster randomized controlled trial

PubMed Central

Washington, Sierra; Owuor, Kevin; Turan, Janet M.; Steinfeld, Rachel L.; Onono, Maricianah; Shade, Starley B.; Bukusi, Elizabeth A.; Ackers, Marta L.; Cohen, Craig R.

2015-01-01

Background Many HIV-infected pregnant women identified during antenatal care do not enroll in long-term HIV care, resulting in deterioration of maternal health and continued risk of HIV transmission to infants. Methods We performed a cluster-randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya. Twelve facilities were randomized to provide either integrated services (ANC, PMTCT, and HIV care delivered in the ANC clinic; n=6 intervention facilities), or standard ANC services (including PMTCT and referral to a separate clinic for HIV care; n=6 control facilities). Results There were high patient attrition rates over the course of this study. Among study participants who enrolled in HIV care, there was twelve month follow up data for 256/611 (41.8%) women, and postpartum data for only 325/1172 (28%) women. By 9 months of age, 382/568 (67.3%) infants at intervention sites and 338/594 (57.0%) at control sites had tested for HIV (OR 1.45, 95% CI 0.71-2.82); 7.3% of infants tested HIV-positive at intervention sites compared to 8.0% of infants at control sites (OR 0.89, 95% CI 0.56-1.43). The composite clinical/immunologic progression into AIDS was similar in both arms (4.9% vs. 5.1 %, OR 0.83, 95% CI 0.41 - 1.68). Conclusions Despite the provision of integrated services, patient attrition was substantial in both arms, suggesting barriers beyond lack of service integration. Integration of HIV services into the ANC clinic was not associated with a reduced risk HIV transmission to infants and did not appear to affect short-term maternal health outcomes. PMID:25886930

Effects of a home care mobile app on the outcomes of discharged patients with a stoma: a randomized controlled trial.

PubMed

Wang, Qing-Qing; Zhao, Jing; Huo, Xiao-Rong; Wu, Ling; Yang, Li-Fang; Li, Ju-Yun; Wang, Jie

2018-05-18

The aim of this study is to explore the effects of a home care mobile app on the outcomes of stoma patients who discharged from hospital. Patients with a newly formed stoma experience many difficulties after surgery. Mobile application (app) has the potential to help patients self-manage their diseases and adjust to the changes in their lives and is a convenient way to ensure the continuity of care. However, there is a lack of studies about the effects of a mobile app on the transitional care for improving discharged stoma-related health outcomes. A randomized controlled trial. 203 patients with a permanent stoma in tertiary hospitals in China were randomly assigned into two groups. Patients in the control group (n=103) received routine discharge care. Patients in the intervention group (n=100) received home care via a mobile app besides routine care. The psychosocial adjustment level, self-efficacy scale and stoma complications incidence were measured in the follow-up period and compared between the two groups. Data was collected at four time points: before intervention (baseline), at 1, 3 and 6 months after discharge. The psychosocial adjustment level and stoma self-efficacy score of the intervention group were significantly higher than those of the control group respectively at 1, 3 and 6-month follow-up (all P<0.05). The incidence of stoma complications in the intervention group were tending to reduce at 1, 3 and 6 months after discharge. The findings indicated that follow-up care at home via a mobile app can effectively improve the psychosocial adjustment level, self-efficacy scale and other related outcomes of stoma patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

A randomized-control trial for the teachers' diploma programme on psychosocial care, support and protection in Zambian government primary schools.

PubMed

Kaljee, Linda; Zhang, Liying; Langhaug, Lisa; Munjile, Kelvin; Tembo, Stephen; Menon, Anitha; Stanton, Bonita; Li, Xiaoming; Malungo, Jacob

2017-04-01

Orphaned and vulnerable children (OVC) experience poverty, stigma, and abuse resulting in poor physical, emotional, and psychological outcomes. The Teachers' Diploma Programme on Psychosocial Care, Support, and Protection is a child-centered 15-month long-distance learning program focused on providing teachers with the knowledge and skills to enhance their school environments, foster psychosocial support, and facilitate school-community relationships. A randomized controlled trial was implemented in 2013-2014. Both teachers (n=325) and students (n=1378) were assessed at baseline and 15-months post-intervention from randomly assigned primary schools in Lusaka and Eastern Provinces, Zambia. Multilevel linear mixed models (MLM) indicate positive significant changes for intervention teachers on outcomes related to self-care, teaching resources, safety, social support, and gender equity. Positive outcomes for intervention students related to future orientation, respect, support, safety, sexual abuse, and bullying. Outcomes support the hypothesis that teachers and students benefit from a program designed to enhance teachers' psychosocial skills and knowledge.

The economics of dementia-care mapping in nursing homes: a cluster-randomised controlled trial.

PubMed

van de Ven, Geertje; Draskovic, Irena; van Herpen, Elke; Koopmans, Raymond T C M; Donders, Rogier; Zuidema, Sytse U; Adang, Eddy M M; Vernooij-Dassen, Myrra J F J

2014-01-01

Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units. 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05) than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02). DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they adopt the DCM method. Dutch Trials Registry NTR2314.

Child-Adult Relationship Enhancement in Primary Care (PriCARE): A Randomized Trial of a Parent Training for Child Behavior Problems.

PubMed

Schilling, Samantha; French, Benjamin; Berkowitz, Steven J; Dougherty, Susan L; Scribano, Philip V; Wood, Joanne N

Child-Adult Relationship Enhancement in Primary Care (PriCARE) is a 6-session group parent training designed to teach positive parenting skills. Our objective was to measure PriCARE's impact on child behavior and parenting attitudes. Parents of children 2 to 6 years old with behavior concerns were randomized to PriCARE (n = 80) or control (n = 40). Child behavior and parenting attitudes were measured at baseline (0 weeks), program completion (9 weeks), and 7 weeks after program completion (16 weeks) using the Eyberg Child Behavior Inventory (ECBI) and the Adult Adolescent Parenting Inventory 2 (AAPI2). Linear regression models compared mean ECBI and AAPI2 change scores from 0 to 16 weeks in the PriCARE and control groups, adjusted for baseline scores. Of those randomized to PriCARE, 43% attended 3 or more sessions. Decreases in mean ECBI intensity and problem scores between 0 and 16 weeks were greater in the PriCARE group, reflecting a larger improvement in behavior problems [intensity: -22 (-29, -16) vs -7 (-17, 2), P = .012; problem: -5 (-7, -4) vs -2 (-4, 0), P = .014]. Scores on 3 of the 5 AAPI2 subscales reflected greater improvements in parenting attitudes in the PriCARE group compared to control in the following areas: empathy toward children's needs [0.82 (0.51, 1.14) vs 0.25 (-0.19, 0.70), P = .04], corporal punishment [0.22 (0.00, 0.45) vs -0.30 (-0.61, 0.02), P = .009], and power and independence [0.37 (-0.02, 0.76) vs -0.64 (-1.19, -0.09), P = .003]. PriCARE shows promise in improving parent-reported child-behavior problems in preschool-aged children and increasing positive parenting attitudes. Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Mindfulness-based stress reduction for treating chronic headache: A systematic review and meta-analysis.

PubMed

Anheyer, Dennis; Leach, Matthew J; Klose, Petra; Dobos, Gustav; Cramer, Holger

2018-01-01

Background Mindfulness-based stress reduction/cognitive therapy are frequently used for pain-related conditions, but their effects on headache remain uncertain. This review aimed to assess the efficacy and safety of mindfulness-based stress reduction/cognitive therapy in reducing the symptoms of chronic headache. Data sources and study selection MEDLINE/PubMed, Scopus, CENTRAL, and PsychINFO were searched to 16 June 2017. Randomized controlled trials comparing mindfulness-based stress reduction/cognitive therapy with usual care or active comparators for migraine and/or tension-type headache, which assessed headache frequency, duration or intensity as a primary outcome, were eligible for inclusion. Risk of bias was assessed using the Cochrane Tool. Results Five randomized controlled trials (two on tension-type headache; one on migraine; two with mixed samples) with a total of 185 participants were included. Compared to usual care, mindfulness-based stress reduction/cognitive therapy did not improve headache frequency (three randomized controlled trials; standardized mean difference = 0.00; 95% confidence interval = -0.33,0.32) or headache duration (three randomized controlled trials; standardized mean difference = -0.08; 95% confidence interval = -1.03,0.87). Similarly, no significant difference between groups was found for pain intensity (five randomized controlled trials; standardized mean difference = -0.78; 95% confidence interval = -1.72,0.16). Conclusions Due to the low number, small scale and often high or unclear risk of bias of included randomized controlled trials, the results are imprecise; this may be consistent with either an important or negligible effect. Therefore, more rigorous trials with larger sample sizes are needed.

Structuring Communication Relationships for Interprofessional Teamwork (SCRIPT): a cluster randomized controlled trial.

PubMed

Zwarenstein, Merrick; Reeves, Scott; Russell, Ann; Kenaszchuk, Chris; Conn, Lesley Gotlib; Miller, Karen-Lee; Lingard, Lorelei; Thorpe, Kevin E

2007-09-18

Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT) to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs) in general internal medicine (GIM) divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS); adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Pre-intervention qualitative analysis revealed that a substantial amount of interprofessional interaction lacks key core elements of collaborative communication such as self-introduction, description of professional role, and solicitation of other professional perspectives. Incorporating these findings, a four-component intervention was designed with a goal of creating a culture of communication in which the fundamentals of collaboration become a routine part of interprofessional interactions during unstructured work periods on GIM wards. Registered with National Institutes of Health as NCT00466297.

Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children’s body mass index

PubMed Central

2014-01-01

Background To address the public health crisis of overweight and obese preschool-age children, the Nutrition And Physical Activity Self Assessment for Child Care (NAP SACC) intervention was delivered by nurse child care health consultants with the objective of improving child care provider and parent nutrition and physical activity knowledge, center-level nutrition and physical activity policies and practices, and children’s body mass index (BMI). Methods A seven-month randomized control trial was conducted in 17 licensed child care centers serving predominantly low income families in California, Connecticut, and North Carolina, including 137 child care providers and 552 families with racially and ethnically diverse children three to five years old. The NAP SACC intervention included educational workshops for child care providers and parents on nutrition and physical activity and consultation visits provided by trained nurse child care health consultants. Demographic characteristics and pre - and post-workshop knowledge surveys were completed by providers and parents. Blinded research assistants reviewed each center’s written health and safety policies, observed nutrition and physical activity practices, and measured randomly selected children’s nutritional intake, physical activity, and height and weight pre- and post-intervention. Results Hierarchical linear models and multiple regression models assessed individual- and center-level changes in knowledge, policies, practices and age- and sex-specific standardized body mass index (zBMI), controlling for state, parent education, and poverty level. Results showed significant increases in providers’ and parents’ knowledge of nutrition and physical activity, center-level improvements in policies, and child-level changes in children’s zBMI based on 209 children in the intervention and control centers at both pre- and post-intervention time points. Conclusions The NAP SACC intervention, as delivered by trained child health professionals such as child care health consultants, increases provider knowledge, improves center policies, and lowers BMI for children in child care centers. More health professionals specifically trained in a nutrition and physical activity intervention in child care are needed to help reverse the obesity epidemic. Trial registration National Clinical Trials Number NCT01921842 PMID:24580983

Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children's body mass index.

PubMed

Alkon, Abbey; Crowley, Angela A; Neelon, Sara E Benjamin; Hill, Sherika; Pan, Yi; Nguyen, Viet; Rose, Roberta; Savage, Eric; Forestieri, Nina; Shipman, Linda; Kotch, Jonathan B

2014-03-01

To address the public health crisis of overweight and obese preschool-age children, the Nutrition And Physical Activity Self Assessment for Child Care (NAP SACC) intervention was delivered by nurse child care health consultants with the objective of improving child care provider and parent nutrition and physical activity knowledge, center-level nutrition and physical activity policies and practices, and children's body mass index (BMI). A seven-month randomized control trial was conducted in 17 licensed child care centers serving predominantly low income families in California, Connecticut, and North Carolina, including 137 child care providers and 552 families with racially and ethnically diverse children three to five years old. The NAP SACC intervention included educational workshops for child care providers and parents on nutrition and physical activity and consultation visits provided by trained nurse child care health consultants. Demographic characteristics and pre - and post-workshop knowledge surveys were completed by providers and parents. Blinded research assistants reviewed each center's written health and safety policies, observed nutrition and physical activity practices, and measured randomly selected children's nutritional intake, physical activity, and height and weight pre- and post-intervention. Hierarchical linear models and multiple regression models assessed individual- and center-level changes in knowledge, policies, practices and age- and sex-specific standardized body mass index (zBMI), controlling for state, parent education, and poverty level. Results showed significant increases in providers' and parents' knowledge of nutrition and physical activity, center-level improvements in policies, and child-level changes in children's zBMI based on 209 children in the intervention and control centers at both pre- and post-intervention time points. The NAP SACC intervention, as delivered by trained child health professionals such as child care health consultants, increases provider knowledge, improves center policies, and lowers BMI for children in child care centers. More health professionals specifically trained in a nutrition and physical activity intervention in child care are needed to help reverse the obesity epidemic. National Clinical Trials Number NCT01921842.

Effectiveness of the Comprehensive Approach to Rehabilitation (CARe) methodology: design of a cluster randomized controlled trial.

PubMed

Bitter, Neis A; Roeg, Diana P K; van Nieuwenhuizen, Chijs; van Weeghel, Jaap

2015-07-22

There is an increasing amount of evidence for the effectiveness of rehabilitation interventions for people with severe mental illness (SMI). In the Netherlands, a rehabilitation methodology that is well known and often applied is the Comprehensive Approach to Rehabilitation (CARe) methodology. The overall goal of the CARe methodology is to improve the client's quality of life by supporting the client in realizing his/her goals and wishes, handling his/her vulnerability and improving the quality of his/her social environment. The methodology is strongly influenced by the concept of 'personal recovery' and the 'strengths case management model'. No controlled effect studies have been conducted hitherto regarding the CARe methodology. This study is a two-armed cluster randomized controlled trial (RCT) that will be executed in teams from three organizations for sheltered and supported housing, which provide services to people with long-term severe mental illness. Teams in the intervention group will receive the multiple-day CARe methodology training from a specialized institute and start working according the CARe Methodology guideline. Teams in the control group will continue working in their usual way. Standardized questionnaires will be completed at baseline (T0), and 10 (T1) and 20 months (T2) post baseline. Primary outcomes are recovery, social functioning and quality of life. The model fidelity of the CARe methodology will be assessed at T1 and T2. This study is the first controlled effect study on the CARe methodology and one of the few RCTs on a broad rehabilitation method or strength-based approach. This study is relevant because mental health care organizations have become increasingly interested in recovery and rehabilitation-oriented care. The trial registration number is ISRCTN77355880 .

Specialist mental health consultation for depression in Australian aged care residents with dementia: a cluster randomized trial.

PubMed

McSweeney, Kate; Jeffreys, Aimee; Griffith, Joanne; Plakiotis, Chris; Kharsas, Renee; O'Connor, Daniel W

2012-11-01

This cluster randomized controlled trial sought to determine whether multidisciplinary specialist mental health consultation was more effective than care as usual in treating the depression of aged care residents with dementia. Three hundred and eighty nine aged care residents were screened for dementia and major depression. Forty four were ultimately included in the intervention sample, selected from 20 aged care facilities located in Melbourne, Australia. Facilities were randomly allocated to an intervention condition involving the provision of multidisciplinary specialist consultation regarding the best-practice management of depression in dementia, or to a care as usual condition. Consultations involved individually tailored medical and psychosocial recommendations provided to care staff and general practitioners. All residents participated in a comprehensive pre-intervention diagnostic assessment, including the administration of the Cornell Scale for Depression in Dementia. This assessment was repeated approximately 15 weeks post-intervention by a rater blind to study condition. Multidisciplinary specialist mental health consultation was significantly more effective than care as usual in treating the clinical depression of aged care residents with dementia (p < 0.05, partial η(2)  = 0.16). At follow-up, the mean Cornell Scale for Depression in Dementia score for the intervention group was 9.47, compared with 14.23 for the control group. In addition, 77% of the intervention group no longer met criteria for major depression. The results of this study suggest that the psychosocial and medical management of depressed aged care residents can be improved by increasing access to specialist mental health consultation. Copyright © 2012 John Wiley & Sons, Ltd.

A Randomized Controlled Trial of Family Finding: A Relative Search and Engagement Intervention for Youth Lingering in Foster Care.

PubMed

Vandivere, Sharon; Malm, Karin E; Allen, Tiffany J; Williams, Sarah Catherine; McKlindon, Amy

2017-12-01

Youth who have experienced foster care are at risk of negative outcomes in adulthood. The family finding model aims to promote more positive outcomes by finding and engaging relatives of children in foster care in order to provide options for legal and emotional permanency. The present study tested whether family finding, as implemented in North Carolina from 2008 through 2011, improved child welfare outcomes for youth at risk of emancipating foster care without permanency. A randomized controlled trial evaluation was carried out in nine counties in North Carolina. All children eligible for intervention services between 2008 and 2011 underwent random assignment. Effects were tested with an intent-to-treat design. Outcome data were obtained for all subjects from child welfare administrative data. Additional outcome data for a subset of older youth came from in-person interviews. Subjects included 568 children who were in foster care, were 10-17 years old (at time of referral), had no identified permanent placement resource, and had no plan for reunification. The confirmatory outcome was moves to more family-like placements, whether through a step-down in foster care placement or discharge from foster care to legal permanency. No impact on the confirmatory outcome was observed. Findings regarding exploratory impacts are also described; these must be interpreted with caution, given the large number of outcomes compared. The evaluation failed to find evidence that family finding improves the outcomes of older youth at risk of emancipation from foster care.

The effect of a supportive educational intervention developed based on the Orem's self-care theory on the self-care ability of patients with myocardial infarction: a randomised controlled trial.

PubMed

Mohammadpour, Ali; Rahmati Sharghi, Narjes; Khosravan, Shahla; Alami, Ali; Akhond, Majid

2015-06-01

The aim of this study was to assess the effect of a supportive educational intervention developed based on the Orem's self-care theory on the self-care ability of patients with myocardial infarction. Patients with cardiovascular disease suffer from the lack of knowledge about the disease and consequently are not able to fulfil their own self-care needs. This was a randomised controlled trial conducted in 2012. We recruited a random sample of 66 patients with myocardial infarction who had been recently discharged from coronary care unit. The study setting was two university hospitals located in Khorasan, Iran. Patients were randomly allocated to either the experimental or the control groups. Patients in the experimental group received education, support, and counselling while patients in the control group received no intervention. We employed a demographic questionnaire and the Myocardial Infarction Self-Care Ability Questionnaire for data collection and spss version 16.00 for data analysis. After the study, patients in the experimental group had higher levels of self-care knowledge, motivation and skills compared to the prestudy readings and the control group. The supportive educational intervention developed based on the Orem's self-care theory can improve nonhospitalised patients' self-care ability and positively affect public health outcomes. Consequently, using the developed programme for providing follow-up care to nonhospitalised patients is recommended. Having the ability to develop caring systems based on the nursing theories is a prerequisite to standard nursing practice. Identifying patients' educational needs is a fundamental prerequisite to patient education. Our findings revealed that the supportive educational intervention developed based on the Orem's self-care theory can help health care providers identify and fulfil patients' self-care needs. © 2015 John Wiley & Sons Ltd.

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial.

PubMed

Grunfeld, Eva; Manca, Donna; Moineddin, Rahim; Thorpe, Kevin E; Hoch, Jeffrey S; Campbell-Scherer, Denise; Meaney, Christopher; Rogers, Jess; Beca, Jaclyn; Krueger, Paul; Mamdani, Muhammad

2013-11-20

Primary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system. However, there remains a gap between recommended preventive services and actual practice. This trial (the BETTER Trial) aimed to improve preventive care of heart disease, diabetes, colorectal, breast and cervical cancers, and relevant lifestyle factors through a practice facilitation intervention set in primary care. Pragmatic two-way factorial cluster RCT with Primary Care Physicians' practices as the unit of allocation and individual patients as the unit of analysis. The setting was urban Primary Care Team practices in two Canadian provinces. Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control; 4 physicians in each team (32 physicians) were randomly assigned to receive the patient-level intervention or wait-list control. Patients randomly selected from physicians' rosters were stratified into two groups: 1) general and 2) moderate mental illness. The interventions involved a multifaceted, evidence-based, tailored practice-level intervention with a Practice Facilitator, and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored 'prevention prescription'. The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets, expressed as the ratio of eligible actions at baseline that were met at follow-up. A cost-effectiveness analysis was conducted. 789 of 1,260 (63%) eligible patients participated. On average, patients were eligible for 8.96 (SD 3.2) actions at baseline. In the adjusted analysis, control patients met 23.1% (95% CI: 19.2% to 27.1%) of target actions, compared to 28.5% (95% CI: 20.9% to 36.0%) receiving the practice-level intervention, 55.6% (95% CI: 49.0% to 62.1%) receiving the patient-level intervention, and 58.9% (95% CI: 54.7% to 63.1%) receiving both practice- and patient-level interventions (patient-level intervention versus control, P < 0.001). The benefit of the patient-level intervention was seen in both strata. The extra cost of the intervention was $26.43CAN (95% CI: $16 to $44) per additional action met. A Prevention Practitioner can improve the implementation of clinically important prevention and screening for chronic diseases in a cost-effective manner.

Effects of live sax music on various physiological parameters, pain level, and mood level in cancer patients: a randomized controlled trial.

PubMed

Burrai, Francesco; Micheluzzi, Valentina; Bugani, Valentina

2014-01-01

Few randomized controlled trial studies have focused on the effect of music in cancer patients, and there are no randomized controlled trials on the effects of live music with saxophone in cancer patients. To determine the effects of live saxophone music on various physiological parameters, pain level, and mood level. A randomized controlled trial study. 52 cancer patients were randomized to a control group (n = 26), an experimental group (n = 26) whose members received 30 minutes of live music therapy with saxophone. Systolic and diastolic blood pressure, pulse rate, glycemia, oxygen saturation, pain level, and mood level were measured before and after the live music performance. There was a statistical difference between the groups for oxygen saturation (0.003) and mood level (0.001). Live music performed with a saxophone could be introduced in oncology care to improve the oxygen saturation and mood in cancer patients.

The Treatment of Recurrent Abdominal Pain in Children: A Controlled Comparison of Cognitive-Behavioral Family Intervention and Standard Pediatric Care.

ERIC Educational Resources Information Center

Sanders, Matthew R.; And Others

1994-01-01

Conducted controlled clinical trial involving 44 children with recurrent abdominal pain randomly assigned to cognitive-behavioral family intervention (CBFI) or standard pediatric care (SPC). Both treatments resulted in significant improvements on measures of pain intensity and pain behavior. CBFI group had higher rate of complete elimination of…

The palliative care in heart failure trial: rationale and design.

PubMed

Mentz, Robert J; Tulsky, James A; Granger, Bradi B; Anstrom, Kevin J; Adams, Patricia A; Dodson, Gwen C; Fiuzat, Mona; Johnson, Kimberly S; Patel, Chetan B; Steinhauser, Karen E; Taylor, Donald H; O'Connor, Christopher M; Rogers, Joseph G

2014-11-01

The progressive nature of heart failure (HF) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management. Limited evidence exists from randomized, controlled trials supporting the use of interdisciplinary palliative care in HF. PAL-HF is a prospective, controlled, unblinded, single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or rehospitalization in the ensuing 6 months. The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief, attention to spiritual concerns, and advanced care planning. The primary end point is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months. Secondary end points include changes in anxiety/depression, spiritual well-being, caregiver satisfaction, cost and resource utilization, and a composite of death, HF hospitalization, and quality of life. PAL-HF is a randomized, controlled clinical trial that will help evaluate the efficacy and cost effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic end points. Copyright © 2014 Elsevier Inc. All rights reserved.

Impact of a care pathway for COPD on adherence to guidelines and hospital readmission: a cluster randomized trial

PubMed Central

Vanhaecht, Kris; Lodewijckx, Cathy; Sermeus, Walter; Decramer, Marc; Deneckere, Svin; Leigheb, Fabrizio; Boto, Paulo; Kul, Seval; Seys, Deborah; Panella, Massimiliano

2016-01-01

Purpose Current in-hospital management of exacerbations of COPD is suboptimal, and patient outcomes are poor. The primary aim of this study was to evaluate whether implementation of a care pathway (CP) for COPD improves the 6 months readmission rate. Secondary outcomes were the 30 days readmission rate, mortality, length of stay and adherence to guidelines. Patients and methods An international cluster randomized controlled trial was performed in Belgium, Italy and Portugal. General hospitals were randomly assigned to an intervention group where a CP was implemented or a control group where usual care was provided. The targeted population included patients with COPD exacerbation. Results Twenty-two hospitals were included, whereof 11 hospitals (n=174 patients) were randomized to the intervention group and 11 hospitals (n=168 patients) to the control group. The CP had no impact on the 6 months readmission rate. However, the 30 days readmission rate was significantly lower in the intervention group (9.7%; 15/155) compared to the control group (15.3%; 22/144) (odds ratio =0.427; 95% confidence interval 0.222–0.822; P=0.040). Performance on process indicators was significantly higher in the intervention group for 2 of 24 main indicators (8.3%). Conclusion The implementation of this in-hospital CP for COPD exacerbation has no impact on the 6 months readmission rate, but it significantly reduces the 30 days readmission rate. PMID:27920516

The impact of dermatology consultation on diagnostic accuracy and antibiotic use among patients with suspected cellulitis seen at outpatient internal medicine offices: a randomized clinical trial.

PubMed

Arakaki, Ryan Y; Strazzula, Lauren; Woo, Elaine; Kroshinsky, Daniela

2014-10-01

Cellulitis is a common and costly problem, often diagnosed in the outpatient setting. Many cutaneous conditions may clinically mimic cellulitis, but little research has been done to assess the magnitude of the problem. To determine if obtaining dermatology consultations in the outpatient primary care setting could assist in the diagnosis of pseudocellulitic conditions and reduce the rate of unnecessary antibiotic use. Nonblinded randomized clinical trial of competent adults who were diagnosed as having cellulitis by their primary care physicians (PCPs), conducted at outpatient internal medical primary care offices affiliated with a large academic medical center. Outpatient dermatology consultation. Primary outcomes were final diagnosis, antibiotic use, and need for hospitalization. A total of 29 patients (12 male and 17 female) were enrolled for participation in this trial. Nine patients were randomized to continue with PCP management (control group), and 20 patients were randomized to receive a dermatology consultation (treatment group). Of the 20 patients in the dermatology consultation group, 2 (10%) were diagnosed as having cellulitis. In the control group, all 9 patients were diagnosed as having cellulitis by PCPs, but dermatologist evaluation determined that 6 (67%) of these patients had a psuedocellulitis rather than true infection. All 9 patients (100%) in the control group were treated for cellulitis with antibiotics vs 2 patients (10%) in the treatment group (P < .001). One patient in the control group was hospitalized. All patients in the treatment group reported improvement of their cutaneous condition at the 1-week follow-up examination. Dermatology consultation in the primary care setting improves the diagnostic accuracy of suspected cellulitis and decreases unnecessary antibiotic use in patients with pseudocellulitic conditions. Obtaining an outpatient dermatology consultation may be a cost-effective strategy that improves quality of care. clinicaltrials.gov Identifier:NCT01795092.

Design of the Violence and Stress Assessment (ViStA) study: a randomized controlled trial of care management for PTSD among predominantly Latino patients in safety net health centers.

PubMed

Meredith, Lisa S; Eisenman, David P; Green, Bonnie L; Kaltman, Stacey; Wong, Eunice C; Han, Bing; Cassells, Andrea; Tobin, Jonathan N

2014-07-01

Posttraumatic stress disorder (PTSD) is a common problem in primary care. Although effective treatments are available, little is known about whether such treatments are effective within the context of Federally Qualified Health Centers (FQHCs) that serve as national "safety nets" for providing primary care for low income and underinsured patients. The Violence and Stress Assessment (ViStA) study is the first randomized controlled trial (RCT) to test the impact of a care management intervention for treating PTSD in FQHCs. To develop a PTSD management intervention appropriate for lower resource FQHCs and the predominantly Latino patients they serve, formative work was conducted through a collaborative effort between researchers and an FQHC practice-based research network. This article describes how FQHC stakeholders were convened to review, assess, and prioritize evidence-based strategies for addressing patient, clinician, and system-level barriers to care. This multi-component care management intervention incorporates diagnosis with feedback, patient education and activation; navigation and linkage to community resources; clinician education and medication guidance; and structured cross-disciplinary communication and continuity of care, all facilitated by care managers with FQHC experience. We also describe the evaluation design of this five-year RCT and the characteristics of the 404 English or Spanish speaking patients enrolled in the study and randomized to either the intervention or to usual care. Patients are assessed at baseline, six months, and 12 months to examine intervention effectiveness on PTSD, other mental health symptoms, health-related quality-of-life, health care service use; and perceived barriers to care and satisfaction with care. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

A randomized controlled trial of comprehensive early intervention care in patients with first-episode psychosis in Japan: 1.5-year outcomes from the J-CAP study.

PubMed

Nishida, Atsushi; Ando, Shuntaro; Yamasaki, Syudo; Koike, Shinsuke; Ichihashi, Kayo; Miyakoshi, Yuji; Maekawa, Sanae; Nakamura, Tomohisa; Natsubori, Tatsunobu; Ichikawa, Eriko; Ishigami, Hiroki; Sato, Kojiro; Matsunaga, Asami; Smith, Jo; French, Paul; Harima, Hirohiko; Kishi, Yoshiki; Fujita, Izumi; Kasai, Kiyoto; Okazaki, Yuji

2018-04-08

The first episode of psychosis represents a critical period wherein comprehensive early intervention in psychosis (EIP) may alter the course of illness. However, evidence from randomized controlled trials that have examined the impact of comprehensive EIP care on clinical and functional recovery assessed by independent blinded raters is limited. The objective of this study was to conduct a single-blinded multicenter trial comparing comprehensive EIP care and standard care in young patients with first-episode psychosis (FEP) in Japan (J-CAP Study). A total of 77 participants with FEP (aged 15-35 years) were randomized to receive standard care or specialized comprehensive EIP care and were followed up for 1.5 years (trial no.: UMIN000005092). Function (measured with the Global Assessment of Functioning) and clinical remission (defined by internationally standardized criteria proposed by the Remission in Schizophrenia Working Group) were evaluated by independent raters who were blinded to group assignment. Dropout rate and other secondary outcomes were also examined. The specialized EIP care group had a higher clinical remission rate (odds ratio, 6.3; 95% confidence interval, 1.0-37.9) and lower treatment dropout rate (odds ratio, 0.038; 95% confidence interval, 0.002-0.923) than the standard care group, even after adjusting for baseline characteristics. Functional improvement in the specialized EIP care group was slightly higher than that in the standard care group, but this difference was not statistically significant (p = 0.195). From the results, we conclude that comprehensive EIP care may provide advantages over standard care in patients with FEP. Copyright © 2018. Published by Elsevier Ltd.

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.

Randomization at the level of primary care practice: use of pre-intervention data and random effects models.

PubMed

Nixon, R M; Duffy, S W; Fender, G R; Day, N E; Prevost, T C

2001-06-30

The Anglia menorrhagia education study tests the effectiveness of an education package for the treatment of menorrhagia given to doctors at a primary care level. General practices were randomized to receive or not receive the package. It is hoped that this intervention will reduce the proportion of women suffering from menorrhagia that are referred to hospital. Data are available on the treatment and referral of women in the practices in the education and control groups, both pre- and post-intervention. We define and demonstrate a random effects logistic regression model that includes pre-intervention data for calculating the effectiveness of the intervention. Copyright 2001 John Wiley & Sons, Ltd.

A randomized controlled trial on rehabilitation through caregiver-delivered nurse-organized service programs for disabled stroke patients in rural china (the RECOVER trial): design and rationale.

PubMed

Yan, Lijing L; Chen, Shu; Zhou, Bo; Zhang, Jing; Xie, Bin; Luo, Rong; Wang, Ninghua; Lindley, Richard; Zhang, Yuhong; Zhao, Yi; Li, Xian; Liu, Xiao; Peoples, Nicholas; Bettger, Janet Prvu; Anderson, Craig; Lamb, Sarah E; Wu, Yangfeng; Shi, Jingpu

2016-10-01

Stroke is the leading cause of death and disability in rural China. For stroke patients residing in resource-limited rural areas, secondary prevention and rehabilitation are largely unavailable, and where present, are far below evidence-based standards. This study aims to develop and implement a simplified stroke rehabilitation program that utilizes nurses and family caregivers for service delivery, and evaluate its feasibility and effectiveness in rural China. This 2-year randomized controlled trial is being conducted in 2-3 county hospitals located in northwest, northeast, and southwest China. Eligible and consenting stroke inpatients (200 in total) have been recruited and randomized into either a control or intervention group. Nurses in the county hospital are trained by rehabilitation specialists and in turn train the family caregivers in the intervention group. They also provide telephone follow-up care three times post discharge. The recruitment, baseline, intervention, follow-up care, and evaluation are guided by the RECOVER mobile phone app specifically designed for this study. The primary outcome is patients' Barthel Index (activities of daily living: mobility, self-care, and toileting) at 6 months. Process and economic evaluation will also be conducted. The results of our study will generate initial high-quality evidence to improve stroke care in resource-scarce settings. If proven effective, this innovative care delivery model has the potential to improve the health and function of stroke patients, relieve caregiver burden, guide policy-making, and advance translational research in the field of stroke care. © 2016 World Stroke Organization.

Should we treat fever in critically ill patients? A summary of the current evidence from three randomized controlled trials

PubMed Central

Serpa, Ary; Pereira, Victor Galvão Moura; Colombo, Giancarlo; Scarin, Farah Christina de la Cruz; Pessoa, Camila Menezes Souza; Rocha, Leonardo Lima

2014-01-01

Fever is a nonspecific response to various types of infectious or non-infectious insult and its significance in disease remains an enigma. Our aim was to summarize the current evidence for the use of antipyretic therapy in critically ill patients. We performed systematic review and meta-analysis of publications from 1966 to 2013. The MEDLINE and CENTRAL databases were searched for studies on antipyresis in critically ill patients. The meta-analysis was limited to: randomized controlled trials; adult human critically ill patients; treatment with antipyretics in one arm versus placebo or non-treatment in another arm; and report of mortality data. The outcomes assessed were overall intensive care unit mortality, changes in temperature, intensive care unit length of stay, and hospital length of stay. Three randomized controlled trials, covering 320 participants, were included. Patients treated with antipyretic agents showed similar intensive care unit mortality (risk ratio 0.91, with 95% confidence interval 0.65-1.28) when compared with controls. The only difference observed was a greater decrease in temperature after 24 hours in patients treated with antipyretics (-1.70±0.40 versus - 0.56±0.25ºC; p=0.014). There is no difference in treating or not the fever in critically ill patients. PMID:25628209

The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial.

PubMed

Ghorob, Amireh; Vivas, Maria Mercedes; De Vore, Diana; Ngo, Victoria; Bodenheimer, Thomas; Chen, Ellen; Thom, David H

2011-04-01

Although self-management support improves diabetes outcomes, it is not consistently provided in health care settings strained for time and resources. One proposed solution to personnel and funding shortages is to utilize peer coaches, patients trained to provide diabetes education and support to other patients. Coaches share similar experiences about living with diabetes and are able to reach patients within and beyond the health care setting. Given the limited body of evidence that demonstrates peer coaching significantly improves chronic disease care, this present study examines the impact of peer coaching delivered in a primary care setting on diabetes outcomes. The aim of this multicenter, randomized control trial is to evaluate the effectiveness of utilizing peer coaches to improve clinical outcomes and self-management skills in low-income patients with poorly controlled diabetes. A total of 400 patients from six primary health centers based in San Francisco that serve primarily low-income populations will be randomized to receive peer coaching (n = 200) or usual care (n = 200) over 6 months. Patients in the peer coach group receive coaching from patients with diabetes who are trained and mentored as peer coaches. The primary outcome is change in HbA1c. Secondary outcomes include change in: systolic blood pressure, body mass index (BMI), LDL cholesterol, diabetes self-care activities, medication adherence, diabetes-related quality of life, diabetes self-efficacy, and depression. Clinical values (HbA1c, LDL cholesterol and blood pressure) and self-reported diabetes self-efficacy and self-care activities are measured at baseline and after 6 months for patients and coaches. Peer coaches are also assessed at 12 months. Patients with diabetes, who are trained as peer health coaches, are uniquely poised to provide diabetes self management support and education to patients. This study is designed to investigate the impact of peer health coaching in patients with poorly controlled diabetes. Additionally, we will assess disease outcomes in patients with well controlled diabetes who are trained and work as peer health coaches. ClinicalTrials.gov identifier: NCT01040806.

Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: a pragmatic randomized controlled trial.

PubMed

Burton, Elissa; Lewin, Gill; Clemson, Lindy; Boldy, Duncan

2013-01-01

Restorative home care services are short-term and aimed at maximizing a person's ability to live independently. They are multidimensional and often include an exercise program to improve strength, mobility, and balance. The aim of this study was to determine whether a lifestyle exercise program would be undertaken more often and result in greater functional gains than the current structured exercise program delivered as part of a restorative home care service for older adults. A pragmatic randomized controlled trial was conducted in an organization with an established restorative home care service. Individuals who were to have an exercise program as part of their service were randomized to receive either a lifestyle and functional exercise program called LiFE (as this was a new program, the intervention) or the structured exercise program currently being used in the service (control). Exercise data collected by the individuals throughout and pre and post intervention testing was used to measure balance, strength, mobility, falls efficacy, vitality, function, and disability. There was no difference between the groups in the amounts of exercise undertaken during the 8-week intervention period. Outcome measurement indicated that the LiFE program was as effective, and on 40% of the measures, more effective, than the structured exercise program. Organizations delivering restorative home care services that include an exercise component should consider whether LiFE rather than the exercise program they are currently using could help their clients achieve better outcomes.

Is hand hygiene before putting on nonsterile gloves in the intensive care unit a waste of health care worker time?--a randomized controlled trial.

PubMed

Rock, Clare; Harris, Anthony D; Reich, Nicholas G; Johnson, J Kristie; Thom, Kerri A

2013-11-01

Hand hygiene (HH) is recognized as a basic effective measure in prevention of nosocomial infections. However, the importance of HH before donning nonsterile gloves is unknown, and few published studies address this issue. Despite the lack of evidence, the World Health Organization and other leading bodies recommend this practice. The aim of this study was to assess the utility of HH before donning nonsterile gloves prior to patient contact. A prospective, randomized, controlled trial of health care workers entering Contact Isolation rooms in intensive care units was performed. Baseline finger and palm prints were made from dominant hands onto agar plates. Health care workers were then randomized to directly don nonsterile gloves or perform HH and then don nonsterile gloves. Postgloving finger and palm prints were then made from the gloved hands. Plates were incubated and colony-forming units (CFU) of bacteria were counted. Total bacterial colony counts of gloved hands did not differ between the 2 groups (6.9 vs 8.1 CFU, respectively, P = .52). Staphylococcus aureus was identified from gloves (once in "hand hygiene prior to gloving" group, twice in "direct gloving" group). All other organisms were expected commensal flora. HH before donning nonsterile gloves does not decrease already low bacterial counts on gloves. The utility of HH before donning nonsterile gloves may be unnecessary. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

Healthy Homes/Healthy Kids: A Randomized Trial of a Pediatric Primary Care Based Obesity Prevention Intervention for At-Risk 5-10 Year Olds

PubMed Central

Sherwood, Nancy E.; Levy, Rona L.; Langer, Shelby L.; Senso, Meghan M.; Crain, A. Lauren; Hayes, Marcia G.; Anderson, Julie D.; Seburg, Elisabeth M.; Jeffery, Robert W.

2014-01-01

Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a contact control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well-child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The contact control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial. PMID:23816490

Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study

PubMed Central

2013-01-01

Background The primary objective of this study was to determine the efficiency of a pneumatic device in controlling cuff pressure (Pcuff) in patients intubated with polyurethane-cuffed tracheal tubes. Secondary objectives were to determine the impact of continuous control of Pcuff, and cuff shape on microaspiration of gastric contents. Methods Prospective randomized controlled study. All patients requiring intubation and mechanical ventilation ≥48 h were eligible. The first 32 patients were intubated with tapered polyurethane-cuffed, and the 32 following patients were intubated with cylindrical polyurethane-cuffed tracheal tubes. Patients randomly received 24 h of continuous control of Pcuff using a pneumatic device (Nosten®), and 24 h of routine care of Pcuff using a manometer. Target Pcuff was 25 cmH2O. Pcuff was continuously recorded, and pepsin was quantitatively measured in all tracheal aspirates during these periods. Results The pneumatic device was efficient in controlling Pcuff (med [IQ] 26 [24, 28] vs 22 [20, 28] cmH2O, during continuous control of Pcuff and routine care, respectively; p = 0.017). In addition, percentage of patients with underinflation (31% vs 68%) or overinflation (53% vs 100%) of tracheal cuff, and percentage of time spent with underinflation (0.9 [0, 17] vs 14% [4, 30]) or overinflation (0 [0, 2] vs 32% [9, 54]) were significantly (p < 0.001) reduced during continuous control of Pcuff compared with routine care. No significant difference was found in microaspiration of gastric content between continuous control of Pcuff compared with routine care, or between patients intubated with tapered compared with cylindrical polyurethane-cuffed tracheal tubes. Conclusion The pneumatic device was efficient in controlling Pcuff in critically ill patients intubated with polyurethane-cuffed tracheal tubes. Trial registration The Australian New Zealand Clinical Trials Registry (NCT01351259) PMID:24369057

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.

Implementation of a guideline for low back pain management in primary care: a cost-effectiveness analysis.

PubMed

Becker, Annette; Held, Heiko; Redaelli, Marcus; Chenot, Jean F; Leonhardt, Corinna; Keller, Stefan; Baum, Erika; Pfingsten, Michael; Hildebrandt, Jan; Basler, Heinz-Dieter; Kochen, Michael M; Donner-Banzhoff, Norbert; Strauch, Konstantin

2012-04-15

Cost-effectiveness analysis alongside a cluster randomized controlled trial. To study the cost-effectiveness of 2 low back pain guideline implementation (GI) strategies. Several evidence-based guidelines on management of low back pain have been published. However, there is still no consensus on the effective implementation strategy. Especially studies on the economic impact of different implementation strategies are lacking. This analysis was performed alongside a cluster randomized controlled trial on the effectiveness of 2 GI strategies (physician education alone [GI] or physician education in combination with motivational counseling [MC] by practice nurses)--both compared with the postal dissemination of the guideline (control group, C). Sociodemographic data, pain characteristics, and cost data were collected by interview at baseline and after 6 and 12 months. low back pain-related health care costs were valued for 2004 from the societal perspective. For the cost analysis, 1322 patients from 126 general practices were included. Both interventions showed lower direct and indirect costs as well as better patient outcomes during follow-up compared with controls. In addition, both intervention arms showed superiority of cost-effectiveness to C. The effects attenuated when adjusting for differences of health care utilization prior to patient recruitment and for clustering of data. Trends in cost-effectiveness are visible but need to be confirmed in future studies. Researchers performing cost-evaluation studies should test for baseline imbalances of health care utilization data instead of judging on the randomization success by reviewing non-cost parameters like clinical data alone.

Adjunctive Hyperbaric Oxygen Therapy for Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Trial.

PubMed

Chen, Chen-Yu; Wu, Re-Wen; Hsu, Mei-Chi; Hsieh, Ching-Jung; Chou, Man-Chun

The purpose of this study was to compare the effect of standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care alone on wound healing, markers of inflammation, glycemic control, amputation rate, survival rate of tissue, and health-related quality of life in patients with diabetic foot ulcers (DFUs). Prospective, randomized, open-label, controlled study. The sample comprised 38 patients with nonhealing DFUs who were deemed poor candidates for vascular surgery. Subjects were randomly allocated to an experimental group (standard care plus HBOT, n = 20) or a control group (standard care alone, n = 18). The study setting was a medical center in Kaohsiung City, Taiwan. Hyperbaric oxygen therapy was administered in a hyperbaric chamber under 2.5 absolute atmospheric pressure for 120 minutes; subjects were treated 5 days a week for 4 consecutive weeks. Both groups received standard wound care including debridement of necrotic tissue, topical therapy for Wagner grade 2 DFUs, dietary control and pharmacotherapy to maintain optimal blood glucose levels. Wound physiological indices were measured and blood tests (eg, markers of inflammation) were undertaken. Health-related quality of life was measured using the Medical Outcomes Study 36-Item Short Form. Complete DFU closure was achieved in 5 patients (25%) in the HBOT group (n = 20) versus 1 participant (5.5%) in the routine care group (n = 18) (P = .001). The amputation rate was 5% for the HBOT group and 11% for the routine care group (χ = 15.204, P = .010). The HBOT group showed statistically significant improvements in inflammation index, blood flow, and health-related quality of life from pretreatment to 2 weeks after the last therapy ended (P < .05). Hemoglobin A1c was significantly lower in the HBOT group following treatment (P < .05) but not in the routine care group. Adjunctive HBOT improved wound healing in persons with DFU. Therapy also reduced the risk of amputation of the affected limb. We assert that at least 20 HBOT sessions are required to be effective.

Impact of peer-led quality improvement networks on quality of inpatient mental health care: study protocol for a cluster randomized controlled trial.

PubMed

Aimola, Lina; Jasim, Sarah; Tripathi, Neeraj; Tucker, Sarah; Worrall, Adrian; Quirk, Alan; Crawford, Mike J

2016-09-21

Quality improvement networks are peer-led programmes in which members of the network assess the quality of care colleagues provide according to agreed standards of practice. These networks aim to help members identify areas of service provision that could be improved and share good practice. Despite the widespread use of peer-led quality improvement networks, there is very little information about their impact. We are conducting a cluster randomized controlled trial of a quality improvement network for low-secure mental health wards to examine the impact of membership on the process and outcomes of care over a 12 month period. Standalone low secure units in England and Wales that expressed an interest in joining the quality improvement network were recruited for the study from 2012 to 2014. Thirty-eight units were randomly allocated to either the active intervention (participation in the network n = 18) or a control arm (delayed participation in the network n = 20). Using a 5 % significance level and 90 % power, it was calculated that a sample size of 60 wards was required taking into account a 10 % drop out. A total of 75 wards were assessed at baseline and 8 wards dropped out the study before the data collection at follow up. Researchers masked to the allocation status of the units assessed all study outcomes at baseline and follow-up 12 months later. The primary outcome is the quality of the physical environment and facilities on the wards. The secondary outcomes are: safety of the ward, patient-rated satisfaction with care and mental well-being, staff burnout, training and supervision. Relative to control wards, it is hypothesized that the quality of the physical environment and facilities will be higher on wards in the active arm of the trial 12 months after randomization. To our knowledge, this is the first randomized evaluation of a peer-led quality improvement network that has examined the impact of participation on both patient-level and service-level outcomes. The study has the potential to help shape future efforts to improve the quality of inpatient care. Current Controlled Trials ISRCTN79614916 . Retrospectively registered 28 March 2014].

