Implementation of a Telephone Postoperative Clinic in an Integrated Health System.

PubMed

Kummerow Broman, Kristy; Roumie, Christianne L; Stewart, Melissa K; Castellanos, Jason A; Tarpley, John L; Dittus, Robert S; Pierce, Richard A

2016-10-01

Earlier work suggested that telephone follow-up could be used in lieu of in-person follow-up after surgery, saving patients time and travel and maximizing use of scarce surgeon and facility resources. We report our experience implementing and evaluating telephone postoperative follow-up within an integrated health system. We conducted a pre-post evaluation of a general surgery telephone postoperative clinic at a tertiary care Veterans Affairs facility from April 2015 to February 2016. Patients were offered a telephone postoperative visit from a surgical provider in lieu of an in-person clinic visit. Telephone clinic operating procedures were refined through iterative cycles of change using the Plan-Do-Study-Act method. The study period included 2 months pre-intervention and 9 months post-intervention. The primary end point was mean number of clinic visits per eligible patient before and after telephone clinic implementation. Secondary outcomes were rates of emergency department visits and readmissions before vs after telephone clinic implementation and complication rates in patients scheduled for telephone vs in-person postoperative care. During the study period, 200 patients underwent eligible operations, 29 pre-intervention and 171 post-intervention. In-person clinic use decreased from 0.83 visits per eligible patient pre-intervention to 0.40 after implementation of the telephone clinic (p < 0.01). There was no difference in rates of emergency department presentation or readmission in eligible patients (0.17 visits/patient pre-intervention vs 0.12 post-intervention; p = 0.36). Complication rates were comparable for eligible patients who were and were not scheduled for telephone care (6% vs 8%; p = 0.31). Telephone postoperative care can be used in select populations as a triage tool to identify patients who require in-person care and decrease overall in-person clinic use. Published by Elsevier Inc.

Pharmacological interventions to improve cognition and adaptive functioning in Down syndrome: Strides to date.

PubMed

Hart, Sarah J; Visootsak, Jeannie; Tamburri, Paul; Phuong, Patrick; Baumer, Nicole; Hernandez, Maria-Clemencia; Skotko, Brian G; Ochoa-Lubinoff, Cesar; Liogier D'Ardhuy, Xavier; Kishnani, Priya S; Spiridigliozzi, Gail A

2017-11-01

Although an increasing number of clinical trials have been developed for cognition in Down syndrome, there has been limited success to date in identifying effective interventions. This review describes the progression from pre-clinical studies with mouse models to human clinical trials research using pharmacological interventions to improve cognition and adaptive functioning in Down syndrome. We also provide considerations for investigators when conducting human clinical trials and describe strategies for the pharmaceutical industry to advance the field in drug discovery for Down syndrome. Future research focusing on earlier pharmaceutical interventions, development of appropriate outcome measures, and greater collaboration between industry, academia, advocacy, and regulatory groups will be important for addressing limitations from prior studies and developing potential effective interventions for cognition in Down syndrome. © 2017 Wiley Periodicals, Inc.

Weight management interventions in adults with intellectual disabilities and obesity: a systematic review of the evidence.

PubMed

Spanos, Dimitrios; Melville, Craig Andrew; Hankey, Catherine Ruth

2013-09-23

To evaluate the clinical effectiveness of weight management interventions in adults with intellectual disabilities (ID) and obesity using recommendations from current clinical guidelines for the first line management of obesity in adults. Full papers on lifestyle modification interventions published between 1982 to 2011 were sought by searching the Medline, Embase, PsycINFO and CINAHL databases. Studies were evaluated based on (1) intervention components, (2) methodology, (3) attrition rate (4) reported weight loss and (5) duration of follow up. Twenty two studies met the inclusion criteria. The interventions were classified according to inclusion of the following components: behaviour change alone, behaviour change plus physical activity, dietary advice or physical activity alone, dietary plus physical activity advice and multi-component (all three components). The majority of the studies had the same methodological limitations: no sample size justification, small heterogeneous samples, no information on randomisation methodologies. Eight studies were classified as multi-component interventions, of which one study used a 600 kilocalorie (2510 kilojoule) daily energy deficit diet. Study durations were mostly below the duration recommended in clinical guidelines and varied widely. No study included an exercise program promoting 225-300 minutes or more of moderate intensity physical activity per week but the majority of the studies used the same behaviour change techniques. Three studies reported clinically significant weight loss (≥ 5%) at six months post intervention. Current data indicate weight management interventions in those with ID differ from recommended practice and further studies to examine the effectiveness of multi-component weight management interventions for adults with ID and obesity are justified.

Weight management interventions in adults with intellectual disabilities and obesity: a systematic review of the evidence

PubMed Central

2013-01-01

To evaluate the clinical effectiveness of weight management interventions in adults with intellectual disabilities (ID) and obesity using recommendations from current clinical guidelines for the first line management of obesity in adults. Full papers on lifestyle modification interventions published between 1982 to 2011 were sought by searching the Medline, Embase, PsycINFO and CINAHL databases. Studies were evaluated based on 1) intervention components, 2) methodology, 3) attrition rate 4) reported weight loss and 5) duration of follow up. Twenty two studies met the inclusion criteria. The interventions were classified according to inclusion of the following components: behaviour change alone, behaviour change plus physical activity, dietary advice or physical activity alone, dietary plus physical activity advice and multi-component (all three components). The majority of the studies had the same methodological limitations: no sample size justification, small heterogeneous samples, no information on randomisation methodologies. Eight studies were classified as multi-component interventions, of which one study used a 600 kilocalorie (2510 kilojoule) daily energy deficit diet. Study durations were mostly below the duration recommended in clinical guidelines and varied widely. No study included an exercise program promoting 225–300 minutes or more of moderate intensity physical activity per week but the majority of the studies used the same behaviour change techniques. Three studies reported clinically significant weight loss (≥ 5%) at six months post intervention. Current data indicate weight management interventions in those with ID differ from recommended practice and further studies to examine the effectiveness of multi-component weight management interventions for adults with ID and obesity are justified. PMID:24060348

Can the theoretical domains framework account for the implementation of clinical quality interventions?

PubMed

Lipworth, Wendy; Taylor, Natalie; Braithwaite, Jeffrey

2013-12-21

The health care quality improvement movement is a complex enterprise. Implementing clinical quality initiatives requires attitude and behaviour change on the part of clinicians, but this has proven to be difficult. In an attempt to solve this kind of behavioural challenge, the theoretical domains framework (TDF) has been developed. The TDF consists of 14 domains from psychological and organisational theory said to influence behaviour change. No systematic research has been conducted into the ways in which clinical quality initiatives map on to the domains of the framework. We therefore conducted a qualitative mapping experiment to determine to what extent, and in what ways, the TDF is relevant to the implementation of clinical quality interventions. We conducted a thematic synthesis of the qualitative literature exploring clinicians' perceptions of various clinical quality interventions. We analysed and synthesised 50 studies in total, in five domains of clinical quality interventions: clinical quality interventions in general, structural interventions, audit-type interventions, interventions aimed at making practice more evidence-based, and risk management interventions. Data were analysed thematically, followed by synthesis of these themes into categories and concepts, which were then mapped to the domains of the TDF. Our results suggest that the TDF is highly relevant to the implementation of clinical quality interventions. It can be used to map most, if not all, of the attitudinal and behavioural barriers and facilitators of uptake of clinical quality interventions. Each of these 14 domains appeared to be relevant to many different types of clinical quality interventions. One possible additional domain might relate to perceived trustworthiness of those instituting clinical quality interventions. The TDF can be usefully applied to a wide range of clinical quality interventions. Because all 14 of the domains emerged as relevant, and we did not identify any obvious differences between different kinds of clinical quality interventions, our findings support an initially broad approach to identifying barriers and facilitators, followed by a "drilling down" to what is most contextually salient. In future, it may be possible to establish a model of clinical quality policy implementation using the TDF.

Can the theoretical domains framework account for the implementation of clinical quality interventions?

PubMed Central

2013-01-01

Background The health care quality improvement movement is a complex enterprise. Implementing clinical quality initiatives requires attitude and behaviour change on the part of clinicians, but this has proven to be difficult. In an attempt to solve this kind of behavioural challenge, the theoretical domains framework (TDF) has been developed. The TDF consists of 14 domains from psychological and organisational theory said to influence behaviour change. No systematic research has been conducted into the ways in which clinical quality initiatives map on to the domains of the framework. We therefore conducted a qualitative mapping experiment to determine to what extent, and in what ways, the TDF is relevant to the implementation of clinical quality interventions. Methods We conducted a thematic synthesis of the qualitative literature exploring clinicians’ perceptions of various clinical quality interventions. We analysed and synthesised 50 studies in total, in five domains of clinical quality interventions: clinical quality interventions in general, structural interventions, audit-type interventions, interventions aimed at making practice more evidence-based, and risk management interventions. Data were analysed thematically, followed by synthesis of these themes into categories and concepts, which were then mapped to the domains of the TDF. Results Our results suggest that the TDF is highly relevant to the implementation of clinical quality interventions. It can be used to map most, if not all, of the attitudinal and behavioural barriers and facilitators of uptake of clinical quality interventions. Each of these 14 domains appeared to be relevant to many different types of clinical quality interventions. One possible additional domain might relate to perceived trustworthiness of those instituting clinical quality interventions. Conclusions The TDF can be usefully applied to a wide range of clinical quality interventions. Because all 14 of the domains emerged as relevant, and we did not identify any obvious differences between different kinds of clinical quality interventions, our findings support an initially broad approach to identifying barriers and facilitators, followed by a “drilling down” to what is most contextually salient. In future, it may be possible to establish a model of clinical quality policy implementation using the TDF. PMID:24359085

Cautionary tales in the interpretation of observational studies of effects of clinical interventions.

PubMed

Scott, I A; Attia, J

2017-02-01

Observational studies of the effectiveness of clinical interventions are proliferating as more 'real-world' clinical data (so called 'big data') are gathered from clinical registries, administrative datasets and electronic health records. While well-conducted randomised controlled trials (RCT) remain the scientific standard in assessing the efficacy of clinical interventions, well-designed observational studies may add to the evidence base of effectiveness in situations where RCT are of limited value or very difficult to perform. Rather than dismissing observational studies, we need to determine what circumstances may justify doing an observational study and when the study is sufficiently rigorous to be considered reasonably trustworthy. This article proposes criteria by which users of the literature might make such determinations. © 2016 Royal Australasian College of Physicians.

A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual

PubMed Central

Sturt, Jackie; Taylor, Hafrun; Docherty, Andrea; Dale, Jeremy; Louise, Taylor

2006-01-01

Background The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews. Methods Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey. Results The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations. Conclusion This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended. PMID:17129376

Information Technology-Based Interventions to Improve Drug-Drug Interaction Outcomes: A Systematic Review on Features and Effects.

PubMed

Nabovati, Ehsan; Vakili-Arki, Hasan; Taherzadeh, Zhila; Saberi, Mohammad Reza; Medlock, Stephanie; Abu-Hanna, Ameen; Eslami, Saeid

2017-01-01

The purpose of this systematic review was to identify features and effects of information technology (IT)-based interventions on outcomes related to drug-drug interactions (DDI outcomes). A literature search was conducted in Medline, EMBASE, and the Cochrane Library for published English-language studies. Studies were included if a main outcome was related to DDIs, the intervention involved an IT-based system, and the study design was experimental or observational with controls. Study characteristics, including features and effects of IT-based interventions, were extracted. Nineteen studies comprising five randomized controlled trials (RCT), five non-randomized controlled trials (NRCT) and nine observational studies with controls (OWC) were included. Sixty-four percent of prescriber-directed interventions, and all non-prescriber interventions, were effective. Each of the following characteristics corresponded to groups of studies of which a majority were effective: automatic provision of recommendations within the providers' workflow, intervention at the time of decision-making, integration into other systems, and requiring the reason for not following the recommendations. Only two studies measured clinical outcomes: an RCT that showed no significant improvement and an OWC that showed improvement, but did not statistically assess the effect. Most studies that measured surrogate outcomes (e.g. potential DDIs) and other outcomes (e.g. adherence to alerts) showed improvements. IT-based interventions improve surrogate clinical outcomes and adherence to DDI alerts. However, there is lack of robust evidence about their effectiveness on clinical outcomes. It is recommended that researchers consider the identified features of effective interventions in the design of interventions and evaluate the effectiveness on DDI outcomes, particularly clinical outcomes.

A group randomized trial using an appointment system to improve adherence to ART at reproductive and child health clinics implementing Option B+ in Tanzania

PubMed Central

Liana, Jafary; Kajoka, Mwikemo Deborah; Valimba, Richard; Kimatta, Suleiman; Dillip, Angel; Vialle-Valentin, Catherine; Embrey, Martha; Lieber, Rachel; Johnson, Keith

2017-01-01

Introduction In October 2013, Tanzania adopted Option B+ under which HIV-positive pregnant women are initiated on antiretroviral therapy in reproductive and child health clinics at diagnosis. Studies have shown that adherence and retention to antiretroviral treatment can be problematic. Methods We implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. The trial tested the impact of implementing paper-based appointment tracking and community outreach systems on the rate of missed appointments and number of days covered by dispensed antiretroviral medications among women previously established on antiretroviral therapy. We used interrupted time series analysis to assess study outcomes. Clinic staff and patients in intervention clinics were aware of the intervention because of change in clinic procedures; data collectors knew the study group assignment. Results Three months pre-intervention, we identified 1924 and 1226 patients established on antiretroviral therapy for six months or more in intervention and control clinics, respectively, of whom 83.4% and 86.9% had one or more post-intervention visits. The unadjusted rate of missed visits declined from 36.5% to 34.4% in intervention clinics and increased from 38.9% to 45.5% in control clinics following the intervention. Interrupted time series analyses demonstrated a net decrease of 13.7% (95% CI [-15.4,-12.1]) for missed visits at six months post-intervention. Similar differential changes were observed for visits missed by 3, 7, 15, or 60 days. Conclusion Appointment-tracking and community outreach significantly improved appointment-keeping for women on antiretroviral therapy. The facility staff controlled their workload better, identified missing patients rapidly, and worked with existing community organizations. There is now enough evidence to scale up this approach to all antiretroviral therapy and Option B+ reproductive and child health clinics in Tanzania as well as to evaluate the intervention in medical clinics that treat other chronic health conditions. Trial registration Registry for International Development Impact Evaluations ID-55310280d8757 PMID:28957381

Pediatric interventional radiology clinic - how are we doing?

PubMed

Rubenstein, Jonathan; Zettel, Julie C; Lee, Eric; Cote, Michelle; Aziza, Albert; Connolly, Bairbre L

2016-07-01

Development of a pediatric interventional radiology clinic is a necessary component of providing a pediatric interventional radiology service. Patient satisfaction is important when providing efficient, high-quality care. To analyze the care provided by a pediatric interventional radiology clinic from the perspective of efficiency and parent satisfaction, so as to identify areas for improvement. The prospective study was both quantitative and qualitative. The quantitative component measured clinic efficiency (waiting times, duration of clinic visit, nurse/physician time allocation and assessments performed; n = 91). The qualitative component assessed parental satisfaction with their experience with the pediatric interventional radiology clinic, using a questionnaire (5-point Likert scale) and optional free text section for feedback (n = 80). Questions explored the family's perception of relevance of information provided, consent process and overall satisfaction with their pediatric interventional radiology clinic experience. Families waited a mean of 11 and 10 min to meet the physician and nurse, respectively. Nurses and physicians spent a mean of 28 and 21 min with the families, respectively. The average duration of the pediatric interventional radiology clinic consultation was 56 min. Of 80 survey participants, 83% were satisfied with their experience and 94% said they believed providing consent before the day of the procedure was helpful. Only 5% of respondents were not satisfied with the time-efficiency of the interventional radiology clinic. Results show the majority of patients/parents are very satisfied with the pediatric interventional radiology clinic visit. The efficiency of the pediatric interventional radiology clinic is satisfactory; however, adherence to stricter scheduling can be improved.

Towards Evidence-Based Practice in Language Intervention for Bilingual Children

ERIC Educational Resources Information Center

Thordardottir, Elin

2010-01-01

Evidence-based practice requires that clinical decisions be based on evidence from rigorously controlled research studies. At this time, very few studies have directly examined the efficacy of clinical intervention methods for bilingual children. Clinical decisions for this population cannot, therefore, be based on the strongest forms of research…

Scientific ways to study intercessory prayer as an intervention in clinical research.

PubMed

Rath, Linda L

2009-01-01

The purpose of this article is to share a "research journey" to study the somewhat controversial subject of Christian intercessory prayer (CIP) utilized as a clinical intervention, and the knowledge gained along the way. This article will explore the steps in the development and implementation of clinical research to scientifically examine a phenomenon that many say cannot--and should not--be studied. The sequential steps in developing this area of study are detailed and explained from the conception of the initial idea through utilization of concept analysis and literature review to develop the researchable topic. The subsequent development of both qualitative and quantitative pilot studies to investigate CIP in depth is presented to illustrate how the intervention of CIP can successfully be incorporated into clinical research. This article provides guidelines for future researchers who may want to utilize CIP as an intervention.

A systematic review on US-based community health navigator (CHN) interventions for cancer screening promotion--comparing community- versus clinic-based navigator models.

PubMed

Hou, Su-I; Roberson, Kiersten

2015-03-01

This study synthesized lessons learned from US-based community and clinic health navigator (CHN) interventions on cancer screening promotion to identify characteristics of models and approaches for addressing cancer disparities. The combination terms "cancer screening" and "community health workers or navigators" or "patient navigators" were used in searching Medline, CINAHL, and PsycInfo. A total of 27 articles published during January 2005∼April 2014 were included. Two CHN models were identified: community-based (15 studies) and clinic/hospital-based (12 studies). While both models used the term "navigators," most community-based programs referred them as community health workers/navigators/advisors, whereas clinic-based programs often called them patient navigators. Most community-based CHN interventions targeted specific racial/ethnic minority or rural groups, while clinic-based programs mostly targeted urban low income or mixed ethnic groups. Most community-based CHN programs outreached members from community networks, while clinic-based programs commonly worked with pre-identified in-service clients. Overall, regardless model type, CHNs had similar roles and responsibilities, and interventions demonstrated effective outcomes. Our review identified characteristics of CHN interventions with attention to different settings. Lessons learned have implication on the dissemination and implementation of CHN interventions for cancer screening promotion across setting and target groups.

The design and methodology of premature ejaculation interventional studies

PubMed Central

2016-01-01

Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials. PMID:27652224

The costs, resource use and cost-effectiveness of Clinical Nurse Specialist–led interventions for patients with palliative care needs: A systematic review of international evidence

PubMed Central

Salamanca-Balen, Natalia; Seymour, Jane; Caswell, Glenys; Whynes, David; Tod, Angela

2017-01-01

Background: Patients with palliative care needs do not access specialist palliative care services according to their needs. Clinical Nurse Specialists working across a variety of fields are playing an increasingly important role in the care of such patients, but there is limited knowledge of the extent to which their interventions are cost-effective. Objectives: To present results from a systematic review of the international evidence on the costs, resource use and cost-effectiveness of Clinical Nurse Specialist–led interventions for patients with palliative care needs, defined as seriously ill patients and those with advanced disease or frailty who are unlikely to be cured, recover or stabilize. Design: Systematic review following PRISMA methodology. Data sources: Medline, Embase, CINAHL and Cochrane Library up to 2015. Studies focusing on the outcomes of Clinical Nurse Specialist interventions for patients with palliative care needs, and including at least one economic outcome, were considered. The quality of studies was assessed using tools from the Joanna Briggs Institute. Results: A total of 79 papers were included: 37 randomized controlled trials, 22 quasi-experimental studies, 7 service evaluations and other studies, and 13 economic analyses. The studies included a wide variety of interventions including clinical, support and education, as well as care coordination activities. The quality of the studies varied greatly. Conclusion: Clinical Nurse Specialist interventions may be effective in reducing specific resource use such as hospitalizations/re-hospitalizations/admissions, length of stay and health care costs. There is mixed evidence regarding their cost-effectiveness. Future studies should ensure that Clinical Nurse Specialists’ roles and activities are clearly described and evaluated. PMID:28655289

Effectiveness of family work interventions on schizophrenia: evidence from a multicentre study in Catalonia.

PubMed

Tomás, Esther Pousa; Hurtado, Gemma; Noguer, Sílvia; Domènech, Cristina; García, Montse; López, Nuria; Negredo, Maríacruz; Penadés, Rafael; Reinares, María; Serrano, Dolors; Dolz, Montse; Gallo, Pedro

2012-11-01

Despite their proven efficacy, family work interventions on families of patients with schizophrenia are not being implemented in routine clinical practice in contexts where expressed emotion levels among caregivers are relatively high. This study aimed to explore the effectiveness of a family work intervention in a Mediterranean environment in Catalonia, Spain. Participants were 23 patients and 35 key relatives in five different clinical settings. The family intervention was provided by 10 trained health care professionals during a nine-month period. A six-month follow-up was also conducted. Statistically significant improvements were found in patients' clinical status, global functioning and social functioning levels, as well as in caregivers' burden of care. These results were maintained during follow-up. This is the first study to explore the effectiveness of family intervention in a high-expressed emotion context in Catalonia. The findings add weight to the growing literature supporting these interventions in different cultural settings.

Clinical relevance of pharmacist intervention in an emergency department.

PubMed

Pérez-Moreno, Maria Antonia; Rodríguez-Camacho, Juan Manuel; Calderón-Hernanz, Beatriz; Comas-Díaz, Bernardino; Tarradas-Torras, Jordi

2017-08-01

To evaluate the clinical relevance of pharmacist intervention on patient care in emergencies, to determine the severity of detected errors. Second, to analyse the most frequent types of interventions and type of drugs involved and to evaluate the clinical pharmacist's activity. A 6-month observational prospective study of pharmacist intervention in the Emergency Department (ED) at a 400-bed hospital in Spain was performed to record interventions carried out by the clinical pharmacists. We determined whether the intervention occurred in the process of medication reconciliation or another activity, and whether the drug involved belonged to the High-Alert Medications Institute for Safe Medication Practices (ISMP) list. To evaluate the severity of the errors detected and clinical relevance of the pharmacist intervention, a modified assessment scale of Overhage and Lukes was used. Relationship between clinical relevance of pharmacist intervention and the severity of medication errors was assessed using ORs and Spearman's correlation coefficient. During the observation period, pharmacists reviewed the pharmacotherapy history and medication orders of 2984 patients. A total of 991 interventions were recorded in 557 patients; 67.2% of the errors were detected during medication reconciliation. Medication errors were considered severe in 57.2% of cases and 64.9% of pharmacist intervention were considered relevant. About 10.9% of the drugs involved are in the High-Alert Medications ISMP list. The severity of the medication error and the clinical significance of the pharmacist intervention were correlated (Spearman's ρ=0.728/p<0.001). In this single centre study, the clinical pharmacists identified and intervened on a high number of severe medication errors. This suggests that emergency services will benefit from pharmacist-provided drug therapy services. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Do educational interventions improve nurses' clinical decision making and judgement? A systematic review.

PubMed

Thompson, Carl; Stapley, Sally

2011-07-01

Despite the growing popularity of decision making in nursing curricula, the effectiveness of educational interventions to improve nursing judgement and decision making is unknown. We sought to synthesise and summarise the comparative evidence for educational interventions to improve nursing judgements and clinical decisions. A systematic review. Electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL and PsycINFO, Social Sciences Citation Index, OpenSIGLE conference proceedings and hand searching nursing journals. Studies published since 1960, reporting any educational intervention that aimed to improve nurses' clinical judgements or decision making were included. Studies were assessed for relevance and quality. Data extracted included study design; educational setting; the nature of participants; whether the study was concerned with the clinical application of skills or the application of theory; the type of decision targeted by the intervention (e.g. diagnostic reasoning) and whether the evaluation of the intervention focused on efficacy or effectiveness. A narrative approach to study synthesis was used due to heterogeneity in interventions, study samples, outcomes and settings and incomplete reporting of effect sizes. From 5262 initial citations 24 studies were included in the review. A variety of educational approaches were reported. Study quality and content reporting was generally poor. Pedagogical theories were widely used but use of decision theory (with the exception of subjective expected utility theory implicit in decision analysis) was rare. The effectiveness and efficacy of interventions was mixed. Educational interventions to improve nurses' judgements and decisions are complex and the evidence from comparative studies does little to reduce the uncertainty about 'what works'. Nurse educators need to pay attention to decision, as well as pedagogical, theory in the design of interventions. Study design and reporting requires improvement to maximise the information contained in reports of educational interventions. Copyright © 2011 Elsevier Ltd. All rights reserved.

Rehabilitation technologies and interventions for individuals with spinal cord injury: translational potential of current trends.

PubMed

Musselman, Kristin E; Shah, Meeral; Zariffa, José

2018-05-16

In the past, neurorehabilitation for individuals with neurological damage, such as spinal cord injury (SCI), was focused on learning compensatory movements to regain function. Presently, the focus of neurorehabilitation has shifted to functional neurorecovery, or the restoration of function through repetitive movement training of the affected limbs. Technologies, such as robotic devices and electrical stimulation, are being developed to facilitate repetitive motor training; however, their implementation into mainstream clinical practice has not been realized. In this commentary, we examined how current SCI rehabilitation research aligns with the potential for clinical implementation. We completed an environmental scan of studies in progress that investigate a physical intervention promoting functional neurorecovery. We identified emerging interventions among the SCI population, and evaluated the strengths and gaps of the current direction of SCI rehabilitation research. Seventy-three study postings were retrieved through website and database searching. Study objectives, outcome measures, participant characteristics and the mode(s) of intervention being studied were extracted from the postings. The FAME (Feasibility, Appropriateness, Meaningfulness, Effectiveness, Economic Evidence) Framework was used to evaluate the strengths and gaps of the research with respect to likelihood of clinical implementation. Strengths included aspects of Feasibility, as the research was practical, aspects of Appropriateness as the research aligned with current scientific literature on motor learning, and Effectiveness, as all trials aimed to evaluate the effect of an intervention on a clinical outcome. Aspects of Feasibility were also identified as a gap; with two thirds of the studies examining emerging technologies, the likelihood of successful clinical implementation was questionable. As the interventions being studied may not align with the preferences of clinicians and priorities of patients, the Appropriateness of these interventions for the current health care environment was questioned. Meaningfulness and Economic Evidence were also identified as gaps since few studies included measures reflecting the perceptions of the participants or economic factors, respectively. The identified gaps will likely impede the clinical uptake of many of the interventions currently being studied. Future research may lessen these gaps through a staged approach to the consideration of the FAME elements as novel interventions and technologies are developed, evaluated and implemented.

An Intimate Partner Violence informational program in a hospital fracture clinic: a pre-test post-test intervention study

PubMed Central

PREVAIL, Investigators

2017-01-01

Abstract: Background: Many organizations have conducted Intimate Partner Violence (IPV) informational campaigns, but the extent to which such cost-effective, simple changes to the clinic environment can improve patient perceptions about IPV is largely unknown. Our primary objective was to determine how an IPV informational program affects patients’ perceptions about discussing IPV in a fracture clinic setting. Methods: We conducted a pre-post intervention study to evaluate the impacts of an IPV informational program on patients’ perceptions and willingness to discuss IPV in an orthopaedic fracture clinic setting. During the intervention phase, there were posters and brochures in each bed area and several places in the waiting area, and the surgeons received a button to wear on their lab coat stating their openness to discuss IPV and a set of instructions on how to ask patients about IPV and refer them to resources. Results: A total of 160 patients (80 pre-intervention and 80 post-intervention) have participated in this study. Overall perception of the clinic as an open place in which to discuss IPV did not change as a result of the informational program compared to the control setting. However, more patients exposed to posters and information about IPV believed the clinic staff possessed resources to help IPV victims compared to the control group; however, this difference did not reach statistical significance (62% vs. 53%, respectively, p=0.29). Conclusions: Passive interventions may serve an adjunctive role in facilitating active interventions in a clinic environment, but should not be considered in isolation as an effective approach. PMID:28039685

An intimate partner violence informational program in a hospital fracture clinic: a pre-test post-test intervention study.

PubMed

Investigators, Prevail

2017-01-01

Many organizations have conducted IPV informational campaigns, but the extent to which such cost-effective, simple changes to the clinic environment can improve patient perceptions about IPV is largely unknown. Our primary objective was to determine how an IPV informational program affects patients' perceptions about discussing IPV in a fracture clinic setting. We conducted a pre-post intervention study to evaluate the impacts of an IPV informational program on patients' perceptions and willingness to discuss IPV in an orthopaedic fracture clinic setting. During the intervention phase, there were posters and brochures in each bed area and several places in the waiting area, and the surgeons received a button to wear on their lab coat stating their openness to discuss IPV and a set of instructions on how to ask patients about IPV and refer them to resources. A total of 160 patients (80 pre-intervention and 80 post-intervention) have participated in this study. Overall perception of the clinic as an open place in which to discuss IPV did not change as a result of the informational program compared to the control setting. However, more patients exposed to posters and information about IPV believed the clinic staff possessed resources to help IPV victims compared to the control group; however, this difference did not reach statistical significance (62% vs. 53%, respectively, p=0.29). Passive interventions may serve an adjunctive role in facilitating active interventions in a clinic environment, but should not be considered in isolation as an effective approach. © 2017 KUMS, All rights reserved.

Prevention and early intervention for behaviour problems in children with developmental disabilities.

PubMed

Einfeld, Stewart L; Tonge, Bruce J; Clarke, Kristina S

2013-05-01

To review the recent evidence regarding early intervention and prevention studies for children with developmental disabilities and behaviour problems from 2011 to 2013. Recent advances in the field are discussed and important areas for future research are highlighted. Recent reviews and studies highlight the utility of antecedent interventions and skills training interventions for reducing behaviour problems. There is preliminary evidence for the effectiveness of parent training interventions when delivered in minimally sufficient formats or in clinical settings. Two recent studies have demonstrated the utility of behavioural interventions for children with genetic causes of disability. Various forms of behavioural and parent training interventions are effective at reducing the behaviour problems in children with developmental disabilities. However, research on prevention and early intervention continues to be relatively scarce. Further large-scale dissemination studies and effectiveness studies in clinical or applied settings are needed.

Implementing Trauma-Informed Partner Violence Assessment in Family Planning Clinics.

PubMed

Decker, Michele R; Flessa, Sarah; Pillai, Ruchita V; Dick, Rebecca N; Quam, Jamie; Cheng, Diana; McDonald-Mosley, Raegan; Alexander, Kamila A; Holliday, Charvonne N; Miller, Elizabeth

2017-09-01

Intimate partner violence (IPV) and reproductive coercion (RC) are associated with poor reproductive health. Little is known about how family planning clinics implement brief IPV/RC assessment interventions in practice. We describe the uptake and impact of a brief, trauma-informed, universal IPV/RC assessment and education intervention. Intervention implementation was evaluated via a mixed methods study among women ages 18 and up receiving care at one of two family planning clinics in greater Baltimore, MD. This mixed methods study entailed a quasi-experimental, single group pretest-posttest study with family planning clinic patients (baseline and exit survey n = 132; 3-month retention n = 68; retention rate = 52%), coupled with qualitative interviews with providers and patients (total n = 35). Two thirds (65%) of women reported receiving at least one element of the intervention on their exit survey immediately following the clinic-visit. Patients reported that clinic-based IPV assessment is helpful, irrespective of IPV history. Relative to those who reported neither, participants who received either intervention element reported greater perceived caring from providers, confidence in provider response to abusive relationships, and knowledge of IPV-related resources at follow-up. Providers and patients alike described the educational card as a valuable tool. Participants described trade-offs of paper versus in-person, electronic medical record-facilitated screening, and patient reluctance to disclose current situations of abuse. In real-world family planning clinic settings, a brief assessment and support intervention was successful in communicating provider caring and increasing knowledge of violence-related resources, endpoints previously deemed valuable by IPV survivors. Results emphasize the merit of universal education in IPV/RC clinical interventions over seeking IPV disclosure.

Closing the quality gap: revisiting the state of the science (vol. 4: medication adherence interventions: comparative effectiveness).

PubMed

Viswanathan, Meera; Golin, Carol E; Jones, Christine D; Ashok, Mahima; Blalock, Susan; Wines, Roberta C M; Coker-Schwimmer, Emmanuel J L; Grodensky, Catherine A; Rosen, David L; Yuen, Andrea; Sista, Priyanka; Lohr, Kathleen N

2012-09-01

To assess the effectiveness of patient, provider, and systems interventions (Key Question [KQ] 1) or policy interventions (KQ 2) in improving medication adherence for an array of chronic health conditions. For interventions that are effective in improving adherence, we then assessed their effectiveness in improving health, health care utilization, and adverse events. MEDLINE®, the Cochrane Library. Additional studies were identified from reference lists and technical experts. Two people independently selected, extracted data from, and rated the risk of bias of relevant trials and systematic reviews. We synthesized the evidence for effectiveness separately for each clinical condition, and within each condition, by type of intervention. We also evaluated the prevalence of intervention components across clinical conditions and the effectiveness of interventions for a range of vulnerable populations. Two reviewers graded the strength of evidence using established criteria. We found a total of 62 eligible studies (58 trials and 4 observational studies) from our review of 3,979 abstracts. These studies included patients with diabetes, hyperlipidemia, hypertension, heart failure, myocardial infarction, asthma, depression, glaucoma, multiple sclerosis, musculoskeletal diseases, and multiple chronic conditions. Fifty-seven trials of patient, provider, or systems interventions (KQ 1) evaluated 20 different types of interventions; 4 observational studies and one trial of policy interventions (KQ 2) evaluated the effect of reduced out-of-pocket expenses or improved prescription drug coverage. We found the most consistent evidence of improvement in medication adherence for interventions to reduce out-of-pocket expenses or improve prescription drug coverage, case management, and educational interventions across clinical conditions. Within clinical conditions, we found the strongest support for self-management of medications for short-term improvement in adherence for asthma patients; collaborative care or case management programs for short-term improvement of adherence and to improve symptoms for patients taking depression medications; and pharmacist-led approaches for hypertensive patients to improve systolic blood pressure. Diverse interventions offer promising approaches to improving medication adherence for chronic conditions, particularly for the short term. Evidence on whether these approaches have broad applicability for clinical conditions and populations is limited, as is evidence regarding long-term medication adherence or health outcomes.

Impact of clinical pharmacist intervention in anticoagulation clinic in Sudan.

PubMed

Ahmed, Nahid Osman; Osman, Bashier; Abdelhai, Yassein Mohamed; El-Hadiyah, Tariq Muhammed Hashim

2017-08-01

Background Many trials have compared anticoagulation management provided by a pharmacist led anticoagulation clinic versus usual physician care showing the role for clinical pharmacist in the management of anticoagulant therapy, and demonstrating excellent outcomes. In Sudan, there is no published research evaluating the role of pharmacist in providing pharmaceutical care for patients taking warfarin. Objective The objective of the study is to assess the role of clinical pharmacist intervention in warfarin patients compared to usual medical care. Setting This study was conducted in Ahmed Gasim cardiac surgery and renal transplant center warfarin clinic. Methods One hundred thirty-five patients were randomly selected from adult patients on warfarin therapy The history of INR records, and adverse effects for the past year, were recorded. Then patients' warfarin dose adjustments according to INR, was done by the clinical pharmacist for one year. Patients received continuous verbal education and written information about warfarin. Main outcome measure The primary outcome for this study was the INR control, while the secondary outcomes were the bleeding events and hospitalization due to warfarin. Results After the clinical pharmacist intervention there was significant (P < 0.01) improvement in INR control and a significant (P < 0.05) reduction in incidence of bleeding after clinical pharmacist intervention. Hospitalization due to warfarin related complications (bleeding, high INR, low INR) was also significantly (P < 0.001) reduced. Conclusion Clinical pharmacists intervention in warfarin therapy improve INR control, reduce bleeding and hospitalization due to warfarin complications.

Adaptation of an evidence-based intervention to promote colorectal cancer screening: a quasi-experimental study

PubMed Central

2014-01-01

Background To accelerate the translation of research findings into practice for underserved populations, we investigated the adaptation of an evidence-based intervention (EBI), designed to increase colorectal cancer (CRC) screening in one limited English-proficient (LEP) population (Chinese), for another LEP group (Vietnamese) with overlapping cultural and health beliefs. Methods Guided by Diffusion of Innovations Theory, we adapted the EBI to achieve greater reach. Core elements of the adapted intervention included: small media (a DVD and pamphlet) translated into Vietnamese from Chinese; medical assistants distributing the small media instead of a health educator; and presentations on CRC screening to the medical assistants. A quasi-experimental study examined CRC screening adherence among eligible Vietnamese patients at the intervention and control clinics, before and after the 24-month intervention. The proportion of the adherence was assessed using generalized linear mixed models that account for clustering under primary care providers and also within-patient correlation between baseline and follow up. Results Our study included two cross-sectional samples: 1,016 at baseline (604 in the intervention clinic and 412 in the control clinic) and 1,260 post-intervention (746 in the intervention and 514 in the control clinic), including appreciable overlaps between the two time points. Pre-post change in CRC screening over time, expressed as an odds ratio (OR) of CRC screening adherence by time, showed a marginally-significant greater increase in CRC screening adherence at the intervention clinic compared to the control clinic (the ratio of the two ORs = 1.42; 95% CI 0.95, 2.15). In the sample of patients who were non-adherent to CRC screening at baseline, compared to the control clinic, the intervention clinic had marginally-significant greater increase in FOBT (adjusted OR = 1.77; 95% CI 0.98, 3.18) and a statistically-significantly greater increase in CRC screening adherence (adjusted OR = 1.70; 95% CI 1.05, 2.75). Conclusions Theoretically guided adaptations of EBIs may accelerate the translation of research into practice. Adaptation has the potential to mitigate health disparities for hard-to-reach populations in a timely manner. PMID:24989083

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

PubMed

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

2014-11-01

The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

How to write a surgical clinical research protocol: literature review and practical guide.

PubMed

Rosenthal, Rachel; Schäfer, Juliane; Briel, Matthias; Bucher, Heiner C; Oertli, Daniel; Dell-Kuster, Salome

2014-02-01

The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

Multifamily Psychoeducation for First-Episode Psychosis: A Cost-Effectiveness Analysis

PubMed Central

Breitborde, Nicholas J. K.; Woods, Scott W.; Srihari, Vinod H.

2017-01-01

Objective Family psychoeducation is considered part of optimal treatment for first-episode psychosis, but concerns about the cost of this intervention have limited its availability. Although evidence suggests that family psychoeducation is cost-effective, many cost-effectiveness analyses have suffered from limitations that reduce their utility in guiding decisions to incorporate this intervention within existing clinical services. These include not presenting results in present-day dollars and not examining whether the intervention would remain cost-effective in situations where the clinical benefits achieved were smaller than those reported in past studies. Thus the goal of this study was to investigate the cost of providing a specific psychoeducation program—multifamily group psychoeducation—to individuals with first-episode psychosis and their families. Methods Statistical simulation was used to estimate the cost and burden of illness associated with usual treatment versus usual treatment plus multifamily group psychoeducation. In addition, the simulation model was rerun to test whether multifamily psychoeducation would remain cost-effective in situations where the clinical benefits achieved were smaller than those reported in past studies. Results When provided for two years, multifamily group psychoeducation ranged from a cost-effective to a cost-saving intervention, depending on the clinical benefits achieved by staff delivering the intervention. When provided for longer durations (five, ten, or 20 years), multifamily psychoeducation was a cost-saving intervention even in scenarios where the clinical benefits of the intervention were reduced by 90%. Conclusions The results suggest that multifamily group psychoeducation may not only be a cost-effective intervention for first-episode psychosis but may often be a cost-saving intervention. PMID:19880465

Multifamily psychoeducation for first-episode psychosis: a cost-effectiveness analysis.

PubMed

Breitborde, Nicholas J K; Woods, Scott W; Srihari, Vinod H

2009-11-01

Family psychoeducation is considered part of optimal treatment for first-episode psychosis, but concerns about the cost of this intervention have limited its availability. Although evidence suggests that family psychoeducation is cost-effective, many cost-effectiveness analyses have suffered from limitations that reduce their utility in guiding decisions to incorporate this intervention within existing clinical services. These include not presenting results in present-day dollars and not examining whether the intervention would remain cost-effective in situations where the clinical benefits achieved were smaller than those reported in past studies. Thus the goal of this study was to investigate the cost of providing a specific psychoeducation program-multifamily group psychoeducation-to individuals with first-episode psychosis and their families. Statistical simulation was used to estimate the cost and burden of illness associated with usual treatment versus usual treatment plus multifamily group psychoeducation. In addition, the simulation model was rerun to test whether multifamily psychoeducation would remain cost-effective in situations where the clinical benefits achieved were smaller than those reported in past studies. When provided for two years, multifamily group psychoeducation ranged from a cost-effective to a cost-saving intervention, depending on the clinical benefits achieved by staff delivering the intervention. When provided for longer durations (five, ten, or 20 years), multifamily psychoeducation was a cost-saving intervention even in scenarios where the clinical benefits of the intervention were reduced by 90%. The results suggest that multifamily group psychoeducation may not only be a cost-effective intervention for first-episode psychosis but may often be a cost-saving intervention.

Does Improving Patient-Practitioner Communication Improve Clinical Outcomes in Patients with Cardiovascular Diseases? A Systematic Review of the Evidence

PubMed Central

Schoenthaler, Antoinette; Kalet, Adina; Nicholson, Joseph; Lipkin, Mack

2014-01-01

Objective To conduct a systematic literature review appraising the effects of interventions to improve patient-practitioner communication on cardiovascular-related clinical outcomes. Methods Databases were searched up to March 27, 2013 to identify eligible studies that included interventions to improve patient and/or practitioner communication skills and assessment of a cardiovascular-related clinical outcome in adults ≥ 18 years of age. Results Fifteen papers were reviewed: The primary focus in seven studies was the patient; seven included a practitioner-focused intervention and one targeted both. Two patient-focused and two practitioner-focused studies demonstrated a beneficial effect of the intervention compared to a control group. Patient-focused studies were designed to improve patients’ information-seeking and question-asking skills with their practitioner. Practitioner-focused studies were designed to either improve practitioner’s general patient-centered communication or risk communication skills. Conclusions Few interventions targeting patient-practitioner communication have assessed the impact on cardiovascular-related clinical outcomes, limiting the ability to determine effectiveness. Additional rigorous research supported by theoretical frameworks and validated measurement is needed to understand the potential of patient-practitioner communication to improve cardiovascular-related clinical outcomes. Practice Implications Investments in communication skills trainings in medical education and practice are needed in order to attain the full potential of patient-centered care on cardiovascular-related clinical outcomes. Systematic Review Protocol Registration CRD42013006302 PMID:24795073

Effect of teaching motivational interviewing via communication coaching on clinician and patient satisfaction in primary care and pediatric obesity-focused offices.

PubMed

Pollak, Kathryn I; Nagy, Paul; Bigger, John; Bilheimer, Alicia; Lyna, Pauline; Gao, Xiaomei; Lancaster, Michael; Watkins, R Chip; Johnson, Fred; Batish, Sanjay; Skelton, Joseph A; Armstrong, Sarah

2016-02-01

Studies indicate needed improvement in clinician communication and patient satisfaction. Motivational interviewing (MI) helps promote patient behavior change and improves satisfaction. In this pilot study, we tested a coaching intervention to teach MI to all clinic staff to improve clinician and patient satisfaction. We included four clinics (n=29 staff members). In the intervention clinics (one primary care and one pediatric obesity-focused), we trained all clinic staff in MI through meetings as a group seven times, directly observing clinicians in practice 4-10 times, and providing real-time feedback on MI techniques. In all clinics, we assessed patient satisfaction via anonymous surveys and also assessed clinician burnout and self-rated MI skills. Clinicians in the intervention clinics reported improvements in burnout scores, self-rated MI skills, and perceived cohesion whereas clinicians in the control clinic reported worse scores. Patient satisfaction improved in the intervention clinics more than in the control clinics. This is the first study to find some benefit of training an entire clinic staff in MI via a coaching model. It might help to train staff in MI to improve clinician satisfaction, team cohesion, perceived skills, and patient satisfaction. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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.

A Feasibility Study of a Web Based Performance Improvement System for Substance Abuse Treatment Providers

PubMed Central

Forman, Robert; Crits-Christoph, Paul; Kaynak, Övgü; Worley, Matt; Hantula, Donald A.; Kulaga, Agatha; Rotrosen, John; Chu, Melissa; Gallop, Robert; Potter, Jennifer; Muchowski, Patrice; Brower, Kirk; Strobbe, Stephen; Magruder, Kathy; Chellis, A’Delle H.; Clodfelter, Tad; Cawley, Margaret

2007-01-01

We report here on the feasibility of implementing a semi-automated performance improvement system - Patient Feedback (PF) - that enables real-time monitoring of patient ratings of therapeutic alliance, treatment satisfaction, and drug/alcohol use in outpatient substance abuse treatment clinics. The study was conducted in 6 clinics within the National Institute on Drug Abuse Clinical Trials Network. It involved a total of thirty-nine clinicians and 6 clinic supervisors. Throughout the course of the study (4 week training period, 4 week baseline, 12 week intervention, 4 week post-intervention assessment, 1 year sustainability phase) there was an overall collection rate of 75.5% of the clinic patient census. In general, the clinicians in these clinics had very positive treatment satisfaction and alliance ratings throughout the study. However, one clinic had worse drug use scores at baseline than other participating clinics, and showed a decrease in self-reported drug use at post-intervention. Although the implementation of the PF system proved to be feasible in actual clinical settings, further modifications of the PF system are needed to enhance any potential clinical usefulness. PMID:17499954

Interventions to improve patient understanding of cancer clinical trial participation: a systematic review.

PubMed

Kao, C Y; Aranda, S; Krishnasamy, M; Hamilton, B

2017-03-01

Patient misunderstanding of cancer clinical trial participation is identified as a critical issue and researchers have developed and tested a variety of interventions to improve patient understanding. This systematic review identified nine papers published between 2000 and 2013, to evaluate the effects of interventions to improve patient understanding of cancer clinical trial participation. Types of interventions included audio-visual information, revised written information and a communication training workshop. Interventions were conducted alone or in combination with other forms of information provision. The nine papers, all with methodological limitations, reported mixed effects on a small range of outcomes regarding improved patient understanding of cancer clinical trial participation. The methodological limitations included: (1) the intervention development process was poorly described; (2) only a small element of the communication process was addressed; (3) studies lacked evidence regarding what information is essential and critical to enable informed consent; (4) studies lacked reliable and valid outcome measures to show that patients are sufficiently informed to provide consent; and (5) the intervention development process lacked a theoretical framework. Future research needs to consider these factors when developing interventions to improve communication and patient understanding during the informed consent process. © 2016 John Wiley & Sons Ltd.

Active involvement and intervention in patients exposed to whiplash trauma in automobile crashes reduces costs: a randomized, controlled clinical trial and health economic evaluation.

PubMed

Rosenfeld, Mark; Seferiadis, Aris; Gunnarsson, Ronny

2006-07-15

To examine and compare the costs and consequences in a partial economic evaluation of two competing interventions in patients exposed to whiplash trauma in automobile crashes. The interventions were an active involvement and intervention using early mobilization and a standard intervention of rest, recommended short-term immobilization in a cervical collar and a cautious, gradual self-exercise program according to a leaflet. The study was randomized and controlled. The aim of the study was to compare the costs of an active involvement and intervention versus a standard intervention and to relate them to the clinical benefits in patients exposed to whiplash trauma in automobile crashes to facilitate decision-making regarding intervention and resource allocation. There is very little known about the health economic aspects of various interventions in the target treatment group of patients. Based on a prospective, randomized, clinical trial, data on clinical effectiveness and resources used for the active involvement and intervention and standard intervention were collected for a comparative analysis of the costs related to physical therapy treatment and sick leave. A cost-consequence analysis consisting of a modified cost-effectiveness analysis was used. The costs were significantly lower after 6 and 36 months with an active involvement and intervention as compared with the standard intervention. The active involvement and intervention were significantly superior in reducing experienced pain and reducing sick leave. For patients exposed to whiplash trauma in a motor vehicle collision, an active involvement and intervention were both less costly and more effective than a standard intervention.

eHealth and the use of individually tailored information: A systematic review.

PubMed

Conway, Nicholas; Webster, Clare; Smith, Blair; Wake, Deborah

2017-09-01

Tailored messages are those that specifically target individuals following an assessment of their unique characteristics. This systematic review assesses the evidence regarding the effectiveness of tailoring within eHealth interventions aimed at chronic disease management. OVID Medline/Embase databases were searched for randomised control trials, controlled clinical, trials, before -after studies, and time series analyses from inception - May 2014. Objectively measured clinical processes/outcomes were considered. Twenty-two papers were eligible for inclusion: 6/22 used fully tailored messaging and 16/22 used partially tailored messages. Two studies isolated tailoring as the active component. The remainder compared intervention with standard care. In all, 12/16 studies measuring clinical processes and 2/6 studies reporting clinical outcomes showed improvements, regardless of target group. Study quality was low and design did not allow for identification of interventions' active component. Heterogeneity precluded meta-analysis. This review has demonstrated that there is a lack of evidence to suggest that tailoring within an eHealth context confers benefit over non-tailored eHealth interventions.

Improving the quality of nurse clinical documentation for chronic patients at primary care clinics: A multifaceted intervention.

PubMed

Mahomed, Ozayr H; Naidoo, Salsohni; Asmall, Shaidah; Taylor, Myra

2015-09-25

Deficiencies in record keeping practices have been reported at primary care level in the public health sector in South Africa. These deficiencies have the potential to negatively impact patient health outcomes as the break in information may hinder continuity of care. This disruption in information management has particular relevance for patients with chronic diseases. The aim of this study was to establish if the implementation of a structured clinical record (SCR) as an adjunct tool to the algorithmic guidelines for chronic disease management improved the quality of clinical records at primary care level. A quasi-experimental study (before and after study with a comparison group) was conducted across 30 primary health care clinics (PHCs) located in three districts in South Africa. Twenty PHCs that received the intervention were selected as intervention clinics and 10 facilities were selected as comparison facilities. The lot quality assurance sampling (LQAS) method was used to determine the number of records required to be reviewed per diagnostic condition per facility. There was a a statistically significant increase in the percentage of clinical records achieving compliance to the minimum criteria from the baseline to six months post-intervention for both HIV patients on antiretroviral treatment and patients with non-communicable diseases (hypertension and diabetes). A multifaceted intervention using a SCR to supplement the educational outreach component (PC 101 training) has demonstrated the potential for improving the quality of clinical records for patients with chronic diseases at primary care clinics in South Africa.

A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care.

PubMed

Quanbeck, Andrew; Brown, Randall T; Zgierska, Aleksandra E; Jacobson, Nora; Robinson, James M; Johnson, Roberta A; Deyo, Brienna M; Madden, Lynn; Tuan, Wen-Jan; Alagoz, Esra

2018-01-25

This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

Impact of locus of control on clinical outcomes in renal dialysis.

PubMed

Dec, Elaine

2006-01-01

This study focused on the relationship between patients' locus of control and their ability to improve selected clinical outcomes related to kidney dialysis. The main hypothesis of this study stated that patients who viewed themselves as having control over their situation would be more successful at improving targeted clinical outcomes than those who believed someone other than themselves had control over their situation. The study found that interventions aimed at increasing awareness of who has control and reducing the aspect of chance had a more significant positive impact on outcomes than did pure cognitive or educational interventions geared mainly toward emotional issues or educational deficits. Interventions that work with the dominant locus of control to increase awareness of where control lies appeared to be more effective in assisting the patients to improve their targeted clinical outcomes rather than are interventions to change the locus of control between internal and powerful others (external).

Limb length inequality: clinical implications for assessment and intervention.

PubMed

Brady, Rebecca J; Dean, John B; Skinner, T Marc; Gross, Michael T

2003-05-01

The purpose of this paper is to review relevant literature concerning limb length inequalities in adults and to make recommendations for assessment and intervention based on the literature and our own clinical experience. Literature searches were conducted in the MEDLINE, PubMed, and CINAHL databases. Limb length inequality and common classification criteria are defined and etiological factors are presented. Common methods of detecting limb length inequality include direct (tape measure methods), indirect (pelvic leveling), and radiological techniques. Interventions include shoe inserts or external shoe lift therapy for mild cases. Surgery may be appropriate in severe cases. Little agreement exists regarding the prevalence of limb length inequality, the degree of limb length inequality that is considered clinically significant, and the reliability and validity of assessment methods. Based on correlational studies, the relationship between limb length inequality and orthopaedic pathologies is questionable. Stronger support for the link between low back pain (LBP) and limb length inequality is provided by intervention studies. Methods involving palpation of pelvic landmarks with block correction have the most support for clinical assessment of limb length inequality. Standing radiographs are suggested when clinical assessment methods are unsatisfactory. Clinicians should exercise caution when undertaking intervention strategies for limb length inequality of less than 5 mm when limb length inequality has been identified with clinical techniques. Recommendations are provided regarding intervention strategies.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

PubMed

Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P; Eron, Joseph; Gifford, Allen L

2011-11-01

Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

Economic evaluations of clinical pharmacist interventions on hospital inpatients: a systematic review of recent literature.

PubMed

Gallagher, James; McCarthy, Suzanne; Byrne, Stephen

2014-12-01

Clinical and cost-effectiveness evidence are needed to justify the existence or extension of routine clinical pharmacy services in hospital settings. Previous reviews have indicated that clinical pharmacist interventions are likely to have a positive economic impact on hospital budgets but highlighted issues relating to the quality of studies. The primary aim of this review was to feature economic evaluations of clinical pharmacy services which targeted hospital inpatients. The review focused on the current cost-effectiveness status of different services, in addition to evaluating the quality of individual studies. Results of this systematic review were compared with cost-effectiveness and quality related findings of reviews which considered earlier time frames and alternative settings. A systematic review of the literature included a review of the following databases: Academic Search Complete, Cochrane Library, EconLit, Embase Elsevier, NHS Economic Evaluation Database and PubMed. Only studies with an economic assessment of a clinical pharmacy service provided in a hospital setting were included. Data relating to the cost-effectiveness was extracted from eligible studies. Methodologies employed and overall quality of the studies was also reviewed. A grading system was applied to determine the quality of studies. Consolidated Health Economic Evaluation Reporting Standards statement was employed to determine which aspects of a high quality health economic study were employed. Twenty studies were deemed eligible for inclusion. Overall, pharmacist interventions had a positive impact on hospital budgets. Only three studies (15 %) were deemed to be "good-quality" studies. No 'novel'clinical pharmacist intervention was identified during the course of this review. Clinical pharmacy interventions continue to provide cost savings. However, the standard of studies published has stagnated or even deteriorated in comparison with those included in previous reviews. Utilisation of published guidelines at initial stages of future studies may help improve the overall quality of studies.

The First Intervention Study in Elder Self-Neglect: A Randomized Clinical Trial to Improve Vitamin D Levels

NASA Technical Reports Server (NTRS)

Burnett, Jason; Hochschild, Ann; Smith, Scott M.; Diamond, Pam; Stotts, Angela; Dyer, Carmel

2011-01-01

Despite high mortality rates, elder self-neglect is characterized by refusal of medical and social interventions. To date there have been no tested clinical interventions in elders who self-neglect. Previous research from the TEAM Institute has shown significantly low vitamin D levels in this population. This study aimed to determine the feasibility of a clinical intervention. Replacement of vitamin D was chosen because of its ease of administration and favorable safety profile. Methods: A randomized clinical trial using directly observed therapy of vitamin D was conducted using 50 elders, >65 years of age, with Adult Protective Services (APS) validated self-neglect. A staggered intervention with waiting controls was used to maximize statistical power. One-third (n=17) of the group was administered 50,000 IU vitamin D2 (ergocalciferol) monthly and the remainder (n=33) were administered 400 IU monthly. Serum 25-OH vitamin D was assessed at baseline and 5-months. Results: 69% agreed to participate in the study and of those n=40 (80%) remained at 5-months. At baseline, 12% (n=7) were deficient in vitamin D (<30nmol/L) and approximately 38% (n=22) had inadequate vitamin D levels (<50nmol/L). The baseline 25-OH vitamin D level was 59 nmol/L +25 (mean SD), and increased significantly to 72nmol/L +21 nmol/L at 5-months. Conclusion: These data are the first to provide evidence that clinical interventions are feasible in elders who self-neglect. The increase in vitamin D levels confirmed that the study personnel were able to successfully intervene community-dwelling elders with self-neglect. This study sets the precedent for future intervention and prevention studies

Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation.

PubMed

Merali, Zamir; Wilson, Jefferson R

2017-11-01

Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factors determined at the design phase of the trial including eligibility criteria, study setting, and outcomes of interest. In general, explanatory trials are optimized to demonstrate the efficacy of an intervention in a highly selected patient group; however, findings from these studies may not be generalizable to the larger clinical problem. In contrast, pragmatic trials attempt to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. In this article we describe the explanatory-pragmatic continuum for clinical trials in greater detail. Further, a well-accepted tool for grading trials on this continuum is described, and applied, to 2 recently published trials pertaining to the surgical management of lumbar degenerative spondylolisthesis.