A novel approach to quality improvement in a safety-net practice: concurrent peer review visits.

PubMed

Fiscella, Kevin; Volpe, Ellen; Winters, Paul; Brown, Melissa; Idris, Amna; Harren, Tricia

2010-12-01

Concurrent peer review visits are structured office visits conducted by clinician peers of the primary care clinician that are specifically designed to reduce competing demands, clinical inertia, and bias. We assessed whether a single concurrent peer review visit reduced clinical inertia and improved control of hypertension, hyperlipidemia, and diabetes control among underserved patients. We conducted a randomized encouragement trial to evaluate concurrent peer review visits with a community health center. Seven hundred twenty-seven patients with hypertension, hyperlipidemia, and/or diabetes who were not at goal for systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), and/or glycated hemoglobin (A1c) were randomly assigned to an invitation to participate in a concurrent peer review visit or to usual care. We compared change in these measures using mixed models and rates of therapeutic intensification during concurrent peer review visits with control visits. One hundred seventy-one patients completed a concurrent peer review visit. SBP improved significantly (p < .01) more among those completing concurrent peer review visits than among those who failed to respond to a concurrent peer review invitation or those randomized to usual care. There were no differences seen for changes in LDL-C or A1c. Concurrent peer review visits were associated with statistically significant greater clinician intensification of blood pressure (p < .001), lipid (p < .001), and diabetes (p < .005) treatment than either for control visits for patients in either the nonresponse group or usual care group. Concurrent peer review visits represent a promising strategy for improving blood pressure control and improving therapeutic intensification in community health centers.

A randomized controlled trial of a pharmacist consultation program for family physicians and their elderly patients

PubMed Central

Sellors, John; Kaczorowski, Janusz; Sellors, Connie; Dolovich, Lisa; Woodward, Christel; Willan, Andrew; Goeree, Ron; Cosby, Roxanne; Trim, Kristina; Sebaldt, Rolf; Howard, Michelle; Hardcastle, Linda; Poston, Jeff

2003-01-01

Background Pharmacists can improve patient outcomes in institutional and pharmacy settings, but little is known about their effectiveness as consultants to primary care physicians. We examined whether an intervention by a specially trained pharmacist could reduce the number of daily medication units taken by elderly patients, as well as costs and health care use. Methods We conducted a randomized controlled trial in family practices in 24 sites in Ontario. We randomly allocated 48 randomly selected family physicians (69.6% participation rate) to the intervention or the control arm, along with 889 (69.5% participation rate) of their randomly selected community-dwelling, elderly patients who were taking 5 or more medications daily. In the intervention group, pharmacists conducted face-to-face medication reviews with the patients and then gave written recommendations to the physicians to resolve any drug-related problems. Process outcomes included the number of drug-related problems identified among the senior citizens in the intervention arm and the proportion of recommendations implemented by the physicians. Results After 5 months, seniors in the intervention and control groups were taking a mean of 12.4 and 12.2 medication units per day respectively (p = 0.50). There were no statistically significant differences in health care use or costs between groups. A mean of 2.5 drug-related problems per senior was identified in the intervention arm. Physicians implemented or attempted to implement 72.3% (790/1093) of the recommendations. Interpretation The intervention did not have a significant effect on patient outcomes. However, physicians were receptive to the recommendations to resolve drug-related problems, suggesting that collaboration between physicians and pharmacists is feasible. PMID:12847034

The Effect of Massage on Acute Postoperative Pain in Critically and Acutely Ill Adults Post-thoracic Surgery: Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Boitor, Madalina; Gélinas, Céline; Richard-Lalonde, Melissa; Thombs, Brett D

Critical care practice guidelines identify a lack of clear evidence on the effectiveness of massage for pain control. To assess the effect of massage on acute pain in critically and acutely ill adults post-thoracic surgery. Medline, Embase, CINAHL, PsychInfo, Web of Science, Scopus and Cochrane Library databases were searched. Eligible studies were randomized controlled trials (RCTs) evaluating the effect of massage compared to attention control/sham massage or standard care alone on acute pain intensity post-thoracic surgery. Twelve RCTs were included. Of these, nine evaluated massage in addition to standard analgesia, including 2 that compared massage to attention control/sham massage in the intensive care unit (ICU), 6 that compared massage to standard analgesia alone early post-ICU discharge, and 1 that compared massage to both attention control and standard care in the ICU. Patients receiving massage with analgesia reported less pain (0-10 scale) compared to attention control/sham massage (3 RCTs; N = 462; mean difference -0.80, 95% confidence interval [CI] -1.25 to -0.35; p < 0.001; I 2  = 13%) and standard care (7 RCTs; N = 1087; mean difference -0.85, 95% CI -1.28 to -0.42; p < 0.001; I 2  = 70%). Massage, in addition to pharmacological analgesia, reduces acute post-cardiac surgery pain intensity. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of person-centred care on health outcomes-A randomized controlled trial in patients with acute coronary syndrome.

PubMed

Pirhonen, Laura; Olofsson, Elisabeth Hansson; Fors, Andreas; Ekman, Inger; Bolin, Kristian

2017-02-01

To study the effects of person-centred care provided to patients with acute coronary syndrome, using four different health-related outcome measures. Also, to examine the performance of these outcomes when measuring person-centred care. The data used in this study consists of primary data from a multicentre randomized parallel group, controlled intervention study for patients with acute coronary syndrome at Sahlgrenska University Hospital in Gothenburg, Sweden. The intervention and control group consisted of 94 and 105 patients, respectively. The effect of the intervention on health-related outcomes was estimated, controlling for socio-economic and disease-related variables. Patients in the intervention group reported significantly higher general self-efficacy than those in the control group six months after intervention start-up. Moreover, the intervention group returned to work in a greater extent than controls; their physical activity level had increased more and they had a higher EQ-5D score, meaning higher health-related quality of life. These latter effects are not significant but are all pointing towards the beneficial effects of person-centred care. All the effects were estimated while controlling for important socio-economic and disease-related variables. The effectiveness of person-centred care varies between different outcomes considered. A statistically significant beneficial effect was found for one of the four outcome measures (self-efficacy). The other measures all captured beneficial, but not significant, effects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Comparative effectiveness of next generation genomic sequencing for disease diagnosis: design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes.

PubMed

Gallego, Carlos J; Bennette, Caroline S; Heagerty, Patrick; Comstock, Bryan; Horike-Pyne, Martha; Hisama, Fuki; Amendola, Laura M; Bennett, Robin L; Dorschner, Michael O; Tarczy-Hornoch, Peter; Grady, William M; Fullerton, S Malia; Trinidad, Susan B; Regier, Dean A; Nickerson, Deborah A; Burke, Wylie; Patrick, Donald L; Jarvik, Gail P; Veenstra, David L

2014-09-01

Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effectiveness and patient-centered outcomes research. We designed a randomized controlled trial that incorporates these research methods to evaluate whole exome sequencing compared to usual care in patients being evaluated for hereditary colorectal cancer and polyposis syndromes. Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings. Patients will receive findings associated with colorectal cancer in a first return of results visit, and findings not associated with colorectal cancer (incidental findings) during a second return of results visit. The primary outcome is efficacy to detect mutations associated with these syndromes; secondary outcomes include psychosocial impact, cost-effectiveness and comparative costs. The secondary outcomes will be obtained via surveys before and after each return visit. The expected challenges in conducting this randomized controlled trial include the relatively low prevalence of genetic disease, difficult interpretation of some genetic variants, and uncertainty about which incidental findings should be returned to patients. The approaches utilized in this study may help guide other investigators in clinical genomics to identify useful outcome measures and strategies to address comparative effectiveness questions about the clinical implementation of genomic sequencing in clinical care. Copyright © 2014 Elsevier Inc. All rights reserved.

Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial.

PubMed

Kuhmmer, Regina; Lima, Karine Margarites; Ribeiro, Rodrigo Antonini; Hammes, Luciano Serpa; Bastos, Gisele Alsina Nader; Cotta de Souza, Maria Claudia Schardosim; Polanczyk, Carisi Anne; Soares Rollin, Guilherme Alcides Flores; Caon, Suhelen; Guterres, Cátia Moreira; Araújo Leite, Leni Everson; Delabary, Tássia Scholante; Falavigna, Maicon

2015-02-25

Patient education on pharmacological therapy may increase medication adherence and decrease hospitalizations. Our aim is to evaluate the effectiveness of pharmaceutical care at emergency department discharge in patients with hypertension and/or diabetes. This is a randomized controlled trial. Participants will be recruited from a public emergency department at Restinga district in Porto Alegre, southern Brazil. A total of 380 patients will be randomly assigned into 2 groups at the moment of emergency department discharge after receiving medical orientations: an intervention group, consisting of a structured individual counseling session by a pharmacist in addition to written orientations, or a control group, consisting only of written information about the disease. Outcomes will be assessed in an ambulatory visit 2 months after the randomization. The primary outcome is the proportion of patients with high medication adherence assessed using the Morisky-Green Test and the Brief Medication Questionnaire. The secondary outcomes are reduction of blood pressure, glycated hemoglobin, fasting plasma glucose, quality of life and number of visits to the emergency department. Pharmaceutical care interventions have shown to be feasible and effective in increasing medication adherence in both hospital outpatient and community pharmacy settings. However, there have been no previous assessments of the effectiveness of pharmacy care interventions initiated in patients discharged from emergency departments. Our hypothesis is that pharmaceutical counseling is also effective in this population. ClinicalTrials.gov registration number: NCT01978925 (11 November 2013) and Brazilian Registry of Clinical Trials U1111-1149-8922 (5 November 2013).

Improving Herpes Zoster Vaccination Rates Through Use of a Clinical Pharmacist and a Personal Health Record

PubMed Central

Otsuka, Shelley H.; Tayal, Neeraj H.; Porter, Kyle; Embi, Peter J.; Beatty, Stuart J.

2014-01-01

BACKGROUND Preventative health services, including herpes zoster vaccination rates, remain low despite known benefits. A new care model to improve preventative health services is warranted. The objective of this study is to investigate whether the functions of an electronic medical record, in combination with a pharmacist as part of the care team, can improve the herpes zoster vaccination rate. METHODS This study was a 6-month, randomized controlled trial at a General Internal Medicine clinic at The Ohio State University. The 2589 patients aged 60 years and older without documented herpes zoster vaccination in the electronic medical record were stratified on the basis of activated personal health record status, an online tool used to share health information between patient and provider. Of the 674 personal health record users, 250 were randomized to receive information regarding the herpes zoster vaccination via an electronic message and 424 were randomized to standard of care. Likewise, of the 1915 nonpersonal health record users, 250 were randomized to receive the same information via the US Postal Service and 1665 were randomized to standard of care. After pharmacist chart review, eligible patients were mailed a herpes zoster vaccine prescription. Herpes zoster vaccination rates were compared by chi-square tests. RESULTS Intervention recipients had significantly higher vaccination rates than controls in both personal health record (relative risk, 2.7; P = .0007) and nonpersonal health record (relative risk, 2.9; P = .0001) patient populations. CONCLUSIONS Communication outside of face-to-face office visits, by both personal health record electronic message and information by mail, can improve preventative health intervention rates compared with standard care. PMID:23830534

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial

PubMed Central

2014-01-01

Background Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. Methods/design The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. Discussion The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. Trial registration NCT01967797. PMID:24947045

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial.

PubMed

Campbell-Scherer, Denise L; Asselin, Jodie; Osunlana, Adedayo M; Fielding, Sheri; Anderson, Robin; Rueda-Clausen, Christian F; Johnson, Jeffrey A; Ogunleye, Ayodele A; Cave, Andrew; Manca, Donna; Sharma, Arya M

2014-06-19

Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. NCT01967797.

The effectiveness of patient navigation to improve healthcare utilization outcomes: A meta-analysis of randomized controlled trials.

PubMed

Ali-Faisal, Sobia F; Colella, Tracey J F; Medina-Jaudes, Naomi; Benz Scott, Lisa

2017-03-01

To determine the effects of patient navigation (PN) on healthcare utilization outcomes using meta-analysis and the quality of evidence. Medical and social science databases were searched for randomized controlled trials published in English between 1989 and May 2015. The review process was guided by PRISMA. Included studies were assessed for quality using the Downs and Black tool. Data were extracted to assess the effect of navigation on: health screening rates, diagnostic resolution, cancer care follow-up treatment adherence, and attendance of care events. Random-effects models were used to compute risk ratios and I 2 statistics determined the impact of heterogeneity. Of 3985 articles screened, 25 articles met inclusion criteria. Compared to usual care, patients who received PN were significantly more likely to access health screening (OR 2.48, 95% CI, 1.93-3.18, P<0.00001) and attend a recommended care event (OR 2.55, 95% CI, 1.27-5.10, P<0.01). PN was favoured to increase adherence to cancer care follow-up treatment and obtain diagnoses. Most studies involved trained lay navigators (n=12) compared to health professionals (n=9). PN is effective to increase screening rates and complete care events. PN is an effective intervention for use in healthcare. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Does the patient‐held record improve continuity and related outcomes in cancer care: a systematic review

PubMed Central

Gysels, Marjolein; Richardson, Alison; Higginson, Irene J.

2006-01-01

Abstract Objectives  To assess the effectiveness of the patient‐held record (PHR) in cancer care. Background  Patients with cancer may receive care from different services resulting in gaps. A PHR could provide continuity and patient involvement in care. Search strategy  Relevant literature was identified through five electronic databases (Medline, Embase, Cinahl, CCTR and CDSR) and hand searches. Inclusion criteria  Patient‐held records in cancer care with the purpose of improving communication and information exchange between and within different levels of care and to promote continuity of care and patients’ involvement in their own care. Data extraction and synthesis  Data extraction recorded characteristics of intervention, type of study and factors that contributed to methodological quality of individual studies. Data were then contrasted by setting, objectives, population, study design, outcome measures and changes in outcome, including knowledge, satisfaction, anxiety and depression. Methodological quality of randomized control trials and non‐experimental studies were assessed with separate standard grading scales. Main results and conclusions  Seven randomized control trials and six non‐experimental studies were identified. Evaluations of the PHR have reached equivocal findings. Randomized trials found an absence of effect, non‐experimental evaluations shed light on the conditions for its successful use. Most patients welcomed introduction of a PHR. Main problems related to its suitability for different patient groups and the lack of agreement between patients and health professionals regarding its function. Further research is required to determine the conditions under which the PHR can realize its potential as a tool to promote continuity of care and patient participation. PMID:17324196

Mini-intervention for subacute low back pain: a randomized controlled trial.

PubMed

Karjalainen, Kaija; Malmivaara, Antti; Pohjolainen, Timo; Hurri, Heikki; Mutanen, Pertti; Rissanen, Pekka; Pahkajärvi, Helena; Levon, Heikki; Karpoff, Hanna; Roine, Risto

2003-03-15

Randomized controlled trial. To investigate the effectiveness and costs of a mini-intervention, provided in addition to the usual care, and the incremental effect of a work site visit for patients with subacute disabling low back pain. There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain. A total of 164 patients with subacute low back pain were randomized to a mini-intervention group (A), a work site visit group (B), or a usual care group (C). Groups A (n = 56) and B (n = 51) underwent one assessment by a physician plus a physiotherapist. Group B received a work site visit in addition. Group C served as controls (n = 57) and was treated in municipal primary health care. All patients received a leaflet on back pain. Pain, disability, specific and generic health-related quality of life, satisfaction with care, days on sick leave, and use and costs of health care consumption were measured at 3-, 6-, and 12-month follow-ups. During follow-up, fewer subjects had daily pain in Groups A and B than in Group C (Group A Group C, = 0.002; Group B Group C, = 0.030). In Group A, pain was less bothersome (Group A Group C, = 0.032) and interfered less with daily life (Group A Group C, = 0.040) than among controls. Average days on sick leave were 19 in Group A, 28 in Group B, and 41 in Group C (Group A Group C, = 0.019). Treatment satisfaction was better in the intervention groups than among the controls, and costs were lowest in the mini-intervention group. Mini-intervention reduced daily back pain symptoms and sickness absence, improved adaptation to pain and patient satisfaction among patients with subacute low back pain, without increasing health care costs. A work site visit did not increase effectiveness.

The Family Navigator: A Pilot Intervention to Support Intensive Care Unit Family Surrogates.

PubMed

Torke, Alexia M; Wocial, Lucia D; Johns, Shelley A; Sachs, Greg A; Callahan, Christopher M; Bosslet, Gabriel T; Slaven, James E; Perkins, Susan M; Hickman, Susan E; Montz, Kianna; Burke, Emily S

2016-11-01

Communication problems between family surrogates and intensive care unit (ICU) clinicians have been documented, but few interventions are effective. Nurses have the potential to play an expanded role in ICU communication and decision making. To conduct a pilot randomized controlled trial of the family navigator (FN), a distinct nursing role to address family members' unmet communication needs early in an ICU stay. An interprofessional team developed the FN protocol. A randomized controlled pilot intervention trial of the FN was performed in a tertiary referral hospital's ICU to test the feasibility and acceptability of the intervention. The intervention addressed informational and emotional communication needs through daily contact by using structured clinical updates, emotional and informational support modules, family meeting support, and follow-up phone calls. Twenty-six surrogate/patient pairs (13 per study arm) were enrolled. Surrogates randomized to the intervention had contact with the FN on 90% or more of eligible patient days. All surrogates agreed that they would recom mend the FN to other families. Open-ended comments from both surrogates and clinicians were uniformly positive. Having a fully integrated nurse empowered to facilitate decision making is a feasible intervention in an ICU and is well-received by ICU families and staff. A larger randomized controlled trial is needed to demonstrate impact on important outcomes, such as surrogates' well-being and decision quality. ©2016 American Association of Critical-Care Nurses.

The COMmunity of Practice And Safety Support (COMPASS) Total Worker Health™ study among home care workers: study protocol for a randomized controlled trial.

PubMed

Olson, Ryan; Elliot, Diane; Hess, Jennifer; Thompson, Sharon; Luther, Kristy; Wipfli, Brad; Wright, Robert; Buckmaster, Annie Mancini

2014-10-27

Home care workers are a high-risk group for injury and illness. Their unique work structure presents challenges to delivering a program to enhance their health and safety. No randomized controlled trials have assessed the impact of a Total Worker Health™ program designed for their needs. The COMPASS (COMmunity of Practice And Safety Support) study is a cluster randomized trial being implemented among Oregon's unionized home care workers. Partnering with the Oregon Home Care Commission allowed recruiting 10 pairs of home care worker groups with 8 participants per group (n = 160) for balanced randomization of groups to intervention and control conditions. Physiologic and survey evaluation of all participants will be at enrollment, 6 months and 12 months. Primary outcomes are to increase health promoting (for example, healthy nutrition and regular physical activity) and health protecting (that is, safety) behaviors. In addition to assessing outcomes adjusted for the hierarchical design, mediation analyses will be used to deconstruct and confirm the program's theoretical underpinnings and intervention processes. Intervention groups will participate in a series of monthly 2-hour meetings designed as ritualized, scripted peer-led sessions to increase knowledge, practice skills and build support for healthy actions. Self-monitoring and individual and team level goals are included to augment change. Because generalizability, reach and achieving dissemination are priorities, following initial wave findings, a second wave of COMPASS groups will be recruited and enrolled with tailoring of the program to align with existing Home Care Commission educational offerings. Outcomes, process and mediation of those tailored groups will be compared with the original wave's findings. The COMPASS trial will assess a novel program to enhance the safety and health of a vulnerable, rapidly expanding group of isolated caregivers, whose critical work allows independent living of frail seniors and the disabled. ClinicalTrials.gov identifier: NCT02113371, first registered 11 March 2014.

Enhanced recovery care versus traditional care after laparoscopic liver resections: a randomized controlled trial.

PubMed

Liang, Xiao; Ying, Hanning; Wang, Hongwei; Xu, Hongxia; Liu, Minjun; Zhou, Haiyan; Ge, Huiqing; Jiang, Wenbin; Feng, Lijun; Liu, Hui; Zhang, Yingchun; Mao, Zhiying; Li, Jianhua; Shen, Bo; Liang, Yuelong; Cai, Xiujun

2018-06-01

Enhanced recovery after surgery (ERAS), with several evidence-based elements, has been shown to shorten length of hospital stay and reduce perioperative hospital costs in many operations. This randomized clinical trial was performed to compare complications and hospital stay of laparoscopic liver resection between ERAS and traditional care. A randomized controlled trial was performed for laparoscopic liver resection from August 2015 to August 2016. Patients were randomly divided into ERAS group and traditional care group. The primary outcome was length of hospital stay (LOS) after surgery. Second outcomes included postoperative complications, hospital cost, and 30-day readmissions. Elements used in ERAS group included more perioperative education, nurse navigators, nutrition support for liver diseases, respiratory therapy, oral carbohydrate 2 h before operation, early mobilization and oral intake, goal-directed fluid therapy, less drainages, postoperative nausea and vomiting (PONV) prophylaxis and multimodal analgesia. The study included 58 (two conversion to laparotomy) patients in ERAS group and 61 (three conversion to laparotomy) patients in the traditional care group. Postoperative LOS was significantly shorter in the ERAS group than traditional care group (5 vs. 8 days; p < 0.001). ERAS program significantly reduced the hospital costs (CNY 45413.1 vs. 55794.1; p = 0.006) and complications (36.2 vs. 55.7%; p = 0.033). Duration till first flatus and PONV were significantly reduced in ERAS group. Pain control was better in ERAS (Visual analogue scale (VAS) POD1 (≥ 4) 19.0 vs. 39.3%, p = 0.017; VAS POD1 2.5 vs. 3.1, p = 0.010). There was no difference in the rate of 30-day readmissions (6.9 vs. 8.2%; p = 1.000). ERAS protocol is feasible and safe for laparoscopic liver resection. Patients in ERAS group have less pain and complications.

Effect of Foster Care on Language Learning at Eight Years: Findings from the Bucharest Early Intervention Project

ERIC Educational Resources Information Center

Windsor, Jennifer; Moraru, Ana; Nelson, Charles A., III.; Fox, Nathan A.; Zeanah, Charles H.

2013-01-01

This study reports on language outcomes at eight years from the Bucharest Early Intervention Project, a randomized controlled study of foster care. We previously have shown that children placed in foster care by age two have substantially stronger preschool language outcomes than children placed later and children remaining in institutional care.…

Pregnancy Rates among Juvenile Justice Girls in Two Randomized Controlled Trials of Multidimensional Treatment Foster Care

ERIC Educational Resources Information Center

Kerr, David C. R.; Leve, Leslie D.; Chamberlain, Patricia

2009-01-01

Preventing adolescent pregnancy is a national research priority that has had limited success. In the present study, the authors examined whether Multidimensional Treatment Foster Care (MTFC) relative to intervention services as usual (group care [GC]) decreased pregnancy rates among juvenile justice girls mandated to out-of-home care. Girls (13-17…

Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials.

PubMed

Carter, Marissa J; Fife, Caroline E; Walker, David; Thomson, Brett

2009-07-01

To determine the percentage of individuals that would be excluded from wound care randomized controlled trials (RCTs) as a surrogate for applicability to general populations. A representative sample of wound-care RCTs was selected from the literature in the past 10 years. Exclusion criteria from the trials were evaluated, and prevalence values for each excluded condition were obtained from a large wound-care population, as well as from the literature. The percentage of patients excluded on this basis was calculated. Seventeen RCTs testing "high-technology" wound-care products were evaluated. : Patients in the trials were treated for ulcers (venous, diabetic foot, and pressure ulcers). A percentage of patients in the study population were excluded for each RCT. More than 50% of the study population would have been excluded in 15 of the 17 RCTs. When less clinically relevant exclusion criteria were removed, 14 of 17 RCTs would still have excluded between 25% and 50% of the study population. The results raise serious questions regarding the applicability of these RCTs to wound-care populations.

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

Influence of maternal factors on the successful outcome of kangaroo mother care in low birth-weight infants: A randomized controlled trial.

PubMed

Lumbanraja, S N

2016-01-01

Kangaroo mother care (KMC) is associated with positive neonatal outcomes. Studies demonstrated significant influence of maternal factors on the success of applying KMC. To determine maternal factors that influence on anthropometric parameters in low birth weight babies that received kangaroo mother care. This is a randomized controlled study that involved low birth weight newborns. We randomly assigned newborns into two groups; a group who received KMC and a group who received conventional care. Maternal factors were recorded. We followed weight, length, and head circumferences of newborns for thirty days. A total of 40 newborns were included. Weight parameters were significantly higher in the KMC group than the conventional group. From maternal characteristics, only gestational age was found to influence increased head circumference in KMC group (p = 0.035); however, it did not affect the increase in weight or length. Maternal age, parity, education, mode of delivery, fetal sex, and initial Apgar score did not influence growth parameters in either groups. KMC was associated with increased weight gain in LBW infants. Gestational age influences head growth in infants who received KMC.

A systematic review of the evidence on home care reablement services.

PubMed

Legg, Lynn; Gladman, John; Drummond, Avril; Davidson, Alex

2016-08-01

To determine whether publically funded 'reablement services' have any effect on patient health or use of services. Systematic review of randomized controlled trials and non-randomized studies in which reablement interventions were compared with no care or usual care in people referred to public-funded personal care services. Data sources included: Cochrane Central Register of Controlled Trials, EPOC register of studies, trials registers, Medline, EMBASE, and CINHAL. Searches were from 2000 up to end February 2015. Not applicable. Investigators' definition of the target population for reablement interventions. Use of publically funded personal care services and dependence in personal activities of daily living. We found no studies fulfilling our inclusion criteria that assessed the effectiveness of reablement interventions. We did note the lack of an agreed understanding of the nature of reablement. Reablement is an ill-defined intervention targeted towards an ill-defined and potentially highly heterogeneous population/patient group. There is no evidence to suggest it is effective at either of its goals; increasing personal independence or reducing use of personal care services. © The Author(s) 2015.

The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes

PubMed Central

Walker, Gemma M; Armstrong, Sarah; Gordon, Adam L; Gladman, John; Robertson, Kate; Ward, Marie; Conroy, Simon; Arnold, Gail; Darby, Janet; Frowd, Nadia; Williams, Wynne; Knowles, Sue; Logan, Pip A

2015-01-01

Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. PMID:26385358

Comprehensive behavioral-motivational nutrition education improves depressive symptoms following bariatric surgery: a randomized, controlled trial of obese Hispanic Americans.

PubMed

Petasne Nijamkin, Monica; Campa, Adriana; Samiri Nijamkin, Shani; Sosa, Jorge

2013-01-01

To evaluate the effect of 2 post-bariatric support interventions on depressive symptoms of Hispanic Americans treated with gastric bypass for morbid or severe obesity. Prospective randomized, controlled trial conducted in a laparoscopic institution. During the Phase 1 clinical trial (from preoperative evaluation to 6 months after surgery), all participants received standard care. During Phase 2 (6-12 months after surgery), participants were randomly assigned to receive either standard care (n = 72) or comprehensive support (n = 72). Comprehensive group participants received 6 educational sessions focused on behavior change strategies and motivation with nutrition counseling. Depression scores and weight change over time. Independent samples t tests and regression analysis assessed relationships among depression scores and excess weight loss. Participants receiving behavioral-motivational intervention scored significantly lower on Beck's Depression Inventory questionnaire scores than those receiving standard care. For those with depressive symptoms at randomization, 24% of participants who received the comprehensive intervention reported no depressive symptoms at 12 months after surgery, compared with 6% of those who received standard care (P < .001). Patients' depressive mood improvement was significantly and positively associated with excess weight loss and attendance at educational sessions (P < .001). Findings support the importance of post-bariatric comprehensive behavioral-motivational nutrition education for decreasing risk for depression and improving weight loss. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

A randomized controlled trial testing the efficacy of a brief cannabis universal prevention program among adolescents in primary care.

PubMed

Walton, Maureen A; Resko, Stella; Barry, Kristen L; Chermack, Stephen T; Zucker, Robert A; Zimmerman, Marc A; Booth, Brenda M; Blow, Frederic C

2014-05-01

To examine the efficacy of a brief intervention delivered by a therapist (TBI) or a computer (CBI) in preventing cannabis use among adolescents in urban primary care clinics. A randomized controlled trial comparing: CBI and TBI versus control. Urban primary care clinics in the United States. Research staff recruited 714 adolescents (aged 12-18 years) who reported no life-time cannabis use on a screening survey for this study, which included a baseline survey, randomization (stratified by gender and grade) to conditions (control; CBI; TBI) and 3-, 6- and 12-month assessments. Using an intent-to-treat approach, primary outcomes were cannabis use (any, frequency); secondary outcomes included frequency of other drug use, severity of alcohol use and frequency of delinquency (among 85% completing follow-ups). Compared with controls, CBI participants had significantly lower rates of any cannabis use over 12 months (24.16%, 16.82%, respectively, P < 0.05), frequency of cannabis use at 3 and 6 months (P < 0.05) and other drug use at 3 months (P < 0.01). Compared with controls, TBI participants did not differ in cannabis use or frequency, but had significantly less other drug use at 3 months (P < 0.05), alcohol use at 6 months (P < 0.01) and delinquency at 3 months (P < 0.01). Among adolescents in urban primary care in the United States, a computer brief intervention appeared to prevent and reduce cannabis use. Both computer and therapist delivered brief interventions appeared to have small effects in reducing other risk behaviors, but these dissipated over time. © 2013 Society for the Study of Addiction.

Impact of a short home-based yoga programme on blood pressure in patients with hypertension: a randomized controlled trial in primary care.

PubMed

Wolff, M; Rogers, K; Erdal, B; Chalmers, J P; Sundquist, K; Midlöv, P

2016-10-01

The present study was designed to evaluate yoga's impact on blood pressure (BP) and quality of life (QOL) and on stress, depression and anxiety in patients with hypertension in a primary care setting. We conducted a multi-centre randomized controlled trial with follow-up after 12-week intervention completion. Adult primary care patients diagnosed with hypertension were randomly allocated to yoga or usual care. The intervention group performed a short home-based Kundalini yoga programme 15 min twice-daily during the 12-week intervention period. At baseline and follow-up, the participants underwent standardized BP measurements and completed questionnaires on QOL, stress, anxiety and depression. Data obtained from 191 patients (mean age 64.7 years, s.d. 8.4) allocated to yoga intervention (n=96) and control group (n=95), with a total proportion of 52% women, showed a significant reduction in systolic and diastolic BP for both groups (-3.8/-1.7 mm Hg for yoga and -4.5/-3.0 mm Hg for control groups, respectively). However, the BP reduction for the yoga group was not significantly different from control. There were small but significant improvements for the yoga group in some of the QOL and depression measures (P<0.05, Hospital Anxiety and Depression scale, HADS-D) compared with control. The findings of our study, which is the largest study from an OECD country (Organization for Economic Co-operation and Development) to date, do not support the suggestion from previous smaller studies that yoga lowers the BP. Further clinical trials are needed to confirm these findings. However, the yoga patients had other health benefits.

Automatic control of tracheal tube cuff pressure in ventilated patients in semirecumbent position: a randomized trial.

PubMed

Valencia, Mauricio; Ferrer, Miquel; Farre, Ramon; Navajas, Daniel; Badia, Joan Ramon; Nicolas, Josep Maria; Torres, Antoni

2007-06-01

The aspiration of subglottic secretions colonized by bacteria pooled around the tracheal tube cuff due to inadvertent deflation (<20 cm H2O) of the cuff plays a relevant role in the pathogenesis of ventilator-associated pneumonia. We assessed the efficacy of an automatic, validated device for the continuous regulation of tracheal tube cuff pressure in preventing ventilator-associated pneumonia. Prospective randomized controlled trial. Respiratory intensive care unit and general medical intensive care unit. One hundred and forty-two mechanically ventilated patients (age, 64 +/- 17 yrs; Acute Physiology and Chronic Health Evaluation II score, 18 +/- 6) without pneumonia or aspiration at admission. Within 24 hrs of intubation, patients were randomly allocated to undergo continuous regulation of the cuff pressure with the automatic device (n = 73) or routine care of the cuff pressure (control group, n = 69). Patients remained in a semirecumbent position in bed. The primary end point variable was the incidence of ventilator-associated pneumonia. Main causes for intubation were decreased consciousness (43, 30%) and exacerbation of chronic respiratory diseases (38, 27%). Cuff pressure <20 cm H2O was more frequently observed in the control than the automatic group (45.3 vs. 0.7% determinations, p < .001). However, the rate of ventilator-associated pneumonia with clinical criteria (16, 22% vs. 20, 29%) and microbiological confirmation (11, 15% vs. 10, 15%), the distribution of early and late onset, the causative microorganisms, and intensive care unit (20, 27% vs. 16, 23%) and hospital mortality (30, 41% vs. 23, 33%) were similar for the automatic and control groups, respectively. Cuff pressure is better controlled with the automatic device. However, it did not result in additional benefits to the semirecumbent position in preventing ventilator-associated pneumonia.

Effect of an orientation group for patients with chronic heart failure: randomized controlled trial 1

PubMed Central

Arruda, Cristina Silva; Pereira, Juliana de Melo Vellozo; Figueiredo, Lyvia da Silva; Scofano, Bruna dos Santos; Flores, Paula Vanessa Peclat; Cavalcanti, Ana Carla Dantas

2018-01-01

ABSTRACT Objective: To evaluate the effect of the orientation group on therapeutic adherence and self-care among patients with chronic heart failure. Method: Randomized controlled trial with 27 patients with chronic heart failure. The intervention group received nursing consultations and participated in group meetings with the multi-professional team. The control group only received nursing consultations in a period of four months. Questionnaires validated for use in Brazil were applied in the beginning and in the end of the study to assess self-care outcomes and adherence to treatment. Categorical variables were expressed through frequency and percentage distributions and the continuous variables through mean and standard deviation. The comparison between the initial and final scores of the intervention and control groups was done through the Student’s t-test. Results: The mean adherence in the intervention group was 13.9 ± 3.6 before the study and 4.8 ± 2.3 after the study. In the control group it was 14.2 ± 3.4 before the study and 14.7 ± 3.5 after the study. The self-care confidence score was lower after the intervention (p=0.01). Conclusion: The orientation group does not improve adherence to treatment and self-care management and maintenance and it may reduce confidence in self-care. Registry REBEC RBR-7r9f2m. PMID:29319747

Effect of an orientation group for patients with chronic heart failure: randomized controlled trial.

PubMed

Arruda, Cristina Silva; Pereira, Juliana de Melo Vellozo; Figueiredo, Lyvia da Silva; Scofano, Bruna Dos Santos; Flores, Paula Vanessa Peclat; Cavalcanti, Ana Carla Dantas

2018-01-08

To evaluate the effect of the orientation group on therapeutic adherence and self-care among patients with chronic heart failure. Randomized controlled trial with 27 patients with chronic heart failure. The intervention group received nursing consultations and participated in group meetings with the multi-professional team. The control group only received nursing consultations in a period of four months. Questionnaires validated for use in Brazil were applied in the beginning and in the end of the study to assess self-care outcomes and adherence to treatment. Categorical variables were expressed through frequency and percentage distributions and the continuous variables through mean and standard deviation. The comparison between the initial and final scores of the intervention and control groups was done through the Student's t-test. The mean adherence in the intervention group was 13.9 ± 3.6 before the study and 4.8 ± 2.3 after the study. In the control group it was 14.2 ± 3.4 before the study and 14.7 ± 3.5 after the study. The self-care confidence score was lower after the intervention (p=0.01). The orientation group does not improve adherence to treatment and self-care management and maintenance and it may reduce confidence in self-care. Registry REBEC RBR-7r9f2m.

Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

PubMed Central

Khorsan, Raheleh; Coulter, Ian D.; Crawford, Cindy; Hsiao, An-Fu

2011-01-01

A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED), BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent reviewers rated each article and assessed the methodological quality of studies using the Scottish Intercollegiate Guidelines Network (SIGN 50). Our search yielded 11,891 total citations but 6 clinical studies, including 4 randomized, met our inclusion criteria. There are no available systematic reviews/meta-analyses published that met our inclusion criteria. The methodological quality of the included studies was assessed independently using quality checklists of the SIGN 50. Only a small number of RCTs and CCTs with a limited number of patients and lack of adequate control groups assessing integrative health care research are available. These studies provide limited evidence of effective integrative health care on some modalities. However, integrative health care regimen appears to be generally safe. PMID:20953383

Perceptions of Primary Care-Based Breastfeeding Promotion Interventions: Qualitative Analysis of Randomized Controlled Trial Participant Interviews

PubMed Central

Bonuck, Karen; Barnett, Josephine; Lischewski-Goel, Jennifer

2012-01-01

Abstract Objective This study examined women's perceptions and reported effects of routine, primary care-based interventions to increase breastfeeding. Subjects and Methods A subsample (n=67) of participants in randomized controlled trials (RCTs) completed semistructured exit interviews at 6 months postpartum. RCT arms included the following: (a) routine pre-/postnatal lactation consultant (LC) support (LC group); (b) electronic prompts (EP) guiding providers to discuss breastfeeding during prenatal care visits (EP group); (c) a combined intervention (LC+EP group); and (d) controls. Interview transcripts were coded and analyzed in MAX.qda. Results Key findings included the following: (1) Brief, non-directive assessment of feeding via postpartum interviews focused attention upon feeding practices. When coupled with breastfeeding promotion interventions, interviews promoted breastfeeding. (2) The EP and LC interventions were complementary: EPs influenced initiation, while LCs helped overcome barriers and sustain breastfeeding. (3) Prenatal intent to feed both breastmilk and formula was associated with the greatest receptivity to study messages. Conclusions Findings underscore the need for interventions across the continuum of care. Trained LCs in prenatal/postpartum settings and prenatal care providers play important complementary roles that, when coupled with brief telephone feeding assessments, may improve breastfeeding rates. PMID:22621223

Perceptions of primary care-based breastfeeding promotion interventions: qualitative analysis of randomized controlled trial participant interviews.

PubMed

Andaya, Elise; Bonuck, Karen; Barnett, Josephine; Lischewski-Goel, Jennifer

2012-12-01

This study examined women's perceptions and reported effects of routine, primary care-based interventions to increase breastfeeding. A subsample (n=67) of participants in randomized controlled trials (RCTs) completed semistructured exit interviews at 6 months postpartum. RCT arms included the following: (a) routine pre-/postnatal lactation consultant (LC) support (LC group); (b) electronic prompts (EP) guiding providers to discuss breastfeeding during prenatal care visits (EP group); (c) a combined intervention (LC+EP group); and (d) controls. Interview transcripts were coded and analyzed in MAX.qda. Key findings included the following: (1) Brief, non-directive assessment of feeding via postpartum interviews focused attention upon feeding practices. When coupled with breastfeeding promotion interventions, interviews promoted breastfeeding. (2) The EP and LC interventions were complementary: EPs influenced initiation, while LCs helped overcome barriers and sustain breastfeeding. (3) Prenatal intent to feed both breastmilk and formula was associated with the greatest receptivity to study messages. Findings underscore the need for interventions across the continuum of care. Trained LCs in prenatal/postpartum settings and prenatal care providers play important complementary roles that, when coupled with brief telephone feeding assessments, may improve breastfeeding rates.

Primary Prevention of Parent-Child Conflict and Abuse in Iranian Mothers: A Randomized-Controlled Trial

ERIC Educational Resources Information Center

Oveisi, Sonia; Ardabili, Hassan Eftekhare; Dadds, Mark R.; Majdzadeh, Reza; Mohammadkhani, Parvaneh; Rad, Javad Alaqband; Shahrivar, Zahra

2010-01-01

Objective: The aim of this study was to assess whether primary health care settings can be used to engage and provide a preventive intervention to mothers of young children. Methods: Two hundred and twenty-four mothers who had come to the health centers were randomly assigned to either control group (CG: n=116) or intervention group (IG: n = 108).…

An Evaluation of the Implementation of Hand Held Health Records with Adults with Learning Disabilities: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Turk, Vicky; Burchell, Sarah; Burrha, Sukhjinder; Corney, Roslyn; Elliott, Sandra; Kerry, Sally; Molloy, Catherine; Painter, Kerry

2010-01-01

Background: Personal health records were implemented with adults with learning disabilities (AWLD) to try to improve their health-care. Materials and Method: Forty GP practices were randomized to the Personal Health Profile (PHP) implementation or control group. Two hundred and one AWLD were interviewed at baseline and 163 followed up after 12…

The Impact of Including Husbands in Antenatal Health Education Services on Maternal Health Practices in Urban Nepal: Results from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Mullany, Britta C.; Becker, S.; Hindin, M. J.

2007-01-01

Observational studies suggest that including men in reproductive health interventions can enhance positive health outcomes. A randomized controlled trial was designed to test the impact of involving male partners in antenatal health education on maternal health care utilization and birth preparedness in urban Nepal. In total, 442 women seeking…

A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

PubMed

Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

2014-05-24

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website. This trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

PubMed

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

Marketing depression care management to employers: design of a randomized controlled trial.

PubMed

Rost, Kathryn M; Marshall, Donna

2010-03-16

Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. By addressing the 'value to whom?' question, the study advances knowledge about one of the most pivotal problems in the translation of evidence-based care to 'real world' settings: whether purchasers can be influenced to buy healthcare products on the basis of value and not exclusively on the basis of cost. If value-based marketing increases depression product purchase rates over usual care, this study will provide encouragement to market new healthcare products on the basis of the product's value to the purchaser as well as the recipient of care. NCT01013220.

Marketing depression care management to employers: design of a randomized controlled trial

PubMed Central

2010-01-01

Background Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. Methods In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. Discussion By addressing the 'value to whom?' question, the study advances knowledge about one of the most pivotal problems in the translation of evidence-based care to 'real world' settings: whether purchasers can be influenced to buy healthcare products on the basis of value and not exclusively on the basis of cost. If value-based marketing increases depression product purchase rates over usual care, this study will provide encouragement to market new healthcare products on the basis of the product's value to the purchaser as well as the recipient of care. Trial Registration Clinical Trials Registration Number: NCT01013220 PMID:20233448

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.

First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT.

PubMed

Hofmann, Reiner; Völler, Heinz; Nagels, Klaus; Bindl, Dominik; Vettorazzi, Eik; Dittmar, Ronny; Wohlgemuth, Walter; Neumann, Till; Störk, Stefan; Bruder, Oliver; Wegscheider, Karl; Nagel, Eckhard; Fleck, Eckart

2015-08-11

Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva®). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System. ClinicalTrials.gov NCT02293252 ; date of registration: 10 November 2014.

A comparison of the test-negative and the traditional case-control study designs for estimation of influenza vaccine effectiveness under nonrandom vaccination.

PubMed

Shi, Meng; An, Qian; Ainslie, Kylie E C; Haber, Michael; Orenstein, Walter A

2017-12-08

As annual influenza vaccination is recommended for all U.S. persons aged 6 months or older, it is unethical to conduct randomized clinical trials to estimate influenza vaccine effectiveness (VE). Observational studies are being increasingly used to estimate VE. We developed a probability model for comparing the bias and the precision of VE estimates from two case-control designs: the traditional case-control (TCC) design and the test-negative (TN) design. In both study designs, acute respiratory illness (ARI) patients seeking medical care testing positive for influenza infection are considered cases. In the TN design, ARI patients seeking medical care who test negative serve as controls, while in the TCC design, controls are randomly selected individuals from the community who did not contract an ARI. Our model assigns each study participant a covariate corresponding to the person's health status. The probabilities of vaccination and of contracting influenza and non-influenza ARI depend on health status. Hence, our model allows non-random vaccination and confounding. In addition, the probability of seeking care for ARI may depend on vaccination and health status. We consider two outcomes of interest: symptomatic influenza (SI) and medically-attended influenza (MAI). If vaccination does not affect the probability of non-influenza ARI, then VE estimates from TN studies usually have smaller bias than estimates from TCC studies. We also found that if vaccinated influenza ARI patients are less likely to seek medical care than unvaccinated patients because the vaccine reduces symptoms' severity, then estimates of VE from both types of studies may be severely biased when the outcome of interest is SI. The bias is not present when the outcome of interest is MAI. The TN design produces valid estimates of VE if (a) vaccination does not affect the probabilities of non-influenza ARI and of seeking care against influenza ARI, and (b) the confounding effects resulting from non-random vaccination are similar for influenza and non-influenza ARI. Since the bias of VE estimates depends on the outcome against which the vaccine is supposed to protect, it is important to specify the outcome of interest when evaluating the bias.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. Methods/design This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes. Discussion This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain. Trial registration This trial registered in ClinicalTrials.gov on 04 March 2011 with the ID number of NCT01312233. PMID:23324133

Effectiveness of advertising availability of prenatal ultrasound on uptake of antenatal care in rural Uganda: A cluster randomized trial

PubMed Central

Anguyo, Geoffrey; Meaney, Christopher; Yuan Kong, Ling; Malhame, Isabelle; Pace, Romina; Sodhi, Sumeet; Silverman, Michael

2017-01-01

In rural Uganda pregnant women often lack access to health services, do not attend antenatal care, and tend to utilize traditional healers/birth attendants. We hypothesized that receiving a message advertising that “you will be able to see your baby by ultrasound” would motivate rural Ugandan women who otherwise might use a traditional birth attendant to attend antenatal care, and that those women would subsequently be more satisfied with care. A cluster randomized trial was conducted across eight rural sub-counties in southwestern Uganda. Sub-counties were randomized to a control arm, with advertisement of antenatal care with no mention of portable obstetric ultrasound (four communities, n = 59), or an intervention arm, with advertisement of portable obstetric ultrasound. Advertisement of portable obstetric ultrasound was further divided into intervention A) word of mouth advertisement of portable obstetric ultrasound and antenatal care (one communitity, n = 16), B) radio advertisement of only antenatal care and word of mouth advertisement of antenatal care and portable obstetric ultrasound (one community, n = 7), or C) word of mouth + radio advertisement of both antenatal care and portable obstetric ultrasound (two communities, n = 75). The primary outcome was attendance to antenatal care. 159 women presented to antenatal care across eight sub-counties. The rate of attendance was 65.1 (per 1000 pregnant women, 95% CI 38.3–110.4) where portable obstetric ultrasound was advertised by radio and word of mouth, as compared to a rate of 11.1 (95% CI 6.1–20.1) in control communities (rate ratio 5.9, 95% CI 2.6–13.0, p<0.0001). Attendance was also improved in women who had previously seen a traditional healer (13.0, 95% CI 5.4–31.2) compared to control (1.5, 95% CI 0.5–5.0, rate ratio 8.7, 95% CI 2.0–38.1, p = 0.004). By advertising antenatal care and portable obstetric ultrasound by radio attendance was significantly improved. This study suggests that women can be motivated to attend antenatal care when offered the concrete incentive of seeing their baby. PMID:28403187

Effectiveness of advertising availability of prenatal ultrasound on uptake of antenatal care in rural Uganda: A cluster randomized trial.

PubMed

Cherniak, William; Anguyo, Geoffrey; Meaney, Christopher; Yuan Kong, Ling; Malhame, Isabelle; Pace, Romina; Sodhi, Sumeet; Silverman, Michael

2017-01-01

In rural Uganda pregnant women often lack access to health services, do not attend antenatal care, and tend to utilize traditional healers/birth attendants. We hypothesized that receiving a message advertising that "you will be able to see your baby by ultrasound" would motivate rural Ugandan women who otherwise might use a traditional birth attendant to attend antenatal care, and that those women would subsequently be more satisfied with care. A cluster randomized trial was conducted across eight rural sub-counties in southwestern Uganda. Sub-counties were randomized to a control arm, with advertisement of antenatal care with no mention of portable obstetric ultrasound (four communities, n = 59), or an intervention arm, with advertisement of portable obstetric ultrasound. Advertisement of portable obstetric ultrasound was further divided into intervention A) word of mouth advertisement of portable obstetric ultrasound and antenatal care (one communitity, n = 16), B) radio advertisement of only antenatal care and word of mouth advertisement of antenatal care and portable obstetric ultrasound (one community, n = 7), or C) word of mouth + radio advertisement of both antenatal care and portable obstetric ultrasound (two communities, n = 75). The primary outcome was attendance to antenatal care. 159 women presented to antenatal care across eight sub-counties. The rate of attendance was 65.1 (per 1000 pregnant women, 95% CI 38.3-110.4) where portable obstetric ultrasound was advertised by radio and word of mouth, as compared to a rate of 11.1 (95% CI 6.1-20.1) in control communities (rate ratio 5.9, 95% CI 2.6-13.0, p<0.0001). Attendance was also improved in women who had previously seen a traditional healer (13.0, 95% CI 5.4-31.2) compared to control (1.5, 95% CI 0.5-5.0, rate ratio 8.7, 95% CI 2.0-38.1, p = 0.004). By advertising antenatal care and portable obstetric ultrasound by radio attendance was significantly improved. This study suggests that women can be motivated to attend antenatal care when offered the concrete incentive of seeing their baby.

Advising people to take more exercise is ineffective: a randomized controlled trial of physical activity promotion in primary care.

PubMed

Hillsdon, Melvyn; Thorogood, Margaret; White, Ian; Foster, Charlie

2002-08-01

Over the last 10 years 'exercise referral schemes' have been popular even though the evidence for effectiveness of any one-to-one intervention in primary care is deficient. We report the results of a primary care based one-to-one intervention that compared the effect of two communication styles with a no-intervention control group on self-reported physical activity at 12 months. In all, 1658 middle-aged men and women were randomly assigned to 30 minutes of brief negotiation or direct advice in primary care or a no-intervention control group. The main outcome was self-reported physical activity at 12 months. Secondary outcome measures included change in blood pressure and body mass index. Intention-to-treat analysis revealed no significant differences in physical activity between groups. Brief negotiation group participants who completed the study increased their physical activity significantly more than controls. There was no change in body mass index in any group. The brief negotiation group produced a greater reduction in diastolic blood pressure than direct advice. If patients whose health may benefit from increased physical activity seek advice in primary care, 20-30 minutes of brief negotiation to increase physical activity is probably more effective than similar attempts to persuade or coerce. However, blanket physical activity promotion in primary care is not effective. The most effective way of increasing physical activity in primary care has yet to be determined.

Telegerontology as a Novel Approach to Address Health and Safety by Supporting Community-Based Rural Dementia Care Triads: Randomized Controlled Trial Protocol.

PubMed

Wallack, Elizabeth M; Harris, Chelsea; Ploughman, Michelle; Butler, Roger

2018-02-22

Telegerontology is an approach using videoconferencing to connect an interdisciplinary team in a regional specialty center to patients in rural communities, which is becoming increasingly practical for addressing current limitations in rural community-based dementia care. Using the remotely-delivered expertise of the Telegerontology dementia care team, we aim to enhance the caregiver/patient/physician triad and thereby provide the necessary support for the person with dementia to "age in place." This is a cluster randomized feasibility trial with four rural regions in the province of Newfoundland and Labrador, Canada (2 regions randomly assigned to "intervention" and 2 to "control"). The study population includes 22 "dementia triads" that consist of a community-dwelling older Canadian with moderate to late dementia, their family caregivers, and their Primary Care Physician (PCP). Over the 6-month active study period, all participants will be provided an iPad. The intervention is intended as an adjunct to existing PCP care, consisting of weekly Skype-based videoconferencing calls with the Telegerontology physician, and other team members as needed (occupational therapist, physical therapist etc). Control participants receive usual community-based dementia care with their PCP. A baseline (pre-) assessment will be performed during a home visit with the study team. Post intervention, 6- and 12-month follow-up assessments will be collected remotely using specialized dementia monitoring applications and Skype calls. Primary outcomes include admission to long-term care, falls, emergency room visits, hospital stays, and caregiver burden. Results will be available in March of 2018. Results from this study will demonstrate a novel approach to dementia care that has the potential to impact both rural PCPs, family caregivers, and people with dementia, as well as provide evidence for the utility of Telegerontology in models of eHealth-based care. ©Elizabeth M. Wallack, Chelsea Harris, Michelle Ploughman, Roger Butler. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.02.2018.

Impact of Skill-Based Approaches in Reducing Stigma in Primary Care Physicians: Results from a Double-Blind, Parallel-Cluster, Randomized Controlled Trial

PubMed Central

Patten, Scott; Knaak, Stephanie; Weinerman, Rivian; Campbell, Helen; Lauria-Horner, Bianca

2017-01-01

Objective: Most interventions to reduce stigma in health professionals emphasize education and social contact–based strategies. We sought to evaluate a novel skill-based approach: the British Columbia Adult Mental Health Practice Support Program. We sought to determine the program’s impact on primary care providers’ stigma and their perceived confidence and comfort in providing care for mentally ill patients. We hypothesized that enhanced skills and increased comfort and confidence on the part of practitioners would lead to diminished social distance and stigmatization. Subsequently, we explored the program’s impact on clinical outcomes and health care costs. These outcomes are reported separately, with reference to this article. Methods: In a double-blind, cluster randomized controlled trial, 111 primary care physicians were assigned to intervention or control groups. A validated stigma assessment tool, the Opening Minds Scale for Health Care Providers (OMS-HC), was administered to both groups before and after training. Confidence and comfort were assessed using scales constructed from ad hoc items. Results: In the primary analysis, no significant differences in stigma were found. However, a subscale assessing social distance showed significant improvement in the intervention group after adjustment for a variable (practice size) that was unequally distributed in the randomization. Significant increases in confidence and comfort in managing mental illness were observed among intervention group physicians. A positive correlation was found between increased levels of confidence/comfort and improvements in overall stigma, especially in men. Conclusions: This study provides some preliminary evidence of a positive impact on health care professionals’ stigma through a skill-building approach to management of mild to moderate depression and anxiety in primary care. The intervention can be used as a primary vehicle for enhancing comfort and skills in health care providers and, ultimately, reducing an important dimension of stigma: preference for social distance. PMID:28095259

Impact of Skill-Based Approaches in Reducing Stigma in Primary Care Physicians: Results from a Double-Blind, Parallel-Cluster, Randomized Controlled Trial.

PubMed

Beaulieu, Tara; Patten, Scott; Knaak, Stephanie; Weinerman, Rivian; Campbell, Helen; Lauria-Horner, Bianca

2017-05-01

Most interventions to reduce stigma in health professionals emphasize education and social contact-based strategies. We sought to evaluate a novel skill-based approach: the British Columbia Adult Mental Health Practice Support Program. We sought to determine the program's impact on primary care providers' stigma and their perceived confidence and comfort in providing care for mentally ill patients. We hypothesized that enhanced skills and increased comfort and confidence on the part of practitioners would lead to diminished social distance and stigmatization. Subsequently, we explored the program's impact on clinical outcomes and health care costs. These outcomes are reported separately, with reference to this article. In a double-blind, cluster randomized controlled trial, 111 primary care physicians were assigned to intervention or control groups. A validated stigma assessment tool, the Opening Minds Scale for Health Care Providers (OMS-HC), was administered to both groups before and after training. Confidence and comfort were assessed using scales constructed from ad hoc items. In the primary analysis, no significant differences in stigma were found. However, a subscale assessing social distance showed significant improvement in the intervention group after adjustment for a variable (practice size) that was unequally distributed in the randomization. Significant increases in confidence and comfort in managing mental illness were observed among intervention group physicians. A positive correlation was found between increased levels of confidence/comfort and improvements in overall stigma, especially in men. This study provides some preliminary evidence of a positive impact on health care professionals' stigma through a skill-building approach to management of mild to moderate depression and anxiety in primary care. The intervention can be used as a primary vehicle for enhancing comfort and skills in health care providers and, ultimately, reducing an important dimension of stigma: preference for social distance.

Sage tea-thyme-peppermint hydrosol oral rinse reduces chemotherapy-induced oral mucositis: A randomized controlled pilot study.

PubMed

Mutluay Yayla, Ezgi; Izgu, Nur; Ozdemir, Leyla; Aslan Erdem, Sinem; Kartal, Murat

2016-08-01

This pilot study aimed to investigate the preventive effect of sage tea-thyme-peppermint hydrosol oral rinse used in conjunction with basic oral care on chemotherapy-induced oral mucositis. An open-label randomized controlled study. Two oncology hospitals in Ankara, Turkey. Patients receiving 5-fluorouracil-based chemotherapy regimens were divided into the intervention group (N=30) and control group (N=30). Basic oral care was prescribed to the control group, while the intervention group was prescribed sage tea-thyme-peppermint hydrosol in addition to basic oral care. All patients were called to assess their compliance with the study instructions on day 5 and 14. Oral mucositis was evaluated using an inspection method or by assessing oral cavity photos based on the World Health Organization oral toxicity scale on day 5 and 14. Most of the patients in the intervention group did not develop oral mucositis on day 5. In addition, the incidence of grade 1 oral mucositis was statistically lower in the intervention group (10%) than the control group (53.3%) on day 5. By day 14, the majority of patients in both the groups had grade 0 oral mucositis. Sage tea-thyme-peppermint hydrosol oral rinse has promising results in alleviating oral mucositis. This hydrosol can be recommended for clinical use as it is well tolerated and cost-effective. However, further randomized controlled trials are needed to support the study. Copyright © 2016 Elsevier Ltd. All rights reserved.

Computer Decision Support Software Safely Improves Glycemic Control in the Burn Intensive Care Unit: A Randomized Controlled Clinical Study

DTIC Science & Technology

2011-01-01

Program Jointly Managed by the USA MRMC, NIH, NASA, and the Juvenile Diabetes Research Foundation and Combat Casualty Care Division, United States Army...were performed in the CP group (p = 0.0003), and nursing staff compliance with CP recommendations was greater (p < 0.0001). Conclusions—Glycemic...enhanced consistency in practice, providing standardization among nursing staff. Keywords Glycemic control; hypoglycemia; computer decision support

Efficacy of Intensive Control of Glucose in Stroke Prevention: A Meta-Analysis of Data from 59197 Participants in 9 Randomized Controlled Trials

PubMed Central

Zhang, Chi; Zhou, Yu-Hao; Xu, Chun-Li; Chi, Feng-Ling; Ju, Hai-Ning

2013-01-01

Background The efficacy of treatments that lower glucose in reducing the risk of incident stroke remains unclear. We therefore did a systematic review and meta-analysis to evaluate the efficacy of intensive control of glucose in the prevention of stroke. Methodology/Principal Findings We systematically searched Medline, EmBase, and the Cochrane Library for trials published between 1950 and June, 2012. We included randomized controlled trials that reported on the effects of intensive control of glucose on incident stroke compared with standard care. Summary estimates of relative risk (RR) reductions were calculated with a random effects model, and the analysis was further stratified by factors that could affect the treatment effects. Of 649 identified studies, we included nine relevant trials, which provided data for 59197 patients and 2037 events of stroke. Overall, intensive control of glucose as compared to standard care had no effect on incident stroke (RR, 0.96; 95%CI 0.88–1.06; P = 0.445). In the stratified analyses, a beneficial effect was seen in those trials when body mass index (BMI) more than 30 (RR, 0.86; 95%CI: 0.75–0.99; P = 0.041). No other significant differences were detected between the effect of intensive control of glucose and standard care when based on other subset factors. Conclusions/Significance Our study indicated intensive control of glucose can effectively reduce the risk of incident stroke when patients with BMI more than 30. PMID:23372729

Systematic review of the effects of chronic disease management on quality-of-life in people with chronic obstructive pulmonary disease.

PubMed

Niesink, A; Trappenburg, J C A; de Weert-van Oene, G H; Lammers, J W J; Verheij, T J M; Schrijvers, A J P

2007-11-01

Chronic disease management for patients with chronic obstructive pulmonary disease (COPD) may improve quality, outcomes and access to care. To investigate effectiveness of chronic disease management programmes on the quality-of-life of people with COPD. Medline and Embase (1995-2005) were searched for relevant articles, and reference lists and abstracts were searched for controlled trials of chronic disease management programmes for patients with COPD. Quality-of-life was assessed as an outcome parameter. Two reviewers independently reviewed each paper for methodological quality and extracted the data. We found 10 randomized-controlled trials comparing chronic disease management with routine care. Patient populations, health-care professionals, intensity, and content of the intervention were heterogeneous. Different instruments were used to assess quality of life. Five out of 10 studies showed statistically significant positive outcomes on one or more domains of the quality of life instruments. Three studies, partly located in primary care, showed positive results. All chronic disease management projects for people with COPD involving primary care improved quality of life. In most of the studies, aspects of chronic disease management were applied to a limited extent. Quality of randomized-controlled trials was not optimal. More research is needed on chronic disease management programmes in patients with COPD across primary and secondary care.

Effects of a mobility monitoring system on the cost of care in relation to reimbursement at Swiss nursing homes: learnings from a randomized controlled trial.

PubMed

Stark, Mario; Tietz, Rigo; Gattinger, Heidrun; Hantikainen, Virpi; Ott, Stefan

2017-12-01

Nursing homes in Switzerland are under pressure to efficiently coordinate staff activities to cover their personnel costs under the care financing system. In this study, the use of a mobility monitoring system accompanied with case conferences was investigated in order to improve sleep quality and estimate the cost benefit of this intervention. In an open two-phase randomized controlled trial at three nursing homes, residents with cognitive impairment were randomly assigned to an intervention group and a control group. In the intervention group, a 10-week period of intensive use of the monitoring system and case conferences led by an advanced nurse practitioner (Phase I) was followed by 3 months of reduced use of the monitoring system and case conferences led by an internal registered nurse (Phase II). In the control group, the monitoring system was only used for data acquisition. Nurses reported the activities with a specifically developed tool. Based on the recorded activities, the cost of care was calculated. The correlating reimbursement per patient was calculated from the care levels in the Swiss reimbursement system. Data from 44 residents was included in the analysis with a linear mixed model. Although analysis revealed no statistically significant effects, results indicate that the use of a monitoring system can guide nurses in organizing their tasks to increase effectiveness. Information systems such as the mobility monitor can help to identify single outliers that do not correspond with the overall situation. In the health care system, problematic individual cases can account for a disproportionally high cost levels. It was shown that information systems can have a significant economic impact in the long run. The study is registered at the German Clinical Trials Register under the Nr. DRKS00006829 .

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol.

PubMed

Pérula-de-Torres, Luis Á; Martínez-Adell, Miguel Á; González-Blanco, Virginia; Baena-Díez, José M; Martín-Rioboó, Enrique; Parras-Rejano, Juan M; González-Lama, Jesús; Martín-Alvarez, Remedios; Ruiz-Moral, Roger; Fernández-García, José Á; Pérez-Díaz, Modesto; Ruiz-de-Castroviejo, Joaquin; Pérula-de-Torres, Carlos; Valero-Martín, Antonio; Roldán-Villalobos, Ana; Criado-Larumbe, Margarita; Burdoy-Joaquín, Emili; Coma-Solé, Montserrat; Cervera-León, Mercè; Cuixart-Costa, Lluís

2012-10-30

Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. The study is registered as NCT01291953 (ClinicalTrials.gob).

Substance Use and Delinquency Among Middle School Girls in Foster Care: A Three-Year Follow-up of a Randomized Controlled Trial

PubMed Central

Kim, Hyoun K.; Leve, Leslie D.

2011-01-01

Objective The present study evaluated the efficacy of the Middle School Success intervention (MSS) for reducing substance use and delinquency among girls in foster care, using a randomized controlled trial (RCT) design. The program was designed to fill a service gap during the summer prior to the middle school transition and to prevent delinquency, substance use, and related problems. Method One hundred girls in foster care and their caregivers were randomly assigned either to the intervention (n = 48) or to a regular foster care control (n = 52) condition. The girls completed a baseline (T1) assessment and follow-up assessments at 6 months (T2), 12 months (T3), 24 months (T4), and 36 months (T5) postbaseline. Caregivers participated in assessments from T1 through T4. This study is a follow up to Smith et al. (2011)’s study, which examined immediate outcomes at T2. Results Girls in the intervention condition showed significantly lower levels of substance use than did girls in the control condition at 36-months postbaseline. The group difference was only marginally significant for delinquency. Further analyses indicated significant indirect effects of the intervention through increased prosocial behaviors which led to decreased internalizing and externalizing symptoms and then to lower levels of substance use. The direct effect of the intervention on substance use remained significant in the presence of the indirect effects. For delinquency, the intervention had positive effects mainly through increased prosocial skills. Conclusions Findings highlight the importance of providing preventive intervention services for early adolescent girls in foster care. PMID:22004305

Methodological and Ethical Challenges in a Web-Based Randomized Controlled Trial of a Domestic Violence Intervention

PubMed Central

Valpied, Jodie; Koziol-McLain, Jane; Glass, Nancy; Hegarty, Kelsey

2017-01-01

The use of Web-based methods to deliver and evaluate interventions is growing in popularity, particularly in a health care context. They have shown particular promise in responding to sensitive or stigmatized issues such as mental health and sexually transmitted infections. In the field of domestic violence (DV), however, the idea of delivering and evaluating interventions via the Web is still relatively new. Little is known about how to successfully navigate several challenges encountered by the researchers while working in this area. This paper uses the case study of I-DECIDE, a Web-based healthy relationship tool and safety decision aid for women experiencing DV, developed in Australia. The I-DECIDE website has recently been evaluated through a randomized controlled trial, and we outline some of the methodological and ethical challenges encountered during recruitment, retention, and evaluation. We suggest that with careful consideration of these issues, randomized controlled trials can be safely conducted via the Web in this sensitive area. PMID:28351830

The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice.

PubMed

Meuldijk, D; Carlier, I V E; van Vliet, I M; van Veen, T; Wolterbeek, R; van Hemert, A M; Zitman, F G

2016-03-01

Depressive and anxiety disorders contribute to a high disease burden. This paper investigates whether concise formats of cognitive behavioral- and/or pharmacotherapy are equivalent with longer standard care in the treatment of depressive and/or anxiety disorders in secondary mental health care. A pragmatic randomized controlled equivalence trial was conducted at five Dutch outpatient Mental Healthcare Centers (MHCs) of the Regional Mental Health Provider (RMHP) 'Rivierduinen'. Patients (aged 18-65 years) with a mild to moderate anxiety and/or depressive disorder, were randomly allocated to concise or standard care. Data were collected at baseline, 3, 6 and 12 months by Routine Outcome Monitoring (ROM). Primary outcomes were the Brief Symptom Inventory (BSI) and the Web Screening Questionnaire (WSQ). We used Generalized Estimating Equations (GEE) to assess outcomes. Between March 2010 and December 2012, 182 patients, were enrolled (n=89 standard care; n=93 concise care). Both intention-to-treat and per-protocol analyses demonstrated equivalence of concise care and standard care at all time points. Severity of illness reduced, and both treatments improved patient's general health status and subdomains of quality of life. Moreover, in concise care, the beneficial effects started earlier. Concise care has the potential to be a feasible and promising alternative to longer standard secondary mental health care in the treatment of outpatients with a mild to moderate depressive and/or anxiety disorder. For future research, we recommend adhering more strictly to the concise treatment protocols to further explore the beneficial effects of the concise treatment. The study is registered in the Netherlands Trial Register, number NTR2590. Clinicaltrials.gov identifier: NCT01643642. Copyright © 2015 Elsevier Inc. All rights reserved.

Training intervention for health care staff in the provision of existential support to patients with cancer: a randomized, controlled study.

PubMed

Henoch, Ingela; Danielson, Ella; Strang, Susann; Browall, Maria; Melin-Johansson, Christina

2013-12-01

When a patient receives a cancer diagnosis, existential issues become more compelling. Throughout the illness trajectory, patients with cancer are cared for in oncology wards, by home care teams or in hospices. Nurses working with these patients are sometimes aware of the patients' existential needs but do not feel confident when discussing these issues. To determine the effects of a training intervention, where the focus is on existential issues and nurses' perceived confidence in communication and their attitude toward caring for dying patients. This was a randomized, controlled trial with a training intervention comprising theoretical training in existential issues combined with individual and group reflection. In total, 102 nurses in oncology and hospice wards and in palliative home care teams were randomized to a training or non-training group. Primary outcomes, confidence in communication, and attitude toward the care of dying patients were measured at baseline, immediately after the training, and five to six months later. Confidence in communication improved significantly in the training group from baseline (before the training) to both the first and second follow-up, that is, immediately after the training and five months later. The attitude toward caring for the dying did not improve in the training group. This study shows that short-term training with reflection improves the confidence of health care staff when communicating, which is important for health care managers with limited resources. Further studies are needed to explore how patients experience the communication skills of health care staff after such training. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Increasing retention in care of HIV-positive women in PMTCT services through continuous quality improvement-breakthrough (CQI-BTS) series in primary and secondary health care facilities in Nigeria: a cluster randomized controlled trial. The Lafiyan Jikin Mata Study.

PubMed

Oyeledun, Bolanle; Oronsaye, Frank; Oyelade, Taiwo; Becquet, Renaud; Odoh, Deborah; Anyaike, Chukwuma; Ogirima, Francis; Ameh, Bernice; Ajibola, Abiola; Osibo, Bamidele; Imarhiagbe, Collins; Abutu, Inedu

2014-11-01

Rates of retention in care of HIV-positive pregnant women in care programs in Nigeria remain generally poor with rates around 40% reported for specific programs. Poor quality of services in health facilities and long waiting times are among the critical factors militating against retention of these women in care. The aim of the interventions in this study is to assess whether a continuous quality improvement intervention using a Breakthrough Series approach in local district hospitals and primary health care clinics will lead to improved retention of HIV-positive women and mothers. A cluster randomized controlled trial with 32 health facilities randomized to receive a continuous quality improvement/Breakthrough Series intervention or not. The care protocol for HIV-infected pregnant women and mothers is the same in all sites. The quality improvement intervention started 4 months before enrollment of individual HIV-infected pregnant women and initially focused on reducing waiting times for women and also ensuring that antiretroviral drugs are dispensed on the same day as clinic attendance. The primary outcome measure is retention of HIV-positive mothers in care at 6 months postpartum. Results of this trial will inform whether quality improvement interventions are an effective means of improving retention in prevention of mother-to-child transmission of HIV programs and will also guide where health system interventions should focus to improve the quality of care for HIV-positive women. This will benefit policymakers and program managers as they seek to improve retention rates in HIV care programs.

Effect of virtual reality on adolescent pain during burn wound care.

PubMed

Jeffs, Debra; Dorman, Dona; Brown, Susan; Files, Amber; Graves, Tamara; Kirk, Elizabeth; Meredith-Neve, Sandra; Sanders, Janise; White, Benjamin; Swearingen, Christopher J

2014-01-01

The objective of this study was to compare the effect of virtual reality to passive distraction and standard care on burn treatment pain in adolescents.This single-blinded, randomized controlled study enrolled 30 adolescents who were 10 to 17 years of age from the burn clinic of a large children's hospital. After providing informed consent/assent, these participants were randomly assigned to one of three groups during wound care: standard care, passive distraction watching a movie, or virtual reality (VR) using a tripod-arm device rather than an immersive helmet. Before wound care, participants completed the Spielberger's State-Trait Anxiety Inventory for Children and Pre-Procedure Questionnaire while blinded to group assignment. A total of 28 participants completed the study and rated treatment pain after wound care by using the Adolescent Pediatric Pain Tool and completed a Post-Procedure Questionnaire. The VR group reported less pain during wound care than either the passive distraction or standard care group as determined by multivariable linear regression adjusted for age, sex, preprocedure pain, state anxiety, opiate use, and treatment length. The VR group was the only group to have an estimated decrease in pain perception from baseline preprocedure pain to procedural pain reported. Adolescents pretreated with opiate analgesics and female adolescents reported more pain during wound care.This between-subjects clinical study provides further support for VR, even without requiring wearing of an immersive helmet, in lessening burn wound care pain in adolescents. Passive distraction by watching a movie may be less effective in reducing treatment pain. Additional between-subjects randomized controlled trials with larger samples of children and during other healthcare treatments may further support VR's effectiveness in pediatric procedural pain management.

Practical health co-operation - the impact of a referral template on quality of care and health care co-operation: study protocol for a cluster randomized controlled trial.

PubMed

Wåhlberg, Henrik; Valle, Per Christian; Malm, Siri; Broderstad, Ann Ragnhild

2013-01-07

The referral letter plays a key role both in the communication between primary and secondary care, and in the quality of the health care process. Many studies have attempted to evaluate and improve the quality of these referral letters, but few have assessed the impact of their quality on the health care delivered to each patient. A cluster randomized trial, with the general practitioner office as the unit of randomization, has been designed to evaluate the effect of a referral intervention on the quality of health care delivered. Referral templates have been developed covering four diagnostic groups: dyspepsia, suspected colonic malignancy, chest pain, and chronic obstructive pulmonary disease. Of the 14 general practitioner offices primarily served by University Hospital of North Norway Harstad, seven were randomized to the intervention group. The primary outcome is a collated quality indicator score developed for each diagnostic group. Secondary outcomes include: quality of the referral, health process outcome such as waiting times, and adequacy of prioritization. In addition, information on patient satisfaction will be collected using self-report questionnaires. Outcome data will be collected on the individual level and analyzed by random effects linear regression. Poor communication between primary and secondary care can lead to inappropriate investigations and erroneous prioritization. This study's primary hypothesis is that the use of a referral template in this communication will lead to a measurable increase in the quality of health care delivered. This trial has been registered at ClinicalTrials.gov. The trial registration number is NCT01470963.

Effects of Nursing Care Based on Watson's Theory of Human Caring on Anxiety, Distress, And Coping, When Infertility Treatment Fails: A Randomized Controlled Trial.

PubMed

Durgun Ozan, Yeter; Okumuş, Hülya

2017-06-01

Introduction: The failure of infertility treatment leads to individual, familial, and social problems. The objective of this study was to evaluate the effectiveness of the nursing care program based on Watson's "Theory of Human Caring" on anxiety and distress caused by coping when the treatment fails. Methods: This study randomized controlled trial study was conducted from April to November 2012, with 86 Turkish women with infertility (intervention group: 45, control group: 41). Follow-up of 32 infertile women, who failed infertility treatment from intervention group, and 35 infertile women, who failed infertility treatment from control group, continued for another four weeks. Data were collected through Spiel Berger's State/Trait Anxiety Inventory, Distress Scale, and Ways of Coping Questionnaire. The analyses of data were conducted using SPSS ver 13. Results: The intervention and control groups significantly differed in terms of anxiety, distress, and coping levels. The intervention group's mean anxiety score decreased by thirteen points and distress by fourteen points (in a positive direction). The intervention group's mean positive coping style score increased. Whereas a negative increase was observed in the control group's values depending on the failure of the treatment. Conclusion: Watson's theory of human caring is recommended as a guide to nursing patients with infertility treatment to decrease levels of anxiety and distress, and to increase the positive coping style among infertile women.

Effects of Nursing Care Based on Watson’s Theory of Human Caring on Anxiety, Distress, And Coping, When Infertility Treatment Fails: A Randomized Controlled Trial

PubMed Central

Durgun Ozan, Yeter; Okumuş, Hülya

2017-01-01

Introduction: The failure of infertility treatment leads to individual, familial, and social problems. The objective of this study was to evaluate the effectiveness of the nursing care program based on Watson’s "Theory of Human Caring" on anxiety and distress caused by coping when the treatment fails. Methods: This study randomized controlled trial study was conducted from April to November 2012, with 86 Turkish women with infertility (intervention group: 45, control group: 41). Follow-up of 32 infertile women, who failed infertility treatment from intervention group, and 35 infertile women, who failed infertility treatment from control group, continued for another four weeks. Data were collected through Spiel Berger’s State/Trait Anxiety Inventory, Distress Scale, and Ways of Coping Questionnaire. The analyses of data were conducted using SPSS ver 13. Results: The intervention and control groups significantly differed in terms of anxiety, distress, and coping levels. The intervention group’s mean anxiety score decreased by thirteen points and distress by fourteen points (in a positive direction). The intervention group’s mean positive coping style score increased. Whereas a negative increase was observed in the control group’s values depending on the failure of the treatment. Conclusion: Watson’s theory of human caring is recommended as a guide to nursing patients with infertility treatment to decrease levels of anxiety and distress, and to increase the positive coping style among infertile women. PMID:28680864

A randomized controlled trial of the effects of transcendental meditation on quality of life in older breast cancer patients.

PubMed

Nidich, Sanford I; Fields, Jeremy Z; Rainforth, Maxwell V; Pomerantz, Rhoda; Cella, David; Kristeller, Jean; Salerno, John W; Schneider, Robert H

2009-09-01

This single-blind, randomized controlled trial evaluated the impact of the Transcendental Meditation program plus standard care as compared with standard care alone on the quality of life (QOL) of older women (>or=55 years) with stage II to IV breast cancer. One hundred and thirty women (mean age = 63.8) were randomly assigned to either experimental (n = 64) or control (n = 66) groups. Functional Assessment of Cancer Therapy-Breast (FACT-B), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being (FACIT-SP), and Short-Form (SF)-36 mental health and vitality scales were administered every 6 months over an average 18-month intervention period. Significant improvements were found in the Transcendental Meditation group compared with controls in overall QOL, measured by the FACT-B total score (P = .037), emotional well-being (P = .046), and social well-being (P = .003) subscales, and SF-36 mental health ( P = .017). It is recommended that this stress reduction program, with its ease of implementation and home practice, be adopted in public health programs.

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].

Development and pilot of an advance care planning website for women with ovarian cancer: a randomized controlled trial.

PubMed

Vogel, Rachel Isaksson; Petzel, Sue V; Cragg, Julie; McClellan, Molly; Chan, Daniel; Dickson, Elizabeth; Jacko, Julie A; Sainfort, François; Geller, Melissa A

2013-11-01

Few available tools facilitate cancer patients and physicians' discussions of quality of life and end-of-life. Our objective was to develop a web-based tool to promote advance care planning for women with ovarian cancer. Women with ovarian cancer, their families, clinicians and researchers met to identify ways to improve cancer care. A prototype website was created to address advance care planning, focusing on advance healthcare directives (AHD) and palliative care consultation. Patients were recruited from a gynecologic oncology clinic for a pilot randomized controlled trial. Primary outcomes included completion of an AHD and palliative care consultation. At study completion, 53 women with ovarian cancer were enrolled and 35 completed the study. The mean age at enrollment was 57.9 ± 9.5 years; most were newly diagnosed or at first recurrence. There were no statistical differences in completion of AHD (p=0.220) or palliative care consultation (p=0.440) between intervention and control groups. However, women in the intervention group showed evidence of moving toward decision making regarding AHD and palliative care and lower decisional conflict. Women assigned to the intervention, compared to control website, were highly satisfied with the amount (p=0.054) and quality (p=0.119) of information and when they accessed the website, used it longer (p=0.049). Overall website use was lower than expected, resulting from several patient-related and design barriers. A website providing information and decisional support for women with ovarian cancer is feasible. Increasing frequency of website use requires future research. © 2013.

Development and pilot of an advance care planning website for women with ovarian cancer: A randomized controlled trial

PubMed Central

Vogel, Rachel Isaksson; Petzel, Sue V.; Cragg, Julie; McClellan, Molly; Chan, Daniel; Dickson, Elizabeth; Jacko, Julie A.; Sainfort, François; Geller, Melissa A.

2015-01-01

Objective Few available tools facilitate cancer patients and physicians' discussions of quality of life and end-of-life. Our objective was to develop a web-based tool to promote advance care planning for women with ovarian cancer. Methods Women with ovarian cancer, their families, clinicians and researchers met to identify ways to improve cancer care. A prototype website was created to address advance care planning, focusing on advance healthcare directives (AHD) and palliative care consultation. Patients were recruited from a gynecologic oncology clinic for a pilot randomized controlled trial. Primary outcomes included completion of an AHD and palliative care consultation. Results At study completion, 53 women with ovarian cancer were enrolled and 35 completed the study. The mean age at enrollment was 57.9 ± 9.5 years; most were newly diagnosed or at first recurrence. There were no statistical differences in completion of AHD (p = 0.220) or palliative care consultation (p = 0.440) between intervention and control groups. However, women in the intervention group showed evidence of moving toward decision making regarding AHD and palliative care and lower decisional conflict. Women assigned to the intervention, compared to control website, were highly satisfied with the amount (p = 0.054) and quality (p = 0.119) of information and when they accessed the website, used it longer (p = 0.049). Overall website use was lower than expected, resulting from several patient-related and design barriers. Conclusions A website providing information and decisional support for women with ovarian cancer is feasible. Increasing frequency of website use requires future research. PMID:23988413

Provision of mouth-care in long-term care facilities: an educational trial.

PubMed

MacEntee, M I; Wyatt, C C L; Beattie, B L; Paterson, B; Levy-Milne, R; McCandless, L; Kazanjian, A

2007-02-01

This randomized clinical trial aimed to assess the effectiveness of a pyramid-based education for improving the oral health of elders in long-term care (LTC) facilities. Fourteen facilities matched for size were assigned randomly to an active or control group. At baseline in each facility, care-aides in the active group participated with a full-time nurse educator in a seminar about oral health care, and had unlimited access to the educator for oral health-related advice throughout the 3-month trial. Care-aides in the control group participated in a similar seminar with a dental hygienist but they received no additional advice. The residents in the facilities at baseline and after 3 months were examined clinically to measure their oral hygiene, gingival health, masticatory potential, Body Mass Index and Malnutrition Indicator Score, and asked to report on chewing difficulties. Clinical measures after 3 months were not significantly different from baseline in either group, indicating that education neither influenced the oral health nor the dental hygiene of the residents. A pyramid-based educational scheme with nurses and care-aides did not improve the oral health of frail elders in this urban sample of LTC facilities.

Health Care Professionals' Attitudes Toward, and Experiences of Using, a Culture-Sensitive Smartphone App for Women with Gestational Diabetes Mellitus: Qualitative Study.

PubMed

Garnweidner-Holme, Lisa; Hoel Andersen, Therese; Sando, Mari Wastvedt; Noll, Josef; Lukasse, Mirjam

2018-05-14

The increasing prevalence of gestational diabetes mellitus (GDM) among women of different ethnic backgrounds provides new challenges for health care professionals, who often find it difficult to provide information about the management of this disease to such individuals. Mobile health (mHealth) may act as a useful tool for blood sugar control and care process enhancement. However, little is known about health care professionals' experiences and attitudes toward the use of mHealth for women with GDM. The aim of this study was to explore how health care professionals perceived the provision of care to pregnant women who managed their GDM using the culture-sensitive Pregnant+ app in a randomized controlled trial. Individual interviews with 9 health care professionals providing care for women with GDM were conducted. Braun and Clark's method of thematic content analysis inspired the analysis. This study included health care professionals who were primarily responsible for providing care to participants with GDM in the Pregnant+ randomized controlled trial at 5 diabetes outpatient clinics in Oslo, Norway. Health care professionals perceived mHealth, particularly the Pregnant+ app, as an appropriate tool for the care of women with GDM, who were described as individuals comprising a heterogeneous, motivated group that could be easily approached with health-related information. Some participants reported challenges with respect to provision of advice to women with different food cultures. The advantages of the Pregnant+ app included provision of information that women could access at home, the information provided being perceived as trustworthy by health care professionals, the culture sensitivity of the app, and the convenience for women to register blood sugar levels. Technical problems, particularly those associated with the automatic transfer of blood glucose measurements, were identified as the main barrier to the use of the Pregnant+ app. Strict inclusion criteria and the inclusion of participants who could not speak Norwegian were the main challenges in the recruitment process for the randomized controlled trial. The findings of this study suggest that mHealth is a useful tool to enhance the care provided by health care professionals to women with GDM. Future mobile apps for the management of GDM should be developed by a trustworthy source and in cooperation with health care professionals. They should also be culture sensitive and should not exhibit technical problems. ©Lisa Garnweidner-Holme, Therese Hoel Andersen, Mari Wastvedt Sando, Josef Noll, Mirjam Lukasse. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 14.05.2018.

Internet-based self-management plus education compared with usual care in asthma: a randomized trial.

PubMed

van der Meer, Victor; Bakker, Moira J; van den Hout, Wilbert B; Rabe, Klaus F; Sterk, Peter J; Kievit, Job; Assendelft, Willem J J; Sont, Jacob K

2009-07-21

The Internet may support patient self-management of chronic conditions, such as asthma. To evaluate the effectiveness of Internet-based asthma self-management. Randomized, controlled trial. 37 general practices and 1 academic outpatient department in the Netherlands. 200 adults with asthma who were treated with inhaled corticosteroids for 3 months or more during the previous year and had access to the Internet. Asthma-related quality of life at 12 months (minimal clinically significant difference of 0.5 on the 7-point scale), asthma control, symptom-free days, lung function, and exacerbations. Participants were randomly assigned by using a computer-generated permuted block scheme to Internet-based self-management (n = 101) or usual care (n = 99). The Internet-based self-management program included weekly asthma control monitoring and treatment advice, online and group education, and remote Web communications. Asthma-related quality of life improved by 0.56 and 0.18 points in the Internet and usual care groups, respectively (adjusted between-group difference, 0.38 [95% CI, 0.20 to 0.56]). An improvement of 0.5 point or more occurred in 54% and 27% of Internet and usual care patients, respectively (adjusted relative risk, 2.00 [CI, 1.38 to 3.04]). Asthma control improved more in the Internet group than in the usual care group (adjusted difference, -0.47 [CI, -0.64 to -0.30]). At 12 months, 63% of Internet patients and 52% of usual care patients reported symptom-free days in the previous 2 weeks (adjusted absolute difference, 10.9% [CI, 0.05% to 21.3%]). Prebronchodilator FEV1 changed with 0.24 L and -0.01 L for Internet and usual care patients, respectively (adjusted difference, 0.25 L [CI, 0.03 to 0.46 L]). Exacerbations did not differ between groups. The study was unblinded and lasted only 12 months. Internet-based self-management resulted in improvements in asthma control and lung function but did not reduce exacerbations, and improvement in asthma-related quality of life was slightly less than clinically significant. Netherlands Organization for Health Research and Development, ZonMw, and Netherlands Asthma Foundation.

Combined cognitive-strategy and task-specific training improves transfer to untrained activities in sub-acute stroke: An exploratory randomized controlled trial

PubMed Central

McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

2014-01-01

Purpose The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared to usual outpatient rehabilitation on activity and participation in people less than 3 months post stroke. Methods An exploratory, single blind, randomized controlled trial with a usual care control arm was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either Usual Care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self Efficacy Gauge. Results Thirty-five (35) eligible participants were randomized; 26 completed the intervention. Post-intervention, PQRS change scores demonstrated CO-OP had a medium effect over Usual Care on trained self-selected activities (d=0.5) and a large effect on untrained (d=1.2). At a 3 month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d=1.6) and untrained activities (d=1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and the Self-Efficacy Gauge. Conclusion CO-OP was associated with a large treatment effect on follow up performances of self-selected activities, and demonstrated transfer to untrained activities. A larger trial is warranted. PMID:25416738

Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial.

PubMed

McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

2015-07-01

The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared with usual outpatient rehabilitation on activity and participation in people <3 months poststroke. An exploratory, single-blind, randomized controlled trial, with a usual-care control arm, was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either usual care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self-Efficacy Gauge. A total of 35 eligible participants were randomized; 26 completed the intervention. Post intervention, PQRS change scores demonstrated that CO-OP had a medium effect over usual care on trained self-selected activities (d = 0.5) and a large effect on untrained activities (d = 1.2). At a 3-month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d = 1.6) and untrained activities (d = 1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and on the Self-Efficacy Gauge. CO-OP was associated with a large treatment effect on follow-up performances of self-selected activities and demonstrated transfer to untrained activities. A larger trial is warranted. © The Author(s) 2014.

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

PubMed

Williams, Joni S; Lynch, Cheryl P; Knapp, Rebecca G; Egede, Leonard E

2014-11-25

Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature. We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ≥ 8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group. Results from this study will add to the current literature examining how best to deliver diabetes education and skills training and provide important insight into effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in African Americans with poorly controlled T2DM. This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 (ClinicalTrials.gov identifier# NCT02088658).

Association Between the Safe Delivery App and Quality of Care and Perinatal Survival in Ethiopia: A Randomized Clinical Trial.

PubMed

Lund, Stine; Boas, Ida Marie; Bedesa, Tariku; Fekede, Wondewossen; Nielsen, Henriette Svarre; Sørensen, Bjarke Lund

2016-08-01

Health apps in low-income countries are emerging tools with the potential to improve quality of health care services, but few apps undergo rigorous scientific evaluation. To determine the effects of the safe delivery app (SDA) on perinatal survival and on health care workers' knowledge and skills in neonatal resuscitation. In a cluster-randomized clinical trial in 5 rural districts of Ethiopia, 73 health care facilities were randomized to the mobile phone intervention or to standard care (control). From September 1, 2013, to February 1, 2015, 3601 women in active labor were included at admission and followed up until 7 days after delivery to record perinatal mortality. Knowledge and skills in neonatal resuscitation were assessed at baseline and at 6 and 12 months after the intervention among 176 health care workers at the included facilities. Analyses were performed based on the intention-to-treat principle. Health care workers in intervention facilities received a smartphone with the SDA. The SDA is a training tool in emergency obstetric and neonatal care that uses visual guidance in animated videos with clinical instructions for management. The primary outcome was perinatal death. Secondary outcomes included the knowledge and clinical management of neonatal resuscitation (skills) of health care workers before the intervention and after 6 and 12 months. The analysis included 3601 women and 176 health care workers. Use of the SDA was associated with a nonsignificant lower perinatal mortality of 14 per 1000 births in intervention clusters compared with 23 per 1000 births in control clusters (odds ratio, 0.76; 95% CI, 0.32-1.81). The skill scores of intervention health care workers increased significantly compared with those of controls at 6 months (mean difference, 6.04; 95% CI, 4.26-7.82) and 12 months (mean difference, 8.79; 95% CI, 7.14-10.45) from baseline, corresponding to 80% and 107%, respectively, above the control level. Knowledge scores also significantly improved in the intervention compared with the control group at 6 months (mean difference, 1.67; 95% CI, 1.02-2.32) and at 12 months (mean difference, 1.54; 95% CI, 0.98-2.09), corresponding to 39% and 38%, respectively, above the control level. The SDA was an effective method to improve and sustain the health care workers' knowledge and skills in neonatal resuscitation as long as 12 months after introduction. Perinatal mortality was nonsignificantly reduced after the intervention. The results are highly relevant in low-income countries, where quality of care is challenged by a lack of continuing education. clinicaltrials.gov Identifier: NCT01945931.

Provider training and experience for people living with HIV/AIDS.

PubMed

Rackal, Julia M; Tynan, Anne-Marie; Handford, Curtis D; Rzeznikiewiz, Damian; Agha, Ayda; Glazier, Richard

2011-06-15

The complexity of HIV/AIDS raises challenges for the effective delivery of care. It is important to ensure that the expertise and experience of care providers is of high quality. Training and experience of HIV/AIDS providers may impact not only individual patient outcomes but increasingly on health care costs as well. The objective of this review is to assess the effects of provider training and experience on people living with HIV/AIDS on the following outcomes: immunological (ie. viral load, CD4 count), medical (ie. mortality, proportion on antiretrovirals), psychosocial (ie. quality of life measures) and economic outcomes (ie health care costs). We searched MEDLINE, EMBASE, Dissertation Abstracts International (DAI), CINAHL, HealthStar, PsycInfo, PsycLit, Social Sciences Abstracts, and Sociological Abstracts from January 1, 1980 through May 29, 2009.  Electronic searches were performed for abstracts from major international AIDS conferences. Reference lists from pertinent articles, books and review articles were retrieved and reviewed. Randomized controlled trials (RCTs), controlled clinical trials, cohort, case control, cross-sectional studies and controlled before and after designs that examined the qualifications/training and patient volume of HIV/AIDS care of providers caring for persons known to be infected with HIV/AIDS were included. At least two authors independently assessed trial quality and extracted data. Study authors were contacted for further information as required. Assessment of confounding factors was undertaken independently by two reviewers. A total of four studies (one randomized controlled trial, three non- randomized studies) involving 8488 people living with HIV/AIDS were included. The main findings of this review demonstrated a trend to improved outcomes when treated by a provider with more training/expertise in HIV/AIDS care in the outpatient (clinic) setting. Due to the heterogeneity of the included studies, we could not perform a meta-analysis. We present a descriptive review of the results. The results demonstrate improved medical outcomes when treated by a provider with more training/expertise in HIV/AIDS care in the outpatient (clinic) setting. Since all of these studies were conducted in North America, this does not address any issues regarding the level of training/expertise required by providers working in countries with more limited resources. Practitioners who do not consider themselves 'experts' in HIV/AIDS care and care for few of these patients need to seriously consider this review which demonstrates a trend towards worse patient outcomes when receiving care by those with low caseloads/training in HIV/AIDS care.

Study protocol of a cluster randomized controlled trial evaluating the efficacy of a comprehensive pressure ulcer prevention programme for private for-profit nursing homes.