EXAMINING EVIDENCE IN U.S. PAYER COVERAGE POLICIES FOR MULTI-GENE PANELS AND SEQUENCING TESTS

PubMed Central

Chambers, James D.; Saret, Cayla J.; Anderson, Jordan E.; Deverka, Patricia A.; Douglas, Michael P.; Phillips, Kathryn A.

2017-01-01

Objectives The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. Methods We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. Results Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73–100 percent), clinical studies in 69 percent (50–87 percent), technology assessments 47 percent (33–86 percent), systematic reviews or meta-analyses 31 percent (7–71 percent), and CEAs 5 percent (0–7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. Conclusions Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions. PMID:29065945

EXAMINING EVIDENCE IN U.S. PAYER COVERAGE POLICIES FOR MULTI-GENE PANELS AND SEQUENCING TESTS.

PubMed

Chambers, James D; Saret, Cayla J; Anderson, Jordan E; Deverka, Patricia A; Douglas, Michael P; Phillips, Kathryn A

2017-01-01

The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73-100 percent), clinical studies in 69 percent (50-87 percent), technology assessments 47 percent (33-86 percent), systematic reviews or meta-analyses 31 percent (7-71 percent), and CEAs 5 percent (0-7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions.

The impact of a reproductive health franchise on client satisfaction in rural Nepal.

PubMed

Agha, Sohail; Karim, Ali Mehryar; Balal, Asma; Sosler, Steve

2007-09-01

This study evaluates the impact of a nurse and paramedic reproductive health franchise in rural Nepal on client satisfaction and utilization of services. A quasi-experimental study design, with baseline and follow-up measurements on nonequivalent control groups, was used to assess the effects of the intervention. The study collected data from exit interviews with male and female clients at clinics and from household interviews with married women. Our assessment covers the project's performance for about a year of actual implementation. Client satisfaction with the quality of services increased across a range of indicators at intervention clinics but not at control clinics. Overall satisfaction with services also increased only at intervention clinics but not at control clinics. Consistent with these changes, loyalty increased among clients of franchised clinics. The analysis showed a positive relationship between client satisfaction and loyalty. Although the project's implementation was examined over a relatively short period of time, there appears to have been a net positive effect of the intervention on obtaining family planning products from medical stores/pharmacies. The study shows that franchising reproductive health services increases a provider's interest in delivering better quality services in rural areas of a developing country.

Maintenance of a smoking cessation program in public health clinics beyond the experimental evaluation period.

PubMed Central

Manfredi, C.; Crittenden, K.; Cho, Y. I.; Engler, J.; Warnecke, R.

2001-01-01

OBJECTIVES: As phase 3 of a study to evaluate a smoking cessation program in public health practice, the authors assess the maintenance and impact of the It's Time smoking cessation program in seven public maternal and child health clinics in Chicago. METHODS: The authors interviewed 404 clinic patients in the study's baseline phase (prior to introduction of the It's Time intervention program), and 610 in the program maintenance phase (in the year after experimental evaluation had ended) to assess exposure to smoking cessation interventions offered at the clinic, and smoking cessation outcomes (quit, actions toward quitting, scores on action, motivation, readiness, and confidence scales). The authors controlled for clustering of smokers within clinics, smokers' characteristics prior to clinic visit, and type of clinic service. They compared outcomes by study group (control or intervention) to which each clinic had been assigned in the earlier experimental phase. RESULTS: Compared to baseline, smokers in the maintenance phase had greater exposure to posters, provider advice and booklet, and better outcomes on seven of eight smoking cessation measures, including quitting. These improvements were larger for clinics with prior experience implementing It's Time. CONCLUSION: Participation in the experimental evaluation of the It's Time program prepared and possibly motivated the clinics to continue the program. Continuing the program resulted in greater delivery of interventions and improved smoking cessation outcomes for smokers in the clinics. PMID:11889280

Methodology Series Module 4: Clinical Trials.

PubMed

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

Methodology Series Module 4: Clinical Trials

PubMed Central

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an “open trial.” However, many of the trials are not open – they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India. PMID:27512184

Applying Lean Six Sigma methodologies to improve efficiency, timeliness of care, and quality of care in an internal medicine residency clinic.

PubMed

Fischman, Daniel

2010-01-01

Patients' connectedness to their providers has been shown to influence the success of preventive health and disease management programs. Lean Six Sigma methodologies were employed to study workflow processes, patient-physician familiarity, and appointment compliance to improve continuity of care in an internal medicine residency clinic. We used a rapid-cycle test to evaluate proposed improvements to the baseline-identified factors impeding efficient clinic visits. Time-study, no-show, and patient-physician familiarity data were collected to evaluate the effect of interventions to improve clinic efficiency and continuity of medical care. Forty-seven patients were seen in each of the intervention and control groups. The wait duration between the end of triage and the resident-patient encounter was statistically shorter for the intervention group. Trends toward shorter wait times for medical assistant triage and total encounter were also seen in the intervention group. On all measures of connectedness, both the physicians and patients in the intervention group showed a statistically significant increased familiarity with each other. This study shows that incremental changes in workflow processes in a residency clinic can have a significant impact on practice efficiency and adherence to scheduled visits for preventive health care and chronic disease management. This project used a structured "Plan-Do-Study-Act" approach.

A Little Effort Can Withstand the Hardship: Fielding an Internet-Based Intervention to Prevent Depression among Urban Racial/Ethnic Minority Adolescents in a Primary Care Setting.

PubMed

Bansa, Melishia; Brown, Darryl; DeFrino, Daniela; Mahoney, Nicholas; Saulsberry, Alexandria; Marko-Holguin, Monika; Fogel, Joshua; Gladstone, Tracy R G; Van Voorhees, Benjamin W

2018-04-01

This study explored the implementation of Chicago Urban Resiliency Building (CURB), a randomized clinical trial designed as an Internet-based primary care depression prevention intervention for urban African American and Latino adolescents. We utilized a mixed methods analysis to explore four aims. First, we estimated the percent of at-risk adolescents that were successfully screened. Second, we examined clinic site factors and performance. Third, primary care providers (n = 10) and clinic staff (n = 18) were surveyed to assess their knowledge and attitudes about the intervention. Fourth, clinic staff (nursing and medical assistant) interviews were analyzed using thematic analysis to gather perspectives of the implementation process. We found that the estimated percent of at-risk adolescents who were successfully screened in each clinic varied widely between clinics with a mean of 14.48%. Daily clinic communication was suggestive of greater successful screening. Feasibility of screening was high for both primary care providers and clinic staff. Clinic staff exit interviews indicated the presence of community barriers that inhibited successful implementation of the intervention. This study shares the challenges and successes for depression screening and implementing Internet-based mental health interventions for urban racial/ethnic minority adolescents in primary care settings. Published by Elsevier Inc.

Effective implementation of research into practice: an overview of systematic reviews of the health literature.

PubMed

Boaz, Annette; Baeza, Juan; Fraser, Alec

2011-06-22

The gap between research findings and clinical practice is well documented and a range of interventions has been developed to increase the implementation of research into clinical practice. A review of systematic reviews of the effectiveness of interventions designed to increase the use of research in clinical practice. A search for relevant systematic reviews was conducted of Medline and the Cochrane Database of Reviews 1998-2009. 13 systematic reviews containing 313 primary studies were included. Four strategy types are identified: audit and feedback; computerised decision support; opinion leaders; and multifaceted interventions. Nine of the reviews reported on multifaceted interventions. This review highlights the small effects of single interventions such as audit and feedback, computerised decision support and opinion leaders. Systematic reviews of multifaceted interventions claim an improvement in effectiveness over single interventions, with effect sizes ranging from small to moderate. This review found that a number of published systematic reviews fail to state whether the recommended practice change is based on the best available research evidence. This overview of systematic reviews updates the body of knowledge relating to the effectiveness of key mechanisms for improving clinical practice and service development. Multifaceted interventions are more likely to improve practice than single interventions such as audit and feedback. This review identified a small literature focusing explicitly on getting research evidence into clinical practice. It emphasizes the importance of ensuring that primary studies and systematic reviews are precise about the extent to which the reported interventions focus on changing practice based on research evidence (as opposed to other information codified in guidelines and education materials).

Feasibility trial of a Spanish-language multimedia educational intervention.

PubMed

Wells, Kristen J; McIntyre, Jessica; Gonzalez, Luis E; Lee, Ji-Hyun; Fisher, Kate J; Jacobsen, Paul B; Meade, Cathy; Muñoz-Antonia, Teresita; Quinn, Gwendolyn P

2013-10-01

Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family. Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics. A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later. Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial. Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results may not generalize to other Hispanic populations. In the pilot project, we demonstrated the feasibility of delivering multimedia information to patients in medical oncology clinics. Because delivery in a clinical setting was found to be feasible, a larger study should be conducted to evaluate the efficacy of the multimedia intervention with respect to promoting accrual of Hispanic patients to clinical trials.

The effect of an educational intervention, based on clinical simulation, on the diagnosis of rheumatoid arthritis and osteoarthritis.

PubMed

Fernández-Ávila, Daniel G; Ruiz, Álvaro J; Gil, Fabián; Mora, Sergio A; Tobar, Carlos; Gutiérrez, Juan M; Rosselli, Diego

2018-03-01

The aim of the present study was to evaluate the effectiveness of an educational tool for general physicians, based on rheumatological clinical simulation, for the diagnosis of rheumatoid arthritis and osteoarthritis. A randomized clinical study was carried out, in which the physician research subjects were assigned to one of two groups: the experimental group (educational intervention for rheumatoid arthritis with clinical simulation) or the control group (educational intervention for the basic aspects of the diagnosis and treatment of osteoporosis). Four weeks after the educational intervention, the members of both groups completed an examination that included four clinical cases with real patients, two clinical cases with two clinical simulation models and six virtual clinical cases. In this examination, the participants noted clinical findings, established a diagnosis and defined the complementary tests they would request, if necessary, to corroborate their diagnosis. A total of 160 doctors participated (80 in the active educational intervention for rheumatoid arthritis and 80 in the control group), of whom 89 were women (56%). The mean age was 35 (standard deviation 7.7) years. Success was defined as a physician correctly diagnosing at least 10 of the 12 cases presented. A significant difference of 81.3% (95% confidence interval 72-90%; p < 0.001) in success was found in favour of the active group (88.8% versus 7.5%). A greater number of correct answers was found in the active group compared with the control group in the detection of clinical findings and in the number of complementary tests requested (p < 0.001). The study showed the effectiveness of an educational intervention based on clinical simulation to improve the diagnostic approach to rheumatoid arthritis and osteoarthritis. The results open a new horizon in the teaching of rheumatology. Copyright © 2017 John Wiley & Sons, Ltd.

Prospects for a Clinical Science of Mindfulness-Based Intervention

PubMed Central

Dimidjian, Sona; Segal, Zindel V.

2017-01-01

Mindfulness-based interventions are at a pivotal point in their future development. Spurred on by an ever-increasing number of studies and breadth of clinical application, the value of such approaches may appear self-evident. We contend, however, that the public health impact of mindfulness-based interventions can be enhanced significantly by situating this work in a broader framework of clinical psychological science. Utilizing the National Institute of Health stage model (Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014), we map the evidence base for mindfulness-based cognitive therapy and mindfulness-based stress reduction as exemplars of mindfulness-based interventions. From this perspective, we suggest that important gaps in the current evidence base become apparent and, furthermore, that generating more of the same types of studies without addressing such gaps will limit the relevance and reach of these interventions. We offer a set of 7 recommendations that promote an integrated approach to core research questions, enhanced methodological quality of individual studies, and increased logical links among stages of clinical translation in order to increase the potential of MBIs to impact positively the mental health needs of individuals and communities. PMID:26436311

Effective interventions on service quality improvement in a physiotherapy clinic.

PubMed

Gharibi, Farid; Tabrizi, JafarSadegh; Eteraf Oskouei, MirAli; AsghariJafarabadi, Mohammad

2014-01-01

Service quality is considered as a main domain of quality associ-ated with non-clinical aspect of healthcare. This study aimed to survey and im-proves service quality of delivered care in the Physiotherapy Clinic affiliated with the Tabriz University of Medical Sciences, Tabriz, Iran. A quasi experimental interventional study was conducted in the Physiotherapy Clinic, 2010-2011. Data were collected using a validated and reli-able researcher made questionnaire with participation of 324 patients and their coadjutors. The study questionnaire consisted of 7 questions about demographic factors and 38 questions for eleven aspects of service quality. Data were then analyzed using paired samples t-test by SPSS16. In the pre intervention phase, six aspects of service quality including choice of provider, safety, prevention and early detection, dignity, autonomy and availability achieved non-acceptable scores. Following interventions, all aspects of the service quality improved and also total service quality score improved from 8.58 to 9.83 (P<0.001). Service quality can be improved by problem implementation of appropriate interventions. The acquired results can be used in health system fields to create respectful environments for healthcare customers.

Adherence and retention in clinical trials: a community-based approach.

PubMed

Fouad, Mona N; Johnson, Rhoda E; Nagy, M Christine; Person, Sharina D; Partridge, Edward E

2014-04-01

The Community Health Advisor (CHA) model has been widely used to recruit rural and low-income, mostly African American women into clinical and behavioral research studies. However, little is known about its effectiveness in promoting retention and adherence of such women in clinical trials. The Community-Based Retention Intervention Study evaluated the effectiveness of a community-based intervention strategy using the CHA model and the empowerment theory to improve the retention and adherence of minority and low-income women in clinical trials. The research strategy included the training and use of the volunteer CHAs as research partners. The target population included women participating in the University of Alabama at Birmingham clinical site of the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), a multicenter, randomized clinical trial. Two communities in Jefferson County, Alabama, that were matched according to population demographics were identified and randomly assigned to either an intervention group or a control group. Thirty community volunteers were recruited to be CHAs and to implement the intervention with the ALTS trial participants. In total, 632 ALTS participants agreed to participate in the project, including 359 in the intervention group, which received CHA care, and 273 in the control group, which received standard care. Adherence rates for scheduled clinic visits were significantly higher in the intervention group (80%) compared with the control group (65%; P < .0001). The results indicate that volunteer CHAs can be trained to serve as research partners and can be effective in improving the retention and adherence of minority and low-income women in clinical trials. © 2014 American Cancer Society.

Impact of the 5As Team study on clinical practice in primary care obesity management: a qualitative study

PubMed Central

Asselin, Jodie; Salami, Eniola; Osunlana, Adedayo M.; Ogunleye, Ayodele A.; Cave, Andrew; Johnson, Jeffrey A.; Sharma, Arya M.; Campbell-Scherer, Denise L.

2017-01-01

Background: The 5As [Ask, Assess, Advise, Agree, Assist] of Obesity Management Team study was a randomized controlled trial of an intervention that was implemented and evaluated to help primary care providers improve clinical practice for obesity management. This paper presents health care provider perspectives of the impacts of the intervention on individual provider and team practices. Methods: This study reports a thematic network analysis of qualitative data collected during the 5As Team study, which involved 24 chronic disease teams affiliated with family practices in a Primary Care Network in Alberta. Qualitative data from 28 primary care providers (registered nurses/nurse practitioners [n = 14], dietitians [n = 7] and mental health workers [n = 7]) in the intervention arm were collected through semistructured interviews, field notes, practice facilitator diaries and 2 evaluation workshop questionnaires. Results: Providers internalized 5As Team intervention concepts, deepening self-evaluation and changing clinical reasoning around obesity. Providers perceived that this internalization changed the provider-patient relationship positively. The intervention changed relations between providers, increasing interdisciplinary understanding, collaboration and discovery of areas for improvement. This personal and interpersonal evolution effected change to the entire Primary Care Network. Interpretation: The 5As Team intervention had multiple impacts on providers and teams to improve obesity management in primary care. Improved provider confidence and capability is a precondition of developing effective patient interventions. Trial registration: ClinicalTrials.gov, no.: NCT01967797. PMID:28450428

Patients' perceptions of sharing in decisions: a systematic review of interventions to enhance shared decision making in routine clinical practice.

PubMed

Légaré, France; Turcotte, Stéphane; Stacey, Dawn; Ratté, Stéphane; Kryworuchko, Jennifer; Graham, Ian D

2012-01-01

Shared decision making is the process in which a healthcare choice is made jointly by the health professional and the patient. Little is known about what patients view as effective or ineffective strategies to implement shared decision making in routine clinical practice. This systematic review evaluates the effectiveness of interventions to improve health professionals' adoption of shared decision making in routine clinical practice, as seen by patients. We searched electronic databases (PubMed, the Cochrane Library, EMBASE, CINAHL, and PsycINFO) from their inception to mid-March 2009. We found additional material by reviewing the reference lists of the studies found in the databases; systematic reviews of studies on shared decision making; the proceedings of various editions of the International Shared Decision Making Conference; and the transcripts of the Society for Medical Decision Making's meetings. In our study selection, we included randomized controlled trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series analyses in which patients evaluated interventions to improve health professionals' adoption of shared decision making. The interventions in question consisted of the distribution of printed educational material; educational meetings; audit and feedback; reminders; and patient-mediated initiatives (e.g. patient decision aids). Two reviewers independently screened the studies and extracted data. Statistical analyses considered categorical and continuous process measures. We computed the standardized effect size for each outcome at the 95% confidence interval. The primary outcome of interest was health professionals' adoption of shared decision making as reported by patients in a self-administered questionnaire. Of the 6764 search results, 21 studies reported 35 relevant comparisons. Overall, the quality of the studies ranged from 0% to 83%. Only three of the 21 studies reported a clinically significant effect for the primary outcome that favored the intervention. The first study compared an educational meeting and a patient-mediated intervention with another patient-mediated intervention (median improvement of 74%). The second compared an educational meeting, a patient-mediated intervention, and audit and feedback with an educational meeting on an alternative topic (improvement of 227%). The third compared an educational meeting and a patient-mediated intervention with usual care (p = 0.003). All three studies were limited to the patient-physician dyad. To reduce bias, future studies should improve methods and reporting, and should analyze costs and benefits, including those associated with training of health professionals. Multifaceted interventions that include educating health professionals about sharing decisions with patients and patient-mediated interventions, such as patient decision aids, appear promising for improving health professionals' adoption of shared decision making in routine clinical practice as seen by patients.

Effectiveness of Standardized Patient Simulations in Teaching Clinical Communication Skills to Dental Students.

PubMed

McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee

2017-10-01

The aim of this study was to investigate dental students' long-term retention of clinical communication skills learned in a second-year standardized patient simulation at one U.S. dental school. Retention was measured by students' performance with an actual patient during their fourth year. The high-fidelity simulation exercise focused on clinical communication skills took place during the spring term of the students' second year. The effect of the simulation was measured by comparing the fourth-year clinical performance of two groups: those who had participated in the simulation (intervention group; Class of 2016) and those who had not (no intervention/control group; Class of 2015). In the no intervention group, all 47 students participated; in the intervention group, 58 of 59 students participated. Both instructor assessments and students' self-assessments were used to evaluate the effectiveness of key patient interaction principles as well as comprehensive presentation of multiple treatment options. The results showed that students in the intervention group more frequently included cost during their treatment option presentation than did students in the no intervention group. The instructor ratings showed that the intervention group included all key treatment option components except duration more frequently than did the no intervention group. However, the simulation experience did not result in significantly more effective student-patient clinical communication on any of the items measured. This study presents limited evidence of the effectiveness of a standardized patient simulation to improve dental students' long-term clinical communication skills with respect to thorough presentation of treatment options to a patient.

Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults.

PubMed

Pyatak, Elizabeth A; Carandang, Kristine; Vigen, Cheryl; Blanchard, Jeanine; Sequeira, Paola A; Wood, Jamie R; Spruijt-Metz, Donna; Whittemore, Robin; Peters, Anne L

2017-03-01

This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical service organisation for heart failure

PubMed Central

Taylor, Stephanie JC; Bestall, Janine C; Cotter, Sarah; Falshaw, Margaret; Hood, Sonja G; Parsons, Suzanne; Wood, Lesley; Underwood, Martin

2014-01-01

Background Chronic heart failure (CHF) is a serious, common condition associated with frequent hospitalisation. Several different disease management interventions (clinical service organisation interventions) for patients with CHF have been proposed. Objectives To assess the effectiveness of disease management interventions for patients with CHF. Search methods We searched: Cochrane CENTRAL Register of Controlled Trials (to June 2003); MEDLINE (January 1966 to July 2003); EMBASE (January 1980 to July 2003); CINAHL (January 1982 to July 2003); AMED (January 1985 to July 2003); Science Citation Index Expanded (searched January 1981 to March 2001); SIGLE (January 1980 to July 2003); DARE (July 2003); National Research Register (July 2003); NHS Economic Evaluations Database (March 2001); reference lists of articles and asked experts in the field. Selection criteria Randomised controlled trials comparing disease management interventions specifically directed at patients with CHF to usual care. Data collection and analysis At least two reviewers independently extracted data information and assessed study quality. Study authors were contacted for further information where necessary. Main results Sixteen trials involving 1,627 people were included. We classified the interventions into three models: multidisciplinary interventions (a holistic approach bridging the gap between hospital admission and discharge home delivered by a team); case management interventions (intense monitoring of patients following discharge often involving telephone follow up and home visits); and clinic interventions (follow up in a CHF clinic). There was considerable overlap within these categories, however the components, intensity and duration of the interventions varied. Case management interventions tended to be associated with reduced all cause mortality but these findings were not statistically significant (odds ratio 0.86, 95% confidence interval 0.67 to 1.10, P = 0.23), although the evidence was stronger when analysis was limited to the better quality studies (odds ratio 0.68, 95% confidence interval 0.46 to 0.98, P = 0.04). There was weak evidence that case management interventions may be associated with a reduction in admissions for heart failure. It is unclear what the effective components of the case management interventions are. The single RCT of a multidisciplinary intervention showed reduced heart-failure related re-admissions in the short term. At present there is little available evidence to support clinic based interventions. Authors’ conclusions The data from this review are insufficient for forming recommendations. Further research should include adequately powered, multicentre studies. Future studies should also investigate the effect of interventions on patients’ and carers’ quality of life, their satisfaction with the interventions and cost effectiveness. PMID:15846638

A systematic review assessing non-pharmacological conservative treatment studies for people with non-inflammatory multi-joint pain: clinical outcomes and research design considerations.

PubMed

Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G

2018-03-01

To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).

Evaluation of clinical pharmacy services offered for palliative care patients in Qatar.

PubMed

Wilby, Kyle John; Mohamad, Alaa Adil; AlYafei, Sumaya AlSaadi

2014-09-01

Palliative care is an emerging concept in the countries of the Gulf Cooperation Council, a political and economic union of Arab states bordering the Persian Gulf, namely Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. Clinical pharmacy services have not yet been evaluated in this region. The objectives of this study were to create a baseline inventory of clinical pharmacy interventions in palliative care and to assess the perceived importance of interventions made. This was a prospective, single-center characterization study. Interventions were documented from September 30 to December 1, 2013. They were characterized into predetermined categories and analyzed using descriptive statistics. Physician acceptance rate and intervention rate per patient were calculated. Classification categories were sent to 10 practicing pharmacists in each of Qatar and Canada, who ranked the categories on the basis of perceived importance. A total of 96 interventions were documented, giving 3 interventions per patient and an acceptance rate of 81%. Discontinuing therapy (29%), initiating therapy (25%), and provision of education/counseling (13.5%) were most common. No differences were found between rankings from pharmacists in Qatar or Canada. Clinical pharmacy interventions are frequent, and those relating to alterations in drug therapy are most common. Interventions align with the perceived importance from pharmacists in both Qatar and Canada.

A narrative review on cervical interventions in adults with chronic whiplash-associated disorder

PubMed Central

Yeung, Euson; Tong, Tiffany; Reed, Nick

2018-01-01

Introduction Whiplash injuries are common in society, but clinical interventions are inconclusive on the most effective treatment. Research and reviews have been completed with the goal of determining clinical interventions that are effective for whiplash injuries and disorders, but literature has not recently been summarised on best practices for cervical spine interventions for adults with chronic whiplash. Purpose The objective of this narrative review is to update and expand on previous works, to provide recommendations for clinical interventions and future research in the area of cervical spine rehabilitation for adults with chronic whiplash-associated disorder. Method The Arskey and O’Malley methodology was used for this narrative review. CINHAL, EMBASE, Medline, PsychInfo, Scopus, Web of Science, as well as grey literature, were searched from 2003 to April 2017. Two reviewers screened titles and abstracts for relevance to the review, and content analysis summarised the study findings. A total of 14 citations were included in the final review. Findings Exercise-based interventions targeted at the cervical spine appear most beneficial for adults with chronic whiplash-associated disorder (WAD). Invasive interventions still require more rigorous studies to deem their effectiveness for this population. Conclusion Further research is required to investigate and determine clinically relevant results for cervical spine intervention in patients with chronic WAD. PMID:29719724

Care and Feeding of the Endocannabinoid System: A Systematic Review of Potential Clinical Interventions that Upregulate the Endocannabinoid System

PubMed Central

McPartland, John M.; Guy, Geoffrey W.; Di Marzo, Vincenzo

2014-01-01

Background The “classic” endocannabinoid (eCB) system includes the cannabinoid receptors CB1 and CB2, the eCB ligands anandamide (AEA) and 2-arachidonoylglycerol (2-AG), and their metabolic enzymes. An emerging literature documents the “eCB deficiency syndrome” as an etiology in migraine, fibromyalgia, irritable bowel syndrome, psychological disorders, and other conditions. We performed a systematic review of clinical interventions that enhance the eCB system—ways to upregulate cannabinoid receptors, increase ligand synthesis, or inhibit ligand degradation. Methodology/Principal Findings We searched PubMed for clinical trials, observational studies, and preclinical research. Data synthesis was qualitative. Exclusion criteria limited the results to 184 in vitro studies, 102 in vivo animal studies, and 36 human studies. Evidence indicates that several classes of pharmaceuticals upregulate the eCB system, including analgesics (acetaminophen, non-steroidal anti-inflammatory drugs, opioids, glucocorticoids), antidepressants, antipsychotics, anxiolytics, and anticonvulsants. Clinical interventions characterized as “complementary and alternative medicine” also upregulate the eCB system: massage and manipulation, acupuncture, dietary supplements, and herbal medicines. Lifestyle modification (diet, weight control, exercise, and the use of psychoactive substances—alcohol, tobacco, coffee, cannabis) also modulate the eCB system. Conclusions/Significance Few clinical trials have assessed interventions that upregulate the eCB system. Many preclinical studies point to other potential approaches; human trials are needed to explore these promising interventions. PMID:24622769

Care and feeding of the endocannabinoid system: a systematic review of potential clinical interventions that upregulate the endocannabinoid system.

PubMed

McPartland, John M; Guy, Geoffrey W; Di Marzo, Vincenzo

2014-01-01

The "classic" endocannabinoid (eCB) system includes the cannabinoid receptors CB1 and CB2, the eCB ligands anandamide (AEA) and 2-arachidonoylglycerol (2-AG), and their metabolic enzymes. An emerging literature documents the "eCB deficiency syndrome" as an etiology in migraine, fibromyalgia, irritable bowel syndrome, psychological disorders, and other conditions. We performed a systematic review of clinical interventions that enhance the eCB system--ways to upregulate cannabinoid receptors, increase ligand synthesis, or inhibit ligand degradation. We searched PubMed for clinical trials, observational studies, and preclinical research. Data synthesis was qualitative. Exclusion criteria limited the results to 184 in vitro studies, 102 in vivo animal studies, and 36 human studies. Evidence indicates that several classes of pharmaceuticals upregulate the eCB system, including analgesics (acetaminophen, non-steroidal anti-inflammatory drugs, opioids, glucocorticoids), antidepressants, antipsychotics, anxiolytics, and anticonvulsants. Clinical interventions characterized as "complementary and alternative medicine" also upregulate the eCB system: massage and manipulation, acupuncture, dietary supplements, and herbal medicines. Lifestyle modification (diet, weight control, exercise, and the use of psychoactive substances--alcohol, tobacco, coffee, cannabis) also modulate the eCB system. Few clinical trials have assessed interventions that upregulate the eCB system. Many preclinical studies point to other potential approaches; human trials are needed to explore these promising interventions.

Harms, benefits, and the nature of interventions in pragmatic clinical trials.

PubMed

Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

2015-10-01

To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems. © The Author(s) 2015.

A peer learning intervention for nursing students in clinical practice education: A quasi-experimental study.

PubMed

Pålsson, Ylva; Mårtensson, Gunilla; Swenne, Christine Leo; Ädel, Eva; Engström, Maria

2017-04-01

Studies of peer learning indicate that the model enables students to practice skills useful in their future profession, such as communication, cooperation, reflection and independence. However, so far most studies have used a qualitative approach and none have used a quasi-experimental design to study effects of nursing students' peer learning in clinical practice. To investigate the effects of peer learning in clinical practice education on nursing students' self-rated performance. Quasi-experimental. The study was conducted during nursing students' clinical practice. All undergraduate nursing students (n=87) attending their first clinical practice were approached. Seventy students out of 87 answered the questionnaires at both baseline and follow-up (42 of 46 in the intervention group and 28 of 39 in the comparison group). During the first two weeks of the clinical practice period, all students were supervised traditionally. Thereafter, the intervention group received peer learning the last two weeks, and the comparison group received traditional supervision. Questionnaire data were collected on nursing students' self-rated performance during the second (baseline) and last (follow-up) week of their clinical practice. Self-efficacy was improved in the intervention group and a significant interaction effect was found for changes over time between the two groups. For the other self-rated variables/tests, there were no differences in changes over time between the groups. Studying each group separately, the intervention group significantly improved on thirteen of the twenty variables/tests over time and the comparison group improved on four. The results indicate that peer learning is a useful method which improves nursing students' self-efficacy to a greater degree than traditional supervision does. Regarding the other self-rated performance variables, no interaction effects were found. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

Challenges in defining 'palliative care' for the purposes of clinical trials.

PubMed

Bausewein, Claudia; Higginson, Irene J

2012-12-01

Palliative care has become part of mainstream medicine with increasing evidence about the effectiveness of specialist palliative care (SPC) on patient and family outcomes. Comparison of studies testing SPC interventions is challenging as types of interventions and reporting of components of the intervention vary. In consequence, study results are difficult to interpret. There is a continuous lack of clarity in palliative care definitions. For clinical trials, multidisciplinary care, supportive care documentation, symptom assessment and symptom management are suggested as key domains. In recent studies testing palliative care as an intervention SPC physicians and palliative care nurses were core members of multiprofessional teams, but integration of other team members varied. Management of symptoms and psychosocial issues were central to SPC with various other areas described. Services were delivered by hospital and community support teams, in palliative care units, outpatient clinics and hospital. Cost information was only provided by a few studies. Due to the lack of an agreed definition of palliative care and heterogeneity in reporting of components of an SPC intervention comparison of studies remains challenging. Key aspects of palliative care interventions are incurable disease, multidisciplinary approach, focus on symptom management including standardized assessment, psychosocial and family support, and (advance) care planning. Detailed information about all aspects of the intervention should be provided.

Monolingual or Bilingual Intervention for Primary Language Impairment? A Randomized Control Trial

ERIC Educational Resources Information Center

Thordardottir, Elin; Cloutier, Geneviève; Ménard, Suzanne; Pelland-Blais, Elaine; Rvachew, Susan

2015-01-01

Purpose: This study investigated the clinical effectiveness of monolingual versus bilingual language intervention, the latter involving speech-language pathologist-parent collaboration. The study focuses on methods that are currently being recommended and that are feasible within current clinical contexts. Method: Bilingual children with primary…

Using a claims data-based sentinel system to improve compliance with clinical guidelines: results of a randomized prospective study.

PubMed

Javitt, Jonathan C; Steinberg, Gregory; Locke, Todd; Couch, James B; Jacques, Jeffrey; Juster, Iver; Reisman, Lonny

2005-02-01

To demonstrate the potential effect of deploying a sentinel system that scans administrative claims information and clinical data to detect and mitigate errors in care and deviations from best medical practices. Members (n = 39 462; age range, 12-64 years) of a midwestern managed care plan were randomly assigned to an intervention or a control group. The sentinel system was programmed with more than 1000 decision rules that were capable of generating clinical recommendations. Clinical recommendations triggered for subjects in the intervention group were relayed to treating physicians, and those for the control group were deferred to study end. Nine hundred eight clinical recommendations were issued to the intervention group. Among those in both groups who triggered recommendations, there were 19% fewer hospital admissions in the intervention group compared with the control group (P < .001). Charges among those whose recommendations were communicated were dollar 77.91 per member per month (pmpm) lower and paid claims were dollar 68.08 pmpm lower than among controls compared with the baseline values (P = .003 for both). Paid claims for the entire intervention group (with or without recommendations) were dollar 8.07 pmpm lower than those for the entire control group. In contrast, the intervention cost dollar 1.00 pmpm, suggesting an 8-fold return on investment. Ongoing use of a sentinel system to prompt clinically actionable, patient-specific alerts generated from administratively derived clinical data was associated with a reduction in hospitalization, medical costs, and morbidity.

The natural history of subjective tinnitus in adults: A systematic review and meta-analysis of no-intervention periods in controlled trials.

PubMed

Phillips, John S; McFerran, Don J; Hall, Deborah A; Hoare, Derek J

2018-01-01

Tinnitus is a prevalent condition, but little has been published regarding the natural history of the condition. One technique for evaluating the long-term progression of the disease is to examine what happens to participants in the no-intervention control arm of a clinical trial. The aim of this study was to examine no-intervention or waiting-list data reported in trials, in which participants on the active arm received any form of tinnitus intervention. CINAHL, PsychINFO, EMBASE, ASSIA, PubMed, Web of Science, Science Direct, EBSCO Host, and Cochrane. Inclusion criteria followed the PICOS principles: Participants, adults with tinnitus; Intervention, none; Control, any intervention for alleviating tinnitus; Outcomes, a measure assessing tinnitus symptoms using a multi-item patient-reported tinnitus questionnaire. Secondary outcome measures included multi-item patient-reported questionnaires of mood and health-related quality of life and measures that quantified change in tinnitus loudness; Study design, randomized controlled trials or observational studies utilizing a no-intervention or waiting-list control group. Data were extracted and standardized mean difference was calculated for each study to enable meta-analysis. The evidence strongly favored a statistically significant decrease in the impact of tinnitus over time, though there was significant heterogeneity and clinical significance cannot be interpreted. Outcome data regarding secondary measures did not demonstrate any clinically significant change. Participants allocated to the no-intervention or waiting-list control arm of clinical trials for a tinnitus intervention show a small but significant improvement in self-reported measures of tinnitus with time; the clinical significance of this finding is unknown. There is, however, considerable variation across individuals. These findings support previous work and can cautiously be used when counseling patients. Laryngoscope, 128:217-227, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Scale Development of a Measure to Assess Community-Based and Clinical Intervention Group Environments

ERIC Educational Resources Information Center

Wilson, Patrick A.; Hansen, Nathan B.; Tarakeshwar, Nalini; Neufeld, Sharon; Kochman, Arlene; Sikkema, Kathleen J.

2008-01-01

Though group interventions are widely used in community-based and clinical settings, there are few brief instruments for assessing the group environment. Two studies on the development of a brief measure to assess intervention group environments are described, and psychometric properties of the new scale are presented. The new measure is based on…

Nursing Education Interventions for Managing Acute Pain in Hospital Settings: A Systematic Review of Clinical Outcomes and Teaching Methods.

PubMed

Drake, Gareth; de C Williams, Amanda C

2017-02-01

The objective of this review was to examine the effects of nursing education interventions on clinical outcomes for acute pain management in hospital settings, relating interventions to health care behavior change theory. Three databases were searched for nursing education interventions from 2002 to 2015 in acute hospital settings with clinical outcomes reported. Methodological quality was rated as strong, moderate, or weak using the Effective Public Health Practice Project Quality Assessment Tool for quantitative studies. The 12 eligible studies used varied didactic and interactive teaching methods. Several studies had weaknesses attributable to selection biases, uncontrolled confounders, and lack of blinding of outcome assessors. No studies made reference to behavior change theory in their design. Eight of the 12 studies investigated nursing documentation of pain assessment as the main outcome, with the majority reporting positive effects of education interventions on nursing pain assessment. Of the remaining studies, two reported mixed findings on patient self-report of pain scores as the key measure, one reported improvements in patient satisfaction with pain management after a nursing intervention, and one study found an increase in nurses' delivery of a relaxation treatment following an intervention. Improvements in design and evaluation of nursing education interventions are suggested, drawing on behavior change theory and emphasizing the relational, contextual, and emotionally demanding nature of nursing pain management in hospital settings. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Assessing Risk/Benefit for Trials Using Preclinical Evidence: A Proposal

PubMed Central

Kimmelman, Jonathan; Henderson, Valerie C.

2015-01-01

Abstract Moral evaluation of risk/benefit in early phase studies requires assessing the clinical promise of a candidate intervention using preclinical evidence. Yet there is little to guide ethics committees, investigators, sponsors or other stakeholders morally charged with making these assessments (“evaluators”). In what follows, we draw on published guidelines for preclinical study design to develop a structured process for assessing the clinical promise of new interventions. In the first step, evaluators gather all relevant preclinical studies, assess the magnitude of treatment effects, and determine clinical promise in light of various threats to valid clinical inference. In the second step, evaluators adjust assessments of clinical promise from preclinical studies by examining how other agents in the same reference class-and supported by similar evidence- have fared in clinical development. Assessments of clinical promise can then be fed into moral evaluation of risk and benefit in early phase trials. Though our approach has limitations, it offers a systematic and transparent method for assessing risk/benefit in early phase trials of novel interventions. PMID:26463620

Design of control-group conditions in clinical trials of behavioral interventions.

PubMed

Lindquist, Ruth; Wyman, Jean F; Talley, Kristine M C; Findorff, Mary J; Gross, Cynthia R

2007-01-01

To review considerations in the design of placebo (attention) control conditions for community-based clinical trials of health behavior change interventions and to provide practical strategies for the design of control conditions. A well-designed control condition is an essential component of a clinical trial to foster the unambiguous interpretation of study findings. Pitfalls in the design of control conditions in clinical trials of behavioral interventions are identified and strategies to address them are offered. Types of control conditions that have been used in fall prevention trials are described, along with their strengths and weaknesses. The control condition used in the recent fall evaluation and prevention program (FEPP) was designed to overcome limitations of previous trial designs; it is provided to illustrate how to apply specific design principles. Pitfalls in the design of behavioral intervention studies may be avoided with the application of sound design principles. The FEPP active control condition can be used as a model in the design of future studies.

Audio-visual presentation of information for informed consent for participation in clinical trials.

PubMed

Ryan, R E; Prictor, M J; McLaughlin, K J; Hill, S J

2008-01-23

Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented for example on the Internet, DVD, or video cassette) are one such method. To assess the effects of providing audio-visual information alone, or in conjunction with standard forms of information provision, to potential clinical trial participants in the informed consent process, in terms of their satisfaction, understanding and recall of information about the study, level of anxiety and their decision whether or not to participate. We searched: the Cochrane Consumers and Communication Review Group Specialised Register (searched 20 June 2006); the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 2, 2006; MEDLINE (Ovid) (1966 to June week 1 2006); EMBASE (Ovid) (1988 to 2006 week 24); and other databases. We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. Randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or oral information as usually employed in the particular service setting), with standard forms of information provision alone, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to participate in a real (not hypothetical) clinical study. Two authors independently assessed studies for inclusion and extracted data. Due to heterogeneity no meta-analysis was possible; we present the findings in a narrative review. We included 4 trials involving data from 511 people. Studies were set in the USA and Canada. Three were randomised controlled trials (RCTs) and the fourth a quasi-randomised trial. Their quality was mixed and results should be interpreted with caution. Considerable uncertainty remains about the effects of audio-visual interventions, compared with standard forms of information provision (such as written or oral information normally used in the particular setting), for use in the process of obtaining informed consent for clinical trials. Audio-visual interventions did not consistently increase participants' levels of knowledge/understanding (assessed in four studies), although one study showed better retention of knowledge amongst intervention recipients. An audio-visual intervention may transiently increase people's willingness to participate in trials (one study), but this was not sustained at two to four weeks post-intervention. Perceived worth of the trial did not appear to be influenced by an audio-visual intervention (one study), but another study suggested that the quality of information disclosed may be enhanced by an audio-visual intervention. Many relevant outcomes including harms were not measured. The heterogeneity in results may reflect the differences in intervention design, content and delivery, the populations studied and the diverse methods of outcome assessment in included studies. The value of audio-visual interventions for people considering participating in clinical trials remains unclear. Evidence is mixed as to whether audio-visual interventions enhance people's knowledge of the trial they are considering entering, and/or the health condition the trial is designed to address; one study showed improved retention of knowledge amongst intervention recipients. The intervention may also have small positive effects on the quality of information disclosed, and may increase willingness to participate in the short-term; however the evidence is weak. There were no data for several primary outcomes, including harms. In the absence of clear results, triallists should continue to explore innovative methods of providing information to potential trial participants. Further research should take the form of high-quality randomised controlled trials, with clear reporting of methods. Studies should conduct content assessment of audio-visual and other innovative interventions for people of differing levels of understanding and education; also for different age and cultural groups. Researchers should assess systematically the effects of different intervention components and delivery characteristics, and should involve consumers in intervention development. Studies should assess additional outcomes relevant to individuals' decisional capacity, using validated tools, including satisfaction; anxiety; and adherence to the subsequent trial protocol.

Physiotherapy and occupational therapy interventions for people with benign joint hypermobility syndrome: a systematic review of clinical trials.

PubMed

Smith, Toby O; Bacon, Holly; Jerman, Emma; Easton, Vicky; Armon, Kate; Poland, Fiona; Macgregor, Alex J

2014-01-01

This study assessed the literature to determine the efficacy and effectiveness of physiotherapy and occupational therapy interventions in the treatment of people with benign joint hypermobility syndrome (BJHS). Published literature databases including: AMED, CINAHL, MEDLINE, EMBASE, PubMed and the Cochrane Library, in addition to unpublished databases and trial registries were searched to October 2012. All clinical trials comparing the clinical outcomes of Occupational Therapy and Physiotherapy interventions compared to non-treatment or control intervention for people with BJHS were included. Of the 126 search results, 3 clinical studies satisfied the eligibility criteria. The data provides limited support for the use of wrist/hand splints for school children. While there is some support for exercise-based intervention, there is insufficient research to determine the optimal mode, frequency, dosage or type of exercise which should be delivered. The current evidence-base surrounding Occupational Therapy and Physiotherapy in the management of BJHS is limited in size and quality. There is insufficient research exploring the clinical outcomes of a number of interventions including sensory integration, positioning and posture management and education. Longer term, rigorous multi-centre randomised controlled trials are warranted to begin to assess the clinical and cost-effectiveness of interventions for children and adults with BJHS. Implications for Rehabilitation There is an evidence-base to support clinician's use of proprioceptive-based exercises in adults, and either tailored or generalised physiotherapy regimes for children with BJHS. Clinicians should be cautious when considering the prescription of hand/wrist splints for school age children with BJHS, based on the current research. Until further multi-centre trials are conducted assessing the clinical and cost-effectiveness of interventions for children and adult with BJHS, clinical decision-making should be based on theoretical rather than evidence-based grounds for this population.

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

PubMed

Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Tong, Seng Fah; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H

2016-11-14

The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect. A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. -4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes. This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting. Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

Postgraduate Clinical Psychology Students' Perceptions of an Acceptance and Commitment Therapy Stress Management Intervention and Clinical Training

ERIC Educational Resources Information Center

Pakenham, Kenneth I.; Stafford-Brown, Johanna

2013-01-01

Background: Research into stress management interventions for clinical psychology trainees (CPTs) is limited, despite evidence indicating that these individuals are at risk for elevated stress, which can negatively impact personal and professional functioning. This study explored: (1) CPTs' perceptions of a previously evaluated Acceptance and…

Enhancing the population impact of collaborative care interventions: Mixed method development and implementation of stepped care targeting posttraumatic stress disorder and related comorbidities after acute trauma

PubMed Central

Zatzick, Douglas; Rivara, Frederick; Jurkovich, Gregory; Russo, Joan; Trusz, Sarah Geiss; Wang, Jin; Wagner, Amy; Stephens, Kari; Dunn, Chris; Uehara, Edwina; Petrie, Megan; Engel, Charles; Davydow, Dimitri; Katon, Wayne

2011-01-01

Objective To develop and implement a stepped collaborative care intervention targeting PTSD and related co-morbidities to enhance the population impact of early trauma-focused interventions. Method We describe the design and implementation of the Trauma Survivors Outcomes & Support Study (TSOS II). An interdisciplinary treatment development team was comprised of trauma surgical, clinical psychiatric and mental health services “change agents” who spanned the boundaries between front-line trauma center clinical care and acute care policy. Mixed method clinical epidemiologic and clinical ethnographic studies informed the development of PTSD screening and intervention procedures. Results Two-hundred and seven acutely injured trauma survivors with high early PTSD symptom levels were randomized into the study. The stepped collaborative care model integrated care management (i.e., posttraumatic concern elicitation and amelioration, motivational interviewing, and behavioral activation) with cognitive behavioral therapy and pharmacotherapy targeting PTSD. The model was feasibly implemented by front-line acute care MSW and ARNP providers. Conclusions Stepped care protocols targeting PTSD may enhance the population impact of early interventions developed for survivors of individual and mass trauma by extending the reach of collaborative care interventions to acute care medical settings and other non-specialty posttraumatic contexts. PMID:21596205

Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Study: Methodology and Baseline Characteristics of a Randomized Controlled Trial Evaluating an Occupation-Based Diabetes Management Intervention for Young Adults

PubMed Central

Pyatak, Elizabeth A.; Carandang, Kristine; Vigen, Cheryl; Blanchard, Jeanine; Sequeira, Paola A.; Wood, Jamie R.; Spruijt-Metz, Donna; Whittemore, Robin; Peters, Anne L.

2017-01-01

Overview This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. Methods In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study’s primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. Results At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6 years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrate clinically significant diabetes distress and 27.2% report symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. Discussion Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. PMID:28064028

Teaching metacognition in clinical decision-making using a novel mnemonic checklist: an exploratory study

PubMed Central

Chew, Keng Sheng; Durning, Steven J; van Merriënboer, Jeroen JG

2016-01-01

INTRODUCTION Metacognition is a cognitive debiasing strategy that clinicians can use to deliberately detach themselves from the immediate context of a clinical decision, which allows them to reflect upon the thinking process. However, cognitive debiasing strategies are often most needed when the clinician cannot afford the time to use them. A mnemonic checklist known as TWED (T = threat, W = what else, E = evidence and D = dispositional factors) was recently created to facilitate metacognition. This study explores the hypothesis that the TWED checklist improves the ability of medical students to make better clinical decisions. METHODS Two groups of final-year medical students from Universiti Sains Malaysia, Malaysia, were recruited to participate in this quasi-experimental study. The intervention group (n = 21) received educational intervention that introduced the TWED checklist, while the control group (n = 19) received a tutorial on basic electrocardiography. Post-intervention, both groups received a similar assessment on clinical decision-making based on five case scenarios. RESULTS The mean score of the intervention group was significantly higher than that of the control group (18.50 ± 4.45 marks vs. 12.50 ± 2.84 marks, p < 0.001). In three of the five case scenarios, students in the intervention group obtained higher scores than those in the control group. CONCLUSION The results of this study support the use of the TWED checklist to facilitate metacognition in clinical decision-making. PMID:26778635

Implementation of the CALM intervention for anxiety disorders: a qualitative study

PubMed Central

2012-01-01

Background Investigators recently tested the effectiveness of a collaborative-care intervention for anxiety disorders: Coordinated Anxiety Learning and Management(CALM) []) in 17 primary care clinics around the United States. Investigators also conducted a qualitative process evaluation. Key research questions were as follows: (1) What were the facilitators/barriers to implementing CALM? (2) What were the facilitators/barriers to sustaining CALM after the study was completed? Methods Key informant interviews were conducted with 47 clinic staff members (18 primary care providers, 13 nurses, 8 clinic administrators, and 8 clinic staff) and 14 study-trained anxiety clinical specialists (ACSs) who coordinated the collaborative care and provided cognitive behavioral therapy. The interviews were semistructured and conducted by phone. Data were content analyzed with line-by-line analyses leading to the development and refinement of themes. Results Similar themes emerged across stakeholders. Important facilitators to implementation included the perception of "low burden" to implement, provider satisfaction with the intervention, and frequent provider interaction with ACSs. Barriers to implementation included variable provider interest in mental health, high rates of part-time providers in clinics, and high social stressors of lower socioeconomic-status patients interfering with adherence. Key sustainability facilitators were if a clinic had already incorporated collaborative care for another disorder and presence of onsite mental health staff. The main barrier to sustainability was funding for the ACS. Conclusions The CALM intervention was relatively easy to incorporate during the effectiveness trial, and satisfaction was generally high. Numerous implementation and sustainability barriers could limit the reach and impact of widespread adoption. Findings should be interpreted with the knowledge that the ACSs in this study were provided and trained by the study. Future research should explore uptake of CALM and similar interventions without the aid of an effectiveness trial. PMID:22404963

IMPROVING THE REPORTING OF THERAPEUTIC EXERCISE INTERVENTIONS IN REHABILITATION RESEARCH.

PubMed

Page, Phil; Hoogenboom, Barb; Voight, Michael

2017-04-01

The foundation of evidence-based practice lies in clinical research, which is based on the utilization of the scientific method. The scientific method requires that all details of the experiment be provided in publications to support replication of the study in order to evaluate and validate the results. More importantly, clinical research can only be translated into practice when researchers provide explicit details of the study. Too often, rehabilitation exercise intervention studies lack the appropriate detail to allow clinicians to replicate the exercise protocol in their patient populations. Therefore, the purpose of this clinical commentary is to provide guidelines for optimal reporting of therapeutic exercise interventions in rehabilitation research. 5.

Promoting oral cancer examinations to medical primary care providers: a cluster randomized trial.

PubMed

Wee, Alvin G; Zimmerman, Lani M; Anderson, James R; Nunn, Martha E; Loberiza, Fausto R; Sitorius, Michael A; Pullen, Carol H

2016-09-01

To compare the percentage of patients who had an oral cancer examination (OCE) by their primary care provider (PCP) in medical clinics participating in a web-based education with poster reminder intervention to that of patients in control clinics. To also determine the effects for PCPs in medical clinics participating in the web-based education with poster reminder intervention as compared with those in control clinics regarding: a) index of knowledge of oral cancer risk factors (RiskOC) and b) index of knowledge of oral cancer diagnostic procedures (DiagOC). Six medical clinics were recruited to participate in this study and randomly assigned to an intervention group or a control group. PCPs (physicians, physician assistants, and advanced practice registered nurses) took a pretest; 2 weeks later, they participated in the web-based educational program, including a posttest (intervention group) or took a posttest only (control group). In each clinic, 1 week following completion of the PCPs' posttests, 94 patients were recruited to complete a one-page survey. The intervention clinics were found to be a significant factor for the PCPs to perform patient OCEs, after controlling for significant covariates, that is, age, main reason for clinic visit, OCE for patient in the past year, clinic's mean DiagOC score, and clinic's mean RiskOC score. The intervention also resulted in the PCPs increasing their pretest to posttest RiskOC scores. The use of intervention has the potential to increase PCPs' short-term knowledge and to increase the frequency of PCPs' routine, nonsymptomatic opportunistic OCE on patients. © 2016 American Association of Public Health Dentistry.

Impact of clinical pharmacist-based parenteral nutrition service for bone marrow transplantation patients: a randomized clinical trial.

PubMed

Mousavi, Maryam; Hayatshahi, Alireza; Sarayani, Amir; Hadjibabaie, Molouk; Javadi, Mohammadreza; Torkamandi, Hassan; Gholami, Kheirollah; Ghavamzadeh, Ardeshir

2013-12-01

Parenteral nutrition (PN) is a well-documented supportive care which maintains the nutritional status of patients. Clinical pharmacists are often involved in providing PN services; however, few studies have investigated the effect of a clinical pharmacy-based PN service in resource-limited settings. We designed a randomized clinical trial to compare the clinical pharmacist-based PN service (intervention group) with the conventional method (control group) for adult patients undergoing hematopoietic stem cell transplantation in Shariati Hospital, Tehran, Iran (2011-2012). In the intervention group, the clinical pharmacists implemented standard guidelines of nutrition support. The conventional method was a routine nutrition support protocol which was pursued for all patients in the bone marrow transplantation wards. Main study outcomes included nutritional status (weight, albumin, total protein, pre-albumin, and nitrogen balance), length of hospital stay, time to engraftment, rate of graft versus host disease, and mortality rate. Patients were followed for 3 months. Fifty-nine patients were randomly allocated to a study group. The overall intake (oral and parenteral) in the control group was significantly lower than standard daily needed calories (P < 0.01). Patients in the intervention group received fewer days of PN (10.7 ± 4.2 vs. 18.4 ± 5.5 days, P < 0.01). All nutritional outcomes were either preserved or improved in the intervention group while the nutritional status in the control group was deteriorated (P values < 0.01). Length of hospital stay was significantly shorter in the intervention group (P < 0.01). Regarding PN complications, hyperglycemia was observed more frequently in the intervention group (34.5 %, P = 0.01). Two patients in the control group expired due to graft versus host disease at the 3-month follow-up. A clinical pharmacist-based nutrition support service significantly improved nutritional status and clinical outcomes in comparison with the suboptimal conventional method. Future studies should assess the cost effectiveness of clinical pharmacists' PN services.

Telephone reminders reduced the non-attendance rate in a gastroenterology outpatient clinic.

PubMed

Jeppesen, Maja Haunstrup; Ainsworth, Mark Andrew

2015-06-01

Non-attendance is a global health-care problem. The aim of the present study was 1) to investigate if a telephone reminder could reduce the non-attendance rate, 2) to study reasons for non-attendance and 3) to evaluate if a permanent implementation would be economically advantageous in a gastroenterology outpatient clinic like ours. This was a comparative intervention study with a historical control group in a gastroenterology outpatient clinic. The study lasted six months. Patients with a scheduled appointment in the first three-month period received no reminder (control group, n = 2,705). Patients in the following three-month period were reminded by telephone one weekday in advance of their appointment, when possible (intervention group, n = 2,479). Non-attending patients in the intervention group received a questionnaire. Based on the results, a financial cost-benefit analysis was made. In the intervention group, 1,577 (64%) patients answered the reminder telephone call. The non-attendance rate was significantly lower in the intervention group (6.1%) than in the control group (10.5%) (p < 0.00001). Only 1.3% of the patients who answered the reminder turned out to be non-attendees. The most common explanation for non-attendance in the intervention group was forgetfulness (39%). The reminder telephone call was cost-effective. In this outpatient clinic, telephone reminders were cost-effective and significantly reduced the non-attendance rate by 43%.

Counseling African Americans to Control Hypertension (CAATCH) Trial: A Multi-level Intervention to Improve Blood Pressure Control in Hypertensive African Americans

PubMed Central

Ogedegbe, Gbenga; Tobin, Jonathan N.; Fernandez, Senaida; Gerin, William; Diaz-Gloster, Marleny; Cassells, Andrea; Khalida, Chamanara; Pickering, Thomas; Schoenthaler, Antoinette; Ravenell, Joseph

2009-01-01

Background Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive African Americans. The goal of this study is to evaluate the effectiveness of a multi-level, multi-component, evidence-based intervention compared to usual care in improving BP control among hypertensive African Americans who receive care in Community Health Centers (CHCs). The primary outcomes are BP control rate at 12 months; and maintenance of intervention one year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost effectiveness of the intervention. Methods and Results Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with two conditions: Intervention Condition (IC) and Usual Care (UC). Thirty CHCs were randomly assigned equally to the IC group (N=15) or the UC group (N=15). The intervention is comprised of three components targeted at patients (interactive computerized hypertension education; home BP monitoring; and monthly behavioral counseling on lifestyle modification) and two components targeted at physicians (monthly case rounds based on JNC-7 guidelines; chart audit and provision of feedback on clinical performance and patients’ home BP readings). All outcomes are assessed at quarterly study visits for one year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Conclusions Poor BP control is one of the major reasons for the mortality gap between African Americans and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population. PMID:20031845

Early clinical outcomes of primary percutaneous coronary intervention in bharatpur, Nepal.

PubMed

Dubey, Laxman; Bhattacharya, Rabindra; Guruprasad, Sogunuu; Subramanyam, Gangapatnam

2013-06-01

Primary percutaneous coronary intervention represents one of the cornerstone management modalities for patients with acute ST-elevation myocardial infarction and has undergone tremendous growth over the past two decades. This study was aimed to determine the early clinical outcomes of primary percutaneous coronary interventions in a tertiary-level teaching hospital without onsite cardiac surgery backup. This was a prospective descriptive study which included all consecutive patients who were admitted for primary percutaneous coronary interventions between March 2011 and January 2013 at the College of Medical Sciences and Teaching Hospital, Bharatpur, Nepal. Total 68 patients underwent primary percutaneous coronary interventions as a mode of revascularization. The primary end point of the study was to identify in-hospital as well as 30-day clinical outcomes of primary percutaneous coronary interventions. The mean age was 56.31 ± 11.47 years, with age range of 32 years to 91 years. Of the 68 primary percutaneous coronary interventions performed, 15 (22.05%) were carried out in women and 10 (14.70%) in patients over 75 years of age. Primary percutaneous coronary intervention for anterior wall myocardial infarction was more common than for non-anterior wall myocardial infarction (55.88% vs. 44.12%). Proximal artery stenting was performed in 38.50% and the non proximal artery stenting in 61.50%. The outcomes were mortality (5.88%), cardiogenic shock (5.88%), contrast-induced nephropathy requiring dialysis (2.94%), arrhythmias requiring treatment (4.41%), early stent thrombosis (2.94%) and minor complications (14.70%). Primary percutaneous coronary intervention improves the early clinical outcomes in patient with acute ST-elevation myocardial infarction. Despite having no onsite cardiac surgery backup, primary percutaneous coronary intervention was feasible with acceptable complications in a tertiary-care teaching hospital.

Measuring Clinical Decision Support Influence on Evidence-Based Nursing Practice.

PubMed

Cortez, Susan; Dietrich, Mary S; Wells, Nancy

2016-07-01

To measure the effect of clinical decision support (CDS) on oncology nurse evidence-based practice (EBP).
. Longitudinal cluster-randomized design.
. Four distinctly separate oncology clinics associated with an academic medical center.
. The study sample was comprised of randomly selected data elements from the nursing documentation software. The data elements were patient-reported symptoms and the associated nurse interventions. The total sample observations were 600, derived from a baseline, posteducation, and postintervention sample of 200 each (100 in the intervention group and 100 in the control group for each sample).
. The cluster design was used to support randomization of the study intervention at the clinic level rather than the individual participant level to reduce possible diffusion of the study intervention. An elongated data collection cycle (11 weeks) controlled for temporary increases in nurse EBP related to the education or CDS intervention.
. The dependent variable was the nurse evidence-based documentation rate, calculated from the nurse-documented interventions. The independent variable was the CDS added to the nursing documentation software.
. The average EBP rate at baseline for the control and intervention groups was 27%. After education, the average EBP rate increased to 37%, and then decreased to 26% in the postintervention sample. Mixed-model linear statistical analysis revealed no significant interaction of group by sample. The CDS intervention did not result in an increase in nurse EBP.
. EBP education increased nurse EBP documentation rates significantly but only temporarily. Nurses may have used evidence in practice but may not have documented their interventions.
. More research is needed to understand the complex relationship between CDS, nursing practice, and nursing EBP intervention documentation. CDS may have a different effect on nurse EBP, physician EBP, and other medical professional EBP.

A cluster randomized trial of a transition intervention for adolescents with congenital heart disease: rationale and design of the CHAPTER 2 study.

PubMed

Mackie, Andrew S; Rempel, Gwen R; Kovacs, Adrienne H; Kaufman, Miriam; Rankin, Kathryn N; Jelen, Ahlexxi; Manlhiot, Cedric; Anthony, Samantha J; Magill-Evans, Joyce; Nicholas, David; Sananes, Renee; Oechslin, Erwin; Dragieva, Dimi; Mustafa, Sonila; Williams, Elina; Schuh, Michelle; McCrindle, Brian W

2016-06-06

The population of adolescents and young adults with congenital heart disease (CHD) is growing exponentially. These survivors are at risk of late cardiac complications and require lifelong cardiology care. However, there is a paucity of data on how to prepare adolescents to assume responsibility for their health and function within the adult health care system. Evidence-based transition strategies are required. The Congenital Heart Adolescents Participating in Transition Evaluation Research (CHAPTER 2) Study is a two-site cluster randomized clinical trial designed to evaluate the efficacy of a nurse-led transition intervention for 16-17 year olds with moderate or complex CHD. The primary endpoint is excess time to adult CHD care, defined as the time interval between the final pediatric cardiology appointment and the first adult CHD appointment, minus the recommended time interval between these appointments. Secondary endpoints include the MyHeart score (CHD knowledge), Transition Readiness Assessment Questionnaire score, and need for catheter or surgical re-intervention. Participants are enrolled in clusters based on week of attendance in the pediatric cardiology clinic. The intervention consists of two one-hour individualized sessions between a cardiology nurse and study participant. Session One focuses on knowledge of the participant's CHD, review of their cardiac anatomy and prior interventions, and potential late cardiac complications. Session Two focuses on self-management and communication skills through review and discussion of videos and role-play. The study will recruit 120 participants. Many adolescents and young adults experience a gap in care predisposing them to late cardiac complications. The CHAPTER 2 Study will investigate the impact of a nurse-led transition intervention among adolescents with CHD. Fidelity of the intervention is a major focus and priority. This study will build on our experience by (i) enrolling at two tertiary care programs, (ii) including a self-management intervention component, and (iii) evaluating the impact of the intervention on time to ACHD care, a clinically relevant outcome. The results of this study will inform pediatric cardiology programs, patients and policy makers in judging whether a structured intervention program provides clinically meaningful outcomes for adolescents and young adults living with CHD. ClinicalTrials.gov ID NCT01723332.

A Parent-Mediated Intervention that Targets Responsive Parental Behaviors Increases Attachment Behaviors in Children with ASD: Results from a Randomized Clinical Trial

ERIC Educational Resources Information Center

Siller, Michael; Swanson, Meghan; Gerber, Alan; Hutman, Ted; Sigman, Marian

2014-01-01

The current study is a randomized clinical trial evaluating the efficacy of Focused Playtime Intervention (FPI) in a sample of 70 children with Autism Spectrum Disorder. This parent-mediated intervention has previously been shown to significantly increase responsive parental communication (Siller et al. in "J Autism Dev Disord"…

Strategies and Challenges in Clinical Trials Targeting Human Aging

PubMed Central

Newman, John C.; Milman, Sofiya; Hashmi, Shahrukh K.; Austad, Steve N.; Kirkland, James L.; Halter, Jeffrey B.

2016-01-01

Interventions that target fundamental aging processes have the potential to transform human health and health care. A variety of candidate drugs have emerged from basic and translational research that may target aging processes. Some of these drugs are already in clinical use for other purposes, such as metformin and rapamycin. However, designing clinical trials to test interventions that target the aging process poses a unique set of challenges. This paper summarizes the outcomes of an international meeting co-ordinated by the NIH-funded Geroscience Network to further the goal of developing a translational pipeline to move candidate compounds through clinical trials and ultimately into use. We review the evidence that some drugs already in clinical use may target fundamental aging processes. We discuss the design principles of clinical trials to test such interventions in humans, including study populations, interventions, and outcomes. As examples, we offer several scenarios for potential clinical trials centered on the concepts of health span (delayed multimorbidity and functional decline) and resilience (response to or recovery from an acute health stress). Finally, we describe how this discussion helped inform the design of the proposed Targeting Aging with Metformin study. PMID:27535968

Improving Translation from Preclinical Studies to Clinical Trials in Acute Kidney Injury.

PubMed

Fiorentino, Marco; Kellum, John A

2018-05-23

Several cellular and molecular targets and mechanisms have been investigated in preclinical studies of acute kidney injury (AKI), but translation in successful clinical studies has failed to date. This article reviews many issues that have limited this and the potential future perspectives in AKI prevention and treatment. Preclinical models of AKI should closely mimic the complexity of human AKI, considering the importance of several comorbidities in determining the clinical course and outcomes in the human disease. Moreover, studies should test novel interventions in models where AKI is already established, instead of focusing only at primary prevention. AKI definitions and endpoints in animal studies should be similar to those applied in clinical studies; in particular, AKI biomarkers should be implemented to guide patient selection for clinical trials and monitor intervention efficacy. In this scenario, cell-cycle arrest biomarkers have been widely investigated as AKI predictors in both preclinical and clinical studies and they serve as useful tools for future interventional studies. A better understanding of human AKI through a large collection of biological samples and kidney biopsies and omics applications, and an iterative relationship between preclinical and clinical studies are critical steps to improve future preclinical models and clinical trials. Finally, given the great variability in clinical manifestation of AKI, a strong collaboration between research centers and industry is recommended. Key messages: Several methodological issues have hampered the translation of basic research findings in clinical studies, and overcoming these obstacles is necessary to achieve success. © 2018 S. Karger AG, Basel.

Clinical and Vitamin Response to a Short-Term Multi-Micronutrient Intervention in Brazilian Children and Teens: From Population Data to Interindividual Responses.

PubMed

Mathias, Mariana Giaretta; Coelho-Landell, Carolina de Almeida; Scott-Boyer, Marie-Pier; Lacroix, Sébastien; Morine, Melissa J; Salomão, Roberta Garcia; Toffano, Roseli Borges Donegá; Almada, Maria Olímpia Ribeiro do Vale; Camarneiro, Joyce Moraes; Hillesheim, Elaine; de Barros, Tamiris Trevisan; Camelo-Junior, José Simon; Campos Giménez, Esther; Redeuil, Karine; Goyon, Alexandre; Bertschy, Emmanuelle; Lévêques, Antoine; Oberson, Jean-Marie; Giménez, Catherine; Carayol, Jerome; Kussmann, Martin; Descombes, Patrick; Métairon, Slyviane; Draper, Colleen Fogarty; Conus, Nelly; Mottaz, Sara Colombo; Corsini, Giovanna Zambianchi; Myoshi, Stephanie Kazu Brandão; Muniz, Mariana Mendes; Hernandes, Lívia Cristina; Venâncio, Vinícius Paula; Antunes, Lusania Maria Greggi; da Silva, Rosana Queiroz; Laurito, Taís Fontellas; Rossi, Isabela Ribeiro; Ricci, Raquel; Jorge, Jéssica Ré; Fagá, Mayara Leite; Quinhoneiro, Driele Cristina Gomes; Reche, Mariana Chinarelli; Silva, Paula Vitória Sozza; Falquetti, Letícia Lima; da Cunha, Thaís Helena Alves; Deminice, Thalia Manfrin Martins; Tambellini, Tâmara Hambúrguer; de Souza, Gabriela Cristina Arces; de Oliveira, Mariana Moraes; Nogueira-Pileggi, Vicky; Matsumoto, Marina Takemoto; Priami, Corrado; Kaput, Jim; Monteiro, Jacqueline Pontes

2018-03-01

Micronutrients are in small amounts in foods, act in concert, and require variable amounts of time to see changes in health and risk for disease. These first principles are incorporated into an intervention study designed to develop new experimental strategies for setting target recommendations for food bioactives for populations and individuals. A 6-week multivitamin/mineral intervention is conducted in 9-13 year olds. Participants (136) are (i) their own control (n-of-1); (ii) monitored for compliance; (iii) measured for 36 circulating vitamin forms, 30 clinical, anthropometric, and food intake parameters at baseline, post intervention, and following a 6-week washout; and (iv) had their ancestry accounted for as modifier of vitamin baseline or response. The same intervention is repeated the following year (135 participants). Most vitamins respond positively and many clinical parameters change in directions consistent with improved metabolic health to the intervention. Baseline levels of any metabolite predict its own response to the intervention. Elastic net penalized regression models are identified, and significantly predict response to intervention on the basis of multiple vitamin/clinical baseline measures. The study design, computational methods, and results are a step toward developing recommendations for optimizing vitamin levels and health parameters for individuals. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

The Efficacy of Endoscopic Palliation of Obstructive Jaundice in Hepatocellular Carcinoma

PubMed Central

Park, Semi; Park, Jeong Youp; Chung, Moon Jae; Chung, Jae Bock; Park, Seung Woo; Han, Kwang-Hyub; Song, Si Young

2014-01-01

Purpose Obstructive jaundice in patients with hepatocellular carcinoma (HCC) is uncommon (0.5-13%). Unlike other causes of obstructive jaundice, the role of endoscopic intervention in obstructive jaundice complicated by HCC has not been clearly defined. The aim of this study was to evaluate the clinical characteristics of obstructive jaundice caused by HCC and predictive factors for successful endoscopic intervention. Materials and Methods From 1999 to 2009, 54 patients with HCC who underwent endoscopic intervention to relieve obstructive jaundice were included. We defined endoscopic intervention as a clinical success when the obstructive jaundice was relieved within 4 weeks. Results Clinical success was achieved in 23 patients (42.6%). Patients in the clinical success group showed better Child-Pugh liver function (C-P grade A or B/C; 17/6 vs. 8/20), lower total bilirubin levels (8.1±5.3 mg/dL vs. 23.1±10.4 mg/dL) prior to the treatment, and no history of alcohol consumption. The only factor predictive of clinical success by multivariate analysis was low total bilirubin level at the time of endoscopic intervention, regardless of history of alcohol consumption [odds ratio 1.223 (95% confidence interval, 1.071-1.396), p=0.003]. The cut-off value of pre-endoscopic treatment total bilirubin level was 12.8 mg/dL for predicting the clinical prognosis. Median survival after endoscopic intervention in the clinical success group was notably longer than that in the clinical failure group (5.6 months vs. 1.5 months, p≤0.001). Conclusion Before endoscopic intervention, liver function, especially total bilirubin level, should be checked to achieve the best clinical outcome. Endoscopic intervention can be helpful to relieve jaundice in well selected patients with HCC. PMID:25048484

Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study): design of a cluster randomised trial

PubMed Central

Cabezas, Carmen; Martin, Carlos; Granollers, Silvia; Morera, Concepció; Ballve, Josep Lluis; Zarza, Elvira; Blade, Jordi; Borras, Margarida; Serra, Antoni; Puente, Diana

2009-01-01

Background There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres. The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC). Methods/Design Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people). Intention to treat analysis. Study population: Smokers (n = 3024) aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial. Intervention: 6-month implementation of recommendations of a Clinical Practice Guideline which includes 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: usual care. Outcome measures: Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of ≤ 10 parts per million. Points of assessment: end of intervention period and 1 and 2 years post-intervention; continuous abstinence rate for 1 year; change in smoking cessation stage; health status measured by SF-36. Discussion The application of a stepped intervention based on the stages of a change model is possible under real and diverse clinical practice conditions, and improves the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline. Trial Registration Clinical Trials.gov Identifier: NCT00125905 PMID:19193233

Effects of a Brief Multimedia Psychoeducational Intervention on the Attitudes and Interest of Patients With Cancer Regarding Clinical Trial Participation: A Multicenter Randomized Controlled Trial

PubMed Central

Jacobsen, Paul B.; Wells, Kristen J.; Meade, Cathy D.; Quinn, Gwendolyn P.; Lee, Ji-Hyun; Fulp, William J.; Gray, Jhanelle E.; Baz, Rachid C.; Springett, Gregory M.; Levine, Richard M.; Markham, Merry-Jennifer; Schreiber, Fred J.; Cartwright, Thomas H.; Burke, James M.; Siegel, Robert D.; Malafa, Mokenge P.; Sullivan, Daniel

2012-01-01

Purpose The negative attitudes of patients with cancer regarding clinical trials are an important contributor to low participation rates. This study evaluated whether a brief psychoeducational intervention was effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials. Patients and Methods A total of 472 adults with cancer who had not been asked previously to participate in a clinical trial were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials. The primary (attitudes) and secondary outcomes (knowledge, self-efficacy, receptivity, and willingness) were assessed via patient self-report before random assignment and 7 to 28 days later. Results Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials (P = .016) and greater willingness to participate (P = .011) at follow-up than patients who received printed educational information. Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168; 95% CI, 0.088 to 0.248) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials. Conclusion A brief psychoeducational intervention can improve the attitudes of patients with cancer toward clinical trials and thereby increase their willingness to participate in clinical trials. Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials. PMID:22614993

Team-Based Care with Pharmacists to Improve Blood Pressure: a Review of Recent Literature.

PubMed

Kennelty, Korey A; Polgreen, Linnea A; Carter, Barry L

2018-01-18

We review studies published since 2014 that examined team-based care strategies and involved pharmacists to improve blood pressure (BP). We then discuss opportunities and challenges to sustainment of team-based care models in primary care clinics. Multiple studies presented in this review have demonstrated that team-based care including pharmacists can improve BP management. Studies highlighted the cost-effectiveness of a team-based pharmacy intervention for BP control in primary care clinics. Little information was found on factors influencing sustainability of team-based care interventions to improve BP control. Future work is needed to determine the best populations to target with team-based BP programs and how to implement team-based approaches utilizing pharmacists in diverse clinical settings. Future studies need to not only identify unmet clinical needs but also address reimbursement issues and stakeholder engagement that may impact sustainment of team-based care interventions.

Pharmacists' interventions on clinical asthma outcomes: a systematic review.

PubMed

Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

2016-04-01

The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

The Bobath (NDT) concept in adult neurological rehabilitation: what is the state of the knowledge? A scoping review. Part II: intervention studies perspectives.

PubMed

Vaughan-Graham, Julie; Cott, Cheryl; Wright, F Virginia

2015-01-01

The study's purpose was to describe the range of knowledge pertaining to the Bobath (NDT) concept in adult neurological rehabilitation, synthesizes the findings, identify knowledge gaps and develop empirically based recommendations for future research. A scoping review of research and non-research articles published from 2007 to 2012. Two independent reviewers selected studies based on a systematic procedure. Inclusion criteria for studies were electronically accessible English language literature with Bobath and/or Neurodevelopmental Therapy as the subject heading in the title/keyword/abstract/intervention comparison with respect to adult neurological conditions. Data were abstracted and summarized with respect to study design, theoretical framework, clinical application including population representation, study fidelity, intervention comparison, duration of care, measurement and findings. Of the 33 publications identified 17 were intervention studies (11 RCT's/1 prospective parallel group design/5 N-of-1). One other paper was a systematic review. The intervention studies, primarily RCT designs, have serious methodological concerns particularly related to study/treatment fidelity and measurement resulting in no clear clinical direction. Aspects such as theoretical framework, therapist skill, quality of movement measurement and individualized interventions require careful consideration in the design of Bobath studies. Implications for Rehabilitation Future intervention studies should be based on the current Bobath theoretical framework and key aspects of clinical practice. Study and treatment fidelity issues need to be carefully considered when interpreting the results of existing RCT's evaluating the Bobath concept. N-of-1 randomized, observational, factorial and mixed method study designs should be considered as alternative study options.

Improving correctional healthcare providers’ ability to care for transgender patients: Development and evaluation of a theory-driven cultural and clinical competence intervention

PubMed Central

White Hughto, Jaclyn M.; Clark, Kirsty A.; Altice, Frederick L.; Reisner, Sari L.; Kershaw, Trace S.; Pachankis, John E.

2017-01-01

Rationale Correctional healthcare providers’ limited cultural and clinical competence to care for transgender patients represents a barrier to care for incarcerated transgender individuals. Objective The present study aimed to adapt, deliver, and evaluate a transgender cultural and clinical competence intervention for correctional healthcare providers. Method In the summer of 2016, a theoretically-informed, group-based intervention to improve transgender cultural and clinical competence was delivered to 34 correctional healthcare providers in New England. A confidential survey assessed providers’ cultural and clinical competence to care for transgender patients, selfefficacy to provide hormone therapy, subjective norms related to transgender care, and willingness to provide gender-affirming care to transgender patients before and after (immediately and 3-months) the intervention. Linear mixed effects regression models were fit to assess change in study outcomes over time. Qualitative exit interviews assessed feasibility and acceptability of the intervention. Results Providers’ willingness to provide gender-affirming care improved immediately post-intervention (β = 0.38; SE = 0.41, p < 0.001) and from baseline to 3-months post-intervention (β = 0.36; SE = 0.09; p < 0.001; omnibus test of fixed effects χ2 = 23.21; p < 0.001). On average, transgender cultural competence (χ2 = 22.49; p < 0.001), medical gender affirmation knowledge (χ2 = 11.24; p = 0.01), self-efficacy to initiate hormones for transgender women, and subjective norms related to transgender care (χ2 = 14.69; p = 0.001) all significantly increased over time. Providers found the intervention to be highly acceptable and recommended that the training be scaled-up to other correctional healthcare providers and expanded to custody staff. Conclusion The intervention increased correctional healthcare providers’ cultural and clinical competence, selfefficacy, subjective norms, and willingness to provide gender-affirming care to transgender patients. Continued efforts should be made to train correctional healthcare providers in culturally and clinically competent gender-affirming care in order to improve the health of incarcerated transgender people. Future efficacy testing of this intervention is warranted. PMID:29096945

A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

PubMed

Kass, Nancy E; Taylor, Holly A; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

2015-02-01

Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.

Is it possible to strengthen psychiatric nursing staff's clinical supervision? RCT of a meta-supervision intervention.

PubMed

Gonge, Henrik; Buus, Niels

2015-04-01

To test the effects of a meta-supervision intervention in terms of participation, effectiveness and benefits of clinical supervision of psychiatric nursing staff. Clinical supervision is regarded as a central component in developing mental health nursing practices, but the evidence supporting positive outcomes of clinical supervision in psychiatric nursing is not convincing. The study was designed as a randomized controlled trial. All permanently employed nursing staff members at three general psychiatric wards at a Danish university hospital (n = 83) were allocated to either an intervention group (n = 40) receiving the meta-supervision in addition to attending usual supervision or to a control group (n = 43) attending usual supervision. Self-reported questionnaire measures of clinical supervision effectiveness and benefits were collected at base line in January 2012 and at follow-up completed in February 2013. In addition, a prospective registration of clinical supervision participation was carried out over 3 months subsequent to the intervention. The main result was that it was possible to motivate staff in the intervention group to participate significantly more frequently in sessions of the ongoing supervision compared with the control group. However, more frequent participation was not reflected in the experienced effectiveness of the clinical supervision or in the general formative or restorative benefits. The intervention had a positive effect on individuals or wards already actively engaged in clinical supervision, which suggested that individuals and wards without well-established supervision practices may require more comprehensive interventions targeting individual and organizational barriers to clinical supervision. © 2014 John Wiley & Sons Ltd.

Cost-effectiveness of a brief video-based HIV intervention for African American and Latino sexually transmitted disease clinic clients.

PubMed

Sweat, M; O'Donnell, C; O'Donnell, L

2001-04-13

Decisions about the dissemination of HIV interventions need to be informed by evidence of their cost-effectiveness in reducing negative health outcomes. Having previously shown the effectiveness of a single-session video-based group intervention (VOICES/VOCES) in reducing incidence of sexually transmitted diseases (STD) among male African American and Latino clients attending an urban STD clinic, this study estimates its cost-effectiveness in terms of disease averted. Cost-effectiveness was calculated using data on effectiveness from a randomized clinical trial of the VOICES/VOCES intervention along with updated data on the costs of intervention from four replication sites. STD incidence and self-reported behavioral data were used to make estimates of reduction in HIV incidence among study participants. The average annual cost to provide the intervention to 10 000 STD clinic clients was estimated to be US$447 005, with a cost per client of US$43.30. This expenditure would result in an average of 27.69 HIV infections averted, with an average savings from averted medical costs of US$5 544 408. The number of quality adjusted life years saved averaged 387.61, with a cost per HIV infection averted of US$21 486. This brief behavioral intervention was found to be feasible and cost-saving when targeted to male STD clinic clients at high risk of contracting and transmitting infections, indicating that this strategy should be considered for inclusion in HIV prevention programming.

Attitudes of palliative care clinical staff toward prolonged grief disorder diagnosis and grief interventions.

PubMed

Davis, Esther L; Deane, Frank P; Barclay, Gregory D; Bourne, Joan; Connolly, Vivienne

2017-07-03

The provision of psychological support to caregivers is an important part of the role of the clinical staff working in palliative care. Staff knowledge and attitudes may determine their openness to referring caregivers to a psychological intervention. We recently developed a self-help intervention for grief and psychological distress among caregivers and were interested in exploring the extent to which staff knowledge and attitudes might affect future implementation. The aims of our study were to: (1) examine the acceptability of self-help psychological intervention for caregivers among palliative care clinical staff; (2) examine potential attitudinal barriers toward prolonged grief disorder (PGD) as a diagnosis and interventions for grief; and (3) bolster staff confidence in skills and knowledge in identifying and managing caregiver psychological distress. An anonymous survey was distributed among clinical staff at two inpatient units and two community health services that assessed the acceptability of self-help interventions for caregivers, attitudes about PGD diagnosis and grief intervention, and staff confidence in skills and knowledge in assessing caregiver psychological distress. Overall, clinical staff were positively oriented toward self-help for caregivers and intervention for grief. They were also basically confident in their skills and knowledge. While it was positive PGD attitudes that were associated with acceptability of self-help for caregivers, it was both positive and negative PGD attitudes that were associated more specifically with a willingness to refer caregivers to such an intervention. Our findings are useful in highlighting the issues to be considered in the implementation of a self-help intervention within the healthcare service. Clinical staff seemed positively oriented toward engaging with a psychological intervention for caregivers and likely to act as key allies in implementation.

The use of music intervention in healthcare research: a narrative review of the literature.

PubMed

Tang, Hsin-Yi Jean; Vezeau, Toni

2010-09-01

Although music has been widely used in healthcare, there has been scant review of literature analyzing the use of music as an intervention in healthcare research. The purpose of this article was to provide a narrative review of the literature to explore how "music therapy" has been used in healthcare research to promote healing in adult populations. The following five questions were addressed: (a) In what populations and under what conditions has music intervention been studied? (b) What specific kinds of music have been used for study intervention? (c) How has the music intervention been operationalized? (d) What metrics have been used as outcome measures? (e) Have music interventions been effective? Articles were retrieved from several scientific databases (PubMed, CINAHL, and PsycINFO) using the following search parameters: MeSH search terms "music therapy" in the title field with the search limit to "adults 19 years and older," "humans," "clinical randomized controlled studies," and "English." A total of 33 clinical randomized controlled studies that met the search criteria were reviewed. (a) In the reviewed studies (studied articles), subjects with dementia were the most commonly studied population group, and the predominant aim of the study was to alleviate anxiety. (b) Employed music interventions may be categorized as one of two types: passive (receptive) and active. The passive (receptive) music intervention commonly involved subjects in a resting position listening to music, whereas the active music intervention is usually carried out in a group format in which subjects are actively involved in the music intervention. (c) Intervention frequency, dosing, and duration were highly variable across the reviewed studies. Very few studies described the intervention setting, which made evaluation of these studies difficult. Direct supervision seemed to be an influential factor for adherence. (d) Outcome measures in retrieved articles involved two types: psychological and physiological or biological. (e) The effectiveness of music intervention was reported as successful in most of the retrieved studies. Much work has been done on the use of music interventions in the clinical setting. Future research should consider participant music selection preferences, and the selection of active versus passive intervention approach should be based on a clear conceptual framework. Combining both physiological and psychological measures in the study design is a recommended approach to increase measurement validity.

Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

PubMed

Curran, Geoffrey M; Bauer, Mark; Mittman, Brian; Pyne, Jeffrey M; Stetler, Cheryl

2012-03-01

This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.

A systematic review of interventions conducted in clinical or community settings to improve dual-task postural control in older adults.

PubMed

Agmon, Maayan; Belza, Basia; Nguyen, Huong Q; Logsdon, Rebecca G; Kelly, Valerie E

2014-01-01

Injury due to falls is a major problem among older adults. Decrements in dual-task postural control performance (simultaneously performing two tasks, at least one of which requires postural control) have been associated with an increased risk of falling. Evidence-based interventions that can be used in clinical or community settings to improve dual-task postural control may help to reduce this risk. THE AIMS OF THIS SYSTEMATIC REVIEW ARE: 1) to identify clinical or community-based interventions that improved dual-task postural control among older adults; and 2) to identify the key elements of those interventions. Studies were obtained from a search conducted through October 2013 of the following electronic databases: PubMed, CINAHL, PsycINFO, and Web of Science. Randomized and nonrandomized controlled studies examining the effects of interventions aimed at improving dual-task postural control among community-dwelling older adults were selected. All studies were evaluated based on methodological quality. Intervention characteristics including study purpose, study design, and sample size were identified, and effects of dual-task interventions on various postural control and cognitive outcomes were noted. Twenty-two studies fulfilled the selection criteria and were summarized in this review to identify characteristics of successful interventions. The ability to synthesize data was limited by the heterogeneity in participant characteristics, study designs, and outcome measures. Dual-task postural control can be modified by specific training. There was little evidence that single-task training transferred to dual-task postural control performance. Further investigation of dual-task training using standardized outcome measurements is needed.

Evaluation of a Shared Decision-Making Intervention on the Utilization of Evidence-Based Psychotherapy in a VA Outpatient PTSD Clinic.

PubMed

Hessinger, Jonathan D; London, Melissa J; Baer, Sheila M

2017-03-13

The Veterans Health Administration (VHA) has continued to emphasize the availability, access, and utilization of high quality mental health care particularly in the treatment of posttraumatic stress disorder (PTSD). While dissemination and availability of evidence-based psychotherapies (EBPs) have only increased, treatment engagement and utilization have continued to be oft-noted challenges. Administrators, researchers, and individual clinicians have continued to develop and explore novel systemic and individualized interventions to address these issues. Pilot studies utilizing shared decision-making models to aid in veteran treatment selection have demonstrated the impact this approach may have on selection of and engagement in EBPs for PTSD. Based on these promising studies, a Department of Veterans Affairs (VA) outpatient PTSD clinic began to implement a shared-decision making intervention as part of a clinic redesign. In seeking to evaluate the impact of this intervention, archival clinical data from 1,056 veterans were reviewed by the authors for rates of treatment selection, EBP initiation, session attendance, and EBP completion. Time elapsed from consult until EBP initiation was also computed by the authors. These variables were then compared on the basis of whether the veteran received the shared-decision making intervention. Veterans who received the intervention were more likely to select and thus initiate an EBP for PTSD sooner than veterans who did not receive this intervention. Veterans, whether receiving the intervention or not, did not differ in therapy session attendance and completion. Implications of these findings and directions for future study are further discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study.

PubMed

Jensen, Morten Lind; Lippert, Freddy; Hesselfeldt, Rasmus; Rasmussen, Maria Birkvad; Mogensen, Simon Skibsted; Jensen, Michael Kammer; Frost, Torben; Ringsted, Charlotte

2009-02-01

The impact of clinical experience on learning outcome from a resuscitation course has not been systematically investigated. To determine whether half a year of clinical experience before participation in an Advanced Life Support (ALS) course increases the immediate learning outcome and retention of learning. This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS-competence assessed using a validated composite test including assessment of skills and knowledge. The intervention was half a year of clinical work before an ALS course. The intervention group received the course after a half-year of clinical experience. The control group participated in an ALS course immediately following graduation. Invitation to participate was accepted by 154/240 (64%) graduates and 117/154 (76%) completed the study. There was no difference between the intervention and control groups with regard to the immediate learning outcome. The intervention group had significantly higher retention of learning compared to the control group, intervention group mean 82% (CI 80-83), control group mean 78% (CI 76-80), P=0.002. The magnitude of this difference was medium (effect size=0.57). Half a year of clinical experience, before participation in an ALS course had a small but statistically significant impact on the retention of learning, but not on the immediate learning outcome.

Setting up a cohort study in speech and language therapy: lessons from The UK Cleft Collective Speech and Language (CC-SL) study.

PubMed

Wren, Yvonne; Humphries, Kerry; Stock, Nicola Marie; Rumsey, Nichola; Lewis, Sarah; Davies, Amy; Bennett, Rhiannon; Sandy, Jonathan

2018-05-01

Efforts to increase the evidence base in speech and language therapy are often limited by methodological factors that have restricted the strength of the evidence to the lower levels of the evidence hierarchy. Where higher graded studies, such as randomized controlled trials, have been carried out, it has sometimes been difficult to obtain sufficient power to detect a potential effect of intervention owing to small sample sizes or heterogeneity in the participants. With certain clinical groups such as cleft lip and palate, systematic reviews of intervention studies have shown that there is no robust evidence to support the efficacy of any one intervention protocol over another. To describe the setting up of an observational clinical cohort study and to present this as an alternative design for answering research questions relating to prevalence, risk factors and outcomes from intervention. The Cleft Collective Speech and Language (CC-SL) study is a national cohort study of children born with cleft palate. Working in partnership with regional clinical cleft centres, a sample size of over 600 children and 600 parents is being recruited and followed up from birth to age 5 years. Variables being collected include demographic, psychological, surgical, hearing, and speech and language data. The process of setting up the study has led to the creation of a unique, large-scale data set which is available for researchers to access now and in future. As well as exploring predictive factors, the data can be used to explore the impact of interventions in relation to individual differences. Findings from these investigations can be used to provide information on sample criteria and definitions of intervention and dosage which can be used in future trials. The observational cohort study is a useful alternative design to explore questions around prevalence, risk factors and intervention for clinical groups where robust research data are not yet available. Findings from such a study can be used to guide service-delivery decisions and to determine power for future clinical trials. © 2017 Royal College of Speech and Language Therapists.

An "XL" endodontics intervention for dental students required to repeat the course: changing frustration to improved grades and attitudes.

PubMed

Alcota, Marcela; Fuenzalida, Alejandra; Barrientos, Claudia; Garrido, Mauricio; Ruiz de Gauna, Pilar; González, Fermín E

2015-04-01

Given the psychological and financial costs involved with failing a clinical course, especially in developing countries, an alternative educational method was tested with students who had to repeat the year-long endodontic course at the University of Chile Faculty of Dentistry. The objectives of the intervention were to deepen theoretical knowledge and practical experiences, as well as to reinforce personal confidence in an endodontic clinical setting for students who failed the regular endodontic course. The aim of this study was to evaluate the success of this new model of educational intervention. In the study, 28 students who had failed the endodontic course repeated it with an alternative teaching method. The students attended patients immediately following practical competence exams, and they had access to simulated models that used rotary instruments and access cavities and had emergency care practice. Feedback sessions were held after each clinical session. Final grades were compared with those of other students who repeated the course without the intervention from 2007 to 2009. A survey was administered to understand the causes of initial failure and their opinions of the intervention. Students who participated in the alternative course did significantly better than their counterparts from previous years who did not receive the intervention (5.7±0.3 vs. 5.4±0.2; p<0.05). Their overall perception of the intervention was positive, and the main cause for previous course failure was personal insecurity and slow clinical care performance (54.2% of the students). The intervention course not only improved grades but also generated interest in endodontics, a contrasting perspective to the frustration students usually express after repeating the course. The results of this study support the introduction of similar interventions in endodontics and perhaps other courses.

Evaluating statistical and clinical significance of intervention effects in single-case experimental designs: an SPSS method to analyze univariate data.

PubMed

Maric, Marija; de Haan, Else; Hogendoorn, Sanne M; Wolters, Lidewij H; Huizenga, Hilde M

2015-03-01

Single-case experimental designs are useful methods in clinical research practice to investigate individual client progress. Their proliferation might have been hampered by methodological challenges such as the difficulty applying existing statistical procedures. In this article, we describe a data-analytic method to analyze univariate (i.e., one symptom) single-case data using the common package SPSS. This method can help the clinical researcher to investigate whether an intervention works as compared with a baseline period or another intervention type, and to determine whether symptom improvement is clinically significant. First, we describe the statistical method in a conceptual way and show how it can be implemented in SPSS. Simulation studies were performed to determine the number of observation points required per intervention phase. Second, to illustrate this method and its implications, we present a case study of an adolescent with anxiety disorders treated with cognitive-behavioral therapy techniques in an outpatient psychotherapy clinic, whose symptoms were regularly assessed before each session. We provide a description of the data analyses and results of this case study. Finally, we discuss the advantages and shortcomings of the proposed method. Copyright © 2014. Published by Elsevier Ltd.

The effectiveness of lifestyle interventions to reduce cardiovascular risk in patients with severe mental disorders: meta-analysis of intervention studies.

PubMed

Fernández-San-Martín, Maria Isabel; Martín-López, Luis Miguel; Masa-Font, Roser; Olona-Tabueña, Noemí; Roman, Yuani; Martin-Royo, Jaume; Oller-Canet, Silvia; González-Tejón, Susana; San-Emeterio, Luisa; Barroso-Garcia, Albert; Viñas-Cabrera, Lidia; Flores-Mateo, Gemma

2014-01-01

Patients with severe mental illness have higher prevalences of cardiovascular risk factors (CRF). The objective is to determine whether interventions to modify lifestyles in these patients reduce anthropometric and analytical parameters related to CRF in comparison to routine clinical practice. Systematic review of controlled clinical trials with lifestyle intervention in Medline, Cochrane Library, Embase, PsycINFO and CINALH. Change in body mass index, waist circumference, cholesterol, triglycerides and blood sugar. Meta-analyses were performed using random effects models to estimate the weighted mean difference. Heterogeneity was determined using i(2) statistical and subgroups analyses. 26 studies were selected. Lifestyle interventions decrease anthropometric and analytical parameters at 3 months follow up. At 6 and 12 months, the differences between the intervention and control groups were maintained, although with less precision. More studies with larger samples and long-term follow-up are needed.

Stepped-Care, Community Clinic Interventions to Promote Mammography Use among Low-Income Rural African American Women

ERIC Educational Resources Information Center

West, Delia Smith; Greene, Paul; Pulley, LeaVonne; Kratt, Polly; Gore, Stacy; Weiss, Heidi; Siegfried, Nicole

2004-01-01

Few studies have investigated community clinic-based interventions to promote mammography screening among rural African American women. This study randomized older low-income rural African American women who had not participated in screening in the previous 2 years to a theory-based, personalized letter or usual care; no group differences in…

Evaluating workforce developments to support children of mentally ill parents: implementing new interventions in the adult mental healthcare in Northern Norway

PubMed Central

Lauritzen, Camilla; van Doesum, Karin T M

2012-01-01

Background According to new Norwegian laws, mental healthcare for adults are obligated to assess all patients who are parents and to act on their children's needs. This article describes the study protocol of implementing the interventions Family Assessment and Child Talks for children of patients in the adult psychiatry of the University Hospital of Northern Norway. The project is designed to evaluate the process of changes in clinical practice due to the implementation of two interventions. The interventions to be implemented are a standardised Family Assessment Form and the intervention called Child Talks. The family assessment form is an intervention to identify children of mentally ill parents and their needs. The intervention Child Talks is a health-promoting and preventive intervention where the mental health workers talk with the family about the situation of the children and their needs. Methods/design There are two groups of participants in this study: (1) mental health workers in the clinic (N=220) and (2) patients who are parents (N=200) receiving treatment in the clinic. (1) In the evaluation of clinical practice, the authors use a pre-test, post-test and 1-year follow-up design. At pre-test, the authors evaluate status quo among mental health workers in the clinic regarding knowledge, attitudes, collaborative routines and clinical practice related to families with parental mental illness. After the pre-test is finished, the project move on to implement the interventions Family Assessment Form and Child Talks in the clinic. At post-test and 1-year follow-up, the authors evaluate the impact of implementing the Family Assessment Form in terms of how many children were identified and offered Child Talks in the clinic or referred to other services for additional support. (2) In the evaluation of parents/patients experience with the interventions, the authors use a pre-test post-test design. To identify children of mentally ill patients, the authors collect data on demographical variables for the patient and the child at pre-measures, as well as data on parental competence (PSOC) and parental concerns (PEDS) about their children. At post-measures, the authors evaluate the impact of the intervention in terms of user satisfaction, as well as changes between pre- and post-measures on parental competence (PSOC) and parental concerns (PEDS) about their children. Discussion The implication of implementing new interventions to safeguard children of mentally ill patients and the limitation of not measuring child development directly are discussed. PMID:22556160

Evaluating workforce developments to support children of mentally ill parents: implementing new interventions in the adult mental healthcare in Northern Norway.

PubMed

Reedtz, Charlotte; Lauritzen, Camilla; van Doesum, Karin T M

2012-01-01

According to new Norwegian laws, mental healthcare for adults are obligated to assess all patients who are parents and to act on their children's needs. This article describes the study protocol of implementing the interventions Family Assessment and Child Talks for children of patients in the adult psychiatry of the University Hospital of Northern Norway. The project is designed to evaluate the process of changes in clinical practice due to the implementation of two interventions. The interventions to be implemented are a standardised Family Assessment Form and the intervention called Child Talks. The family assessment form is an intervention to identify children of mentally ill parents and their needs. The intervention Child Talks is a health-promoting and preventive intervention where the mental health workers talk with the family about the situation of the children and their needs. There are two groups of participants in this study: (1) mental health workers in the clinic (N=220) and (2) patients who are parents (N=200) receiving treatment in the clinic. (1) In the evaluation of clinical practice, the authors use a pre-test, post-test and 1-year follow-up design. At pre-test, the authors evaluate status quo among mental health workers in the clinic regarding knowledge, attitudes, collaborative routines and clinical practice related to families with parental mental illness. After the pre-test is finished, the project move on to implement the interventions Family Assessment Form and Child Talks in the clinic. At post-test and 1-year follow-up, the authors evaluate the impact of implementing the Family Assessment Form in terms of how many children were identified and offered Child Talks in the clinic or referred to other services for additional support. (2) In the evaluation of parents/patients experience with the interventions, the authors use a pre-test post-test design. To identify children of mentally ill patients, the authors collect data on demographical variables for the patient and the child at pre-measures, as well as data on parental competence (PSOC) and parental concerns (PEDS) about their children. At post-measures, the authors evaluate the impact of the intervention in terms of user satisfaction, as well as changes between pre- and post-measures on parental competence (PSOC) and parental concerns (PEDS) about their children. The implication of implementing new interventions to safeguard children of mentally ill patients and the limitation of not measuring child development directly are discussed.

The scientific establishment of a new therapeutic intervention for developmental conditions: practical and ethical principles.

PubMed

Ijichi, Shinji; Ijichi, Naomi

2003-11-01

Although the randomized controlled trial (RCT) is a major methodological breakthrough extending the limits of objectivity in clinical medical science, clinical trials of surgery have seldom included placebo surgery as a control, for ethical reasons. Especially in clinical studies intended eventually to establish a new intervention for developmental conditions, it has been recognized that there is huge examiner bias. In addition, the many miraculous cases that have been reported in nonsurgical open trials for developmental conditions and have eventually been evaluated as nonspecific positive outcomes in RCTs suggest that empirically promising interventions must be subjected to scientific scrutiny as soon as possible in the field of developmental conditions. Therefore, in childhood neurosurgery, clinical studies to establish a new therapeutic measure for developmental conditions should be designed as rigorously as possible using optimized scientific methods. The worldwide ethical guideline, the Declaration of Helsinki issued by the World Medical Association, can provide principles for the establishment of a new intervention in the treatment of a patient when proven therapeutic methods do not exist or methods used thus far have been ineffective. Physicians' discretion to use unproven or new therapeutic measures for such patients is approved in the presence of efforts of an ethical and scientific approach. Even if the measure is a very promising intervention, the research aspects must completely be demonstrated for informed consent and review by the ethical committee and the trial must be regarded as a clinical research. Especially when an RCT is not possible for ethical reasons, appropriate epidemiological data or animal experiments should suggest that the new measure is effective before a clinical trial. In a clinical setting, where neither epidemiological studies nor animal experimentation can be introduced, if necessary the researcher should collaborate with experts to obtain multidisciplinary justification for clinical testing.

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation

PubMed Central

2012-01-01

Background Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial. This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness. Methods The clinical content of a care pathway for COPD exacerbation was developed based on recognized process design and guideline development methods. Subsequently, based on the COPD case study, a generalized eight-step method was designed to support the development of the clinical content of an evidence-based care pathway. Results A set of 38 evidence-based key interventions and a set of 24 process and 15 outcome indicators were developed in eight different steps. Nine Belgian multidisciplinary teams piloted both the set of key interventions and indicators. The key intervention set was judged by the teams as being valid and clinically applicable. In addition, the pilot study showed that the indicators were feasible for the involved clinicians and patients. Conclusions The set of 38 key interventions and the set of process and outcome indicators were found to be appropriate for the development and standardization of the clinical content of the COPD care pathway in the context of a cRCT on pathway effectiveness. The developed eight-step method may facilitate multidisciplinary teams caring for other patient populations in designing the clinical content of their future care pathways. PMID:23190552

Brief educational interventions to improve performance on novel quality metrics in ambulatory settings in Kenya: A multi-site pre-post effectiveness trial.

PubMed

Korom, Robert Ryan; Onguka, Stephanie; Halestrap, Peter; McAlhaney, Maureen; Adam, Mary

2017-01-01

The quality of primary care delivered in resource-limited settings is low. While some progress has been made using educational interventions, it is not yet clear how to sustainably improve care for common acute illnesses in the outpatient setting. Management of urinary tract infection is particularly important in resource-limited settings, where it is commonly diagnosed and associated with high levels of antimicrobial resistance. We describe an educational programme targeting non-physician health care providers and its effects on various clinical quality metrics for urinary tract infection. We used a series of educational interventions including 1) formal introduction of a clinical practice guideline, 2) peer-to-peer chart review, and 3) peer-reviewed literature describing local antimicrobial resistance patterns. Interventions were conducted for clinical officers (N = 24) at two outpatient centers near Nairobi, Kenya over a one-year period. The medical records of 474 patients with urinary tract infections were scored on five clinical quality metrics, with the primary outcome being the proportion of cases in which the guideline-recommended antibiotic was prescribed. The results at baseline and following each intervention were compared using chi-squared tests and unpaired two-tailed T-tests for significance. Logistic regression analysis was used to assess for possible confounders. Clinician adherence to the guideline-recommended antibiotic improved significantly during the study period, from 19% at baseline to 68% following all interventions (Χ2 = 150.7, p < 0.001). The secondary outcome of composite quality score also improved significantly from an average of 2.16 to 3.00 on a five-point scale (t = 6.58, p < 0.001). Interventions had different effects at different clinical sites; the primary outcome of appropriate antibiotic prescription was met 83% of the time at Penda Health, and 50% of the time at AICKH, possibly reflecting differences in onboarding and management of clinical officers. Logistic regression analysis showed that intervention stage and clinical site were independent predictors of the primary outcome (p < 0.0001), while all other features, including provider and patient age, were not significant at a conservative threshold of p < 0.05. This study shows that brief educational interventions can dramatically improve the quality of care for routine acute illnesses in the outpatient setting. Measurement of quality metrics allows for further targeting of educational interventions depending on the needs of the providers and the community. Further study is needed to expand routine measurement of quality metrics and to identify the interventions that are most effective in improving quality of care.

ClinicalTrials.gov, stem cells and 'pay-to-participate' clinical studies.

PubMed

Turner, Leigh

2017-09-01

Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.

Feedback intervention to doctors improves patient satisfaction among outpatients in Inner Mongolia Autonomous Region, China.

PubMed

Qiao, T; Geater, A F; Chongsuvivatwong, V; Fan, Y; Guo, Z

2017-11-01

The doctor-patient relationship (DPR) in China is known to be tense. We tested whether an intervention program providing individualized feedback to doctors by patients could improve patients' satisfaction in an outpatient setting. A non-randomized controlled prepost intervention study in a tertiary hospital. Six surgery clinics were chosen as the intervention group and eight internal medicine clinics as the control group. Before the program started, patients attending each group of clinics were asked to fill in the Short-Form Patient Satisfaction Questionnaire (PSQ-18). In the experimental period, patients attending the intervention clinics were requested to rate their perception of the doctor's quality of care in various domains on an 8-question feedback card immediately after exiting from the examination room and to drop the completed card into the feedback box for the particular doctor. The cards were then collected by the doctor confidentially at the end of each day. There was no feedback in the control clinics. After the experimental period ended, the doctors in both groups of clinics were reassessed by a new series of patients using PSQ-18. The PSQ-18 scores were compared within the same group of clinics over time, and the changes in satisfaction score compared between intervention and control clinics. There were 189 and 190 responders in the intervention group and 190 and 200 in the control group, before and after the intervention period, respectively. Scores in all domains increased significantly (P < 0.001) in the intervention group but not in the control group. Significant improvement in the patient satisfaction scores in the intervention clinics compared with the control clinics was confirmed by mixed-effects linear regression controlling for the effects of gender, age, marital status, education, and household income in the domains of general satisfaction, technical quality, communication, and accessibility and convenience. Timely feedback to doctors of patients' perception of quality of care received can improve outpatient satisfaction in a Chinese hospital. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l=515) and the intervention group received lecture plus a simulation exercise (n l+s=1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

Background The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. Purpose To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. Methods This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l =515) and the intervention group received lecture plus a simulation exercise (n l+s =1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Results Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Discussion Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

Educational Intervention for Nutrition Education in Patients Attending an Outpatient Wound Care Clinic: A Feasibility Study.

PubMed

Green, Lisa M; Ratcliffe, Desi; Masters, Kathleen; Story, Lachel

2016-01-01

The purpose of this study was to determine whether nurses could use a structured intervention to educate patients with wounds about foods that promote healing and whether this educational intervention could be provided in a cost-effective manner. Cross-sectional survey. The study was conducted at an outpatient wound care center located on a hospital campus in the Southern United States; 3 full-time nurses and 2 nurses employed on part-time status delivered the intervention. A nutrition education intervention was developed through collaborative efforts of a registered dietitian and a nurse. A cross-sectional survey design was used to (1) evaluate nurses' perceptions of the intervention and (2) identify barriers to implementation of the intervention. Direct costs related to materials and nursing time required to deliver the intervention were calculated. Participants indicated they were competent to deliver the structured intervention, and all were willing to continue its use. Survey results indicated that nurses believed the intervention was beneficial to their patients and they indicated that patients were responsive to the intervention. The intervention was found to be low cost ($8.00 per teaching session); no barriers to implementation of the intervention were identified. The results of this exploratory study suggest that a structured nutrition education intervention can be provided by nurses in outpatient wound clinics at low cost. Further study is needed to determine the impact of this intervention on nutritional intake and wound healing.

Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

PubMed

Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

2015-01-01

We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

A feasibility study of a theory-based intervention to improve appropriate polypharmacy for older people in primary care.

PubMed

Cadogan, Cathal A; Ryan, Cristín; Gormley, Gerard J; Francis, Jill J; Passmore, Peter; Kerse, Ngaire; Hughes, Carmel M

2018-01-01

A general practitioner (GP)-targeted intervention aimed at improving the prescribing of appropriate polypharmacy for older people was previously developed using a systematic, theory-based approach based on the UK Medical Research Council's complex intervention framework. The primary intervention component comprised a video demonstration of a GP prescribing appropriate polypharmacy during a consultation with an older patient. The video was delivered to GPs online and included feedback emphasising the positive outcomes of performing the behaviour. As a complementary intervention component, patients were invited to scheduled medication review consultations with GPs. This study aimed to test the feasibility of the intervention and study procedures (recruitment, data collection). GPs from two general practices were given access to the video, and reception staff scheduled consultations with older patients receiving polypharmacy (≥4 medicines). Primary feasibility study outcomes were the usability and acceptability of the intervention to GPs. Feedback was collected from GP and patient participants using structured questionnaires. Clinical data were also extracted from recruited patients' medical records (baseline and 1 month post-consultation). The feasibility of applying validated assessment of prescribing appropriateness (STOPP/START criteria, Medication Appropriateness Index) and medication regimen complexity (Medication Regimen Complexity Index) to these data was investigated. Data analysis was descriptive, providing an overview of participants' feedback and clinical assessment findings. Four GPs and ten patients were recruited across two practices. The intervention was considered usable and acceptable by GPs. Some reservations were expressed by GPs as to whether the video truly reflected resource and time pressures encountered in the general practice working environment. Patient feedback on the scheduled consultations was positive. Patients welcomed the opportunity to have their medications reviewed. Due to the short time to follow-up and a lack of detailed clinical information in patient records, it was not feasible to detect any prescribing changes or to apply the assessment tools to patients' clinical data. The findings will help to further refine the intervention and study procedures (including time to follow-up) which will be tested in a randomised pilot study that will inform the design of a definitive trial to evaluate the intervention's effectiveness. ISRCTN18176245.

Congruence between patient characteristics and interventions may partly explain medication adherence intervention effectiveness: an analysis of 190 randomized controlled trials from a Cochrane systematic review.

PubMed

Allemann, Samuel S; Nieuwlaat, Robby; Navarro, Tamara; Haynes, Brian; Hersberger, Kurt E; Arnet, Isabelle

2017-11-01

Due to the negative outcomes of medication nonadherence, interventions to improve adherence have been the focus of countless studies. The congruence between adherence-related patient characteristics and interventions may partly explain the variability of effectiveness in medication adherence studies. In their latest update of a Cochrane review reporting inconsistent effects of adherence interventions, the authors offered access to their database for subanalysis. We aimed to use this database to assess congruence between adherence-related patient characteristics and interventions and its association with intervention effects. We developed a congruence score consisting of six features related to inclusion criteria, patient characteristics at baseline, and intervention design. Two independent raters extracted and scored items from the 190 studies available in the Cochrane database. We correlated overall congruence score and individual features with intervention effects regarding adherence and clinical outcomes using Kruskal-Wallis rank sum test and Fisher's exact test. Interrater reliability for newly extracted data was almost perfect with a Cohen's Kappa of 0.92 [95% confidence interval (CI) = 0.89-0.94; P < 0.001]. Although present in only six studies, the inclusion of nonadherent patients was the single feature significantly associated with effective adherence interventions (P = 0.003). Moreover, effective adherence interventions were significantly associated with improved clinical outcomes (odds ratio = 6.0; 95% CI = 3.1-12.0; P < 0.0001). However, neither the overall congruence score nor any other individual feature (i.e., "determinants of nonadherence as inclusion criteria," "tailoring of interventions to the inclusion criteria," "reasons for nonadherence assessed at baseline," "adjustment of intervention to individual patient needs," and "theory-based interventions") was significantly associated with intervention effects. The presence of only six studies that included nonadherent patients and the interdependency of this feature with the remaining five might preclude a conclusive assessment of congruence between patient characteristics and adherence interventions. In order to obtain clinical benefits from effective adherence interventions, we encourage researchers to focus on the inclusion of nonadherent patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Tobacco cessation intervention for pregnant women in Argentina and Uruguay: study protocol

PubMed Central

2013-01-01

Background Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and infants. The “5 A’s” (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5–15 minutes delivered by a trained provider. The “5 A’s” is considered the standard of care worldwide; however, it is under used in Argentina and Uruguay. Methods We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal care settings in Argentina and Uruguay. Prenatal care settings will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwives’ facilitators in the 10 intervention prenatal clinics (clusters) will be identified and trained to deliver the “5 A’s” to pregnant women and will then disseminate and implement the program. The 10 clusters in the control group will continue with their standard in-service activities. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at maternity hospitals and acceptable to local pregnant women and health providers. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy in the intervention clinics compared to the control clinics. Our secondary hypotheses are that the intervention will decrease the frequency of women who smoke by the end of pregnancy, and that the intervention will increase the attitudes and readiness of midwives towards providing counseling to women in the intervention clinics compared to the control clinics. Trial registration ClinicalTrials.gov. Identifier: NCT01852617 PMID:23971512

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

PubMed Central

2016-01-01

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

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

PubMed

2016-01-01

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

Tailored weight loss intervention in obese adults within primary care practice: rationale, design, and methods of Choose to Lose.

PubMed

Hartman, Sheri J; Risica, Patricia M; Gans, Kim M; Marcus, Bess H; Eaton, Charles B

2014-07-01

Although there are efficacious weight loss interventions that can improve health and delay onset of diabetes and hypertension, these interventions have not been translated into clinical practice. The primary objective of this study is to evaluate the effectiveness and cost effectiveness of a tailored lifestyle intervention in primary care patients. Patients were recruited by their primary care physicians and eligible participants were randomized to an enhanced intervention or standard intervention. All participants met with a lifestyle counselor to set calorie and physical activity goals and to discuss behavioral strategies at baseline, 6 and 12 months. During the first year, enhanced intervention participants receive monthly counseling phone calls to assist in attaining and maintaining their goals. Enhanced intervention participants also receive weekly mailings consisting of tailored and non-tailored print materials and videos focusing on weight loss, physical activity promotion and healthy eating. The second year focuses on maintenance with enhanced intervention participants receiving tailored and non-tailored print materials and videos regularly throughout the year. Standard intervention participants receive five informational handouts on weight loss across the two years. This enhanced intervention that consists of multiple modalities of print, telephone, and video with limited face-to-face counseling holds promise for being effective for encouraging weight loss, increasing physical activity and healthy eating, and also for being cost effective and generalizable for wide clinical use. This study will fill an important gap in our knowledge regarding the translation and dissemination of research from efficacy studies to best practices in clinical settings. Copyright © 2014 Elsevier Inc. All rights reserved.

Cost-benefit of a clinical services integrated with a decentralized unit dose system.

PubMed

Warrian, K; Irvine-Meek, J

1988-06-01

Clinical pharmacy services are believed to be beneficial to patient care and to have the potential to reduce drug costs. This study was designed to apply cost-benefit analysis techniques to selected clinical pharmacy services provided by staff pharmacists assigned to a mobile decentralized unit-dose drug distribution system. Pharmacists' interventions were identified and recorded by the pharmacists and the investigator over an eight-week period. Interventions, to which a monetary value could be assigned, included non-formulary drug use, drug regimen adjustments, and the duration of drug therapy. A total of 543 interventions were recorded or observed. Of these, 174 (32 percent) fit the criteria for inclusion in the study. Those interventions accepted by physicians (87 percent) were assigned a dollar value and tabulated. Costs to provide the service were the pharmacists' salaries. Benefit to cost ratios of 1.08 and 1.59 demonstrated that the benefits accrued from selected clinical pharmacy services exceeded the costs to the hospital.