PubMed

Kwong, Enid Wai-yung; Lee, Paul Hong; Yeung, Kwan-mo

2016-01-18

Because the demand for government-subsidized nursing homes in Hong Kong outstrips the supply, the number of for-profit private nursing homes has been increasing rapidly. However, the standard of care in such homes is always criticized. Pressure ulcers are a major long-term care issue that is closely associated with the quality of care delivered in nursing home settings. The aim of this study is to evaluate the effectiveness of a pressure ulcer prevention programme for residents in private for-profit nursing homes. This is a two-arm cluster randomized controlled trial with an estimated sample size of 1088 residents and 74 care staff from eight for-profit private nursing homes. Eligible nursing homes will be those classified as category A2 homes in the Enhanced Bought Place Scheme (EBPS), having a capacity of around 130-150 beds, and no structured PU prevention protocol and/or programmes in place. Care staff will be health workers, personal care workers, and nurses who are front-line staff providing direct care to residents. Eight nursing homes will be randomly assigned to either an experimental or control group. The experimental group will be provided with an intensive training programme and will be involved in the implementation of a 16-week pressure ulcer prevention protocol, while the control group will deliver the usual pressure ulcer prevention care. The study outcomes are the pressure ulcer prevention knowledge and skills of the care staff and the prevalence and incidence of pressure ulcers. Data on the knowledge and skills of care staff, and prevalence of pressure ulcer will be collected at the base line, and then at the 8(th) week and at completion of the implementation of the protocol. The assessment of the incidence of pressures will start from before the commencement of the intensive training course to the end of the implementation of the protocol. In view of the negative impact of pressure ulcers, it is important to have an effective and evidence-based pressure ulcer prevention programme to improve preventive care in private for-profit nursing homes. The programme will potentially improve the knowledge and skills of care staff on the prevention of pressure ulcers and also lead to a reduction in the development of pressure ulcers in nursing homes. The Current Controlled Trial is NCT02270385, 18 October 2014.

Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

PubMed

Dhopte, Prakash; Ahmed, Sara; Mayo, Nancy; French, Simon; Quon, Jeffrey A; Bussières, André

2016-01-01

Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95 % confidence intervals for parameters of a priori interest (recruitment, retention, adherence, pain intensity, Neck Disability Index). Results of this study will inform the design of a larger cluster-randomized controlled trial aimed at evaluating the effectiveness of the theory-based tailored intervention and increasing the use of multimodal care by chiropractors managing patients with NSNP. https://clinicaltrials.gov/, NCT02483091.

Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial.

PubMed

Roets-Merken, Lieve M; Graff, Maud J L; Zuidema, Sytse U; Hermsen, Pieter G J M; Teerenstra, Steven; Kempen, Gertrudis I J M; Vernooij-Dassen, Myrra J F J

2013-10-07

Five to 25 percent of residents in aged care settings have a combined hearing and visual sensory impairment. Usual care is generally restricted to single sensory impairment, neglecting the consequences of dual sensory impairment on social participation and autonomy. The aim of this study is to evaluate the effectiveness of a self-management program for seniors who acquired dual sensory impairment at old age. In a cluster randomized, single-blind controlled trial, with aged care settings as the unit of randomization, the effectiveness of a self-management program will be compared to usual care. A minimum of 14 and maximum of 20 settings will be randomized to either the intervention cluster or the control cluster, aiming to include a total of 132 seniors with dual sensory impairment. Each senior will be linked to a licensed practical nurse working at the setting. During a five to six month intervention period, nurses at the intervention clusters will be trained in a self-management program to support and empower seniors to use self-management strategies. In two separate diaries, nurses keep track of the interviews with the seniors and their reflections on their own learning process. Nurses of the control clusters offer care as usual. At senior level, the primary outcome is the social participation of the seniors measured using the Hearing Handicap Questionnaire and the Activity Card Sort, and secondary outcomes are mood, autonomy and quality of life. At nurse level, the outcome is job satisfaction. Effectiveness will be evaluated using linear mixed model analysis. The results of this study will provide evidence for the effectiveness of the Self-Management Program for seniors with dual sensory impairment living in aged care settings. The findings are expected to contribute to the knowledge on the program's potential to enhance social participation and autonomy of the seniors, as well as increasing the job satisfaction of the licensed practical nurses. Furthermore, an extensive process evaluation will take place which will offer insight in the quality and feasibility of the sampling and intervention process. If it is shown to be effective and feasible, this Self-Management Program could be widely disseminated. ClinicalTrials.gov, NCT01217502.

Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background Five to 25 percent of residents in aged care settings have a combined hearing and visual sensory impairment. Usual care is generally restricted to single sensory impairment, neglecting the consequences of dual sensory impairment on social participation and autonomy. The aim of this study is to evaluate the effectiveness of a self-management program for seniors who acquired dual sensory impairment at old age. Methods/Design In a cluster randomized, single-blind controlled trial, with aged care settings as the unit of randomization, the effectiveness of a self-management program will be compared to usual care. A minimum of 14 and maximum of 20 settings will be randomized to either the intervention cluster or the control cluster, aiming to include a total of 132 seniors with dual sensory impairment. Each senior will be linked to a licensed practical nurse working at the setting. During a five to six month intervention period, nurses at the intervention clusters will be trained in a self-management program to support and empower seniors to use self-management strategies. In two separate diaries, nurses keep track of the interviews with the seniors and their reflections on their own learning process. Nurses of the control clusters offer care as usual. At senior level, the primary outcome is the social participation of the seniors measured using the Hearing Handicap Questionnaire and the Activity Card Sort, and secondary outcomes are mood, autonomy and quality of life. At nurse level, the outcome is job satisfaction. Effectiveness will be evaluated using linear mixed model analysis. Discussion The results of this study will provide evidence for the effectiveness of the Self-Management Program for seniors with dual sensory impairment living in aged care settings. The findings are expected to contribute to the knowledge on the program’s potential to enhance social participation and autonomy of the seniors, as well as increasing the job satisfaction of the licensed practical nurses. Furthermore, an extensive process evaluation will take place which will offer insight in the quality and feasibility of the sampling and intervention process. If it is shown to be effective and feasible, this Self-Management Program could be widely disseminated. Clinical trials registration ClinicalTrials.gov, NCT01217502. PMID:24099315

Effectiveness of a Web-Based Health Education Program to Promote Oral Hygiene Care Among Stroke Survivors: Randomized Controlled Trial.

PubMed

Ab Malik, Normaliza; Mohamad Yatim, Sa'ari; Lam, Otto Lok Tao; Jin, Lijian; McGrath, Colman Patrick Joseph

2017-03-31

Oral hygiene care is of key importance among stroke patients to prevent complications that may compromise rehabilitation or potentially give rise to life-threatening infections such as aspiration pneumonia. The aim of this study was to evaluate the effectiveness of a Web-based continuing professional development (CPD) program on "general intention" of the health carers to perform daily mouth cleaning for stroke patients using the theory of planned behavior (TPB). A double-blind cluster randomized controlled trial was conducted among 547 stroke care providers across 10 hospitals in Malaysia. The centers were block randomized to receive either (1) test intervention (a Web-based CPD program on providing oral hygiene care to stroke patients using TPB) or (2) control intervention (a Web-based CPD program not specific to oral hygiene). Domains of TPB: "attitude," "subjective norm" (SN), "perceived behavior control" (PBC), "general intention" (GI), and "knowledge" related to providing oral hygiene care were assessed preintervention and at 1 month and 6 months postintervention. The overall response rate was 68.2% (373/547). At 1 month, between the test and control groups, there was a significant difference in changes in scores of attitude (P=.004) and subjective norm (P=.01), but not in other TPB domains (GI, P=.11; PBC, P=.51; or knowledge, P=.08). At 6 months, there were significant differences in changes in scores of GI (P=.003), attitude (P=.009), SN (P<.001) and knowledge (P=.001) between the test and control groups. Regression analyses identified that the key factors associated with a change in GI at 6 months were changes in SN (beta=.36, P<.001) and changes in PBC (beta=.23, P<.001). The Web-based CPD program based on TPB increased general intention, attitudes, subjective norms, and knowledge to provide oral hygiene care among stroke carers for their patients. Changing subjective norms and perceived behavioral control are key factors associated with changes in general intention to provide oral hygiene care. National Medical Research Register, Malaysia NMRR-13-1540-18833 (IIR); https://www.nmrr.gov.my/ fwbLoginPage.jsp. ©Normaliza Ab Malik, Sa'ari Mohamad Yatim, Otto Lok Tao Lam, Lijian Jin, Colman Patrick Joseph McGrath. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 31.03.2017.

The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study.

PubMed

Griffin, D R; Dickenson, E J; Wall, P D H; Realpe, A; Adams, A; Parsons, N; Hobson, R; Achten, J; Costa, M L; Foster, N E; Hutchinson, C E; Petrou, S; Donovan, J L

2016-10-01

To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a 'definitive solution'. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT.

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…

Randomized controlled trial of skin-to-skin contact from birth versus conventional incubator for physiological stabilization in 1200- to 2199-gram newborns.

PubMed

Bergman, N J; Linley, L L; Fawcus, S R

2004-06-01

Conventional care of prematurely born infants involves extended maternal-infant separation and incubator care. Recent research has shown that separation causes adverse effects. Maternal-infant skin-to-skin contact (SSC) provides an alternative habitat to the incubator, with proven benefits for stable prematures; this has not been established for unstable or newborn low-birthweight infants. SSC from birth was therefore compared to incubator care for infants between 1200 and 2199 g at birth. This was a prospective, unblinded, randomized controlled clinical trial; potential subjects were identified before delivery and randomized by computerized minimization technique at 5 min if eligible. Standardized care and observations were maintained for 6 h. Stability was measured in terms of a set of pre-determined physiological parameters, and a composite cardio-respiratory stabilization score (SCRIP). 34 infants were analysed in comparable groups: 3/18 SSC compared to 12/13 incubator babies exceeded the pre-determined parameters (p < 0.001). Stabilization scores were 77.11 for SSC versus 74.23 for incubator (maximum 78), mean difference 2.88 (95% CI: 0.3-5.46, p = 0.031). All 18 SSC subjects were stable in the sixth hour, compared to 6/13 incubator infants. Eight out of 13 incubator subjects experienced hypothermia. Newborn care provided by skin-to-skin contact on the mother's chest results in better physiological outcomes and stability than the same care provided in closed servo-controlled incubators. The cardio-respiratory instability seen in separated infants in the first 6 h is consistent with mammalian "protest-despair" biology, and with "hyper-arousal and dissociation" response patterns described in human infants: newborns should not be separated from their mothers.

Weight gain in preterm infants following parent-administered Vimala massage: a randomized controlled trial.

PubMed

Gonzalez, Alma Patricia; Vasquez-Mendoza, Guadalupe; García-Vela, Alfonso; Guzmán-Ramirez, Andres; Salazar-Torres, Marcos; Romero-Gutierrez, Gustavo

2009-04-01

Massage has been proposed as a way of facilitating development and growth of newborns through its effects on increasing blood flow, heart rate, digestion, and immunity. Massage might increase basal metabolism and nutrient absorption through endocrine effects such as increase in insulin and adrenaline and decrease in cortisol. Preliminary studies have suggested significant impact on weight gain with shortening of in-hospital stays of up to 6 days. We compared weight gain among preterm infants receiving Vimala massage plus usual care versus usual care alone. A randomized controlled trial was conducted. Sixty clinically stable preterm newborns with a corrected gestational age of 30 to 35 weeks receiving enteral nutrition in the hospital nursery were included. Half of them were assigned at random to receive Vimala massage twice daily for 10 days plus usual nursery care; the others received usual nursery care. Weight, head circumference, caloric intake, and nutritional method were recorded daily. Group characteristics were compared with analysis of variance, T test, and chi (2) test as appropriate. There were no differences between groups in gender, gestational age, initial weight, head circumference, and caloric intake and type of nutrition at baseline. Infants receiving massage had a larger weight gain versus the control group since the third day (188.2 +/- 41.20 g/kg versus 146.7 +/- 56.43 g/kg, P < 0.001). Hospital stay was shorter in infants receiving massage and usual nursery care (15.63 +/- 5.41 days versus 19.33 +/- 7.92 days, P = 0.03). The addition of parent-administered Vimala massage to usual nursery care resulted in increased weight gain and shorter hospital stay among clinically stable preterm newborns.

Effects of the Diabetes Manual 1:1 structured education in primary care.

PubMed

Sturt, J A; Whitlock, S; Fox, C; Hearnshaw, H; Farmer, A J; Wakelin, M; Eldridge, S; Griffiths, F; Dale, J

2008-06-01

To determine the effects of the Diabetes Manual on glycaemic control, diabetes-related distress and confidence to self-care of patients with Type 2 diabetes. A cluster randomized, controlled trial of an intervention group vs. a 6-month delayed-intervention control group with a nested qualitative study. Participants were 48 urban general practices in the West Midlands, UK, with high population deprivation levels and 245 adults with Type 2 diabetes with a mean age of 62 years recruited pre-randomization. The Diabetes Manual is 1:1 structured education designed for delivery by practice nurses. Measured outcomes were HbA(1c), cardiovascular risk factors, diabetes-related distress measured by the Problem Areas in Diabetes Scale and confidence to self-care measured by the Diabetes Management Self-Efficacy Scale. Outcomes were assessed at baseline and 26 weeks. There was no significant difference in HbA(1c) between the intervention group and the control group [difference -0.08%, 95% confidence interval (CI) -0.28, 0.11]. Diabetes-related distress scores were lower in the intervention group compared with the control group (difference -4.5, 95% CI -8.1, -1.0). Confidence to self-care Scores were 11.2 points higher (95% CI 4.4, 18.0) in the intervention group compared with the control group. The patient response rate was 18.5%. In this population, the Diabetes Manual achieved a small improvement in patient diabetes-related distress and confidence to self-care over 26 weeks, without a change in glycaemic control. Further study is needed to optimize the intervention and characterize those for whom it is more clinically and psychologically effective to support its use in primary care.

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 Functional Progressive Resistance Exercise Training on Walking Ability in Children with Cerebral Palsy: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Scholtes, Vanessa A.; Becher, Jules G.; Janssen-Potten, Yvonne J.; Dekkers, Hurnet; Smallenbroek, Linda; Dallmeijer, Annet J.

2012-01-01

The objective of the study was to evaluate the effectiveness of functional progressive resistance exercise (PRE) training on walking ability in children with cerebral palsy (CP). Fifty-one ambulant children with spastic CP (mean age 10 years 5 months, 29 boys) were randomized to an intervention (n=26) or control group (n=25, receiving usual care).…

Child oral health-related quality of life and early childhood caries: a non-inferiority randomized control trial.

PubMed

Arrow, P; Klobas, E

2016-06-01

The aim of this study was to compare changes in child oral health-related quality of life (COHRQoL) after treatment for early childhood caries (ECC) using two alternative treatment approaches. A randomized control trial with random allocation of parent/child dyads with ECC to test (minimum intervention) or control (standard care). Participating parents completed the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and follow-up. Changes in ECOHIS scores and extent of COHRQoL impacts between and within groups were tested using the chi-squared statistic for groups, Wilcoxon's rank-sum test, and matched-pairs signed-rank test. Two hundred and fifty-four children were randomized (test = 127; control = 127). At baseline, mean ECOHIS score 11.1, sd 8.2; mean age = 3.8 years, sd 0.90; mean dmft = 4.9, sd 4.0; and 59% male. After a mean interval of 11.4 months, 210 children were followed-up and returned a completed questionnaire (test = 111; control = 99). There was no significant difference in COHRQoL changes between test and control. For all the children combined, there were significantly fewer impacts at follow-up in the child and family domains and the total ECOHIS, Wilcoxon signed-rank test, p < 0.05. COHRQoL improved with primary dental care for ECC, and there was no statistically significant difference between test and control in the extent of the improvement. © 2016 Australian Dental Association.

NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

PubMed

Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

2016-12-01

Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

Internal versus external motivation in referral of primary care patients with depression to an internet support group: randomized controlled trial.

PubMed

Van Voorhees, Benjamin W; Hsiung, Robert C; Marko-Holguin, Monika; Houston, Thomas K; Fogel, Joshua; Lee, Royce; Ford, Daniel E

2013-03-12

Depressive disorders and symptoms affect more than one-third of primary care patients, many of whom do not receive or do not complete treatment. Internet-based social support from peers could sustain depression treatment engagement and adherence. We do not know whether primary care patients will accept referral to such websites nor do we know which methods of referral would be most effective. We conducted a randomized clinical trial to determine whether (1) a simple generic referral card (control), (2) a patient-oriented brochure that provided examples of online postings and experience (internal motivation), or (3) a physician letter of recommendation (external motivation) would generate the greatest participation in a primary care Internet depression treatment support portal focused around an Internet support group (ISG). We used 3 offline methods to identify potential participants who had not used an ISG in the past 6 months. Eligibility was determined in part by a brief structured psychiatric interview based on the Patient Health Questionnaire-9 (PHQ-9). After consent and enrollment, participants were randomly assigned to 1 of 3 groups (control, internal motivation, or external motivation). We constructed a portal to connect primary care patients to both fact-based information and an established ISG (Psycho-Babble). The ISG allowed participants to view messages and then decide if they actually wished to register there. Participation in the portal and the ISG was assessed via automated activity tracking. Fifty participants were assigned to the 3 groups: a motivation-neutral control group (n=18), an internal motivation group (n=19), and an external motivation group (n=13). Of these participants, 31 (62%) visited the portal; 27 (54%) visited the ISG itself. The internal motivation group showed significantly greater participation than the control group on several measures. The external motivation group spent significantly less time logged onto the portal than the control group. The internal motivation group showed significantly greater participation than the external motivation group on several measures. Referral of primary care patients with depressive disorders and symptoms to an ISG is feasible even if they have never previously used one. This may best be accomplished by enhancing their internal motivation.

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.

Virtual reality skills training for health care professionals in alcohol screening and brief intervention.

PubMed

Fleming, Michael; Olsen, Dale; Stathes, Hilary; Boteler, Laura; Grossberg, Paul; Pfeifer, Judie; Schiro, Stephanie; Banning, Jane; Skochelak, Susan

2009-01-01

Educating physicians and other health care professionals about the identification and treatment of patients who drink more than recommended limits is an ongoing challenge. An educational randomized controlled trial was conducted to test the ability of a stand-alone training simulation to improve the clinical skills of health care professionals in alcohol screening and intervention. The "virtual reality simulation" combined video, voice recognition, and nonbranching logic to create an interactive environment that allowed trainees to encounter complex social cues and realistic interpersonal exchanges. The simulation included 707 questions and statements and 1207 simulated patient responses. A sample of 102 health care professionals (10 physicians; 30 physician assistants or nurse practitioners; 36 medical students; 26 pharmacy, physican assistant, or nurse practitioner students) were randomly assigned to a no training group (n = 51) or a computer-based virtual reality intervention (n = 51). Professionals in both groups had similar pretest standardized patient alcohol screening skill scores: 53.2 (experimental) vs 54.4 (controls), 52.2 vs 53.7 alcohol brief intervention skills, and 42.9 vs 43.5 alcohol referral skills. After repeated practice with the simulation there were significant increases in the scores of the experimental group at 6 months after randomization compared with the control group for the screening (67.7 vs 58.1; P < .001) and brief intervention (58.3 vs 51.6; P < .04) scenarios. The technology tested in this trial is the first virtual reality simulation to demonstrate an increase in the alcohol screening and brief intervention skills of health care professionals.

Virtual Reality Skills Training for Health Care Professionals in Alcohol Screening and Brief Intervention

PubMed Central

Fleming, Michael; Olsen, Dale; Stathes, Hilary; Boteler, Laura; Grossberg, Paul; Pfeifer, Judie; Schiro, Stephanie; Banning, Jane; Skochelak, Susan

2009-01-01

Background Educating physicians and other health care professionals to identify and treat patients who drink above recommended limits is an ongoing challenge. Methods An educational Randomized Control Trial (RCT) was conducted to test the ability of a stand alone training simulation to improve the clinical skills of health care professionals in alcohol screening and intervention. The “virtual reality simulation” combines video, voice recognition and non branching logic to create an interactive environment that allows trainees to encounter complex social cues and realistic interpersonal exchanges. The simulation includes 707 questions and statements and 1207 simulated patient responses. Results A sample of 102 health care professionals (10 physicians; 30 physician assistants [PAs] or nurse practitioners [NPs]; 36 medical students; 26 pharmacy, PA or NP students) were randomly assigned to no training (n=51) or a computer based virtual reality intervention (n=51). Subjects in both groups had similar pre-test standardized patient alcohol screening skill scores – 53.2 (experimental) vs. 54.4 (controls), 52.2 vs. 53.7 alcohol brief intervention skills, and 42.9 vs. 43.5 alcohol referral skills. Following repeated practice with the simulation there were significant increases in the scores of the experimental group at 6 months post-randomization compared to the control group for the screening (67.7 vs. 58.1, p<.001) and brief intervention (58.3 vs. 51.6, p<.04) scenarios. Conclusions The technology tested in this trial is the first virtual reality simulation to demonstrate an increase in the alcohol screening and brief intervention skills of health care professionals. PMID:19587253

Effects of a caregiver-inclusive assistive technology intervention: a randomized controlled trial.

PubMed

Ben Mortenson, W; Demers, Louise; Fuhrer, Marcus J; Jutai, Jeffrey W; Bilkey, Jessica; Plante, Michelle; DeRuyter, Frank

2018-04-18

The principal aim of this study was to investigate whether a caregiver-inclusive assistive technology intervention improved older care recipients' functional autonomy and decreased the perceived burden of their family caregivers compared to customary care. The study was a single-blind, mixed-methods, randomized controlled trial with baseline data collection and follow-ups at 6-, 22-, and 58-weeks after baseline evaluation, which was prospectively registered ( ClinicalTrials.gov Identifier: NCT01640470. Registered 11/21/2011). Dyads comprising a care recipient and family caregiver were randomly assigned to either a caregiver-inclusive experimental group (N = 44) or a customary-care comparison group (N = 46). Eligible care recipients were aged ≥55 years and had one or more limitations with mobility or daily activities, and family caregivers provided at least four hours per week of assistance. Outcome measures were administered to both groups at baseline and at the three follow-up time points. The data collectors were blinded regarding participants' intervention group. The primary outcome measures were the Functional Autonomy Measurement System to assess care recipients' functional performance, and the Caregiver Assistive Technology Outcome Measure to assess caregivers' burden. Qualitative interviews examined participants' perceptions of the caregiver-inclusive and customary care interventions. The experimental intervention addressed significantly more dyad-identified problematic activities, but caregiver involvement was evident in both groups and outcomes were not significantly different over time. In both groups, care recipients' functional autonomy declined significantly (P < .01), and caregivers' activity-specific and overall burden decreased significantly (P < .01). Given the unintended congruence between the caregiver-inclusive and customary care interventions, the overall findings lend support for the provision of assistive technology to reduce caregiver burden.

Improving the evidence base in palliative care to inform practice and policy: thinking outside the box.

PubMed

Aoun, Samar M; Nekolaichuk, Cheryl

2014-12-01

The adoption of evidence-based hierarchies and research methods from other disciplines may not completely translate to complex palliative care settings. The heterogeneity of the palliative care population, complexity of clinical presentations, and fluctuating health states present significant research challenges. The aim of this narrative review was to explore the debate about the use of current evidence-based approaches for conducting research, such as randomized controlled trials and other study designs, in palliative care, and more specifically to (1) describe key myths about palliative care research; (2) highlight substantive challenges of conducting palliative care research, using case illustrations; and (3) propose specific strategies to address some of these challenges. Myths about research in palliative care revolve around evidence hierarchies, sample heterogeneity, random assignment, participant burden, and measurement issues. Challenges arise because of the complex physical, psychological, existential, and spiritual problems faced by patients, families, and service providers. These challenges can be organized according to six general domains: patient, system/organization, context/setting, study design, research team, and ethics. A number of approaches for dealing with challenges in conducting research fall into five separate domains: study design, sampling, conceptual, statistical, and measures and outcomes. Although randomized controlled trials have their place whenever possible, alternative designs may offer more feasible research protocols that can be successfully implemented in palliative care. Therefore, this article highlights "outside the box" approaches that would benefit both clinicians and researchers in the palliative care field. Ultimately, the selection of research designs is dependent on a clearly articulated research question, which drives the research process. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Effects of nursing intervention models on social adaption capability development in preschool children with malignant tumors: a randomized control trial.

PubMed

Yu, Lu; Mo, Lin; Tang, Yan; Huang, Xiaoyan; Tan, Juan

2014-06-01

The objectives of this study are to compare the effects of two nursing intervention models on the ability of preschool children with malignant tumors to socialize and to determine if these interventions improved their social adaption capability (SAC) and quality of life. Inpatient preschool children with malignant tumors admitted to the hospital between December 2009 and March 2012 were recruited and randomized into either the experimental or control groups. The control group received routine nursing care, and the experimental group received family-centered nursing care, including physical, psychological, and social interventions. The Infants-Junior Middle School Student's Social-Life Abilities Scale was used to evaluate SAC development of participants. Participants (n = 240) were recruited and randomized into two groups. After the intervention, the excellent and normal SAC rates were 27.5% and 55% in the experimental group, respectively, compared with 2.5% and 32.5% in the control group (p < 0.001). After the intervention, SAC in experimental group was improved compared with before intervention (54.68 ± 10.85 vs 79.9 ± 22.3, p < 0.001). However, no differences in SAC were observed between baseline and after intervention in the control group (54.70 ± 11.47 vs. 52 ± 15.8, p = 0.38). The family-centered nursing care model that included physical, psychological, and social interventions improved the SAC of children with malignancies compared with children receiving routine nursing care. Establishing a standardized family-school-community-hospital hierarchical multi-management intervention model for children is important to the efficacy of long-term interventions and to the improvement of SAC of children with malignancies. Copyright © 2014 John Wiley & Sons, Ltd.

Prevention of Recurrent Foot Ulcers With Plantar Pressure–Based In-Shoe Orthoses: The CareFUL Prevention Multicenter Randomized Controlled Trial

PubMed Central

Ulbrecht, Jan S.; Hurley, Timothy; Mauger, David T.

2014-01-01

OBJECTIVE To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration. RESEARCH DESIGN AND METHODS Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination. Proportional hazards regression was used for analysis. RESULTS There was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3–8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study. CONCLUSIONS We conclude that shape- and barefoot plantar pressure–based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses, but they did not significantly reduce nonulcerative lesions. PMID:24760263

Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.

PubMed

Ulbrecht, Jan S; Hurley, Timothy; Mauger, David T; Cavanagh, Peter R

2014-07-01

To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration. Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination. Proportional hazards regression was used for analysis. There was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3-8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study. We conclude that shape- and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses, but they did not significantly reduce nonulcerative lesions. © 2014 by the American Diabetes Association.

Effects of a lifestyle intervention on psychosocial well-being of severe mentally ill residential patients: ELIPS, a cluster randomized controlled pragmatic trial.

PubMed

Stiekema, Annemarie P M; Looijmans, Anne; van der Meer, Lisette; Bruggeman, Richard; Schoevers, Robert A; Corpeleijn, Eva; Jörg, Frederike

2018-03-01

Large studies investigating the psychosocial effects of lifestyle interventions in patients with a severe mental illness (SMI) are scarce, especially in residential patients. This large, randomized controlled, multicentre pragmatic trial assessed the psychosocial effects of a combined diet-and-exercise lifestyle intervention targeting the obesogenic environment of SMI residential patients. Twenty-nine sheltered and clinical care teams were randomized into intervention (n=15) or control (n=14) arm. Team tailored diet-and-exercise lifestyle plans were set up to change the obesogenic environment into a healthier setting, and team members were trained in supporting patients to make healthier choices. The control group received care-as-usual. The Calgary Depression Scale for Schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Health of the Nation Outcome Scales (HoNOS) and the Manchester Short Assessment of Quality of Life (MANSA) were assessed at baseline and after three and twelve months. Data were available for 384 intervention and 386 control patients (48.6±12.5years old, 62.7% males, 73.7% psychotic disorder). Linear mixed model analysis showed no psychosocial improvements in the intervention group compared to care-as-usual; the intervention group showed a slightly reduced quality of life (overall) and a small increase in depressive symptoms (clinical care facilities) and psychotic symptoms (sheltered facilities). This may be due to difficulties with implementation, the intervention not being specifically designed for improvements in mental well-being, or the small change approach, which may take longer to reach an effect. Further research might elucidate what type of lifestyle intervention under what circumstances positively affects psychosocial outcomes in this population. Copyright © 2018 Elsevier B.V. All rights reserved.

Randomized Controlled Trial of Primary Care Pediatric Parenting Programs

PubMed Central

Mendelsohn, Alan L.; Dreyer, Benard P.; Brockmeyer, Carolyn A.; Berkule-Silberman, Samantha B.; Huberman, Harris S.; Tomopoulos, Suzy

2011-01-01

Objectives To determine whether pediatric primary care–based programs to enhance parenting and early child development reduce media exposure and whether enhanced parenting mediates the effects. Design Randomized controlled trial. Setting Urban public hospital pediatric primary care clinic. Participants A total of 410 mother-newborn dyads enrolled after childbirth. Interventions Patients were randomly assigned to 1 of 2 interventions, the Video Interaction Project (VIP) and Building Blocks (BB) interventions, or to a control group. The VIP intervention comprised 1-on-1 sessions with a child development specialist who facilitated interactions in play and shared reading through review of videotapes made of the parent and child on primary care visit days; learning materials and parenting pamphlets were also provided. The BB intervention mailed parenting materials, including age-specific newsletters suggesting activities to facilitate interactions, learning materials, and parent-completed developmental questionnaires (Ages and Stages questionnaires). Outcome Measures Electronic media exposure in the home using a 24-hour recall diary. Results The mean (SD) exposure at 6 months was 146.5 (125.0) min/d. Exposure to VIP was associated with reduced total duration of media exposure compared with the BB and control groups (mean [SD] min/d for VIP, 131.6 [118.7]; BB, 151.2 [116.7]; control, 155.4 [138.7]; P=.009). Enhanced parent-child interactions were found to partially mediate relations between VIP and media exposure for families with a ninth grade or higher literacy level (Sobel statistic=2.49; P=.01). Conclusion Pediatric primary care may represent an important venue for addressing the public health problem of media exposure in young children at a population level. Trial Registration clinicaltrials.gov Identifier: NCT00212576 PMID:21199979

The effects of asking a fertility intention question in primary care settings: a systematic review protocol.

PubMed

Henning, Paul A; Burgess, Carolyne K; Jones, Heidi E; Norman, Wendy V

2017-01-19

Planning for pregnancy has been associated with reduced unwanted pregnancies and improved pregnancy outcomes. Despite the benefits of planned pregnancy, there are no guideline recommendations on routine counseling regarding pregnancy intention in primary care settings. The objective of the systematic review is to determine the effectiveness of incorporating questions of pregnancy intention into primary care. A systematic search of the literature will be conducted for any studies comparing questions of pregnancy intention in primary care settings with no intervention or a control intervention. Types of studies will include randomized controlled trials, non-randomized trials, and observation studies. Participants will include patients of reproductive age presenting to primary health care settings. Interventions will include any assessment of fertility intention and follow-up care compared with a control group or no intervention. Outcomes will include quantitative data with rates for contraceptive uptake, and any pregnancy related outcome. Databases (Ovid MEDLINE; Pubmed; CINAHL; EMBASE; CDR/DARE databases; Web of Science; ISRCTN registry; Clinicaltrials.gov; Cochrane Library) will be searched from the year 2000 to current. Screening of identified articles and data extraction will be conducted in duplicate by two independent reviewers. Methodological quality will be assessed using the Jadad scale. Methodological quality of observational and non-randomized trials will be assessed using the Newcastle-Ottawa scale. Discrepancies will be resolved by consensus or by consulting a third author. Meta-analyses will be performed if appropriate. Determining the effect of including questions of pregnancy intention into primary care can provide evidence for the development of clinical practice guidelines and inform primary care providers if this simple and low-cost intervention should be routinely employed. This review will also identify any gaps in the current literature on this topic and provide direction for future research in this area of study. Systematic Review Registration: PROSPERO CRD42015019726.

The Effect of Group Discussion-based Education on Self-management of Adults with Type 2 Diabetes Mellitus Compared with Usual Care: A Randomized Control Trial.

PubMed

Habibzadeh, Hosein; Sofiani, Akbar; Alilu, Leyla; Gillespie, Mark

2017-11-01

We sought to determine the effect of group discussion-based education on the self-management capability of patients with type 2 diabetes in Iran. This randomized control trial was conducted on 90 patients with type 2 diabetes. Participants were allocated randomly into one of two groups; intervention and control. The intervention group received the group discussion-based education while the control group received routine care only. The Lin's self-management questionnaire was completed at baseline and three months post-intervention. Statistical analysis, including the use of independent t -test, identified that in comparison to the control group, significant increases were observed in the scores of self-organization ( t =11.24, p < 0.001), self-adjustment ( t = 7.53, p < 0.001), interaction with health experts ( t = 7.31, p < 0.001), blood sugar self-monitoring ( t = 6.42, p < 0.001), adherence to the proposed diet ( t = 5.22, p < 0.001), and total self-management ( t = 10.82, p < 0.001) in the intervention group. Sharing experiences through group discussions and receiving instructive feedback can improve the ability to self-manage diabetes.

Improving depression and enhancing resilience in family dementia caregivers: a pilot randomized placebo-controlled trial of escitalopram.

PubMed

Lavretsky, Helen; Siddarth, Prabha; Irwin, Michael R

2010-02-01

This study examined the potential of an antidepressant drug, escitalopram, to improve depression, resilience to stress, and quality of life in family dementia caregivers in a randomized placebo-controlled double-blinded trial. Forty family caregivers (43-91 years of age, 25 children and 15 spouses; 26 women) who were taking care of their relatives with Alzheimer disease were randomized to receive either escitalopram 10 mg/day or placebo for 12 weeks. Severity of depression, resilience, burden, distress, quality of life, and severity of care-recipient's cognitive and behavioral disturbances were assessed at baseline and over the course of the study. The Hamilton Depression Rating Scale scores at baseline ranged between 10 and 28. The groups were stratified by the diagnosis of major and minor depression. Most outcomes favored escitalopram over placebo. The severity of depression improved, and the remission rate was greater with the drug compared with placebo. Measures of anxiety, resilience, burden, and distress improved on escitalopram compared with placebo. Among caregivers, this small randomized controlled trial found that escitalopram use resulted in improvement in depression, resilience, burden and distress, and quality of life. Our results need to be confirmed in a larger sample.

Personal navigation increases colorectal cancer screening uptake.

PubMed

Ritvo, Paul G; Myers, Ronald E; Paszat, Lawrence F; Tinmouth, Jill M; McColeman, Joshua; Mitchell, Brian; Serenity, Mardie; Rabeneck, Linda

2015-03-01

Prior randomized, controlled trials (RCTs) indicate that patient navigation can boost colorectal cancer screening rates in primary care. The sparse literature on pragmatic trials of interventions designed to increase colorectal cancer screening adherence motivated this trial on the impact of a patient navigation intervention that included support for performance of the participants' preferred screening test (colonoscopy or stool blood testing). Primary care patients (n = 5,240), 50 to 74 years of age, with no prior diagnosis of bowel cancer and no record of a recent colorectal cancer screening test, were identified at the Group Health Centre in northern Ontario. These patients were randomly assigned to an intervention group (n = 2,629) or a usual care control group (n = 2,611). Intervention group participants were contacted by a trained nurse navigator by telephone to discuss colorectal cancer screening. Interested patients met with the navigator, who helped them identify and arrange for performance of the preferred screening test. Control group participants received usual care. Multivariate analyses were conducted using medical records data to assess intervention impact on screening adherence within 12 months after randomization. Mean patient age was 59 years, and 50% of participants were women. Colorectal cancer screening adherence was higher in the intervention group (35%) than in the control group (20%), a difference that was statistically significant (OR, 2.11; confidence interval, 1.87-2.39). Preference-based patient navigation increased screening uptake in a pragmatic RCT. Patient navigation increased colorectal cancer screening rates in a pragmatic RCT in proportions similar to those observed in explanatory RCTs. ©2014 American Association for Cancer Research.

The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)

PubMed Central

2013-01-01

Background Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is relatively common in children with limited evidence for treatment. The Phil Parker Lightning Process (LP) is a trademarked intervention, which >250 children use annually. There are no reported studies investigating the effectiveness or possible side effects of LP. Methods The trial population was drawn from the Bath and Bristol NHS specialist paediatric CFS or ME service. The study was designed as a pilot randomized trial with children (aged 12 to 18 years) comparing specialist medical care with specialist medical care plus the Lightning Process. Integrated qualitative methodology was used to explore the feasibility and acceptability of the recruitment, randomization and interventions. Results A total of 56 children were recruited from 156 eligible children (1 October 2010 to 16 June 2012). Recruitment, randomization and both interventions were feasible and acceptable. Participants suggested changes to improve feasibility and acceptability and we incorporated the following in the trial protocol: stopped collecting 6-week outcomes; introduced a second reminder letter; used phone calls to collect primary outcomes from nonresponders; informed participants about different approaches of each intervention and changed our recommendation for the primary outcome for the full study from school attendance to disability (SF-36 physical function subscale) and fatigue (Chalder Fatigue Scale). Conclusions Conducting randomized controlled trials (RCTs) to investigate an alternative treatment such as LP is feasible and acceptable for children with CFS or ME. Feasibility studies that incorporate qualitative methodology enable changes to be made to trial protocols to improve acceptability to participants. This is likely to improve recruitment rate and trial retention. Trial registration Feasibility study first randomization: 29 September 2010. Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012). Full trial first randomization: 19 September 2012. PMID:24304689

Excessive drinking--brief intervention by a primary health care nurse. A randomized controlled trial.

PubMed

Tomson, Y; Romelsjö, A; Aberg, H

1998-09-01

To evaluate the effect of a nurse-conducted intervention on excessive drinkers. Randomized, controlled trial. Vårby Health Centre, Stockholm. The intervention group visited a nurse three times during a 12-month period. The controls met once with a general practitioner (GP). Patients were recruited at a health screening on the basis of a raised gamma-glutamyl transferase (GGT). Of 2338 subjects, aged 25-54 years, 222 had a screening GGT of > or = 0.9 mukat/l. 100 were randomized to the treatment and 122 to the control group. GGT, self-reported alcohol consumption (g/week), sickness allowance and use of health care. After 2 years a reduction of GGT from 1.52 to 1.21 mukat/l (p = 0.02) had occurred in the treatment group. The controls increased their mean level of GGT from 1.75 to 2.16 mukat/l. Mean weekly alcohol consumption in the intervention group was reduced from 337 to 228 g/week (p = 0.02). The controls did not quantify their alcohol consumption initially, but reported a reduced weekly consumption at follow-up. The intervention had an impact on GGT and self-reported consumption. The controls also reported decreased consumption possibly because their appointment with the GP functioned as a very brief intervention.

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.

A Pilot Trial of Early Specialty Palliative Care for Patients with Advanced Pancreatic Cancer: Challenges Encountered and Lessons Learned.

PubMed

Schenker, Yael; Bahary, Nathan; Claxton, Rene; Childers, Julie; Chu, Edward; Kavalieratos, Dio; King, Linda; Lembersky, Barry; Tiver, Greer; Arnold, Robert M

2018-01-01

Patients with advanced pancreatic cancer suffer from high morbidity and mortality. Specialty palliative care may improve quality of life. Assess the feasibility, acceptability, and perceived effectiveness of early specialty physician-led palliative care for patients with advanced pancreatic cancer and their caregivers. A mixed-methods pilot randomized controlled trial in which patient-caregiver pairs were randomized (2:1) to receive specialty palliative care, in addition to standard oncology care versus standard oncology care alone. At a National Cancer Institute-designated comprehensive cancer center in Western Pennsylvania, 30 patients with advanced pancreatic adenocarcinoma and their caregivers (N = 30), oncologists (N = 4), and palliative care physicians (N = 3) participated. Feasibility (enrollment, three-month outcome-assessment, and intervention completion rates), acceptability, and perceived effectiveness (process interviews with patients, caregivers, and physicians). Consent:approach rate was 49%, randomized:consent rate 55%, and three-month outcome assessment rate 75%. Two patients and three caregivers withdrew early. The three-month mortality rate was 13%. Patients attended a mean of 1.3 (standard deviation 1.1) palliative care visits during the three-month period. Positive experiences with palliative care included receiving emotional support and symptom management. Negative experiences included inconvenience, long travel times, spending too much time at the cancer center, and no perceived palliative care needs. Physicians suggested embedding palliative care within oncology clinics, tailoring services to patient needs, and facilitating face-to-face communication between oncologists and palliative physicians. A randomized trial of early palliative care for advanced pancreatic cancer did not achieve feasibility goals. Integrating palliative care within oncology clinics may increase acceptability and perceived effectiveness.

Just-in-time information improved decision-making in primary care: a randomized controlled trial.

PubMed

McGowan, Jessie; Hogg, William; Campbell, Craig; Rowan, Margo

2008-01-01

The "Just-in-time Information" (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. A randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued. In this study, providing timely information to clinical questions had a highly positive impact on decision-making and a high approval rating from participants. Using a librarian to respond to clinical questions may allow primary care professionals to have more time in their day, thus potentially increasing patient access to care. Such services may reduce costs through decreasing the need for referrals, further tests, and other courses of action. Controlled-Trials.com ISRCTN96823810.

Just-in-Time Information Improved Decision-Making in Primary Care: A Randomized Controlled Trial

PubMed Central

McGowan, Jessie; Hogg, William; Campbell, Craig; Rowan, Margo

2008-01-01

Background The “Just-in-time Information” (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. Methods and Finding A randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued. Conclusions In this study, providing timely information to clinical questions had a highly positive impact on decision-making and a high approval rating from participants. Using a librarian to respond to clinical questions may allow primary care professionals to have more time in their day, thus potentially increasing patient access to care. Such services may reduce costs through decreasing the need for referrals, further tests, and other courses of action. Trial Registration Controlled-Trials.com ISRCTN96823810 PMID:19023446

Comparative Effectiveness Research in Oncology

PubMed Central

2013-01-01

Although randomized controlled trials represent the gold standard for comparative effective research (CER), a number of additional methods are available when randomized controlled trials are lacking or inconclusive because of the limitations of such trials. In addition to more relevant, efficient, and generalizable trials, there is a need for additional approaches utilizing rigorous methodology while fully recognizing their inherent limitations. CER is an important construct for defining and summarizing evidence on effectiveness and safety and comparing the value of competing strategies so that patients, providers, and policymakers can be offered appropriate recommendations for optimal patient care. Nevertheless, methodological as well as political and social challenges for CER remain. CER requires constant and sophisticated methodological oversight of study design and analysis similar to that required for randomized trials to reduce the potential for bias. At the same time, if appropriately conducted, CER offers an opportunity to identify the most effective and safe approach to patient care. Despite rising and unsustainable increases in health care costs, an even greater challenge to the implementation of CER arises from the social and political environment questioning the very motives and goals of CER. Oncologists and oncology professional societies are uniquely positioned to provide informed clinical and methodological expertise to steer the appropriate application of CER toward critical discussions related to health care costs, cost-effectiveness, and the comparative value of the available options for appropriate care of patients with cancer. PMID:23697601

Testing the Replicability of a Successful Care Management Program: Results from a Randomized Trial and Likely Explanations for Why Impacts Did Not Replicate.

PubMed

Peterson, G Greg; Zurovac, Jelena; Brown, Randall S; Coburn, Kenneth D; Markovich, Patricia A; Marcantonio, Sherry A; Clark, William D; Mutti, Anne; Stepanczuk, Cara

2016-12-01

To test whether a care management program could replicate its success in an earlier trial and determine likely explanations for why it did not. Medicare claims and nurse contact data for Medicare fee-for-service beneficiaries with chronic illnesses enrolled in the trial in eastern Pennsylvania (N = 483). A randomized trial with half of enrollees receiving intensive care management services and half receiving usual care. We developed and tested hypotheses for why impacts declined. All outcomes and covariates were derived from claims and the nurse contact data. From 2010 to 2014, the program did not reduce hospitalizations or generate Medicare savings to offset program fees that averaged $260 per beneficiary per month. These estimates are statistically different (p < .05) from the large reductions in hospitalizations and spending in the first trial (2002-2010). The treatment-control differences in the second trial disappeared because the control group's risk-adjusted hospitalization rate improved, not because the treatment group's outcomes worsened. Even if demonstrated in a randomized trial, successful results from one test may not replicate in other settings or time periods. Assessing whether gaps in care that the original program filled exist in other settings can help identify where earlier success is likely to replicate. © Health Research and Educational Trust.

The results of a randomized trial of a quality improvement intervention in the care of patients with heart failure. The MISCHF Study Investigators.

PubMed

Philbin, E F; Rocco, T A; Lindenmuth, N W; Ulrich, K; McCall, M; Jenkins, P L

2000-10-15

Quality improvement and disease management programs for heart failure have improved quality of care and patient outcomes at large tertiary care hospitals. The purpose of this study was to measure the effects of a regional, multihospital, collaborative quality improvement intervention on care and outcomes in heart failure in community hospitals. This randomized controlled study included 10 acute care community hospitals in upstate New York. After a baseline period, 5 hospitals were randomly assigned to receive a multifaceted quality improvement intervention (n = 762 patients during the baseline period; n = 840 patients postintervention), while 5 were assigned to a "usual care" control (n = 640 patients during the baseline period; n = 664 patients postintervention). Quality of care was determined using explicit criteria by reviewing the charts of consecutive patients hospitalized with the primary diagnosis of heart failure during the baseline period and again in the postintervention period. Clinical outcomes included hospital length of stay and charges, in-hospital and 6-month mortality, hospital readmission, and quality of life measured after discharge. Patients had similar characteristics in the baseline and postintervention phases in the intervention and control groups. Using hospital-level analyses, the intervention had mixed effects on 5 quality-of-care markers that were not statistically significant. The mean of the average length of stay among hospitals decreased from 8.0 to 6.2 days in the intervention group, with a smaller decline in mean length of stay in the control group (7.7 to 7.0 days). The net effects of the intervention were nonsignificant changes in length of stay of -1.1 days (95% confidence interval [CI]: -2.9 to 0.7 days, P = 0.18) and in hospital charges of -$817 (95% CI: -$2560 to $926, P = 0.31). There were small and nonsignificant effects on mortality, hospital readmission, and quality of life. The incremental effect of regional collaboration among peer community hospitals toward the goal of quality improvement was small and limited to a slightly, but not significantly, shorter length of stay.