Interventions for Enhancing Adherence to Antiretroviral Therapy (ART): A Systematic Review of High Quality Studies

PubMed Central

Sivaramalingam, Bhairavi; Navarro, Tamara; Hobson, Nicholas; Keepanasseril, Arun; Wilczynski, Nancy J.; Haynes, R. Brian

2015-01-01

Abstract We sought to review the effectiveness of interventions designed to improve adherence to antiretroviral therapy (ART) from studies included in a recent Cochrane review that reported a clinical and an adherence outcome, with at least 80% follow-up for 6 months or more. Data were extracted independently and in duplicate, with an adjudicator for disagreements. Risk of bias was assessed using the Cochrane Risk of Bias tool. Of 182 relevant studies in the Cochrane review, 49 were related to ART. Statistical pooling was not warranted due to heterogeneity in interventions, participants, treatments, adherence measures and outcomes. Many studies had high risk of bias in elements of design and outcome ascertainment. Only 10 studies improved both adherence and clinical outcomes. These used the following interventions: adherence counselling (two studies); a once-daily regimen (compared to twice daily); text messaging; web-based cognitive behavioral intervention; face-to-face multi-session intensive behavioral interventions (two studies); contingency management; modified directly observed therapy; and nurse-delivered home visits combined with telephone calls. Patient-related adherence interventions were the most frequently tested. Uniform adherence measures and higher quality studies of younger populations are encouraged. PMID:25825938

A systematic review of psychoneuroimmunology-based interventions.

PubMed

Moraes, Lucam J; Miranda, Márcia B; Loures, Liliany F; Mainieri, Alessandra G; Mármora, Cláudia Helena C

2018-07-01

Psychoneuroimmunology-based interventions are used to attenuated disease progression and/or side effects of pharmacological treatment. This systematic review evaluates the different therapeutic and/or clinical psychoneuroimmunology-based interventions associated to both psychological, neuroendocrine and immunological variables. The review was conducted for all English, Portuguese and Spanish language articles published between 2005 and 2015. Independent investigators analyzed 42 studies concerning human psychoneuroimmunology-based interventions. Decreased levels of cortisol, epinephrine and norepinephrine (stress-related hormones) were associated to interventions like yoga, meditation, tai chi, acupuncture, mindfulness, religious/spiritual practices, cognitive behavior therapy, coping and physical exercises. Moreover, those interventions were also associated to reductions in inflammatory processes and levels of pro-inflammatory cytokines in cancer, HIV, depression, anxiety, wound healing, sleep disorder, cardiovascular diseases and fibromyalgia. Despite the associations between PNI variables and clinical/therapeutic interventions, only one study evidenced significant effects on a disease progression.

Increasing reliability of APACHE II scores in a medical-surgical intensive care unit: a quality improvement study.

PubMed

Donahoe, Laura; McDonald, Ellen; Kho, Michelle E; Maclennan, Margaret; Stratford, Paul W; Cook, Deborah J

2009-01-01

Given their clinical, research, and administrative purposes, scores on the Acute Physiology and Chronic Health Evaluation (APACHE) II should be reliable, whether calculated by health care personnel or a clinical information system. To determine reliability of APACHE II scores calculated by a clinical information system and by health care personnel before and after a multifaceted quality improvement intervention. APACHE II scores of 37 consecutive patients admitted to a closed, 15-bed, university-affiliated intensive care unit were collected by a research coordinator, a database clerk, and a clinical information system. After a quality improvement intervention focused on health care personnel and the clinical information system, the same methods were used to collect data on 32 consecutive patients. The research coordinator and the clerk did not know each other's scores or the information system's score. The data analyst did not know the source of the scores until analysis was complete. APACHE II scores obtained by the clerk and the research coordinator were highly reliable (intraclass correlation coefficient, 0.88 before vs 0.80 after intervention; P = .25). No significant changes were detected after the intervention; however, compared with scores of the research coordinator, the overall reliability of APACHE II scores calculated by the clinical information system improved (intraclass correlation coefficient, 0.24 before intervention vs 0.91 after intervention, P < .001). After completion of a quality improvement intervention, health care personnel and a computerized clinical information system calculated sufficiently reliable APACHE II scores for clinical, research, and administrative purposes.

A Systematic Review of the Unintended Consequences of Clinical Interventions to Reduce Adverse Outcomes.

PubMed

Manojlovich, Milisa; Lee, Soohee; Lauseng, Deborah

2016-12-01

This is a systematic review of the literature on unintended consequences of clinical interventions to reduce falls, catheter-related urinary tract infection, and vascular catheter-related infections in hospitalized patients. A systematic search of the literature was conducted in CINAHL and PubMed. We developed a screening tool and a two-stage screening process to identify relevant articles. Nine articles met inclusion criteria, and of those, 8 reported on interventions to reduce patient falls. Four studies reported a positive, unexpected benefit; 3 studies reported a negative, unexpected detriment; and 4 reported a perverse effect (different from what was expected). Three studies reported both positive and perverse effects arising from the intervention. In 4 of the studies, despite fall prevention interventions, patients fell while trying to get to the bathroom, suggesting that interventions to reduce one adverse outcome (i.e., CAUTI) may be associated with another outcome (i.e., patient falls). In some cases, there were positive outcomes for those who implemented and/or evaluated interventions. We encourage colleagues to collect and report data on possible unintended consequences of their interventions to allow a fuller picture of the relationship between intervention and all outcomes to emerge.

Evaluation of a hand hygiene campaign in outpatient health care clinics.

PubMed

Kukanich, Kate Stenske; Kaur, Ramandeep; Freeman, Lisa C; Powell, Douglas A

2013-03-01

To improve hand hygiene in two outpatient health care clinics through the introduction of a gel sanitizer and an informational poster. In this interventional study, health care workers at two outpatient clinics were observed for frequency of hand hygiene (attempts versus opportunities). Gel sanitizer and informational posters were introduced together as an intervention. Direct observation of the frequency of hand hygiene was performed during baseline, intervention, and follow-up. A poststudy survey of health care workers was also distributed and collected. In both clinics, the frequency of hand hygiene was poor at baseline (11% and 21%) but improved significantly after intervention (36% and 54%) and was maintained through the follow-up period (32% and 51%). Throughout the study, postcontact hand hygiene was observed significantly more often than precontact hand hygiene. In both clinics, health care workers reported a preference for soap and water; yet observations showed that when the intervention made gel sanitizer available, sanitizer use predominated. Fifty percent of the surveyed health care workers considered the introduction of gel sanitizer to be an effective motivating tool for improving hand hygiene. Hand hygiene performance by health care workers in outpatient clinics may be improved through promoting the use of gel sanitizer and using informational posters. Compared with surveys, direct observation by trained observers may provide more accurate information about worker preferences for hand hygiene tools.

The Program Cost of a Brief Video Intervention Shown in Sexually Transmitted Disease Clinic Waiting Rooms.

PubMed

Gift, Thomas L; OʼDonnell, Lydia N; Rietmeijer, Cornelis A; Malotte, Kevin C; Klausner, Jeffrey D; Margolis, Andrew D; Borkowf, Craig B; Kent, Charlotte K; Warner, Lee

2016-01-01

Patients in sexually transmitted disease (STD) clinic waiting rooms represent a potential audience for delivering health messages via video-based interventions. A controlled trial at 3 sites found that patients exposed to one intervention, Safe in the City, had a significantly lower incidence of STDs compared with patients in the control condition. An evaluation of the intervention's cost could help determine whether such interventions are programmatically viable. The cost of producing the Safe in the City intervention was estimated using study records, including logs, calendars, and contract invoices. Production costs were divided by the 1650 digital video kits initially fabricated to get an estimated cost per digital video. Clinic costs for showing the video in waiting rooms included staff time costs for equipment operation and hardware depreciation and were estimated for the 21-month study observation period retrospectively. The intervention cost an estimated $416,966 to develop, equaling $253 per digital video disk produced. Per-site costs to show the video intervention were estimated to be $2699 during the randomized trial. The cost of producing and implementing Safe in the City intervention suggests that similar interventions could potentially be produced and made available to end users at a price that would both cover production costs and be low enough that the end users could afford them.

Interventions to Modify Health Care Provider Adherence to Asthma Guidelines: A Systematic Review

PubMed Central

Okelo, Sande O.; Butz, Arlene M.; Sharma, Ritu; Diette, Gregory B.; Pitts, Samantha I.; King, Tracy M.; Linn, Shauna T.; Reuben, Manisha; Chelladurai, Yohalakshmi

2013-01-01

BACKGROUND AND OBJECTIVE: Health care provider adherence to asthma guidelines is poor. The objective of this study was to assess the effect of interventions to improve health care providers’ adherence to asthma guidelines on health care process and clinical outcomes. METHODS: Data sources included Medline, Embase, Cochrane CENTRAL Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Educational Resources Information Center, PsycINFO, and Research and Development Resource Base in Continuing Medical Education up to July 2012. Paired investigators independently assessed study eligibility. Investigators abstracted data sequentially and independently graded the evidence. RESULTS: Sixty-eight eligible studies were classified by intervention: decision support, organizational change, feedback and audit, clinical pharmacy support, education only, quality improvement/pay-for-performance, multicomponent, and information only. Half were randomized trials (n = 35). There was moderate evidence for increased prescriptions of controller medications for decision support, feedback and audit, and clinical pharmacy support and low-grade evidence for organizational change and multicomponent interventions. Moderate evidence supports the use of decision support and clinical pharmacy interventions to increase provision of patient self-education/asthma action plans. Moderate evidence supports use of decision support tools to reduce emergency department visits, and low-grade evidence suggests there is no benefit for this outcome with organizational change, education only, and quality improvement/pay-for-performance. CONCLUSIONS: Decision support tools, feedback and audit, and clinical pharmacy support were most likely to improve provider adherence to asthma guidelines, as measured through health care process outcomes. There is a need to evaluate health care provider-targeted interventions with standardized outcomes. PMID:23979092

Neurodevelopmental delay among children under the age of three years at immunization clinics in Lagos State, Nigeria - Preliminary report.

PubMed

Bakare, Muideen O; Bello-Mojeed, Mashudat A; Munir, Kerim M; Ogun, Oluwayemi C; Eaton, Julian

2016-04-29

Late diagnosis and interventions characterize childhood neurodevelopmental disorders in Sub-Saharan Africa. This has negatively impacted on the prognosis of the children with neurodevelopmental disorders. This study examined the prevalence and pattern of neurodevelopmental delays among children under the age of 3 years attending immunization clinics in Lagos State, Nigeria and also affords opportunity of early follow-up and interventions, which had been documented to improve prognosis. The study involved two stage assessments; which consisted of first phase screening of the children for neurodevelopmental delays in immunization clinics at primary healthcare centers Lagos State, Nigeria and second phase which consists of definitive clinical evaluation and follow-up interventions for children screened positive for neurodevelopmental delays. Twenty seven (0.9%) of a total of 3,011 children under the age of 3 years were screened positive for neurodevelopmental delays and subsequently undergoing clinical evaluation and follow-up interventions. Preliminary working diagnoses among these children include cerebral palsy, autism spectrum disorder trait, nutritional deficiency, Down syndrome and Non-specific neurodevelopmental delay with co-morbid seizure disorder accounting for 33.3%, 14.8%, 18.5%, 7.4% and 25.9% respectively. This is a preliminary report that would be followed up with information on medium and long term intervention phase.

A systematic review of interventions conducted in clinical or community settings to improve dual-task postural control in older adults

PubMed Central

Agmon, Maayan; Belza, Basia; Nguyen, Huong Q; Logsdon, Rebecca G; Kelly, Valerie E

2014-01-01

Background Injury due to falls is a major problem among older adults. Decrements in dual-task postural control performance (simultaneously performing two tasks, at least one of which requires postural control) have been associated with an increased risk of falling. Evidence-based interventions that can be used in clinical or community settings to improve dual-task postural control may help to reduce this risk. Purpose The aims of this systematic review are: 1) to identify clinical or community-based interventions that improved dual-task postural control among older adults; and 2) to identify the key elements of those interventions. Data sources Studies were obtained from a search conducted through October 2013 of the following electronic databases: PubMed, CINAHL, PsycINFO, and Web of Science. Study selection Randomized and nonrandomized controlled studies examining the effects of interventions aimed at improving dual-task postural control among community-dwelling older adults were selected. Data extraction All studies were evaluated based on methodological quality. Intervention characteristics including study purpose, study design, and sample size were identified, and effects of dual-task interventions on various postural control and cognitive outcomes were noted. Data synthesis Twenty-two studies fulfilled the selection criteria and were summarized in this review to identify characteristics of successful interventions. Limitations The ability to synthesize data was limited by the heterogeneity in participant characteristics, study designs, and outcome measures. Conclusion Dual-task postural control can be modified by specific training. There was little evidence that single-task training transferred to dual-task postural control performance. Further investigation of dual-task training using standardized outcome measurements is needed. PMID:24741296

Reporting of interventions and "standard of care" control arms in pediatric clinical trials: a quantitative analysis.

PubMed

Yu, Ashley M; Balasubramanaiam, Bannuya; Offringa, Martin; Kelly, Lauren E

2018-06-13

In pediatric medicine, the usual treatment received by children ("standard of care") varies across centers. Evaluations of new treatments often compare to the existing "standard of care" to determine if a treatment is more effective, has a better safety profile, or costs less. The objective of our study was to evaluate intervention and "standard of care" control arms reported in published pediatric clinical trials. Pediatric clinical trials, published in 2014, reporting the use of a "standard of care" control arm were included. Duplicate assessment of reporting completeness was done using the 12-item TIDieR (Template for Intervention Description and Replication) checklist for both the "standard of care" control arms and intervention arms within the same published study. Following screening, 214 pediatric trials in diverse therapeutic areas were included. Several different terms were used to describe "standard of care." There was a significant difference between the mean reported TIDieR checklist items of "standard of care" control arms (5.81 (SD 2.13) and intervention arms (8.45 (SD 1.39, p < 0.0001). Reporting of intervention and "standard of care" control arms in pediatric clinical trials should be improved as current "standard of care" reporting deficiencies limit reproducibility of research and may ultimately contribute to research waste.

Lifestyle interventions and independence for elders study: Recruitment and baseline characteristics

USDA-ARS?s Scientific Manuscript database

Recruitment of older adults into long-term clinical trials involving behavioral interventions is a significant challenge. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled multisite trial, designed to compare the effects of a moderate...

The effectiveness of nurse education and training for clinical alarm response and management: a systematic review.

PubMed

Yue, Liqing; Plummer, Virginia; Cross, Wendy

2017-09-01

To identify the effectiveness of education interventions provided for nurses for clinical alarm response and management. Some education has been undertaken to improve clinical alarm response, but the evidence for evaluating effectiveness for nurse education interventions is limited. Systematic review. A systematic review of experimental studies published in English from 2005-2015 was conducted in four computerised databases (MEDLINE, EMBASE, CINAHL and Scopus). After identification, screening and appraisal using Joanna Briggs Institute instruments, quality research papers were selected, data extraction and analysis followed. Five studies met the inclusion criteria for alarm response and no articles were concerned with clinical alarm education for management. All had different types and methods of interventions and statistical pooling was not possible. Response accuracy, response time and perceptions were consistent when different interventions were adopted. A positive effect was identified when learning about general alarms, single alarms, sequential alarms and medium-level alarms for learning as the primary task. Nurses who were musically trained had a faster and more accurate alarm response. Simulation interventions had a positive effect, but the effect of education provided in the care unit was greater. Overall, clinical alarm awareness was improved through education activities. Nurses are the main users of healthcare alarms and work in complex environments with high numbers of alarms, including nuisance alarms and other factors. Alarm-related adverse events are common. The findings of a small number of experimental studies with diverse evidence included consideration of various factors when formulating education strategies. The factors which influence effectiveness of nurse education are nurse demographics, nurse participants with musical training, workload and characteristics of alarms. Education interventions based in clinical practice settings increase education effectiveness, although simulation can be effective. No study shows any type of intervention results in sustained improvement. There are workload implications in education and the matching of load, number and type of alarms with nurse demographics which should be evaluated. There also needs to be a connection between education and the clinical setting to contribute to clinical alarm awareness for undergraduate nurses and practicing nurses. Education solely supported by employers is insufficient. Patient safety and long-term effects must be further explored. © 2016 John Wiley & Sons Ltd.

Audio-visual presentation of information for informed consent for participation in clinical trials.

PubMed

Synnot, Anneliese; Ryan, Rebecca; Prictor, Megan; Fetherstonhaugh, Deirdre; Parker, Barbara

2014-05-09

Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented, for example, on the Internet or on DVD) are one such method. We updated a 2008 review of the effects of these interventions for informed consent for trial participation. To assess the effects of audio-visual information interventions regarding informed consent compared with standard information or placebo audio-visual interventions regarding informed consent for potential clinical trial participants, in terms of their understanding, satisfaction, willingness to participate, and anxiety or other psychological distress. We searched: the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 6, 2012; MEDLINE (OvidSP) (1946 to 13 June 2012); EMBASE (OvidSP) (1947 to 12 June 2012); PsycINFO (OvidSP) (1806 to June week 1 2012); CINAHL (EbscoHOST) (1981 to 27 June 2012); Current Contents (OvidSP) (1993 Week 27 to 2012 Week 26); and ERIC (Proquest) (searched 27 June 2012). We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. We included randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or verbal information), with standard forms of information provision or placebo audio-visual information, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to consider participating in a real or hypothetical clinical study. (In the earlier version of this review we only included studies evaluating informed consent interventions for real studies). Two authors independently assessed studies for inclusion and extracted data. We synthesised the findings using meta-analysis, where possible, and narrative synthesis of results. We assessed the risk of bias of individual studies and considered the impact of the quality of the overall evidence on the strength of the results. We included 16 studies involving data from 1884 participants. Nine studies included participants considering real clinical trials, and eight included participants considering hypothetical clinical trials, with one including both. All studies were conducted in high-income countries.There is still much uncertainty about the effect of audio-visual informed consent interventions on a range of patient outcomes. However, when considered across comparisons, we found low to very low quality evidence that such interventions may slightly improve knowledge or understanding of the parent trial, but may make little or no difference to rate of participation or willingness to participate. Audio-visual presentation of informed consent may improve participant satisfaction with the consent information provided. However its effect on satisfaction with other aspects of the process is not clear. There is insufficient evidence to draw conclusions about anxiety arising from audio-visual informed consent. We found conflicting, very low quality evidence about whether audio-visual interventions took more or less time to administer. No study measured researcher satisfaction with the informed consent process, nor ease of use.The evidence from real clinical trials was rated as low quality for most outcomes, and for hypothetical studies, very low. We note, however, that this was in large part due to poor study reporting, the hypothetical nature of some studies and low participant numbers, rather than inconsistent results between studies or confirmed poor trial quality. We do not believe that any studies were funded by organisations with a vested interest in the results. The value of audio-visual interventions as a tool for helping to enhance the informed consent process for people considering participating in clinical trials remains largely unclear, although trends are emerging with regard to improvements in knowledge and satisfaction. Many relevant outcomes have not been evaluated in randomised trials. Triallists should continue to explore innovative methods of providing information to potential trial participants during the informed consent process, mindful of the range of outcomes that the intervention should be designed to achieve, and balancing the resource implications of intervention development and delivery against the purported benefits of any intervention.More trials, adhering to CONSORT standards, and conducted in settings and populations underserved in this review, i.e. low- and middle-income countries and people with low literacy, would strengthen the results of this review and broaden its applicability. Assessing process measures, such as time taken to administer the intervention and researcher satisfaction, would inform the implementation of audio-visual consent materials.

Prevalence of prescription opioid use disorder among chronic opioid therapy patients after health plan opioid dose and risk reduction initiatives.

PubMed

Von Korff, Michael; Walker, Rod L; Saunders, Kathleen; Shortreed, Susan M; Thakral, Manu; Parchman, Michael; Hansen, Ryan N; Ludman, Evette; Sherman, Karen J; Dublin, Sascha

2017-08-01

No studies have assessed the comparative effectiveness of guideline-recommended interventions to reduce risk of prescription opioid use disorder among chronic opioid therapy (COT) patients. We compared the prevalence of prescription opioid use disorder among COT patients from intervention clinics that had implemented opioid dose and risk reduction initiatives for more than 4 years relative to control clinics that had not. After a healthcare system in Washington State implemented interventions to reduce opioid dose and risks, we surveyed 1588 adult primary care COT patients to compare the prevalence of prescription opioid use disorder among COT patients from the intervention and control clinics. Intervention clinics managed COT patients at lower COT doses and with more consistent use of risk reduction practices. Control clinics cared for similar COT patients but prescribed higher opioid doses and used COT risk reduction practices inconsistently. Prescription opioid use disorder was assessed with the Psychiatric Research Interview for Substance and Mental Disorders. The prevalence of prescription opioid use disorder was 21.5% (95% CI=18.9% to 24.4%) among COT patients in the intervention clinics and 23.9% (95% CI=20.5% to 27.6%) among COT patients in the control clinics. The adjusted relative risk of prescription opioid use disorder was 1.08 (95% CI=0.89, 1.32) among the control clinic patients relative to the intervention clinic patients. Long-term implementation of opioid dose and risk reduction initiatives was not associated with lower rates of prescription opioid use disorder among prevalent COT patients. Extreme caution should be exercised by clinicians considering COT for patients with chronic non-cancer pain until benefits of this treatment and attendant risks are clarified. Copyright © 2017 Elsevier B.V. All rights reserved.

DPT Student Perceptions of the Physical Therapist Assistant's Role: Effect of Collaborative Case-Based Learning Compared to Traditional Content Delivery and Clinical Experience.

PubMed

Colgrove, Yvonne M; VanHoose, Lisa D

2017-01-01

Doctor of physical therapy (DPT) student learning about role delineation of physical therapist assistants (PTAs) is essential to ethical and legal practice. Survey assessment of three DPT student cohorts compared collaborative interprofessional case-based learning with PTA students to traditional curriculum delivery strategies. Control cohorts were assessed one time. The intervention group was assessed pre-intervention, immediately post-intervention, and after completing a full-time clinical experience. The case-based learning covered 46% of survey content, allowing for the assessment of content-specific material and potential learning through collaboration. Following the educational intervention, the intervention group improved significantly in areas inside and outside the case-based study content, outscoring both control groups on 25-34% of the survey items. Following the clinical experience, the intervention group declined answer accuracy for patient evaluation and treatment implementation, suggesting unlearning. Improvement in the administrative section was observed after the clinical experience. Perceptions of the tasks within the PTA role were diminished while tasks outside the scope of practice appeared clarified following the clinical experience. While case-based collaborative intraprofessional learning proves effective in student learning about the PTA role, changes following the clinical experience raise questions about the influence of the clinical environment on learning and the practical application of recently learned knowledge.

Implementing a WIC-Based Intervention to Promote Exclusive Breastfeeding: Challenges, Facilitators, and Adaptive Strategies.

PubMed

Eldridge, Johanna D; Hartnett, Josette O; Lee, Furrina F; Sekhobo, Jackson P; Edmunds, Lynn S

Understand factors that contributed to the implementation of a successful multicomponent intervention to promote exclusive breastfeeding (EBF) within Special Supplemental Nutrition Program for Woman, Infants, and Children (WIC) clinics. Qualitative study of staff implementers' experiences using implementation status reports, facilitated group discussion immediately after implementation, and WIC administrative data. WIC staff from 12 clinics participated in an EBF Learning Community composed of 8 intervention trainings and ongoing support from trainers and peers. A total of 47 WIC staff including 11 directors, 20 other administrators, 8 nutritionists, and 6 peer counselors. A WIC-integrated EBF promotion initiative, supported through a Learning Community, composed of prenatal screening, tailored trimester-specific counseling, and timely postpartum follow-up. Challenges and facilitators to implementation within clinics. Iterative qualitative analysis using directed, emergent, and thematic coding. Implementation experiences were characterized by (1) perceived benefits of implementation, including improved EBF knowledge and counseling confidence among staff; and (2) managing implementation, including responding to challenges posed by clinic settings (resources, routine practices, values, and perceptions of mothers) through strategies such as adapting clinic practices and intervention components. Implementation was shaped by clinic setting and adaptive strategies. Future WIC interventions may benefit from formal consideration of intervention fit with local clinic setting and allowable adaptations. Copyright © 2017 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Utility of an Occupational Therapy Driving Intervention for a Combat Veteran

PubMed Central

Monahan, Miriam; Canonizado, Maria; Winter, Sandra

2014-01-01

Many combat veterans are injured in motor vehicle crashes shortly after returning to civilian life, yet little evidence exists on effective driving interventions. In this single-subject design study, we compared clinical test results and driving errors in a returning combat veteran before and after an occupational therapy driving intervention. A certified driving rehabilitation specialist administered baseline clinical and simulated driving assessments; conducted three intervention sessions that discussed driving errors, retrained visual search skills, and invited commentary on driving; and administered a postintervention evaluation in conditions resembling those at baseline. Clinical test results were similar pre- and postintervention. Baseline versus postintervention driving errors were as follows: lane maintenance, 23 versus 7; vehicle positioning, 5 versus 1; signaling, 2 versus 0; speed regulation, 1 versus 1; visual scanning, 1 versus 0; and gap acceptance, 1 versus 0. Although the intervention appeared efficacious for this participant, threats to validity must be recognized and controlled for in a follow-up study. PMID:25005503

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

PubMed

Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

2013-11-01

To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

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

PubMed Central

2011-01-01

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

Application of Balanced Scorecard in the Evaluation of a Complex Health System Intervention: 12 Months Post Intervention Findings from the BHOMA Intervention: A Cluster Randomised Trial in Zambia

PubMed Central

Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

2014-01-01

Introduction In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. Methods The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. Results The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. Conclusion This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health intervention. Trial number ClinicalTrials.gov NCT01942278 PMID:24751780

Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia.

PubMed

Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

2014-01-01

In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health intervention. ClinicalTrials.gov NCT01942278.

Effects of antenatal care and HIV treatment integration on elements of the PMTCT cascade: Results from the SHAIP cluster-randomized controlled trial in Kenya

PubMed Central

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

2015-01-01

Background Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. The current study aimed to determine if integration of HIV services into ANC settings improves PMTCT service utilization outcomes. Methods ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or non-integrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), while control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. Results HIV care enrollment was higher in intervention compared to control clinics (69% versus 36%, Odds Ratio (OR)=3.94, 95% Confidence Interval (CI): 1.14–13.63). Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, Hazard Ratio (HR)=2.20, 95% CI: 1.62–3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%, OR=3.22, 95% CI: 1.81–5.72). Infant testing was more common in the intervention arm (25% versus 18%), however not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. Conclusions Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions. PMID:25967269

An education and motivation intervention to change clinical management of the third stage of labor - the GIRMMAHP Initiative.

PubMed

Figueras, Albert; Narváez, Edgar; Valsecia, Mabel; Vásquez, Susana; Rojas, Germán; Camilo, Angiolina; del Valle, José-María; Aguilera, Cristina

2008-12-01

Hemorrhage and hypertensive disorders are major contributors to death after delivery in developing countries. The GIRMMAHP Initiative was designed to describe the actual delivery care in five Latin American countries and to educate and motivate clinical staff at 17 hospitals with the purpose of implementing their own clinical practice guidelines to prevent postpartum hemorrhage. A multicountry education intervention was developed in four consecutive stages, using two analyses: (a) an observational study of the clinical records in eight teaching and nine nonteaching hospitals and (b) a study of the long-term changes measured 12 months after completion of an education intervention and writing a local clinical guideline. Data from 2,247 pregnant women showed that only 23.3 percent had an active management of the third stage of labor and that 22.7 percent received no prenatal care visit. These data were used to prepare local clinical practice guidelines in each participant hospital. The proportion of active management increased to 72.6 percent of deliveries at 3 months and 58.7 percent 1 year later. Use of oxytocin during the third stage of labor increased to 85.9 percent of included deliveries. The proportion of women who had postpartum hemorrhage decreased from 12.7 percent at baseline to 5 percent at 1 year after the intervention. An education intervention and discussion of actual clinical practice problems with health professionals and their involvement in drafting clinical guidelines helped improve health care quality and practitioners' adherence to these guidelines.

Tobacco dependence counseling in a randomized multisite clinical trial

PubMed Central

Croghan, Ivana T.; Trautman, Judith A.; Winhusen, Theresa; Ebbert, Jon O.; Kropp, Frankie; Schroeder, Darrell R.; Hurt, Richard D.

2012-01-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a “train-the-trainer” model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3 ± 2.8 sessions (mean ± SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and “meeting expectations” on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. PMID:22406192

Tobacco dependence counseling in a randomized multisite clinical trial.

PubMed

Croghan, Ivana T; Trautman, Judith A; Winhusen, Theresa; Ebbert, Jon O; Kropp, Frankie B; Schroeder, Darrell R; Hurt, Richard D

2012-07-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3±2.8 sessions (mean±SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. Copyright © 2012 Elsevier Inc. All rights reserved.

Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial.

PubMed

Wilcox, Joanne; Waite, Chantelle; Tomlinson, Lyndsey; Driscoll, Joanne; Karim, Asra; Day, Edward; Sharif, Adnan

2016-08-22

Lifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation. We designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n = 65, leaflet guidance only) versus active lifestyle modification (n = 65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention period. This is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care. This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491 ).

A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol.

PubMed

Kestler, Edgar; Walker, Dilys; Bonvecchio, Anabelle; de Tejada, Sandra Sáenz; Donner, Allan

2013-03-21

Maternal and perinatal mortality continue to be a high priority problem on the health agendas of less developed countries. Despite the progress made in the last decade to quantify the magnitude of maternal mortality, few interventions have been implemented with the intent to measure impact directly on maternal or perinatal deaths. The success of interventions implemented in less developed countries to reduce mortality has been questioned, in terms of the tendency to maintain a clinical perspective with a focus on purely medical care separate from community-based approaches that take cultural and social aspects of maternal and perinatal deaths into account. Our innovative approach utilizes both the clinical and community perspectives; moreover, our study will report the weight that each of these components may have had on reducing perinatal mortality and increasing institution-based deliveries. A matched pair cluster-randomized trial will be conducted in clinics in four rural indigenous districts with the highest maternal mortality ratios in Guatemala. The individual clinic will serve as the unit of randomization, with 15 matched pairs of control and intervention clinics composing the final sample. Three interventions will be implemented in indigenous, rural and poor populations: a simulation training program for emergency obstetric and perinatal care, increased participation of the professional midwife in strengthening the link between traditional birth attendants (TBA) and the formal health care system, and a social marketing campaign to promote institution-based deliveries. No external intervention is planned for control clinics, although enhanced monitoring, surveillance and data collection will occur throughout the study in all clinics throughout the four districts. All obstetric events occurring in any of the participating health facilities and districts during the 18 months implementation period will be included in the analysis, controlling for the cluster design. Our main outcome measures will be the change in perinatal mortality and in the proportion of institution-based deliveries. A unique feature of this protocol is that we are not proposing an individual intervention, but rather a package of interventions, which is designed to address the complexities and realities of maternal and perinatal mortality in developing countries. To date, many other countries, has focused its efforts to decrease maternal mortality indirectly by improving infrastructure and data collection systems rather than on implementing specific interventions to directly improve outcomes. ClinicalTrial.gov,http://NCT01653626.

A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol

PubMed Central

2013-01-01

Background Maternal and perinatal mortality continue to be a high priority problem on the health agendas of less developed countries. Despite the progress made in the last decade to quantify the magnitude of maternal mortality, few interventions have been implemented with the intent to measure impact directly on maternal or perinatal deaths. The success of interventions implemented in less developed countries to reduce mortality has been questioned, in terms of the tendency to maintain a clinical perspective with a focus on purely medical care separate from community-based approaches that take cultural and social aspects of maternal and perinatal deaths into account. Our innovative approach utilizes both the clinical and community perspectives; moreover, our study will report the weight that each of these components may have had on reducing perinatal mortality and increasing institution-based deliveries. Methods/Design A matched pair cluster-randomized trial will be conducted in clinics in four rural indigenous districts with the highest maternal mortality ratios in Guatemala. The individual clinic will serve as the unit of randomization, with 15 matched pairs of control and intervention clinics composing the final sample. Three interventions will be implemented in indigenous, rural and poor populations: a simulation training program for emergency obstetric and perinatal care, increased participation of the professional midwife in strengthening the link between traditional birth attendants (TBA) and the formal health care system, and a social marketing campaign to promote institution-based deliveries. No external intervention is planned for control clinics, although enhanced monitoring, surveillance and data collection will occur throughout the study in all clinics throughout the four districts. All obstetric events occurring in any of the participating health facilities and districts during the 18 months implementation period will be included in the analysis, controlling for the cluster design. Our main outcome measures will be the change in perinatal mortality and in the proportion of institution-based deliveries. Discussion A unique feature of this protocol is that we are not proposing an individual intervention, but rather a package of interventions, which is designed to address the complexities and realities of maternal and perinatal mortality in developing countries. To date, many other countries, has focused its efforts to decrease maternal mortality indirectly by improving infrastructure and data collection systems rather than on implementing specific interventions to directly improve outcomes. Trial registration ClinicalTrial.gov,http://NCT01653626. PMID:23517050

Challenges in Patient Recruitment, Implementation, and Fidelity in a Mobile Telehealth Study.

PubMed

Baron, Justine; Hirani, Shashivadan; Newman, Stanton

2016-05-01

Mobile telehealth (MTH) evaluations in diabetes have been conducted, but few report details and issues related to recruitment, implementation (intervention delivery), fidelity, and context. These have important implications on the interpretation of the findings and effectiveness of the intervention. This article reports these data from an MTH study and describes the challenges experienced in running an intervention such as this in an active clinical environment. We conducted a mixed-methods MTH study that included a 9-month randomized controlled trial in people with poorly controlled diabetes. Detailed recruitment data were recorded during the study. Data on contacts between MTH participants and the MTH team were collected and used to report on intervention delivery and fidelity. Meeting and field notes, as well as communications between research team members during the study, were used to report on the contextual factors that affected recruitment, implementation, and fidelity. The recruited sample size represented 6% of the total clinic population (n = 1,360) and 10.7% of the number of potentially eligible people at the clinic (n = 802) identified at the beginning of the study. Contextual factors related to patients, healthcare providers, the institution, or the recruitment protocol contributed to influence access to study participants and the number of participants randomized (n = 81). Technical and device-related aspects of the MTH intervention were delivered successfully, but the expected education and clinical feedback by the MTH nurse were not delivered according to the protocol. Although 92.5% of introductory calls were made by the MTH nurses, only 13.3% of expected educational calls were performed. Changes to the MTH nursing staff affected intervention participants differently and contributed to the low fidelity of intervention delivery. The current article presents data on the influence of contextual factors on the conduct of this MTH study and underlines the need for these processes to be assessed and reported adequately in future MTH research.

Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

PubMed

Becker, Jan; Beutel, Manfred E; Gerzymisch, Katharina; Schulz, Dirk; Siepmann, Martin; Knickenberg, Rudolf J; Schmädeke, Stefan; Ferdinand, Peter; Zwerenz, Rüdiger

2016-06-13

Patients' treatment expectations are a key factor in psychotherapy. Several studies have linked higher expectations to better treatment success. Therefore, we want to evaluate the impact of a targeted video-based intervention on patients' expectations and the treatment success of inpatient rehabilitation. All patients who will be referred to inpatient psychosomatic rehabilitation in three clinics will receive a study flyer with information about how to log in to the study platform together with the usual clinic information leaflet. Patients will receive the study information and informed consent upon login and will be randomized into the intervention or the control group. The intervention group (n = 394) will get access to our virtual online clinic, containing several videos about inpatient rehabilitation, until their admission to inpatient rehabilitation. The control group (n = 394) will receive no special treatment preparation. Questionnaires will be given at study inclusion (T0), two weeks before admission to (T1), and at the end of (T2) inpatient rehabilitation. The primary outcome is the outcome expectancy measured with the Credibility Expectancy Questionnaire at T1. Secondary outcomes include treatment motivation, mental health, work ability, depression, anxiety, and satisfaction with and usage of the Internet platform. We expect the intervention group to benefit from the additional preparation concerning their outcome expectancy. If successful, this approach could be used in the future to enhance the efficacy of inpatient rehabilitation. ClinicalTrials.gov: NCT02532881 . Registered on 25 August 2015.

Web-based, self-management enhancing interventions with e-diaries and personalized feedback for persons with chronic illness: a tale of three studies.

PubMed

Nes, Andréa A G; Eide, Hilde; Kristjánsdóttir, Ólöf Birna; van Dulmen, Sandra

2013-12-01

Chronic illness places high demands on patients. Interventions supporting self-management and providing personalized feedback might help patients to gain new perspectives and enhance use of constructive self-management strategies. We developed three comparable web-based CBT-grounded interventions including e-diaries and feedback delivered through PDAs/smartphones. The feasibility and efficacy of these interventions have been investigated for patients with irritable bowel syndrome (in an RCT), chronic widespread pain (RCT) and type 2 diabetes (feasibility study). This is a descriptive study that summarizes the content, feasibility and efficacy of the interventions and discusses issues relevant for implementing this type of web-based therapeutic interventions in clinical practice. The web-based interventions appear feasible, acceptable and supportive. In a short and midterm time frame, the interventions promote self-management. Booster sessions may be needed for prolonged effects. Given the physical and mental symptoms of the patients under study and the nature of the intervention, providers who deliver the feedback need a health care background and training in this specific way of counseling. The results of the three studies suggest that personalized web-based interventions are effective and have the potential to support self-management in daily healthcare. Studies concerning clinical significance and implementation are needed. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Long-term Clinical and Cost Outcomes of a Pharmacist-managed Risk Factor Management Clinic in Singapore: An Observational Study.

PubMed

Tan, She Hui; Kng, Kwee Keng; Lim, Sze Mian; Chan, Alexandre; Loh, Jason Kwok Kong; Lee, Joyce Yu-Chia

2017-12-01

Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clinic (RFMP) in an acute care setting through the comparison of clinical (improvement in glycosylated hemoglobin level) and cost outcomes with patients receiving usual care. This single-center, observational study included patients aged ≥21 years old and diagnosed with type 2 diabetes mellitus (DM) who received care within the cardiology department of a tertiary institution between January 1, 2014, and December 31, 2015. The intervention group comprised patients who attended the RFMP for 3 to 6 months, and the usual-care group comprised patients who received standard cardiologist care. Univariate analysis and multiple linear regression were conducted to analyze the clinical and cost outcomes. A total of 142 patients with DM (71 patients in the intervention group and 71 patients in the usual-care group) with similar baseline characteristics were included. After adjusting for differences in baseline systolic blood pressure and triglyceride levels, the mean reduction in glycosylated hemoglobin level at 6 months from baseline in the intervention group was significantly lower by 0.78% compared with the usual-care group. Patients in the usual-care group had a significantly higher risk of hospital admissions within the 12 months from baseline compared with the intervention group (odds ratio, 3.84 [95% CI, 1.17-12.57]; P = 0.026). Significantly lower mean annual direct medical costs were also observed in the intervention group (US $8667.03 [$17,416.20] vs US $56,665.02 [$127,250.10]; P = 0.001). The pharmacist-managed RFMP exhibited improved clinical outcomes and reduced health care costs compared with usual care within a tertiary institute. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Greater involvement of HIV-infected peer-mothers in provision of reproductive health services as "family planning champions" increases referrals and uptake of family planning among HIV-infected mothers.

PubMed

Mudiope, Peter; Musingye, Ezra; Makumbi, Carolyne Onyango; Bagenda, Danstan; Homsy, Jaco; Nakitende, Mai; Mubiru, Mike; Mosha, Linda Barlow; Kagawa, Mike; Namukwaya, Zikulah; Fowler, Mary Glenn

2017-06-27

In 2012, Makerere University Johns - Hopkins University, and Mulago National Referral Hospital, with support from the National Institute of Health (under Grant number: NOT AI-01-023) undertook operational research at Mulago National Hospital PMTCT/PNC clinics. The study employed Peer Family Planning Champions to offer health education, counselling, and triage aimed at increasing the identification, referral and family planning (FP) uptake among HIV positive mothers attending the clinic. The Peer Champion Intervention to improve FP uptake was introduced into Mulago Hospital PMTCT/PNC clinic, Kampala Uganda. During the intervention period, peers provided additional FP counselling and education; assisted in identification and referral of HIV Positive mothers in need of FP services; and accompanied referred mothers to FP clinics. We compiled and compared the average proportions of mothers in need that were referred and took up FP in the pre-intervention (3 months), intervention (6 months), and post-intervention(3 months) periods using interrupted time series with segmented regression models with an autoregressive term of one. Overall, during the intervention, the proportion of referred mothers in need of FP increased by 30.4 percentage points (P < 0.001), from 52.7 to 83.2 percentage points. FP uptake among mothers in need increased by over 31 percentage points (P < 0.001) from 47.2 to 78.5 percentage points during the intervention. There was a positive non-significant change in the weekly trend of referral β 3  = 2.9 percentage points (P = 0.077) and uptake β 3  = 1.9 percentage points (P = 0.176) during the intervention as compared to the pre-intervention but this was reversed during the post intervention. Over 57% (2494) mothers took up Depo-Provera injectable-FP method during the study. To support overstrained health care work force in post-natal clinics, peers in trained effective family planning can be a valuable addition to clinic staff in limited-resource settings. The study provides additional evidence on the utilization of peer mothers in HIV care, improves health services uptake including family planning which is a common practice in many donor supported programs. It also provides evidence that may be used to advocate for policy revisions in low-income countries to include peers as support staff especially in busy clinic settings with poor services uptake.

Cost-effectiveness of food, supplement and environmental interventions to address malnutrition in residential aged care: a systematic review.

PubMed

Hugo, Cherie; Isenring, Elisabeth; Miller, Michelle; Marshall, Skye

2018-05-01

observational studies have shown that nutritional strategies to manage malnutrition may be cost-effective in aged care; but more robust economic data is needed to support and encourage translation to practice. Therefore, the aim of this systematic review is to compare the cost-effectiveness of implementing nutrition interventions targeting malnutrition in aged care homes versus usual care. residential aged care homes. systematic literature review of studies published between January 2000 and August 2017 across 10 electronic databases. Cochrane Risk of Bias tool and GRADE were used to evaluate the quality of the studies. eight included studies (3,098 studies initially screened) reported on 11 intervention groups, evaluating the effect of modifications to dining environment (n = 1), supplements (n = 5) and food-based interventions (n = 5). Interventions had a low cost of implementation (<£2.30/resident/day) and provided clinical improvement for a range of outcomes including weight, nutritional status and dietary intake. Supplements and food-based interventions further demonstrated a low cost per quality adjusted life year or unit of physical function improvement. GRADE assessment revealed the quality of the body of evidence that introducing malnutrition interventions, whether they be environmental, supplements or food-based, are cost-effective in aged care homes was low. this review suggests supplements and food-based nutrition interventions in the aged care setting are clinically effective, have a low cost of implementation and may be cost-effective at improving clinical outcomes associated with malnutrition. More studies using well-defined frameworks for economic analysis, stronger study designs with improved quality, along with validated malnutrition measures are needed to confirm and increase confidence with these findings.

The Impact of a Microfinance Program on Client Perceptions of the Quality of Care Provided by Private Sector Midwives in Uganda

PubMed Central

Agha, Sohail; Balal, Asma; Ogojo-Okello, Francis

2004-01-01

Objective To assess the impact of a microfinance program that provided business skills training and revolving loans to private sector midwives on perceived quality of services and client loyalty. Study Design A quasi-experimental study with a pretest, posttest design was used to evaluate the impact of the intervention. Exit interviews were conducted at 15 clinics that received the intervention and 7 clinics that did not. Baseline exit interviews were conducted between November and December 2000. Five days of business skills training were provided to midwives, and loans (averaging $454) were given during January and February 2001. A follow-up clinic visit was made to assess whether midwives were implementing what was emphasized during the training. The loans were to be repaid with interest within 6 to 12 months, at an interest rate that is standard within the local commercial market. For those who repaid the first set of loans (11 clinics), a second set of loans (averaging $742) was provided after June 2001. Follow-up exit interviews were conducted at the same clinics between February and March 2002. We assessed the effect of the intervention at both clinic and client levels. T-tests, the analysis of variance, and multivariate logistic regression analysis were conducted. Principal Findings These findings should be interpreted cautiously since secular trends were observed during the study period. The intervention was associated with improvement in clients' perceptions of the quality of care received at intervention clinics. The intervention was also associated with a higher level of client loyalty. Conclusions The enthusiastic response of midwives and the high loan repayment rate indicate that midwives were very receptive to the microfinance program. Overall, these findings suggest that microfinance may have an important role in strengthening private sector health services by increasing private providers' business skills and clients' satisfaction with services. PMID:15544645

A mindfulness-based intervention for self-management of verbal and physical aggression by adolescents with Prader-Willi syndrome.

PubMed

Singh, Nirbhay N; Lancioni, Giulio E; Myers, Rachel E; Karazsia, Bryan T; Courtney, Theresa M; Nugent, Kristen

2017-07-01

There is a dearth of clinical and research literature on the treatment of maladaptive behaviors in adolescents with Prader-Willi syndrome (PWS). The purpose of this study was to evaluate the effectiveness of a mindfulness-based intervention, Meditation on the Soles of the Feet (SoF), to facilitate self-management of verbal and physical aggression. We utilized a multiple-baseline design across participants to test the intervention with three adolescents diagnosed with PWS. Relative to baseline, verbal aggression decreased to minimal levels following mindfulness-based practice and physical aggression was nearly eliminated. Intervention effects were maintained at 12-month follow-up. Quantitative analytics confirmed statistically significant outcomes. The SoF mindfulness intervention was effective in reducing verbal and physical aggression in three adolescents with PWS. Future research should test the SoF intervention with this clinical population in a larger clinical trial, and the SoF intervention may be applicable to other pediatric populations.

Clinical and economic impact of clinical pharmacy service on hyperlipidemic management in Hong Kong.

PubMed

Chung, Jennifer S T; Lee, Kenneth K C; Tomlinson, Brian; Lee, Vivian W Y

2011-03-01

To assess the clinical and economic outcomes of a clinical pharmacy service (CPS) in dyslipidemic management. This was a 24-month prospective controlled trial conducted at the lipid clinic of a public hospital in Hong Kong. In the intervention group, a clinical pharmacist assessed low-density lipoprotein cholesterol (LDL-C) levels and provided recommendations in accordance to the Adult Treatment Panel III (ATP III) guidelines. Medication compliance and the proper use of drugs were assessed. Education on healthy lifestyles was reinforced. Monthly telephone follow-ups were made to check on the progress of patients. In the control group, patients received usual medical care with no pharmacist intervention. Primary outcome was the percentage of patients achieving the ATP III LDL-C goal at the end of study. The estimated cost of such service was also evaluated. A total of 300 patients were recruited into the study (150 in intervention group and 150 in control group). In the intervention group, 58.7% patients achieved LDL-C goals compared with 45.3% in the control group (P < .05). The intervention group achieved 26.4%, 17.4%, and 30.0% mean reduction in LDL-C, total cholesterol (TC), and triglycerides (TG) levels, respectively, compared with 12.6%, 6.6%, and 11.5% in the control group (P < .05). The estimated cost for this clinical service was US$385/month for a total of 600 dyslipidemic patients seen per year. The results of this study demonstrate the positive impact CPS can have on achieving treatment goals in lipid management. Similar services for other problematic conditions such as hypertension and diabetes mellitus may also be benefited by similar CPSs.

Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients With Cancer

PubMed Central

Hamel, Lauren M.; Penner, Louis A.; Albrecht, Terrance L.; Heath, Elisabeth; Gwede, Clement K.; Eggly, Susan

2016-01-01

Background Clinical trials that study cancer are essential for testing the safety and effectiveness of promising treatments, but most people with cancer never enroll in a clinical trial — a challenge exemplified in racial and ethnic minorities. Underenrollment of racial and ethnic minorities reduces the generalizability of research findings and represents a disparity in access to high-quality health care. Methods Using a multilevel model as a framework, potential barriers to trial enrollment of racial and ethnic minorities were identified at system, individual, and interpersonal levels. Exactly how each level directly or indirectly contributes to doctor–patient communication was also reviewed. Selected examples of implemented interventions are included to help address these barriers. We then propose our own evidence-based intervention addressing barriers at the individual and interpersonal levels. Results Barriers to enrolling a diverse population of patients in clinical trials are complex and multilevel. Interventions focused at each level have been relatively successful, but multilevel interventions have the greatest potential for success. Conclusion To increase the enrollment of racial and ethnic minorities in clinical trials, future interventions should address barriers at multiple levels. PMID:27842322

Recommendations for Obesity Clinical Trials in Cancer Survivors: American Society of Clinical Oncology Statement.

PubMed

Ligibel, Jennifer A; Alfano, Catherine M; Hershman, Dawn; Ballard, Rachel M; Bruinooge, Suanna S; Courneya, Kerry S; Daniels, Elvan C; Demark-Wahnefried, Wendy; Frank, Elizabeth S; Goodwin, Pamela J; Irwin, Melinda L; Levit, Laura A; McCaskill-Stevens, Worta; Minasian, Lori M; O'Rourke, Mark A; Pierce, John P; Stein, Kevin D; Thomson, Cynthia A; Hudis, Clifford A

2015-11-20

Observational evidence has established a relationship between obesity and cancer risk and outcomes. Interventional studies have demonstrated the feasibility and benefits of lifestyle change after cancer diagnosis, and guidelines recommend weight management and regular physical activity in cancer survivors; however, lifestyle interventions are not a routine part of cancer care. The ASCO Research Summit on Advancing Obesity Clinical Trials in Cancer Survivors sought to identify the knowledge gaps that clinical trials addressing energy balance factors in cancer survivors have not answered and to develop a roadmap for the design and implementation of studies with the potential to generate data that could lead to the evidence-based incorporation of weight management and physical activity programs into standard oncology practice. Recommendations highlight the need for large-scale trials evaluating the impact of energy balance interventions on cancer outcomes, as well as the concurrent conduct of studies focused on dissemination and implementation of interventions in diverse populations of cancer survivors, including answering critical questions about the degree of benefit in key subgroups of survivors. Other considerations include the importance of incorporating economic metrics into energy balance intervention trials, the need to establish intermediate biomarkers, and the importance of integrating traditional and nontraditional funding sources. Establishing lifestyle change after cancer diagnosis as a routine part of cancer care will require a multipronged effort to overcome barriers related to study development, funding, and stakeholder engagement. Given the prevalence of obesity and inactivity in cancer survivors in the United States and elsewhere, energy balance interventions hold the potential to reduce cancer morbidity and mortality in millions of patients, and it is essential that we move forward in determining their role in cancer care with the same care and precision used to test pharmacologic and other interventions.

Comparing the acceptability of a positive psychology intervention versus a cognitive behavioural therapy for clinical depression.

PubMed

Lopez-Gomez, Irene; Chaves, Covadonga; Hervas, Gonzalo; Vazquez, Carmelo

2017-09-01

There is growing evidence on the efficacy of positive psychology interventions (PPI) to treat clinical disorders. However, very few studies have addressed their acceptability. The present study aimed to analyse 2 key components of acceptability (i.e., client satisfaction and adherence to treatment) of a new PPI programme, the Integrative Positive Psychological Intervention for Depression (IPPI-D), in comparison to a standard cognitive behavioural therapy (CBT) programme in the treatment of clinical depression. One hundred twenty-eight women with a DSM-IV diagnosis of major depression or dysthymia were allocated to a 10-session IPPI-D or CBT group intervention condition. Results showed that both interventions were highly acceptable for participants. Attendance rates were high, and there were no significant differences between conditions. However, the IPPI-D condition showed significantly higher client satisfaction than the CBT condition. Moreover, acceptability did not differ based on participants' severity of symptoms, regardless of condition. These findings encourage further investigations of the applicability of PPI in clinical settings in order to broaden the range of acceptable and suitable therapies for depressed patients. Key Practitioner Message This study sheds light on the client satisfaction and adherence to a positive intervention. For participants, positive psychology interventions (PPI) may be more satisfactory than CBT as PPI are framed within a positive mental health model and, consequently, may reduce the risk of stigmatization Because acceptability of treatments and preferences may affect the efficacy of treatments, this study provides an excellent opportunity to offer professionals more therapeutic options to tailor treatments to clients' needs and expectations. Copyright © 2017 John Wiley & Sons, Ltd.

Evaluating the impact of mobile telephone technology on type 2 diabetic patients' self-management: the NICHE pilot study.

PubMed

Faridi, Zubaida; Liberti, Lauren; Shuval, Kerem; Northrup, Veronika; Ali, Ather; Katz, David L

2008-06-01

Utilizing information technology, such as Internet and cellphones, holds great promise in enhancing diabetic care. Yet few studies have examined the impact of cellphone technology on type 2 diabetics' self-care. The primary aim of the study is to examine the feasibility of utilizing this technology to assist with diabetes self-care in a clinic population as well as its impact on clinical outcomes. Thirty patients with a diagnosis of type 2 diabetes at two Community Health Centers were randomized to intervention or control. Intervention patients participated in a brief intervention and received tailored daily messages via cellphone prompting them to enhance their diabetic self-care behaviour. Patients at the control site continued with their standard diabetes self-management. A mean improvement in HbA1c levels was apparent (-0.1, SD = 0.3%; P = 0.1534) in the intervention group, compared with a mean deterioration in the control (0.3, SD = 1.0%; P = 0.3813), yet without statistical significance. Self-efficacy scores improved significantly in the intervention group (-0.5, SD = 0.6; P = 0.0080) compared with no improvement in the control (0.0, SD = 1.0; P = 0.9060). Participants encountered numerous technological barriers when attempting to adhere to the intervention protocol. The results indicate the intervention had a positive impact on some clinical outcome and self-efficacy. Although the technology appears feasible in a clinical setting technology must be made more user-friendly before a larger phase II trial is conducted.

Knowledge translation and implementation in spinal cord injury: a systematic review.

PubMed

Noonan, V K; Wolfe, D L; Thorogood, N P; Park, S E; Hsieh, J T; Eng, J J

2014-08-01

To conduct a systematic review examining the effectiveness of knowledge translation (KT) interventions in changing clinical practice and patient outcomes. MEDLINE/PubMed, CINAHL, EMBASE and PsycINFO were searched for studies published from January 1980 to July 2012 that reported and evaluated an implemented KT intervention in spinal cord injury (SCI) care. We reviewed and summarized results from studies that documented the implemented KT intervention, its impact on changing clinician behavior and patient outcomes as well as the facilitators and barriers encountered during the implementation. A total of 13 articles featuring 10 studies were selected and abstracted from 4650 identified articles. KT interventions included developing and implementing patient care protocols, providing clinician education and incorporating outcome measures into clinical practice. The methods (or drivers) to facilitate the implementation included organizing training sessions for clinical staff, introducing computerized reminders and involving organizational leaders. The methodological quality of studies was mostly poor. Only 3 out of 10 studies evaluated the success of the implementation using statistical analyses, and all 3 reported significant behavior change. Out of the 10 studies, 6 evaluated the effect of the implementation on patient outcomes using statistical analyses, with 4 reporting significant improvements. The commonly cited facilitators and barriers were communication and resources, respectively. The field of KT in SCI is in its infancy with only a few relevant publications. However, there is some evidence that KT interventions may change clinician behavior and improve patient outcomes. Future studies should ensure rigorous study methods are used to evaluate KT interventions.

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

PubMed

Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

2013-05-22

The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. ClinicalTrials.gov: NCT01815710.

Barriers to participation in clinical trials: a physician survey.

PubMed

Mahmud, A; Zalay, O; Springer, A; Arts, K; Eisenhauer, E

2018-04-01

Clinical trials are vital for evidence-based cancer care. Oncologist engagement in clinical trials has an effect on patient recruitment, which in turn can affect trial success. Identifying barriers to clinical trial participation might enable interventions that could help to increase physician participation. To assess factors affecting physician engagement in oncology trials, a national survey was conducted using the online SurveyMonkey tool (SurveyMonkey, San Mateo, CA, U.S.A.; http://www.surveymonkey.com). Physicians associated with the Canadian Cancer Clinical Trials Network and the Canadian Cancer Trials Group were asked about their specialty, years of experience, barriers to participation, and motivating interventions, which included an open-ended question inviting survey takers to suggest interventions. The survey collected 207 anonymous responses. Respondents were predominantly medical oncologists (46.4%), followed by radiation oncologists (24.6%). Almost 70% of the respondents had more than 10 years of experience. Significant time constraints included extra paperwork (77%), patient education (54%), and extended follow-up or clinic visits (53%). Timing of events within trials was also a barrier to participation (55%). Most respondents favoured clinical work credits (72%), academic credits (67%), a clinical trial alert system (75%), a regular meeting to review trial protocols (65%), and a screening log to aid in patient accrual (67%) as motivational strategies. Suggested interventions included increased support staff, streamlined regulatory burden, and provision of greater funding for trials and easier access to ancillary services. The present study confirms that Canadian oncologists are willing to participate in clinical research, but face multiple barriers to trial participation. Those barriers could be mitigated by the implementation of several interventions identified in the study.

CLINICAL outcomes and loss to follow-up among people living with HIV participating in the NAMWEZA intervention in Dar es Salaam, Tanzania: a prospective cohort study.

PubMed

Siril, Hellen N; Kaaya, Sylvia F; Smith Fawzi, Mary Kay; Mtisi, Expeditho; Somba, Magreat; Kilewo, Japheth; Mugusi, Ferdinand; Minja, Anna; Kaale, Anna; Todd, Jim

2017-03-28

Psychosocial factors have been linked with loss to follow-up (LTFU) and clinical outcomes among people living with HIV (PLH), however little is known about the effect of psychosocial support on LTFU among PLH in treatment and care. The purpose of this study was to explore the effect of NAMWEZA ("Yes, together we can") friends' psychosocial support intervention on clinical outcomes and LTFU among PLH. NAMWEZA is based on a novel program using "appreciative inquiry", positive psychology approaches to empower, promote positive attitudes and foster hope. PLH participating in the NAMWEZA intervention in HIV care clinics in Dar es Salaam Tanzania were compared with non-exposed PLH obtained from facilities that routinely collect clinical information and both followed longitudinally for 24 months. Baseline sociodemographic, clinical measures (CD4 cell count, hemoglobin (HGB), weight), and LTFU measures were collected. Chi square, Fisher's exact tests, and t-tests were used to compare the frequencies for categorical variables and the means of continuous variables from the intervention and the comparison groups to identify variables that were significantly different across the two groups. Random effects models were performed to examine the bivariate associations between the intervention status and clinical outcomes. At the end of 24 months of follow-up mean CD4 count and HGB levels increased significantly in both intervention and comparison groups (p = 0.009 and p < 0.0001, respectively). Weight increased significantly only in the intervention group (p = 0.003). Cumulative LTFU was three times higher in the comparison compared to the intervention (p < 0.001) group. Having a low CD4 count, extremes of weight, low HGB, younger age, and male gender were significantly associated with LTFU among the unexposed group, while being on ART for duration of 12 months or more was protective against LTFU in those intervened. Among PLH on ART, exposed or not exposed to NAMWEZA intervention, clinical care outcomes improved over time. LTFU was much higher in the comparison group with factors commonly known to predict LTFU only apparent in the comparison group. NAMWEZA could be a promising peer-facilitated model to reduce LTFU among PLH in care that can be integrated in ART services; however, more research is needed to evaluate its longer term effects.

Patient-mediated knowledge translation (PKT) interventions for clinical encounters: a systematic review.

PubMed

Gagliardi, Anna R; Légaré, France; Brouwers, Melissa C; Webster, Fiona; Badley, Elizabeth; Straus, Sharon

2016-02-29

Patient-mediated knowledge translation (PKT) interventions engage patients in their own health care. Insight on which PKT interventions are effective is lacking. We sought to describe the type and impact of PKT interventions. We performed a systematic review of PKT interventions, defined as strategies that inform, educate and engage patients in their own health care. We searched MEDLINE, EMBASE and the Cochrane Library from 2005 to 2014 for English language studies that evaluated PKT interventions delivered immediately before, during or upon conclusion of clinical encounters to individual patients with arthritis or cancer. Data were extracted on study characteristics, PKT intervention (theory, content, delivery, duration, personnel, timing) and outcomes. Interventions were characterized by type of patient engagement (inform, activate, collaborate). We performed content analysis and reported summary statistics. Of 694 retrieved studies, 16 were deemed eligible (5 arthritis, 11 cancer; 12 RCTs, 4 cohort studies; 7 low, 3 uncertain, 6 high risk of bias). PKT interventions included print material in 10 studies (brochures, booklets, variety of print material, list of websites), electronic material in 10 studies (video, computer program, website) and counselling in 2 studies. They were offered before, during and after consultation in 4, 1 and 4 studies, respectively; as single or multifaceted interventions in 10 and 6 studies, respectively; and by clinicians, health educators, researchers or volunteers in 4, 3, 5 and 1 study, respectively. Most interventions informed or activated patients. All studies achieved positive impact in one or more measures of patient knowledge, decision-making, communication and behaviour. This was true regardless of condition, PKT intervention, timing, personnel, type of engagement or delivery (single or multifaceted). No studies assessed patient harms, or interventions for providers to support PKT intervention delivery. Two studies evaluated the impact on providers of PKT interventions aimed at patients. Single interventions involving print material achieved beneficial outcomes as did more complex interventions. Few studies were eligible, and no studies evaluated patient harms, or provider outcomes. Further research is warranted to evaluate these PKT interventions in more patients, or patients with different conditions; different types of PKT interventions for patients and for providers; and potential harms associated with interventions.

A Tale of Smoking Cessation Promotion: The Utilization of a Children's Book to Increase Screening and Counseling in the Pediatric Clinic.

PubMed

Thomas, Katharine E H; Kisely, Steve; Urrego, Fernando

2017-10-01

The rate at which pediatricians promote smoking cessation in clinical settings is low. The literature demonstrates that interventions paired with tangible health promotion materials may significantly increase screening rates to the pediatric office. The aim of this study was to investigate whether the addition of a children's book in the pediatric clinic could result in an increase in the rate in which pediatricians screened for secondhand smoke exposure (SHSe) and counseled caregivers to stop smoking. This randomized controlled study was performed at 7 pediatric clinics. Seven pediatric clinic sites were randomly assigned to either an intervention or control group. Pediatricians in the intervention group were given children's books about SHSe to distribute to their patients while the control group did not receive any materials. At baseline, there was no difference between the control group and intervention group in rates at which pediatricians screened for SHSe ( P = .8728) and counseled caregivers to stop smoking ( P = .29). After the intervention, screening for SHSe and counseling caregivers to stop smoking were statistically significantly greater in the intervention group, when compared to controls ( P < .01 and P < .001, respectively). The use of a health promotion children's book in the pediatric setting can increase the rate at which pediatricians screen for SHSe and counsel caregivers to stop smoking. Future research should examine the effect of the storybook on various parameters of smoking cessation and future smoking behaviors.

[Clinical interventions in overweight and obesity: a systematic literature review 2009-2014].

PubMed

Rajmil, Luis; Bel, Joan; Clofent, Rosa; Cabezas, Carmen; Castell, Conxa; Espallargues, Mireia

2017-04-01

To update the literature review on the effectiveness of clinical interventions on childhood obesity, proposed in Clinical Practice Guidelines, excluding prevention and pharmacological and surgical treatments. A systematic review was carried out in electronic databases of the Cochrane Database of Systematic Reviews (The Cochrane Library), MEDLINE, and SCOPUS, replicating the search for the Clinical Practice Guidelines, from 2009 to 2014. The Clinical Practice Guidelines of National Institute for Health and Care Excellence were taken as a reference. Systematic reviews were given priority, and the quality of the studies was assessed. Out of a total of 3,703 documents initially identified, 48 were finally included. Studies showed great heterogeneity in the type and duration of interventions, and in outcome measures. Adherence to treatment was, in general, low. Multi-component interventions including diet, physical activity, sedentary lifestyle, and behaviour changes, involving the family, and starting at early ages, were the most effective for reducing body mass index. There is no consensus on criteria for referral to specialised care. It is recommended to implement multi-component programs conducted by professionals with previous training, involving the family, and addressing behavioural, individual and socio-demographic aspects. Lack of adherence is one of the reasons for failure of interventions. Diagnostic and referral criteria, the outcome measures, and the type and duration of interventions need to be improved and standardised. Copyright © 2016 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

Time course of clinical change following neurofeedback.

PubMed

Rance, Mariela; Walsh, Christopher; Sukhodolsky, Denis G; Pittman, Brian; Qiu, Maolin; Kichuk, Stephen A; Wasylink, Suzanne; Koller, William N; Bloch, Michael; Gruner, Patricia; Scheinost, Dustin; Pittenger, Christopher; Hampson, Michelle

2018-05-02

Neurofeedback - learning to modulate brain function through real-time monitoring of current brain state - is both a powerful method to perturb and probe brain function and an exciting potential clinical tool. For neurofeedback effects to be useful clinically, they must persist. Here we examine the time course of symptom change following neurofeedback in two clinical populations, combining data from two ongoing neurofeedback studies. This analysis reveals a shared pattern of symptom change, in which symptoms continue to improve for weeks after neurofeedback. This time course has several implications for future neurofeedback studies. Most neurofeedback studies are not designed to test an intervention with this temporal pattern of response. We recommend that new studies incorporate regular follow-up of subjects for weeks or months after the intervention to ensure that the time point of greatest effect is sampled. Furthermore, this time course of continuing clinical change has implications for crossover designs, which may attribute long-term, ongoing effects of real neurofeedback to the control intervention that follows. Finally, interleaving neurofeedback sessions with assessments and examining when clinical improvement peaks may not be an appropriate approach to determine the optimal number of sessions for an application. Copyright © 2018 Elsevier Inc. All rights reserved.

Effects of Clinical Pathways for Common Outpatient Infections on Antibiotic Prescribing

PubMed Central

Jenkins, Timothy C.; Irwin, Amy; Coombs, Letoynia; DeAlleaume, Lauren; Ross, Stephen E.; Rozwadowski, Jeanne; Webster, Brian; Dickinson, L. Miriam; Sabel, Allison L.; MacKenzie, Thomas D.; West, David R.; Price, Connie S.

2013-01-01

Background Antibiotic overuse in the primary care setting is common. Our objective was to evaluate the effect of a clinical pathway-based intervention on antibiotic use. Methods Eight primary care clinics were randomized to receive clinical pathways for upper respiratory infection, acute bronchitis, acute rhinosinusitis, pharyngitis, acute otitis media, urinary tract infection, skin infections, and pneumonia and patient education materials (study group) versus no intervention (control group). Generalized linear mixed effects models were used to assess trends in antibiotic prescriptions for non-pneumonia acute respiratory infections and broad-spectrum antibiotic use for all eight conditions during a 2-year baseline and 1-year intervention period. Results In the study group, antibiotic prescriptions for non-pneumonia acute respiratory infections decreased from 42.7% of cases at baseline to 37.9% during the intervention period (11.2% relative reduction) (p <.0001) and from 39.8% to 38.7%, respectively, in the control group (2.8% relative reduction) (p=0.25). Overall use of broad-spectrum antibiotics in the study group decreased from 26.4% to 22.6% of cases, respectively, (14.4% relative reduction) (p <.0001) and from 20.0% to 19.4%, respectively, in the control group (3.0% relative reduction) (p=0.35). There were significant differences in the trends of prescriptions for acute respiratory infections (p<.0001) and broad-spectrum antibiotic use (p=0.001) between the study and control groups during the intervention period, with greater declines in the study group. Conclusions This intervention was associated with declining antibiotic prescriptions for non-pneumonia acute respiratory infections and use of broad-spectrum antibiotics over the first year. Evaluation of the impact over a longer study period is warranted. PMID:23507206

Characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov.

PubMed

Stockmann, Chris; Sherwin, Catherine M T; Koren, Gideon; Campbell, Sarah C; Constance, Jonathan E; Linakis, Matthew; Balch, Alfred; Varner, Michael W; Spigarelli, Michael G

2014-04-01

Physiologic changes during pregnancy alter the pharmacokinetics, safety, and efficacy of many drugs. For clinicians, there is often uncertainty regarding the safety of these drugs due to a scarcity of published data. This study aimed to comprehensively evaluate the characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov from 2007 to 2012. Primary outcome measures, funding sources, inclusion criteria, and the reporting of study results were evaluated. A manual review of Medline/PubMed was performed to identify publications associated with studies registered in ClinicalTrials.gov. Of 93,709 total studies, there were 5,203 (6%) obstetric studies registered in ClinicalTrials.gov. Interventional studies accounted for 70% and 30% were observational. Clinical trials of drugs (49%), procedures (13%), and behavioral interventions (12%) were most common. Among interventional drug trials, 84% featured randomized allocation to study arms and 93% included measures of safety and/or efficacy as primary endpoints. Of 946 (18%) studies completed more than 2 years ago, only 11% had reported results and <7% had been published. In an area with a great need for evidence of safe and effective therapies, the low publication rate of completed studies incorporating elements of high-quality trial design is concerning. The sources of this trend should be closely investigated. © 2013, The American College of Clinical Pharmacology.

Family Crisis Intervention in War Contexts: A Case Study of a Traumatised Palestinian Family

ERIC Educational Resources Information Center

Veronese, Guido; Said, Mahmud S.; Castiglioni, Marco

2014-01-01

The aim of this study was to analyse the phases of an innovative in vivo exposure intervention in which all family members were present at the scene of a traumatic incident. Clinical practice has borne out the efficacy of family intervention and its benefits for traumatised individuals and family groups. The intervention discussed here was…

Group Patient Education: Effectiveness of a Brief Intervention in People with Type 2 Diabetes Mellitus in Primary Health Care in Greece: A Clinically Controlled Trial

ERIC Educational Resources Information Center

Merakou, K.; Knithaki, A.; Karageorgos, G.; Theodoridis, D.; Barbouni, A.

2015-01-01

This study aims to assess the impact of a brief patient group education intervention in people with type 2 diabetes mellitus. The sample, 193 people with type 2 diabetes mellitus who were patients at the diabetic clinic of a primary health care setting in Attica, was assigned to two groups, intervention (138 individuals) and control group (55…

Doubling Pharmacist Coverage in the Intensive Care Unit: Impact on the Pharmacists' Clinical Activities and Team Members' Satisfaction.

PubMed

McDaniel, Joshua; Bass, Lynn; Pate, Toni; DeValve, Michael; Miller, Susan

2017-09-01

Background: National professional organizations have recognized pharmacists as essential members of the intensive care unit (ICU) team. Critical care pharmacists' clinical activities have been categorized as fundamental, desirable, and optimal, providing a structure for gauging ICU pharmacy services being provided. Objective: To determine the impact the addition of a second ICU pharmacist covering 30 adult ICU beds at a large regional medical center has on the complexity of pharmacists' interventions, the types of clinical activities performed by the pharmacists, and the ICU team members' satisfaction. Methods: A prospective mixed-method descriptive study was conducted. Pharmacists recorded their interventions and clinical activities performed. A focus group composed of randomly selected ICU team members was held to qualitatively describe the impact of the additional pharmacist coverage on patient care, team dynamics, and pharmacy services provided. Results: The baseline period consisted of 33 days, and the intervention period consisted of 20 days. The average complexity of interventions was 1.72 during the baseline period (mode = 2) versus 1.69 (mode = 2) during the intervention period. The number of desirable and optimal clinical activities performed daily increased during the intervention from 8.4 (n = 279) to 16.4 (n = 328) and 2.3 (n = 75) to 8.6 (n = 171) compared with the baseline, respectively. Focus group members qualitatively described additional pharmacist coverage as beneficial. Conclusion: The additional critical care pharmacist did not increase pharmacy intervention complexity; however, more interventions were performed per day. Additional pharmacist coverage increased the daily number of desirable and optimal clinical activities performed and positively impacted ICU team members' satisfaction.

Structured representation for core elements of common clinical decision support interventions to facilitate knowledge sharing.

PubMed

Zhou, Li; Hongsermeier, Tonya; Boxwala, Aziz; Lewis, Janet; Kawamoto, Kensaku; Maviglia, Saverio; Gentile, Douglas; Teich, Jonathan M; Rocha, Roberto; Bell, Douglas; Middleton, Blackford

2013-01-01

At present, there are no widely accepted, standard approaches for representing computer-based clinical decision support (CDS) intervention types and their structural components. This study aimed to identify key requirements for the representation of five widely utilized CDS intervention types: alerts and reminders, order sets, infobuttons, documentation templates/forms, and relevant data presentation. An XML schema was proposed for representing these interventions and their core structural elements (e.g., general metadata, applicable clinical scenarios, CDS inputs, CDS outputs, and CDS logic) in a shareable manner. The schema was validated by building CDS artifacts for 22 different interventions, targeted toward guidelines and clinical conditions called for in the 2011 Meaningful Use criteria. Custom style sheets were developed to render the XML files in human-readable form. The CDS knowledge artifacts were shared via a public web portal. Our experience also identifies gaps in existing standards and informs future development of standards for CDS knowledge representation and sharing.

Interventions for improving research productivity in clinical radiology.

PubMed

Akhtar, Waseem; Arain, Mubashir Aslam; Ali, Arif; Sajjad, Zafar

2012-07-01

The purpose of this study was to evaluate the effects of research promotion activities on overall quality and quantity of research output in a clinical department of a teaching tertiary care hospital. Simple research enhancing strategies including regular journal club, research hour, basic research skills training, hiring of research faculty, research awards, and annual research retreat and research board to increase research production were implemented in the Department of Radiology of a teaching hospital in Pakistan. A total of 77 papers were produced by the Department of Radiology before the intervention, which increased to 92 after the introduction of research initiatives. There was a significant increase in the overall proportion of publications in the international journals after the intervention (p < 0.001) with an increasing trend towards indexed journals (p < 0.001). The research enhancing interventions had a positive effect on increasing clinical research output by the Department of Radiology. Such interventions can also be replicated in other clinical departments to increase their research productivity.

Design of a cluster-randomized minority recruitment trial: RECRUIT.

PubMed

Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

2017-06-01

Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

A Randomised Controlled Trial of a Brief Online Mindfulness-Based Intervention on Paranoia in a Non-Clinical Sample.

PubMed

Shore, Robert; Strauss, Clara; Cavanagh, Kate; Hayward, Mark; Ellett, Lyn

2018-01-01

Paranoia is common and distressing in the general population and can impact on health, emotional well-being and social functioning, such that effective interventions are needed. Brief online mindfulness-based interventions (MBIs) have been shown to reduce symptoms of anxiety and depression in non-clinical samples; however, at present, there is no research investigating whether they can reduce paranoia. The current study explored whether a brief online MBI increased levels of mindfulness and reduced levels of paranoia in a non-clinical population. The mediating effect of mindfulness on any changes in paranoia was also investigated. One hundred and ten participants were randomly allocated to either a 2-week online MBI including 10 min of daily guided mindfulness practice or to a waitlist control condition. Measures of mindfulness and paranoia were administered at baseline, post-intervention and 1-week follow-up. Participants in the MBI group displayed significantly greater reductions in paranoia compared to the waitlist control group. Mediation analysis demonstrated that change in mindfulness skills (specifically the observe, describe and non-react facets of the FFMQ) mediated the relationship between intervention type and change in levels of paranoia. This study provides evidence that a brief online MBI can significantly reduce levels of paranoia in a non-clinical population. Furthermore, increases in mindfulness skills from this brief online MBI can mediate reductions in non-clinical paranoia. The limitations of the study are discussed.

EQUIP Healthcare: An overview of a multi-component intervention to enhance equity-oriented care in primary health care settings.

PubMed

Browne, Annette J; Varcoe, Colleen; Ford-Gilboe, Marilyn; Wathen, C Nadine

2015-12-14

The primary health care (PHC) sector is increasingly relevant as a site for population health interventions, particularly in relation to marginalized groups, where the greatest gains in health status can be achieved. The purpose of this paper is to provide an overview of an innovative multi-component, organizational-level intervention designed to enhance the capacity of PHC clinics to provide equity-oriented care, particularly for marginalized populations. The intervention, known as EQUIP, is being implemented in Canada in four diverse PHC clinics serving populations who are impacted by structural inequities. These PHC clinics serve as case studies for the implementation and evaluation of the EQUIP intervention. We discuss the evidence and theory that provide the basis for the intervention, describe the intervention components, and discuss the methods used to evaluate the implementation and impact of the intervention in diverse contexts. Research and theory related to equity-oriented care, and complexity theory, are central to the design of the EQUIP intervention. The intervention aims to enhance capacity for equity-oriented care at the staff level, and at the organizational level (i.e., policy and operations) and is novel in its dual focus on: (a) Staff education: using standardized educational models and integration strategies to enhance staff knowledge, attitudes and practices related to equity-oriented care in general, and cultural safety, and trauma- and violence-informed care in particular, and; (b) Organizational integration and tailoring: using a participatory approach, practice facilitation, and catalyst grants to foster shifts in organizational structures, practices and policies to enhance the capacity to deliver equity-oriented care, improve processes of care, and shift key client outcomes. Using a mixed methods, multiple case-study design, we are examining the impact of the intervention in enhancing staff knowledge, attitudes and practices; improving processes of care; shifting organizational policies and structures; and improving selected client outcomes. The multiple case study design provides an ideal opportunity to study the contextual factors shaping the implementation, uptake and impact of our tailored intervention within diverse PHC settings. The EQUIP intervention illustrates the complexities involved in enhancing the PHC sector's capacity to provide equity-oriented care in real world clinical contexts.

Knowledge Translation and Barriers to Imaging Optimization in the Emergency Department: A Research Agenda.

PubMed

Probst, Marc A; Dayan, Peter S; Raja, Ali S; Slovis, Benjamin H; Yadav, Kabir; Lam, Samuel H; Shapiro, Jason S; Farris, Coreen; Babcock, Charlene I; Griffey, Richard T; Robey, Thomas E; Fortin, Emily M; Johnson, Jamlik O; Chong, Suzanne T; Davenport, Moira; Grigat, Daniel W; Lang, Eddy L

2015-12-01

Researchers have attempted to optimize imaging utilization by describing which clinical variables are more predictive of acute disease and, conversely, what combination of variables can obviate the need for imaging. These results are then used to develop evidence-based clinical pathways, clinical decision instruments, and clinical practice guidelines. Despite the validation of these results in subsequent studies, with some demonstrating improved outcomes, their actual use is often limited. This article outlines a research agenda to promote the dissemination and implementation (also known as knowledge translation) of evidence-based interventions for emergency department (ED) imaging, i.e., clinical pathways, clinical decision instruments, and clinical practice guidelines. We convened a multidisciplinary group of stakeholders and held online and telephone discussions over a 6-month period culminating in an in-person meeting at the 2015 Academic Emergency Medicine consensus conference. We identified the following four overarching research questions: 1) what determinants (barriers and facilitators) influence emergency physicians' use of evidence-based interventions when ordering imaging in the ED; 2) what implementation strategies at the institutional level can improve the use of evidence-based interventions for ED imaging; 3) what interventions at the health care policy level can facilitate the adoption of evidence-based interventions for ED imaging; and 4) how can health information technology, including electronic health records, clinical decision support, and health information exchanges, be used to increase awareness, use, and adherence to evidence-based interventions for ED imaging? Advancing research that addresses these questions will provide valuable information as to how we can use evidence-based interventions to optimize imaging utilization and ultimately improve patient care. © 2015 by the Society for Academic Emergency Medicine.

Predictors for in-hospital mortality and need for clinical intervention in upper GI bleeding: a 5-year observational study.

PubMed

Balaban, D V; Strâmbu, V; Florea, B G; Cazan, A R; Brătucu, M; Jinga, M

2014-01-01

Upper GI bleeding (UGIB) is a potentially life threatening gastrointestinal emergency whose effective management depends on early risk stratification. We retrospectively studied 151 patients admitted to our unit with UGIB between 1st January 2007 and 31st December 2011 and in whom we calculated the clinical and complete Rockall, the Glasgow-Blatchford and modified Glasgow-Blatchford risk scores. We performed an analysis of the predictive value of these scores for in-hospital mortality and need for clinical intervention. Of the 151 patients enrolled, 68.87% were male, and the mean age was 59.48 years. One in three patients had a history of chronic liver disease and one in eight had a previous episode of UGIB. Clinically, 58.3% of the patients presented with melena, 18.5% with hematemesis and 23.1% with both hematemesis and melena. 22% of cases were variceal hemorrhages and the other non-variceal. 16 patients died during hospitalization. The prognostic accuracy of all four scores for in-hospital death and need for clinical intervention was good, the complete Rockall score having the best performance (AUROC 0.849 and 0.653 respectively). The Rockall and Blatchford scores were good predictors of mortality and need for clinical intervention in our study. The good predictive performance of these scores highlight the need for their use in day-to-day practice to select patients with likelihood of poor clinical outcome. Celsius.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis.

PubMed

Messier, S P; Callahan, L F; Golightly, Y M; Keefe, F J

2015-05-01

The objective was to develop a set of "best practices" for use as a primer for those interested in entering the clinical trials field for lifestyle diet and/or exercise interventions in osteoarthritis (OA), and as a set of recommendations for experienced clinical trials investigators. A subcommittee of the non-pharmacologic therapies committee of the OARSI Clinical Trials Working Group was selected by the Steering Committee to develop a set of recommended principles for non-pharmacologic diet/exercise OA randomized clinical trials. Topics were identified for inclusion by co-authors and reviewed by the subcommittee. Resources included authors' expert opinions, traditional search methods including MEDLINE (via PubMed), and previously published guidelines. Suggested steps and considerations for study methods (e.g., recruitment and enrollment of participants, study design, intervention and assessment methods) were recommended. The recommendations set forth in this paper provide a guide from which a research group can design a lifestyle diet/exercise randomized clinical trial in patients with OA. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Cerebral palsy research funding from the National Institutes of Health, 2001 to 2013.

PubMed

Wu, Yvonne W; Mehravari, Alison S; Numis, Adam L; Gross, Paul

2015-10-01

Cerebral palsy (CP) is a poorly understood disorder with no cure. We determined the landscape of National Institutes of Health (NIH) funding for CP-related research. We searched NIH databases Research Portfolio Online Reporting Tools Expenditures and Results, and Research, Condition, and Disease Categorization for keywords 'cerebral palsy' among all NIH-funded studies, 2001 to 2013. We classified grants by type and area of study. NIH funding, averaging $30 million per year, supported clinical ($215 million), basic ($187 million), and translational ($26.3 million) CP-related research. Clinical intervention studies comprised 19% of funding, and focused on treatments ($60.3 million), early parent intervention ($2.7 million), and CP prevention ($2.5 million). Among grants that specified gestational age, more funds were devoted to preterm ($166 million) than term infants ($15 million). CP in adulthood was the main focus of 4% of all funding. Annual NIH funding for CP increased steadily over the study period from $3.6 to $66.7 million. However, funding for clinical intervention studies peaked in 2008, and has since decreased. Additional research funds are needed to improve the treatment and prevention of CP. Topics that have been relatively underfunded include clinical interventions, prevention, and term infants and adults with CP. © 2015 Mac Keith Press.

Aromatherapy Massage for Neuropathic Pain and Quality of Life in Diabetic Patients.

PubMed

Gok Metin, Zehra; Arikan Donmez, Ayse; Izgu, Nur; Ozdemir, Leyla; Arslan, Ismail Emre

2017-07-01

This study aimed to examine the effects of aromatherapy massage on neuropathic pain severity and quality of life (QoL) in patients suffering from painful diabetic neuropathy. This open-label randomized controlled clinical study was conducted in a university hospital endocrine outpatient clinic in Turkey. The study sample consisted of 46 patients, randomly allocated to an intervention group (n = 21) and a control group (n = 25). The intervention group received aromatherapy massage three times per week for a period of 4 weeks. The control group received only routine care. Data were collected from patients using the Douleur Neuropathique questionnaire, the visual analog scale, and the Neuropathic Pain Impact on Quality of Life questionnaire. Neuropathic pain scores significantly decreased in the intervention group compared with the control group in the fourth week of the study. Similarly, QoL scores significantly improved in the intervention group in the fourth week of the study. Aromatherapy massage is a simple and effective nonpharmacological nursing intervention that can be used to manage neuropathic pain and improve QoL in patients with painful neuropathy. Aromatherapy massage is a well-tolerated, feasible, and safe nonpharmacological method that can be readily integrated into clinical settings by nursing staff. The essential oils rosemary, geranium, lavender, eucalyptus, and chamomile can be safely used by nurses in the clinical setting, if applicable. However, training and experience of nurses in aromatherapy massage is critical to achieving positive results. © 2017 Sigma Theta Tau International.

A Manual-Based Intervention to Address Clinical Crises and Retain Patients in the Treatment of Adolescents with Depression Study (TADS)

ERIC Educational Resources Information Center

May, Diane E.; Kratochvil, Christopher J.; Puumala, Susan E.; Silva, Susan G.; Rezac, Amy J.; Hallin, Mary J.; Reinecke, Mark A.; Vitiello, Benedetto; Weller, Elizabeth B.; Pathak, Sanjeev; Simons, Anne D.; March, John S.

2007-01-01

Objective: To describe a manual-based intervention to address clinical crises and retain participants in the Treatment for Adolescents with Depression Study (TADS). Method: The use of adjunct services for attrition prevention (ASAP) is described for adolescents (ages 12-17 years) during the 12-week acute treatment in TADS, from 2000 to 2003.…

Clinical and Cognitive Insight in a Compensatory Cognitive Training Intervention

PubMed Central

Burton, Cynthia Z.; Vella, Lea; Twamley, Elizabeth W.

2013-01-01

The impact of limited insight is a crucial consideration in the treatment of individuals with psychiatric illness. In the context of psychosis, both clinical and cognitive insight have been described. This study aimed to evaluate the relationships between clinical and cognitive insight and neuropsychological functioning, psychiatric symptom severity, and everyday functioning in patients with a primary psychotic disorder participating in a compensatory cognitive training (CT) intervention. Sixty-nine individuals diagnosed with a primary psychotic disorder were randomized to a 3-month CT intervention or to standard pharmacotherapy, and they completed a comprehensive neuropsychological, clinical, and functional battery at baseline, 3 months, and 6 months. The CT intervention focused on habit formation and compensatory strategy learning in four domains: prospective memory, attention and vigilance, learning and memory, and problem-solving/cognitive flexibility. At baseline, better clinical insight was significantly related to better executive functioning and less severe negative symptoms. There was no significant association between cognitive insight and cognitive functioning, symptom severity, or everyday functioning ability. The CT intervention did not have an effect on clinical or cognitive insight, but better cognitive insight prior to participation in CT significantly predicted decreased positive and depressive symptom severity posttreatment, and better clinical insight predicted improved self-reported quality of life. Although clinical insight is related to executive functioning, the correlates of cognitive insight remain elusive. Intact insight appears to be beneficial in ameliorating clinical symptomatology like positive symptoms and depression, rather than augmenting cognition. It may be valuable to develop brief interventions aimed at improving clinical and cognitive insight prior to other psychosocial rehabilitation in order to maximize the benefit of treatment. PMID:23990763

Parents as Agents of Change (PAC) in pediatric weight management: The protocol for the PAC randomized clinical trial

PubMed Central

2012-01-01

Background There is an urgent need to develop and evaluate weight management interventions to address childhood obesity. Recent research suggests that interventions designed for parents exclusively, which have been named parents as agents of change (PAC) approaches, have yielded positive outcomes for managing pediatric obesity. To date, no research has combined a PAC intervention approach with cognitive behavioural therapy (CBT) to examine whether these combined elements enhance intervention effectiveness. This paper describes the protocol our team is using to examine two PAC-based interventions for pediatric weight management. We hypothesize that children with obesity whose parents complete a CBT-based PAC intervention will achieve greater reductions in adiposity and improvements in cardiometabolic risk factors, lifestyle behaviours, and psychosocial outcomes than children whose parents complete a psycho-education-based PAC intervention (PEP). Methods/Design This study is a pragmatic, two-armed, parallel, single-blinded, superiority, randomized clinical trial. The primary objective is to examine the differential effects of a CBT-based PAC vs PEP-based PAC intervention on children’s BMI z-score (primary outcome). Secondary objectives are to assess intervention-mediated changes in cardiometabolic, lifestyle, and psychosocial variables in children and parents. Both interventions are similar in frequency of contact, session duration, group facilitation, lifestyle behaviour goals, and educational content. However, the interventions differ insofar as the CBT-based intervention incorporates theory-based concepts to help parents link their thoughts, feelings, and behaviours; these cognitive activities are enabled by group leaders who possess formal training in CBT. Mothers and fathers of children (8–12 years of age; BMI ≥85th percentile) are eligible to participate if they are proficient in English (written and spoken) and agree for at least one parent to attend group-based sessions on a weekly basis. Anthropometry, cardiometabolic risk factors, lifestyle behaviours, and psychosocial health of children and parents are assessed at pre-intervention, post-intervention, 6-, and 12-months follow-up. Discussion This study is designed to extend findings from earlier efficacy studies and provide data on the effect of a CBT-based PAC intervention for managing pediatric obesity in a real-world, outpatient clinical setting. Trial Registration ClinicalTrials.gov identifier: NCT01267097 PMID:22866998

Therapeutic horticulture in clinical depression: a prospective study.

PubMed

Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

2009-01-01

Clinically depressed persons suffer from impaired mood and distortion of cognition. This study assessed changes in depression severity and perceived attentional capacity of clinically depressed adults (N=18) during a 12-week therapeutic horticulture program. The Beck Depression Inventory (BDI) and Attentional Function Index (AFI) were administered at baseline, twice during (4 and 8 weeks), and immediately after the intervention (12 weeks), and at a 3-month follow-up. Experiences of being away and fascination related to the intervention were measured at 4, 8, and 12 weeks. The mean BDI score declined 9.7 points from pretest (27.3) to posttest (p < .001) and were clinically relevant (deltaBDI > or =6) for 72% of the cases. The mean AFI score increased 10.2 points from pretest (68.8) to posttest (p = .06). The greatest change in BDI and AFI scores occurred in the initial weeks of the intervention. The reduction in BDI scores remained significant and clinically relevant at the 3-month follow-up (N=16). The decline in depression severity during the intervention correlated strongly with the degree to which the participants found that it captured their attention. Therapeutic horticulture may decrease depression severity and improve perceived attentional capacity by engaging effortless attention and interrupting rumination.

Interventions for reducing fear of childbirth: A systematic review and meta-analysis of clinical trials.

PubMed

MoghaddamHosseini, Vahideh; Nazarzadeh, Milad; Jahanfar, Shayesteh

2017-11-07

Fear of childbirth is a problematic mental health issue during pregnancy. But, effective interventions to reduce this problem are not well understood. To examine effective interventions for reducing fear of childbirth. The Cochrane Central Register of Controlled Trials, PubMed, Embase and PsycINFO were searched since inception till September 2017 without any restriction. Randomised controlled trials and quasi-randomised controlled trials comparing interventions for treatment of fear of childbirth were included. The standardized mean differences were pooled using random and fixed effect models. The heterogeneity was determined using the Cochran's test and I 2 index and was further explored in meta-regression model and subgroup analyses. Ten studies inclusive of 3984 participants were included in the meta-analysis (2 quasi-randomized and 8 randomized clinical trials). Eight studies investigated education and two studies investigated hypnosis-based intervention. The pooled standardized mean differences of fear for the education intervention and hypnosis group in comparison with control group were -0.46 (95% CI -0.73 to -0.19) and -0.22 (95% CI -0.34 to -0.10), respectively. Both types of interventions were effective in reducing fear of childbirth; however our pooled results revealed that educational interventions may reduce fear with double the effect of hypnosis. Further large scale randomized clinical trials and individual patient data meta-analysis are warranted for assessing the association. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

Prioritising Responses Of Nurses To deteriorating patient Observations (PRONTO) protocol: testing the effectiveness of a facilitation intervention in a pragmatic, cluster-randomised trial with an embedded process evaluation and cost analysis.

PubMed

Bucknall, Tracey K; Harvey, Gill; Considine, Julie; Mitchell, Imogen; Rycroft-Malone, Jo; Graham, Ian D; Mohebbi, Mohammadreza; Watts, Jennifer; Hutchinson, Alison M

2017-07-11

Vital signs are the primary indicator of physiological status and for determining the need for urgent clinical treatment. Yet, if physiological signs of deterioration are missed, misinterpreted or mismanaged, then critical illness, unplanned intensive care admissions, cardiac arrest and death may ensue. Although evidence demonstrates the benefit of early recognition and management of deteriorating patients, failure to escalate care and manage deteriorating patients remains a relatively frequent occurrence in hospitals. A pragmatic cluster-randomised controlled trial design will be used to measure clinical effectiveness and cost of a facilitation intervention to improve nurses' vital sign measurement, interpretation, treatment and escalation of care for patients with abnormal vital signs. A cost consequence analysis will evaluate the intervention cost and effectiveness, and a process evaluation will determine how the implementation of the intervention contributes to outcomes. We will compare clinical outcomes and costs from standard implementation of clinical practice guidelines (CPGs) to facilitated implementation of CPGs. The primary outcome will be adherence to the CPGs by nurses, as measured by escalation of care as per organisational policy. The study will be conducted in four Australian major metropolitan teaching hospitals. In each hospital, eight to ten wards will be randomly allocated to intervention and control groups. Control wards will receive standard implementation of CPGs, while intervention wards will receive standard CPG implementation plus facilitation, using facilitation methods and processes tailored to the ward context. The intervention will be administered to all nursing staff at the ward level for 6 months. At each hospital, two types of facilitators will be provided: a hospital-level facilitator as the lead; and two ward-level facilitators for each ward. This study uses an innovative, networked approach to facilitation to enable uptake of CPGs. Findings will inform the intervention utility and knowledge translation measurement approaches. If successful, the study methodology and intervention has potential for translation to other health care standards. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12616000544471p.

Pressure ulcer risk assessment and prevention: a systematic comparative effectiveness review.

PubMed

Chou, Roger; Dana, Tracy; Bougatsos, Christina; Blazina, Ian; Starmer, Amy J; Reitel, Katie; Buckley, David I

2013-07-02

Pressure ulcers are associated with substantial health burdens but may be preventable. To review the clinical utility of pressure ulcer risk assessment instruments and the comparative effectiveness of preventive interventions in persons at higher risk. MEDLINE (1946 through November 2012), CINAHL, the Cochrane Library, grant databases, clinical trial registries, and reference lists. Randomized trials and observational studies on effects of using risk assessment on clinical outcomes and randomized trials of preventive interventions on clinical outcomes. Multiple investigators abstracted and checked study details and quality using predefined criteria. One good-quality trial found no evidence that use of a pressure ulcer risk assessment instrument, with or without a protocolized intervention strategy based on assessed risk, reduces risk for incident pressure ulcers compared with less standardized risk assessment based on nurses' clinical judgment. In higher-risk populations, 1 good-quality and 4 fair-quality randomized trials found that more advanced static support surfaces were associated with lower risk for pressure ulcers compared with standard mattresses (relative risk range, 0.20 to 0.60). Evidence on the effectiveness of low-air-loss and alternating-air mattresses was limited, with some trials showing no clear differences from advanced static support surfaces. Evidence on the effectiveness of nutritional supplementation, repositioning, and skin care interventions versus usual care was limited and had methodological shortcomings, precluding strong conclusions. Only English-language articles were included, publication bias could not be formally assessed, and most studies had methodological shortcomings. More advanced static support surfaces are more effective than standard mattresses for preventing ulcers in higher-risk populations. The effectiveness of formal risk assessment instruments and associated intervention protocols compared with less standardized assessment methods and the effectiveness of other preventive interventions compared with usual care have not been clearly established.

Offering Annual Fecal Occult Blood Tests at Annual Flu Shot Clinics Increases Colorectal Cancer Screening Rates

PubMed Central

Potter, Michael B.; Phengrasamy, La; Hudes, Esther S.; McPhee, Stephen J.; Walsh, Judith M.E.

2009-01-01

PURPOSE We wanted to determine whether providing home fecal occult blood test (FOBT) kits to eligible patients during influenza inoculation (flu shot) clinics can contribute to higher colorectal cancer screening (CRCS) rates. METHODS The study was time randomized. On 8 dates of an annual flu shot clinic at the San Francisco General Hospital, patients were offered flu shots as usual (control group) and on 9 other dates, patients were offered both flu shots and FOBT kits (intervention group). RESULTS The study included 514 patients aged 50 to 79 years, with 246 in the control group and 268 in the intervention group. At the conclusion of flu season, FOBT screening rates increased by 4.4 percentage points from 52.9% at baseline to 57.3% (P = .07) in the control group, and increased by 29.8 percentage points from 54.5% to 84.3% (P <.001) in the intervention group, with the change among intervention participants 25.4 percentage points greater than among control participants (P value for change difference <.001). Among patients initially due for CRCS, 20.7% in the control group and 68.0% in the intervention group were up-to-date at the conclusion of the study (P <.001). In multivariate analyses, the odds ratio for becoming up-to-date with screening in the intervention group (vs the control group) was 11.3 (95% CI, 5.8–22.0). CONCLUSIONS Offering FOBT kits during flu shot clinics dramatically increased the CRCS rate for flu shot clinic attendees. Pairing home FOBT kits with annual flu shots may be a useful strategy to improve CRCS rates in other primary care or public health settings. PMID:19139445

Efficacy of a family intervention program for prevention of hospitalization in patients with schizophrenia. A naturalistic multicenter controlled and randomized study in Spain.

PubMed

Mayoral, Fermín; Berrozpe, Adela; de la Higuera, Jesús; Martinez-Jambrina, Juan José; de Dios Luna, Juan; Torres-Gonzalez, Francisco

2015-01-01

According to most relevant guidelines, family psycho-educational interventions are considered to be one the most effective psychosocial treatments for people with schizophrenia. The main outcome measure in controlled and randomized studies has been prevention of relapses and admissions, and encouragement of compliance, although some questions remain about its applicability and results in clinical practice. The aim of study was to evaluate the efficacy and implementation of a single family psychoeducational intervention in 'real' conditions for people diagnosed with schizophrenia. A total of 88 families were randomized in two groups. The family intervention group received a 12 months psychoeducational treatment, and the other group followed normal standard treatment. Assessments were made at baseline, at 12 and at 18 months. The main outcome measure was hospitalization, and secondary outcome measures were clinical condition (BPRS-E) and social disability (DAS-II). A total of 71 patients finished the study (34 family intervention group and 37 control group). Patients who received family intervention reduced the risk of hospitalization by 40% (P = .4018; 95%CI: 0.1833-0.6204). Symptomatology improved significantly at 12 months (P = .4018; 95%CI: 0.1833-0.6204), but not at 18 months (P = .4018; 95%CI: 0.1833-0.6204). Social disability was significantly reduced in the family intervention group at 12 months and 18 months. Family psychoeducational intervention reduces hospitalization risk and improves clinical condition and social functioning of people with schizophrenia. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

Interventional management of neuropathic pain: NeuPSIG recommendations

PubMed Central

Dworkin, Robert H.; O’Connor, Alec B.; Kent, Joel; Mackey, Sean C.; Raja, Srinivasa N.; Stacey, Brett R.; Levy, Robert M.; Backonja, Miroslav; Baron, Ralf; Harke, Henning; Loeser, John D.; Treede, Rolf-Detlef; Turk, Dennis C.; Wells, Christopher D.

2015-01-01

Neuropathic pain (NP) is often refractory to pharmacologic and non-interventional treatment. On behalf of the International Association for the Study of Pain Neuropathic Pain Special Interest Group (NeuPSIG), the authors evaluated systematic reviews, clinical trials, and existing guidelines for the interventional management of NP. Evidence is summarized and presented for neural blockade, spinal cord stimulation (SCS), intrathecal medication, and neurosurgical interventions in patients with the following peripheral and central NP conditions: herpes zoster and postherpetic neuralgia (PHN); painful diabetic and other peripheral neuropathies; spinal cord injury NP; central post-stroke pain; radiculopathy and failed back surgery syndrome (FBSS); complex regional pain syndrome (CRPS); and trigeminal neuralgia and neuropathy. Due to the paucity of high-quality clinical trials, no strong recommendations can be made. Four weak recommendations based on the amount and consistency of evidence, including degree of efficacy and safety, are: (1) epidural injections for herpes zoster; (2) steroid injections for radiculopathy; (3) SCS for FBSS; and (4) SCS for CRPS type 1. Based on the available data, we recommend not to use sympathetic blocks for PHN nor RF lesions for radiculopathy. No other conclusive recommendations can be made due to the poor quality of available of data. Whenever possible, these interventions should either be part of randomized clinical trials or documented in pain registries. Priorities for future research include randomized clinical trials; long-term studies; and head-to-head comparisons among different interventional and non-interventional treatments. PMID:23748119

Effectiveness of a medical education intervention to treat hypertension in primary care.

PubMed

Martínez-Valverde, Silvia; Castro-Ríos, Angélica; Pérez-Cuevas, Ricardo; Klunder-Klunder, Miguel; Salinas-Escudero, Guillermo; Reyes-Morales, Hortensia

2012-04-01

In Mexico, hypertension is among the top five causes for visits to primary care clinics; its complications are among the main causes of emergency and hospital care. The present study reports the effectiveness of a continuing medical education (CME) intervention to improve appropriate care for hypertension, on blood pressure control of hypertensive patients in primary care clinics. A secondary data analysis was carried out using data of hypertensive patients treated by family doctors who participated in the CME intervention. The evaluation was designed as a pre-/post-intervention study with control group in six primary care clinics. The effect of the CME intervention was analysed using multiple logistic regression modelling in which the dependent variable was uncontrolled blood pressure in the post-intervention patient measurement. After the CME intervention, the net reduction of uncontrolled blood pressure between stages in the intervention group was 10.3%. The model results were that being treated by a family doctor who participated in the CME intervention reduced by 53% the probability of lack of control of blood pressure; receiving dietary recommendations reduced 57% the probability of uncontrolled blood pressure. Having uncontrolled blood pressure at the baseline stage increased the probability of lack of control in 166%, and per each unit of increase in body mass index the lack of control increased 7%. CME intervention improved the medical decision-making process to manage hypertension, thus increasing the probability of hypertensive patients to have blood pressure under control. © 2010 Blackwell Publishing Ltd.

Systematic Review of Integrated Medical and Psychiatric Self-Management Interventions for Adults with Serious Mental Illness

PubMed Central

Whiteman, Karen L.; Naslund, John A.; DiNapoli, Elizabeth A.; Bruce, Martha L.; Bartels, Stephen J.

2016-01-01

Objective Adults with serious mental illness are disproportionately affected by medical comorbidity, earlier onset of disease, and premature mortality. Integrated self-management interventions have been developed to address both medical and psychiatric illnesses. This systematic review aimed to: review the evidence of the effect of self-management interventions targeting both medical and psychiatric illnesses and evaluate the potential for implementation. Methods Databases including CINAHL, Cochrane Central, Ovid Medline, PsycINFO, and Web of Science were searched for articles published between 1946 and July 2015. Studies evaluating integrated medical and psychiatric self-management interventions for adults with schizophrenia spectrum or mood disorders and medical comorbidity were included. Results Fifteen studies reported on nine interventions (i.e., nine randomized control trials, six pre/post designs). Most studies demonstrated feasibility, acceptability, and preliminary effectiveness; however, clinical effectiveness could not be established in most of the studies due to methodological limitations. Factors identified that may deter implementation included operating costs, impractical length of the intervention, and the workforce needs of these interventions. Conclusions Integrated medical and psychiatric illness self-management interventions appear feasible and acceptable, with high potential for clinical effectiveness. However, implementation considerations were rarely considered in intervention development, contributing to limited uptake and reach in real-world settings. PMID:27301767

Important elements in farm animal-assisted interventions for persons with clinical depression: a qualitative interview study.

PubMed

Pedersen, Ingeborg; Ihlebæk, Camilla; Kirkevold, Marit

2012-01-01

The main aim of this study was to obtain participants' own experience of a farm animal-assisted intervention, and what they perceived as important elements in relation to their mental health. A qualitative study, inspired by a phenomenological-hermeneutical perspective was conducted. Eight persons with clinical depression who had completed a 12-week farm animal-assisted intervention at a dairy farm participated in thematic interviews between May and June 2009. The intervention was regarded as a positive experience for the participants. The analyses revealed that central elements in the intervention were the possibility to experience an ordinary work life, but also the importance of a distraction to their illness. Furthermore, the flexibility of the intervention made it possible to adjust the intervention to the participants' shifting reality and was thereby a key element in farm animal-assisted intervention. The flexibility and adapted work tasks were important elements that the participants associated with their experience of coping. A model showing the interaction between the different elements reported as important by the participants was constructed. This study shows that a farm animal-assisted intervention could be a supplement in mental health rehabilitation. All the elements in our model could possibly influence positively on mental health.

The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol.

PubMed

Levy, Natalie; Moynihan, Victoria; Nilo, Annielyn; Singer, Karyn; Bernik, Lidia S; Etiebet, Mary-Ann; Fang, Yixin; Cho, James; Natarajan, Sundar

2015-03-13

Patients on insulin glargine typically visit a clinician to obtain advice on how to adjust their insulin dose. These multiple clinic visits can be costly and time-consuming, particularly for low-income patients. It may be feasible to achieve insulin titration through text messages and phone calls with patients instead of face-to-face clinic visits. The objectives of this study are to (1) evaluate if the Mobile Insulin Titration Intervention (MITI) is clinically effective by helping patients reach their optimal dose of insulin glargine, (2) determine if the intervention is feasible within the setting and population, (3) assess patient satisfaction with the intervention, and (4) measure the costs associated with this intervention. This is a pilot study evaluating an approach to insulin titration using text messages and phone calls among patients with insulin-dependent type 2 diabetes in the outpatient medical clinic of Bellevue Hospital Center, a safety-net hospital in New York City. Patients will be randomized in a 1:1 ratio to either the MITI arm (texting/phone call intervention) or the usual-care arm (in-person clinic visits). Using a Web-based platform, weekday text messages will be sent to patients in the MITI arm, asking them to text back their fasting blood glucose values. In addition to daily reviews for alarm values, a clinician will rereview the texted values weekly, consult our physician-approved titration algorithm, and call the patients with advice on how to adjust their insulin dose. The primary outcome will be whether or not a patient reaches his/her optimal dose of insulin glargine within 12 weeks. Recruitment for this study occurred between June 2013 and December 2014. We are continuing to collect intervention and follow-up data from our patients who are currently enrolled. The results of our data analysis are expected to be available in 2015. This study explores the use of widely-available text messaging and voice technologies for insulin titration. We aim to show that remote insulin titration is clinically effective, feasible, satisfactory, and cost saving for low-income patients in a busy, urban clinic. Clinicaltrials.gov NCT01879579; http://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6WUEgjZUO).

Enhancing system-wide implementation of opioid prescribing guidelines in primary care: protocol for a stepped-wedge quality improvement project.

PubMed

Zgierska, Aleksandra E; Vidaver, Regina M; Smith, Paul; Ales, Mary W; Nisbet, Kate; Boss, Deanne; Tuan, Wen-Jan; Hahn, David L

2018-06-05

Systematic implementation of guidelines for opioid therapy management in chronic non-cancer pain can reduce opioid-related harms. However, implementation of guideline-recommended practices in routine care is subpar. The goal of this quality improvement (QI) project is to assess whether a clinic-tailored QI intervention improves the implementation of a health system-wide, guideline-driven policy on opioid prescribing in primary care. This manuscript describes the protocol for this QI project. A health system with 28 primary care clinics caring for approximately 294,000 primary care patients developed and implemented a guideline-driven policy on long-term opioid therapy in adults with opioid-treated chronic non-cancer pain (estimated N = 3980). The policy provided multiple recommendations, including the universal use of treatment agreements, urine drug testing, depression and opioid misuse risk screening, and standardized documentation of the chronic pain diagnosis and treatment plan. The project team drew upon existing guidelines, feedback from end-users, experts and health system leadership to develop a robust QI intervention, targeting clinic-level implementation of policy-directed practices. The resulting multi-pronged QI intervention included clinic-wide and individual clinician-level educational interventions. The QI intervention will augment the health system's "routine rollout" method, consisting of a single educational presentation to clinicians in group settings and a separate presentation for staff. A stepped-wedge design will enable 9 primary care clinics to receive the intervention and assessment of within-clinic and between-clinic changes in adherence to the policy items measured by clinic-level electronic health record-based measures and process measures of the experience with the intervention. Developing methods for a health system-tailored QI intervention required a multi-step process to incorporate end-user feedback and account for the needs of targeted clinic team members. Delivery of such tailored QI interventions has the potential to enhance uptake of opioid therapy management policies in primary care. Results from this study are anticipated to elucidate the relative value of such QI activities.

RCT of a care manager intervention for major depression in primary care: 2-year costs for patients with physical vs psychological complaints.

PubMed

Dickinson, L Miriam; Rost, Kathryn; Nutting, Paul A; Elliott, Carl E; Keeley, Robert D; Pincus, Harold

2005-01-01

Depression care management for primary care patients results in sustained improvement in clinical outcomes with diminishing costs over time. Clinical benefits, however, are concentrated primarily in patients who report to their primary care clinicians psychological rather than exclusively physical symptoms. This study proposes to determine whether the intervention affects outpatient costs differentially when comparing patients who have psychological with patients who have physical complaints. We undertook a group-randomized controlled trial (RCT) of depression comparing intervention with usual care in 12 primary care practices. Intervention practices encouraged depressed patients to engage in active treatment, using nurses to provide regularly scheduled care management for 24 months. The study sample included 200 adults beginning a new depression treatment episode where patient presentation style could be identified. Outpatient costs were defined as intervention plus outpatient treatment costs for the 2 years. Cost-offset analysis used general linear mixed models, 2-part models, and bootstrapping to test hypotheses regarding a differential intervention effect by patients' style, and to obtain 95% confidence intervals for costs. Intervention effects on outpatient costs over time differed by patient style (P <.05), resulting in a $980 cost decrease for depressed patients who complain of psychological symptoms and a 1,378 dollars cost increase for depressed patients who complain of physical symptoms only. Depression intervention for a 2-year period produced observable clinical benefit with decreased outpatient costs for depressed patients who complain of psychological symptoms. It produced limited clinical benefit with increased costs, however, for depressed patients who complain exclusively of physical symptoms, suggesting the need for developing new intervention approaches for this group.

A multi-level system quality improvement intervention to reduce racial disparities in hypertension care and control: study protocol

PubMed Central

2013-01-01

Background Racial disparities in blood pressure control have been well documented in the United States. Research suggests that many factors contribute to this disparity, including barriers to care at patient, clinician, healthcare system, and community levels. To date, few interventions aimed at reducing hypertension disparities have addressed factors at all of these levels. This paper describes the design of Project ReD CHiP (Reducing Disparities and Controlling Hypertension in Primary Care), a multi-level system quality improvement project. By intervening on multiple levels, this project aims to reduce disparities in blood pressure control and improve guideline concordant hypertension care. Methods Using a pragmatic trial design, we are implementing three complementary multi-level interventions designed to improve blood pressure measurement, provide patient care management services and offer expanded provider education resources in six primary care clinics in Baltimore, Maryland. We are staggering the introduction of the interventions and will use Statistical Process Control (SPC) charting to determine if there are changes in outcomes at each clinic after implementation of each intervention. The main hypothesis is that each intervention will have an additive effect on improvements in guideline concordant care and reductions in hypertension disparities, but the combination of all three interventions will result in the greatest impact, followed by blood pressure measurement with care management support, blood pressure measurement with provider education, and blood pressure measurement only. This study also examines how organizational functioning and cultural competence affect the success of the interventions. Discussion As a quality improvement project, Project ReD CHiP employs a novel study design that specifically targets multi-level factors known to contribute to hypertension disparities. To facilitate its implementation and improve its sustainability, we have incorporated stakeholder input and tailored components of the interventions to meet the specific needs of the involved clinics and communities. Results from this study will provide knowledge about how integrated multi-level interventions can improve hypertension care and reduce disparities. Trial Registration ClinicalTrials.gov NCT01566864 PMID:23734703

Motivational interviewing to improve postabortion contraceptive uptake by young women: development and feasibility of a counseling intervention.

PubMed

Whitaker, A K; Quinn, M T; Martins, S L; Tomlinson, A N; Woodhams, E J; Gilliam, M

2015-10-01

The objective was to develop and test a postabortal contraception counseling intervention using motivational interviewing (MI) and to determine the feasibility, impact and patient acceptability of the intervention when integrated into an urban academic abortion clinic. A single-session postabortal contraception counseling intervention for young women aged 15-24 years incorporating principles, skills and style of MI was developed. Medical and social work professionals were trained to deliver the intervention, their competency was assessed, and the intervention was integrated into the clinical setting. Feasibility was determined by assessing ability to approach and recruit participants, ability to complete the full intervention without interruption and participant satisfaction with the counseling. We approached 90% of eligible patients and 71% agreed to participate (n=20). All participants received the full counseling intervention. The median duration of the intervention was 29 min. Immediately after the intervention and at the 1-month follow-up contact, 95% and 77% of participants reported that the session was helpful, respectively. MI counseling can be tailored to the abortion setting. It is feasible to train professionals to use MI principles, skills and style and to implement an MI-based contraception counseling intervention in an urban academic abortion clinic. The sessions are acceptable to participants. The use of motivational interviewing in contraception counseling may be an appropriate and effective strategy for increasing use of contraception after abortion. This study demonstrates that this patient-centered, directive and collaborative approach can be developed into a counseling intervention that can be integrated into an abortion clinic. Copyright © 2015 Elsevier Inc. All rights reserved.