The effectiveness of a skin care program for the prevention of contact dermatitis in health care workers (the Healthy Hands Project): study protocol for a cluster randomized controlled trial.

PubMed

Soltanipoor, Maryam; Kezic, Sanja; Sluiter, Judith K; Rustemeyer, Thomas

2017-02-28

Health care workers (HCW) are at high risk for developing occupational hand dermatitis (HD) due to frequent exposure to 'wet work'. Amongst HCWs, nurses are at highest risk, with an estimated point prevalence of HD ranging between 12 and 30%. The burden of disease is high with chronicity, sick leave, risk of unemployment and impaired quality of life. Despite evidence from the medical literature on the risk factors and the importance of skin care in the prevention of HD, in practice, compliance to skin care protocols are below 30%. New preventive strategies are obviously needed. This is a cluster randomized controlled trial, focusing on nurses performing wet work. In total, 20 wards are recruited to include 504 participating nurses in the study at baseline. The wards will be randomized to an intervention or a control group and followed up for 18 months. The intervention consists of the facilitation of creams being available at the wards combined with the continuous electronic monitoring of their consumption with regular feedback on skin care performance in teams of HCWs. Both the intervention and the control group receive basic education on skin protection (as 'care as usual'). Every 6 months, participants of both groups will fill in the questionnaires regarding exposure to wet work and skin protective behavior. Furthermore, skin condition will be assessed and samples of the stratum corneum collected. The effect of the intervention will be measured by comparing the change in Hand Eczema Severity Index (HECSI score) from baseline to 12 months. The Natural Moisturizing Factor (NMF) levels, measured in the stratum corneum as an early biomarker of skin barrier damage, and the total consumption of creams per ward will be assessed as a secondary outcome. This trial will assess the clinical effectiveness of an intervention program to prevent hand dermatitis among health care workers TRIAL REGISTRATION: Netherlands Trial Register (NTR), identification number NTR5564 . Registered on 2 November 2015.

Effect of the 2011 vs 2003 duty hour regulation-compliant models on sleep duration, trainee education, and continuity of patient care among internal medicine house staff: a randomized trial.

PubMed

Desai, Sanjay V; Feldman, Leonard; Brown, Lorrel; Dezube, Rebecca; Yeh, Hsin-Chieh; Punjabi, Naresh; Afshar, Kia; Grunwald, Michael R; Harrington, Colleen; Naik, Rakhi; Cofrancesco, Joseph

2013-04-22

On July 1, 2011, the Accreditation Council for Graduate Medical Education implemented further restrictions of its 2003 regulations on duty hours and supervision. It remains unclear if the 2003 regulations improved trainee well-being or patient safety. To determine the effects of the 2011 Accreditation Council for Graduate Medical Education duty hour regulations compared with the 2003 regulations concerning sleep duration, trainee education, continuity of patient care, and perceived quality of care among internal medicine trainees. Crossover study design in an academic research setting. Medical house staff. General medical teams were randomly assigned using a sealed-envelope draw to an experimental model or a control model. We randomly assigned 4 medical house staff teams (43 interns) using a 3-month crossover design to a 2003-compliant model of every fourth night overnight call (control) with 30-hour duty limits or to one of two 2011-compliant models of every fifth night overnight call (Q5) or a night float schedule (NF), both with 16-hour duty limits. We measured sleep duration using actigraphy and used admission volumes, educational opportunities, the number of handoffs, and satisfaction surveys to assess trainee education, continuity of patient care, and perceived quality of care. RESULTS The study included 560 control, 420 Q5, and 140 NF days that interns worked and 834 hospital admissions. Compared with controls, interns on NF slept longer during the on call period (mean, 5.1 vs 8.3 hours; P = .003), and interns on Q5 slept longer during the postcall period (mean, 7.5 vs 10.2 hours; P = .05). However, both the Q5 and NF models increased handoffs, decreased availability for teaching conferences, and reduced intern presence during daytime work hours. Residents and nurses in both experimental models perceived reduced quality of care, so much so with NF that it was terminated early. Compared with a 2003-compliant model, two 2011 duty hour regulation-compliant models were associated with increased sleep duration during the on-call period and with deteriorations in educational opportunities, continuity of patient care, and perceived quality of care.

Improving hypertension management through pharmacist prescribing; the rural alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods

PubMed Central

2011-01-01

Background Patients with hypertension continue to have less than optimal blood pressure control, with nearly one in five Canadian adults having hypertension. Pharmacist prescribing is gaining favor as a potential clinically efficacious and cost-effective means to improve both access and quality of care. With Alberta being the first province in Canada to have independent prescribing by pharmacists, it offers a unique opportunity to evaluate outcomes in patients who are prescribed antihypertensive therapy by pharmacists. Methods The study is a randomized controlled trial of enhanced pharmacist care, with the unit of randomization being the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up, and prescribing/titration of antihypertensive medications) or usual care. Participants are patients in rural Alberta with undiagnosed/uncontrolled blood pressure, as defined by the Canadian Hypertension Education Program. The primary outcome is the change in systolic blood pressure between baseline and 24 weeks in the enhanced-care versus usual-care arms. There are also three substudies running in conjunction with the project examining different remuneration models, investigating patient knowledge, and assessing health-resource utilization amongst patients in each group. Discussion To date, one-third of the required sample size has been recruited. There are 15 communities and 17 pharmacists actively screening, recruiting, and following patients. This study will provide high-level evidence regarding pharmacist prescribing. Trial Registration Clinicaltrials.gov NCT00878566. PMID:21834970

The Effects of Quality Improvement for Depression in Primary Care at Nine Years: Results from a Randomized, Controlled Group-Level Trial

PubMed Central

Wells, Kenneth B; Tang, Lingqi; Miranda, Jeanne; Benjamin, Bernadette; Duan, Naihua; Sherbourne, Cathy D

2008-01-01

Objective To examine 9-year outcomes of implementation of short-term quality improvement (QI) programs for depression in primary care. Data Sources Depressed primary care patients from six U.S. health care organizations. Study Design Group-level, randomized controlled trial. Data Collection Patients were randomly assigned to short-term QI programs supporting education and resources for medication management (QI-Meds) or access to evidence-based psychotherapy (QI-Therapy); and usual care (UC). Of 1,088 eligible patients, 805 (74 percent) completed 9-year follow-up; results were extrapolated to 1,269 initially enrolled and living. Outcomes were psychological well-being (Mental Health Inventory, five-item version [MHI5]), unmet need, services use, and intermediate outcomes. Principal Findings At 9 years, there were no overall intervention status effects on MHI5 or unmet need (largest F (2,41)=2.34, p=.11), but relative to UC, QI-Meds worsened MHI5, reduced effectiveness of coping and among whites lowered tangible social support (smallest t(42)=2.02, p=.05). The interventions reduced outpatient visits and increased perceived barriers to care among whites, but reduced attitudinal barriers due to racial discrimination and other factors among minorities (smallest F (2,41)=3.89, p=.03). Conclusions Main intervention effects were over but the results suggest some unintended negative consequences at 9 years particularly for the medication-resource intervention and shifts to greater perceived barriers among whites yet reduced attitudinal barriers among minorities. PMID:18522664

A clinical carepath for obese pregnant women: A pragmatic pilot cluster randomized controlled trial.

PubMed

McDonald, Sarah D; Viaje, Kristen A; Rooney, Rebecca A; Jarde, Alexander; Giglia, Lucia; Maxwell, Cynthia V; Small, David; Kelly, Tracy Pearce; Midwifery, B H Sc; Sabatino, Lisa; Thabane, Lehana

2018-05-17

Obese women are at increased risks for complications during pregnancy, birth and in their infants. Although guidelines have been established for the clinical care of obese pregnant women, management is sometimes suboptimal. Our goal was to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women compared to standard care, in a pilot cluster randomized controlled trial (RCT). A pragmatic pilot cluster RCT was conducted, randomly allocating eight clinics to the carepath or standard care for obese pregnant women. Women were eligible if they had a prepregnancy body mass index of ≥ 30 kg/m 2 and a viable singleton < 21 weeks. The primary outcomes were the feasibility of conducting a full-scale cluster RCT (defined as > 80%: randomization of clinics, use in eligible women, and completeness of follow-up) and of the intervention (defined as > 80%: compliance with each step in the carepath, and recommendation of the carepath by clinicians to a colleague). All eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath, resulting in < 80% uptake of eligible women. High follow-up (99.5%) was achieved, in 188 of 189 women. The carepath was feasible for numerous guideline-directed recommendations for screening, but less so for counselling topics. When the carepath was used in the majority of women, all clinicians, most of whom were midwives, reported they would recommend it to a colleague. The intervention group had significantly higher overall adherence to the guideline recommendations compared to control (relative risk 1.71, 95% confidence interval 1.57-1.87). In this pragmatic pilot cluster RCT, a guideline-directed clinical carepath improved some aspects of care of obese pregnant women and was recommended by clinicians, particularly midwives. A cluster RCT may not be feasible in a mix of obstetric and midwifery clinics, but may be feasible in midwifery clinics. This pragmatic pilot cluster RCT was registered on clinicaltrials.gov (identifier: NCT02534051 ).

Effect of a governmentally-led physical activity program on motor skills in young children attending child care centers: a cluster randomized controlled trial.

PubMed

Bonvin, Antoine; Barral, Jérôme; Kakebeeke, Tanja H; Kriemler, Susi; Longchamp, Anouk; Schindler, Christian; Marques-Vidal, Pedro; Puder, Jardena J

2013-07-08

To assess the effect of a governmentally-led center based child care physical activity program (Youp'là Bouge) on child motor skills. We conducted a single blinded cluster randomized controlled trial in 58 Swiss child care centers. Centers were randomly selected and 1:1 assigned to a control or intervention group. The intervention lasted from September 2009 to June 2010 and included training of the educators, adaptation of the child care built environment, parental involvement and daily physical activity. Motor skill was the primary outcome and body mass index (BMI), physical activity and quality of life secondary outcomes. The intervention implementation was also assessed. At baseline, 648 children present on the motor test day were included (age 3.3 ± 0.6, BMI 16.3 ± 1.3 kg/m2, 13.2% overweight, 49% girls) and 313 received the intervention. Relative to children in the control group (n = 201), children in the intervention group (n = 187) showed no significant increase in motor skills (delta of mean change (95% confidence interval: -0.2 (-0.8 to 0.3), p = 0.43) or in any of the secondary outcomes. Not all child care centers implemented all the intervention components. Within the intervention group, several predictors were positively associated with trial outcomes: (1) free-access to a movement space and parental information session for motor skills (2) highly motivated and trained educators for BMI (3) free-access to a movement space and purchase of mobile equipment for physical activity (all p < 0.05). This "real-life" physical activity program in child care centers confirms the complexity of implementing an intervention outside a study setting and identified potentially relevant predictors that could improve future programs. Clinical trials.gov NCT00967460.

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.

Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial.

PubMed

Tannenbaum, Cara; Martin, Philippe; Tamblyn, Robyn; Benedetti, Andrea; Ahmed, Sara

2014-06-01

The American Board of Internal Medicine Foundation Choosing Wisely Campaign recommends against the use of benzodiazepine drugs for adults 65 years and older. The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown. To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults. Cluster randomized trial (EMPOWER [Eliminating Medications Through Patient Ownership of End Results] study [2010-2012, 6-month follow-up]). Community pharmacies were randomly allocated to the intervention or control arm in nonstratified, blocked groups of 4. Participants (303 long-term users of benzodiazepine medication aged 65-95 years, recruited from 30 community pharmacies) were screened and enrolled prior to randomization: 15 pharmacies randomized to the educational intervention included 148 participants and 15 pharmacies randomized to the "wait list" control included 155 participants. Participants, physicians, pharmacists, and evaluators were blinded to outcome assessment. The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol. The control arm received usual care. Benzodiazepine therapy discontinuation at 6 months after randomization, ascertained by pharmacy medication renewal profiles. A total of 261 participants (86%) completed the 6-month follow-up. Of the recipients in the intervention group, 62% initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist. At 6 months, 27% of the intervention group had discontinued benzodiazepine use compared with 5% of the control group (risk difference, 23% [95% CI, 14%-32%]; intracluster correlation, 0.008; number needed to treat, 4). Dose reduction occurred in an additional 11% (95% CI, 6%-16%). In multivariate subanalyses, age greater than 80 years, sex, duration of use, indication for use, dose, previous attempt to taper, and concomitant polypharmacy (10 drugs or more per day) did not have a significant interaction effect with benzodiazepine therapy discontinuation. Direct-to-consumer education effectively elicits shared decision making around the overuse of medications that increase the risk of harm in older adults. clinicaltrials.gov Identifier: NCT01148186.

Parent involvement in pain management for NICU infants: a randomized controlled trial.

PubMed

Franck, Linda S; Oulton, Kate; Nderitu, Sue; Lim, Magdalene; Fang, Swee; Kaiser, Anthony

2011-09-01

To demonstrate feasibility and estimate the effect of an intervention to increase parental involvement in infant pain management in the NICU on parents' stress and postdischarge parenting competence and confidence. The study involved a randomized controlled trial. Parents recruited from 4 NICUs were randomly assigned by site to receive (1) a pain information booklet and instruction on infant comforting techniques (n = 84 intervention) in addition to a generic NICU care booklet or (2) the generic NICU care booklet alone (n = 85 control). The primary outcome was postintervention Parent Stressor Scale: NICU (PSS:NICU) scores. Secondary outcomes included parent attitudes about infant pain, nursing pain assessment, and parenting competence and role attainment after discharge. No differences were found between groups in PSS:NICU scores. Significant differences favoring the intervention group were found for satisfaction with pain information, parents shown infant pain cues and comforting techniques, nursing pain assessment, and parent preference for involvement during painful procedures. Role attainment after discharge was higher for the intervention group than for the control group. Both the intervention and control groups highly valued attention to infant pain and wanted information and involvement. These results provide no evidence of a reduction in NICU-related stress for parents who receive an intervention to increase their understanding and involvement in infant pain management. However, parents in the intervention group were better prepared to take an active role in infant pain care and had more positive views about their role attainment in the postdischarge period.

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.

A randomized comparison of online- and telephone-based care management with internet training alone in adult patients with poorly controlled type 2 diabetes.

PubMed

McMahon, Graham T; Fonda, Stephanie J; Gomes, Helen E; Alexis, George; Conlin, Paul R

2012-11-01

Care management may improve the quality of diabetes care by enhancing contact between high-risk patients and their providers. This prospective, longitudinal, randomized trial sought to investigate whether telephone or online care management improves diabetes-related outcomes over time compared with usual care supplemented with Internet access and training. One hundred fifty-one adult subjects with type 2 diabetes mellitus and an elevated hemoglobin A1c (A1c) level (≥8.5%) were randomly assigned to online care management (n=51), telephone-based care management (n=51), or Web training (n=49) groups. Online and telephone participants interacted with a care manager through a diabetes education and care management Web site and by telephone, respectively. The Web training group was provided with online diabetes self-management resources but no care management support. The primary outcome measure was A1c measured every 3 months for a year. A1c declined significantly and substantially in all groups over 12 months. A1c declined linearly at a rate of 0.32% (P<0.0001) per quarter for the online group, 0.36% (P<0.0001) for the telephone group, and 0.41% for the Web training group (P<0.0001). The rate of change over time did not differ significantly among groups. The groups converged at 12 months with average absolute A1c difference of -1.5%. The number of interactions with care providers was not significantly associated with the change in A1c. Blood pressure, weight, lipid levels, and diabetes distress did not differ among groups over time. Online, telephone-based care management, and Web training for diabetes patients with elevated A1c were each associated with a substantial improvement in A1c over a 1-year period. Internet access and training alone may be as effective as care management in patients with poorly controlled diabetes.

Structuring communication relationships for interprofessional teamwork (SCRIPT): a cluster randomized controlled trial

PubMed Central

Zwarenstein, Merrick; Reeves, Scott; Russell, Ann; Kenaszchuk, Chris; Conn, Lesley Gotlib; Miller, Karen-Lee; Lingard, Lorelei; Thorpe, Kevin E

2007-01-01

Background Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT) to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. Objectives The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. Methods The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs) in general internal medicine (GIM) divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS); adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Discussion Pre-intervention qualitative analysis revealed that a substantial amount of interprofessional interaction lacks key core elements of collaborative communication such as self-introduction, description of professional role, and solicitation of other professional perspectives. Incorporating these findings, a four-component intervention was designed with a goal of creating a culture of communication in which the fundamentals of collaboration become a routine part of interprofessional interactions during unstructured work periods on GIM wards. Trial registration Registered with National Institutes of Health as NCT00466297. PMID:17877830

Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study.

PubMed

Majumdar, S R; Johnson, J A; Bellerose, D; McAlister, F A; Russell, A S; Hanley, D A; Garg, S; Lier, D A; Maksymowych, W P; Morrish, D W; Rowe, B H

2011-01-01

Few outpatients with fractures are treated for osteoporosis in the years following fracture. In a randomized pilot study, we found a nurse case-manager could double rates of osteoporosis testing and treatment compared with a proven efficacious quality improvement strategy directed at patients and physicians (57% vs 28% rates of appropriate care). Few patients with fractures are treated for osteoporosis. An intervention directed at wrist fracture patients (education) and physicians (guidelines, reminders) tripled osteoporosis treatment rates compared to controls (22% vs 7% within 6 months of fracture). More effective strategies are needed. We undertook a pilot study that compared a nurse case-manager to the multifaceted intervention using a randomized trial design. The case-manager counseled patients, arranged bone mineral density (BMD) tests, and prescribed treatments. We included controls from our first trial who remained untreated for osteoporosis 1-year post-fracture. Primary outcome was bisphosphonate treatment and secondary outcomes were BMD testing, appropriate care (BMD test-treatment if bone mass low), and costs. Forty six patients untreated 1-year after wrist fracture were randomized to case-manager (n = 21) or multifaceted intervention (n = 25). Median age was 60 years and 68% were female. Six months post-randomization, 9 (43%) case-managed patients were treated with bisphosphonates compared with 3 (12%) multifaceted intervention patients (relative risk [RR] 3.6, 95% confidence intervals [CI] 1.1-11.5, p = 0.019). Case-managed patients were more likely than multifaceted intervention patients to undergo BMD tests (81% vs 52%, RR 1.6, 95%CI 1.1-2.4, p = 0.042) and receive appropriate care (57% vs 28%, RR 2.0, 95%CI 1.0-4.2, p = 0.048). Case-management cost was $44 (CDN) per patient vs $12 for the multifaceted intervention. A nurse case-manager substantially increased rates of appropriate testing and treatment for osteoporosis in patients at high-risk of future fracture when compared with a multifaceted quality improvement intervention aimed at patients and physicians. Even with case-management, nearly half of patients did not receive appropriate care. clinicaltrials.gov identifier: NCT00152321.

Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care.

PubMed

Francis, Nick A; Ridd, Matthew J; Thomas-Jones, Emma; Butler, Christopher C; Hood, Kerenza; Shepherd, Victoria; Marwick, Charis A; Huang, Chao; Longo, Mirella; Wootton, Mandy; Sullivan, Frank

2017-03-01

Eczema may flare because of bacterial infection, but evidence supporting antibiotic treatment is of low quality. We aimed to determine the effect of oral and topical antibiotics in addition to topical emollient and corticosteroids in children with clinically infected eczema. We employed a 3-arm, blinded, randomized controlled trial in UK ambulatory care. Children with clinical, non-severely infected eczema were randomized to receive oral and topical placebos (control), oral antibiotic (flucloxacillin) and topical placebo, or topical antibiotic (fusidic acid) and oral placebo, for 1 week. We compared Patient Oriented Eczema Measure (POEM) scores at 2 weeks using analysis of covariance (ANCOVA). We randomized 113 children (40 to control, 36 to oral antibiotic, and 37 to topical antibiotic). Mean (SD) baseline Patient Oriented Eczema Measure scores were 13.4 (5.1) for the control group, 14.6 (5.3) for the oral antibiotic group, and 16.9 (5.5) for the topical antibiotic group. At baseline, 104 children (93%) had 1 or more of the following findings: weeping, crusting, pustules, or painful skin. Mean (SD) POEM scores at 2 weeks were 6.2 (6.0) for control, 8.3 (7.3) for the oral antibiotic group, and 9.3 (6.2) for the topical antibiotic group. Controlling for baseline POEM score, neither oral nor topical antibiotics produced a significant difference in mean (95% CI) POEM scores (1.5 [-1.4 to 4.4] and 1.5 [-1.6 to 4.5] respectively). There were no significant differences in adverse effects and no serious adverse events. We found rapid resolution in response to topical steroid and emollient treatment and ruled out a clinically meaningful benefit from the addition of either oral or topical antibiotics. Children seen in ambulatory care with mild clinically infected eczema do not need treatment with antibiotics. © 2017 Annals of Family Medicine, Inc.

Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial

PubMed Central

Huirne, Judith AF; Bouwsma, Esther VA; van Dongen, Johanna M; Terwee, Caroline B; van de Ven, Peter M; den Bakker, Chantal M; van der Meij, Suzan; van Baal, W Marchien; Leclercq, Wouter KG; Geomini, Peggy MAJ; Consten, Esther CJ; Schraffordt Koops, Steven E; van Kesteren, Paul JM; Stockmann, Hein BAC; ten Cate, A Dorien; Davids, Paul HP; Scholten, Petrus C; van den Heuvel, Baukje; Schaafsma, Frederieke G; Meijerink, Wilhelmus JHJ; Bonjer, H Jaap; Anema, Johannes R

2016-01-01

Background Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. Objective With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. Methods This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. Results The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. Conclusions We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. ClinicalTrial Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy) PMID:28003177

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.

Effects of Cash and Counseling on Personal Care and Well-Being

PubMed Central

Carlson, Barbara Lepidus; Foster, Leslie; Dale, Stacy B; Brown, Randall

2007-01-01

Objective To examine how a new model of consumer-directed care changes the way that consumers with disabilities meet their personal care needs and, in turn, affects their well-being. Study Setting Eligible Medicaid beneficiaries in Arkansas, Florida, and New Jersey volunteered to participate in the demonstration and were randomly assigned to receive an allowance and direct their own Medicaid supportive services as Cash and Counseling consumers (the treatment group) or to rely on Medicaid services as usual (the control group). The demonstration included elderly and nonelderly adults in all three states and children in Florida. Data Sources Telephone interviews administered 9 months after random assignment. Methods Outcomes for the treatment and control group were compared, using regression analysis to control for consumers' baseline characteristics. Principal Findings Treatment group members were more likely to receive paid care, had greater satisfaction with their care, and had fewer unmet needs than control group members in nearly every state and age group. However, among the elderly in Florida, Cash and Counseling had little effect on these outcomes because so few treatment group members actually received the allowance. Within each state and age group, consumers were not more susceptible to adverse health outcomes or injuries under Cash and Counseling. Conclusions Cash and Counseling substantially improves the lives of Medicaid beneficiaries of all ages if consumers actually receive the allowance that the program offers. PMID:17244293

Multimedia based health information to parents in a pediatric acute ward: a randomized controlled trial.

PubMed

Botngård, Anja; Skranes, Lars P; Skranes, Jon; Døllner, Henrik

2013-12-01

To determine whether multimedia based health information presented to parents of children with breathing difficulties in a pediatric acute ward, is more effective than verbal information, to reduce parental anxiety and increase satisfaction. This randomized controlled trial was conducted in a pediatric acute ward in Norway, from January to March 2011. Parents were randomly assigned to a multimedia intervention (n=53), or verbal health information (n=48). Primary outcome measure was parental anxiety, and secondary outcome measures were parental satisfaction with nursing care and health information. Parental anxiety decreased from arrival to discharge within both groups. At discharge the anxiety levels in the intervention group were no lower than in the control group. There was no difference in satisfaction with nursing care between the groups, but parents in the intervention group reported higher satisfaction with the health information given in the acute ward (p=.005). Multimedia based health information did not reduce anxiety more than verbal information, among parents to children with breathing difficulties. However, after discharge the parents were more satisfied with the multimedia approach. More research is needed to recommend the use of multimedia based information as a routine to parents in pediatric emergency care. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Effects of resistance and functional-skills training on habitual activity and constipation among older adults living in long-term care facilities: a randomized controlled trial.

PubMed

Chin A Paw, Marijke J M; van Poppel, Mireille N M; van Mechelen, Willem

2006-07-31

Large-scale RCTs comparing different types of exercise training in institutionalised older people are scarce, especially regarding effects on habitual physical activity and constipation. This study investigated the effects of different training protocols on habitual physical activity and constipation of older adults living in long-term care facilities. A randomized controlled trial with 157 participants, aged 64 to 94 years, who were randomly assigned to 1) resistance training; 2) all-round functional-skills training; 3) both; or 4) an 'educational' control condition. Habitual physical activity was assessed with a physical activity questionnaire and accelerometers. Constipation was assessed by a questionnaire. Measurements were performed at baseline and after six months of training. At baseline the median time spent sitting was 8.2 hr/d, the median time spent on activity of at least moderate intensity was 32 min/d. At baseline, about 22% of the subjects were diagnosed with constipation and 23% were taking laxatives. There were no between-group differences for changes in habitual physical activity or constipation over 6-months. Six months of moderate intensity exercise training neither enhances habitual physical activity nor affects complaints of constipation among older people living in long-term care facilities.

A Randomized Trial of a Hepatitis Care Coordination Model in Methadone Maintenance Treatment

PubMed Central

Delucchi, Kevin L.; McKnight, Courtney; Hettema, Jennifer; Khalili, Mandana; Min, Albert; Jordan, Ashly E.; Pepper, Nicole; Hall, Jessica; Hengl, Nicholas S.; Young, Christopher; Shopshire, Michael S.; Manuel, Jennifer K.; Coffin, Lara; Hammer, Hali; Shapiro, Bradley; Seewald, Randy M.; Bodenheimer, Henry C.; Sorensen, James L.; Des Jarlais, Don C.; Perlman, David C.

2013-01-01

Objectives. We evaluated the efficacy of a hepatitis care coordination intervention to improve linkage to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and clinical evaluation of hepatitis C virus (HCV) infection among methadone maintenance patients. Methods. We conducted a randomized controlled trial of 489 participants from methadone maintenance treatment programs in San Francisco, California, and New York City from February 2008 through June 2011. We randomized participants to a control arm (n = 245) and an intervention arm (n = 244), which included on-site screening, motivational-enhanced education and counseling, on-site vaccination, and case management services. Results. Compared with the control group, intervention group participants were significantly more likely (odds ratio [OR] = 41.8; 95% confidence interval [CI] = 19.4, 90.0) to receive their first vaccine dose within 30 days and to receive an HCV evaluation within 6 months (OR = 4.10; 95% CI = 2.35, 7.17). A combined intervention adherence outcome that measured adherence to HAV–HBV vaccination, HCV evaluation, or both strongly favored the intervention group (OR = 8.70; 95% CI = 5.56, 13.61). Conclusions. Hepatitis care coordination was efficacious in increasing adherence to HAV–HBV vaccination and HCV clinical evaluation among methadone patients. PMID:23947319

Costs and Effects of an Ambulatory Geriatric Unit (the AGe-FIT Study): A Randomized Controlled Trial.

PubMed

Ekdahl, Anne W; Wirehn, Ann-Britt; Alwin, Jenny; Jaarsma, Tiny; Unosson, Mitra; Husberg, Magnus; Eckerblad, Jeanette; Milberg, Anna; Krevers, Barbro; Carlsson, Per

2015-06-01

To examine costs and effects of care based on comprehensive geriatric assessment (CGA) provided by an ambulatory geriatric care unit (AGU) in addition to usual care. Assessor-blinded, single-center randomized controlled trial. AGU in an acute hospital in southeastern Sweden. Community-dwelling individuals aged 75 years or older who had received inpatient hospital care 3 or more times in the past 12 months and had 3 or more concomitant medical diagnoses were eligible for study inclusion and randomized to the intervention group (IG; n = 208) or control group (CG; n = 174). Mean age (SD) was 82.5 (4.9) years. Participants in the IG received CGA-based care at the AGU in addition to usual care. The primary outcome was number of hospitalizations. Secondary outcomes were days in hospital and nursing home, mortality, cost of public health and social care, participant' sense of security in care, and health-related quality of life (HRQoL). Baseline characteristics did not differ between groups. The number of hospitalizations did not differ between the IG (2.1) and CG (2.4), but the number of inpatient days was lower in the IG (11.1 vs 15.2; P = .035). The IG showed trends of reduced mortality (hazard ratio 1.51; 95% confidence interval [CI] 0.988-2.310; P = .057) and an increased sense of security in care interaction. No difference in HRQoL was observed. Costs for the IG and CG were 33,371 £ (39,947 £) and 30,490 £ (31,568 £; P = .432). This study of CGA-based care was performed in an ambulatory care setting, in contrast to the greater part of studies of the effects of CGA, which have been conducted in hospital settings. This study confirms the superiority of this type of care to elderly people in terms of days in hospital and sense of security in care interaction and that a shift to more accessible care for older people with multimorbidity is possible without increasing costs. This study can aid the planning of future interventions for older people. clinicaltrials.gov identifier: NCT01446757. Copyright © 2015 AMDA - The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. 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.

Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).

PubMed

Labhardt, Niklaus Daniel; Ringera, Isaac; Lejone, Thabo Ishmael; Masethothi, Phofu; Thaanyane, T'sepang; Kamele, Mashaete; Gupta, Ravi Shankar; Thin, Kyaw; Cerutti, Bernard; Klimkait, Thomas; Fritz, Christiane; Glass, Tracy Renée

2016-04-14

Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation. This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms. This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to improve the care cascade in similar settings. NCT02692027 , registered February 21, 2016.

Effectiveness of a Technology-Based Supportive Educational Parenting Program on Parental Outcomes in Singapore: Protocol for a Randomized Controlled Trial.

PubMed

Shorey, Shefaly; Ng, Yvonne Peng Mei; Siew, An Ling; Yoong, Joanne; Mörelius, Evalotte

2018-01-10

Supportive educational programs during the perinatal period are scarce in Singapore. There is no continuity of care available in terms of support from community care nurses in Singapore. Parents are left on their own most of the time, which results in a stressful transition to parenthood. There is a need for easily accessible technology-based educational programs that can support parents during this crucial perinatal period. The aim of this study was to describe the study protocol of a randomized controlled trial on a technology-based supportive educational parenting program. A randomized controlled two-group pretest and repeated posttest experimental design will be used. The study will recruit 118 parents (59 couples) from the antenatal clinics of a tertiary public hospital in Singapore. Eligible parents will be randomly allocated to receive either the supportive educational parenting program or routine perinatal care from the hospital. Outcome measures include parenting self-efficacy, parental bonding, postnatal depression, social support, parenting satisfaction, and cost evaluation. Data will be collected at the antenatal period, immediate postnatal period, and at 1 month and 3 months post childbirth. Recruitment of the study participants commenced in December 2016 and is still ongoing. Data collection is projected to finish within 12 months, by December 2017. This study will identify a potentially clinically useful, effective, and cost-effective supportive educational parenting program to improve parental self-efficacy and bonding in newborn care, which will then improve parents' social support-seeking behaviors, emotional well-being, and satisfaction with parenting. It is hoped that better supported and satisfied parents will consider having more children, which may in turn influence Singapore's ailing birth rate. International Standard Randomized Controlled Trial Number (ISRCTN): 48536064; https://www.isrctn.com/ISRCTN48536064 (Archived by WebCite at http://www.webcitation.org/6wMuEysiO). ©Shefaly Shorey, Yvonne Peng Mei Ng, An Ling Siew, Joanne Yoong, Evalotte Mörelius. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.01.2018.

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 Mammography Screening Decision Aid for Women Aged 75 and Older: Protocol for a Cluster-randomized Controlled Trial

PubMed Central

Schonberg, Mara A; Kistler, Christine E; Nekhlyudov, Larissa; Fagerlin, Angela; Davis, Roger B; Wee, Christina C; Marcantonio, Edward R; Lewis, Carmen L; Stanley, Whitney A; Crutchfield, Trisha M.; Hamel, Mary Beth

2015-01-01

Purpose There is insufficient evidence to recommend mammography for women >75 years. Guidelines recommend that older women be informed of the uncertainty of benefit and potential for harm, especially for women with short life expectancy. However, few older women are informed of harms of screening and many with short life expectancy are screened. Therefore, we aim to test whether a mammography screening decision aid (DA) for women >75 years affects their use of mammography, particularly for women with <10 year life expectancy. Methods/Design The DA is a self-administered pamphlet that includes information on screening outcomes, tailored information on breast cancer risk, health, life expectancy, and competing mortality risks, and includes a values clarification exercise. We are conducting a large cluster randomized controlled trial (RCT) of the DA with the primary care provider (PCP) as the unit of randomization to evaluate its efficacy. We plan to recruit 550 women 75-89 years from 100 PCPs to receive either the mammography DA or a pamphlet on home safety for older adults (control arm) before a visit with their PCP, depending on their PCP's randomization assignment. The primary outcome is receipt of mammography screening assessed through chart abstraction. Secondary outcomes include effect of the DA on older women's screening intentions, knowledge, and decisional conflict, and on documented discussions about mammography by their PCPs. We will recruit women from 5 Boston-based primary care practices (3 community-based internal medicine practices and 2 academic practices), and 2 North Carolina-based academic primary care practices. Discussion It is essential that we test the DA in a large RCT to determine if it is efficacious and to substantiate the need for broad translation into clinical practice. Our DA has the potential to improve health care utilization and care in a manner dictated by patient preferences. PMID:26229741

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.

Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.

PubMed

Thiese, Matthew S; Hughes, Matthew; Biggs, Jeremy

2013-03-28

Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients. Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period. Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor. H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours). Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension. Outcome measures assessed at baseline, 1, 4, 8, and 12 weeks. Treatment failure will be defined if patient terminates assigned treatment arm for non-efficacy or undergoes invasive procedure or other excluded cointerventions. Data will be analyzed using intention-to-treat analysis and adjusted for covariates related to LBP (e.g. age) as needed. Study strengths include complex randomization, treatment group allocation concealment, double blinding, controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing for each treatment arm, and planned intention-to-treat analyses.

Pre-Visit Prioritization for Complex Patients with Diabetes: Randomized Trial Design and Implementation within an Integrated Health Care System

PubMed Central

Grant, Richard W; Uratsu, Connie S; Hansen, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-01-01

Background/Aims Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. Methods We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. Results This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015 – 6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) Navigating research vs. quality improvement requirements; (2) Addressing informed consent considerations; and (3) Introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for “self-learning health system” research. Conclusions By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. PMID:26820612

A randomized trial using telehealth technology to link caregivers with dementia care experts for in-home caregiving support: FamTechCare protocol.

PubMed

Williams, Kristine; Blyler, Diane; Vidoni, Eric D; Shaw, Clarissa; Wurth, JoEllen; Seabold, Denise; Perkhounkova, Yelena; Van Sciver, Angela

2018-06-01

The number of persons with dementia (PWD) in the United States is expected to reach 16 million by 2050. Due to the behavioral and psychological symptoms of dementia, caregivers face challenging in-home care situations that lead to a range of negative health outcomes such as anxiety and depression for the caregivers and nursing home placement for PWD. Supporting Family Caregivers with Technology for Dementia Home Care (FamTechCare) is a multisite randomized controlled trial evaluating the effects of a telehealth intervention on caregiver well-being and PWD behavioral symptoms. The FamTechCare intervention provides individualized dementia-care strategies to in-home caregivers based on video recordings that the caregiver creates of challenging care situations. A team of dementia care experts review videos submitted by caregivers and provide interventions to improve care weekly for the experimental group. Caregivers in the control group receive feedback for improving care based on a weekly phone call with the interventionist and receive feedback on their videos at the end of the 3-month study. Using linear mixed modeling, we will compare experimental and control group outcomes (PWD behavioral symptoms and caregiver burden) after 1 and 3 months. An exploratory descriptive design will identify a typology of interventions for telehealth support for in-home dementia caregivers. Finally, the cost for FamTechCare will be determined and examined in relation to hypothesized effects on PWD behavioral symptoms, placement rates, and caregiver burden. This research will provide the foundation for future research for telehealth interventions with this population, especially for families in rural or remote locations. © 2018 Wiley Periodicals, Inc.

Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system.

PubMed

Grant, Richard W; Uratsu, Connie S; Estacio, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-03-01

Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015-6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) navigating research vs. quality improvement requirements; (2) addressing informed consent considerations; and (3) introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for "self-learning health system" research. By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. Copyright © 2016 Elsevier Inc. All rights reserved.

Impact of a Web-Portal Intervention on Community ADHD Care and Outcomes.

PubMed

Epstein, Jeffery N; Kelleher, Kelly J; Baum, Rebecca; Brinkman, William B; Peugh, James; Gardner, William; Lichtenstein, Phil; Langberg, Joshua M

2016-08-01

The quality of care for children with attention-deficit/hyperactivity disorder (ADHD) delivered in community-based pediatric settings is often poor. Interventions have been developed to improve community-based ADHD care but have not demonstrated that better care results in improved patient outcomes. The objective of this study was to determine whether an ADHD quality improvement (QI) intervention for community-based pediatric practices improves patient outcomes. A cluster randomized controlled trial was conducted in which 50 community-based pediatric primary care practices (213 providers) were randomized either to receive a technology-assisted QI intervention or to a control condition. The intervention consisted of 4 training sessions, office flow modification, guided QI, and an ADHD Internet portal to assist with treatment monitoring. ADHD treatment processes and parent- and teacher-rated ADHD symptoms over the first year of treatment were collected for 577 patients. Intent-to-treat analyses examining outcomes of all children assessed for ADHD were not significant (b = -1.97, P = .08). However, among the 373 children prescribed ADHD medication, there was a significant intervention effect (b = -2.42, P = .04) indicating greater reductions in parent ratings of ADHD symptoms after treatment among patients treated by intervention physicians compared with patients treated at control practices. There were no group differences on teacher ratings of ADHD symptoms. ADHD treatment care around medication was significantly better at intervention practices compared with control practices. A technology-assisted QI intervention improved some ADHD care quality and resulted in additional reductions in parent-rated ADHD symptoms among patients prescribed ADHD medications. Copyright © 2016 by the American Academy of Pediatrics.

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.

Caring letters for suicide prevention: implementation of a multi-site randomized clinical trial in the U.S. military and Veteran Affairs healthcare systems.

PubMed

Luxton, David D; Thomas, Elissa K; Chipps, Joan; Relova, Rona M; Brown, Daphne; McLay, Robert; Lee, Tina T; Nakama, Helenna; Smolenski, Derek J

2014-03-01

Caring letters is a suicide prevention intervention that entails the sending of brief messages that espouse caring concern to patients following discharge from treatment. First tested more than four decades ago, this intervention is one of the only interventions shown in a randomized controlled trial to reduce suicide mortality rates. Due to elevated suicide risk among patients following psychiatric hospitalization and the steady increase in suicide rates among the U.S. military personnel, it is imperative to test interventions that may help prevent suicide among high-risk military personnel and veterans. This paper describes the design, methods, study protocol, and regulatory implementation processes for a multi-site randomized controlled trial that aims to evaluate the effectiveness of a caring emails intervention for suicide prevention in the military and VA healthcare systems. The primary outcome is suicide mortality rates to be determined 24 months post-discharge from index hospital stay. Healthcare re-utilization rates will also be evaluated and comprehensive data will be collected regarding suicide risk factors. Recommendations for navigating the military and VA research regulatory processes and implementing a multi-site clinical trial at military and VA hospitals are discussed. Published by Elsevier Inc.

Evaluating the Effect of Web-Based Iranian Diabetic Personal Health Record App on Self-Care Status and Clinical Indicators: Randomized Controlled Trial.

PubMed

Azizi, Amirabbas; Aboutorabi, Robab; Mazloum-Khorasani, Zahra; Afzal-Aghaea, Monavar; Tabesh, Hamed; Tara, Mahmood

2016-10-21

There are 4 main types of chronic or noncommunicable diseases. Of these, diabetes is one of the major therapeutic concerns globally. Moreover, Iran is among the countries with the highest incidence of diabetic patients. Furthermore, library-based studies by researchers have shown that thus far no study has been carried out to evaluate the relationship between Web-based diabetic personal health records (DPHR) and self-care indicators in Iran. The objective of this study is to examine the effect of Web-based DPHR on self-care status of diabetic patients in an intervention group as compared with a control group. The effect of DPHR on self-care was assessed by using a randomized controlled trial (RCT) protocol for a 2-arm parallel group with a 1:1 allocation ratio. During a 4-month trial period, the control group benefited from the routine care; the intervention group additionally had access to the Web-based DPHR app besides routine care. During the trial, 2 time points at baseline and postintervention were used to evaluate the impact of the DPHR app. A sample size of 72 people was randomly and equally assigned to both the control and intervention groups. The primary outcome measure was the self-care status of the participants. Test results showed that the self-care status in the intervention group in comparison with the control group had a significant difference. In addition, the dimensions of self-care, including normal values, changes trend, the last measured value, and the last time measured values had a significant difference while other dimensions had no significant difference. Furthermore, we found no correlation between Web-based DPHR system and covariates, including scores of weight, glycated hemoglobin (HbA1c), serum creatinine, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, and planned visit adherence, as well as the change trend of mean for blood glucose and blood pressure. We found that as a result of the Web-based DPHR app, the self-care scores in the intervention group were significantly higher than those of the control group. In total, we found no correlation between the Web-based DPHR app and covariates, including planned visit adherence, HbA1c, serum creatinine, HDL, LDL, total cholesterol, weight, and the change trend of mean for blood glucose and blood pressure. Iranian Registry of Clinical Trials (IRCT): 2013082914522N1; http://www.irct.ir/searchresult.php?id= 14522&number=1 (Archived by WebCite at http://www.webcitation.org/6cC4PCcau).

Evaluating online continuing medical education seminars: evidence for improving clinical practices.

PubMed

Weston, Christine M; Sciamanna, Christopher N; Nash, David B

2008-01-01

The purpose of this study was to evaluate the potential for online continuing medical education (CME) seminars to improve quality of care. Primary care physicians (113) participated in a randomized controlled trial to evaluate an online CME series. Physicians were randomized to view either a seminar about type 2 diabetes or a seminar about systolic heart failure. Following the seminar, physicians were presented with 4 clinical vignettes and asked to describe what tests, treatments, counseling, or referrals they would recommend. Physicians who viewed the seminars were significantly more likely to recommend guideline-consistent care to patients in the vignettes. For example, physicians who viewed the diabetes seminar were significantly more likely to order an eye exam for diabetes patients (63%) compared with physicians in the control group (27%). For some guidelines there were no group differences. These results provide early evidence of the effectiveness of online CME programs to improve physician clinical practice.

The effect of primary care interventions on children's media viewing habits and exposure to violence.

PubMed

Aragon Neely, Jill; Hudnut-Beumler, Julia; White Webb, Margaret; Chavis, Antwon; Dietrich, Mary S; Bickman, Len; Scholer, Seth J

2013-01-01

To determine if brief primary care interventions can affect children's media viewing habits and exposure to violence. English- and Spanish-speaking parents of 2- to 12-year-old children presenting to a pediatric primary care clinic participated in a randomized controlled trial. There were 2 intervention groups; one group viewed 5 minutes from the Play Nicely program and another received a handout, "Pulling the Plug on TV Violence." There were 2 control groups; the primary control group received standard primary care, and the alternative control group viewed a program about obesity prevention. The outcome measure was parental report of changes in media viewing habits and changes in exposure to violence. A total of 312 of 443 parents who were randomized completed a 2-week follow-up survey. Compared with the primary control group, parents in the video intervention group were more likely to report a change in their children's media viewing habits (odds ratio [OR] 3.29; 95% confidence interval [CI] 1.66-6.51) and a change in their children's exposure to violence (OR 4.26; 95% CI 1.95-9.27). Compared with the primary control group, parents in the handout group were more likely to report a change in their children's media viewing habits (OR 4.35; 95% CI 2.20-8.60) and a change in their children's exposure to violence (OR 3.35; 95% CI 1.52-7.35). Brief primary care interventions can affect children's media viewing habits and children's exposure to violence. These results have implications for how to improve primary care services related to decreasing children's media exposure and violence prevention. Copyright © 2013 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Improving Urban African Americans’ Blood Pressure Control through Multi-level Interventions in the Achieving Blood Pressure Control Together (ACT) Study: A Randomized Clinical Trial

PubMed Central

Ephraim, Patti L.; Hill-Briggs, Felicia; Roter, Debra; Bone, Lee; Wolff, Jennifer; Lewis-Boyer, LaPricia; Levine, David; Aboumatar, Hanan; Cooper, Lisa A; Fitzpatrick, Stephanie; Gudzune, Kimberly; Albert, Michael; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary; Fagan, Peter; Ramamurthi, Hema; Ameling, Jessica; Charlston, Jeanne; Sam, Tanyka; Carson, Kathryn A.; Wang, Nae-Yuh; Crews, Deidra; Greer, Raquel; Sneed, Valerie; Flynn, Sarah J.; DePasquale, Nicole; Boulware, L. Ebony

2014-01-01

Background Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients’ management of a variety of chronic illnesses. However, studies of multilevel interventions designed specifically to improve urban African American patients’ blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. Methods/Design We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients’ improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients’ blood pressure control at 12 months. Discussion Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients’ hypertension control. PMID:24956323

Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: a randomized clinical trial.

PubMed

Ephraim, Patti L; Hill-Briggs, Felicia; Roter, Debra L; Bone, Lee R; Wolff, Jennifer L; Lewis-Boyer, LaPricia; Levine, David M; Aboumatar, Hanan J; Cooper, Lisa A; Fitzpatrick, Stephanie J; Gudzune, Kimberly A; Albert, Michael C; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary J; Fagan, Peter J; Ramamurthi, Hema C; Ameling, Jessica M; Charlston, Jeanne; Sam, Tanyka S; Carson, Kathryn A; Wang, Nae-Yuh; Crews, Deidra C; Greer, Raquel C; Sneed, Valerie; Flynn, Sarah J; DePasquale, Nicole; Boulware, L Ebony

2014-07-01

Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. However, studies of multi-level interventions designed specifically to improve urban African American patients' blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients' improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients' blood pressure control at 12months. Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients' hypertension control. Copyright © 2014 Elsevier Inc. All rights reserved.

A Randomized Educational Intervention Trial to Determine the Effect of Online Education on the Quality of Resident-Delivered Care.