Students' Evidence-Based Practice Intervention for Children with Oppositional Defiant Disorder

ERIC Educational Resources Information Center

Ronen, Tammie

2005-01-01

Objective: This project integrates clinical intervention as an integral part of social work studies for third-year students. Students applied a new manual-based intervention aiming to develop self-control skills among children exhibiting oppositional defiant disorder. Throughout, students were involved in assessment, intervention, and evaluation.…

Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): protocol for the ICEPOC study.

PubMed

Barnestein-Fonseca, Pilar; Leiva-Fernández, José; Vidal-España, Francisca; García-Ruiz, Antonio; Prados-Torres, Daniel; Leiva-Fernández, Francisca

2011-02-14

Low therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment. The therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is extremely poor according to most studies. The research about COPD adherence has mainly focussed on quantifying its effect, and few studies have researched factors that affect non-adherence. Our study will evaluate the effectiveness of a multifactor intervention to improve the therapeutic adherence of COPD patients. A randomized controlled clinical trial with 140 COPD diagnosed patients selected by a non-probabilistic method of sampling. Subjects will be randomly allocated into two groups, using the block randomization technique. Every patient in each group will be visited four times during the year of the study. Motivational aspects related to adherence (beliefs and behaviour): group and individual interviews; cognitive aspects: information about illness; skills: inhaled technique training. Reinforcement of the cognitive-emotional aspects and inhaled technique training will be carried out in all visits of the intervention group. Adherence to a prescribed treatment involves a behavioural change. Cognitive, emotional and motivational aspects influence this change and so we consider the best intervention procedure to improve adherence would be a cognitive and emotional strategy which could be applied in daily clinical practice. Our hypothesis is that the application of a multifactor intervention (COPD information, dose reminders and reinforcing audiovisual material, motivational aspects and inhalation technique training) to COPD patients taking inhaled treatment will give a 25% increase in the number of patients showing therapeutic adherence in this group compared to the control group.We will evaluate the effectiveness of this multifactor intervention on patient adherence to inhaled drugs considering that it will be right and feasible to the clinical practice context. Current Controlled Trials ISRCTN18841601.

Just-in-Time Evidence-Based E-mail “Reminders” in Home Health Care: Impact on Nurse Practices

PubMed Central

Murtaugh, Christopher M; Pezzin, Liliana E; McDonald, Margaret V; Feldman, Penny H; Peng, Timothy R

2005-01-01

Objective To test the effectiveness of two interventions designed to improve the adoption of evidence-based practices by home health nurses caring for heart failure (HF) patients. Data Sources/Study Setting Information on nurse practices was abstracted from the clinical records of patients admitted between June 2000 and November 2001 to the care of 354 study nurses at a large, urban, nonprofit home care agency. Study Design The study employed a randomized design with nurses assigned to usual care or one of two intervention groups upon identification of an eligible patient. The basic intervention was a one-time e-mail reminder highlighting six HF-specific clinical recommendations. The augmented intervention consisted of the initial e-mail reminder supplemented by provider prompts, patient education material, and clinical nurse specialist outreach. Data Collection At each home health visit provided by a study nurse to an eligible HF patient during the 45-day follow-up period, a structured chart abstraction tool was used to collect information on whether the nurse provided the care practices highlighted in the e-mail reminder. Principal Findings Both the basic and the augmented interventions greatly increased the practice of evidence-based care, according to patient records, in the areas of patient assessment and instructions about HF disease management. While not all results were statistically significant at conventional levels, intervention effects were positive in virtually all cases and effect magnitudes frequently were large. Conclusions The results of this randomized trial strongly support the efficacy of just-in-time evidence-based reminders as a means of changing clinical practice among home health nurses who are geographically dispersed and spend much of their time in the field. PMID:15960694

The role of analogy-guided learning experiences in enhancing students' clinical decision-making skills.

PubMed

Edelen, Bonnie Gilbert; Bell, Alexandra Alice

2011-08-01

The purpose of this study was to address the need for effective educational interventions to promote students' clinical decision making (CDM) within clinical practice environments. Researchers used a quasi-experimental, non-equivalent groups, posttest-only design to assess differences in CDM ability between intervention group students who participated in analogy-guided learning activities and control group students who participated in traditional activities. For the intervention, analogy-guided learning activities were incorporated into weekly group discussions, reflective journal writing, and questioning with clinical faculty. The researcher-designed Assessment of Clinical Decision Making Rubric was used to assess indicators of CDM ability in all students' reflective journal entries. Results indicated that the intervention group demonstrated significantly higher levels of CDM ability in their journals compared with the control group (ES(sm) = 0.52). Recommendations provide nurse educators with strategies to maximize students' development of CDM ability, better preparing students for the demands they face when they enter the profession. Copyright 2011, SLACK Incorporated.

Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial.

PubMed

Carmona-Terés, Victoria; Lumillo-Gutiérrez, Iris; Jodar-Fernández, Lina; Rodriguez-Blanco, Teresa; Moix-Queraltó, Joanna; Pujol-Ribera, Enriqueta; Mas, Xavier; Batlle-Gualda, Enrique; Gobbo-Montoya, Milena; Berenguera, Anna

2015-02-25

The prevalence of osteoarthritis and knee osteoarthritis in the Spanish population is estimated at 17% and 10.2%, respectively. The clinical guidelines concur that the first line treatment for knee osteoarthritis should be non-pharmacological and include weight loss, physical activity and self-management of pain. Health Coaching has been defined as an intervention that facilitates the achievement of health improvement goals, the reduction of unhealthy lifestyles, the improvement of self-management for chronic conditions and quality of life enhancement. The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, pain, overweight and physical activity in patients from 18 primary care centres of Barcelona with knee osteoarthritis. Methodology from the Medical Research Council on developing complex interventions. Phase 1: Intervention modelling and operationalization through a qualitative, socioconstructivist study using theoretical sampling with 10 in-depth interviews to patients with knee osteoarthritis and 4 discussion groups of 8-12 primary care professionals, evaluated using a sociological discourse analysis. Phase 2: Effectiveness, cost-effectiveness and cost-utility study with a community-based randomized clinical trial. 360 patients with knee osteoarthritis (180 in each group). Randomization unit: Primary Care Centre. Intervention Group: will receive standard care plus 20-hour health coaching and follow-up sessions. will receive standard care. quality of life as measured by the WOMAC index. Data Analyses: will include standardized response mean and multilevel analysis of repeated measures. Economic analysis: based on cost-effectiveness and cost-utility measures. Phase 3: Evaluation of the intervention programme with a qualitative study. Methodology as in Phase 1. If the analyses show the cost-effectiveness and cost-utility of the intervention the results can be incorporated into the clinical guidelines for the management of knee osteoarthritis in primary care. ISRCTN57405925. Registred 20 June 2014.

Theory based interventions for caries related sugar intake in adults: systematic review.

PubMed

Al Rawahi, Said Hartih; Asimakopoulou, Koula; Newton, Jonathon Timothy

2017-07-25

Theories of behavior change are essential in the design of effective behaviour change strategies. No studies have assessed the effectiveness of interventions based on psychological theories to reduce sugar intake related to dental caries. The study assessed the effect of interventions based on Social Congition Models (SCMs) on sugar intake in adults, when compared with educational interventions or no intervention. A range of papers were considered: Systematic review Systematic Reviews with or without Meta Analyses; Randomised Controlled Trials; Controlled Clinical Trials and Before and after studies, of interventions based on Social Cognition Models aimed at dietary intake of sugar in adults. The Cochrane database including: Oral Health Group's Trials Register (2015), MEDLINE (from 1966 to September 2015), EMBASE (from 1980 to September 2015), PsycINFO (from 1966 to September 2015) were searched. No article met the full eligibility criteria for the current systematic review so no articles were included. There is a need for more clinical trials to assess the effectiveness of interventions based on psychological theory in reducing dietary sugar intake among adults. PROSPERO: CRD42015026357 .

Describing the implementation of an innovative intervention and evaluating its effectiveness in increasing research capacity of advanced clinical nurses: using the consolidated framework for implementation research.

PubMed

McKee, Gabrielle; Codd, Margaret; Dempsey, Orla; Gallagher, Paul; Comiskey, Catherine

2017-01-01

Despite advanced nursing roles having a research competency, participation in research is low. There are many barriers to participation in research and few interventions have been developed to address these. This paper aims to describe the implementation of an intervention to increase research participation in advanced clinical nursing roles and evaluate its effectiveness. The implementation of the intervention was carried out within one hospital site. The evaluation utilised a mixed methods design and a implementation science framework. All staff in advanced nursing roles were invited to take part, all those who were interested and had a project in mind could volunteer to participate in the intervention. The intervention consisted of the development of small research groups working on projects developed by the nurse participant/s and supported by an academic and a research fellow. The main evaluation was through focus groups. Output was analysed using thematic analysis. In addition, a survey questionnaire was circulated to all participants to ascertain their self-reported research skills before and after the intervention. The results of the survey were analysed using descriptive statistics. Finally an inventory of research outputs was collated. In the first year, twelve new clinical nurse-led research projects were conducted and reported in six peer reviewed papers, two non-peer reviewed papers and 20 conference presentations. The main strengths of the intervention were its promptness to complete research, to publish and to showcase clinical innovations. Main barriers identified were time, appropriate support from academics and from peers. The majority of participants had increased experience at scientific writing and data analysis. This study shows that an intervention, with minor financial resources; a top down approach; support of a hands on research fellow; peer collaboration with academics; strong clinical ownership by the clinical nurse researcher; experiential learning opportunities; focused and with needs based educational sessions, is an intervention that can both increase research outputs and capacity of clinically based nurses. Interventions to further enhance nursing research and their evaluation are crucial if we are to address the deficit of nurse-led patient-centred research in the literature.

Managing diabetes mellitus using information technology: a systematic review.

PubMed

Riazi, H; Larijani, B; Langarizadeh, M; Shahmoradi, L

2015-01-01

To review published evidences about using information technology interventions in diabetes care and determine their effects on managing diabetes. Systematic review of information technology based interventions. MEDLINE®/PubMed were electronically searched for articles published between 2004/07/01 and 2014/07/01. A comprehensive, electronic search strategy was used to identify eligible articles. Inclusion criteria were defined based on type of study and effect of information technology based intervention in relation to glucose control and other clinical outcomes in diabetic patients. Studies must have used a controlled design to evaluate an information technology based intervention. A total of 3613 articles were identified based on the searches conducted in MEDLINE from PubMed. After excluding duplicates (n = 6), we screened titles and abstracts of 3607 articles based on inclusion criteria. The remaining articles matched with inclusion criteria (n = 277) were reviewed in full text, and 210 articles were excluded based on exclusion criteria. Finally, 67 articles complied with our eligibility criteria and were included in this study. In this study, the effect of various information technology based interventions on clinical outcomes in diabetic patients extracted and measured from selected articles is described and compared to each other. Information technology based interventions combined with the usual care are associated with improved glycemic control with different efficacy on various clinical outcomes in diabetic patients.

[Collaboration between science and practice: experiences of conducting a nursing intervention study].

PubMed

Panfil, Eva-Maria; Kirchner, Elisabeth; Bauder-Missbach, Heidi; Haasenritter, Jörg; Eisenschink, Anna Maria

2009-09-01

In a five-year intervention study about the impact of pre-operative mobilisation training session of patients receiving an elective medial laparotomy experiences about the collaboration between practice (University Hospital Ulm) and science (Hessian Institute of Nursing Research) were made. During the project possibilities and borders of clinical nursing research became clear. A research question based on practice experiences of nurses helps to develop and maintain motivation to conduct a study at a nursing unit. There was a lack of nursing knowledge to develop the best possible design, e.g. outcome criteria for mobilisation and standardized assessment instruments. The cooperation with other health care professionals (human movement science, statistics) was important and without difficulties. In Germany, without doctors' agreement and common application it is impossible to conduct nursing intervention studies in hospitals. It is necessary to train nursing specialists with both scientific and clinical competence to explore systematically clinical research questions.

A Systematic Review of Strategies for Implementing Empirically Supported Mental Health Interventions

PubMed Central

Powell, Byron J.; Proctor, Enola K.; Glass, Joseph E.

2013-01-01

Objective This systematic review examines experimental studies that test the effectiveness of strategies intended to integrate empirically supported mental health interventions into routine care settings. Our goal was to characterize the state of the literature and to provide direction for future implementation studies. Methods A literature search was conducted using electronic databases and a manual search. Results Eleven studies were identified that tested implementation strategies with a randomized (n = 10) or controlled clinical trial design (n = 1). The wide range of clinical interventions, implementation strategies, and outcomes evaluated precluded meta-analysis. However, the majority of studies (n = 7; 64%) found a statistically significant effect in the hypothesized direction for at least one implementation or clinical outcome. Conclusions There is a clear need for more rigorous research on the effectiveness of implementation strategies, and we provide several suggestions that could improve this research area. PMID:24791131

Statin-Induced Cardioprotection Against Ischemia-Reperfusion Injury: Potential Drug-Drug Interactions. Lesson to be Learnt by Translating Results from Animal Models to the Clinical Settings.

PubMed

Birnbaum, Gilad D; Birnbaum, Itamar; Ye, Yumei; Birnbaum, Yochai

2015-01-01

Numerous interventions have been shown to limit myocardial infarct size in animal models; however, most of these interventions have failed to have a significant effect in clinical trials. One potential explanation for the lack of efficacy in the clinical setting is that in bench models, a single intervention is studied without the background of other interventions or modalities. This is in contrast to the clinical setting in which new medications are added to the "standard of care" treatment that by now includes a growing number of medications. Drug-drug interaction may lead to alteration, dampening, augmenting or masking the effects of the intended intervention. We use the well described model of statin-induced myocardial protection to demonstrate potential interactions with agents which are commonly concomitantly used in patients with stable coronary artery disease and/or acute coronary syndromes. These interactions could potentially explain the reduced efficacy of statins in the clinical trials compared to the animal models. In particular, caffeine and aspirin could attenuate the infarct size limiting effects of statins; morphine could delay the onset of protection or mask the protective effect in patients with ST elevation myocardial infarction, whereas other anti-platelet agents (dipyridamole, cilostazol and ticagrelor) may augment (or mask) the effect due to their favorable effects on adenosine cell reuptake and intracellular cAMP levels. We recommend that after characterizing the effects of new modalities in single intervention bench research, studies should be repeated in the background of standard-of-care medications to assure that the magnitude of the effect is not altered before proceeding with clinical trials.

The cost-saving effect and prevention of medication errors by clinical pharmacist intervention in a nephrology unit.

PubMed

Chen, Chia-Chi; Hsiao, Fei-Yuan; Shen, Li-Jiuan; Wu, Chien-Chih

2017-08-01

Medication errors may lead to adverse drug events (ADEs), which endangers patient safety and increases healthcare-related costs. The on-ward deployment of clinical pharmacists has been shown to reduce preventable ADEs, and save costs. The purpose of this study was to evaluate the ADEs prevention and cost-saving effects by clinical pharmacist deployment in a nephrology ward.This was a retrospective study, which compared the number of pharmacist interventions 1 year before and after a clinical pharmacist was deployed in a nephrology ward. The clinical pharmacist attended ward rounds, reviewed and revised all medication orders, and gave active recommendations of medication use. For intervention analysis, the numbers and types of the pharmacist's interventions in medication orders and the active recommendations were compared. For cost analysis, both estimated cost saving and avoidance were calculated and compared.The total numbers of pharmacist interventions in medication orders were 824 in 2012 (preintervention), and 1977 in 2013 (postintervention). The numbers of active recommendation were 40 in 2012, and 253 in 2013. The estimated cost savings in 2012 and 2013 were NT$52,072 and NT$144,138, respectively. The estimated cost avoidances of preventable ADEs in 2012 and 2013 were NT$3,383,700 and NT$7,342,200, respectively. The benefit/cost ratio increased from 4.29 to 9.36, and average admission days decreased by 2 days after the on-ward deployment of a clinical pharmacist.The number of pharmacist's interventions increased dramatically after her on-ward deployment. This service could reduce medication errors, preventable ADEs, and costs of both medications and potential ADEs.

Clinical Efficacy of Psychoeducational Interventions with Family Caregivers

ERIC Educational Resources Information Center

Limiñana-Gras, Rosa M.; Colodro-Conde, Lucía; Cuéllar-Flores, Isabel; Sánchez-López, M. Pilar

2016-01-01

The goal of this study is to investigate the efficacy of psychoeducational interventions geared to reducing psychological distress for caregivers in a sample of 90 family caregivers of elderly dependent (78 women and 12 men). We conducted an analysis of the statistical and clinical significance of the changes observed in psychological health…

Clinical Reasoning in the Assessment and Intervention Planning for a Reading Disability

ERIC Educational Resources Information Center

Sotelo-Dynega, Marlene

2017-01-01

The purpose of this article is to provide the reader with insight into the clinical reasoning process involved in the assessment and intervention planning for a child with a reading disability. A Cattell-Horn-Carroll (CHC) theoretical/neuropsychological approach shall serve as the foundational theoretical framework for this case study, and…

Features and Effects of Information Technology-Based Interventions to Improve Self-Management in Chronic Kidney Disease Patients: a Systematic Review of the Literature.

PubMed

Jeddi, Fateme Rangraz; Nabovati, Ehsan; Amirazodi, Shahrzad

2017-09-18

Slowing down the progression of chronic kidney disease (CKD) and its adverse health outcomes requires the patient's self-management and attention to treatment recommendations. Information technology (IT)-based interventions are increasingly being used to support self-management in patients with chronic diseases such as CKD. We conducted a systematic review of randomized controlled trials (RCTs) to assess the features and effects of IT-based interventions on self-management outcomes of CKD patients. A comprehensive search was conducted in Medline, Scopus, and the Cochrane Library to identify relevant papers that were published until May 2016. RCT Studies that assessed at least one automated IT tool in patients with CKD stages 1 to 5, and reported at least one self-management outcome were included. Studies were appraised for quality using the Cochrane Risk of Bias assessment tool. Out of 12,215 papers retrieved, eight study met the inclusion criteria. Interventions were delivered via smartphones/personal digital assistants (PDAs) (three studies), wearable devices (three studies), computerized systems (one study), and multiple component (one study). The studies assessed 15 outcomes, including eight clinical outcomes and seven process of care outcomes. In 12 (80%) of the 15 outcomes, the studies had revealed the effects of the interventions as statistically significant positive. These positive effects were observed in 75% of the clinical outcomes and 86% of the process of care outcomes. The evidence indicates the potential of IT-based interventions (i.e. smartphones/PDAs, wearable devices, and computerized systems) in self-management outcomes (clinical and process of care outcomes) of CKD patients.

Effects of lifestyle education program for type 2 diabetes patients in clinics: study design of a cluster randomized trial.

PubMed

Adachi, Misa; Yamaoka, Kazue; Watanabe, Mariko; Nishikawa, Masako; Hida, Eisuke; Kobayashi, Itsuro; Tango, Toshiro

2010-11-30

The number of patients with type 2 diabetes is drastically increasing worldwide. It is a serious health problem in Japan as well. Lifestyle interventions can reduce progression from impaired glucose tolerance to type 2 diabetes, and glycemic control has been shown to improve postprandial plasma glucose levels. Moreover, several studies have suggested that continuous interventions (combined diet and exercise) can improve the plasma glucose level and reduce dosage of hypoglycemic agents.Although many interventional studies of lifestyle education for persons with diabetes in hospitals have been reported, only a few have been clinic-based studies employing an evidence-based lifestyle education program. This article describes the design of a cluster randomized controlled trial of the effectiveness of lifestyle education for patients with type 2 diabetes in clinics by registered dietitians. In Japan, general practitioners generally have their own medical clinics to provide medical care for outpatients in the community, including those with type 2 diabetes. With the collaboration of such general practitioners, the study patients were enrolled in the present study. Twenty general practitioners were randomly allocated to each provide patients for entry into either an intervention group (10) or a control group (10). In total, 200 participants will be included in the study. The intervention group will receive intensive education on lifestyle improvement related to type 2 diabetes by registered dietitians in clinics. Lifestyle education will be conducted several times during the study period. The control group will receive information on dietary intake and standard advice on glycemic control by registered dietitians. The primary endpoint is the change from the baseline value of HbA1c at 6 months. Data on health behavior and related issues will be gathered continuously over a 6-month period. This is the first study to evaluate lifestyle education in clinics by a cluster randomization trial in Japan. The proposed study will provide practical information about the usefulness of the intensive lifestyle improvement education program in primary care settings. The study was started in September 2007 and entry of subjects was completed in December 2010. Data on the effect evaluation will be available in 2011. UMIN000004049.

Dissonance-based interventions for health behaviour change: a systematic review.

PubMed

Freijy, Tanya; Kothe, Emily J

2013-05-01

Increasing evidence suggests that various health behaviours are amenable to change following the induction of cognitive dissonance. This systematic review sought to evaluate the effectiveness and methodological quality of dissonance-based health behaviour interventions and to explore identified sources of heterogeneity in intervention effects. Bibliographic databases were searched for relevant articles from inception to March 2012. Only studies targeting non-clinical health behaviour in non-clinical populations were included in the review. One author extracted data and assessed quality of evidence and a second author verified all content. Reports of 20 studies were included. A variety of health behaviours and outcome measures were addressed across studies. Most studies produced one or more significant effects on measures of behaviour, attitude or intention. Across studies, methodological risk for bias was frequently high, particularly for selection bias. Gender and self-esteem were identified as potential moderator variables. The evidence for the effectiveness of dissonance-based interventions was generally positive. The hypocrisy paradigm was found to be the most commonly applied research paradigm and was most effective at inciting change across a range of health behaviours. There was no observable link between type of target behaviour and positive outcomes. Researchers are encouraged to minimize potential for bias in future studies and explore moderators of the dissonance effect. What is already known on this subject? A recent meta-analysis indicates that dissonance-based interventions primarily based on the induced compliance paradigm are effective for eating disorder prevention (Stice, Shaw, Becker, & Rohde, 2008, Prev. Sci., 9, 114). However, it is currently unclear whether such outcomes are generalizable to interventions targeting non-clinical health behaviours such as smoking, sun protection and sexual risk taking. Other research indicates that studies based on the hypocrisy paradigm may lead to changes in non-clinical health behaviours (Stone & Fernandez, 2008, Soc. Personal. Psychol. Compass, 2, 1024; Stone & Focella, 2011, Self Identity, 10, 295) although this literature lacks systematic evaluation of interventions across a range of experimental paradigms. What does this study add? The hypocrisy paradigm appears most effective in inciting change across a range of non-clinical health behaviours. The dissonance effect may be moderated by variables such as self-esteem and gender. Risk of bias needs to be minimised to increase the validity of studies within this topic area. © 2013 The British Psychological Society.

Efficacy of Pharmacist Based Diabetes Educational Interventions on Clinical Outcomes of Adults With Type 2 Diabetes Mellitus: A Network Meta-Analysis.

PubMed

Bukhsh, Allah; Khan, Tahir M; Lee, Shaun W H; Lee, Learn-Han; Chan, Kok-Gan; Goh, Bey-Hing

2018-01-01

Background: Comparative efficacy of different pharmacist based interventions on glycemic control of type 2 diabetes patients is unclear. This review aimed to evaluate and compare the efficacy of different pharmacist based interventions on clinical outcomes of type 2 diabetes patients. Methods: A systematic search was conducted across five databases from date of database inception to September 2017. All randomized clinical trials evaluating the efficacy of pharmacist based interventions on type 2 diabetes patients were included for network meta-analysis (NMA). The protocol is available with PROSPERO (CRD42017078854). Results: A total of 43 studies, involving 6259 type 2 diabetes patients, were included. NMA demonstrated that all interventions significantly lowered glycosylated hemoglobin (HbA1c) levels compared to usual care, but there was no statistical evidence from this study that one intervention was significantly better than the other for reducing HbA1c levels. Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy for reducing HbA1c levels [-0.86, 95% CI -0.983, -0.727; p < 0.001]. Pharmacist based diabetes education plus pharmaceutical care was observed to be statistically significant in lowering levels of systolic blood pressure [-4.94; 95%CI -8.65, -1.23] and triglycerides levels [-0.26, 95%CI -0.51, -0.01], as compared to the interventions which involved diabetes education by pharmacist, and for body mass index (BMI) [-0.57; 95%CI -1.25, -0.12] in comparison to diabetes education by health care team involving pharmacist as member. Conclusion: The findings of this review demonstrate that all interventions had a significantly positive effect on HbA1c, but there was no statistical evidence from this study that one intervention was significantly better than the other for achieving glycemic control.Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy on HbA1c and rest of the clinical outcomes.

Clinical outcomes of an early intervention program for preschool children with Autism Spectrum Disorder in a community group setting.

PubMed

Eapen, Valsamma; Crnčec, Rudi; Walter, Amelia

2013-01-07

Available evidence indicates that early intervention programs, such as the Early Start Denver Model (ESDM), can positively affect key outcomes for children with Autism Spectrum Disorder (ASD). However, programs involving resource intensive one-to-one clinical intervention are not readily available or deliverable in the community, resulting in many children with ASD missing out on evidence-based intervention during their early and most critical preschool years. This study evaluated the effectiveness of the ESDM for preschool-aged children with ASD using a predominantly group-based intervention in a community child care setting. Participants were 26 children (21 male) with ASD with a mean age of 49.6 months. The ESDM, a comprehensive early intervention program that integrates applied behaviour analysis with developmental and relationship-based approaches, was delivered by trained therapists during the child's attendance at a child care centre for preschool-aged children with ASD. Children received 15-20 hours of group-based, and one hour of one-to-one, ESDM intervention per week. The average intervention period was ten months. Outcome measures were administered pre- and post-intervention, and comprised a developmental assessment - the Mullen Scales of Early Learning (MSEL); and two parent-report questionnaires - the Social Communication Questionnaire (SCQ) and Vineland Adaptive Behaviours Scales-Second Edition (VABS-II). Statistically significant post-intervention improvements were found in children's performance on the visual reception, receptive language and expressive language domains of the MSEL in addition to their overall intellectual functioning, as assessed by standardised developmental quotients. Parents reported significant increases in their child's receptive communication and motor skills on the VABS-II, and a significant decrease in autism-specific features on the SCQ. These effects were of around medium size, and appeared to be in excess of what may have been expected due to maturation. Nonetheless, these results need to be confirmed in a controlled study. This study suggests community dissemination of the ESDM using predominantly group-based intervention may be an effective intervention. Making the ESDM accessible to the wider ASD community in child care settings has the potential for significant clinical and economic benefits. Further studies are indicated in this area, including those with younger children, and which incorporate a control group and standardised ASD assessments. This trial is registered with the Australian New Zealand Clinical Trials Registry: Registry number ACTRN12612000461897.

Dietary interventions in overweight and obese pregnant women: a systematic review of the content, delivery, and outcomes of randomized controlled trials.

PubMed

Flynn, Angela C; Dalrymple, Kathryn; Barr, Suzanne; Poston, Lucilla; Goff, Louise M; Rogozińska, Ewelina; van Poppel, Mireille N M; Rayanagoudar, Girish; Yeo, SeonAe; Barakat Carballo, Ruben; Perales, Maria; Bogaerts, Annick; Cecatti, Jose G; Dodd, Jodie; Owens, Julie; Devlieger, Roland; Teede, Helena; Haakstad, Lene; Motahari-Tabari, Narges; Tonstad, Serena; Luoto, Riitta; Guelfi, Kym; Petrella, Elisabetta; Phelan, Suzanne; Scudeller, Tânia T; Hauner, Hans; Renault, Kristina; Sagedal, Linda Reme; Stafne, Signe N; Vinter, Christina; Astrup, Arne; Geiker, Nina R W; McAuliffe, Fionnuala M; Mol, Ben W; Thangaratinam, Shakila

2016-05-01

Interventions targeting maternal obesity are a healthcare and public health priority. The objective of this review was to evaluate the adequacy and effectiveness of the methodological designs implemented in dietary intervention trials for obesity in pregnancy. A systematic review of the literature, consistent with PRISMA guidelines, was performed as part of the International Weight Management in Pregnancy collaboration. Thirteen randomized controlled trials, which aimed to modify diet and physical activity in overweight and obese pregnant women, were identified. There was significant variability in the content, delivery, and dietary assessment methods of the dietary interventions examined. A number of studies demonstrated improved dietary behavior in response to diet and/or lifestyle interventions. Nine studies reduced gestational weight gain. This review reveals large methodological variability in dietary interventions to control gestational weight gain and improve clinical outcomes in overweight and obese pregnant women. This lack of consensus limits the ability to develop clinical guidelines and apply the evidence in clinical practice. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Development and validation of a screening procedure to identify speech-language delay in toddlers with cleft palate.

PubMed

Jørgensen, Line Dahl; Willadsen, Elisabeth

2017-01-01

The purpose of this study was to develop and validate a clinically useful speech-language screening procedure for young children with cleft palate ± cleft lip (CP) to identify those in need of speech-language intervention. Twenty-two children with CP were assigned to a +/- need for intervention conditions based on assessment of consonant inventory using a real-time listening procedure in combination with parent-reported expressive vocabulary. These measures allowed evaluation of early speech-language skills found to correlate significantly with later speech-language performance in longitudinal studies of children with CP. The external validity of this screening procedure was evaluated by comparing the +/- need for intervention assignment determined by the screening procedure to experienced speech-language pathologist (SLP)s' clinical judgement of whether or not a child needed early intervention. The results of real-time listening assessment showed good-excellent inter-rater agreement on different consonant inventory measures. Furthermore, there was almost perfect agreement between the children selected for intervention with the screening procedure and the clinical judgement of experienced SLPs indicate that the screening procedure is a valid way of identifying children with CP who need early intervention.

Targeting premeal anxiety in eating disordered clients and normal controls: a preliminary investigation into the use of mindful eating vs. distraction during food exposure.

PubMed

Marek, Ryan J; Ben-Porath, Denise D; Federici, Anita; Wisniewski, Lucene; Warren, Mark

2013-09-01

Studies have demonstrated that negative affect increases prior to food intake in individuals diagnosed with an eating disorder. Mindfulness has been supported empirically to treat experiential avoidance stemming from anxiety. Thus, the current objective in this study is to empirically compare mindfulness vs. thought suppression invention during a food exposure in both clinical and nonclinical samples. In a 2 (Group: clinical vs. nonclinical) × 2 (INTERVENTION: mindfulness vs. distraction) counterbalanced within treatment design, the current investigation sought to determine the differential effectiveness of a brief mindfulness intervention vs. a brief distraction intervention in women diagnosed with AN and BN in a clinical and nonclinical sample during a food exposure. Results indicated that the eating disorder group reported a significant increase in negative affect after the mindfulness intervention as compared to the distraction intervention, whereas the nonclinical group reported a significant decrease in negative affect after the mindfulness intervention as compared to the distraction intervention. Preliminary findings suggest that clinicians may want to proceed cautiously when using mindful eating in those with severe eating disorders during the early stages of food exposure. Limitations and future directions are discussed. Copyright © 2013 Wiley Periodicals, Inc.

Emtonjeni—A Structural Intervention to Integrate Sexual and Reproductive Health into Public Sector HIV Care in Cape Town, South Africa: Results of a Phase II Study

PubMed Central

Mantell, J. E.; Cooper, D.; Exner, T. M.; Moodley, J.; Hoffman, S.; Myer, L.; Leu, C.-S.; Bai, D.; Kelvin, E. A.; Jennings, K.; Stein, Z. A.; Constant, D.; Zweigenthal, V.; Cishe, N.; Nywagi, N.

2016-01-01

Integration of sexual and reproductive health within HIV care services is a promising strategy for increasing access to family planning and STI services and reducing unwanted pregnancies, perinatal HIV transmission and maternal and infant mortality among people living with HIV and their partners. We conducted a Phase II randomized futility trial of a multi-level intervention to increase adherence to safer sex guidelines among those wishing to avoid pregnancy and adherence to safer conception guidelines among those seeking conception in newly-diagnosed HIV-positive persons in four public-sector HIV clinics in Cape Town. Clinics were pair-matched and the two clinics within each pair were randomized to either a three-session provider-delivered enhanced intervention (EI) (onsite contraceptive services and brief milieu intervention for staff) or standard-of-care (SOC) provider-delivered intervention. The futility analysis showed that we cannot rule out the possibility that the EI intervention has a 10 % point or greater success rate in improving adherence to safer sex/safer conception guidelines than does SOC (p = 0.573), indicating that the intervention holds merit, and a larger-scale confirmatory study showing whether the EI is superior to SOC has merit. PMID:27807792

Mirror Therapy and Task-Oriented Training for People With a Paretic Upper Extremity.

PubMed

Bondoc, Salvador; Booth, Julie; Budde, Grace; Caruso, Katelyn; DeSousa, Michelle; Earl, Brittany; Hammerton, Kaitlynn; Humphreys, Jill

This study investigates the effect of mirror therapy and task-oriented training on the paretic upper extremity function and occupational performance of people with stroke. This study used a repeated-measures, case-series design in which 4 participants completed a 4-wk intervention consisting of mirror therapy and task-specific training. The intervention was conducted 2×/wk in the clinic and 4×/wk at home. All participants displayed clinically meaningful improvements in self-identified goals at the end of the intervention and at follow-up. Three participants showed clinically meaningful changes in motor function. Although only 1 participant improved in his reported amount of use, all participants showed clinically meaningful improvements in perceived movement quality at varying points of assessment. Mirror therapy, when used as priming for task-oriented training, can produce clinical improvements in upper extremity function and occupational performance in people with hemiparesis. Copyright © 2018 by the American Occupational Therapy Association, Inc.

Cost-outcome description of clinical pharmacist interventions in a university teaching hospital.

PubMed

Gallagher, James; Byrne, Stephen; Woods, Noel; Lynch, Deirdre; McCarthy, Suzanne

2014-04-17

Pharmacist interventions are one of the pivotal parts of a clinical pharmacy service within a hospital. This study estimates the cost avoidance generated by pharmacist interventions due to the prevention of adverse drug events (ADE). The types of interventions identified are also analysed. Interventions recorded by a team of hospital pharmacists over a one year time period were included in the study. Interventions were assigned a rating score, determined by the probability that an ADE would have occurred in the absence of an intervention. These scores were then used to calculate cost avoidance. Net cost benefit and cost benefit ratio were the primary outcomes. Categories of interventions were also analysed. A total cost avoidance of €708,221 was generated. Input costs were calculated at €81,942. This resulted in a net cost benefit of €626,279 and a cost benefit ratio of 8.64: 1. The most common type of intervention was the identification of medication omissions, followed by dosage adjustments and requests to review therapies. This study provides further evidence that pharmacist interventions provide substantial cost avoidance to the healthcare payer. There is a serious issue of patient's regular medication being omitted on transfer to an inpatient setting in Irish hospitals.

The intended and unintended consequences of communication systems on general internal medicine inpatient care delivery: a prospective observational case study of five teaching hospitals.

PubMed

Wu, Robert C; Lo, Vivian; Morra, Dante; Wong, Brian M; Sargeant, Robert; Locke, Ken; Cavalcanti, Rodrigo; Quan, Sherman D; Rossos, Peter; Tran, Kim; Cheung, Mark

2013-01-01

Effective clinical communication is critical to providing high-quality patient care. Hospitals have used different types of interventions to improve communication between care teams, but there have been few studies of their effectiveness. To describe the effects of different communication interventions and their problems. Prospective observational case study using a mixed methods approach of quantitative and qualitative methods. General internal medicine (GIM) inpatient wards at five tertiary care academic teaching hospitals. Clinicians consisting of residents, attending physicians, nurses, and allied health (AH) staff working on the GIM wards. Ethnographic methods and interviews with clinical staff (doctors, nurses, medical students, and AH professionals) were conducted over a 16-month period from 2009 to 2010. We identified four categories that described the intended and unintended consequences of communication interventions: impacts on senders, receivers, interprofessional collaboration, and the use of informal communication processes. The use of alphanumeric pagers, smartphones, and web-based communication systems had positive effects for senders and receivers, but unintended consequences were seen with all interventions in all four categories. Interventions that aimed to improve clinical communications solved some but not all problems, and unintended effects were seen with all systems.

A Systematic Review of Community-Based Participatory Research to Enhance Clinical Trials in Racial and Ethnic Minority Groups

PubMed Central

De Las Nueces, Denise; Hacker, Karen; DiGirolamo, Ann; Hicks, LeRoi S

2012-01-01

Objective To examine the effectiveness of current community-based participatory research (CBPR) clinical trials involving racial and ethnic minorities. Data Source All published peer-reviewed CBPR intervention articles in PubMed and CINAHL databases from January 2003 to May 2010. Study Design We performed a systematic literature review. Data Collection/Extraction Methods Data were extracted on each study's characteristics, community involvement in research, subject recruitment and retention, and intervention effects. Principle Findings We found 19 articles meeting inclusion criteria. Of these, 14 were published from 2007 to 2010. Articles described some measures of community participation in research with great variability. Although CBPR trials examined a wide range of behavioral and clinical outcomes, such trials had very high success rates in recruiting and retaining minority participants and achieving significant intervention effects. Conclusions Significant publication gaps remain between CBPR and other interventional research methods. CBPR may be effective in increasing participation of racial and ethnic minority subjects in research and may be a powerful tool in testing the generalizability of effective interventions among these populations. CBPR holds promise as an approach that may contribute greatly to the study of health care delivery to disadvantaged populations. PMID:22353031

Illustrating idiographic methods for translation research: moderation effects, natural clinical experiments, and complex treatment-by-subgroup interactions.

PubMed

Ridenour, Ty A; Wittenborn, Andrea K; Raiff, Bethany R; Benedict, Neal; Kane-Gill, Sandra

2016-03-01

A critical juncture in translation research involves the preliminary studies of intervention tools, provider training programs, policies, and other mechanisms used to leverage knowledge garnered at one translation stage into another stage. Potentially useful for such studies are rigorous techniques for conducting within-subject clinical trials, which have advanced incrementally over the last decade. However, these methods have largely not been utilized within prevention or translation contexts. The purpose of this manuscript is to demonstrate the flexibility, wide applicability, and rigor of idiographic clinical trials for preliminary testing of intervention mechanisms. Specifically demonstrated are novel uses of state-space modeling for testing intervention mechanisms of short-term outcomes, identifying heterogeneity in and moderation of within-person treatment mechanisms, a horizontal line plot to refine sampling design during the course of a clinic-based experimental study, and the need to test a treatment's efficacy as treatment is administered along with (e.g., traditional 12-month outcomes).

Effects of Mindfulness-Based Interventions in High School and College Athletes for Reducing Stress and Injury, and Improving Quality of Life.

PubMed

Petterson, Haley; Olson, Bernadette L

2017-11-01

Clinical Scenario: Student athletes experience a variety of stressors from school and social activities, as well as the additional demands of sport participation. Mindfulness-based interventions can help increase mental awareness and acceptance, as well as mitigate negative thoughts and emotions. The use of mindfulness-based interventions may be beneficial for reducing thoughts of stress, injury reduction, and improving overall wellbeing. Does the use of mindfulness-based interventions for student-athletes aged 13-24 years reduce stress and injury as well as improve overall quality of life? The literature was searched for studies that investigated the use of mindfulness-based strategies for student-athletes specifically for reducing stress and injury and/or improving quality of life. The literature search returned 8 possible studies related to the clinical question and 3 studies met the inclusion criteria (1 randomized control trial, 2 nonrandomized control cohort studies). All 3 included studies demonstrated overall improved levels of mindfulness among student-athletes after the use of a mindfulness-based intervention. Mindfulness-based interventions had positive effects for reducing negative thoughts and levels of perceived stress. The number of injury occurrences were found to decrease following the integration of a mindfulness-based intervention within an athletic population. Clinical Bottom Line: There is sufficient evidence supporting the use of mindfulness-based interventions with student-athletes for increasing mindfulness, managing negative emotions and perceived stress, as well as improving overall well-being. There is also current literature that advocates the use of mindfulness-based interventions for reducing injury, but further research is needed for support. Strength of Recommendation: Grade B evidence exists to support that the use of mindfulness-based interventions for student-athletes will reduce stress and improve overall well-being as well as support the possibility that if a student-athlete is more mindful, it may help decrease risk of injury incurred if the student-athlete is under mental stress.

Adoption and implementation of a computer-delivered HIV/STD risk-reduction intervention for African American adolescent females seeking services at county health departments: implementation optimization is urgently needed.

PubMed

DiClemente, Ralph J; Bradley, Erin; Davis, Teaniese L; Brown, Jennifer L; Ukuku, Mary; Sales, Jessica M; Rose, Eve S; Wingood, Gina M

2013-06-01

Although group-delivered HIV/sexually transmitted disease (STD) risk-reduction interventions for African American adolescent females have proven efficacious, they require significant financial and staffing resources to implement and may not be feasible in personnel- and resource-constrained public health clinics. We conducted a study assessing adoption and implementation of an evidence-based HIV/STD risk-reduction intervention that was translated from a group-delivered modality to a computer-delivered modality to facilitate use in county public health departments. Usage of the computer-delivered intervention was low across 8 participating public health clinics. Further investigation is needed to optimize implementation by identifying, understanding, and surmounting barriers that hamper timely and efficient implementation of technology-delivered HIV/STD risk-reduction interventions in county public health clinics.

Adoption and Implementation of a Computer-delivered HIV/STD Risk-Reduction Intervention for African American Adolescent Females Seeking Services at County Health Departments: Implementation Optimization is Urgently Needed

PubMed Central

DiClemente, Ralph J.; Bradley, Erin; Davis, Teaniese L.; Brown, Jennifer L.; Ukuku, Mary; Sales, Jessica M.; Rose, Eve S.; Wingood, Gina M.

2013-01-01

Although group-delivered HIV/STD risk-reduction interventions for African American adolescent females have proven efficacious, they require significant financial and staffing resources to implement and may not be feasible in personnel- and resource-constrained public health clinics. We conducted a study assessing adoption and implementation of an evidence-based HIV/STD risk-reduction intervention that was translated from a group-delivered modality to a computer-delivered modality to facilitate use in county public health departments. Usage of the computer-delivered intervention was low across eight participating public health clinics. Further investigation is needed to optimize implementation by identifying, understanding and surmounting barriers that hamper timely and efficient implementation of technology-delivered HIV/STD risk-reduction interventions in county public health clinics. PMID:23673891

Community health workers on a college campus: Effects on influenza vaccination.

PubMed

Huang, Jack J; Francesconi, Maria; Cooper, Madeline H; Covello, Allyson; Guo, Michelle; Gharib, Soheyla D

2018-01-01

To assess the impact of a campus community health worker program (HealthPALs) on student influenza vaccination. Undergraduate students at a northeastern US university (enrollment 6650), influenza seasons 2011-2012 through 2015-2016. Study design: Difference-in-differences analysis of student vaccination at campus dormitory influenza clinics during intervention vs. baseline. In the first intervention year, HealthPALs conducted in-person peer outreach at several campus dormitory flu clinics. Subsequent years, HealthPALs conducted an enhanced intervention, with the addition of a personalized, dormitory-specific social media campaign appealing to students' community identity. The initial intervention increased vaccinations by 66% (IRR = 1.66, 95%CI 1.39-1.97) at intervention clinics relative to control. The enhanced intervention increased vaccinations by 85% (IRR = 1.85, 95%CI 1.75-1.96). Community health workers can be a highly effective, low-cost strategy for increasing influenza vaccination among college students. This model could also be used to address other campus health challenges where student engagement is key.

A Randomized Clinical Trial Comparison Between Pivotal Response Treatment (PRT) and Structured Applied Behavior Analysis (ABA) Intervention for Children with Autism

PubMed Central

Mohammadzaheri, Fereshteh; Koegel, Lynn Kern; Rezaee, Mohammad; Rafiee, Seyed Majid

2014-01-01

Accumulating studies are documenting specific motivational variables that, when combined into a naturalistic teaching paradigm, can positively influence the effectiveness of interventions for children with autism spectrum disorder (ASD). The purpose of this study was to compare two ABA intervention procedures, a naturalistic approach, Pivotal Response Treatment (PRT) with a structured ABA approach in a school setting. A Randomized Clinical Trial design using two groups of children, matched according to age, sex and mean length of utterance was used to compare the interventions. The data showed that the PRT approach was significantly more effective in improving targeted and untargeted areas after three months of intervention. The results are discussed in terms of variables that produce more rapid improvements in communication for children with ASD. PMID:24840596

Usefulness of Cochrane Skin Group reviews for clinical practice.

PubMed

Davila-Seijo, P; Batalla, A; Garcia-Doval, I

2013-10-01

Systematic reviews are one of the most important sources of information for evidence-based medicine. However, there is a general impression that these reviews rarely report results that provide sufficient evidence to change clinical practice. The aim of this study was to determine the percentage of Cochrane Skin Group reviews reporting results with the potential to guide clinical decision-making. We performed a bibliometric analysis of all the systematic reviews published by the Cochrane Skin Group up to 16 August, 2012. We retrieved 55 reviews, which were analyzed and graded independently by 2 investigators into 3 categories: 0 (insufficient evidence to support or reject the use of an intervention), 1 (insufficient evidence to support or reject the use of an intervention but sufficient evidence to support recommendations or suggestions), and 2 (sufficient evidence to support or reject the use of an intervention). Our analysis showed that 25.5% (14/55) of the studies did not provide sufficient evidence to support or reject the use of the interventions studied, 45.5% (25/25) provided sufficient but not strong evidence to support recommendations or suggestions, and 29.1% (16/55) provided strong evidence to support or reject the use of 1 or more of the interventions studied. Most of the systematic reviews published by the Cochrane Skin Group provide useful information to improve clinical practice. Clinicians should read these reviews and reconsider their current practice. Copyright © 2012 Elsevier España, S.L. and AEDV. All rights reserved.

Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study): design of a cluster randomised trial.

PubMed

Cabezas, Carmen; Martin, Carlos; Granollers, Silvia; Morera, Concepció; Ballve, Josep Lluis; Zarza, Elvira; Blade, Jordi; Borras, Margarida; Serra, Antoni; Puente, Diana

2009-02-04

There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres. The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC). Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people). Intention to treat analysis. Smokers (n = 3024) aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial. 6-month implementation of recommendations of a Clinical Practice Guideline which includes 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. usual care. Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of

Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial.

PubMed

Grünzig, Sasha-Denise; Baumeister, Harald; Bengel, Jürgen; Ebert, David; Krämer, Lena

2018-05-22

Due to limited resources, waiting periods for psychotherapy are often long and burdening for those in need of treatment and the health care system. In order to bridge the gap between initial contact and the beginning of psychotherapy, web-based interventions can be applied. The implementation of a web-based depression intervention during waiting periods has the potential to reduce depressive symptoms and enhance well-being in depressive individuals waiting for psychotherapy. In a two-arm randomized controlled trial, effectiveness and acceptance of a guided web-based intervention for depressive individuals on a waitlist for psychotherapy are evaluated. Participants are recruited in several German outpatient clinics. All those contacting the outpatient clinics with the wish to enter psychotherapy receive study information and a depression screening. Those adults (age ≥ 18) with depressive symptoms above cut-off (CES-D scale > 22) and internet access are randomized to either intervention condition (treatment as usual and immediate access to the web-based intervention) or waiting control condition (treatment as usual and delayed access to the web-based intervention). At three points of assessment (baseline, post-treatment, 3-months-follow-up) depressive symptoms and secondary outcomes, such as quality of life, attitudes towards psychotherapy and web-based interventions and adverse events are assessed. Additionally, participants' acceptance of the web-based intervention is evaluated, using measures of intervention adherence and satisfaction. This study investigates a relevant setting for the implementation of web-based interventions, potentially improving the provision of psychological health care. The results of this study contribute to the evaluation of innovative and resource-preserving health care models for outpatient psychological treatment. This trial has been registered on 13 February 2017 in the German clinical trials register (DRKS); registration number DRKS00010282 .

Knowledge translation and implementation in spinal cord injury: a systematic review

PubMed Central

Noonan, VK; Wolfe, DL; Thorogood, NP; Park, SE; Hsieh, JT; Eng, JJ

2015-01-01

Objective To conduct a systematic review examining the effectiveness of knowledge translation (KT) interventions in changing clinical practice and patient outcomes. Methods MEDLINE/PubMed, CINAHL, EMBASE and PsycINFO were searched for studies published from January 1980 to July 2012 that reported and evaluated an implemented KT intervention in spinal cord injury (SCI) care. We reviewed and summarized results from studies that documented the implemented KT intervention, its impact on changing clinician behavior and patient outcomes as well as the facilitators and barriers encountered during the implementation. Results A total of 13 articles featuring 10 studies were selected and abstracted from 4650 identified articles. KT interventions included developing and implementing patient care protocols, providing clinician education and incorporating outcome measures into clinical practice. The methods (or drivers) to facilitate the implementation included organizing training sessions for clinical staff, introducing computerized reminders and involving organizational leaders. The methodological quality of studies was mostly poor. Only 3 out of 10 studies evaluated the success of the implementation using statistical analyses, and all 3 reported significant behavior change. Out of the 10 studies, 6 evaluated the effect of the implementation on patient outcomes using statistical analyses, with 4 reporting significant improvements. The commonly cited facilitators and barriers were communication and resources, respectively. Conclusion The field of KT in SCI is in its infancy with only a few relevant publications. However, there is some evidence that KT interventions may change clinician behavior and improve patient outcomes. Future studies should ensure rigorous study methods are used to evaluate KT interventions. PMID:24796445

Exploring the use of Option Grid™ patient decision aids in a sample of clinics in Poland.

PubMed

Scalia, Peter; Elwyn, Glyn; Barr, Paul; Song, Julia; Zisman-Ilani, Yaara; Lesniak, Monika; Mullin, Sarah; Kurek, Krzysztof; Bushell, Matt; Durand, Marie-Anne

2018-05-29

Research on the implementation of patient decision aids to facilitate shared decision making in clinical settings has steadily increased across Western countries. A study which implements decision aids and measures their impact on shared decision making has yet to be conducted in the Eastern part of Europe. To study the use of Option Grid TM patient decision aids in a sample of Grupa LUX MED clinics in Warsaw, Poland, and measure their impact on shared decision making. We conducted a pre-post interventional study. Following a three-month period of usual care, clinicians from three Grupa LUX MED clinics received a one-hour training session on how to use three Option Grid TM decision aids and were provided with copies for use for four months. Throughout the study, all eligible patients were asked to complete the three-item CollaboRATE patient-reported measure of shared decision making after their clinical encounter. CollaboRATE enables patients to assess the efforts clinicians make to: (i) inform them about their health issues; (ii) listen to 'what matters most'; (iii) integrate their treatment preference in future plans. A Hierarchical Logistic Regression model was performed to understand which variables had an effect on CollaboRATE. 2,048 patients participated in the baseline phase; 1,889 patients participated in the intervention phase. Five of the thirteen study clinicians had a statistically significant increase in their CollaboRATE scores (p<.05) when comparing baseline phase to intervention phase. All five clinicians were located at the same clinic, the only clinic where an overall increase (non-significant) in the mean CollaboRATE top score percentage occurred from baseline phase (M=60 %, SD=0.49; 95 % CI [57-63 %]) to intervention phase (M=62 %, SD=0.49; 95% CI [59-65%]). Only three of those five clinicians who had a statistically significant increase had a clinically significant difference. The implementation of Option Grid TM helped some clinicians practice shared decision making as reflected in CollaboRATE scores, but most clinicians did not have a significant increase in their scores. Our study indicates that the effect of these interventions may be dependent on clinic contexts and clinician engagement. Copyright © 2018. Published by Elsevier GmbH.

Toward Improving Quality of End-of-Life Care: Encoding Clinical Guidelines and Standing Orders Using the Omaha System.

PubMed

Slipka, Allison F; Monsen, Karen A

2018-02-01

End-of-life care (EOLC) relieves the suffering of millions of people around the globe each year. A growing body of hospice care research has led to the creation of several evidence-based clinical guidelines for EOLC. As evidence for the effectiveness of timely EOLC swells, so does the increased need for efficient information exchange between disciplines and across the care continuum. The purpose of this study was to investigate the feasibility of using the Omaha System as a framework for encoding interoperable evidence-based EOL interventions with specified temporality for use across disciplines and settings. Four evidence-based clinical guidelines and one current set of hospice standing orders were encoded using the Omaha System Problem Classification Scheme and Intervention Scheme, as well as Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT). The resulting encoded guideline was entered on a Microsoft Excel spreadsheet and made available for public use on the Omaha System Guidelines website. The resulting EOLC guideline consisted of 153 interventions that may enable patients and their surrogates, clinicians, and ancillary providers to communicate interventions in a universally comprehensible way. Evidence-based interventions from diverse disciplines involved in EOLC are described within this guideline using the Omaha System. Because the Omaha System and clinical guidelines are maintained in the public domain, encoding interventions is achievable by anyone with access to the Internet and basic Excel skills. Using the guideline as a documentation template customized for unique patient needs, clinicians can quantify and track patient care across the care continuum to ensure timely evidence-based interventions. Clinical guidelines coded in the Omaha System can support the use of multidisciplinary evidence-based interventions to improve quality of EOLC across settings and professions. © 2017 Sigma Theta Tau International.

Using video feedback to improve early father-infant interaction: a pilot study.

PubMed

Lawrence, Peter J; Davies, Beverley; Ramchandani, Paul G

2013-01-01

Preventive interventions with parents of infants have tended to focus on mothers. Recent research focused on fathers suggests that their involvement in interventions might enhance effectiveness. One effective approach with mothers is the brief, home-based Video-feedback Intervention to promote Positive Parenting (VIPP). This paper is a report of a pilot study of VIPP with fathers to assess its feasibility. Five fathers were recruited from an existing longitudinal study of parents. The primary outcome was acceptability, assessed using a semi-structured questionnaire after completion of the intervention. All fathers completed all sessions of the intervention. Fathers rated the intervention as having had a significant impact on their understanding of their child's thoughts and feelings, and as having improved their communication and relationship with their baby. Fathers' feedback was generally positive. The flexibility to conduct sessions at home (or at fathers' places of work) and the flexible timing of sessions were identified as fundamental to successful delivery. The results of this pilot study are encouraging, as VIPP with fathers was feasible. In light of the modest sample size, and the use of a non-clinical sample, the intervention must be evaluated with larger, clinical samples to evaluate its efficacy with fathers.

Interest in Health Behavior Intervention Delivery Modalities Among Cancer Survivors: A Cross-Sectional Study

PubMed Central

Basen-Engquist, Karen; Cox, Matthew G; Lyons, Elizabeth J; Carmack, Cindy L; Blalock, Janice A; Demark-Wahnefried, Wendy

2016-01-01

Background Effective, broad-reaching channels are important for the delivery of health behavior interventions in order to meet the needs of the growing population of cancer survivors in the United States. New technology presents opportunities to increase the reach of health behavior change interventions and therefore their overall impact. However, evidence suggests that older adults may be slower in their adoption of these technologies than the general population. Survivors’ interest for more traditional channels of delivery (eg, clinic) versus new technology-based channels (eg, smartphones) may depend on a variety of factors, including demographics, current health status, and the behavior requiring intervention. Objective The aim of this study was to determine the factors that predict cancer survivors’ interest in new technology-based health behavior intervention modalities versus traditional modalities. Methods Surveys were mailed to 1871 survivors of breast, prostate, and colorectal cancer. Participants’ demographics, diet and physical activity behaviors, interest in health behavior interventions, and interest in intervention delivery modalities were collected. Using path analysis, we explored the relationship between four intervention modality variables (ie, clinic, telephone, computer, and smartphone) and potential predictors of modality interest. Results In total, 1053 respondents to the survey (56.3% response rate); 847 provided complete data for this analysis. Delivery channel interest was highest for computer-based interventions (236/847, 27.9% very/extremely interested) and lowest for smartphone–based interventions (73/847, 8.6%), with interest in clinic-based (147/847, 17.3%) and telephone-delivered (143/847, 16.9%) falling in between. Use of other technology platforms, such as Web cameras and social networking sites, was positively predictive of interest in technology-based delivery channels. Older survivors were less likely to report interest in smartphone–based diet interventions. Physical activity, fruit and vegetable consumption, weight status, and age moderated relationships between interest in targeted intervention behavior and modality. Conclusions This study identified several predictors of survivor interest in various health behavior intervention delivery modalities. Overall, computer-based interventions were found to be most acceptable, while smartphones were the least. Factors related to survivors’ current technology use and health status play a role in their interest for technology-based intervention versus more traditional delivery channels. Future health behavior change research in this population should consider participants’ demographic, clinical, and lifestyle characteristics when selecting a delivery channel. Furthermore, current health behavior interventions for older cancer survivors may be best delivered over the Internet. Smartphone interventions may be feasible in the future following further adoption and familiarization by this particular population. PMID:28410164

Advanced practice nurses core competencies: a framework for developing and testing an advanced practice nurse discharge intervention.

PubMed

Cooke, Liz; Gemmill, Robin; Grant, Marcia

2008-01-01

The purpose of this paper was to describe evidenced-based interventions as implemented by advanced practice nurses (APNs) conducting intervention research with a vulnerable population of blood and marrow transplant patients. In addition, each of the 6 core competencies of the APN role identified by Hamric are outlined and applied using a patient case study. These competencies are the following: direct clinical practice, expert coaching and advice, consultation, research skills, clinical and professional leadership, collaboration, and ethical decision making. This article chronicles a typical patient's journey through a post-hospital discharge nursing research study involving APNs as "intervention nurses" and discusses the various aspects of the APN core competencies throughout the process.

Methodological considerations in the design and implementation of clinical trials.

PubMed

Cirrincione, Constance T; Lavoie Smith, Ellen M; Pang, Herbert

2014-02-01

To review study design issues related to clinical trials led by oncology nurses, with special attention to those conducted within the cooperative group setting; to emphasize the importance of the statistician's role in the process of clinical trials. Studies available at clinicaltrials.gov using experimental designs that have been published in peer-reviewed journals; cooperative group trials are highlighted. The clinical trial is a primary means to test intervention efficacy. A properly designed and powered study with clear and measurable objectives is as important as the intervention itself. Collaboration among the study team, including the statistician, is central in developing and conducting appropriately designed studies. For optimal results, collaboration is an ongoing process that should begin early on. Copyright © 2014 Elsevier Inc. All rights reserved.

Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children.

PubMed

Lepore, Stephen J; Winickoff, Jonathan P; Moughan, Beth; Bryant-Stephens, Tyra C; Taylor, Daniel R; Fleece, David; Davey, Adam; Nair, Uma S; Godfrey, Melissa; Collins, Bradley N

2013-08-30

Secondhand smoke exposure (SHSe) harms children's health, yet effective interventions to reduce child SHSe in the home and car have proven difficult to operationalize in pediatric practice. A multilevel intervention combining pediatric healthcare providers' advice with behavioral counseling and navigation to pharmacological cessation aids may improve SHSe control in pediatric populations. This trial uses a randomized, two-group design with three measurement periods: pre-intervention, end of treatment and 12-month follow-up. Smoking parents of children < 11-years-old are recruited from pediatric clinics. The clinic-level intervention includes integrating tobacco intervention guideline prompts into electronic health record screens. The prompts guide providers to ask all parents about child SHSe, advise about SHSe harms, and refer smokers to cessation resources. After receiving clinic intervention, eligible parents are randomized to receive: (a) a 3-month telephone-based behavioral counseling intervention designed to promote reduction in child SHSe, parent smoking cessation, and navigation to access nicotine replacement therapy or cessation medication or (b) an attention control nutrition education intervention. Healthcare providers and assessors are blind to group assignment. Cotinine is used to bioverify child SHSe (primary outcome) and parent quit status. This study tests an innovative multilevel approach to reducing child SHSe. The approach is sustainable, because clinics can easily integrate the tobacco intervention prompts related to "ask, advise, and refer" guidelines into electronic health records and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. NCT01745393 (clinicaltrials.gov).

Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children

PubMed Central

2013-01-01

Background Secondhand smoke exposure (SHSe) harms children’s health, yet effective interventions to reduce child SHSe in the home and car have proven difficult to operationalize in pediatric practice. A multilevel intervention combining pediatric healthcare providers’ advice with behavioral counseling and navigation to pharmacological cessation aids may improve SHSe control in pediatric populations. Methods/design This trial uses a randomized, two-group design with three measurement periods: pre-intervention, end of treatment and 12-month follow-up. Smoking parents of children < 11-years-old are recruited from pediatric clinics. The clinic-level intervention includes integrating tobacco intervention guideline prompts into electronic health record screens. The prompts guide providers to ask all parents about child SHSe, advise about SHSe harms, and refer smokers to cessation resources. After receiving clinic intervention, eligible parents are randomized to receive: (a) a 3-month telephone-based behavioral counseling intervention designed to promote reduction in child SHSe, parent smoking cessation, and navigation to access nicotine replacement therapy or cessation medication or (b) an attention control nutrition education intervention. Healthcare providers and assessors are blind to group assignment. Cotinine is used to bioverify child SHSe (primary outcome) and parent quit status. Discussion This study tests an innovative multilevel approach to reducing child SHSe. The approach is sustainable, because clinics can easily integrate the tobacco intervention prompts related to “ask, advise, and refer” guidelines into electronic health records and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. Trial registration NCT01745393 (clinicaltrials.gov). PMID:23987302

The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC): a randomised cluster controlled trial.

PubMed

Li, Yanping; Hu, Xiaoqi; Zhang, Qian; Liu, Ailing; Fang, Hongyun; Hao, Linan; Duan, Yifan; Xu, Haiquan; Shang, Xianwen; Ma, Jun; Xu, Guifa; Du, Lin; Li, Ying; Guo, Hongwei; Li, Tingyu; Ma, Guansheng

2010-05-02

Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook) and physical activity intervention (Happy 10 program) will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years) will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device), physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the intervention strategies would justify a national school-based program to prevent childhood obesity in China.

A mapping review of international guidance on the management and care of amyotrophic lateral sclerosis (ALS).

PubMed

Janssens, Astrid I W A; Ruytings, Marijke; Al-Chalabi, Ammar; Chio, Adriano; Hardiman, Orla; Mcdermott, Christopher J; Meyer, Thomas; Mora, Gabriele; Van Damme, Philip; Van Den Berg, Leonard H; Vanhaecht, Kris; Winkler, Andrea S; Sermeus, Walter

2016-01-01

Management of ALS is suboptimal. Consequently, quality improvement interventions are needed to improve ALS care. An evidence-based insight into how patients should be managed is essential when developing quality improvement interventions. Therefore, this study aimed to map, categorize and summarize international guidance on the management and care of ALS and to identify gaps in this guidance by means of a mapping review. Literature was searched for clinical practice guidelines, quality indicators and evidence-based clinical summaries. A content analysis and meta-synthesis of the included literature was performed. Interventions and outcomes used in the management and care of ALS were identified and categorized. Furthermore, the amount of guidance underpinning these interventions and outcomes was analysed. Six clinical practice guidelines, one set of quality indicators and three evidence-based clinical summaries were identified. The results demonstrated that certain domains in ALS care, mainly disease-specific domains such as breathing and swallowing, are extensively addressed in the literature whereas other subjects, such as care coordination, receive little attention. In conclusion, this mapping review provides a scientific basis for targeting and developing the clinical content of a quality improvement intervention for the management of ALS.

Multimodal interventions including nutrition in the prevention and management of disease-related malnutrition in adults: a systematic review of randomised control trials.

PubMed

Thorne, Frances; Baldwin, Christine

2014-06-01

There has been a move to improve nutritional status in malnourished patients through the use of multimodal interventions (MI). There are currently no systematic reviews that have examined their effectiveness. This analysis aimed to examine the effects on nutritional, clinical, functional and patient-centred outcomes. A systematic review and meta-analysis using Cochrane methodology. 15 studies were included in the analysis, 13 comparing MI with usual care and 2 comparing MI with a nutrition intervention alone. Quality of studies varied and studies reported few relevant outcomes. Only 3 outcomes were compatible with meta-analysis; weight, mortality and length of stay (LOS). No statistically significant differences between groups were found. Narrative review was inconclusive. There was no evidence of benefit in the intervention groups in relation to body composition, functional status or quality of life (QoL). Intervention groups appeared to show a trend towards increased energy and protein intake however data was provided by only 2 studies (301 participants). No conclusive evidence of benefit for MI on any of the reviewed outcomes was found. Well designed, high quality trials addressing the impact of MI on relevant nutritional, functional and clinical outcomes are required. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Multidisciplinary COPD disease management program: impact on clinical outcomes.

PubMed

Morganroth, Melvin; Pape, Ginger; Rozenfeld, Yelena; Heffner, John E

2016-01-01

We hypothesized performance improvement interventions would improve COPD guideline-recommended care and decrease COPD exacerbations in primary care clinic practices. We initiated a performance improvement project in 12 clinics to improve COPD outcomes incorporating physician education, case management, web-based decision support (CareManager(TM)), and performance feedback. We collected baseline and one-year follow up data on 242 patients who had COPD with acute exacerbations. We analyzed data by two methods. First, the 12 clinics were cluster randomized to 4 intervention (117 patients) and 8 control (125 patients) clinics which all had access to CareManager(TM) but only intervention clinic physicians received case management, academic detailing, and decision support assistance. Exacerbation rates and guideline adherence were compared. Second, data from all 12 clinics were pooled in a quasi-experimental design comparing baseline and post-implementation of CareManager(TM) to determine the value of system-wide performance improvement during the study period. In the randomized analysis, baseline demographics were similar. No differences (p = 0.79) occurred in exacerbation rates between intervention and control clinics although both groups had decreased numbers of exacerbations from baseline to follow up (p < 0.05). The pooled data from all 12 clinics demonstrated a reduction (p < 0.05) in mean exacerbations/patient from 2.3 (CI 2.0-2.6) during baseline to 1.4 (CI 1.1-1.7) at one-year follow up. Emergency department visits and hospitalizations/patient decreased (p = 0.003). Patients naïve at study start to depression screening, pneumococcal vaccination, inhaled control medications or smoking cessation had fewer (p < 0.05) exacerbations after these interventions. We observed no difference in exacerbation rates between clinics receiving case management, academic detailing, and ongoing assistance with decision support and controls. Implementation of a web-based disease management system (CareManager(TM)) along with health system-wide COPD performance improvement efforts was associated with fewer COPD exacerbations and increased adherence to guideline recommendations.

[Selection of "surrogate" and "endpoints" evaluation of the efficacy of medical interventions].

PubMed

Lazebnik, L B; Gusein-Zade, M G; Efremov, L I

2011-01-01

With the advent of new medical technologies and medicines, as well as due to changes in disease patterns and demographic problems rises the need for continued increases in health spending. Increased costs can be totally inadequate, if it has been done without studying the effectiveness of medical interventions, based on the results of evidence-based medicine and economic of their feasibility. To evaluate the clinical effectiveness of medical interventions have been recently used specific criteria, so called points of clinical efficacy (surrogate and endpoints), that allow to conclude feasibility or harmfulness of the introduction or application of the intervention in clinical practice. The endpoint is reliable indicator the effectiveness of medical intervention. Surrogate point--is a biomarker that is intended to replace the endpoint and is a predictor of the effectiveness of medical intervention. The use of surrogate points has several advantages such as simple in identification and measurement, as well as more higher in compare with endpoints the vents frequency, that can significantly reduce the size of the selection and duration and cost of clinical trials, respectively. Finally, the surrogate points allow to evaluate treatment effect in situations where the use of endpoints is difficult or is unethical.

Implementation of national guidelines, incorporated within structured diabetes and hypertension records at primary level care in Cape Town, South Africa: a randomised controlled trial.

PubMed

Steyn, Krisela; Lombard, Carl; Gwebushe, Nomonde; Fourie, Jean M; Everett-Murphy, Katherine; Zwarenstein, Merrick; Levitt, Naomi S

2013-09-25

Many clinical management guidelines for chronic diseases have been published, but they have not been put into practice by busy clinicians at primary care levels. This study evaluates the implementation of national guidelines incorporated within a structured diabetes and hypertension clinical record (SR) in Cape Town in a randomised controlled trial (RCT). Eighteen public sector community health centres (CHC) were randomly selected and allocated as intervention or control CHC. At each clinic, 25 patients with diabetes and 35 patients with hypertension were enrolled at baseline. Questionnaires were completed, blood samples were collected, blood pressure (BP) and anthropometric measures were taken and patient records were audited. SR with clinical guideline prompts were introduced at the intervention clinics after training doctors in their use and suggestions to incorporate them in regular patient records. Contact was maintained during the year of intervention with the clinic staff. A follow-up survey was conducted 1 year later to assess BP and HbA1c, and the patient records were examined to ascertain the extent of use of the SR in the intervention clinics. In-depth interviews were conducted with doctors and nurses to record their response to the intervention. The intervention evaluated in this RCT had no impact on either diabetes or hypertension control. In the intervention clinics, less than 60% of the patient folders contained the SR and when present was seldom used. Although the staff were well disposed to the research team, their workload prohibited them from undertaking a true evaluation of the SR, and overall they did not perceive the SR as supporting their current process of patient care. No benefit to diabetes of hypertension care by introducing and availability of the staff in the use of the SR was shown in this RCT. The process measures suggest that the SR was not widely used by the healthcare provided in the primary care clinics.

Effect of a Brief Video Intervention on Incident Infection among Patients Attending Sexually Transmitted Disease Clinics

PubMed Central

Warner, Lee; Klausner, Jeffrey D; Rietmeijer, Cornelis A; Malotte, C. Kevin; O'Donnell, Lydia; Margolis, Andrew D; Greenwood, Gregory L; Richardson, Doug; Vrungos, Shelley; O'Donnell, Carl R; Borkowf, Craig B

2008-01-01

Background Sexually transmitted disease (STD) prevention remains a public health priority. Simple, practical interventions to reduce STD incidence that can be easily and inexpensively administered in high-volume clinical settings are needed. We evaluated whether a brief video, which contained STD prevention messages targeted to all patients in the waiting room, reduced acquisition of new infections after that clinic visit. Methods and Findings In a controlled trial among patients attending three publicly funded STD clinics (one in each of three US cities) from December 2003 to August 2005, all patients (n = 38,635) were systematically assigned to either a theory-based 23-min video depicting couples overcoming barriers to safer sexual behaviors, or the standard waiting room environment. Condition assignment alternated every 4 wk and was determined by which condition (intervention or control) was in place in the clinic waiting room during the patient's first visit within the study period. An intent-to-treat analysis was used to compare STD incidence between intervention and control patients. The primary endpoint was time to diagnosis of incident laboratory-confirmed infections (gonorrhea, chlamydia, trichomoniasis, syphilis, and HIV), as identified through review of medical records and county STD surveillance registries. During 14.8 mo (average) of follow-up, 2,042 patients (5.3%) were diagnosed with incident STD (4.9%, intervention condition; 5.7%, control condition). In survival analysis, patients assigned to the intervention condition had significantly fewer STDs compared with the control condition (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.84 to 0.99). Conclusions Showing a brief video in STD clinic waiting rooms reduced new infections nearly 10% overall in three clinics. This simple, low-intensity intervention may be appropriate for adoption by clinics that serve similar patient populations. Trial registration: http://www.ClinicalTrials.gov (#NCT00137670). PMID:18578564

Interprofessional collaboration to improve professional practice and healthcare outcomes.

PubMed

Reeves, Scott; Pelone, Ferruccio; Harrison, Reema; Goldman, Joanne; Zwarenstein, Merrick

2017-06-22

Poor interprofessional collaboration (IPC) can adversely affect the delivery of health services and patient care. Interventions that address IPC problems have the potential to improve professional practice and healthcare outcomes. To assess the impact of practice-based interventions designed to improve interprofessional collaboration (IPC) amongst health and social care professionals, compared to usual care or to an alternative intervention, on at least one of the following primary outcomes: patient health outcomes, clinical process or efficiency outcomes or secondary outcomes (collaborative behaviour). We searched CENTRAL (2015, issue 11), MEDLINE, CINAHL, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform to November 2015. We handsearched relevant interprofessional journals to November 2015, and reviewed the reference lists of the included studies. We included randomised trials of practice-based IPC interventions involving health and social care professionals compared to usual care or to an alternative intervention. Two review authors independently assessed the eligibility of each potentially relevant study. We extracted data from the included studies and assessed the risk of bias of each study. We were unable to perform a meta-analysis of study outcomes, given the small number of included studies and their heterogeneity in clinical settings, interventions and outcomes. Consequently, we summarised the study data and presented the results in a narrative format to report study methods, outcomes, impact and certainty of the evidence. We included nine studies in total (6540 participants); six cluster-randomised trials and three individual randomised trials (1 study randomised clinicians, 1 randomised patients, and 1 randomised clinicians and patients). All studies were conducted in high-income countries (Australia, Belgium, Sweden, UK and USA) across primary, secondary, tertiary and community care settings and had a follow-up of up to 12 months. Eight studies compared an IPC intervention with usual care and evaluated the effects of different practice-based IPC interventions: externally facilitated interprofessional activities (e.g. team action planning; 4 studies), interprofessional rounds (2 studies), interprofessional meetings (1 study), and interprofessional checklists (1 study). One study compared one type of interprofessional meeting with another type of interprofessional meeting. We assessed four studies to be at high risk of attrition bias and an equal number of studies to be at high risk of detection bias.For studies comparing an IPC intervention with usual care, functional status in stroke patients may be slightly improved by externally facilitated interprofessional activities (1 study, 464 participants, low-certainty evidence). We are uncertain whether patient-assessed quality of care (1 study, 1185 participants), continuity of care (1 study, 464 participants) or collaborative working (4 studies, 1936 participants) are improved by externally facilitated interprofessional activities, as we graded the evidence as very low-certainty for these outcomes. Healthcare professionals' adherence to recommended practices may be slightly improved with externally facilitated interprofessional activities or interprofessional meetings (3 studies, 2576 participants, low certainty evidence). The use of healthcare resources may be slightly improved by externally facilitated interprofessional activities, interprofessional checklists and rounds (4 studies, 1679 participants, low-certainty evidence). None of the included studies reported on patient mortality, morbidity or complication rates.Compared to multidisciplinary audio conferencing, multidisciplinary video conferencing may reduce the average length of treatment and may reduce the number of multidisciplinary conferences needed per patient and the patient length of stay. There was little or no difference between these interventions in the number of communications between health professionals (1 study, 100 participants; low-certainty evidence). Given that the certainty of evidence from the included studies was judged to be low to very low, there is not sufficient evidence to draw clear conclusions on the effects of IPC interventions. Neverthess, due to the difficulties health professionals encounter when collaborating in clinical practice, it is encouraging that research on the number of interventions to improve IPC has increased since this review was last updated. While this field is developing, further rigorous, mixed-method studies are required. Future studies should focus on longer acclimatisation periods before evaluating newly implemented IPC interventions, and use longer follow-up to generate a more informed understanding of the effects of IPC on clinical practice.

An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical centers.

PubMed

Hagedorn, Hildi J; Stetler, Cheryl B; Bangerter, Ann; Noorbaloochi, Siamak; Stitzer, Maxine L; Kivlahan, Daniel

2014-07-09

One of the pressing concerns in health care today is the slow rate at which promising interventions, supported by research evidence, move into clinical practice. One potential way to speed this process is to conduct hybrid studies that simultaneously combine the collection of effectiveness and implementation relevant data. This paper presents implementation relevant data collected during a randomized effectiveness trial of an abstinence incentive intervention conducted in substance use disorders treatment clinics at two Veterans Health Administration (VHA) medical centers. Participants included patients entering substance use disorders treatment with diagnoses of alcohol dependence and/or stimulant dependence that enrolled in the randomized trial, were assigned to the intervention arm, and completed a post intervention survey (n = 147). All staff and leadership from the participating clinics were eligible to participate. A descriptive process evaluation was used, focused on participant perceptions and contextual/feasibility issues. Data collection was guided by the RE-AIM and PARIHS implementation frameworks. Data collection methods included chart review, intervention cost tracking, patient and staff surveys, and qualitative interviews with staff and administrators. Results indicated that patients, staff and administrators held generally positive attitudes toward the incentive intervention. However, staff and administrators identified substantial barriers to routine implementation. Despite the documented low cost and modest staff time required for implementation of the intervention, securing funding for the incentives and freeing up any staff time for intervention administration were identified as primary barriers. Recommendations to facilitate implementation are presented. Recommendations include: 1) solicit explicit support from the highest levels of the organization through, for example, performance measures or clinical practice guideline recommendations; 2) adopt the intervention incrementally starting within a specific treatment track or clinic to reduce staff and funding burden until local evidence of effectiveness and feasibility is available to support spread; and 3) educate staff about the process, goals, and value/effectiveness of the intervention and engage them in implementation planning from the start to enhance investment in the intervention.

Cognition before curriculum: rethinking the integration of basic science and clinical learning.

PubMed

Kulasegaram, Kulamakan Mahan; Martimianakis, Maria Athina; Mylopoulos, Maria; Whitehead, Cynthia R; Woods, Nicole N

2013-10-01

Integrating basic science and clinical concepts in the undergraduate medical curriculum is an important challenge for medical education. The health professions education literature includes a variety of educational strategies for integrating basic science and clinical concepts at multiple levels of the curriculum. To date, assessment of this literature has been limited. In this critical narrative review, the authors analyzed literature published in the last 30 years (1982-2012) using a previously published integration framework. They included studies that documented approaches to integration at the level of programs, courses, or teaching sessions and that aimed to improve learning outcomes. The authors evaluated these studies for evidence of successful integration and to identify factors that contribute to integration. Several strategies at the program and course level are well described but poorly evaluated. Multiple factors contribute to successful learning, so identifying how interventions at these levels result in successful integration is difficult. Evidence from session-level interventions and experimental studies suggests that integration can be achieved if learning interventions attempt to link basic and clinical science in a causal relationship. These interventions attend to how learners connect different domains of knowledge and suggest that successful integration requires learners to build cognitive associations between basic and clinical science. One way of understanding the integration of basic and clinical science is as a cognitive activity occurring within learners. This perspective suggests that learner-centered, content-focused, and session-level-oriented strategies can achieve cognitive integration.

Prevalence of Recommendations Made Within Dental Research Articles Using Uncontrolled Intervention or Observational Study Designs.

PubMed

Wilson, M K; Chestnutt, I G

2016-03-01

Evidence to inform clinical practice is reliant on research carried out using appropriate study design. The objectives of this work were to (i) identify the prevalence of articles reporting on human studies using uncontrolled intervention or observational research designs published in peer-reviewed dental journals and (ii) determine the nature of recommendations made by these articles. Six peer-reviewed dental journals were selected. Issues published in January to June 2013 were examined and the types of articles published categorized. Following pre-defined inclusion/exclusion criteria, human studies classified as using uncontrolled intervention or observational research designs were subject to detailed review by two independent investigators, to examine if they presented clinical, policy or research recommendations and if these recommendations were supported by the data presented. 52.9% (n = 156) of studies published during the time period met the inclusion criteria. Studies with uncontrolled intervention or observational research designs comprised a larger proportion of the primary research studies published in the journals with lower impact factors (73.3%; n = 107) compared to the high impact journals (38.9%; n = 49). Analysis showed that 60.9% (n = 95) of the included studies made recommendations for clinical practice/dental policy. In 28.2% (n = 44) of studies, the clinical/policy recommendations made were judged to not be fully supported by the data presented. Many studies published in the current dental literature, which are not considered to produce strong evidence, make recommendations for clinical practice or policy. There were some cases when the recommendations were not fully supported by the data presented. Copyright © 2016 Elsevier Inc. All rights reserved.

Minor Children of Palliative Patients: A Systematic Review of Psychosocial Family Interventions

PubMed Central

Krattenmacher, Thomas; Beierlein, Volker; Grimm, Johann Christian; Bergelt, Corinna; Romer, Georg; Möller, Birgit

2012-01-01

Abstract Although the whole family is affected by a parent's palliative disease, palliative care research does not yet routinely consider patients' minor children. Children's and adolescents' psychosocial functioning may be impaired during prolonged parental disease with poor prognosis. Therefore, more and more health care providers are establishing clinical initiatives for families of palliative patients with minor children. However, the number of these family interventions, as well as their theoretical and empirical backgrounds and evidence base, has yet to be determined. The purpose of this study was to systematically review structured and published interventions for this target group, as well as empirical studies on these interventions. The evidence base and impact of interventions on families were considered. Literature published between 1980 and present focusing on psychosocial family-, child- or parent-centered interventions during palliative care was retrieved from PsycINFO®, Embase, MEDLINE®, CINAHL®, and PSYNDEX databases. Five interventions met the inclusion criteria. Programs focused on different populations, had diverse empirical and theoretical backgrounds and features, and were evaluated by studies of varying methodological quality. This systematic review illustrates the lack of well designed and elaborated intervention concepts and evaluation studies in this field, highlighting the necessity of conceptual and methodological rigor to inform clinical practice on a sustainable basis in the future. PMID:22849598

Asthma interventions in primary schools--a review.

PubMed

Al Aloola, Noha A; Naik-Panvelkar, Pradnya; Nissen, Lisa; Saini, Bandana

2014-10-01

To explore, in depth, the literature for evidence supporting asthma interventions delivered within primary schools and to identify any "gaps" in this research area. A literature search using electronic search engines (i.e. Medline, PubMed, Education Resources Information Center (ERIC), International Pharmaceutical Abstracts (IPA), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase and Informit) and the search terms "asthma", "asthma intervention" and "school-based asthma education program" (and derivatives of these keywords) was conducted. Twenty-three articles met the inclusion criteria; of these eight were Randomised Controlled Trials. There was much variety in the type, content, delivery and outcome measures in these 23 studies. The most common intervention type was asthma education delivery. Most studies demonstrated improvement in clinical and humanistic markers, for example, asthma symptoms medication use (decrease in reliever medication use or decrease in the need for rescue oral steroid), inhaler use technique and spacer use competency, lung function and quality of life. Relatively few studies explored the effect of the intervention on academic outcomes. Most studies did not report on the sustainability or cost effectiveness of the intervention tested. Another drawback in the literature was the lack of details about the intervention and inconsistency in instruments selected for measuring outcomes. School-based asthma interventions regardless of their heterogeneity have positive clinical, humanistic, health economical and academic outcomes.

Clinical utilization of musculoskeletal sonography involving non-physician rehabilitation providers: A scoping review

PubMed Central

Roll, Shawn C.; Asai, Christina; Tsai, Julieann

2015-01-01

Background Musculoskeletal sonography use in point-of-care physical medicine and rehabilitation is rapidly expanding, not only by physiatrists, but also by non-physician rehabilitation providers. Aim To evaluate the current range, extent and nature of literature and to identify emerging areas of evidence for the use of musculoskeletal sonography involving non-physician rehabilitation providers to guide research and clinical practice. Design Scoping Review Setting Inpatient, Outpatient, Other Population Musculoskeletal conditions Methods Five databases were searched and 578 unique abstracts were identified and screened for eligibility. Three raters independently read 68 full texts and 36 articles that reported on applied uses of sonography by non-physician rehabilitation providers were included. Results Eighteen studies described direct clinical use, primarily for outcomes measurement (n=12) or as a biofeedback intervention (n=10). Twelve laboratory studies were included that related morphology to patient reports or validated clinical interventions. Six additional studies, although not involving non-physician providers, were included as they presented potential valuable uses that were not noted in the other included studies, such as monitoring bone healing, tendon repair, and evaluation of idiopathic symptom reports or non-specific primary diagnoses. Conclusion This review indicates that non-physician rehabilitation providers use sonography for outcomes measurement and biofeedback interventions. Research is needed to evaluate effects of these uses on patient outcomes and to explore additional potential uses for clinical reasoning, treatment planning, and monitoring of tissue healing related to intervention. Clinical Rehabilitation Impact Implementation of musculoskeletal sonography by non-physician rehabilitation providers has the potential to be a critically advantageous addition to improve care. PMID:26201705

Pediatric Psychologist Use of Adherence Assessments and Interventions

PubMed Central

Rohan, Jennifer M.; Martin, Staci; Hommel, Kevin; Greenley, Rachel Neff; Loiselle, Kristin; Ambrosino, Jodie; Fredericks, Emily M.

2013-01-01

Objective To document current clinical practices for medical regimen adherence assessment and intervention in the field of pediatric psychology. Methods 113 members of the Society of Pediatric Psychology completed an anonymous online survey that assessed use of adherence assessments and interventions in clinical practice, barriers and facilitators to their use, and preferred resources for obtaining information on adherence assessments and interventions. Results Respondents reported using a range of adherence assessment and intervention strategies, some of which are evidence-based. Barriers to implementing these clinical strategies included time constraints and lack of familiarity with available clinical tools. Respondents reported that education about effective clinical tools would facilitate their use of adherence assessments and interventions. Conclusions Future research and clinical efforts in adherence should consider developing practical tools for clinical practice, making accessible resources to promote dissemination of these tools, and increase understanding of clinician implementation of adherence assessments and interventions. PMID:23658375

Effectiveness of interventions designed to reduce the use of imaging for low-back pain: a systematic review

PubMed Central

Jenkins, Hazel J.; Hancock, Mark J.; French, Simon D.; Maher, Chris G.; Engel, Roger M.; Magnussen, John S.

2015-01-01

Background: Rates of imaging for low-back pain are high and are associated with increased health care costs and radiation exposure as well as potentially poorer patient outcomes. We conducted a systematic review to investigate the effectiveness of interventions aimed at reducing the use of imaging for low-back pain. Methods: We searched MEDLINE, Embase, CINAHL and the Cochrane Central Register of Controlled Trials from the earliest records to June 23, 2014. We included randomized controlled trials, controlled clinical trials and interrupted time series studies that assessed interventions designed to reduce the use of imaging in any clinical setting, including primary, emergency and specialist care. Two independent reviewers extracted data and assessed risk of bias. We used raw data on imaging rates to calculate summary statistics. Study heterogeneity prevented meta-analysis. Results: A total of 8500 records were identified through the literature search. Of the 54 potentially eligible studies reviewed in full, 7 were included in our review. Clinical decision support involving a modified referral form in a hospital setting reduced imaging by 36.8% (95% confidence interval [CI] 33.2% to 40.5%). Targeted reminders to primary care physicians of appropriate indications for imaging reduced referrals for imaging by 22.5% (95% CI 8.4% to 36.8%). Interventions that used practitioner audits and feedback, practitioner education or guideline dissemination did not significantly reduce imaging rates. Lack of power within some of the included studies resulted in lack of statistical significance despite potentially clinically important effects. Interpretation: Clinical decision support in a hospital setting and targeted reminders to primary care doctors were effective interventions in reducing the use of imaging for low-back pain. These are potentially low-cost interventions that would substantially decrease medical expenditures associated with the management of low-back pain. PMID:25733741

Critical Care Follow-up Clinics: A Scoping Review of Interventions and Outcomes.

PubMed

Lasiter, Sue; Oles, Sylwia K; Mundell, James; London, Susan; Khan, Babar

2016-01-01

The purpose of this scoping review is to identify evidence describing benefits of interventions provided in intensive care unit (ICU) survivor follow-up clinics. Advances in ICU treatments have increased the number of survivors who require specialized care for ICU-related sequelae. Intensive care unit survivor follow-up clinics exist, yet little is known about the nature and impact of interventions provided in such clinics. A scoping review of publications about in-person post-ICU follow-up care was undertaken. Ten databases were searched yielding 111 relevant unique publication titles and abstracts. Sample heterogeneity supported using a scoping review method. After excluding nonrelated publications, 33 reports were fully reviewed. Twenty international publications were included that described ICU follow-up clinic interventions and/or outcomes. Authors discussed very diverse interventions in 15 publications, and 9 reported some level of intervention effectiveness. Evidence was strongest that supported the use of prospective diaries as an intervention to prevent or improve psychological symptoms, whereas evidence to support implementation of other interventions was weak. Although ICU follow-up clinics exist, evidence for interventions and effectiveness of treatments in these clinics remains underexplored. Intensive care unit survivor follow-up clinics provide a venue for further interdisciplinary intervention research that could lead to better health outcomes for ICU survivors.

Sustained effect of simulation-based ultrasound training on clinical performance: a randomized trial

PubMed Central

Tolsgaard, M G; Ringsted, C; Dreisler, E; Nørgaard, L N; Petersen, J H; Madsen, M E; Freiesleben, N L C; Sørensen, J L; Tabor, A

2015-01-01

Objective To study the effect of initial simulation-based transvaginal sonography (TVS) training compared with clinical training only, on the clinical performance of residents in obstetrics and gynecology (Ob-Gyn), assessed 2 months into their residency. Methods In a randomized study, new Ob-Gyn residents (n = 33) with no prior ultrasound experience were recruited from three teaching hospitals. Participants were allocated to either simulation-based training followed by clinical training (intervention group; n = 18) or clinical training only (control group; n = 15). The simulation-based training was performed using a virtual-reality TVS simulator until an expert performance level was attained, and was followed by training on a pelvic mannequin. After 2 months of clinical training, one TVS examination was recorded for assessment of each resident's clinical performance (n = 26). Two ultrasound experts blinded to group allocation rated the scans using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. Results During the 2 months of clinical training, participants in the intervention and control groups completed an average ± SD of 58 ± 41 and 63 ± 47 scans, respectively (P = 0.67). In the subsequent clinical performance test, the intervention group achieved higher OSAUS scores than did the control group (mean score, 59.1% vs 37.6%, respectively; P < 0.001). A greater proportion of the intervention group passed a pre-established pass/fail level than did controls (85.7% vs 8.3%, respectively; P < 0.001). Conclusion Simulation-based ultrasound training leads to substantial improvement in clinical performance that is sustained after 2 months of clinical training. © 2015 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology. PMID:25580809

The clinical effectiveness of individual behaviour change interventions to reduce risky sexual behaviour after a negative human immunodeficiency virus test in men who have sex with men: systematic and realist reviews and intervention development.

PubMed

Flowers, Paul; Wu, Olivia; Lorimer, Karen; Ahmed, Bipasha; Hesselgreaves, Hannah; MacDonald, Jennifer; Cayless, Sandi; Hutchinson, Sharon; Elliott, Lawrie; Sullivan, Ann; Clutterbuck, Dan; Rayment, Michael; McDaid, Lisa

2017-01-01

Men who have sex with men (MSM) experience significant inequalities in health and well-being. They are the group in the UK at the highest risk of acquiring a human immunodeficiency virus (HIV) infection. Guidance relating to both HIV infection prevention, in general, and individual-level behaviour change interventions, in particular, is very limited. To conduct an evidence synthesis of the clinical effectiveness of behaviour change interventions to reduce risky sexual behaviour among MSM after a negative HIV infection test. To identify effective components within interventions in reducing HIV risk-related behaviours and develop a candidate intervention. To host expert events addressing the implementation and optimisation of a candidate intervention. All major electronic databases (British Education Index, BioMed Central, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Educational Resource Index and Abstracts, Health and Medical Complete, MEDLINE, PsycARTICLES, PsycINFO, PubMed and Social Science Citation Index) were searched between January 2000 and December 2014. A systematic review of the clinical effectiveness of individual behaviour change interventions was conducted. Interventions were examined using the behaviour change technique (BCT) taxonomy, theory coding assessment, mode of delivery and proximity to HIV infection testing. Data were summarised in narrative review and, when appropriate, meta-analysis was carried out. Supplemental analyses for the development of the candidate intervention focused on post hoc realist review method, the assessment of the sequential delivery and content of intervention components, and the social and historical context of primary studies. Expert panels reviewed the candidate intervention for issues of implementation and optimisation. Overall, trials included in this review ( n  = 10) demonstrated that individual-level behaviour change interventions are effective in reducing key HIV infection risk-related behaviours. However, there was considerable clinical and methodological heterogeneity among the trials. Exploratory meta-analysis showed a statistically significant reduction in behaviours associated with high risk of HIV transmission (risk ratio 0.75, 95% confidence interval 0.62 to 0.91). Additional stratified analyses suggested that effectiveness may be enhanced through face-to-face contact immediately after testing, and that theory-based content and BCTs drawn from 'goals and planning' and 'identity' groups are important. All evidence collated in the review was synthesised to develop a candidate intervention. Experts highlighted overall acceptability of the intervention and outlined key ways that the candidate intervention could be optimised to enhance UK implementation. There was a limited number of primary studies. All were from outside the UK and were subject to considerable clinical, methodological and statistical heterogeneity. The findings of the meta-analysis must therefore be treated with caution. The lack of detailed intervention manuals limited the assessment of intervention content, delivery and fidelity. Evidence regarding the effectiveness of behaviour change interventions suggests that they are effective in changing behaviour associated with HIV transmission. Exploratory stratified meta-analyses suggested that interventions should be delivered face to face and immediately after testing. There are uncertainties around the generalisability of these findings to the UK setting. However, UK experts found the intervention acceptable and provided ways of optimising the candidate intervention. There is a need for well-designed, UK-based trials of individual behaviour change interventions that clearly articulate intervention content and demonstrate intervention fidelity. The study is registered as PROSPERO CRD42014009500. The National Institute for Health Research Health Technology Assessment programme.

A Bayesian micro-simulation to evaluate the cost-effectiveness of interventions for mastitis control during the dry period in UK dairy herds.

PubMed

Down, P M; Bradley, A J; Breen, J E; Browne, W J; Kypraios, T; Green, M J

2016-10-01

Importance of the dry period with respect to mastitis control is now well established although the precise interventions that reduce the risk of acquiring intramammary infections during this time are not clearly understood. There are very few intervention studies that have measured the clinical efficacy of specific mastitis interventions within a cost-effectiveness framework so there remains a large degree of uncertainty about the impact of a specific intervention and its costeffectiveness. The aim of this study was to use a Bayesian framework to investigate the cost-effectiveness of mastitis controls during the dry period. Data were assimilated from 77 UK dairy farms that participated in a British national mastitis control programme during 2009-2012 in which the majority of intramammary infections were acquired during the dry period. The data consisted of clinical mastitis (CM) and somatic cell count (SCC) records, herd management practices and details of interventions that were implemented by the farmer as part of the control plan. The outcomes used to measure the effectiveness of the interventions were i) changes in the incidence rate of clinical mastitis during the first 30days after calving and ii) the rate at which cows gained new infections during the dry period (measured by SCC changes across the dry period from <200,000cells/ml to >200,000cells/ml). A Bayesian one-step microsimulation model was constructed such that posterior predictions from the model incorporated uncertainty in all parameters. The incremental net benefit was calculated across 10,000 Markov chain Monte Carlo iterations, to estimate the cost-benefit (and associated uncertainty) of each mastitis intervention. Interventions identified as being cost-effective in most circumstances included selecting dry-cow therapy at the cow level, dry-cow rations formulated by a qualified nutritionist, use of individual calving pens, first milking cows within 24h of calving and spreading bedding evenly in dry-cow yards. The results of this study highlighted the efficacy of specific mastitis interventions in UK conditions which, when incorporated into a costeffectiveness framework, can be used to optimize decision making in mastitis control. This intervention study provides an example of how an intuitive and clinically useful Bayesian approach can be used to form the basis of an on-farm decision support tool. Copyright © 2016. Published by Elsevier B.V.

Positive Family Intervention for Severe Challenging Behavior I: A Multisite Randomized Clinical Trial

ERIC Educational Resources Information Center

Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.

2013-01-01

The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…

Effectiveness of a Therapeutic Summer Camp for Children with ADHD: Phase I Clinical Intervention Trial

ERIC Educational Resources Information Center

Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie

2012-01-01

Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…

Behavioural and Developmental Interventions for Autism Spectrum Disorder: A Clinical Systematic Review

PubMed Central

Ospina, Maria B.; Krebs Seida, Jennifer; Clark, Brenda; Karkhaneh, Mohammad; Hartling, Lisa; Tjosvold, Lisa; Vandermeer, Ben; Smith, Veronica

2008-01-01

Background Much controversy exists regarding the clinical efficacy of behavioural and developmental interventions for improving the core symptoms of autism spectrum disorders (ASD). We conducted a systematic review to summarize the evidence on the effectiveness of behavioural and developmental interventions for ASD. Methods and Findings Comprehensive searches were conducted in 22 electronic databases through May 2007. Further information was obtained through hand searching journals, searching reference lists, databases of theses and dissertations, and contacting experts in the field. Experimental and observational analytic studies were included if they were written in English and reported the efficacy of any behavioural or developmental intervention for individuals with ASD. Two independent reviewers made the final study selection, extracted data, and reached consensus on study quality. Results were summarized descriptively and, where possible, meta-analyses of the study results were conducted. One-hundred-and-one studies at predominantly high risk of bias that reported inconsistent results across various interventions were included in the review. Meta-analyses of three controlled clinical trials showed that Lovaas treatment was superior to special education on measures of adaptive behaviour, communication and interaction, comprehensive language, daily living skills, expressive language, overall intellectual functioning and socialization. High-intensity Lovaas was superior to low-intensity Lovaas on measures of intellectual functioning in two retrospective cohort studies. Pooling the results of two randomized controlled trials favoured developmental approaches based on initiative interaction compared to contingency interaction in the amount of time spent in stereotyped behaviours and distal social behaviour, but the effect sizes were not clinically significant. No statistically significant differences were found for: Lovaas versus special education for non-verbal intellectual functioning; Lovaas versus Developmental Individual-difference relationship-based intervention for communication skills; computer assisted instruction versus no treatment for facial expression recognition; and TEACCH versus standard care for imitation skills and eye-hand integration. Conclusions While this review suggests that Lovaas may improve some core symptoms of ASD compared to special education, these findings are based on pooling of a few, methodologically weak studies with few participants and relatively short-term follow-up. As no definitive behavioural or developmental intervention improves all symptoms for all individuals with ASD, it is recommended that clinical management be guided by individual needs and availability of resources. PMID:19015734

An exploration of clinical interventions provided by pharmacists within a complex asthma service.

PubMed

Lemay, Kate S; Saini, Bandana; Bosnic-Anticevich, Sinthia; Smith, Lorraine; Stewart, Kay; Emmerton, Lynne; Burton, Deborah L; Krass, Ines; Armour, Carol L

2015-01-01

Pharmacists in Australia are accessible health care professionals, and their provision of clinical pharmacy interventions in a range of areas has been proven to improve patient outcomes. Individual clinical pharmacy interventions in the area of asthma management have been very successful. An understanding of the nature of these interventions will inform future pharmacy services. What we do not know is when pharmacists provide a complex asthma service, what elements of that service (interventions) they choose to deliver. To explore the scope and frequency of asthma-related clinical interventions provided by pharmacists to patients in an evidence-based complex asthma service. Pharmacists from 4 states/territories of Australia were trained in asthma management. People with asthma had 3 or 4 visits to the pharmacy. Guided by a structured patient file, the pharmacist assessed the patient's asthma and management and provided interventions where and when considered appropriate, based on their clinical decision making skills. The interventions were recorded in a checklist in the patient file. They were then analysed descriptively and thematically. Pharmacists provided 22,909 clinical pharmacy interventions over the service to 570 patients (398 of whom completed the service). The most frequently delivered interventions were in the themes 'Education on asthma', 'Addressing trigger factors', 'Medications - safe and effective use' and 'Explore patient perspectives'. The patients had a high and ongoing need for interventions. Pharmacists selected interventions based on their assessment of perceived need then revisited and reinforced these interventions. Pharmacists identified a number of areas in which patients required interventions to assist with their asthma management. Many of these were perceived to require continuing reinforcement over the duration of the service. Pharmacists were able to use their clinical judgement to assess patients and provide clinical pharmacy interventions across a range of asthma management needs.

The efficacy of the direct clinical intervention for infectious diseases by a pediatric infectious disease specialist in the pediatric ward of a tertiary medical facility without a pediatric antimicrobial stewardship program.

PubMed

Hoshina, T; Yamamoto, N; Ogawa, M; Nakamoto, T; Kusuhara, K

2017-08-01

Antimicrobial stewardship programs (ASPs) have been introduced in most hospital complexes; however, they are not always useful for pediatric patients. The aim of this study is to investigate the efficacy of direct clinical intervention for infectious diseases by a pediatric infectious disease specialist in a tertiary medical facility without pediatric ASP. This retrospective study included 1,821 patients who were hospitalized in the pediatric ward of a large metropolitan hospital from 2010 to 2015. The clinical course, the use of intravenous antimicrobial agents and the results of a microbiological analysis were compared between the period after the beginning of direct intervention by the specialist (post-intervention period) and the previous period (pre-intervention period). In the post-intervention period, the proportion of the patients who received intravenous antimicrobial agents, the number of antimicrobial agents used for each episode, and the proportion of episodes in which an antimicrobial agent was re-administrated were significantly lower (P = 0.006, P = 0.004, P = 0.036, respectively), and the duration of antimicrobial treatment was significantly shorter (P < 0.001). In addition, narrower spectrum antimicrobial agents were used, and the incidence of meropenem-sensitive Pseudomonas aeruginosa significantly increased (P = 0.037) in the post-intervention period. There was no change of mortality between the two periods. Direct clinical intervention by a pediatric infectious diseases specialist is useful for the treatment of infectious diseases in the pediatric ward of a tertiary medical facility without a pediatric ASP. The creation of a pediatric ASP is recommended in hospital complexes.

Hypnotherapy for the Management of Chronic Pain

PubMed Central

Elkins, Gary; Jensen, Mark P.; Patterson, David R.

2009-01-01

This article reviews controlled prospective trials of hypnosis for the treatment of chronic pain. Thirteen studies, excluding studies of headaches, were identified that compared outcomes from hypnosis for the treatment of chronic pain to either baseline data or a control condition. The findings indicate that hypnosis interventions consistently produce significant decreases in pain associated with a variety of chronic-pain problems. Also, hypnosis was generally found to be more effective than nonhypnotic interventions such as attention, physical therapy, and education. Most of the hypnosis interventions for chronic pain include instructions in self-hypnosis. However, there is a lack of standardization of the hypnotic interventions examined in clinical trials, and the number of patients enrolled in the studies has tended to be low and lacking long-term follow-up. Implications of the findings for future clinical research and applications are discussed. PMID:17558718

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. Methods/Design We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. Discussion This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. Clinical trial registration ClinicalTrials.gov NCT02054598. PMID:25004983

The clinical effectiveness and cost-effectiveness of low-intensity psychological interventions for the secondary prevention of relapse after depression: a systematic review.

PubMed

Rodgers, M; Asaria, M; Walker, S; McMillan, D; Lucock, M; Harden, M; Palmer, S; Eastwood, A

2012-05-01

Depression is the most common mental disorder in community settings and a major cause of disability across the world. The objective of treatment is to achieve remission or at least adequate control of depressive symptoms; however, even after successful treatment, the risk of relapse after remission is significant. Although the effectiveness of low-intensity interventions has been extensively evaluated to treat primary symptoms of psychological difficulties, there has been substantially less research examining the use of these interventions as a relapse prevention strategy. To systematically review the clinical effectiveness and cost-effectiveness of low-intensity psychological or psychosocial interventions to prevent relapse or recurrence in patients with depression. As the broader definition of 'low-intensity' psychological intervention is somewhat contested, the review was conducted in two parts: A, a systematic review of all evaluations of 'low-intensity' interventions that were delivered by para-professionals, peer supporters or psychological well-being practitioners as defined by the Improving Access to Psychological Therapies programme; and B, a scoping review of relevant evaluations of interventions involving qualified mental health professionals (e.g. psychiatrists, clinical psychologists, cognitive behavioural therapists) involving < 6 hours of contact per patient. Comprehensive literature searches were developed; electronic databases were searched from inception until September 2010 (including MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO, EMBASE, The Cochrane Library), internet resources were used to identify guidelines on the treatment of depression, and the bibliographies of relevant reviews, guidelines and included studies were scrutinised. Two reviewers independently screened titles and abstracts; data were extracted independently by one reviewer using a standardised data extraction form and checked by another. Discrepancies were resolved by consensus, with involvement of a third reviewer when necessary. The inclusion criteria were population - adults or adolescents who had received treatment for depression; intervention - part A, low-intensity interventions, specifically any unsupported psychological/psychosocial interventions or any supported interventions that did not involve highly qualified mental health professionals, and, part B, interventions carried out by qualified mental health professionals that involved < 6 hours of contact per patient; comparator - any, including no treatment, placebo, psychological or pharmacological interventions; outcomes - relapse or recurrence, other outcomes (e.g. social function, quality of life) were recorded where reported; and study design - for clinical effectiveness, randomised, quasi-randomised and non-randomised studies with concurrent control patients. For cost-effectiveness, full economic evaluations that compared two or more treatment options and considered both costs and consequences. No studies met the main part A inclusion criteria. For the clinical effectiveness review, 17 studies (14 completed, three ongoing), reported in 27 publications, met the part B inclusion criteria. These studies were clinically and methodologically diverse, and reported differing degrees of efficacy for the evaluated interventions. One randomised controlled trial (RCT), which evaluated a collaborative care-type programme, was potentially relevant to part A; this study reported no difference between patients receiving the intervention and those receiving usual care in terms of relapse of depression over 12 months. For the cost-effectiveness review, two studies met the criteria for part B. One of these was an economic evaluation of the RCT above, which was potentially relevant to part A. This evaluation found that the intervention may be a cost-effective use of resources when compared with usual care; however, it was unclear how valid these estimates were for the NHS. Although any definition of 'brief' is likely to be somewhat arbitrary, an inclusion threshold of 6 hours contact per patient was used to select brief high-intensity intervention studies. Most excluded studies evaluated clearly resource-intensive interventions, though occasionally, studies were excluded on the basis of having only slightly more than 6 hours contact per patient. There is inadequate evidence to determine the clinical effectiveness or cost-effectiveness of low-intensity interventions for the prevention of relapse or recurrence of depression. A scoping review of brief high-intensity therapies indicates that some approaches have shown promise in some studies, but findings have not been consistent. Many uncertainties remain and further primary research is required. Careful consideration should be given to the scope of such research; it is important to evaluate the broader patient pathway accounting for the heterogeneous patient groups of interest. Future RCTs conducted in a UK primary care setting should include adult participants in remission or recovery from depression, and evaluate the quality of the intervention and consistency of delivery across practitioners where appropriate. The occurrence of relapse or recurrence should be measured using established methods, and functional outcomes as well as symptoms should be measured; data on quality of life using a generic instrument, such as the European Quality of Life-5 Dimensions (EQ-5D), should be collected. The National Institute for Health Research Health Technology Assessment programme.

Arab-American adolescent tobacco use: four pilot studies.

PubMed

Rice, Virginia Hill; Templin, Thomas; Kulwicki, Anahid

2003-11-01

Four pilot studies were conducted to determine the (1) current tobacco use patterns and predictors among 14- to 18-year-old Arab-American youths; (2) psychometric properties of study measures (English and Arabic); (3) cultural appropriateness of Project Toward No Tobacco (TNT) for intervention; (4) accessible population for a longitudinal study. Three studies were descriptive and one used a pretest-posttest design. From four Pilot Focus groups (N = 28 smokers) key tobacco use themes emerged along with information on study measures and the Project TNT intervention; Pilot Intervention tested the tailored Project TNT intervention with 9 Arab-American teens; Pilot Clinic (N = 44) determined the characteristics of the accessible teen health clinic population; and Pilot School (N = 119) obtained tobacco use data only. From Pilot Focus seven themes (being cool, "nshar ma'a al shabab" [hanging out with the guys], present [time] orientation, smoking feels and tastes good, keeps your mind off trouble, easy to get, and (many) "barriers to quitting") emerged from the data. In the Pilot Intervention a 37.5% cessation rate was found. In the Pilot Clinic study, 24% males and 17% females smoked. The current smoking rate in the Pilot School (N = 119) sample was 17%; 34% admitted to having ever smoked (even a puff). Significant predictors for current tobacco use included poor grades, stress, having many family members and peers who smoke, being exposed to many hours of smoking each day, receiving offers of tobacco products, advertising and mail, and believing that tobacco can help one to make friends. The four pilots contributed unique and essential knowledge for designing a longitudinal clinical trial on tobacco use by Arab-American adolescents.

Analyzing global trends of biomarker use in drug interventional clinical studies.

PubMed

Hayashi, K; Masuda, S; Kimura, H

2012-04-01

The trend of biomarker use in drug interventional clinical studies was analyzed using ClinicalTrials.gov to provide an overview of how biomarkers are used to streamline clinical studies and to examine regional differences. A total of 3,383 clinical study data was analyzed according to phase, region, sponsor, and therapeutic class. The number of clinical studies using biomarkers has been increasing constantly and is dependent on the number of Phase I and II studies. The majority of studies (58.5%) were sponsored by the United States, with the studies being conducted mainly in the sponsor's home region (80.3%). The use of biomarkers was prominent in the oncology area (37.1%). Although current data indicates some bias in the clinical use of biomarkers, it is expected that their use will increase in later phase studies or other therapeutic areas as biomarker development proceeds. In addition, limited regional use of biomarkers may lead to differences in biomarker use in drug development and in combination with political support may result in differences in competitiveness of drug development. Biomarkers would be a powerful tool against deteriorating research and development productivity when used more in appropriate clinical study conditions.

Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial.

PubMed

Bell, Imogen H; Fielding-Smith, Sarah F; Hayward, Mark; Rossell, Susan L; Lim, Michelle H; Farhall, John; Thomas, Neil

2018-05-02

Smartphone-based ecological momentary assessment and intervention (EMA/I) show promise for enhancing psychological treatments for psychosis. EMA has the potential to improve assessment and formulation of experiences which fluctuate day-to-day, and EMI may be used to prompt use of therapeutic strategies in daily life. The current study is an examination of these capabilities in the context of a brief, coping-focused intervention for distressing voice hearing experiences. This is a rater-blinded, pilot randomised controlled trial comparing a four-session intervention in conjunction with use of smartphone EMA/I between sessions, versus treatment-as-usual. The recruitment target is 34 participants with persisting and distressing voice hearing experiences, recruited through a Voices Clinic based in Melbourne, Australia, and via wider advertising. Allocation will be made using minimisation procedure, balancing of the frequency of voices between groups. Assessments are completed at baseline and 8 weeks post-baseline. The primary outcomes of this trial will focus on feasibility and acceptability of the intervention and trial methodology, with secondary outcomes examining preliminary clinical effects related to overall voice severity, the emotional and functional impact of the voices, and emotional distress. This study offers a highly novel examination of specific smartphone capabilities and their integration with traditional psychological treatment for distressing voices. Such technology has potential to enhance psychological interventions and promote adaptation to distressing experiences. Australian New Zealand Clinical Trial Registry, ACTRN12617000348358 . Registered on 7 March 2017.

Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

PubMed

Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

2015-11-01

To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

Clinical Impact Research – how to choose experimental or observational intervention study?

PubMed Central

Malmivaara, Antti

2016-01-01

Abstract Background: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. Aims: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. Methods: The new concept is based on a narrative review of the literature and on author’s idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author’s previous work on the concepts benchmarking controlled trial and system impact research (SIR). Results: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. Conclusions: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messagesThe new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals.The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental) and benchmarking controlled trials (BCTs) (observational). Suggestions on how to choose between RCT and BCT as the most suitable study design are presented.Simple way of determining the study question in CIR based on the PICO (patient, intervention, control intervention, outcome) framework is presented.CIR creates the scientific basis for clinical decisions. Clinicians and leaders at all levels of health care and those working for public health can use the evidence from CIR for the benefit of patients and the population. PMID:27494394

Clinical Impact Research - how to choose experimental or observational intervention study?

PubMed

Malmivaara, Antti

2016-11-01

Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental) and benchmarking controlled trials (BCTs) (observational). Suggestions on how to choose between RCT and BCT as the most suitable study design are presented. Simple way of determining the study question in CIR based on the PICO (patient, intervention, control intervention, outcome) framework is presented. CIR creates the scientific basis for clinical decisions. Clinicians and leaders at all levels of health care and those working for public health can use the evidence from CIR for the benefit of patients and the population.

Pilot Study of Implementation of an Internet-Based Depression Prevention Intervention (CATCH-IT) for Adolescents in 12 US Primary Care Practices: Clinical and Management/Organizational Behavioral Perspectives

PubMed Central

Eisen, Jeffrey C.; Marko-Holguin, Monika; Fogel, Joshua; Cardenas, Alonso; Bahn, My; Bradford, Nathan; Fagan, Blake; Wiedmann, Peggy

2013-01-01

Objective: To explore the implementation of CATCH-IT (Competent Adulthood Transition with Cognitive-behavioral Humanistic and Interpersonal Training), an Internet-based depression intervention program in 12 primary care sites, occurring as part of a randomized clinical trial comparing 2 versions of the intervention (motivational interview + Internet program versus brief advice + Internet program) in 83 adolescents aged 14 to 21 years recruited from February 1, 2007, to November 31, 2007. Method: The CATCH-IT intervention model consists of primary care screening to assess risk, a primary care physician interview to encourage participation, and 14 online modules of Internet training to teach adolescents how to reduce behaviors that increase vulnerability to depressive disorders. Specifically, we evaluated this program from both a management/organizational behavioral perspective (provider attitudes and demonstrated competence) and a clinical outcomes perspective (depressed mood scores) using the RE-AIM model (Reach, Efficacy, Adoption, Implementation, and Maintenance of the intervention). Results: While results varied by clinic, overall, clinics demonstrated satisfactory reach, efficacy, adoption, implementation, and maintenance of the CATCH-IT depression prevention program. Measures of program implementation and management predicted clinical outcomes at practices in exploratory analyses. Conclusion: Multidisciplinary approaches may be essential to evaluating the impact of complex interventions to prevent depression in community settings. Primary care physicians and nurses can use Internet-based programs to create a feasible and cost-effective model for the prevention of mental disorders in adolescents in primary care settings. Trial Registration: ClinicalTrials.gov identifiers: NCT00152529 and NCT00145912 PMID:24800110

Pilot Study of Implementation of an Internet-Based Depression Prevention Intervention (CATCH-IT) for Adolescents in 12 US Primary Care Practices: Clinical and Management/Organizational Behavioral Perspectives.