PubMed

Dolan, Brigid M; Yialamas, Maria A; McMahon, Graham T

2015-09-01

There is limited research on whether online formative self-assessment and learning can change the behavior of medical professionals. We sought to determine if an adaptive longitudinal online curriculum in bone health would improve resident physicians' knowledge, and change their behavior regarding prevention of fragility fractures in women. We used a randomized control trial design in which 50 internal medicine resident physicians at a large academic practice were randomized to either receive a standard curriculum in bone health care alone, or to receive it augmented with an adaptive, longitudinal, online formative self-assessment curriculum delivered via multiple-choice questions. Outcomes were assessed 10 months after the start of the intervention. Knowledge outcomes were measured by a multiple-choice question examination. Clinical outcomes were measured by chart review, including bone density screening rate, calculation of the fracture risk assessment tool (FRAX) score, and rate of appropriate bisphosphonate prescription. Compared to the control group, residents participating in the intervention had higher scores on the knowledge test at the end of the study. Bone density screening rates and appropriate use of bisphosphonates were significantly higher in the intervention group compared with the control group. FRAX score reporting did not differ between the groups. Residents participating in a novel adaptive online curriculum outperformed peers in knowledge of fragility fracture prevention and care practices to prevent fracture. Online adaptive education can change behavior to improve patient care.

A Randomized Educational Intervention Trial to Determine the Effect of Online Education on the Quality of Resident-Delivered Care

PubMed Central

Dolan, Brigid M.; Yialamas, Maria A.; McMahon, Graham T.

2015-01-01

Background There is limited research on whether online formative self-assessment and learning can change the behavior of medical professionals. Objective We sought to determine if an adaptive longitudinal online curriculum in bone health would improve resident physicians' knowledge, and change their behavior regarding prevention of fragility fractures in women. Methods We used a randomized control trial design in which 50 internal medicine resident physicians at a large academic practice were randomized to either receive a standard curriculum in bone health care alone, or to receive it augmented with an adaptive, longitudinal, online formative self-assessment curriculum delivered via multiple-choice questions. Outcomes were assessed 10 months after the start of the intervention. Knowledge outcomes were measured by a multiple-choice question examination. Clinical outcomes were measured by chart review, including bone density screening rate, calculation of the fracture risk assessment tool (FRAX) score, and rate of appropriate bisphosphonate prescription. Results Compared to the control group, residents participating in the intervention had higher scores on the knowledge test at the end of the study. Bone density screening rates and appropriate use of bisphosphonates were significantly higher in the intervention group compared with the control group. FRAX score reporting did not differ between the groups. Conclusions Residents participating in a novel adaptive online curriculum outperformed peers in knowledge of fragility fracture prevention and care practices to prevent fracture. Online adaptive education can change behavior to improve patient care. PMID:26457142

Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial.

PubMed

Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W

2015-04-01

Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

A randomized, controlled trial of disability prevention in frail older patients screened in primary care: the FRASI study. Design and baseline evaluation.

PubMed

Bandinelli, Stefania; Lauretani, Fulvio; Boscherini, Vittorio; Gandi, Francesca; Pozzi, Martina; Corsi, Anna Maria; Bartali, Benedetta; Lova, Raffaello Molino; Guralnik, Jack M; Ferrucci, Luigi

2006-10-01

We describe the enrollment and intervention phases of FRASI (FRAilty, Screening and Intervention), a randomized controlled trial aimed at preventing ADL disability in frail older persons screened in primary care. Patients, 70-85 years old, non-disabled and noncognitively impaired, were screened for frailty (score < or = 9 on the Short Physical Performance Battery, SPPB) during primary care visits. Of 447 eligible persons, 410 came to the study clinic and 251 were randomized into treatment (n=126) and control groups (n=125). The active group received an intensive medical intervention, and sixteen 90-minute supervised exercise sessions over 8 weeks. The primary outcome was time to ADL disability onset or death in the 12-month period after study enrollment. The two study arms were similar for demographics, cognitive function, physical function and health status. Compared with a population-based sample selected according to FRASI inclusion criteria except SPPB score, FRASI participants had significantly worse health and functional status. Restricting the comparison to persons with SPPB < or = 9, all differences disappeared. The 99 participants (78.6% of 126) who completed the intervention participated in a mean of 15.3+/-1.6 exercise sessions. Screening in primary care for non-disabled, older persons with SPPB < or = 9 yields individuals with substantial morbidity, impairments and functional limitations that can be successfully involved in an intensive medical and exercise intervention. Whether such an intervention effectively prevents new disability remains to be confirmed.

Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1.

PubMed

Jansen, Jeroen P; Fleurence, Rachael; Devine, Beth; Itzler, Robbin; Barrett, Annabel; Hawkins, Neil; Lee, Karen; Boersma, Cornelis; Annemans, Lieven; Cappelleri, Joseph C

2011-06-01

Evidence-based health-care decision making requires comparisons of all relevant competing interventions. In the absence of randomized, controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best choice(s) of treatment. Mixed treatment comparisons, a special case of network meta-analysis, combine direct and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than a traditional meta-analysis. This report from the ISPOR Indirect Treatment Comparisons Good Research Practices Task Force provides guidance on the interpretation of indirect treatment comparisons and network meta-analysis to assist policymakers and health-care professionals in using its findings for decision making. We start with an overview of how networks of randomized, controlled trials allow multiple treatment comparisons of competing interventions. Next, an introduction to the synthesis of the available evidence with a focus on terminology, assumptions, validity, and statistical methods is provided, followed by advice on critically reviewing and interpreting an indirect treatment comparison or network meta-analysis to inform decision making. We finish with a discussion of what to do if there are no direct or indirect treatment comparisons of randomized, controlled trials possible and a health-care decision still needs to be made. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Maternal and Child Health Handbook use for maternal and child care: a cluster randomized controlled study in rural Java, Indonesia.

PubMed

Osaki, Keiko; Hattori, Tomoko; Toda, Akemi; Mulati, Erna; Hermawan, Lukas; Pritasari, Kirana; Bardosono, Saptawati; Kosen, Soewarta

2018-01-09

Effectiveness of the Maternal and Child Health Handbook (MCHHB), a home-based booklet for pregnancy, delivery and postnatal/child health, was evaluated on care acquisition and home care in rural Java, a low service-coverage area. We conducted a health centre-based randomized trial, with a 2-year follow-up. Intervention included (i) MCHHB provision at antenatal care visits; (ii) records and guides by health personnel on and with the MCHHB; and (iii) sensitization of care by volunteers using the MCHHB. The follow-up rate was 70.2% (183, intervention area; 271, control area). Respondents in the intervention area received consecutive MCH services including two doses of tetanus toxoid injections and antenatal care four times or more during pregnancy, professional assistance during child delivery and vitamin A supplements administration to their children, after adjustment for confounding variables and cluster effects (OR = 2.03, 95% CI: 1.19-3.47). In the intervention area, home care (continued breastfeeding; introducing complementary feeding; proper feeding order; varied foods feeding; self-feeding training; and care for cough), perceived support by husbands, and lower underweight rates and stunting rates among children were observed. MCHHB use promoted continuous care acquisition and care at home from pregnancy to early child-rearing stages in rural Java. © The Author(s) 2018. Published by Oxford University Press on behalf of Faculty of Public Health.

Head Start’s Impact is Contingent on Alternative Type of Care in Comparison Group

PubMed Central

Brooks-Gunn, Jeanne; Waldfogel, Jane

2014-01-01

Using data (n = 3,790 with 2,119 in the 3-year-old cohort and 1,671 in the 4-year-old cohort) from 353 Head Start centers in the Head Start Impact Study, the only large-scale randomized experiment in Head Start history, this paper examined the impact of Head Start on children’s cognitive and parent-reported social-behavioral outcomes through first grade contingent on the child care arrangements used by children who were randomly assigned to the control group (i.e., parental care, relative/non-relative care, another Head Start program, or other center-based care). A principal score matching approach was adopted to identify children assigned to Head Start who were similar to children in the control group with a specific care arrangement. Overall, the results showed that the effects of Head Start varied substantially contingent on the alternative child care arrangements. Compared to children in parental care and relative/non-relative care, Head Start participants generally had better cognitive and parent-reported behavioral development, with some benefits of Head Start persisting through first grade; in contrast, few differences were found between Head Start and other center-based care. The results have implications regarding the children for whom Head Start is most beneficial as well as how well Head Start compares to other center-based programs. PMID:25329552

Increasing older adults’ walking through primary care: results of a pilot randomized controlled trial

PubMed Central

Mutrie, Nanette

2012-01-01

Background. Physical activity can positively influence health for older adults. Primary care is a good setting for physical activity promotion. Objective. To assess the feasibility of a pedometer-based walking programme in combination with physical activity consultations. Methods. Design: Two-arm (intervention/control) 12-week randomized controlled trial with a 12-week follow-up for the intervention group. Setting: One general practice in Glasgow, UK. Participants: Participants were aged ≥65 years. The intervention group received two 30-minute physical activity consultations from a trained practice nurse, a pedometer and a walking programme. The control group continued as normal for 12 weeks and then received the intervention. Both groups were followed up at 12 and 24 weeks. Outcome measures: Step counts were measured by sealed pedometers and an activPALTM monitor. Psychosocial variables were assessed and focus groups conducted. Results. The response rate was 66% (187/284), and 90% of those randomized (37/41) completed the study. Qualitative data suggested that the pedometer and nurse were helpful to the intervention. Step counts (activPAL) showed a significant increase from baseline to week 12 for the intervention group, while the control group showed no change. Between weeks 12 and 24, step counts were maintained in the intervention group, and increased for the control group after receiving the intervention. The intervention was associated with improved quality of life and reduced sedentary time. Conclusions. It is feasible to recruit and retain older adults from primary care and help them increase walking. A larger trial is necessary to confirm findings and consider cost-effectiveness. PMID:22843637

Cloud-based BP system integrated with CPOE improves self-management of the hypertensive patients: A randomized controlled trial.

PubMed

Lee, Peisan; Liu, Ju-Chi; Hsieh, Ming-Hsiung; Hao, Wen-Rui; Tseng, Yuan-Teng; Liu, Shuen-Hsin; Lin, Yung-Kuo; Sung, Li-Chin; Huang, Jen-Hung; Yang, Hung-Yu; Ye, Jong-Shiuan; Zheng, He-Shun; Hsu, Min-Huei; Syed-Abdul, Shabbir; Lu, Richard; Nguyen, Phung-Anh; Iqbal, Usman; Huang, Chih-Wei; Jian, Wen-Shan; Li, Yu-Chuan Jack

2016-08-01

Less than 50% of patients with hypertensive disease manage to maintain their blood pressure (BP) within normal levels. The aim of this study is to evaluate whether cloud BP system integrated with computerized physician order entry (CPOE) can improve BP management as compared with traditional care. A randomized controlled trial done on a random sample of 382 adults recruited from 786 patients who had been diagnosed with hypertension and receiving treatment for hypertension in two district hospitals in the north of Taiwan. Physicians had access to cloud BP data from CPOE. Neither patients nor physicians were blinded to group assignment. The study was conducted over a period of seven months. At baseline, the enrollees were 50% male with a mean (SD) age of 58.18 (10.83) years. The mean sitting BP of both arms was no different. The proportion of patients with BP control at two, four and six months was significantly greater in the intervention group than in the control group. The average capture rates of blood pressure in the intervention group were also significantly higher than the control group in all three check-points. Cloud-based BP system integrated with CPOE at the point of care achieved better BP control compared to traditional care. This system does not require any technical skills and is therefore suitable for every age group. The praise and assurance to the patients from the physicians after reviewing the Cloud BP records positively reinforced both BP measuring and medication adherence behaviors. Copyright © 2016. Published by Elsevier Ireland Ltd.

Evaluation of a bibliotherapy manual for reducing psychological distress in people with depression: a randomized controlled trial.

PubMed

Songprakun, Wallapa; McCann, Terence V

2012-12-01

This article reports a study to evaluate the efficacy of a self-help manual in reducing psychological distress in individuals with moderate depression. The prevalence of depression in Thailand is increasing markedly (e.g. from 56-197 per 100,000 population between 1997-2007). We conducted a randomized controlled trial with 54 outpatients with depression in Chiang Mai Province in Thailand. Participants were assigned randomly to an intervention or control group. The intervention group participants were given a self-help manual in addition to standard care and treatment while the control group received standard care and treatment. Psychological distress was measured with the Kessler Psychological Distress Scale. Data were collected between October 2007-April 2008. The findings showed statistically significant differences between both groups in their levels of psychological distress (e.g. tiredness, hopelessness, restlessness). At post-test, the distress scores of the intervention group were lower than those in the control group. Between post-test and 1-month follow-up, distress scores continued to decrease steadily in the intervention group but only decreased slightly in the control group. The findings affirm the benefits of bibliotherapy or self-help therapy in book form in helping to reduce psychological distress in people with moderate depression. The approach is easy to use and can be incorporated as an adjunct to standard care and treatment. Bibliotherapy can be used by community mental health nurses and other clinicians to reduce psychological distress and promote recovery in people with moderate depression. © 2012 Blackwell Publishing Ltd.

A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial.

PubMed

Black, Jeanne T; Romano, Patrick S; Sadeghi, Banafsheh; Auerbach, Andrew D; Ganiats, Theodore G; Greenfield, Sheldon; Kaplan, Sherrie H; Ong, Michael K

2014-04-13

Heart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure. A multi-center, randomized controlled trial is being conducted at six academic health systems in California. A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure. Patients in the intervention group will receive intensive patient education using the 'teach-back' method and receive instruction in using the telemonitoring equipment. Following hospital discharge, they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also will call patients and patients' physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. The primary outcome is readmission for any cause within 180 days. Secondary outcomes include 30-day readmission, mortality, hospital days, emergency department (ED) visits, hospital cost, and health-related quality of life. BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics. Once completed, the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure. ClinicalTrials.gov # NCT01360203.

Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial.

PubMed

Chester, Stephen J; Stockton, Kellie; De Young, Alexandra; Kipping, Belinda; Tyack, Zephanie; Griffin, Bronwyn; Chester, Ralph L; Kimble, Roy M

2016-04-29

Burns and the associated wound care procedures can be extremely painful and anxiety-provoking for children. Burn injured children and adolescents are therefore at greater risk of experiencing a range of psychological reactions, in particular posttraumatic stress disorder, which can persist for months to years after the injury. Non-pharmacological intervention is critical for comprehensive pain and anxiety management and is used alongside pharmacological analgesia and anxiolysis. However, effective non-pharmacological pain and anxiety management during pediatric burn procedures is an area still needing improvement. Medical hypnosis has received support as a technique for effectively decreasing pain and anxiety levels in adults undergoing burn wound care and in children during a variety of painful medical procedures (e.g., bone marrow aspirations, lumbar punctures, voiding cystourethrograms, and post-surgical pain). Pain reduction during burn wound care procedures is linked with improved wound healing rates. To date, no randomized controlled trials have investigated the use of medical hypnosis in pediatric burn populations. Therefore this study aims to determine if medical hypnosis decreases pain, anxiety, and biological stress markers during wound care procedures; improves wound healing times; and decreases rates of traumatic stress reactions in pediatric burn patients. This is a single-center, superiority, parallel-group, prospective randomized controlled trial. Children (4 to 16 years, inclusive) with acute burn injuries presenting for their first dressing application or change are randomly assigned to either the (1) intervention group (medical hypnosis) or (2) control group (standard care). A minimum of 33 participants are recruited for each treatment group. Repeated measures of pain, anxiety, stress, and wound healing are taken at every dressing change until ≥95 % wound re-epithelialization. Further data collection assesses impact on posttraumatic stress symptomatology, speed of wound healing, and parent perception of how easy the dressing change is for their child. Study results will elucidate whether the disease process can be changed by using medical hypnosis with children to decrease pain, anxiety, and stress in the context of acute burn wounds. Australian New Zealand Clinical Trials Registry ACTRN12615000419561.

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

PubMed

Deschamps, Alain; Hall, Richard; Grocott, Hilary; Mazer, C David; Choi, Peter T; Turgeon, Alexis F; de Medicis, Etienne; Bussières, Jean S; Hudson, Christopher; Syed, Summer; Seal, Doug; Herd, Stuart; Lambert, Jean; Denault, André; Deschamps, Alain; Mutch, Alan; Turgeon, Alexis; Denault, Andre; Todd, Andrea; Jerath, Angela; Fayad, Ashraf; Finnegan, Barry; Kent, Blaine; Kennedy, Brent; Cuthbertson, Brian H; Kavanagh, Brian; Warriner, Brian; MacAdams, Charles; Lehmann, Christian; Fudorow, Christine; Hudson, Christopher; McCartney, Colin; McIsaac, Dan; Dubois, Daniel; Campbell, David; Mazer, David; Neilpovitz, David; Rosen, David; Cheng, Davy; Drapeau, Dennis; Dillane, Derek; Tran, Diem; Mckeen, Dolores; Wijeysundera, Duminda; Jacobsohn, Eric; Couture, Etienne; de Medicis, Etienne; Alam, Fahad; Abdallah, Faraj; Ralley, Fiona E; Chung, Frances; Lellouche, Francois; Dobson, Gary; Germain, Genevieve; Djaiani, George; Gilron, Ian; Hare, Gregory; Bryson, Gregory; Clarke, Hance; McDonald, Heather; Roman-Smith, Helen; Grocott, Hilary; Yang, Homer; Douketis, James; Paul, James; Beaubien, Jean; Bussières, Jean; Pridham, Jeremy; Armstrong, J N; Parlow, Joel; Murkin, John; Gamble, Jonathan; Duttchen, Kaylene; Karkouti, Keyvan; Turner, Kim; Baghirzada, Leyla; Szabo, Linda; Lalu, Manoj; Wasowicz, Marcin; Bautista, Michael; Jacka, Michael; Murphy, Michael; Schmidt, Michael; Verret, Michaël; Perrault, Michel-Antoine; Beaudet, Nicolas; Buckley, Norman; Choi, Peter; MacDougall, Peter; Jones, Philip; Drolet, Pierre; Beaulieu, Pierre; Taneja, Ravi; Martin, Rene; Hall, Richard; George, Ronald; Chun, Rosa; McMullen, Sarah; Beattie, Scott; Sampson, Sonia; Choi, Stephen; Kowalski, Stephen; McCluskey, Stuart; Syed, Summer; Boet, Sylvain; Ramsay, Tim; Saha, Tarit; Mutter, Thomas; Chowdhury, Tumul; Uppal, Vishal; Mckay, William

2016-04-01

Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

Effects of enterostomal nurse telephone follow-up on postoperative adjustment of discharged colostomy patients.

PubMed

Zhang, Jun-e; Wong, Frances Kam Yuet; You, Li-ming; Zheng, Mei-chun; Li, Qiong; Zhang, Bing-yan; Huang, Man-rong; Ye, Xin-Mei; Liang, Ming-juan; Liu, Jin-ling

2013-01-01

People with a new colostomy encounter many difficulties as they struggle to adjust to their ostomies. Nurse telephone follow-up is a convenient way to ensure continuity of care. There is a paucity of studies testing if nurse telephone follow-up can enhance adjustment of postdischarged colostomy patients. The purpose of this study was to evaluate the effect of enterostomal nurse telephone follow-up on the adjustment levels of discharged colostomy patients. This was a randomized controlled trial. Participants (n = 103) who had undergone colostomy operations in China were recruited and randomly assigned to the study or control group. Both the study and control groups received routine discharge care, whereas the study group received 2-3 nurse telephone calls in the follow-up period. The outcome measures included Ostomy Adjustment Scale, Stoma Self-efficacy Scale, satisfaction with care, and stoma complications. Results of this study indicated that participants in the study group had significantly better ostomy adjustment, higher stoma self-efficacy, higher satisfaction with care, and less stoma complications compared with those in the control group. This study provided evidence to support that enterostomal nurse telephone follow-up can improve patient ostomy adjustment level and other related outcomes. Nurse telephone follow-up is an effective intervention to support the adjustment of stoma patients after hospital discharge.

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.

KMC facilitates mother baby attachment in low birth weight infants.

PubMed

Gathwala, Geeta; Singh, Bir; Balhara, Bharti

2008-01-01

To determine whether Kangaroo mother care (KMC) facilitates mother baby attachment in low birth weight infants. Over 16 month period 110 neonates were randomized into kangaroo mother care group and control group using a random number table. The kangaroo group was subjected to Kangaroo mother care for at least 6 hours per day. The babies also received kangaroo care after shifting out from NICU and at home. The control group received standard care (incubator or open care system). After 3 months followup, structured maternal interview was conducted to assess attachment between mothers and their babies. Mean birth weight was 1.69 +/- 0.11 Kg in KMC group compared to 1.690 +/- 0.12 Kg in control group (p>0.05). Mean gestational age was 35.48 +/- 1.20 week in KMC group and 35.04+/-1.09 week in the control group (p>0.05). KMC was initiated at a mean age of 1.72+/-0.45 days. The duration of KMC in first month was 10.21+/-1.50 hour, in the 2nd month was 10.03+/-1.57 hour and in the 3rd month was 8.97+/-1.37 hours. The duration of hospital stay was significantly shorter in the KMC group (3.56+/-0.57 days) compared to control group (6.80+/-1.30 days). The total attachment score (24.46+/-1.64) in the KMC group was significantly higher than that obtained in control group (18.22+/-1.79, p< 0.001). In KMC group, mother was more often the main caretaker of the baby. Mothers were significantly more involved in care taking activities like bathing, diapering, sleeping with their babies and spent more time beyond usual care taking. They went out without their babies less often and only for unavoidable reasons. They derived greater pleasure from their babies. KMC facilitates mother baby attachment in low birth weight infants.

Effect of a facility-based multifaceted intervention on the quality of obstetrical care: a cluster randomized controlled trial in Mali and Senegal

PubMed Central

2013-01-01

Background Maternal mortality in referral hospitals in Mali and Senegal surpasses 1% of obstetrical admissions. Poor quality obstetrical care contributes to high maternal mortality; however, poor care is often linked to insufficient hospital resources. One promising method to improve obstetrical care is maternal death review. With a cluster randomized trial, we assessed whether an intervention, based on maternal death review, could improve obstetrical quality of care. Methods The trial began with a pre-intervention year (2007), followed by two years of intervention activities and a post-intervention year. We measured obstetrical quality of care in the post-intervention year using a criterion-based clinical audit (CBCA). We collected data from 32 of the 46 trial hospitals (16 in each trial arm) and included 658 patients admitted to the maternity unit with a trial of labour. The CBCA questionnaire measured 5 dimensions of care- patient history, clinical examination, laboratory examination, delivery care and postpartum monitoring. We used adjusted mixed models to evaluate differences in CBCA scores by trial arms and examined how levels of hospital human and material resources affect quality of care differences associated with the intervention. Results For all women, the mean percentage of care criteria met was 66.3 (SD 13.5). There were significantly greater mean CBCA scores in women treated at intervention hospitals (68.2) compared to control hospitals (64.5). After adjustment, women treated at intervention sites had 5 points’ greater scores than those at control sites. This difference was mostly attributable to greater clinical examination and post-partum monitoring scores. The association between the intervention and quality of care was the same, irrespective of the level of resources available to a hospital; however, as resources increased, so did quality of care scores in both arms of the trial. Trial registration The QUARITE trial is registered on the Current Controlled Trials website under ISRCTN46950658 PMID:23351269

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.

Involvements of Parents in the Care of Preterm Infants: A Pilot Study Evaluating a Family-Centered Care Intervention in a Chinese Neonatal ICU.

PubMed

Zhang, Rong; Huang, Rui-Wena; Gao, Xi-Ronga; Peng, Xiao-Minga; Zhu, Li-Hui; Rangasamy, Ramanathan; Latour, Jos M

2018-05-17

To evaluate the effectiveness and safety of a family-centered care intervention in a Chinese neonatal ICU. Pilot study using a randomized controlled trial design to inform a main randomized controlled trial study. Stand-alone tertiary children's hospital in China with a 60-bed neonatal ICU serving as a regional neonatal ICU center. Premature infants (n = 61) and their parents (n = 110). Parent education program followed by parents' participation in care as primary caregiver until discharge for a minimum of 4 hours per day. Primary outcomes were infants' weight gain at discharge, length of stay, and readmission. Parental outcomes were stress, anxiety, satisfaction, and clinical knowledge. Infants in family-centered care group (n = 31) had higher weight gain (886g vs 542g; p = 0.013), less neonatal ICU length of stay in days (43 vs 46; p = 0.937), and decreased readmission rate at 1 week (41.9 vs 70.0; p = 0.045) and at 1 month (6.5% vs 50%; p < 0.001) compared with the control group (n = 30). Total Mean Parental Stress and Anxiety scores were lower in the family-centered care group (42 vs 59; p ≤ 0.007), mean satisfaction rates in family-centered care group were higher compared with control group (96 vs 90; p < 0.001), and parents in the family-centered care group had better educational outcomes related to neonatal specialized care skills (p < 0.05). Involving parents in the care of their infant improved clinical outcomes of infants. Family-centered care also contributed to a better understanding of parent's clinical education, decrease stress levels, and increased parental satisfaction. Our study suggests that involving parents in the daily care of their infants is feasible and should be promoted by neonatal ICU clinicians.

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.

Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial.

PubMed

Goertz, Christine M; Salsbury, Stacie A; Long, Cynthia R; Vining, Robert D; Andresen, Andrew A; Hondras, Maria A; Lyons, Kevin J; Killinger, Lisa Z; Wolinsky, Fredric D; Wallace, Robert B

2017-10-13

Low back pain is a debilitating condition for older adults, who may seek healthcare from multiple providers. Few studies have evaluated impacts of different healthcare delivery models on back pain outcomes in this population. The purpose of this study was to compare clinical outcomes of older adults receiving back pain treatment under 3 professional practice models that included primary medical care with or without chiropractic care. We conducted a pilot randomized controlled trial with 131 community-dwelling, ambulatory older adults with subacute or chronic low back pain. Participants were randomly allocated to 12 weeks of individualized primary medical care (Medical Care), concurrent medical and chiropractic care (Dual Care), or medical and chiropractic care with enhanced interprofessional collaboration (Shared Care). Primary outcomes were low back pain intensity rated on the numerical rating scale and back-related disability measured with the Roland-Morris Disability Questionnaire. Secondary outcomes included clinical measures, adverse events, and patient satisfaction. Statistical analyses included mixed-effects regression models and general estimating equations. At 12 weeks, participants in all three treatment groups reported improvements in mean average low back pain intensity [Shared Care: 1.8; 95% confidence interval (CI) 1.0 to 2.6; Dual Care: 3.0; 95% CI 2.3 to 3.8; Medical Care: 2.3; 95% CI 1.5 to 3.2)] and back-related disability (Shared Care: 2.8; 95% CI 1.6 to 4.0; Dual Care: 2.5; 95% CI 1.3 to 3.7; Medical Care: 1.5; 95% CI 0.2 to 2.8). No statistically significant differences were noted between the three groups on the primary measures. Participants in both models that included chiropractic reported significantly better perceived low back pain improvement, overall health and quality of life, and greater satisfaction with healthcare services than patients who received medical care alone. Professional practice models that included primary care and chiropractic care led to modest improvements in low back pain intensity and disability for older adults, with chiropractic-inclusive models resulting in better perceived improvement and patient satisfaction over the primary care model alone. Clinicaltrials.gov, NCT01312233 , 4 March 2011.

The effect of foot massage on long-term care staff working with older people with dementia: a pilot, parallel group, randomized controlled trial.

PubMed

Moyle, Wendy; Cooke, Marie; O'Dwyer, Siobhan T; Murfield, Jenny; Johnston, Amy; Sung, Billy

2013-02-18

Caring for a person with dementia can be physically and emotionally demanding, with many long-term care facility staff experiencing increased levels of stress and burnout. Massage has been shown to be one way in which nurses' stress can be reduced. However, no research has been conducted to explore its effectiveness for care staff working with older people with dementia in long-term care facilities. This was a pilot, parallel group, randomized controlled trial aimed at exploring feasibility for a larger randomized controlled trial. Nineteen staff, providing direct care to residents with dementia and regularly working ≥ two day-shifts a week, from one long-term care facility in Queensland (Australia), were randomized into either a foot massage intervention (n=9) or a silent resting control (n=10). Each respective session lasted for 10-min, and participants could receive up to three sessions a week, during their allocated shift, over four-weeks. At pre- and post-intervention, participants were assessed on self-report outcome measures that rated mood state and experiences of working with people with dementia. Immediately before and after each intervention/control session, participants had their blood pressure and anxiety measured. An Intention To Treat framework was applied to the analyses. Individual qualitative interviews were also undertaken to explore participants' perceptions of the intervention. The results indicate the feasibility of undertaking such a study in terms of: recruitment; the intervention; timing of intervention; and completion rates. A change in the intervention indicated the importance of a quiet, restful environment when undertaking a relaxation intervention. For the psychological measures, although there were trends indicating improvement in mood there was no significant difference between groups when comparing their pre- and post- scores. There were significant differences between groups for diastolic blood pressure (p= 0.04, partial η2=0.22) and anxiety (p= 0.02, partial η2=0.31), with the foot massage group experiencing greatest decreases immediately after the session. The qualitative interviews suggest the foot massage was well tolerated and although taking staff away from their work resulted in some participants feeling guilty about taking time out, a 10-min foot massage was feasible during a working shift. This pilot trial provides data to support the feasibility of the study in terms of recruitment and consent, the intervention and completion rates. Although the outcome data should be treated with caution, the pilot demonstrated the foot massage intervention showed trends in improved mood, reduced anxiety and lower blood pressure in long-term care staff working with older people with dementia. A larger study is needed to build on these promising, but preliminary, findings. ACTRN: ACTRN12612000659808.

Mobile phones improve antenatal care attendance in Zanzibar: a cluster randomized controlled trial

PubMed Central

2014-01-01

Background Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems. Antenatal care has the potential to reduce maternal morbidity and improve newborns’ survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining. We evaluated the association between a mobile phone intervention and antenatal care in a resource-limited setting. We aimed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy. Methods This study was an open label pragmatic cluster-randomised controlled trial with primary healthcare facilities in Zanzibar as the unit of randomisation. 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery. 24 primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text-message and voucher component. Primary outcome measure was four or more antenatal care visits during pregnancy. Secondary outcome measures were tetanus vaccination, preventive treatment for malaria, gestational age at last antenatal care visit, and antepartum referral. Results The mobile phone intervention was associated with an increase in antenatal care attendance. In the intervention group 44% of the women received four or more antenatal care visits versus 31% in the control group (OR, 2.39; 95% CI, 1.03-5.55). There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant. Conclusions The wired mothers’ mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care visits during pregnancy and there was a trend towards improved quality of care with more women receiving preventive health services, more women attending antenatal care late in pregnancy and more women with antepartum complications identified and referred. Mobile phone applications may contribute towards improved maternal and newborn health and should be considered by policy makers in resource-limited settings. Trial registration ClinicalTrials.gov, NCT01821222. PMID:24438517

[The OPTIMISE study (Optimal Type 2 Diabetes Management Including Benchmarking and Standard Treatment]. Results for Luxembourg].

PubMed

Michel, G

2012-01-01

The OPTIMISE study (NCT00681850) has been run in six European countries, including Luxembourg, to prospectively assess the effect of benchmarking on the quality of primary care in patients with type 2 diabetes, using major modifiable vascular risk factors as critical quality indicators. Primary care centers treating type 2 diabetic patients were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). Primary endpoint was percentage of patients in the benchmarking group achieving pre-set targets of the critical quality indicators: glycated hemoglobin (HbAlc), systolic blood pressure (SBP) and low-density lipoprotein (LDL) cholesterol after 12 months follow-up. In Luxembourg, in the benchmarking group, more patients achieved target for SBP (40.2% vs. 20%) and for LDL-cholesterol (50.4% vs. 44.2%). 12.9% of patients in the benchmarking group met all three targets compared with patients in the control group (8.3%). In this randomized, controlled study, benchmarking was shown to be an effective tool for improving critical quality indicator targets, which are the principal modifiable vascular risk factors in diabetes type 2.

Cognitive recovery in socially deprived young children: the Bucharest Early Intervention Project.

PubMed

Nelson, Charles A; Zeanah, Charles H; Fox, Nathan A; Marshall, Peter J; Smyke, Anna T; Guthrie, Donald

2007-12-21

In a randomized controlled trial, we compared abandoned children reared in institutions to abandoned children placed in institutions but then moved to foster care. Young children living in institutions were randomly assigned to continued institutional care or to placement in foster care, and their cognitive development was tracked through 54 months of age. The cognitive outcome of children who remained in the institution was markedly below that of never-institutionalized children and children taken out of the institution and placed into foster care. The improved cognitive outcomes we observed at 42 and 54 months were most marked for the youngest children placed in foster care. These results point to the negative sequelae of early institutionalization, suggest a possible sensitive period in cognitive development, and underscore the advantages of family placements for young abandoned children.

Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project.

PubMed

Fisher, Jeffrey D; Amico, K Rivet; Fisher, William A; Cornman, Deborah H; Shuper, Paul A; Trayling, Cynthia; Redding, Caroline; Barta, William; Lemieux, Anthony F; Altice, Frederick L; Dieckhaus, Kevin; Friedland, Gerald

2011-11-01

We evaluated the efficacy of LifeWindows, a theory-based, computer-administered antiretroviral (ARV) therapy adherence support intervention, delivered to HIV + patients at routine clinical care visits. 594 HIV + adults receiving HIV care at five clinics were randomized to intervention or control arms. Intervention vs. control impact in the intent-to-treat sample (including participants whose ARVs had been entirely discontinued, who infrequently attended care, or infrequently used LifeWindows) did not reach significance. Intervention impact in the On Protocol sample (328 intervention and control arm participants whose ARVs were not discontinued, who attended care and were exposed to LifeWindows regularly) was significant. On Protocol intervention vs. control participants achieved significantly higher levels of perfect 3-day ACTG-assessed adherence over time, with sensitivity analyses maintaining this effect down to 70% adherence. This study supports the utility of LifeWindows and illustrates that patients on ARVs who persist in care at clinical care sites can benefit from adherence promotion software.

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.

Did a quality improvement collaborative make stroke care better? A cluster randomized trial

PubMed Central

2014-01-01

Background Stroke can result in death and long-term disability. Fast and high-quality care can reduce the impact of stroke, but UK national audit data has demonstrated variability in compliance with recommended processes of care. Though quality improvement collaboratives (QICs) are widely used, whether a QIC could improve reliability of stroke care was unknown. Methods Twenty-four NHS hospitals in the Northwest of England were randomly allocated to participate either in Stroke 90:10, a QIC based on the Breakthrough Series (BTS) model, or to a control group giving normal care. The QIC focused on nine processes of quality care for stroke already used in the national stroke audit. The nine processes were grouped into two distinct care bundles: one relating to early hours care and one relating to rehabilitation following stroke. Using an interrupted time series design and difference-in-difference analysis, we aimed to determine whether hospitals participating in the QIC improved more than the control group on bundle compliance. Results Data were available from nine interventions (3,533 patients) and nine control hospitals (3,059 patients). Hospitals in the QIC showed a modest improvement from baseline in the odds of average compliance equivalent to a relative improvement of 10.9% (95% CI 1.3%, 20.6%) in the Early Hours Bundle and 11.2% (95% CI 1.4%, 21.5%) in the Rehabilitation Bundle. Secondary analysis suggested that some specific processes were more sensitive to an intervention effect. Conclusions Some aspects of stroke care improved during the QIC, but the effects of the QIC were modest and further improvement is needed. The extent to which a BTS QIC can improve quality of stroke care remains uncertain. Some aspects of care may respond better to collaboratives than others. Trial registration ISRCTN13893902. PMID:24690267

A randomized trial of a primary care-based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes.

PubMed

Rothman, Russell L; Malone, Robb; Bryant, Betsy; Shintani, Ayumi K; Crigler, Britton; Dewalt, Darren A; Dittus, Robert S; Weinberger, Morris; Pignone, Michael P

2005-03-01

To assess the efficacy of a pharmacist-led, primary care-based, disease management program to improve cardiovascular risk factors and glycated hemoglobin (A(1C)) levels in vulnerable patients with poorly controlled diabetes. A randomized controlled trial of 217 patients with type 2 diabetes and poor glycemic control (A(1C) level >or=8.0%) was conducted at an academic general medicine practice from February 2001 to April 2003. Intervention patients received intensive management from clinical pharmacists, as well as from a diabetes care coordinator who provided diabetes education, applied algorithms for managing glucose control and decreasing cardiovascular risk factors, and addressed barriers to care. Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider. Outcomes were recorded at baseline and at 6 and 12 months. Primary outcomes included blood pressure, A(1C) level, cholesterol level, and aspirin use. Secondary outcomes included diabetes knowledge, satisfaction, use of clinical services, and adverse events. For the 194 patients (89%) with 12-month data, the intervention group had significantly greater improvement than did the control group for systolic blood pressure (-9 mm Hg; 95% confidence interval [CI]: -16 to -3 mm Hg) and A(1C) level (-0.8%; 95% CI: -1.7% to 0%). Change in total cholesterol level was not significant. At 12 months, aspirin use was 91% in the intervention group versus 58% among controls (P <0.0001). Intervention patients had greater improvements in diabetes knowledge and satisfaction than did control patients. There were no significant differences in use of clinical services or adverse events. Our comprehensive disease management program reduced cardiovascular risk factors and A(1C) levels among vulnerable patients with type 2 diabetes and poor glycemic control.

Blood pressure and anthropometrics of 4-y-old children born after preimplantation genetic screening: follow-up of a unique, moderately sized, randomized controlled trial.

PubMed

Seggers, Jorien; Haadsma, Maaike L; Bastide-van Gemert, Sacha la; Heineman, Maas Jan; Kok, Joke H; Middelburg, Karin J; Roseboom, Tessa J; Schendelaar, Pamela; Van den Heuvel, Edwin R; Hadders-Algra, Mijna

2013-11-01

Recent studies suggest that in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) are associated with suboptimal cardiometabolic outcome in offspring. It is unknown whether preimplantation genetic screening (PGS), which involves embryo biopsy, affects blood pressure (BP), anthropometrics, and the frequency of received medical care. In this prospective multicenter follow-up study, we assessed BP, anthropometrics, and received medical care of 4-y-old children born to women who were randomly assigned to IVF/ICSI with PGS (n = 49) or without PGS (controls; n = 64). We applied linear and generalized linear mixed-effects models to investigate possible effects of PGS. BP in the PGS and control groups was similar: 102/64 and 100/64 mm Hg, respectively. Main anthropometric outcomes in the PGS vs. control group were: BMI: 16.1 vs. 15.8; triceps skinfold: 108 vs. 98 mm; and subscapular skinfold: 54 vs. 53 mm (all P values > 0.05). More PGS children than controls had received paramedical care (speech, physical, or occupational therapy: 14 (29%) vs. 9 (14%); P = 0.03 in multivariable analysis). The frequency of medicial treatment was comparable. PGS does not seem to affect BP or anthropometrics in 4-y-old children. The higher frequency of received paramedical care after PGS may suggest an effect of PGS on subtle developmental parameters.

Randomized, Controlled Trial of Behavioral Family Systems Therapy for Diabetes: Maintenance and Generalization of Effects on Parent-Adolescent Communication

ERIC Educational Resources Information Center

Wysocki, Tim; Harris, Michael A.; Buckloh, Lisa M.; Mertlich, Deborah; Lochrie, Amanda Sobel; Taylor, Alexandra; Sadler, Michelle; White, Neil H.

2008-01-01

We report a randomized trial of a revised Behavioral Family Systems Therapy for Diabetes (BFST-D) intervention. Families of 104 adolescents with diabetes were randomized to standard care (SC) or to 6 months of an educational support group (ES) or BFST-D. Family communication and problem-solving skills were assessed at 0, 6, 12, and 18 months by…

Patterns of antimicrobial use for respiratory tract infections in older residents of long-term care facilities

USDA-ARS?s Scientific Manuscript database

OBJECTIVE: To describe patterns of antimicrobial use for respiratory tract infections (RTIs) among elderly residents of long-term care facilities (LTCFs). DESIGN: Data from a prospective, randomized, controlled study conducted from April 1998 through August 2001 to investigate the effect of vitamin ...

A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial.

PubMed

Pressman, Alice R; Kinoshita, Linda; Kirk, Susan; Barbosa, Gina Monraz; Chou, Cathy; Minkoff, Jerome

2014-02-01

Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. We conducted a two-arm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 μmol; usual care, -59.4 μmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm (-17.1 mg/dL versus -5.4 mg/dL; P=0.045). Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended.

Long-term outcomes and costs of an integrated rehabilitation program for chronic knee pain: a pragmatic, cluster randomized, controlled trial.

PubMed

Hurley, M V; Walsh, N E; Mitchell, H; Nicholas, J; Patel, A

2012-02-01

Chronic joint pain is a major cause of pain and disability. Exercise and self-management have short-term benefits, but few studies follow participants for more than 6 months. We investigated the long-term (up to 30 months) clinical and cost effectiveness of a rehabilitation program combining self-management and exercise: Enabling Self-Management and Coping of Arthritic Knee Pain Through Exercise (ESCAPE-knee pain). In this pragmatic, cluster randomized, controlled trial, 418 people with chronic knee pain (recruited from 54 primary care surgeries) were randomized to usual care (pragmatic control) or the ESCAPE-knee pain program. The primary outcome was physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] function), with a clinically meaningful improvement in physical function defined as a ≥15% change from baseline. Secondary outcomes included pain, psychosocial and physiologic variables, costs, and cost effectiveness. Compared to usual care, ESCAPE-knee pain participants had large initial improvements in function (mean difference in WOMAC function -5.5; 95% confidence interval [95% CI] -7.8, -3.2). These improvements declined over time, but 30 months after completing the program, ESCAPE-knee pain participants still had better physical function (difference in WOMAC function -2.8; 95% CI -5.3, -0.2); lower community-based health care costs (£-47; 95% CI £-94, £-7), medication costs (£-16; 95% CI £-29, £-3), and total health and social care costs (£-1,118; 95% CI £-2,566, £-221); and a high probability (80-100%) of being cost effective. Clinical and cost benefits of ESCAPE-knee pain were still evident 30 months after completing the program. ESCAPE-knee pain is a more effective and efficient model of care that could substantially improve the health, well-being, and independence of many people, while reducing health care costs. Copyright © 2012 by the American College of Rheumatology.

Short-Term Impact of a Teen Pregnancy-Prevention Intervention Implemented in Group Homes.

PubMed

Oman, Roy F; Vesely, Sara K; Green, Jennifer; Fluhr, Janene; Williams, Jean

2016-11-01

Youth living in group home settings are at significantly greater risk for sexual risk behaviors; however, there are no sexual health programs designed specifically for these youth. The study's purpose was to assess the effectiveness of a teen pregnancy-prevention program for youth living in group home foster care settings and other out-of-home placements. The study design was a cluster randomized controlled trial involving youth (N = 1,037) recruited from 44 residential group homes located in California, Maryland, and Oklahoma. Within each state, youth (mean age = 16.2 years; 82% male; 37% Hispanic, 20% African-American, 20% white, and 17% multiracial) in half the group homes were randomly assigned to the intervention group (n = 40 clusters) and the other half were randomly assigned to a control group that offered "usual care" (n = 40 clusters). The intervention (i.e., Power Through Choices [PTC]) was a 10-session, age-appropriate, and medically accurate sexual health education program. Compared to the control group, youth in the PTC intervention showed significantly greater improvements (p < .05) from preintervention to postintervention in all three knowledge areas, one of two attitude areas, all three self-efficacy areas, and two of three behavioral intention areas. This is the first published randomized controlled trial of a teen pregnancy-prevention program designed for youth living in foster care settings and other out-of-home placements. The numerous significant improvements in short-term outcomes are encouraging and provide preliminary evidence that the PTC program is an effective pregnancy-prevention program. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

PubMed

Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

2014-02-01

Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

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.

Effectiveness of a fluid chart in outpatient management of suspected dengue fever: A pilot study.

PubMed

Nasir, Nazrila Hairin; Mohamad, Mohazmi; Lum, Lucy Chai See; Ng, Chirk Jenn

2017-01-01

Dengue infection is the fastest spreading mosquito-borne viral disease in the world. One of the complications of dengue is dehydration which, if not carefully monitored and treated, may lead to shock, particularly in those with dengue haemorrhagic fever. WHO has recommended oral fluid intake of five glasses or more for adults who are suspected to have dengue fever. However, there have been no published studies looking at self-care intervention measures to improve oral fluid intake among patients suspected of dengue fever. To assess the feasibility and effectiveness of using a fluid chart to improve oral fluid intake in patients with suspected dengue fever in a primary care setting. This feasibility study used a randomized controlled study design. The data was collected over two months at a primary care clinic in a teaching hospital. The inclusion criteria were: age > 12 years, patients who were suspected to have dengue fever based on the assessment by the primary healthcare clinician, fever for > three days, and thrombocytopenia (platelets < 150 x 109/L). Both groups received a dengue home care card. The intervention group received the fluid chart and a cup (200ml). Baseline clinical and laboratory data, 24-hour fluid recall (control group), and fluid chart were collected. The main outcomes were: hospitalization rates, intravenous fluid requirement and total oral fluid intake. Among the 138 participants who were included in the final analysis, there were fewer hospital admissions in the intervention group (n = 7, 10.0%) than the control group (n = 12, 17.6%) (p = 0.192). Similarly, fewer patients (n = 9, 12.9%) in the intervention group required intravenous fluid compared to the control group (n = 15, 22.1%), (p = 0.154). There was an increase in the amount of daily oral fluid intake in the intervention group (about 3,000 ml) compared to the control group (about 2,500 ml, p = 0.521). However, these differences did not reach statistical significance. This is a feasible and acceptable study to perform in a primary care setting. The fluid chart is a simple, inexpensive tool that may reduce hospitalization and intravenous fluid requirement in suspected dengue patients. A randomized controlled trial with larger sample size is needed to determine this conclusively. International Standard Randomized Controlled Trial Number (ISRCTN) Registry ISRCTN25394628 http://www.isrctn.com/ISRCTN25394628.

[Telemetric monitoring reduces visits to the emergency room and cost of care in patients with chronic heart failure].

PubMed

Pérez-Rodríguez, Gilberto; Brito-Zurita, Olga Rosa; Sistos-Navarro, Enrique; Benítez-Aréchiga, Zaria Margarita; Sarmiento-Salazar, Gloria Leticia; Vargas-Lizárraga, José Feliciano

2015-01-01

Tele-cardiology is the use of information technologies that help prolong survival, improve quality of life and reduce costs in health care. Heart failure is a chronic disease that leads to high care costs. To determine the effectiveness of telemetric monitoring for controlling clinical variables, reduced emergency room visits, and cost of care in a group of patients with heart failure compared to traditional medical consultation. A randomized, controlled and open clinical trial was conducted on 40 patients with Heart failure in a tertiary care centre in north-western Mexico. The patients were divided randomly into 2 groups of 20 patients each (telemetric monitoring, traditional medical consultation). In each participant was evaluated for: blood pressure, heart rate and body weight. The telemetric monitoring group was monitored remotely and traditional medical consultation group came to the hospital on scheduled dates. All patients could come to the emergency room if necessary. The telemetric monitoring group decreased their weight and improved control of the disease (P=.01). Systolic blood pressure and cost of care decreased (51%) significantly compared traditional medical consultation group (P>.05). Admission to the emergency room was avoided in 100% of patients in the telemetric monitoring group. In patients with heart failure, the telemetric monitoring was effective in reducing emergency room visits and saved significant resources in care during follow-up. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

Telephone-Based Coping Skills Training for Patients Awaiting Lung Transplantation

ERIC Educational Resources Information Center

Blumenthal, James A.; Babyak, Michael A.; Keefe, Francis J.; Davis, R. Duane; LaCaille, Rick A.; Carney, Robert M.; Freedland, Kenneth E.; Trulock, Elbert; Palmer, Scott M.

2006-01-01

Impaired quality of life is associated with increased mortality in patients with advanced lung disease. Using a randomized controlled trial with allocation concealment and blinded outcome assessment at 2 tertiary care teaching hospitals, the authors randomly assigned 328 patients with end-stage lung disease awaiting lung transplantation to 12…

How are palliative care cancer populations characterized in randomized controlled trials? A literature review.

PubMed

Sigurdardottir, Katrin Ruth; Oldervoll, Line; Hjermstad, Marianne Jensen; Kaasa, Stein; Knudsen, Anne Kari; Løhre, Erik Torbjørn; Loge, Jon Håvard; Haugen, Dagny Faksvåg

2014-05-01

The difficulties in defining a palliative care patient accentuate the need to provide stringent descriptions of the patient population in palliative care research. To conduct a systematic literature review with the aim of identifying which key variables have been used to describe adult palliative care cancer populations in randomized controlled trials (RCTs). The data sources used were MEDLINE (1950 to January 25, 2010) and Embase (1980 to January 25, 2010), limited to RCTs in adult cancer patients with incurable disease. Forty-three variables were systematically extracted from the eligible articles. The review includes 336 articles reporting RCTs in palliative care cancer patients. Age (98%), gender (90%), cancer diagnosis (89%), performance status (45%), and survival (45%) were the most frequently reported variables. A large number of other variables were much less frequently reported. A substantial variation exists in how palliative care cancer populations are described in RCTs. Few variables are consistently registered and reported. There is a clear need to standardize the reporting. The results from this work will serve as the basis for an international Delphi process with the aim of reaching consensus on a minimum set of descriptors to characterize a palliative care cancer population. Copyright © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Effects of prenatal yoga on women's stress and immune function across pregnancy: A randomized controlled trial.

PubMed

Chen, Pao-Ju; Yang, Luke; Chou, Cheng-Chen; Li, Chia-Chi; Chang, Yu-Cune; Liaw, Jen-Jiuan

2017-04-01

The effects of prenatal yoga on biological indicators have not been widely studied. Thus, we compared changes in stress and immunity salivary biomarkers from 16 to 36 weeks' gestation between women receiving prenatal yoga and those receiving routine prenatal care. For this longitudinal, prospective, randomized controlled trial, we recruited 94 healthy pregnant women at 16 weeks' gestation through convenience sampling from a prenatal clinic in Taipei. Participants were randomly assigned to intervention (n=48) or control (n=46) groups using Clinstat block randomization. The 20-week intervention comprised two weekly 70-min yoga sessions led by a midwife certified as a yoga instructor; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A levels were collected before and after yoga every 4 weeks from 16 to 36 weeks' gestation. The intervention group had lower salivary cortisol (p<0.001) and higher immunoglobulin A (p<0.001) levels immediately after yoga than the control group. Specifically, the intervention group had significantly higher long-term salivary immunoglobulin A levels than the control group (p=0.018), and infants born to women in the intervention group weighed more than those born to the control group (p<0.001). Prenatal yoga significantly reduced pregnant women's stress and enhanced their immune function. Clinicians should learn the mechanisms of yoga and its effects on pregnant women. Our findings can guide clinicians to help pregnant women alleviate their stress and enhance their immune function. Copyright © 2017. Published by Elsevier Ltd.

Can Telemedicine Improve Adherence to Resuscitation Guidelines for Critically Ill Children at Community Hospitals? A Randomized Controlled Trial Using High-Fidelity Simulation.

PubMed

Yang, Chris P; Hunt, Elizabeth A; Shilkofski, Nicole; Dudas, Robert; Egbuta, Chinyere; Schwartz, Jamie M

2017-07-01

Children transferred from community hospitals lacking specialized pediatric care are more seriously ill than those presenting to pediatric centers. Pediatric consultation and adherence to management guidelines improve outcomes. The aims of the study were (1) to assess whether telemedicine consultation in critical situations is feasible and (2) to compare the impact of pediatric critical care medicine (PCCM) consultation via telemedicine versus telephone on community hospital adherence to resuscitation guidelines through a randomized controlled telemedicine trial. In situ, high-fidelity simulation scenarios of critically ill children presenting to a community hospital and progressing to cardiopulmonary arrest were performed. Scenarios were randomized to PCCM consultation via telephone (control) or telemedicine (intervention). Primary outcome measure was proportion of teams who successfully defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia. The following 30 scenarios were completed: 15 control and 15 intervention. Only 11 (37%) of 30 teams, defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia; control: 6 (40%) of 15 versus intervention: 5 (33%) of 15, P = 0.7. Request for or use of backboard during cardiopulmonary resuscitation occurred in 24 (80%) of 30 scenarios; control: 9 (60%) of 15 versus intervention: 15 (100%) of 15, P = 0.006. Request for or use of stepstool during cardiopulmonary resuscitation occurred in 6 (20%) of 30 scenarios; control: 1 (7%) of 15 versus intervention: 5 (33%) of 15, P = 0.07. This study demonstrates the feasibility of using telemedicine to support acute management of children who present to community hospitals. Neither study arm adhered to current resuscitation guidelines and telemedicine consultation with PCCM experts was not associated with improvement. However, further research on optimizing telemedicine impact on the quality of pediatric care at community hospitals is warranted.

A Cluster Randomized Evaluation of a Health Department Data to Care Intervention Designed to Increase Engagement in HIV Care and Antiretroviral Use.

PubMed

Dombrowski, Julia C; Hughes, James P; Buskin, Susan E; Bennett, Amy; Katz, David; Fleming, Mark; Nunez, Angela; Golden, Matthew R

2018-06-01

Many US health departments have implemented Data to Care interventions, which use HIV surveillance data to identify persons who are inadequately engaged in HIV medical care and assist them with care reengagement, but the effectiveness of this strategy is uncertain. We conducted a stepped-wedge, cluster-randomized evaluation of a Data to Care intervention in King County, Washington, 2011 to 2014. Persons diagnosed as having HIV for at least 6 months were eligible based on 1 of 2 criteria: (1) viral load (VL) greater than 500 copies/mL and CD4 less than 350 cells/μL at the last report in the past 12 months or (2) no CD4 or VL reported to the health department for at least 12 months. The intervention included medical provider contact, patient contact, and a structured individual interview. Health department staff assisted patients with reengagement using health systems navigation, brief counseling, and referral to support services. We clustered all eligible cases in the county by the last known medical provider and randomized the order of clusters for intervention, creating contemporaneous intervention and control periods (cases in later clusters contributed person-time to the control period at the same time that cases in earlier clusters contributed person-time to the intervention period). We compared the time to viral suppression (VL <200 copies/mL) for individuals during intervention and control periods using a Cox proportional hazards model. We identified 997 persons (intention to treat [ITT]), 18% of whom had moved or died. Of the remaining 822 (modified ITT), 161 (20%) had an undetectable VL reported before contact and 164 (20%) completed the individual interview. The hazard ratio (HR) for time to viral suppression did not differ between the intervention and control periods in ITT (HR, 1.21 [95% confidence interval, 0.85-1.71]) or modified ITT (HR, 1.18 [95% confidence interval, 0.83-1.68]) analysis. The Data to Care intervention did not impact time to viral suppression.

Preoperative pain neuroscience education for lumbar radiculopathy: a multicenter randomized controlled trial with 1-year follow-up.

PubMed

Louw, Adriaan; Diener, Ina; Landers, Merrill R; Puentedura, Emilio J

2014-08-15

Multicenter, randomized, controlled trial on preoperative pain neuroscience education (NE) for lumbar radiculopathy. To determine if the addition of NE to usual preoperative education would result in superior outcomes with regard to pain, function, surgical experience, and health care utilization postsurgery. One in 4 patients after lumbar surgery (LS) for radiculopathy experience persistent pain and disability, which is nonresponsive to perioperative treatments. NE focusing on the neurophysiology of pain has been shown to decrease pain and disability in populations with chronic low back pain. Eligible patients scheduled for LS for radiculopathy were randomized to receive either preoperative usual care (UC) or a combination of UC plus 1 session of NE delivered by a physical therapist (verbal one-on-one format) and a NE booklet. Sixty-seven patients completed the following outcomes prior to LS (baseline), and 1, 3, 6, and 12 months after LS: low back pain (numeric rating scale), leg pain (numeric rating scale), function (Oswestry Disability Index), various beliefs and experiences related to LS (10-item survey with Likert scale responses), and postoperative utilization of health care (utilization of health care questionnaire). At 1-year follow-up, there were no statistical differences between the experimental and control groups with regard to primary outcome measure of low back pain (P = 0.183), leg pain (P = 0.075), and function (P = 0.365). In a majority of the categories regarding surgical experience, the NE group scored significantly better: better prepared for LS (P = 0.001); preoperative session preparing them for LS (P < 0.001) and LS meeting their expectations (P = 0.021). Health care utilization post-LS also favored the NE group (P = 0.007) resulting in 45% less health care expenditure compared with the control group in the 1-year follow-up period. NE resulted in significant behavior change. Despite a similar pain and functional trajectory during the 1-year trial, patients with LS who received NE viewed their surgical experience more favorably and used less health care facility in the form of medical tests and treatments. 2.

An adapted mindfulness-based stress reduction program for elders in a continuing care retirement community: quantitative and qualitative results from a pilot randomized controlled trial.

PubMed

Moss, Aleezé S; Reibel, Diane K; Greeson, Jeffrey M; Thapar, Anjali; Bubb, Rebecca; Salmon, Jacqueline; Newberg, Andrew B

2015-06-01

The purpose of this study was to test the feasibility and effectiveness of an adapted 8-week Mindfulness-Based Stress Reduction (MBSR) program for elders in a continuing care community. This mixed-methods study used both quantitative and qualitative measures. A randomized waitlist control design was used for the quantitative aspect of the study. Thirty-nine elderly were randomized to MBSR (n = 20) or a waitlist control group (n = 19), mean age was 82 years. Both groups completed pre-post measures of health-related quality of life, acceptance and psychological flexibility, facets of mindfulness, self-compassion, and psychological distress. A subset of MBSR participants completed qualitative interviews. MBSR participants showed significantly greater improvement in acceptance and psychological flexibility and in role limitations due to physical health. In the qualitative interviews, MBSR participants reported increased awareness, less judgment, and greater self-compassion. Study results demonstrate the feasibility and potential effectiveness of an adapted MBSR program in promoting mind-body health for elders. © The Author(s) 2014.

Effect of N-Methyl-D-Aspartate Receptor Antagonist Dextromethorphan on Opioid Analgesia in Pediatric Intensive Care Unit

PubMed Central

Al Alem, Hala; Al Shehri, Ali; Al-Jeraisy, Majed

2016-01-01

Objective. Pain control is an essential goal in the management of critical children. Narcotics are the mainstay for pain control. Patients frequently need escalating doses of narcotics. In such cases an adjunctive therapy may be beneficial. Dextromethorphan (DM) is NMDA receptor antagonist and may prevent tolerance to narcotics; however, its definitive role is still unclear. We sought whether dextromethorphan addition could decrease the requirements of fentanyl to control pain in critical children. Design. Double-blind, randomized control trial (RCT). Setting. Pediatric multidisciplinary ICU in tertiary care center. Patients. Thirty-six pediatric patients 2–14 years of age in a multidisciplinary PICU requiring analgesia were randomized into dextromethorphan and placebo. The subjects in both groups showed similarity in most of the characteristics. Interventions. Subjects while receiving fentanyl for pain control received dextromethorphan or placebo through nasogastric/orogastric tubes for 96 hours. Pain was assessed using FLACC and faces scales. Measurements and Main Results. This study found no statistical significant difference in fentanyl requirements between subjects receiving dextromethorphan and those receiving placebo (p = 0.127). Conclusions. Dextromethorphan has no effect on opioid requirement for control of acute pain in children admitted with acute critical care illness in PICU. The registration number for this trial is NCT01553435. PMID:27867308

Effect of N-Methyl-D-Aspartate Receptor Antagonist Dextromethorphan on Opioid Analgesia in Pediatric Intensive Care Unit.

PubMed

Naeem, Mohammed; Al Alem, Hala; Al Shehri, Ali; Al-Jeraisy, Majed

2016-01-01

Objective . Pain control is an essential goal in the management of critical children. Narcotics are the mainstay for pain control. Patients frequently need escalating doses of narcotics. In such cases an adjunctive therapy may be beneficial. Dextromethorphan (DM) is NMDA receptor antagonist and may prevent tolerance to narcotics; however, its definitive role is still unclear. We sought whether dextromethorphan addition could decrease the requirements of fentanyl to control pain in critical children. Design . Double-blind, randomized control trial (RCT). Setting . Pediatric multidisciplinary ICU in tertiary care center. Patients . Thirty-six pediatric patients 2-14 years of age in a multidisciplinary PICU requiring analgesia were randomized into dextromethorphan and placebo. The subjects in both groups showed similarity in most of the characteristics. Interventions . Subjects while receiving fentanyl for pain control received dextromethorphan or placebo through nasogastric/orogastric tubes for 96 hours. Pain was assessed using FLACC and faces scales. Measurements and Main Results . This study found no statistical significant difference in fentanyl requirements between subjects receiving dextromethorphan and those receiving placebo ( p = 0.127). Conclusions . Dextromethorphan has no effect on opioid requirement for control of acute pain in children admitted with acute critical care illness in PICU. The registration number for this trial is NCT01553435.

Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

PubMed

Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D

2010-01-01

The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

The Outcomes of Peer-Led Diabetes Education in Comparison to Education Delivered by Health Professionals in Iranian Patients

ERIC Educational Resources Information Center

Ahmadi, Zakieh; Sadeghi, Tabandeh; Loripoor, Marzeyeh

2018-01-01

Education is an important aspect of care for diabetic patients. This study aimed to compare the effect of education by health care provider and peer on self-care behaviors among Iranian patients with diabetes. In this clinical randomized control trial, we enrolled 120 patients with type 2 diabetes who were referred to the Diabetes Clinic at a…

Smart Care Based on Telemonitoring and Telemedicine for Type 2 Diabetes Care: Multi-center Randomized Controlled Trial.

PubMed

Jeong, Ji Yun; Jeon, Jae-Han; Bae, Kwi-Hyun; Choi, Yeon-Kyung; Park, Keun-Gyu; Kim, Jung-Guk; Won, Kyu Chang; Cha, Bong Soo; Ahn, Chul Woo; Kim, Dong Won; Lee, Chang Hee; Lee, In-Kyu

2018-01-17

This study was performed to determine the effectiveness of the Smart Care service on glucose control based on telemedicine and telemonitoring compared with conventional treatment in patients with type 2 diabetes. This 24-week prospective multi-center randomized controlled trial involved 338 adult patients with type 2 diabetes at four university hospitals in South Korea. The patients were randomly assigned to a control group (group A, n = 113), a telemonitoring group (group B, n = 113), or a telemedicine group (group C, n = 112). Patients in the telemonitoring group visited the outpatient clinic regularly, accompanied by an additional telemonitoring service that included remote glucose monitoring with automated patient decision support by text. Remote glucose monitoring was identical in the telemedicine group, but assessment by outpatient visits was replaced by video conferencing with an endocrinologist. The adjusted net reductions in HbA1c concentration after 24 weeks were similar in the conventional, telemonitoring, and telemedicine groups (-0.66% ± 1.03% vs. -0.66% ± 1.09% vs. -0.81% ± 1.05%; p > 0.05 for each pairwise comparison). Fasting glucose concentrations were lower in the telemonitoring and telemedicine groups than in the conventional group. Rates of hypoglycemia were lower in the telemedicine group than in the other two groups, and compliance with medication was better in the telemonitoring and telemedicine than in the conventional group. No serious adverse events were associated with telemedicine. Telehealthcare was as effective as conventional care at improving glycemia in patients with type 2 diabetes without serious adverse effects.

The Effects of Self-Book© Art Therapy on Cancer-Related Distress in Female Cancer Patients during Active Treatment: A Randomized Controlled Trial.

PubMed

Radl, Donna; Vita, Maureen; Gerber, Nancy; Gracely, Edward J; Bradt, Joke

2018-05-10

National attention on patients' cancer-related emotional distress produced a need for evidence-based, psychosocial interventions in oncology care. The purpose of this study was to evaluate the efficacy of Self-Book© art therapy for emotional distress and psychological well-being of female oncology patients during active oncology treatment. Sixty consenting women with cancer were randomly assigned to either a six-session Self-Book© art therapy program or standard care. A repeated measures randomized controlled trial design was employed. Data were collected using the Distress Thermometer (DT), Perceived Emotional Distress Inventory (PEDI), Patient-Reported Outcomes Measurement Information System (PROMIS) Brief Psychological Well-being test, and the Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp). Measurements were obtained at baseline, week 3, week 6, and 1-to-2 months post-intervention. Forty participants were included in the final analysis. No significant differences between groups were found for the primary outcome measures: emotional distress and psychological well-being. Greater improvements in Self-Book© art therapy participants' spiritual well-being were found compared to the standard care control participants (p = 0.02). Although no statistically significant differences were present between the groups for the primary outcomes, several positive trends were noted. Thirty percent of Self-Book© art therapy participants reported post-intervention emotional distress scores that were below the abnormal range for emotional distress, compared with only 5% of standard care control participants, suggesting that Self-Book© art therapy may have clinical value. Further studies are recommended to better understand the therapeutic mechanisms of Self-Book© art therapy for enhancing psychological well-being. This article is protected by copyright. All rights reserved.

Effect of a pragmatic, cluster-randomized controlled trial on patient experience with care: The Transforming Outcomes for Patients through Medical home Evaluation and reDesign (TOPMED) study

PubMed Central

Dorr, David A.; Anastas, Tracy; Ramsey, Katrina; Wagner, Jesse; Sachdeva, Bhavaya; Michaels, LeAnn; Fagnan, Lyle

2016-01-01

Background Health reform programs like the Patient-Centered Medical Home (PCMH) are intended to improve the Triple Aim. Previous studies on PCMHs have shown mixed effects, but High Value Elements (HVEs) are expected to improve the Triple Aim. Objective To understand whether focusing on high value elements (HVEs) would improve patient experience with care. Methods Eight clinics were cluster-randomized in a year-long trial. Both arms received practice facilitation, IT-based reporting, and financial incentives. Intervention practices were encouraged to choose HVEs for QI goals. To assess patient experience, 1,597 Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys were sent pre- and post-trial to a stratified random sample of patients. Difference in difference multivariate analysis was used to compare patient responses from intervention and control practices, adjusting for confounders. Results The response rate was 43% (n=686). Non-respondent analysis showed no difference between arms, although differences were seen by risk status and age. The overall difference in difference was 2.8%, favoring the intervention. The intervention performed better in 9 of 11 composites. The intervention performed significantly better in Follow-up on test results (p=.091) and Patients’ rating of the provider (p=.091), while the control performed better in Access to care (p=.093). Both arms also had decreases, including 4 of 11 composites for the intervention, and 8 of 11 for the control. Discussion Practices that targeted HVEs showed significantly more improvement in patient experience of care. However, contemporaneous trends may have affected results, leading to declines in patient experience in both arms. PMID:27116107

The Effects of a Cluster Randomized Controlled Workplace Intervention on Sleep and Work-Family Conflict Outcomes in an Extended Care Setting.

PubMed

Marino, Miguel; Killerby, Marie; Lee, Soomi; Klein, Laura Cousino; Moen, Phyllis; Olson, Ryan; Kossek, Ellen Ernst; King, Rosalind; Erickson, Leslie; Berkman, Lisa F; Buxton, Orfeu M

2016-12-01

To evaluate the effects of a workplace-based intervention on actigraphic and self-reported sleep outcomes in an extended care setting. Cluster randomized trial. Extended-care (nursing) facilities. US employees and managers at nursing homes. Nursing homes were randomly selected to intervention or control settings. The Work, Family and Health Study developed an intervention aimed at reducing work-family conflict within a 4-month work-family organizational change process. Employees participated in interactive sessions with facilitated discussions, role-playing, and games designed to increase control over work processes and work time. Managers completed training in family-supportive supervision. Primary actigraphic outcomes included: total sleep duration, wake after sleep onset, nighttime sleep, variation in nighttime sleep, nap duration, and number of naps. Secondary survey outcomes included work-to-family conflict, sleep insufficiency, insomnia symptoms and sleep quality. Measures were obtained at baseline, 6-months and 12-months post-intervention. A total of 1,522 employees and 184 managers provided survey data at baseline. Managers and employees in the intervention arm showed no significant difference in sleep outcomes over time compared to control participants. Sleep outcomes were not moderated by work-to-family conflict or presence of children in the household for managers or employees. Age significantly moderated an intervention effect on nighttime sleep among employees (p=0.040), where younger employees benefited more from the intervention. In the context of an extended-care nursing home workplace, the intervention did not significantly alter sleep outcomes in either managers or employees. Moderating effects of age were identified where younger employees' sleep outcomes benefited more from the intervention.

The effects of a nurse case manager and a community health worker team on diabetic control, emergency department visits, and hospitalizations among urban African Americans with type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Gary, Tiffany L; Batts-Turner, Marian; Yeh, Hsin-Chieh; Hill-Briggs, Felicia; Bone, Lee R; Wang, Nae-Yuh; Levine, David M; Powe, Neil R; Saudek, Christopher D; Hill, Martha N; McGuire, Maura; Brancati, Frederick L

2009-10-26

Although African American adults bear a disproportionate burden from diabetes mellitus (DM), few randomized controlled trials have tested culturally appropriate interventions to improve DM care. We randomly assigned 542 African Americans with type 2 DM enrolled in an urban managed care organization to either an intensive or minimal intervention group. The intensive intervention group consisted of all components of the minimal intervention plus individualized, culturally tailored care provided by a nurse case manager (NCM) and a community health worker (CHW), using evidence-based clinical algorithms with feedback to primary care providers (eg, physicians, nurse practitioners, or physician assistants). The minimal intervention consisted of mailings and telephone calls every 6 months to remind participants about preventive screenings. Data on diabetic control were collected at baseline and at 24 months by blind observers; data emergency department (ER) visits and hospitalizations were assessed using administrative data. At baseline, participants had a mean age of 58 years, 73% were women, and 50% were living in poverty. At 24 months, compared with the minimal intervention group, those in the intensive intervention group were 23% less likely to have ER visits (rate difference [RD], -14.5; adjusted rate ratio [RR], 0.77; 95% confidence interval [CI], 0.59-1.00). In on-treatment analyses, the rate reduction was strongest for patients who received the most NCM and CHW visits (RD, -31.0; adjusted RR, 0.66; 95% CI, 0.43-1.00; rate reduction downward arrow 34%). These data suggest that a culturally tailored intervention conducted by an NCM/CHW team reduced ER visits in urban African Americans with type 2 DM. clinicaltrials.gov Identifier: NCT00022750.

Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial.

PubMed

Diamantidis, Clarissa J; Bosworth, Hayden B; Oakes, Megan M; Davenport, Clemontina A; Pendergast, Jane F; Patel, Sejal; Moaddeb, Jivan; Barnhart, Huiman X; Merrill, Peter D; Baloch, Khaula; Crowley, Matthew J; Patel, Uptal D

2018-06-01

Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This manuscript describes the study protocol, recruitment, and baseline participant characteristics for the Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study. The STOP-DKD study is a randomized controlled trial designed to evaluate the effectiveness of a multifactorial behavioral and medication management intervention to mitigate kidney function decline at 3 years compared to usual care. The intervention consists of up to 36 monthly educational modules delivered via telephone by a study pharmacist, home blood pressure monitoring, and medication management recommendations delivered electronically to primary care physicians. Patients seen at seven primary care clinics in North Carolina, with diabetes and [1] uncontrolled hypertension and [2] evidence of kidney dysfunction (albuminuria or reduced estimated glomerular filtration rate [eGFR]) were eligible to participate. Study recruitment completed in December 2014. Of the 281 participants randomized, mean age at baseline was 61.9; 52% were male, 56% were Black, and most were high school graduates (89%). Baseline co-morbidity was high- mean blood pressure was 134/76 mmHg, mean body mass index was 35.7 kg/m 2 , mean eGFR was 80.7 ml/min/1.73 m 2 , and mean glycated hemoglobin was 8.0%. Experiences of recruiting and implementing a comprehensive DKD program to individuals at high risk seen in the primary care setting are provided. NCT01829256. Copyright © 2018 Elsevier Inc. All rights reserved.

Physical activity prescription by primary care nurses using health assets: Study design of a randomized controlled trial in patients with cardiovascular risk factors.

PubMed

Riera-Sampol, Aina; Tauler, Pedro; Bennasar-Veny, Miquel; Leiva, Alfonso; Artigues-Vives, Guillem; De Pedro-Gómez, Joan; Pericàs, Jordi; Moreno, Carlos; Arbos, Maite; Aguilo, Antoni

2017-09-01

To analyse the efficacy of a 12-month multifactorial intervention by primary care nurses in increasing adherence to physical activity prescription (150 min/week) in patients with two or more cardiovascular risk factors and with cardiovascular risk up to 15% determined by the REGICOR equation. In Spain, cardiovascular diseases are responsible for 30.5% of deaths. Regular physical activity decreases mortality risk due to cardiovascular diseases but the effectiveness of physical activity prescription in routine in primary care settings has been shown to be low. Multicentre, single-blind, parallel randomized (in two different branches) clinical trial. At least 368 participants will be recruited (184 control and 184 intervention), to show an 8% increase in adherence to the physical activity prescription (1.2% control group and 9.2% intervention group). Participants will be patients aged 35-75 years with at least two cardiovascular risk factors and with a cardiovascular risk of up to 15% measured using the Framingham-REGICOR equation. Intervention will be performed throughout baseline and three follow-up visits. A motivational interview, the trans-theoretical stages of changes of Prochaska and DiClemente and an individualized prescription of physical exercise using physical activity assets will be used in the intervention. Data will be collected at baseline and after the 1-year intervention. The present study will allow us to find out whether this brief multifactorial intervention induces greater adherence to physical activity prescription than usual practice, improving the quality of patient care. International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN76069254. Protocol version 1.1, 6 July 2015. © 2017 John Wiley & Sons Ltd.

The Effects of a Cluster Randomized Controlled Workplace Intervention on Sleep and Work-Family Conflict Outcomes in an Extended Care Setting

PubMed Central

Marino, Miguel; Killerby, Marie; Lee, Soomi; Klein, Laura Cousino; Moen, Phyllis; Olson, Ryan; Kossek, Ellen Ernst; King, Rosalind; Erickson, Leslie; Berkman, Lisa F.; Buxton, Orfeu M.

2016-01-01

Objectives To evaluate the effects of a workplace-based intervention on actigraphic and self-reported sleep outcomes in an extended care setting. Design Cluster randomized trial. Setting Extended-care (nursing) facilities. Participants US employees and managers at nursing homes. Nursing homes were randomly selected to intervention or control settings. Intervention The Work, Family and Health Study developed an intervention aimed at reducing work-family conflict within a 4-month work-family organizational change process. Employees participated in interactive sessions with facilitated discussions, role-playing, and games designed to increase control over work processes and work time. Managers completed training in family-supportive supervision. Measurements Primary actigraphic outcomes included: total sleep duration, wake after sleep onset, nighttime sleep, variation in nighttime sleep, nap duration, and number of naps. Secondary survey outcomes included work-to-family conflict, sleep insufficiency, insomnia symptoms and sleep quality. Measures were obtained at baseline, 6-months and 12-months post-intervention. Results A total of 1,522 employees and 184 managers provided survey data at baseline. Managers and employees in the intervention arm showed no significant difference in sleep outcomes over time compared to control participants. Sleep outcomes were not moderated by work-to-family conflict or presence of children in the household for managers or employees. Age significantly moderated an intervention effect on nighttime sleep among employees (p=0.040), where younger employees benefited more from the intervention. Conclusion In the context of an extended-care nursing home workplace, the intervention did not significantly alter sleep outcomes in either managers or employees. Moderating effects of age were identified where younger employees’ sleep outcomes benefited more from the intervention. PMID:28239635

Online diabetes self-management program: a randomized study.

PubMed

Lorig, Kate; Ritter, Philip L; Laurent, Diana D; Plant, Kathryn; Green, Maurice; Jernigan, Valarie Blue Bird; Case, Siobhan

2010-06-01

We hypothesized that people with type 2 diabetes in an online diabetes self-management program, compared with usual-care control subjects, would 1) demonstrate reduced A1C at 6 and 18 months, 2) have fewer symptoms, 3) demonstrate increased exercise, and 4) have improved self-efficacy and patient activation. In addition, participants randomized to listserve reinforcement would have better 18-month outcomes than participants receiving no reinforcement. A total of 761 participants were randomized to 1) the program, 2) the program with e-mail reinforcement, or 3) were usual-care control subjects (no treatment). This sample included 110 American Indians/Alaska Natives (AI/ANs). Analyses of covariance models were used at the 6- and 18-month follow-up to compare groups. At 6 months, A1C, patient activation, and self-efficacy were improved for program participants compared with usual care control subjects (P < 0.05). There were no changes in other health or behavioral indicators. The AI/AN program participants demonstrated improvements in health distress and activity limitation compared with usual-care control subjects. The subgroup with initial A1C >7% demonstrated stronger improvement in A1C (P = 0.01). At 18 months, self-efficacy and patient activation were improved for program participants. A1C was not measured. Reinforcement showed no improvement. An online diabetes self-management program is acceptable for people with type 2 diabetes. Although the results were mixed they suggest 1) that the program may have beneficial effects in reducing A1C, 2) AI/AN populations can be engaged in and benefit from online interventions, and 3) our follow-up reinforcement appeared to have no value.

My Team of Care Study: A Pilot Randomized Controlled Trial of a Web-Based Communication Tool for Collaborative Care in Patients With Advanced Cancer.

PubMed

Voruganti, Teja; Grunfeld, Eva; Jamieson, Trevor; Kurahashi, Allison M; Lokuge, Bhadra; Krzyzanowska, Monika K; Mamdani, Muhammad; Moineddin, Rahim; Husain, Amna

2017-07-18

The management of patients with complex care needs requires the expertise of health care providers from multiple settings and specialties. As such, there is a need for cross-setting, cross-disciplinary solutions that address deficits in communication and continuity of care. We have developed a Web-based tool for clinical collaboration, called Loop, which assembles the patient and care team in a virtual space for the purpose of facilitating communication around care management. The objectives of this pilot study were to evaluate the feasibility of integrating a tool like Loop into current care practices and to capture preliminary measures of the effect of Loop on continuity of care, quality of care, symptom distress, and health care utilization. We conducted an open-label pilot cluster randomized controlled trial allocating patients with advanced cancer (defined as stage III or IV disease) with ≥3 months prognosis, their participating health care team and caregivers to receive either the Loop intervention or usual care. Outcome data were collected from patients on a monthly basis for 3 months. Trial feasibility was measured with rate of uptake, as well as recruitment and system usage. The Picker Continuity of Care subscale, Palliative care Outcomes Scale, Edmonton Symptom Assessment Scale, and Ambulatory and Home Care Record were patient self-reported measures of continuity of care, quality of care, symptom distress, and health services utilization, respectively. We conducted a content analysis of messages posted on Loop to understand how the system was used. Nineteen physicians (oncologists or palliative care physicians) were randomized to the intervention or control arms. One hundred twenty-seven of their patients with advanced cancer were approached and 48 patients enrolled. Of 24 patients in the intervention arm, 20 (83.3%) registered onto Loop. In the intervention and control arms, 12 and 11 patients completed three months of follow-up, respectively. A mean of 1.2 (range: 0 to 4) additional healthcare providers with an average total of 3 healthcare providers participated per team. An unadjusted between-arm increase of +11.4 was observed on the Picker scale in favor of the intervention arm. Other measures showed negligible changes. Loop was primarily used for medical care management, symptom reporting, and appointment coordination. The results of this study show that implementation of Loop was feasible. It provides useful information for planning future studies further examining effectiveness and team collaboration. Numerically higher scores were observed for the Loop arm relative to the control arm with respect to continuity of care. Future work is required to understand the incentives and barriers to participation so that the implementation of tools like Loop can be optimized. ClinicalTrials.gov NCT02372994; https://clinicaltrials.gov/ct2/show/NCT02372994 (Archived by WebCite at http://www.webcitation.org/6r00L4Skb). ©Teja Voruganti, Eva Grunfeld, Trevor Jamieson, Allison M Kurahashi, Bhadra Lokuge, Monika K Krzyzanowska, Muhammad Mamdani, Rahim Moineddin, Amna Husain. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 18.07.2017.

Cost-effectiveness of a primary care treatment program for depression in low-income women in Santiago, Chile.

PubMed

Araya, Ricardo; Flynn, Terry; Rojas, Graciela; Fritsch, Rosemarie; Simon, Greg

2006-08-01

The authors compared the incremental cost-effectiveness of a stepped-care, multicomponent program with usual care for the treatment of depressed women in primary care in Santiago, Chile. A cost-effectiveness study was conducted of a previous randomized controlled trial involving 240 eligible women with DSM-IV major depression who were selected from a consecutive sample of adult women attending primary care clinics. The patients were randomly allocated to usual care or a multicomponent stepped-care program led by a nonmedical health care worker. Depression-free days and health care costs derived from local sources were assessed after 3 and 6 months. A health service perspective was used in the economic analysis. Complete data were determined for 80% of the randomly assigned patients. After we adjusted for initial severity, women receiving the stepped-care program had a mean of 50 additional depression-free days over 6 months relative to patients allocated to usual care. The stepped-care program was marginally more expensive than usual care (an extra 216 Chilean pesos per depression-free day). There was a 90% probability that the incremental cost of obtaining an extra depression-free day with the intervention would not exceed 300 pesos (1.04 US dollars). The stepped-care program was significantly more effective and marginally more expensive than usual care for the treatment of depressed women in primary care. Small investments to improve depression appear to yield larger gains in poorer environments. Simple and inexpensive treatment programs tested in developing countries might provide good study models for developed countries.

Race-ethnicity on blood pressure control after ischemic stroke: a prospective cohort study.

PubMed

Nguyen-Huynh, Mai N; Hills, Nancy K; Sidney, Stephen; Klingman, Jeffrey G; Johnston, S Claiborne

2017-01-01

Disparities in health care access and socioeconomic status (SES) have been associated with racial-ethnic differences in blood pressure (BP) control. We examined post-ischemic stroke BP in a multiethnic cohort with good health care access. We included all hypertensive patients (n = 2972) from a randomized quality improvement trial on secondary stroke prevention, conducted in 14 Kaiser Permanente hospitals in Northern California from 2004-2006 (QUISP). Average age 73.2 ± 12.2 years; 52% female, 66% non-Hispanic white, 14% African-American, 11% Asian, 8% Hispanic, and 1% other. Demographics, diagnoses, health care utilization, BP measurements, and medications were obtained as part of routine care. We used random effects logistic regression models to examine race as a predictor of blood pressure control (<140/90 mm Hg) at 6 months post-discharge, adjusted for SES, age, gender, dementia, antihypertensive therapy, and attendance at follow-up visits. At 6 months, BP was controlled in 52.7% of blacks compared to 61.4% of whites (OR = 0.63, 95% CI, 0.48-0.82, P = .001). Black race remained independently associated with poorer BP control in adjusted analysis, although blacks were as likely to attend post-discharge visits, and more likely to be on any antihypertensive therapy than whites. Greater difficulty in controlling BP and lifestyle differences may account for this difference. Copyright © 2016 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

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.

Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.

PubMed

Wise, Robert A; Bartlett, Susan J; Brown, Ellen D; Castro, Mario; Cohen, Rubin; Holbrook, Janet T; Irvin, Charles G; Rand, Cynthia S; Sockrider, Marianna M; Sugar, Elizabeth A

2009-09-01

Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multicenter, nonblinded, randomized controlled trial.

PubMed

Kim, Jung-Eun; Seo, Byung-Kwan; Choi, Jin-Bong; Kim, Hyeong-Jun; Kim, Tae-Hun; Lee, Min-Hee; Kang, Kyung-Won; Kim, Joo-Hee; Shin, Kyung-Min; Lee, Seunghoon; Jung, So-Young; Kim, Ae-Ran; Shin, Mi-Suk; Jung, Hee-Jung; Park, Hyo-Ju; Kim, Sung-Phil; Baek, Yong-Hyeon; Hong, Kwon-Eui; Choi, Sun-Mi

2015-07-26

The causes of chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) are not clearly known, and there are no definitive treatments for them. Therefore, patients with CFS and ICF are interested in Oriental medicine or complementary and alternative medicine. For this reason, the effectiveness of complementary and alternative treatments should be verified. We investigated the effectiveness of two forms of acupuncture added to usual care for CFS and ICF compared to usual care alone. A three-arm parallel, non-blinded, randomized controlled trial was performed in four hospitals. We divided 150 participants into treatment and control groups at the same ratio. The treatment groups (Group A, body acupuncture; Group B, Sa-am acupuncture) received 10 sessions for 4 weeks. The control group (Group C) continued usual care alone. The primary outcome was the Fatigue Severity Scale (FSS) at 5 weeks after randomization. Secondary outcomes were the FSS at 13 weeks and a short form of the Stress Response Inventory (SRI), the Beck Depression Inventory (BDI), the Numeric Rating Scale (NRS), and the EuroQol-5 Dimension (EQ-5D) at 5 and 13 weeks. Group A showed significantly lower FSS scores than Group C at 5 weeks (P = 0.023). SRI scores were significantly lower in the treatment groups than in the control group at 5 (Group A, P = 0.032; B, P <0.001) and 13 weeks (Group A, P = 0.037; B, P <0.001). Group B showed significantly lower BDI scores than Group C at 13 weeks (P = 0.007). NRS scores from the treatment groups were significantly reduced compared to control at 5 (Group A and B, P <0.001) and 13 weeks (Group A, P = 0.011; B, P = 0.002). Body acupuncture for 4 weeks in addition to usual care may help improve fatigue in CFS and ICF patients. Clinical Research Information Service (CRIS) KCT0000508; Registered on 12 August 2012.

Patient navigation for lung cancer screening among current smokers in community health centers a randomized controlled trial.

PubMed

Percac-Lima, Sanja; Ashburner, Jeffrey M; Rigotti, Nancy A; Park, Elyse R; Chang, Yuchiao; Kuchukhidze, Salome; Atlas, Steven J

2018-03-01

Annual chest computed tomography (CT) can decrease lung cancer mortality in high-risk individuals. Patient navigation improves cancer screening rates in underserved populations. Randomized controlled trial was conducted from February 2016 to January 2017 to evaluate the impact of a patient navigation program on lung cancer screening (LCS) among current smokers in five community health centers (CHCs) affiliated with an academic primary care network. We randomized 1200 smokers aged 55-77 years to intervention (n = 400) or usual care (n = 800). Navigators contacted patients to determine LCS eligibility, introduce shared decision making about screening, schedule appointments with primary care physicians (PCPs), and help overcome barriers to obtaining screening and follow-up. Control patients received usual care. The main outcome was the proportion of patients who had any chest CT. Secondary outcomes were the proportion of patients contacted, proportion receiving LCS CTs, screening results and number of lung cancers diagnosed. Of the 400 intervention patients, 335 were contacted and 76 refused participation. Of the 259 participants, 124 (48%) were ineligible for screening; 119 had smoked <30 pack-years, and five had competing comorbidities. Among the 135 eligible participants in the intervention group, 124 (92%) had any chest CT performed. In intention-to-treat analyses, 124 intervention patients (31%) had any chest CT versus 138 control patients (17.3%, P < 0.001). LCS CTs were performed in 94 intervention patients (23.5%) versus 69 controls (8.6%, P < 0.001). A total of 20% of screened patients required follow-up. Lung cancer was diagnosed in eight intervention (2%) and four control (0.5%) patients. A patient navigation program implemented in CHCs significantly increased LCS among high-risk current smokers. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Comprehensive approach for hypertension control in low-income populations: rationale and study design for the hypertension control program in Argentina.

PubMed

Mills, Katherine T; Rubinstein, Adolfo; Irazola, Vilma; Chen, Jing; Beratarrechea, Andrea; Poggio, Rosana; Dolan, Jacquelyn; Augustovski, Federico; Shi, Lizheng; Krousel-Wood, Marie; Bazzano, Lydia A; He, Jiang

2014-08-01

Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low-income communities. This article summarizes interventions to improve hypertension management and describes the rationale and study design for a cluster randomized trial testing whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive men and women and their families. We will recruit 1,890 adults from 18 clinics within a public primary care network in Argentina. Clinic patients with uncontrolled hypertension, their spouses and hypertensive family members will be enrolled. The comprehensive intervention program targets the primary care system through health care provider education, a home-based intervention among patients and their families (home delivery of antihypertensive medication, self-monitoring of blood pressure [BP], health education for medication adherence and lifestyle modification) conducted by community health workers and a mobile health intervention. The primary outcome is net change in systolic BP from baseline to month 18 between intervention and control groups among hypertensive study participants. The secondary outcomes are net change in diastolic BP, BP control and cost-effectiveness of the intervention. This study will generate urgently needed data on effective, practical and sustainable intervention programs aimed at controlling hypertension and concomitant cardiovascular disease in underserved populations in low- and middle-income countries.

Comprehensive Approach for Hypertension Control in Low-income Populations: Rationale and Study Design for the Hypertension Control Program in Argentina (HCPIA)

PubMed Central

Mills, Katherine T.; Rubinstein, Adolfo; Irazola, Vilma; Chen, Jing; Beratarrechea, Andrea; Poggio, Rosana; Dolan, Jacquelyn; Augustovski, Federico; Shi, Lizheng; Krousel-Wood, Marie; Bazzano, Lydia A.; He, Jiang

2014-01-01

Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low-income communities. This paper summarizes interventions to improve hypertension management and describes the rationale and study design for a cluster randomized trial testing whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive men and women and their families. We will recruit 1,890 adults from 18 clinics within a public primary care network in Argentina. Clinic patients with uncontrolled hypertension, their spouses and hypertensive family members will be enrolled. The comprehensive intervention program targets the primary care system through health care provider education, a home-based intervention among patients and their families (home delivery of antihypertensive medication, self-monitoring of blood pressure, health education for medication adherence and lifestyle modification) conducted by community health workers, and a mobile health intervention. The primary outcome is net change in systolic blood pressure from baseline to month 18 between intervention and control groups among hypertensive study participants. The secondary outcomes are net change in diastolic blood pressure, blood pressure control, and cost-effectiveness of the intervention. This study will generate urgently needed data on effective, practical, and sustainable intervention programs aimed at controlling hypertension and concomitant cardiovascular disease in underserved populations in low- and middle-income countries. PMID:24978148

Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial.

PubMed

Sussman, Jonathan; Bainbridge, Daryl; Whelan, Timothy J; Brazil, Kevin; Parpia, Sameer; Wiernikowski, Jennifer; Schiff, Susan; Rodin, Gary; Sergeant, Myles; Howell, Doris

2018-05-01

Better coordination of supportive services during the early phases of cancer care has been proposed to improve the care experience of patients. We conducted a randomized trial to test a community-based nurse-led coordination of care intervention in cancer patients. Surgical practices were cluster randomized to a control group involving usual care practices or a standardized nursing intervention consisting of an in-person supportive care assessment with ongoing support to meet identified needs, including linkage to community services. Newly diagnosed breast and colorectal cancer patients within 7 days of cancer surgery were eligible. The primary outcome was the patient-reported outcome (PRO) of continuity of care (CCCQ) measured at 3 weeks. Secondary outcomes included unmet supportive care needs (SCNS), quality of life (EORTC QLQ-C30), health resource utilization, and level of uncertainty with care trajectory (MUIS) at 3 and/or 8 weeks. A total of 121 breast and 72 colorectal patients were randomized through 28 surgical practices. There was a small improvement in the informational domain of continuity of care (difference 0.29 p = 0.05) and a trend to less emergency room use (15.8 vs 7.1%) (p = 0.07). There were no significant differences between groups on unmet need, quality of life, or uncertainty. We did not find substantial gaps in the PROs measured immediately following surgery for breast and colorectal cancer patients. The results of this study support a more targeted approach based on need and inform future research focused on improving navigation during the initial phases of cancer treatment. ClinicalTrials.gov Identifier: NCT00182234. SONICS-Effectiveness of Specialist Oncology Nursing.

Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: Study Protocol for a Prospective, Single-Blinded, Randomized Controlled Trial.

PubMed

Rühle, Annika; Oehme, Florian; Börnert, Katja; Fourie, Lana; Babst, Reto; Link, Björn-Christian; Metzger, Jürg; Beeres, Frank Jp

2017-05-01

Skin abscesses are a frequent encountered health care problem and lead to a significant source of morbidity. They consequently have an essential impact on the quality of life and work. To date, the type of aftercare for surgically drained abscesses remains under debate. This leads to undesirable practice variations. Many clinical standard protocols include sterile wound dressings twice a day by a home-care service to reduce the chance of a recurrent wound infection. It is unknown, however, whether reinfection rates are comparable to adequate wound irrigation with a nonsterile solution performed by the patient. Our hypothesis is that simple wound irrigation with nonsterile water for postoperative wound care after an abscess is surgically drained is feasible. We assume that in terms of reinfection and reintervention rates unsterile wound irrigation is equal to sterile wound irrigation. The primary aim of this study is therefore to investigate if there is a need for sterile wound irrigation after surgically drained spontaneous skin abscesses. In a prospective, randomized controlled, single-blinded, single-center trial based on a noninferiority design, we will enroll 128 patients randomized to either the control or the intervention group. The control group will be treated according to our current, standard protocol in which all patients receive a sterile wound irrigation performed by a home-care service twice a day. Patients randomized to the intervention group will be treated with a nonsterile wound irrigation (shower) twice a day. All patients will have a routine clinical control visit after 1, 3, 6, and 12 weeks in the outpatient clinic. Primary outcome is the reinfection and reoperation rate due to insufficient wound healing diagnosed either at the outpatient control visit or during general practitioner visits. Secondary outcome measures include a Short Form Health Survey, Visual Analog Scale, Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the EurolQol 5-Dimension Questionnaire. Those questionnaires will be completed at the outpatient control visits. The trial was started in June 2016 and enrolled 50 patients by article publication. Regarding the adherence to our protocol, we found 10% of loss to follow-up until now. Only 2 patients needed reoperation and only 1 patient needed a change of treatment (antiseptic therapy). Most patients are happy with their randomized treatment but as expected some patients in the sterile group complained about timing problems with their working hours and home-care service appointments. Most patients in the nonsterile group are satisfied being able to take care of their wounds independently although some patients still depend on the home-care service for the wound dressing. We are hoping to have enrolled enough patients by summer 2017. The follow-up will take until autumn 2017, and study results are expected to be published by the end of 2017. This trial is solely supported by the cantonal hospital of Lucerne. Nonsterile wound irrigation is more likely to be carried out independently by the patient than sterile wound irrigation. Therefore, if nonsterile wound care shows comparable results in terms of reinfection and reintervention rates, patient independence in the aftercare of surgically drained abscesses will increase, patients can return to work earlier, and health care costs can be reduced. In a preliminary, conservative estimation of health care costs, an annual savings of 300,000 CHF will be achieved in our hospital. German Clinical Trials Register DRKS00010418; https://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010418 (Archived by WebCite at http://www.webcitation.org/6q0AXp5EX). ©Annika Rühle, Florian Oehme, Katja Börnert, Lana Fourie, Reto Babst, Björn-Christian Link, Jürg Metzger, Frank JP Beeres. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.05.2017.

A controlled trial of web-based diabetes disease management: the MGH diabetes primary care improvement project.

PubMed

Meigs, James B; Cagliero, Enrico; Dubey, Anil; Murphy-Sheehy, Patricia; Gildesgame, Catharyn; Chueh, Henry; Barry, Michael J; Singer, Daniel E; Nathan, David M

2003-03-01

To test effects of a web-based decision support tool, the diabetes Disease Management Application (DMA), developed to improve evidence-based management of type 2 diabetes. We conducted a group randomized controlled trial of 12 intervention and 14 control staff providers and 307 intervention and 291 control patients with type 2 diabetes in a hospital-based internal medicine clinic. Providers were randomly assigned from May 1998 through April 1999 to have access to the DMA (intervention) or not to have access (control). The DMA displays interactive patient-specific clinical data, treatment advice, and links to other web-based care resources. We compared patients in the intervention and control groups for changes in processes and outcomes of care from the year preceding the study through the year of the study by intention-to-treat analysis. The DMA was used for 42% of scheduled patient visits. The number of HbA(1c) tests obtained per year increased significantly in the intervention group (+0.3 tests/year) compared with the control group (-0.04 tests/year, P = 0.008), as did the number of LDL cholesterol tests (intervention, +0.2 tests/year; control, +0.01 tests/year; P = 0.02) and the proportions of patients undergoing at least one foot examination per year (intervention, +9.8%; control, -0.7%; P = 0.003). Levels of HbA(1c) decreased by 0.2 in the intervention group and increased by 0.1 in the control group (P = 0.09); proportions of patients with LDL cholesterol levels <130 mg/dl increased by 20.3% in the intervention group and 10.5% in the control group (P = 0.5). Web-based patient-specific decision support has the potential to improve evidence-based parameters of diabetes care.

Effect of Kangaroo Mother Care on physical growth, breastfeeding and its acceptability.

PubMed

Gathwala, Geeta; Singh, Bir; Singh, Jagjit

2010-10-01

The aim of this study was to determine whether the implementation of Kangaroo Mother Care (KMC) to low birth weight infants would improve physical growth, breastfeeding and its acceptability. A randomized controlled trial was performed over 16 months in which 110 neonates were randomized into a KMC group and a control group using a random number table. The KMC group was subjected to KMC for at least 6 h per day. The babies also received KMC after moving from the neonatal intensive care unit and at home. The control group received standard care (incubator or open care system). Weight, length and occipitofrontal circumference (OFC) were measured weekly for three months. The acceptability of KMC by mothers and nursing staff was assessed on day 7 after the start of KMC using a questionnaire incorporating the Likert scale. Breastfeeding rates were calculated based on history at end of three months. The mean gestational age was 35.48 ± 1.20 weeks in the KMC group and 35.04 ± 1.09 weeks in the control group (P > 0.05). KMC was initiated at a mean age of 1.72 ± 0.45 days and the duration of KMC was 9.74 ± 1.48 h/day. The mean birth weight was 1.69 ± 0.11 kg in the KMC group compared to 1.69 ± 0.12 kg in the control group (P > 0.05). The mean weight gain in gm/day in the KMC group was 21.92 ± 1.44 compared to 18.61 ± 1.28 in the control group (P < 0.05). The mean length gain in cm/week was 1.03 ± 0.5 in the KMC group compared to 0.74 ± 0.05 in the control group (P < 0.05). The mean OFC gain in cm/week was 0.59 ± 0.04 in the KMC group compared to 0.47 ± 0.03 in the control group (P < 0.05). The exclusive breast-feeding rate at end of three months was 88% in the KMC group compared to 72% in the control group (P < 0.05). KMC improved physical growth, breastfeeding rates and was well accepted by both mothers and nursing staff.

Patient Navigation in Medically Underserved Areas study design: A trial with implications for efficacy, effect modification, and full continuum assessment.

PubMed

Molina, Yamile; Glassgow, Anne E; Kim, Sage J; Berrios, Nerida M; Pauls, Heather; Watson, Karriem S; Darnell, Julie S; Calhoun, Elizabeth A

2017-02-01

The Patient Navigation in Medically Underserved Areas study objectives are to assess if navigation improves: 1) care uptake and time to diagnosis; and 2) outcomes depending on patients' residential medically underserved area (MUA) status. Secondary objectives include the efficacy of navigation across 1) different points of the care continuum among patients diagnosed with breast cancer; and 2) multiple regular screening episodes among patients who did not obtain breast cancer diagnoses. Our randomized controlled trial was implemented in three community hospitals in South Chicago. Eligible participants were: 1) female, 2) 18+years old, 3) not pregnant, 4) referred from a primary care provider for a screening or diagnostic mammogram based on an abnormal clinical breast exam. Participants were randomized to 1) control care or 2) receive longitudinal navigation, through treatment if diagnosed with cancer or across multiple years if asymptomatic, by a lay health worker. Participants' residential areas were identified as: 1) established MUA (before 1998), 2) new MUA (after 1998), 3) eligible/but not designated as MUA, and 4) affluent/ineligible for MUA. Primary outcomes include days to initially recommended care after randomization and days to diagnosis for women with abnormal results. Secondary outcomes concern days to treatment initiation following a diagnosis and receipt of subsequent screening following normal/benign results. This intervention aims to assess the efficacy of patient navigation on breast cancer care uptake across the continuum. If effective, the program may improve rates of early cancer detection and breast cancer morbidity. Copyright © 2016 Elsevier Inc. All rights reserved.

Managing the space between visits: a randomized trial of disease management for diabetes in a community health center.

PubMed

Anderson, Daren R; Christison-Lagay, Joan; Villagra, Victor; Liu, Haibei; Dziura, James

2010-10-01

Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority populations. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients. We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center. Randomized controlled trial. All patients had type 2 diabetes, and the majority was Hispanic or African American. Most were urban-dwelling with low socioeconomic status, and nearly all had Medicaid or were uninsured. Clinical measures included glycemic control, blood pressure, lipid levels, and body mass index. Validated surveys were used to measure dietary habits and physical activity. A total of 146 patients were randomized to the intervention and 149 to the control group. Depressive symptoms were highly prevalent in both groups. Using an intention to treat analysis, there were no significant differences in the primary outcome (HbA1c) between the intervention and control groups at 12 months. There were also no significant differences for secondary clinical or behavioral outcome measures including BMI, systolic or diastolic blood pressure, LDL cholesterol, smoking, or intake of fruits and vegetables, or physical activity. A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone.

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease. Methods/Design The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial. Discussion The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage. Trial registration Trial registration reference: ISRCTN45433299 PMID:23356861

The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial

PubMed Central

2010-01-01

Background Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates. The European Quality of Care Pathway (EQCP) study on acute exacerbations of COPD (NTC00962468) is undertaken to determine how care pathways (CP) as complex intervention for hospital treatment of COPD affects care variability, adherence to evidence based key interventions and clinical outcomes. Methods An international cluster Randomized Controlled Trial (cRCT) will be performed in Belgium, Italy, Ireland and Portugal. Based on the power analysis, a sample of 40 hospital teams and 398 patients will be included in the study. In the control arm of the study, usual care will be provided. The experimental teams will implement a CP as complex intervention which will include three active components: a formative evaluation of the quality and organization of care, a set of evidence based key interventions, and support on the development and implementation of the CP. The main outcome will be six-month readmission rate. As a secondary endpoint a set of clinical outcome and performance indicators (including care process evaluation and team functioning indicators) will be measured in both groups. Discussion The EQCP study is the first international cRCT on care pathways. The design of the EQCP project is both a research study and a quality improvement project and will include a realistic evaluation framework including process analysis to further understand why and when CP can really work. Trial Registration number NCT00962468 PMID:21092098

Minimal impact of a care pathway for geriatric hip fracture patients.

PubMed

Panella, Massimiliano; Seys, Deborah; Sermeus, Walter; Bruyneel, Luk; Lodewijckx, Cathy; Deneckere, Svin; Sermon, An; Nijs, Stefaan; Boto, Paulo; Vanhaecht, Kris

2018-06-04

Adherence to guidelines for patients with proximal femur fracture is suboptimal. To evaluate the effect of a care pathway for the in-hospital management of older geriatric hip fracture patients on adherence to guidelines and patient outcomes. The European Quality of Care Pathways study is a cluster randomized controlled trial. 26 hospitals in Belgium, Italy and Portugal. Older adults with a proximal femur fracture (n = 514 patients) were included. Hospitals treating older adults (>65) with a proximal femur fracture were randomly assigned to an intervention group, i.e. implementation of a care pathway, or control group, i.e. usual care. Thirteen patient outcomes and 24 process indicators regarding in-hospital management, as well as three not-recommended care activities were measured. Adjusted and unadjusted regression analyses were conducted using intention-to-treat procedures. In the intervention group 301 patients in 15 hospitals were included, and in the control group 213 patients in 11 hospitals. Sixty-five percent of the patients were older than 80 years. The implementation of this care pathway had no significant impact on the thirteen patient outcomes. The preoperative management improved significantly. Eighteen of 24 process indicators improved, but only two improved significantly. Only for a few teams a geriatrician was an integral member of the treatment team. Implementation of a care pathway improved compliance to evidence, but no significant effect on patient outcomes was found. The impact of the collaboration between surgeons and geriatricians on adherence to guidelines and patient outcomes should be studied. ClinicalTrials.gov: NCT00962910. Copyright © 2018 Elsevier Ltd. All rights reserved.

Smoking relapse-prevention intervention for cancer patients: Study design and baseline data from the surviving SmokeFree randomized controlled trial.

PubMed

Díaz, Diana B; Brandon, Thomas H; Sutton, Steven K; Meltzer, Lauren R; Hoehn, Hannah J; Meade, Cathy D; Jacobsen, Paul B; McCaffrey, Judith C; Haura, Eric B; Lin, Hui-Yi; Simmons, Vani N

2016-09-01

Continued smoking after a cancer diagnosis contributes to several negative health outcomes. Although many cancer patients attempt to quit smoking, high smoking relapse rates have been observed. This highlights the need for a targeted, evidence-based smoking-relapse prevention intervention. The design, method, and baseline characteristics of a randomized controlled trial assessing the efficacy of a self-help smoking-relapse prevention intervention are presented. Cancer patients who had recently quit smoking were randomized to one of two conditions. The Usual Care (UC) group received the institution's standard of care. The smoking relapse-prevention intervention (SRP) group received standard of care, plus 8 relapse-prevention booklets mailed over a 3month period, and a targeted educational DVD developed specifically for cancer patients. Four hundred and fourteen participants were enrolled and completed a baseline survey. Primary outcomes will be self-reported smoking status at 6 and 12-months after baseline. Biochemical verification of smoking status was completed for a subsample. If found to be efficacious, this low-cost intervention could be easily disseminated with significant potential for reducing the risk of negative cancer outcomes associated with continued smoking. Copyright © 2016 Elsevier Inc. All rights reserved.

Cost-effectiveness of early interventions for non-specific low back pain: a randomized controlled study investigating medical yoga, exercise therapy and self-care advice.

PubMed

Aboagye, Emmanuel; Karlsson, Malin Lohela; Hagberg, Jan; Jensen, Irene

2015-02-01

To evaluate the cost-effectiveness of medical yoga as an early intervention compared with evidence-based exercise therapy and self-care advice for non-specific low back pain. Randomized controlled trial with a cost-effectiveness analysis. A total of 159 participants randomized into the medical yoga group (n = 52), the exercise therapy group (n = 52) and the self-care advice group (n = 55). The health outcome measure EQ-5D was applied to measure quality of life data combined with cost data collected from treatment groups from baseline to 12 months follow-up. Outcome measure was health-related quality of life (HRQL). Incremental cost per quality adjusted life year (QALY) was also calculated. Cost-effectiveness analysis was conducted primarily from the societal and employer perspectives. Medical yoga is cost-effective compared with self-care advice if an employer considers the significant improvement in the HRQL of an employee with low back pain justifies the additional cost of treatment (i.e. in this study EUR 150). From a societal perspective, medical yoga is a cost-effective treatment compared with exercise therapy and self-care advice if an additional QALY is worth EUR 11,500. Sensitivity analysis suggests that medical yoga is more cost-effective than its alternatives. Six weeks of uninterrupted medical yoga thera-py is a cost-effective early intervention for non-specific low back pain, when treatment recommendations are adhered to.

Yoga effects on mood and quality of life in Chinese women undergoing heroin detoxification: a randomized controlled trial.

PubMed

Zhuang, Shu-mei; An, Shi-hui; Zhao, Yue

2013-01-01

Yoga, as a mind-body therapy, is effective in improving quality of life for patients with chronic diseases, yet little is known about its effectiveness in female heroin addicts. The aim of this study was to evaluate the effects of yoga on mood status and quality of life among women undergoing detoxification for heroin dependence in China. This study was a randomized controlled trial. Seventy-five women aged 20-37 years undergoing detoxification for heroin dependence at AnKang Hospital were allocated randomly into an intervention or a control group. Women in the intervention group received a 6-month yoga intervention in addition to hospital routine care, and women in the control group received hospital routine care only. Mood status and quality of life were assessed using the Profile of Mood States and Medical Outcomes Study 36-item Short-Form Health Survey at baseline and following 3 and 6 months of treatment. Repeated-measures analysis of variance was used to evaluate treatment and time effects on mood and quality of life. Most female heroin addicts were young and single, with a low education level. Most had used heroin by injection. Mood state and quality of life of female heroin addicts were poor. The intervention group showed a significant improvement in mood status and quality of life over time compared with their counterparts in the control group. Yoga may improve mood status and quality of life for women undergoing detoxification for heroin dependence. Yoga can be used as an auxiliary treatment with traditional hospital routine care for these women.

Foot massage and physiological stress in people with dementia: a randomized controlled trial.

PubMed

Moyle, Wendy; Cooke, Marie Louise; Beattie, Elizabeth; Shum, David H K; O'Dwyer, Siobhan T; Barrett, Sue; Sung, Billy

2014-04-01

The anxiety associated with unfamiliar surroundings, the disorientation and mental confusion, and the social isolation that accompanies dementia can often create increased stress for people living in long-term care settings. Such a response is thought to affect the autonomic nervous system and result in emotional and physical symptoms of distress that may be manifested as agitation. There is the potential for such distress to influence the physiological response and in particular Blood Pressure and Heart Rate. A relaxation intervention such as massage may influence the physiological stress response. This randomized controlled trial aimed to compare the effect of foot massage (FM) versus a control activity (quiet presence, QP) on physiological stress response (i.e., blood pressure [BP] and heart rate [HR]) in people living with moderate-to-severe dementia in long-term-care settings. Fifty-three residents were randomized to intervention (10-minute FM) or control group (QP). While the FM group experienced a greater reduction in HR than the control group, these reductions were not significantly different between groups (p=0.83; see Table 1 ), or across time (p=0.46). Both groups experienced a reduction in systolic BP and diastolic BP, while the mean reduction in systolic BP was greater for those in the FM group. While the findings do not provide strong support for FM, the finding that both conditions allowed the person with dementia to rest in the presence of another human being is of importance in the care of people with dementia. The close presence of another person may in fact promote relaxation and therefore improve BP and HR measures.

Physiotherapy programme reduces fatigue in patients with advanced cancer receiving palliative care: randomized controlled trial.

PubMed

Pyszora, Anna; Budzyński, Jacek; Wójcik, Agnieszka; Prokop, Anna; Krajnik, Małgorzata

2017-09-01

Cancer-related fatigue (CRF) is a common and relevant symptom in patients with advanced cancer that significantly decreases their quality of life. The aim of this study was to evaluate the effect of a physiotherapy programme on CRF and other symptoms in patients diagnosed with advanced cancer. The study was designed as a randomized controlled trial. Sixty patients diagnosed with advanced cancer receiving palliative care were randomized into two groups: the treatment group (n = 30) and the control group (n = 30). The therapy took place three times a week for 2 weeks. The 30-min physiotherapy session included active exercises, myofascial release and proprioceptive neuromuscular facilitation (PNF) techniques. The control group did not exercise. The outcomes included Brief Fatigue Inventory (BFI), Edmonton Symptom Assessment Scale (ESAS) and satisfaction scores. The exercise programme caused a significant reduction in fatigue scores (BFI) in terms of severity of fatigue and its impact on daily functioning. In the control group, no significant changes in the BFI were observed. Moreover, the physiotherapy programme improved patients' general well-being and reduced the intensity of coexisting symptoms such as pain, drowsiness, lack of appetite and depression. The analysis of satisfaction scores showed that it was also positively evaluated by patients. The physiotherapy programme, which included active exercises, myofascial release and PNF techniques, had beneficial effects on CRF and other symptoms in patients with advanced cancer who received palliative care. The results of the study suggest that physiotherapy is a safe and effective method of CRF management.

Effectiveness of Training Clinicians' Communication Skills on Patients' Clinical Outcomes: A Systematic Review.

PubMed

Oliveira, Vinicius C; Ferreira, Manuela L; Pinto, Rafael Z; Filho, Ruben F; Refshauge, Kathryn; Ferreira, Paulo H

2015-10-01

The aim of this systematic review was to investigate the literature on the effectiveness of communication skills training for clinicians on patients' clinical outcomes in primary care and rehabilitation settings. We systematically reviewed the literature for randomized controlled trials investigating the effectiveness of communication skills training for clinicians on patients' satisfaction with care and on pain and disability in primary care and rehabilitation settings. The search strategy was conducted using AMED, PsycINFO, MEDLINE, CINAHL, EMBASE, PEDro, and Cochrane Central Register of Controlled Trials through June 2015. Methodological quality of included trials was assessed by 2 independent investigators using the PEDro scale, and consensus was used to resolve disagreements. Data were extracted, and meta-analyses were performed. Nineteen randomized controlled trials were included. Of these, 16 investigated communication training for clinicians that emphasized patient participation (eg, shared decision-making approaches). Communication training had small effects on patients' satisfaction with care when compared to control (4.1 points on a 100-point scale, 95% confidence interval [CI], 1.1-7.0). Communication training also had small effects on pain and disability with pooled results showing weighted mean differences of -3.8 points (95% CI, -6.5 to -1.1) and -3.6 (95% CI, -5.4 to -1.7), respectively. Studies show that communication training for clinicians produces small effects in improving patients' satisfaction with care or reducing pain and disability in primary care and rehabilitation settings. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

A 30-month worksite-based lifestyle program to promote cardiovascular health in middle-aged bank employees: Design of the TANSNIP-PESA randomized controlled trial.

PubMed

Coffeng, Jennifer K; van der Ploeg, Hidde P; Castellano, José M; Fernández-Alvira, Juan M; Ibáñez, Borja; García-Lunar, Inés; van der Beek, Allard J; Fernández-Ortiz, Antonio; Mocoroa, Agustín; García-Leal, Laura; Cárdenas, Evelyn; Rojas, Carolina; Martínez-Castro, María I; Santiago-Sacristán, Silvia; Fernández-Gallardo, Miriam; Mendiguren, José M; Bansilal, Sameer; van Mechelen, Willem; Fuster, Valentín

2017-02-01

Cardiovascular disease (CVD) is the leading cause of death worldwide. With atherosclerosis as the underlying cause for many CVD events, prevention or reduction of subclinical atherosclerotic plaque burden (SAPB) through a healthier lifestyle may have substantial public health benefits. The objective was to describe the protocol of a randomized controlled trial investigating the effectiveness of a 30-month worksite-based lifestyle program aimed to promote cardiovascular health in participants having a high or a low degree of SAPB compared with standard care. We will conduct a randomized controlled trial including middle-aged bank employees from the Progression of Early Subclinical Atherosclerosis cohort, stratified by SAPB (high SAPB n=260, low SAPB n=590). Within each stratum, participants will be randomized 1:1 to receive a lifestyle program or standard care. The program consists of 3 elements: (a) 12 personalized lifestyle counseling sessions using Motivational Interviewing over a 30-month period, (b) a wrist-worn physical activity tracker, and (c) a sit-stand workstation. Primary outcome measure is a composite score of blood pressure, physical activity, sedentary time, body weight, diet, and smoking (ie, adapted Fuster-BEWAT score) measured at baseline and at 1-, 2-, and 3-year follow-up. The study will provide insights into the effectiveness of a 30-month worksite-based lifestyle program to promote cardiovascular health compared with standard care in participants with a high or low degree of SAPB. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Improving depression and enhancing resilience in family dementia caregivers: a pilot randomized placebo-controlled trial of escitalopram

PubMed Central

Lavretsky, H.; Siddarth, P.; Irwin, M. R.

2009-01-01

Background This study examined the potential of an antidepressant drug, escitalopram, to improve depression, resilience to stress, and quality of life in family dementia caregivers in a randomized placebo-controlled double-blind trial. Methods Forty family caregivers (43–91 years of age, 25 children and 15 spouses; 26 women) who were taking care of their relatives with Alzheimer’s disease were randomized to receive either escitalopram 10 mg/day or placebo for 12 weeks. Severity of depression, resilience, burden, distress, quality of life, and severity of care-recipient’s cognitive and behavioral disturbances were assessed at baseline and over the course of the study. The Hamilton Depression Rating Scale (HDRS) scores at baseline ranged between 10–28. The groups were stratified by the diagnosis of major and minor depression. Results Most outcomes favored escitalopram over placebo. The severity of depression improved and the remission rate was greater with the drug compared to placebo. Measures of anxiety, resilience, burden and distress improved on escitalopram compared to placebo. Discussion Among caregivers, this small randomized controlled trial found that escitalopram use resulted in improvement in depression, resilience, burden and distress, and quality of life. Our results need to be confirmed in a larger sample. PMID:20104071

The Cost-Effectiveness of Using PARO, a Therapeutic Robotic Seal, to Reduce Agitation and Medication Use in Dementia: Findings from a Cluster-Randomized Controlled Trial.

PubMed

Mervin, Merehau C; Moyle, Wendy; Jones, Cindy; Murfield, Jenny; Draper, Brian; Beattie, Elizabeth; Shum, David H K; O'Dwyer, Siobhan; Thalib, Lukman

2018-01-09

To examine the within-trial costs and cost-effectiveness of using PARO, compared with a plush toy and usual care, for reducing agitation and medication use in people with dementia in long-term care. An economic evaluation, nested within a cluster-randomized controlled trial. Twenty-eight facilities in South-East Queensland, Australia. A total of 415 residents, all aged 60 years or older, with documented diagnoses of dementia. Facilities were randomized to 1 of 3 groups: PARO (individual, nonfacilitated 15-minute sessions, 3 afternoons per week for 10 weeks); plush toy (as per PARO but with artificial intelligence disabled); and usual care. The incremental cost per Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) point averted from a provider's perspective. Australian New Zealand Clinical Trials Registry (BLINDED FOR REVIEW). For the within-trial costs, the PARO group was $50.47 more expensive per resident compared with usual care, whereas the plush toy group was $37.26 more expensive than usual care. There were no statistically significant between-group differences in agitation levels after the 10-week intervention. The point estimates of the incremental cost-effectiveness ratios were $13.01 for PARO and $12.85 for plush toy per CMAI-SF point averted relative to usual care. The plush toy used in this study offered marginally greater value for money than PARO in improving agitation. However, these costs are much lower than values estimated for psychosocial group activities and sensory interventions, suggesting that both a plush toy and the PARO are cost-effective psychosocial treatment options for agitation. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Testing the effects of brief intervention in primary care for problem drug use in a randomized controlled trial: rationale, design, and methods.

PubMed

Krupski, Antoinette; Joesch, Jutta M; Dunn, Chris; Donovan, Dennis; Bumgardner, Kristin; Lord, Sarah Peregrine; Ries, Richard; Roy-Byrne, Peter

2012-12-14

A substantial body of research has established the effectiveness of brief interventions for problem alcohol use. Following these studies, national dissemination projects of screening, brief intervention (BI), and referral to treatment (SBIRT) for alcohol and drugs have been implemented on a widespread scale in multiple states despite little existing evidence for the impact of BI on drug use for non-treatment seekers. This article describes the design of a study testing the impact of SBIRT on individuals with drug problems, its contributions to the existing literature, and its potential to inform drug policy. The study is a randomized controlled trial of an SBIRT intervention carried out in a primary care setting within a safety net system of care. Approximately 1,000 individuals presenting for scheduled medical care at one of seven designated primary care clinics who endorse problematic drug use when screened are randomized in a 1:1 ratio to BI versus enhanced care as usual (ECAU). Individuals in both groups are reassessed at 3, 6, 9, and 12 months after baseline. Self-reported drug use and other psychosocial measures collected at each data point are supplemented by urine analysis and public health-related data from administrative databases. This study will contribute to the existing literature by providing evidence for the impact of BI on problem drug use based on a broad range of measures including self-reported drug use, urine analysis, admission to drug abuse treatment, and changes in utilization and costs of health care services, arrests, and death with the intent of informing policy and program planning for problem drug use at the local, state, and national levels. ClinicalTrials.gov NCT00877331.

Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED).

PubMed

Towfighi, Amytis; Cheng, Eric M; Ayala-Rivera, Monica; McCreath, Heather; Sanossian, Nerses; Dutta, Tara; Mehta, Bijal; Bryg, Robert; Rao, Neal; Song, Shlee; Razmara, Ali; Ramirez, Magaly; Sivers-Teixeira, Theresa; Tran, Jamie; Mojarro-Huang, Elizabeth; Montoya, Ana; Corrales, Marilyn; Martinez, Beatrice; Willis, Phyllis; Macias, Mireya; Ibrahim, Nancy; Wu, Shinyi; Wacksman, Jeremy; Haber, Hilary; Richards, Adam; Barry, Frances; Hill, Valerie; Mittman, Brian; Cunningham, William; Liu, Honghu; Ganz, David A; Factor, Diane; Vickrey, Barbara G

2017-02-06

Recurrent strokes are preventable through awareness and control of risk factors such as hypertension, and through lifestyle changes such as healthier diets, greater physical activity, and smoking cessation. However, vascular risk factor control is frequently poor among stroke survivors, particularly among socio-economically disadvantaged blacks, Latinos and other people of color. The Chronic Care Model (CCM) is an effective framework for multi-component interventions aimed at improving care processes and outcomes for individuals with chronic disease. In addition, community health workers (CHWs) have played an integral role in reducing health disparities; however, their effectiveness in reducing vascular risk among stroke survivors remains unknown. Our objectives are to develop, test, and assess the economic value of a CCM-based intervention using an Advanced Practice Clinician (APC)-CHW team to improve risk factor control after stroke in an under-resourced, racially/ethnically diverse population. In this single-blind randomized controlled trial, 516 adults (≥40 years) with an ischemic stroke, transient ischemic attack or intracerebral hemorrhage within the prior 90 days are being enrolled at five sites within the Los Angeles County safety-net setting and randomized 1:1 to intervention vs usual care. Participants are excluded if they do not speak English, Spanish, Cantonese, Mandarin, or Korean or if they are unable to consent. The intervention includes a minimum of three clinic visits in the healthcare setting, three home visits, and Chronic Disease Self-Management Program group workshops in community venues. The primary outcome is blood pressure (BP) control (systolic BP <130 mmHg) at 1 year. Secondary outcomes include: (1) mean change in systolic BP; (2) control of other vascular risk factors including lipids and hemoglobin A1c, (3) inflammation (C reactive protein [CRP]), (4) medication adherence, (5) lifestyle factors (smoking, diet, and physical activity), (6) estimated relative reduction in risk for recurrent stroke or myocardial infarction (MI), and (7) cost-effectiveness of the intervention versus usual care. If this multi-component interdisciplinary intervention is shown to be effective in improving risk factor control after stroke, it may serve as a model that can be used internationally to reduce race/ethnic and socioeconomic disparities in stroke in resource-constrained settings. ClinicalTrials.gov Identifier NCT01763203 .

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).

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

An investigation of associations between clinicians' ethnic or racial bias and hypertension treatment, medication adherence and blood pressure control.

PubMed

Blair, Irene V; Steiner, John F; Hanratty, Rebecca; Price, David W; Fairclough, Diane L; Daugherty, Stacie L; Bronsert, Michael; Magid, David J; Havranek, Edward P

2014-07-01

Few studies have directly investigated the association of clinicians' implicit (unconscious) bias with health care disparities in clinical settings. To determine if clinicians' implicit ethnic or racial bias is associated with processes and outcomes of treatment for hypertension among black and Latino patients, relative to white patients. Primary care clinicians completed Implicit Association Tests of ethnic and racial bias. Electronic medical records were queried for a stratified, random sample of the clinicians' black, Latino and white patients to assess treatment intensification, adherence and control of hypertension. Multilevel random coefficient models assessed the associations between clinicians' implicit biases and ethnic or racial differences in hypertension care and outcomes. Standard measures of treatment intensification and medication adherence were calculated from pharmacy refills. Hypertension control was assessed by the percentage of time that patients met blood pressure goals recorded during primary care visits. One hundred and thirty-eight primary care clinicians and 4,794 patients with hypertension participated. Black patients received equivalent treatment intensification, but had lower medication adherence and worse hypertension control than white patients; Latino patients received equivalent treatment intensification and had similar hypertension control, but lower medication adherence than white patients. Differences in treatment intensification, medication adherence and hypertension control were unrelated to clinician implicit bias for black patients (P = 0.85, P = 0.06 and P = 0.31, respectively) and for Latino patients (P = 0.55, P = 0.40 and P = 0.79, respectively). An increase in clinician bias from average to strong was associated with a relative change of less than 5 % in all outcomes for black and Latino patients. Implicit bias did not affect clinicians' provision of care to their minority patients, nor did it affect the patients' outcomes. The identification of health care contexts in which bias does not impact outcomes can assist both patients and clinicians in their efforts to build trust and partnership.

Mindfulness-based cognitive therapy for anxiety symptoms in older adults in residential care.

PubMed

Helmes, Edward; Ward, Bradley G

2017-03-01

Anxiety in older people is under-diagnosed and poorly treated despite significant impairments that arise from anxiety. Mindfulness-based cognitive therapy (MBCT) has been shown to be a promising treatment for anxiety. The aim of this study was to determine the effect of an MBCT program on anxiety symptoms in older people living in residential care. Fifty-two participants (34 females) were randomly allocated into therapy and control groups using a 2 × 3 mixed design. The average age of participants was 83 years. The group effect showed significant improvements on all measures at the end of the seven-week program in the therapy group, while the control group did not show significant changes. This study represents one of the first studies of the effectiveness of an MBCT program on anxiety symptoms for older people using a randomized controlled trial. The study has implications for future research that include the effectiveness of MBCT for the treatment of anxiety symptoms in older people, the utility of group therapy programs in residential care and the benefits of using specialized instruments for older populations.

Patient navigation to promote smoking cessation among low-income primary care patients: a pilot randomized controlled trial.

PubMed

Lasser, Karen E; Kenst, Karey S; Quintiliani, Lisa M; Wiener, Renda Soylemez; Murillo, Jennifer; Pbert, Lori; Xuan, Ziming; Bowen, Deborah J

2013-01-01

We conducted a pilot randomized controlled trial to determine the feasibility and acceptability of a patient navigation intervention. Forty-seven smokers from one safety-net hospital were randomized to either a control group, in which they received a smoking cessation brochure and a list of smoking cessation resources, or a navigation group, in which they received the smoking cessation brochure, a list of smoking cessation resources, and patient navigation. Follow-up data were obtained for 33 participants. Nine (47.4%) of 19 of navigation group participants had engaged in smoking cessation treatment by 3 months versus 6 (42.9%) of 14 control group participants (chi-square p = ns). Patient navigation to promote engagement in smoking cessation treatment was feasible and acceptable to participants.

Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial

PubMed Central

Wolf, Michael S.; Kaiser, Darren; Morrow, Daniel G.

2016-01-01

Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™) implemented via an electronic medical record to improve patients' medication knowledge, adherence, and glycemic control compared to usual care. Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months. Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients' knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients' demonstrated medication use, regimen adherence, or glycemic control (HbA1c). Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.gov NCT01296633. PMID:27699179

Reflexology: its effects on physiological anxiety signs and sedation needs.

PubMed

Akin Korhan, Esra; Khorshid, Leyla; Uyar, Mehmet

2014-01-01

To investigate whether reflexology has an effect on the physiological signs of anxiety and level of sedation in patients receiving mechanically ventilated support, a single blinded, randomized controlled design with repeated measures was used in the intensive care unit of a university hospital in Turkey. Patients (n = 60) aged between 18 and 70 years and were hospitalized in the intensive care unit and receiving mechanically ventilated support. Participants were randomized to a control group or an intervention group. The latter received 30 minutes of reflexology therapy on their feet, hands, and ears for 5 days. Subjects had vital signs taken immediately before the intervention and at the 10th, 20th, and 30th minutes of the intervention. In the collection of the data, "American Association of Critical-Care Nurses Sedation Assessment Scale" was used. The reflexology therapy group had a significantly lower heart rate, systolic blood pressure, diastolic blood pressure, and respiratory rate than the control group. A statistically significant difference was found between the averages of the scores that the patients included in the experimental and control groups received from the agitation, anxiety, sleep, and patient-ventilator synchrony subscales of the American Association of Critical-Care Nurses Sedation Assessment Scale. Reflexology can serve as an effective method of decreasing the physiological signs of anxiety and the required level of sedation in patients receiving mechanically ventilated support. Nurses who have appropriate training and certification may include reflexology in routine care to reduce the physiological signs of anxiety of patients receiving mechanical ventilation.

Assessing the value of disease management: impact of 2 disease management strategies in an underserved asthma population.

PubMed

Galbreath, Autumn Dawn; Smith, Brad; Wood, Pamela R; Inscore, Stephen; Forkner, Emma; Vazquez, Marilu; Fallot, Andre; Ellis, Robert; Peters, Jay I

2008-12-01

The goal of disease management (DM) is to improve health outcomes and reduce cost through decreasing health care utilization. Although some studies have shown that DM improves asthma outcomes, these interventions have not been examined in a large randomized controlled trial. To compare the effectiveness of 2 previously successful DM programs with that of traditional care. Nine hundred two individuals with asthma (429 adults; 473 children) were randomly assigned to telephonic DM, augmented DM (ADM; DM plus in-home visits by a respiratory therapist), or traditional care. Data were collected at enrollment and at 6 and 12 months. Primary outcomes were time to first asthma-related event, quality of life (QOL), and rates of asthma-related health care utilization. Secondary outcomes included rate of controller medication initiation, number of oral corticosteroid bursts, asthma symptom scores, and number of school days missed. There were no significant differences between groups in time to first asthma-related event or health care utilization. Adult participants in the ADM group had greater improvement in QOL (P = .04) and a decrease in asthma symptoms (P = .001) compared with other groups. Of children not receiving controller medications at enrollment (13%), those in the intervention groups were more likely to have controller medications initiated than the control group (P = .01). Otherwise, there were no differences in outcomes. Overall, participation in asthma DM did not result in significant differences in utilization or clinical outcomes. The only significant impact was a higher rate of controllermedication initiation in children and improvement in asthma symptoms and QOL in adults who received ADM.

Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial.

PubMed

Rossignol, Patrick; Dorval, Marc; Fay, Renaud; Ros, Joan Fort; Loughraieb, Nathalie; Moureau, Frédérique; Laville, Maurice

2013-06-01

Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Current guidelines state that in patients with increased bleeding risks, strategies that can induce systemic anticoagulation should be avoided. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding, although on-line blood predilution may also be used. A new dialyzer, Evodial (Gambro, Lund, Sweden), is grafted with unfractionated heparin during the manufacturing process and may allow safe and efficient heparin-free hemodialysis sessions. In the present trial, Evodial was compared to standard care with either saline flushes or blood predilution. The HepZero study is the first international (seven countries), multicenter (10 centers), randomized, controlled, open-label, non-inferiority (and if applicable subsequently, superiority) trial with two parallel groups, comprising 252 end-stage renal disease patients treated by maintenance hemodialysis for at least 3 months and requiring heparin-free dialysis treatments. Patients will be treated during a maximum of three heparin-free dialysis treatments with either saline flushes or blood predilution (control group), or Evodial. The first heparin-free dialysis treatment will be considered successful when there is: no complete occlusion of air traps or dialyzer rendering dialysis impossible; no additional saline flushes to prevent clotting; no change of dialyzer or blood lines because of clotting; and no premature termination (early rinse-back) because of clotting.The primary objectives of the study are to determine the effectiveness of the Evodial dialyzer, compared with standard care in terms of successful treatments during the first heparin-free dialysis. If the non-inferiority of Evodial is demonstrated then the superiority of Evodial over standard care will be tested. The HepZero study results may have major clinical implications for patient care. ClinicalTrials.gov NCT01318486.

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

PubMed Central

2012-01-01

Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob) PMID:23130754

Effectiveness of advance care planning with family carers in dementia nursing homes: A paired cluster randomized controlled trial.

PubMed

Brazil, Kevin; Carter, Gillian; Cardwell, Chris; Clarke, Mike; Hudson, Peter; Froggatt, Katherine; McLaughlin, Dorry; Passmore, Peter; Kernohan, W George

2018-03-01

In dementia care, a large number of treatment decisions are made by family carers on behalf of their family member who lacks decisional capacity; advance care planning can support such carers in the decision-making of care goals. However, given the relative importance of advance care planning in dementia care, the prevalence of advance care planning in dementia care is poor. To evaluate the effectiveness of advance care planning with family carers in dementia care homes. Paired cluster randomized controlled trial. The intervention comprised a trained facilitator, family education, family meetings, documentation of advance care planning decisions and intervention orientation for general practitioners and nursing home staff. A total of 24 nursing homes with a dementia nursing category located in Northern Ireland, United Kingdom. Family carers of nursing home residents classified as having dementia and judged as not having decisional capacity to participate in advance care planning discussions. The primary outcome was family carer uncertainty in decision-making about the care of the resident (Decisional Conflict Scale). There was evidence of a reduction in total Decisional Conflict Scale score in the intervention group compared with the usual care group (-10.5, 95% confidence interval: -16.4 to -4.7; p < 0.001). Advance care planning was effective in reducing family carer uncertainty in decision-making concerning the care of their family member and improving perceptions of quality of care in nursing homes. Given the global significance of dementia, the implications for clinicians and policy makers include them recognizing the importance of family carer education and improving communication between family carers and formal care providers.

Effects of group prenatal care on psychosocial risk in pregnancy: Results from a randomised controlled trial

PubMed Central

Ickovics, Jeannette R.; Reed, Elizabeth; Magriples, Urania; Westdahl, Claire; Rising, Sharon Schindler; Kershaw, Trace S.

2012-01-01

Few interventions have succeeded in reducing psychosocial risk among pregnant women. The objective of this study was to determine whether an integrated group prenatal care intervention already shown to improve perinatal and sexual risk outcomes can also improve psychosocial outcomes compared to standard individual care. This randomised controlled trial included pregnant women ages 14–25 from two public hospitals (N = 1047) who were randomly assigned to standard individual care, group prenatal care or integrated group prenatal care intervention (CenteringPregnancy Plus, CP+). Timing and content of visits followed obstetrical guidelines, from 18-week gestation through birth. Each 2-h group prenatal care session included physical assessment, education/skills building and support via facilitated discussion. Using intention-to-treat models, there were no significant differences in psychosocial function; yet, women in the top tertile of psychosocial stress at study entry did benefit from integrated group care. High-stress women randomly assigned to CP+ reported significantly increased self-esteem, decreased stress and social conflict in the third trimester of pregnancy; social conflict and depression were significantly lower 1-year postpartum (all p-values <0.02). CP+ improved psychosocial outcomes for high-stress women. This ‘bundled’ intervention has promise for improving psychosocial outcomes, especially for young pregnant women who are traditionally more vulnerable and underserved. PMID:21318932

Results of the Medicare Health Support disease-management pilot program.

PubMed

McCall, Nancy; Cromwell, Jerry

2011-11-03

In the Medicare Modernization Act of 2003, Congress required the Centers for Medicare and Medicaid Services to test the commercial disease-management model in the Medicare fee-for-service program. The Medicare Health Support Pilot Program was a large, randomized study of eight commercial programs for disease management that used nurse-based call centers. We randomly assigned patients with heart failure, diabetes, or both to the intervention or to usual care (control) and compared them with the use of a difference-in-differences method to evaluate the effects of the commercial programs on the quality of clinical care, acute care utilization, and Medicare expenditures for Medicare fee-for-service beneficiaries. The study included 242,417 patients (163,107 in the intervention group and 79,310 in the control group). The eight commercial disease-management programs did not reduce hospital admissions or emergency room visits, as compared with usual care. We observed only 14 significant improvements in process-of-care measures out of 40 comparisons. These modest improvements came at substantial cost to the Medicare program in fees paid to the disease-management companies ($400 million), with no demonstrable savings in Medicare expenditures. In this large study, commercial disease-management programs using nurse-based call centers achieved only modest improvements in quality-of-care measures, with no demonstrable reduction in the utilization of acute care or the costs of care.

The Uganda Newborn Study (UNEST): an effectiveness study on improving newborn health and survival in rural Uganda through a community-based intervention linked to health facilities - study protocol for a cluster randomized controlled trial

PubMed Central

2012-01-01

Background Reducing neonatal-related deaths is one of the major bottlenecks to achieving Millennium Development Goal 4. Studies in Asia and South America have shown that neonatal mortality can be reduced through community-based interventions, but these have not been adapted to scalable intervention packages for sub-Saharan Africa where the culture, health system and policy environment is different. In Uganda, health outcomes are poor for both mothers and newborn babies. Policy opportunities for neonatal health include the new national Health Sector Strategic Plan, which now prioritizes newborn health including use of a community model through Village Health Teams (VHT). The aim of the present study is to adapt, develop and cost an integrated maternal-newborn care package that links community and facility care, and to evaluate its effect on maternal and neonatal practices in order to inform policy and scale-up in Uganda. Methods/Design Through formative research around evidence-based practices, and dialogue with policy and technical advisers, we constructed a home-based neonatal care package implemented by the responsible VHT member, effectively a Community Health Worker (CHW). This CHW was trained to identify pregnant women and make five home visits - two before and three just after birth - so that linkages will be made to facility care and targeted messages for home-care and care-seeking delivered. The project is improving care in health units to provide standardized care for the mother and the newborn in both intervention and comparison areas. The study is taking place in a new Demographic Surveillance Site in two rural districts, Iganga and Mayuge, in Uganda. It is a two-arm cluster randomized controlled design with 31 intervention and 32 control areas (villages). The comparison parishes receive the standard care already being provided by the district, but to the intervention villages are added a system for CHWs to visit the mother five times in her home during pregnancy and the neonatal period. Both areas benefit from a standardized strengthening of facility care for mothers and neonates. Discussion UNEST is designed to directly feed into the operationalization of maternal and newborn care in the national VHT strategy, thereby helping to inform scale-up in rural Uganda. The study is registered as a randomized controlled trial, number ISRCTN50321130. PMID:23153395

Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial.

PubMed

Cox, Vincent Cm; Schepers, Vera Pm; Ketelaar, Marjolijn; van Heugten, Caroline M; Visser-Meily, Johanna Ma

2018-02-16

Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y). ©Vincent CM Cox, Vera PM Schepers, Marjolijn Ketelaar, Caroline M van Heugten, Johanna MA Visser-Meily. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.02.2018.

Effect of foot massage to decrease physiological lower leg oedema in late pregnancy: a randomized controlled trial in Turkey.

PubMed

Coban, Ayden; Sirin, Ahsen

2010-10-01

This study aims to evaluate the effect of foot massage for decreasing physiological lower leg oedema in late pregnancy. Eighty pregnant women were randomly divided into two groups; study group had a 20 min foot massage daily for 5 days whereas the control group did not receive any intervention beyond standard prenatal care. The research was conducted between March and August 2007 in Manisa Province Health Ministry Central Primary Health Care Clinic 1, in Manisa, Western Turkey. Compared with the control group, women in the experimental group had a significantly smaller lower leg circumference (right and left, ankle, instep and metatarsal-phalanges joint) after 5 days of massage. The results obtained from our research show that foot massage was found to have a positive effect on decreasing normal physiological lower leg oedema in late pregnancy. © 2010 Blackwell Publishing Asia Pty Ltd.

Evaluation of the Efficiency of the Nursing Care Plan Applied Using NANDA, NOC, and NIC Linkages to Elderly Women with Incontinence Living in a Nursing Home: A Randomized Controlled Study.

PubMed

Gencbas, Dercan; Bebis, Hatice; Cicek, Hatice

2017-05-30

Evaluate the efficiency of the nursing care plan, applied with the use of NANDA-I, NOC, and NIC (NNN) linkages, for elderly women with incontinence who live in nursing homes. A randomized controlled experimental design was applied. NNN linkages were prepared and applied for 12 weeks in an experimental group. NOC scales were evaluated again for two groups. A 0.5 NOC point change targeted in all elderly in the experimental group were provided between pretest-posttest scores. The experimental group had higher life quality and lower incontinence severity/symptoms than the control group. It is important that NNN linkages effective for solving the problems are used in different groups and with larger samples to create further evidence linking NNN. © 2017 NANDA International, Inc.