PubMed

Eisen, Jeffrey C; Marko-Holguin, Monika; Fogel, Joshua; Cardenas, Alonso; Bahn, My; Bradford, Nathan; Fagan, Blake; Wiedmann, Peggy; Van Voorhees, Benjamin W

2013-01-01

To explore the implementation of CATCH-IT (Competent Adulthood Transition with Cognitive-behavioral Humanistic and Interpersonal Training), an Internet-based depression intervention program in 12 primary care sites, occurring as part of a randomized clinical trial comparing 2 versions of the intervention (motivational interview + Internet program versus brief advice + Internet program) in 83 adolescents aged 14 to 21 years recruited from February 1, 2007, to November 31, 2007. The CATCH-IT intervention model consists of primary care screening to assess risk, a primary care physician interview to encourage participation, and 14 online modules of Internet training to teach adolescents how to reduce behaviors that increase vulnerability to depressive disorders. Specifically, we evaluated this program from both a management/organizational behavioral perspective (provider attitudes and demonstrated competence) and a clinical outcomes perspective (depressed mood scores) using the RE-AIM model (Reach, Efficacy, Adoption, Implementation, and Maintenance of the intervention). While results varied by clinic, overall, clinics demonstrated satisfactory reach, efficacy, adoption, implementation, and maintenance of the CATCH-IT depression prevention program. Measures of program implementation and management predicted clinical outcomes at practices in exploratory analyses. Multidisciplinary approaches may be essential to evaluating the impact of complex interventions to prevent depression in community settings. Primary care physicians and nurses can use Internet-based programs to create a feasible and cost-effective model for the prevention of mental disorders in adolescents in primary care settings. ClinicalTrials.gov identifiers: NCT00152529 and NCT00145912.

Effectiveness-implementation Hybrid Designs

PubMed Central

Curran, Geoffrey M.; Bauer, Mark; Mittman, Brian; Pyne, Jeffrey M.; Stetler, Cheryl

2013-01-01

Objectives This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a “hybrid effectiveness-implementation” typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. Results An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention’s impact on relevant outcomes. Conclusions The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice. PMID:22310560

Organ and tissue donation in clinical settings: a systematic review of the impact of interventions aimed at health professionals

PubMed Central

2014-01-01

In countries where presumed consent for organ donation does not apply, health professionals (HP) are key players for identifying donors and obtaining their consent. This systematic review was designed to verify the efficacy of interventions aimed at HPs to promote organ and tissue donation in clinical settings. CINAHL (1982 to 2012), COCHRANE LIBRARY, EMBASE (1974 to 2012), MEDLINE (1966 to 2012), PsycINFO (1960 to 2012), and ProQuest Dissertations and Theses were searched for papers published in French or English until September 2012. Studies were considered if they met the following criteria: aimed at improving HPs’ practices regarding the donation process or at increasing donation rates; HPs working in clinical settings; and interventions with a control group or pre-post assessments. Intervention behavioral change techniques were analyzed using a validated taxonomy. A risk ratio was computed for each study having a control group. A total of 15 studies were identified, of which only 5 had a control group. Interventions were either educational, organizational or a combination of both, and had a weak theoretical basis. The most common behavior change technique was providing instruction. Two sets of interventions showed a significant risk ratio. However, most studies did not report the information needed to compute their efficacy. Therefore, interventions aimed at improving the donation process or at increasing donation rates should be based on sound theoretical frameworks. They would benefit from more rigorous evaluation methods to ensure good knowledge translation and appropriate organizational decisions to improve professional practices. PMID:24628967

Skin cancer interventions across the cancer control continuum: A review of experimental evidence (1/1/2000-6/30/2015) and future research directions.

PubMed

Geller, Alan C; Dickerman, Barbra A; Taber, Jennifer M; Dwyer, Laura A; Hartman, Anne M; Perna, Frank M

2018-06-01

While the general efficacy of skin cancer interventions have been reviewed, employing the cancer control continuum would be useful to identify research gaps at specific cancer control points. We characterized the intervention evidence base for specific behavioral targets (e.g., tanning, sun protection, screening) and clinically related targets (e.g., sunburn, skin exams, cancers) at each point in the cancer control continuum. The review included articles published from 1/1/2000-6/30/15 that had an experimental design and targeted behavioral intervention in skin cancer (e.g., specific behaviors or clinically related targets). The search yielded 86 articles, including seven dissemination studies. Of the 79 non-dissemination studies, 57 exclusively targeted primary prevention behaviors, five exclusively targeted screening, 10 targeted both detection and prevention, and eight addressed cancer survivorship. Among prevention studies (n=67), 29 (43%) targeted children and 38 (57%) targeted adults. Of the 15 screening studies, nine targeted high-risk groups (e.g., men aged ≥50 years) and six targeted the general population. Although research has focused on skin cancer prevention, empirically validated interventions are still needed for youth engaged in indoor tanning and for behavioral interventions to pursue change in clinically relevant targets. Research must also address detection among those at highest risk for skin cancer, amelioration of emotional distress attendant to diagnosis and treatment, and survivorship concerns. We discuss essential qualities and opportunities for intervention development and translational research to inform the field. Copyright © 2018 Elsevier Inc. All rights reserved.

Influence of Clinical and Sociodemographic Characteristics on Early Intervention Enrollment after NICU Discharge

ERIC Educational Resources Information Center

Litt, Jonathan S.; Perrin, James M.

2014-01-01

This study aims to characterize participation of neonatal intensive care unit (NICU) graduates in early intervention (EI). We used data from the National Early Intervention Longitudinal Study. We fit models of days from referral to Individualized Family Service Plan creation (plan time), days from referral to initiation of services (service time),…

A Randomized Clinical Trial Comparison between Pivotal Response Treatment (PRT) and Structured Applied Behavior Analysis (ABA) Intervention for Children with Autism

ERIC Educational Resources Information Center

Mohammadzaheri, Fereshteh; Koegel, Lynn Kern; Rezaee, Mohammad; Rafiee, Seyed Majid

2014-01-01

Accumulating studies are documenting specific motivational variables that, when combined into a naturalistic teaching paradigm, can positively influence the effectiveness of interventions for children with autism spectrum disorder (ASD). The purpose of this study was to compare two applied behavior analysis (ABA) intervention procedures, a…

Strategies for Data Collection in Social Skills Group Interventions: A Case Study

ERIC Educational Resources Information Center

Goforth, Anisa N.; Rennie, Brandon J.; Hammond, Julia; Schoffer Closson, Jennifer K.

2016-01-01

For many practitioners in schools and clinics, collecting data to show the effectiveness of an intervention is probably one of the most important yet challenging components of intervention implementation. This article provides practitioners with an example case study of how data can be organized and collected to determine the effectiveness of a…

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for ‘point of care’ management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. Design/methods We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma—the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis—the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. Discussion This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. Trial registration ClinicalTrials.gov: NCT01815710 PMID:23692634

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

PubMed

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

2011-11-11

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

Improving Care for Patients With or at Risk for Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster-Randomized Trial Protocol

PubMed Central

Nash, Danielle M.; Ivers, Noah M.; Young, Jacqueline; Jaakkimainen, R. Liisa; Garg, Amit X.; Tu, Karen

2017-01-01

Background: Many patients with or at risk for chronic kidney disease (CKD) in the primary care setting are not receiving recommended care. Objective: The objective of this study is to determine whether a multifaceted, low-cost intervention compared with usual care improves the care of patients with or at risk for CKD in the primary care setting. Design: A pragmatic cluster-randomized trial, with an embedded qualitative process evaluation, will be conducted. Setting: The study population comes from the Electronic Medical Record Administrative data Linked Database®, which includes clinical data for more than 140 000 rostered adults cared for by 194 family physicians in 34 clinics across Ontario, Canada. The 34 primary care clinics will be randomized to the intervention or control group. Intervention: The intervention group will receive resources from the “CKD toolkit” to help improve care including practice audit and feedback, printed educational materials for physicians and patients, electronic decision support and reminders, and implementation support. Measurements: Patients with or at risk for CKD within participating clinics will be identified using laboratory data in the electronic medical records. Outcomes will be assessed after dissemination of the CKD tools and after 2 rounds of feedback on performance on quality indicators have been sent to the physicians using information from the electronic medical records. The primary outcome is the proportion of patients aged 50 to 80 years with nondialysis-dependent CKD who are on a statin. Secondary outcomes include process of care measures such as screening tests, CKD recognition, monitoring tests, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescriptions, blood pressure targets met, and nephrologist referral. Hierarchical analytic modeling will be performed to account for clustering. Semistructured interviews will be conducted with a random purposeful sample of physicians in the intervention group to understand why the intervention achieved the observed effects. Conclusions: If our intervention improves care, then the CKD toolkit can be adapted and scaled for use in other primary care clinics which use electronic medical records. Trial Registration: ClinicalTrials.gov Identifier: NCT02274298 PMID:28607686

Enhancing the Clinical Reasoning Skills of Postgraduate Students in Internal Medicine Through Medical Nonfiction and Nonmedical Fiction Extracurricular Books.

PubMed

Kiran, H S; Chacko, Thomas V; Murthy, K A Sudharshana; Gowdappa, H Basavana

2016-12-01

To improve the clinical reasoning skills of postgraduate students in internal medicine through 2 kinds of extracurricular books: medical nonfiction and nonmedical fiction. Clinical reasoning is difficult to define, understand, observe, teach, and measure. This is an educational innovation under an experimental framework based on a cognitive intervention grounded in constructivist and cognitivist theories. This study was conducted from June 1, 2014, through May 31, 2015. It was a pre-post, randomized, controlled, prospective, mixed-methods, small-group study. The intervention was through medical nonfiction and nonmedical fiction books. The process was structured to ensure that the students would read the material in phases and reflect on them. Clinical reasoning (pretests and posttests) was quantitatively assessed using the Diagnostic Thinking Inventory (DTI) and clinical reasoning exercises (CREs) and their assessment using a rubric. A qualitative design was used, and face-to-face semistructured interviews were conducted. Posttest total scores (DTI=188.92; CREs=53.92) were higher for the study group after the intervention compared with its own pretest scores (DTI=165.25; CREs=41.17) and with the pretest (DTI=159.27; CRE=40.73) and posttest (DTI=166.91; CREs=41.18) scores of the control group. Interviews with the study group confirmed that the intervention was acceptable and useful in daily practice. We introduced, evaluated, and proved an approach to teaching-learning clinical reasoning based on the assumption that the clinical reasoning skills of postgraduate students in internal medicine can be enhanced through 2 kinds of extracurricular books and that fun as well as interest will enhance learning. This study is not only about teaching-learning clinical reasoning but also about the humanities in medical education. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

Pilot study of a multi-pronged intervention using social norms and priming to improve adherence to antiretroviral therapy and retention in care among adults living with HIV in Tanzania.

PubMed

McCoy, Sandra I; Fahey, Carolyn; Rao, Aarthi; Kapologwe, Ntuli; Njau, Prosper F; Bautista-Arredondo, Sergio

2017-01-01

Interventions incorporating constructs from behavioral economics and psychology have the potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this hypothesis, we evaluated an intervention to improve antiretroviral therapy (ART) adherence based on the concepts of social norms and priming. We used tools from marketing research and patient-centered design to develop a combination intervention that included visual feedback about clinic-level retention in care, a self-relevant prime, and useful take-home items with the priming image. The intervention was implemented at two HIV primary clinics in Shinyanga, Tanzania in 2-week intervals for six months. We conducted a quasi-experimental pilot study with a random sample of exposed and unexposed adult patients living with HIV infection (PLHIV) to compare retention and the proportion of patients with medication possession ratio (MPR) ≥95% after six months. Intervention acceptability was determined with a convenience sample of 405 PLHIV at baseline (n = 189) and endline (n = 216). Medical records were reviewed for 438 PLHIV (320 intervention, 118 standard of care). In adjusted analyses, PLHIV exposed to the intervention were significantly more likely to be in care after 6 months (87% vs. 79%, adjusted odds ratio (ORa) = 1.73, 95% CI: 1.08, 2.78, p<0.05) and were more likely to achieve MPR≥95% (70% vs. 59%, OR = 1.51, 95% CI: 0.96, 2.37, p = 0.07). The intervention was associated with increases in staff support of treatment goals (100% vs. 95%, p = 0.01) and life goals (66% vs. 50%, p<0.01), the perceived likelihood of other patients' adherence (54% vs. 32%, p<0.01), support from other patients (71% vs. 60%, p = 0.03), and being very satisfied with care (53% vs. 35%, p<0.01). This novel intervention has the potential to improve the clinic experience, short-term retention in care, and ART adherence. Future studies are needed to expand the generalizability of the approach and evaluate effectiveness on clinical outcomes. Clinicaltrials.gov NCT02938533.

Pilot study of a multi-pronged intervention using social norms and priming to improve adherence to antiretroviral therapy and retention in care among adults living with HIV in Tanzania

PubMed Central

Fahey, Carolyn; Rao, Aarthi; Kapologwe, Ntuli; Njau, Prosper F.; Bautista-Arredondo, Sergio

2017-01-01

Background Interventions incorporating constructs from behavioral economics and psychology have the potential to enhance HIV ‘treatment as prevention’ (TasP) strategies. To test this hypothesis, we evaluated an intervention to improve antiretroviral therapy (ART) adherence based on the concepts of social norms and priming. Methods We used tools from marketing research and patient-centered design to develop a combination intervention that included visual feedback about clinic-level retention in care, a self-relevant prime, and useful take-home items with the priming image. The intervention was implemented at two HIV primary clinics in Shinyanga, Tanzania in 2-week intervals for six months. We conducted a quasi-experimental pilot study with a random sample of exposed and unexposed adult patients living with HIV infection (PLHIV) to compare retention and the proportion of patients with medication possession ratio (MPR) ≥95% after six months. Intervention acceptability was determined with a convenience sample of 405 PLHIV at baseline (n = 189) and endline (n = 216). Results Medical records were reviewed for 438 PLHIV (320 intervention, 118 standard of care). In adjusted analyses, PLHIV exposed to the intervention were significantly more likely to be in care after 6 months (87% vs. 79%, adjusted odds ratio (ORa) = 1.73, 95% CI: 1.08, 2.78, p<0.05) and were more likely to achieve MPR≥95% (70% vs. 59%, OR = 1.51, 95% CI: 0.96, 2.37, p = 0.07). The intervention was associated with increases in staff support of treatment goals (100% vs. 95%, p = 0.01) and life goals (66% vs. 50%, p<0.01), the perceived likelihood of other patients’ adherence (54% vs. 32%, p<0.01), support from other patients (71% vs. 60%, p = 0.03), and being very satisfied with care (53% vs. 35%, p<0.01). Conclusions This novel intervention has the potential to improve the clinic experience, short-term retention in care, and ART adherence. Future studies are needed to expand the generalizability of the approach and evaluate effectiveness on clinical outcomes. Trial registration Clinicaltrials.gov NCT02938533 PMID:28486553

The paediatric change laboratory: optimising postgraduate learning in the outpatient clinic.

PubMed

Skipper, Mads; Musaeus, Peter; Nøhr, Susanne Backman

2016-02-02

This study aimed to analyse and redesign the outpatient clinic in a paediatric department. The study was a joint collaboration with the doctors of the department (paediatric residents and specialists) using the Change Laboratory intervention method as a means to model and implement change in the outpatient clinic. This study was motivated by a perceived failure to integrate the activities of the outpatient clinic, patient care and training of residents. The ultimate goal of the intervention was to create improved care for patients through resident learning and development. We combined the Change Laboratory intervention with an already established innovative process for residents, 3-h meetings. The Change Laboratory intervention method consists of a well-defined theory (Cultural-historical activity theory) and concrete actions where participants construct a new theoretical model of the activity, which in this case was paediatric doctors' workplace learning modelled in order to improve medical social practice. The notion of expansive learning was used during the intervention in conjunction with thematic analysis of data in order to fuel the process of analysis and intervention. The activity system of the outpatient clinic can meaningfully be analysed in terms of the objects of patient care and training residents. The Change Laboratory sessions resulted in a joint action plan for the outpatient clinic structured around three themes: (1) Before: Preparation, expectations, and introduction; (2) During: Structural context and resources; (3) After: Follow-up and feedback. The participants found the Change Laboratory method to be a successful way of sharing reflections on how to optimise the organisation of work and training with patient care in mind. The Change Laboratory approach outlined in this study succeeded to change practices and to help medical doctors redesigning their work. Participating doctors must be motivated to uncover inherent contradictions in their medical activity systems of which care and learning are both part. Facilitators must be willing to spend time analysing both historical paediatric practice, current data on practice, and steer clear of organisational issues that might hamper a transformative learning environment. To ensure long-term success, economical and organisational resources, participant buy-in and department leadership support play a major role.

The Mobile Insulin Titration Intervention (MITI) for Insulin Adjustment in an Urban, Low-Income Population: Randomized Controlled Trial.

PubMed

Levy, Natalie; Moynihan, Victoria; Nilo, Annielyn; Singer, Karyn; Bernik, Lidia S; Etiebet, Mary-Ann; Fang, Yixin; Cho, James; Natarajan, Sundar

2015-07-17

Diabetes patients are usually started on a low dose of insulin and their dose is adjusted or "titrated" according to their blood glucose levels. Insulin titration administered through face-to-face visits with a clinician can be time consuming and logistically burdensome for patients, especially those of low socioeconomic status (SES). Given the wide use of mobile phones among this population, there is the potential to use short message service (SMS) text messaging and phone calls to perform insulin titration remotely. The goals of this pilot study were to (1) evaluate if our Mobile Insulin Titration Intervention (MITI) intervention using text messaging and phone calls was effective in helping patients reach their optimal insulin glargine dose within 12 weeks, (2) assess the feasibility of the intervention within our clinic setting and patient population, (3) collect data on the cost savings associated with the intervention, and (4) measure patient satisfaction with the intervention. This was a pilot study evaluating an intervention for patients requiring insulin glargine titration in the outpatient medical clinic of Bellevue Hospital Center in New York City. Patients in the intervention arm received weekday SMS text messages from a health management platform requesting their fasting blood glucose values. The clinic's diabetes nurse educator monitored the texted responses on the platform website each weekday for alarm values. Once a week, the nurse reviewed the glucose values, consulted the MITI titration algorithm, and called patients to adjust their insulin dose. Patients in the usual care arm continued to receive their standard clinic care for insulin titration. The primary outcome was whether a patient reached his/her optimal insulin glargine dose within 12 weeks. A total of 61 patients consented and were randomized into the study. A significantly greater proportion of patients in the intervention arm reached their optimal insulin glargine dose than patients in the usual care arm (88%, 29/33 vs 37%, 10/27; P<.001). Patients responded to 84.3% (420/498) of the SMS text messages requesting their blood glucose values. The nurse reached patients within 2 attempts or by voicemail 91% of the time (90/99 assigned calls). When patients traveled to the clinic, they spent a median of 45 minutes (IQR 30-60) on travel and 39 minutes (IQR 30-64) waiting prior to appointments. A total of 61% (37/61) of patients had appointment copays. After participating in the study, patients in the intervention arm reported higher treatment satisfaction than those in the usual care arm. MITI is an effective way to help low-SES patients reach their optimal insulin glargine dose using basic SMS text messaging and phone calls. The intervention was feasible and patients were highly satisfied with their treatment. The intervention was cost saving in terms of time for patients, who were able to have their insulin titrated without multiple clinic appointments. Similar interventions should be explored to improve care for low-SES patients managing chronic disease. Clinicaltrials.gov NCT01879579; https://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6YZik33L3).

Methodological Overview of an African American Couple-Based HIV/STD Prevention Trial

PubMed Central

2010-01-01

Objective To provide an overview of the NIMH Multisite HIV/STD Prevention Trial for African American Couples conducted in four urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. Design This is a two arm randomized Trial, implementing a modified randomized block design, to evaluate the efficacy of a couples based intervention designed for HIV serodiscordant African American couples. Methods The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV serodiscordant heterosexual African American couples. There are two theoretically derived behavioral interventions with eight group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction while the control was individual based and focused on health promotion. The two study conditions were structurally similar in length and types of activities. At baseline, participants completed an Audio Computer-assisted Self Interview (ACASI) interview as well as interviewer-administered questionnaire, and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. Results The Trial results will be analyzed across the four sites by randomization assignment. Generalized estimating equations (GEE) and mixed effects modeling (MEM) are planned to test: (1) the effects of the intervention on STD incidence and condom use as well as on mediator variables of these outcomes, and (2) whether the effects of the intervention differ depending on key moderator variables (e.g., gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history). Conclusions The lessons learned from the design and conduct of this clinical trial provide guidelines for future couples based clinical trials in HIV/STD risk reduction and can be generalized to other couples based behavioral interventions. PMID:18724188

Costs associated with implementation of computer-assisted clinical decision support system for antenatal and delivery care: case study of Kassena-Nankana district of northern Ghana.

PubMed

Dalaba, Maxwell Ayindenaba; Akweongo, Patricia; Williams, John; Saronga, Happiness Pius; Tonchev, Pencho; Sauerborn, Rainer; Mensah, Nathan; Blank, Antje; Kaltschmidt, Jens; Loukanova, Svetla

2014-01-01

This study analyzed cost of implementing computer-assisted Clinical Decision Support System (CDSS) in selected health care centres in Ghana. A descriptive cross sectional study was conducted in the Kassena-Nankana district (KND). CDSS was deployed in selected health centres in KND as an intervention to manage patients attending antenatal clinics and the labour ward. The CDSS users were mainly nurses who were trained. Activities and associated costs involved in the implementation of CDSS (pre-intervention and intervention) were collected for the period between 2009-2013 from the provider perspective. The ingredients approach was used for the cost analysis. Costs were grouped into personnel, trainings, overheads (recurrent costs) and equipment costs (capital cost). We calculated cost without annualizing capital cost to represent financial cost and cost with annualizing capital costs to represent economic cost. Twenty-two trained CDSS users (at least 2 users per health centre) participated in the study. Between April 2012 and March 2013, users managed 5,595 antenatal clients and 872 labour clients using the CDSS. We observed a decrease in the proportion of complications during delivery (pre-intervention 10.74% versus post-intervention 9.64%) and a reduction in the number of maternal deaths (pre-intervention 4 deaths versus post-intervention 1 death). The overall financial cost of CDSS implementation was US$23,316, approximately US$1,060 per CDSS user trained. Of the total cost of implementation, 48% (US$11,272) was pre-intervention cost and intervention cost was 52% (US$12,044). Equipment costs accounted for the largest proportion of financial cost: 34% (US$7,917). When economic cost was considered, total cost of implementation was US$17,128-lower than the financial cost by 26.5%. The study provides useful information in the implementation of CDSS at health facilities to enhance health workers' adherence to practice guidelines and taking accurate decisions to improve maternal health care.

Cost effectiveness of adopted quality requirements in hospital laboratories.

PubMed

Hamza, Alneil; Ahmed-Abakur, Eltayib; Abugroun, Elsir; Bakhit, Siham; Holi, Mohamed

2013-01-01

The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. The quality management intervention based on ISO 15189 was conceded through three phases; pre - intervention phase, Intervention phase and Post-intervention phase. In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen's d) of (0.00) in pre-intervention phase and (0.99) in post - intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure.

Clinical inertia in the pharmacological management of hypertension: A systematic review and meta-analysis.

PubMed

Milman, Tal; Joundi, Raed A; Alotaibi, Naif M; Saposnik, Gustavo

2018-06-01

Clinical Inertia is defined as "failure of health care providers to initiate or intensify therapy according to current guidelines". This phenomenon is gaining increasing attention as a major cause of clinicians' failure to adequately manage hypertension, thus leading to an increased incidence of cardiovascular events. We performed a systematic review and meta-analysis of randomized controlled trials to determine whether interventions aimed at reducing clinical inertia in the pharmacological treatment of hypertension improve blood pressure (BP) control. MEDLINE, Embase, and Cochrane Database of Systematic Reviews were searched from the start of their database until October 3, 2017 for the MESH terms "Hypertension" or "Blood Pressure", their subheadings, and the keywords "Therapeutic Inertia" or "Clinical Inertia". Studies were included if they addressed pharmacologic hypertension management, clinical inertia, were randomized controlled trials, reported an outcome describing prescriber behavior, and were available in English. Data for the included studies was extracted by two independent observers. Quality of studies was analyzed using the Cochrane Risk of Bias Assessment. Data was pooled for statistical analysis using both fixed- and random-effects models. The primary study outcome was the percentage of patients achieving blood pressure control as defined by the Joint National Committee guidelines or study authors. Of 474 citations identified, ten met inclusion criteria comprising a total of 26,871 patients, and eight were selected for meta-analysis. Interventions included Physician Education, Physician Reminders, Patient Education, Patient Reminders, Ambulatory BP Monitoring, Digital Medication Offerings, Physician Peer Visits, and Pharmacist-led Counselling. Pooled event rates revealed more patients with controlled BP in the intervention group versus control (55%, 95% CI 46-63% versus 45%, 95% CI 37-53%) and interventions significantly improved the odds of BP control (OR = 1.19, 95% CI = 1.12-1.27, P < .001). Heterogeneity in the quantitative analysis was moderate. Addressing clinical inertia through physician reminders, ambulatory BP monitoring, and educational interventions for primary care providers was associated with an improvement in blood pressure control. Our findings encourage further research to investigate strategies at reducing clinical inertia in the management of hypertension.

Pursuing cost-effectiveness in mental health service delivery for youth with complex needs.

PubMed

Grimes, Katherine E; Schulz, Margaret F; Cohen, Steven A; Mullin, Brian O; Lehar, Sophie E; Tien, Shelly

2011-06-01

Mental health advocates seek to expand children's services, noting widespread failure to meet the needs of public sector youth suffering from serious emotional disturbance (SED). However, state and national budgets face deepening cuts, with rising health care costs taking the blame. As the gap between needs and finances widens, identification of cost-effective treatments that will benefit children with SED and their families is of increasing importance. Community-based interventions for this population, such as the wraparound approach and systems-of-care, are being disseminated but literature is scant regarding effects on expense. The Mental Health Services Program for Youth (MHSPY) model is aligned philosophically with wraparound and systems-of-care but unique in blending public agency dollars to deliver integrated medical, mental health and social services. MHSPY's linked clinical and expense data is useful to study community-based treatment cost-effectiveness. To examine the cost-effectiveness of an intensively integrated, family and community-based clinical intervention for youth with mental health needs in comparison to "usual care.'' Study and reference populations were matched on age, gender, community, psychiatric diagnosis, morbidity and insurance type. Claims analyses included patterns of service utilization and medical expense for both groups. Using propensity score matching, results for study youth are compared with results for the population receiving "usual care.'' Clinical functioning was measured for the intervention group at baseline and 12 months. The intervention group used lower intensity services and had substantially lower claims expense (e.g. 32% lower for emergency room, 74% lower for inpatient psychiatry) than their matched counterparts in the "usual care'' group. Intervention youth were consistently maintained in least restrictive settings, with over 88% of days spent at home and showed improved clinical functioning on standard measures. The intensive MHSPY model of service delivery offers potential as a cost-effective intervention for complex youth. Its integrated approach, recognizing needs across multiple life domains, appears to enhance engagement and the effectiveness of mental health treatment, resulting in statistically significant clinical improvements. Functional measures are not collected in "usual care,'' limiting comparisons. However, claims expense for intervention youth was substantially lower than claims expense for Medicaid comparison youth, suggesting clinical needs for intervention youth post-enrollment were lower than for those receiving "usual care.'' The MHSPY model, which intentionally engages families in "clustered'' traditional and non-traditional services, represents a replicable strategy for enhancing the impact of clinical interventions, thereby reducing medical expense. Blending categorical state agency dollars and insurance funds creates flexibility to support community-based care, including individualized services for high-risk youth. Resulting expenses total no more, and are often less, than "treatment as usual'' but yield greater clinical benefits. Further research is needed regarding which intervention elements contribute the most towards improved clinical functioning, as well as which patients are most likely to benefit. A randomized trial of MHSPY vs. "usual care,'' including examination of the sustainability of effects post-disenrollment, would provide a chance to further test this innovative model.

Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

PubMed

Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

2016-01-01

Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m 2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline release without active dissemination. We hypothesize that the clinics randomized to the intervention group will have a lower proportion of early dialysis starts. Limitations include passive dissemination of the guideline through publication, and lead-time and survivor bias, which favors delayed dialysis initiation. If successful, this active knowledge translation intervention will reduce early dialysis starts, lead to health and economic benefits, and provide a successful framework for evaluating and disseminating future guidelines. ClinicalTrials.gov, NCT02183987.

Lifestyle Medicine and the Management of Cardiovascular Disease.

PubMed

Doughty, Kimberly N; Del Pilar, Nelson X; Audette, Amanda; Katz, David L

2017-10-04

Evidence has clearly demonstrated the importance of lifestyle factors (e.g., diet, physical activity, smoking) in the development of cardiovascular disease (CVD). Interventions targeting these behaviors may improve outcomes for CVD patients. The aim of this review is to summarize the effects of lifestyle interventions in individuals with established CVD. Most recent trials focused on diet, physical activity, stress reduction, or a combination of these. Findings were mixed, but most interventions improved at least some markers of cardiovascular risk. Few studies measured long-term clinical outcomes, but some suggested a possible benefit of stress reduction and multifaceted interventions on cardiovascular events. The benefits of lifestyle change for CVD patients have been established by decades of evidence. However, further research is needed to determine the optimal intensity, duration, and mode of delivery for interventions. Additional studies with long-term follow-up and measurement of clinical outcomes are also needed.

Mental health pharmacists as interim prescribers

PubMed Central

2017-01-01

Introduction: Turnover leading to fluctuations in prescriber availability presents many challenges, most notably in access to and continuity of care. In 2015, the Veterans Affairs Eastern Colorado Healthcare System (VA ECHCS) experienced a period of significant mental health prescriber turnover leading to patient utilization of psychiatric emergency services (PES) for nonemergent medication management. The resulting increase in volume placed excessive stress on PES prescribers. Mental health pharmacists have opportunities to provide interim medication management while patients are between prescribers. Methods: This study was a retrospective, cohort study of patients unassigned to an outpatient mental health prescriber due to prescriber turnover, receiving care at VA ECHCS between October 1, 2015, and February 28, 2016. The primary outcome was the number of pharmacist interventions performed. Secondary outcomes characterize the interventions performed and describe the change in the mean monthly volume of patients presenting to PES. Results: In this veteran population, 152 interventions were performed in 81 unique patients. The most common intervention was prescription renewals (80%). Interventions most commonly involved antidepressants (28%), antipsychotics (10%), and mood stabilizers (10%). Before initiation of the clinic, Denver VA PES experienced a mean of 300 monthly visits. After clinic implementation, PES visits decreased significantly to a mean of 237 visits per month (P = .041). Discussion: The pharmacist interim prescriber clinic was associated with a significant decrease in mean number of patients seen per month in PES. The success of the clinic also contributed to interest by the mental health service to expand clinical pharmacy services.

An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes - the MID-Frail study: study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. Methods/Design The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. Discussion The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. Trial registration ClinicalTrials.gov: NCT01654341. PMID:24456998

An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial.

PubMed

Rodríguez-Mañas, Leocadio; Bayer, Antony J; Kelly, Mark; Zeyfang, Andrej; Izquierdo, Mikel; Laosa, Olga; Hardman, Timothy C; Sinclair, Alan J; Moreira, Severina; Cook, Justin

2014-01-24

Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. ClinicalTrials.gov: NCT01654341.

SBAR improves communication and safety climate and decreases incident reports due to communication errors in an anaesthetic clinic: a prospective intervention study.

PubMed

Randmaa, Maria; Mårtensson, Gunilla; Leo Swenne, Christine; Engström, Maria

2014-01-21

We aimed to examine staff members' perceptions of communication within and between different professions, safety attitudes and psychological empowerment, prior to and after implementation of the communication tool Situation-Background-Assessment-Recommendation (SBAR) at an anaesthetic clinic. The aim was also to study whether there was any change in the proportion of incident reports caused by communication errors. A prospective intervention study with comparison group using preassessments and postassessments. Questionnaire data were collected from staff in an intervention (n=100) and a comparison group (n=69) at the anaesthetic clinic in two hospitals prior to (2011) and after (2012) implementation of SBAR. The proportion of incident reports due to communication errors was calculated during a 1-year period prior to and after implementation. Anaesthetic clinics at two hospitals in Sweden. All licensed practical nurses, registered nurses and physicians working in the operating theatres, intensive care units and postanaesthesia care units at anaesthetic clinics in two hospitals were invited to participate. Implementation of SBAR in an anaesthetic clinic. The primary outcomes were staff members' perception of communication within and between different professions, as well as their perceptions of safety attitudes. Secondary outcomes were psychological empowerment and incident reports due to error of communication. In the intervention group, there were statistically significant improvements in the factors 'Between-group communication accuracy' (p=0.039) and 'Safety climate' (p=0.011). The proportion of incident reports due to communication errors decreased significantly (p<0.0001) in the intervention group, from 31% to 11%. Implementing the communication tool SBAR in anaesthetic clinics was associated with improvement in staff members' perception of communication between professionals and their perception of the safety climate as well as with a decreased proportion of incident reports related to communication errors. ISRCTN37251313.

A systematic review of evidence relating to clinical supervision for nurses, midwives and allied health professionals.

PubMed

Pollock, Alex; Campbell, Pauline; Deery, Ruth; Fleming, Mick; Rankin, Jean; Sloan, Graham; Cheyne, Helen

2017-08-01

The aim of this study was to systematically review evidence relating to clinical supervision for nurses, midwives and allied health professionals. Since 1902 statutory supervision has been a requirement for UK midwives, but this is due to change. Evidence relating to clinical supervision for nurses and allied health professions could inform a new model of clinical supervision for midwives. A systematic review with a contingent design, comprising a broad map of research relating to clinical supervision and two focussed syntheses answering specific review questions. Electronic databases were searched from 2005 - September 2015, limited to English-language peer-reviewed publications. Systematic reviews evaluating the effectiveness of clinical supervision were included in Synthesis 1. Primary research studies including a description of a clinical supervision intervention were included in Synthesis 2. Quality of reviews were judged using a risk of bias tool and review results summarized in tables. Data describing the key components of clinical supervision interventions were extracted from studies included in Synthesis 2, categorized using a reporting framework and a narrative account provided. Ten reviews were included in Synthesis 1; these demonstrated an absence of convincing empirical evidence and lack of agreement over the nature of clinical supervision. Nineteen primary studies were included in Synthesis 2; these highlighted a lack of consistency and large variations between delivered interventions. Despite insufficient evidence to directly inform the selection and implementation of a framework, the limited available evidence can inform the design of a new model of clinical supervision for UK-based midwives. © 2017 John Wiley & Sons Ltd.

Outcomes of psychotherapeutic and psychoeducative group interventions for children exposed to intimate partner violence.

PubMed

Pernebo, Karin; Fridell, Mats; Almqvist, Kjerstin

2018-05-01

Witnessing violence toward a caregiver during childhood is associated with negative impact on children's health and development, and there is a need for effective interventions for children exposed to intimate partner violence in clinical as well as in community settings. The current effectiveness study investigated symptom reduction after participation in two established group interventions (one community-based psychoeducative intervention; one psychotherapeutic treatment intervention) for children exposed to intimate partner violence and for their non-offending parent. The study included 50 children-24 girls and 26 boys-aged 4-13 years and their mothers. Child and maternal mental health problems and trauma symptoms were assessed pre- and post-treatment. The results indicate that although children showed benefits from both interventions, symptom reduction was larger in the psychotherapeutic intervention, and children with initially high levels of trauma symptoms benefited the most. Despite these improvements, a majority of the children's mothers still reported child trauma symptoms at clinical levels post-treatment. Both interventions substantially reduced maternal post-traumatic stress. The results indicate a need for routine follow-up of children's symptoms after interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

Evaluating the short-term and long-term effects of an internet-based aural rehabilitation programme for hearing aid users in general clinical practice: a randomised controlled trial

PubMed Central

Malmberg, Milijana; Lunner, Thomas; Kähäri, Kim; Andersson, Gerhard

2017-01-01

Objective Guided internet-based intervention beyond hearing aid (HA) fitting has been shown to be efficacious in randomised controlled trials (RCTs). However, internet interventions have rarely been applied clinically as a part of regular aural rehabilitation (AR). Our aim was to evaluate the effectiveness of internet-based AR for HA users from a clinical population. Outcome measures The Hearing Handicap Inventory for the Elderly (HHIE) was used as the primary outcome measure, and the Communication Strategies Scale (CSS) and the Hospital Anxiety and Depression Scale were used as secondary outcome measures. All questionnaires were administered before and directly after the intervention and at 6 months postintervention. Methods We used a parallel group design (RCT). The data were collected in 2013–2014 at three different clinics. Seventy-four HA users were randomly assigned to receive either full internet-based AR (intervention group, n=37) or one element of the internet-based AR (control group, n=37). Results Data were analysed following the intention-to-treat principle. Each group showed improved HHIE scores over time and did not differ significantly from each other. The intervention group showed significantly greater improvement compared with the control group for the CSS total and the non-verbal subscale scores. The intervention group and control group were also subdivided into two age groups: 20–59 years and 60–80 years. Significantly better improvement on the CSS total and non-verbal subscale scores was found in the older group compared with the younger participants. Conclusions This study indicates that participants in an internet-based intervention applied in general clinical practice showed improved self-reported communication skills compared with a control group. Receiving a full intervention was not more effective in improving self-reported hearing problems than receiving just one element of the internet-based intervention. Trial registration number This trial is registered at ClinicalTrals.gov, NCT01837550; results. PMID:28592571

Achieving recovery in patients with schizophrenia through psychosocial interventions: A retrospective study.

PubMed

Buonocore, Mariachiara; Bosia, Marta; Baraldi, Maria A; Bechi, Margherita; Spangaro, Marco; Cocchi, Federica; Bianchi, Laura; Guglielmino, Carmelo; Mastromatteo, Antonella R; Cavallaro, Roberto

2018-01-01

Recovery, or functional remission, represents the ultimate treatment goal in schizophrenia. Despite its importance, a standardized definition of remission is still lacking, thus reported rates significantly vary across studies. Moreover, the effects of rehabilitative interventions on recovery have not been thoroughly investigated. This study aimed to evaluate recovery in a sample of patients with chronic schizophrenia engaged in rehabilitation programs and to explore contributing factors, with a focus on sociocognitive rehabilitative interventions. Data from 104 patients with schizophrenia treated either with a standard rehabilitation program, including cognitive remediation (n = 46), or the latter plus a specific sociocognitive intervention (n = 58), and assessed for psychopathology, cognition, social cognition, and Quality of Life Scale, were retrospectively analyzed for this study. Recovery, evaluated with the Quality of Life Scale, was achieved by 56.76% of patients in our sample. While no effects were observed for clinical, cognitive, or sociocognitive variables, participation in the sociocognitive rehabilitative interventions was positively associated with recovery. Our results indicate that high rates of recovery can be achieved in patients treated with psychosocial interventions and suggest that rehabilitative programs targeting social cognition may further facilitate the process of recovery. If confirmed, these results may have relevant implications for daily clinical practice and service provision, allowing clinicians to develop and optimize specific rehabilitation programs in order to promote recovery. © 2017 The Authors. Psychiatry and Clinical Neurosciences © 2017 Japanese Society of Psychiatry and Neurology.

Effectiveness of Workplace Weight Management Interventions: a Systematic Review.

PubMed

Weerasekara, Yasoma Kumari; Roberts, Susan B; Kahn, Mira A; LaVertu, Amy E; Hoffman, Ben; Das, Sai Krupa

2016-06-01

A systematic review was conducted of randomized trials of workplace weight management interventions, including trials with dietary, physical activity, environmental, behavioral, and incentive-based components. Main outcomes were defined as change in weight-related measures. Keywords related to weight management and workplace interventions were used to search relevant databases, and 23 eligible studies were reviewed in detail using a data extraction form and quality assessment checklist. The trials were conducted mainly in the USA and Europe, with four additional countries represented. Interventions were mostly multicomponent and were implemented in both sexes and in a range of employment categories. Intervention effectiveness appeared unrelated to region of the world and was highest in 6-12-month trials. The results ranged widely from clinically significant 8.8-kg weight loss in one trial to less effective than the control treatment in others. Some workplace interventions achieve clinically significant benefits, and further studies are needed to replicate those results in wider sociocultural and geographical contexts.

[Clinical trials in nursing journals].

PubMed

Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

2014-01-01

Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

Evaluation of clinical pharmacy interventions in a Veterans Affairs medical center primary care clinic.

PubMed

Hough, Augustus; Vartan, Christine M; Groppi, Julie A; Reyes, Sonia; Beckey, Nick P

2013-07-01

The development of an electronic tool to quantify and characterize the interventions made by clinical pharmacy specialists (CPSs) in a primary care setting is described. An electronic clinical tool was developed to document the clinical pharmacy interventions made by CPSs at the Veterans Affairs Medical Center in West Palm Beach, Florida. The tool, embedded into the electronic medical record, utilizes a novel reminder dialogue to complete pharmacotherapy visit encounters and allows CPSs to document interventions made during patient care visits. Interventions are documented using specific electronic health factors so that the type and number of interventions made for both disease-specific and other pharmacotherapy interventions can be tracked. These interventions were assessed and analyzed to evaluate the impact of CPSs in the primary care setting. From February 2011 through January 2012, a total of 16,494 pharmacotherapy interventions (therapeutic changes and goals attained) were recorded. The average numbers of interventions documented per patient encounter were 0.96 for the management of diabetes mellitus, hypertension, dyslipidemia, and heart failure and 1.36 for non-disease-specific interventions, independent of those interventions being made by the primary physician or other members of the primary care team. A clinical reminder tool developed to quantify and characterize the interventions provided by CPSs found that for every visit with a CPS, approximately one disease-specific intervention and one additional pharmacotherapy intervention were made, independent of those interventions being made by the primary physician or other members of the primary care team.

The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): Rationale for a Tailored Behavioral and Educational Pharmacist-Administered Intervention for Achieving Cardiovascular Disease Risk Reduction

PubMed Central

Zullig, Leah L.; Melnyk, S. Dee; Stechuchak, Karen M.; McCant, Felicia; Danus, Susanne; Oddone, Eugene; Bastian, Lori; Olsen, Maren; Edelman, David; Rakley, Susan; Morey, Miriam

2014-01-01

Abstract Background: Hypertension, hyperlipidemia, and diabetes are significant, but often preventable, contributors to cardiovascular disease (CVD) risk. Medication and behavioral nonadherence are significant barriers to successful hypertension, hyperlidemia, and diabetes management. Our objective was to describe the theoretical framework underlying a tailored behavioral and educational pharmacist-administered intervention for achieving CVD risk reduction. Materials and Methods: Adults with poorly controlled hypertension and/or hyperlipidemia were enrolled from three outpatient primary care clinics associated with the Durham Veterans Affairs Medical Center (Durham, NC). Participants were randomly assigned to receive a pharmacist-administered, tailored, 1-year telephone-based intervention or usual care. The goal of the study was to reduce the risk for CVD through a theory-driven intervention to increase medication adherence and improve health behaviors. Results: Enrollment began in November 2011 and is ongoing. The target sample size is 500 patients. Conclusions: The Cardiovascular Intervention Improvement Telemedicine Study (CITIES) intervention has been designed with a strong theoretical underpinning. The theoretical foundation and intervention are designed to encourage patients with multiple comorbidities and poorly controlled CVD risk factors to engage in home-based monitoring and tailored telephone-based interventions. Evidence suggests that clinical pharmacist-administered telephone-based interventions may be efficiently integrated into primary care for patients with poorly controlled CVD risk factors. PMID:24303930

Educational interventions by pharmacists to patients with chronic pain: systematic review and meta-analysis.

PubMed

Bennett, Michael I; Bagnall, Anne-Marie; Raine, Gary; Closs, S José; Blenkinsopp, Alison; Dickman, Andrew; Ellershaw, John

2011-09-01

We hypothesized that educational interventions delivered by pharmacists to patients with chronic pain might improve pain-related outcomes and sought to establish "proof of concept" for this hypothesis. We searched electronic databases and published literature for randomized studies that examined an educational intervention in relation to the management of chronic pain that was delivered by a pharmacist to an adult patient. Four studies were included that randomized 400 patients with chronic pain and which followed up patients between 1 and 16 weeks. Patients receiving these interventions experienced statistically significant benefits in the following outcomes compared with controls: a reduction in average pain intensity of 0.5 on a 0 to 10 rating scale, a reduction in adverse effects by more than 50%, and an improvement in satisfaction with treatment equivalent to approximately 1 point on a 0 to 10 rating scale. The interventions neither had effect on reducing interference from pain on daily life, nor on improving self-efficacy. Pharmacist-delivered educational interventions seem to reduce adverse events and improve satisfaction, but their clinical benefit on pain intensity is debatable. Our analysis suggests that the role of pharmacists may be important but a deeper understanding and evaluation of the active components of these interventions is needed within clinical trials before wider implementation into clinical practice can be recommended.

Interventions Using Social Media for Cancer Prevention and Management: A Systematic Review.

PubMed

Han, Claire Jungyoun; Lee, Young Ji; Demiris, George

2017-07-27

Regarding cancer awareness, social media effectively promotes health and supports self-management. Given the diverse study designs, methodologies, and approaches of social media interventions in oncology, it is difficult to determine the effects of social media on cancer prevention and management. We aim to systematically review intervention studies using social media for cancer care. A systematic search, using 7 electronic databases (PubMed, Web of Science, CINAHL, Cochrane Library, Scopus, EMBASE, and PsycINFO), was conducted to identify surveys and interventions using contemporary social media tools with a focus on cancer. Of the 18 selected studies, 7 were randomized controlled trials. Most studies were conducted for all types of cancer, and some were conducted for breast cancer in the United States, with mostly white female participants. Facebook was the most frequently used platform. Most studies targeted healthy participants providing cancer prevention education. With social media platforms as part of a larger intervention, or the main component of interventions, interventions were overall feasible and showed a significant improvement in cancer prevention and management. Social media tools have the potential to be effective in delivering interventions for cancer prevention and management. However, there was a dearth of studies with rigorous study methodologies to test social media effects on various cancer-related clinical outcomes. Social media use in cancer care will facilitate improved communication and support among patients, caregivers, and clinicians and, ultimately, improved patient care. Clinicians need to carefully harness social media to enhance patient care and clinical outcomes.

A systematic review of assessment and intervention strategies for effective clinical communication in culturally and linguistically diverse students.

PubMed

Chan, Annie; Purcell, Alison; Power, Emma

2016-09-01

Culturally and linguistically diverse (CALD) students often experience difficulties with the clinical communication skills that are essential for successful interactions in the workplace. However, there is little evidence on the effectiveness of assessment and intervention strategies for this population. The two aims of this study were: to evaluate the effectiveness of assessment tools in identifying and describing the clinical communication difficulties of CALD health care students; and to determine whether communication programmes improved their clinical communication skills. Systematic review based on the Cochrane protocol. Articles were identified through a search of established databases using MeSH and key search terms. Studies published in English from 1990 to March 2015 were included if they described assessment strategies or a training programme for communication skills of CALD students. Studies were excluded if they did not describe implementation of a specific assessment or intervention programme. Data were extracted independently by the first author and verified by the second author. Quality was measured by the Best Evidence Medical Education guide and the Educational Interventions Critical Appraisal Tool. The Kirkpatrick hierarchy was used to measure impact. Meta-analysis was not conducted because of the heterogeneity of programme design and outcome measures. One hundred and twenty-nine articles met the criteria for full text review. Eighty-six articles were excluded. Thirteen articles addressing assessment and 30 articles reporting on communication training programmes were included in this review. Assessment tools used rubrics and rating scales effectively. Intervention studies focused on speech and language skills (n = 20), interpersonal skills (n = 7) and faculty-level support (n = 5). Although 17 studies reported positive findings on student satisfaction, only eight reported improved skills post-training. The development of effective assessment and intervention programmes should have an integrated design and include specific outcome measures to increase educational impact. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Critical Care Follow-up Clinics: A Scoping Review of Interventions and Outcomes

PubMed Central

Oles, Sylwia K.; Mundell, James; London, Susan; Khan, Babar

2016-01-01

Objective The purpose of this scoping review was to identify evidence describing benefits of interventions provided in ICU-survivor follow-up clinics. Background Advances in intensive care unit (ICU) treatments have increased the number of survivors who require specialized care for ICU-related sequelae. ICU survivor follow-up clinics exist yet little is known about the nature and impact of interventions provided in such clinics. A scoping review of publications about in-person post-ICU follow-up care was undertaken. Method Ten databases were searched yielding one-hundred eleven relevant unique publication titles and abstracts. Sample heterogeneity supported using a scoping review method. After excluding non-related publications, 33 reports were fully reviewed. Twenty international publications were included that described ICU follow-up clinic interventions and/or outcomes. Results Authors discussed very diverse interventions in 15 publications, and 9 reported some level of intervention effectiveness. Evidence was strongest that supported the use of prospective diaries as an intervention to prevent or improve psychological symptoms whereas evidence to support implementation of other interventions was weak. Conclusions Although ICU follow-up clinics exist, evidence for interventions and effectiveness of treatments in these clinics remains under-explored. Implications ICU survivor follow-up clinics provide a venue for further interdisciplinary intervention research that could lead to better health outcomes for ICU survivors. PMID:27309787

Effectiveness of an intervention promoting the female condom to patients at sexually transmitted disease clinics.

PubMed Central

Artz, L; Macaluso, M; Brill, I; Kelaghan, J; Austin, H; Fleenor, M; Robey, L; Hook, E W

2000-01-01

OBJECTIVES: This study evaluated a behavioral intervention designed to promote female condoms and reduce unprotected sex among women at high risk for acquiring sexually transmitted diseases (STDs). METHODS: The effect of the intervention on barrier use was evaluated with a pretest-posttest design with 1159 female STD clinic patients. RESULTS: Among participants with follow-up data, 79% used the female condom at least once and often multiple times. More than one third of those who completed the study used female condoms throughout follow-up. Use of barrier protection increased significantly after the intervention, and high use was maintained during a 6-month follow-up. To account for attrition, the use of protection by all subjects was projected under 3 conservative assumptions. The initial visit and termination visit projections suggest that use increased sharply after the intervention and declined during follow-up but remained elevated compared with the baseline. CONCLUSIONS: Many clients of public STD clinics will try, and some will continue, to use female condoms when they are promoted positively and when women are trained to use them correctly and to promote them to their partners. A behavioral intervention that promotes both female and male condoms can increase barrier use. PMID:10667185

Effectiveness of a clinical practice change intervention in increasing the provision of nicotine dependence treatment in inpatient psychiatric facilities: an implementation trial.

PubMed

Wye, Paula M; Stockings, Emily A; Bowman, Jenny A; Oldmeadow, Chris; Wiggers, John H

2017-02-07

Despite clinical practice guidelines recommending the routine provision of nicotine dependence treatment to smokers in inpatient psychiatric facilities, the prevalence of such treatment provision is low. The aim of this study was to examine the effectiveness of a clinical practice change intervention in increasing clinician recorded provision of nicotine dependence treatment to patients in inpatient psychiatric facilities. We undertook an interrupted time series analysis of nicotine dependence treatment provision before, during and after a clinical practice change intervention to increase clinician recorded provision of nicotine dependence treatment for all hospital discharges (aged >18 years, N = 4175) over a 19 month period in two inpatient adult psychiatric facilities in New South Wales, Australia. The clinical practice change intervention comprised six key strategies: leadership and consensus, enabling systems and procedures, training and education, information and resources, audit and feedback and an on-site practice change support officer. Systematic medical record audit and segmented logistic regression was used to determine differences in proportions for each nicotine dependence treatment outcome measure between the 'pre', 'during' and 'post-intervention' periods. The prevalence of all five outcome measures increased significantly between the pre and post-intervention periods, including clinician recorded: assessment of patient smoking status (36.43 to 51.95%; adjusted odds ratio [AOR] = 2.39, 99% Confidence Interval [CI]: 1.23 to 4.66); assessment of patient nicotine dependence status (4.74 to 11.04%; AOR = 109.67, 99% CI: 35.35 to 340.22); provision of brief advice to quit (0.85 to 8.81%; AOR = 97.43, 99% CI: 31.03 to 306.30); provision of nicotine replacement therapy (8.06 to 26.25%; AOR = 19.59, 99% CI: 8.17 to 46.94); and provision of nicotine dependence treatment on discharge (8.82 to 13.45%, AOR = 12.36; 99% CI: 6.08 to 25.14). This is the first study to provide evidence that a clinical practice change intervention may increase clinician recorded provision of nicotine dependence treatment in inpatient psychiatric settings. The intervention offers a mechanism for psychiatric facilities to increase the provision of nicotine dependence treatment in accordance with clinical guidelines.

Endoscopic vs. Surgical Interventions for Painful Chronic Pancreatitis: What is Needed for Future Clinical Trials

PubMed Central

Windsor, John A; Reddy, Nageshwar D

2017-01-01

The treatment of painful chronic pancreatitis remains controversial. The available evidence from two randomized controlled trials favor surgical intervention, whereas an endotherapy-first approach is widely practiced. Chronic pancreatitis is complex disease with different genetic and environmental factors, different pain mechanisms and different treatment modalities including medical, endoscopic, and surgical. The widely practiced step-up approach remains unproven. In designing future clinical trials there are some important pre-requisites including a more comprehensive pain assessment tool, the optimization of conservative medical treatment and interventional techniques. Consideration should be given to the need of a control arm and the optimal timing of intervention. Pending better designed studies, the practical way forward is to identify subgroups of patients who clearly warrant endotherapy or surgery first, and to design the future clinical trials for the remainder. PMID:28079861

An ethnography of clinic "noise" in a community-based, promotora-centered mental health intervention.

PubMed

Getrich, Christina; Heying, Shirley; Willging, Cathleen; Waitzkin, Howard

2007-07-01

Community-based health interventions have emerged as a growing focus for anthropological research. The application of ethnographic approaches in clinical practice settings reveals that community-based interventions must grapple with "noise," or unanticipated factors such as patients' own perceptions of illness and treatment, primary care providers' non-adherence to guidelines-based treatment, the social dynamics of the clinic site itself, and incomplete understanding and acceptance of an intervention by a clinic's staff members. Such noise can influence the implementation and quality of treatment. Thus, identifying clinic-based noise is critical in assessments of fidelity to intervention protocols as well as outcomes of community-based interventions. This paper highlights findings from an evaluation of a mental health intervention focusing on the role of promotoras (briefly trained, non-professional community health workers) as mental health practitioners in two urban New Mexico, USA, community health centers. Our research identified three areas of clinic-based noise: the clinics' physical ability to "absorb" the intervention, the challenges of co-worker instability and interpersonal relationships, and balancing extra workplace demands. The findings demonstrate the value of ethnographic approaches in community-based intervention research.

Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma

PubMed Central

Wechsler, Michael E.; Kelley, John M.; Boyd, Ingrid O.E.; Dutile, Stefanie; Marigowda, Gautham; Kirsch, Irving; Israel, Elliot; Kaptchuk, Ted J.

2011-01-01

BACKGROUND In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma. METHODS In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV1) was measured, and patients’ self-reported improvement ratings were recorded. RESULTS Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV1, as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients’ reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001). CONCLUSIONS Although albuterol, but not the two placebo interventions, improved FEV1 in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine; ClinicalTrials.gov number, NCT01143688.) PMID:21751905

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

PubMed

Acri, Mary; Hamovitch, Emily; Mini, Maria; Garay, Elene; Connolly, Claire; McKay, Mary

2017-12-04

Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting. This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses. The aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems. ClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.

Cognitive Defusion versus Thought Distraction: A Clinical Rationale, Training, and Experiential Exercise in Altering Psychological Impacts of Negative Self-Referential Thoughts

ERIC Educational Resources Information Center

Masuda, Akihiko; Feinstein, Amanda B.; Wendell, Johanna W.; Sheehan, Shawn T.

2010-01-01

Using two modes of intervention delivery, the present study compared the effects of a cognitive defusion strategy with a thought distraction strategy on the emotional discomfort and believability of negative self-referential thoughts. One mode of intervention delivery consisted of a clinical rationale and training (i.e., Partial condition). The…

A critical appraisal of nutritional intervention studies in malnourished, community dwelling older persons.

PubMed

de van der Schueren, M A E; Wijnhoven, H A H; Kruizenga, H M; Visser, M

2016-10-01

With the rapidly increasing number of malnourished older persons in the community, this review aims to summarize the effects of nutritional intervention studies for this target group. Based on 2 previous reviews (2009, 2011) an update of the literature was performed. Selected were higher quality studies which included malnourished community dwelling older adults who received dietetic counselling and/or oral nutritional supplements. Ten studies were included. Six studies showed (trends towards) weight gain. Meta-analysis showed a modest effect of the intervention on weight gain, standardized mean difference 0.210 kg (95% CI 0.03-0.40). Effects on other relevant functional and clinical outcomes were inconsistent. Studies were hampered by low sample sizes, low adherence to the interventions, and participants not meeting nutritional requirements. Currently, nutritional intervention studies for malnourished community dwelling older adults show limited effects, which may be caused by methodological shortcomings and participants not meeting treatment goals. High quality studies are eagerly awaited to be able to identify (sub)groups of older persons who are most likely to benefit from nutritional support. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Do team processes really have an effect on clinical performance? A systematic literature review.

PubMed

Schmutz, J; Manser, T

2013-04-01

There is a growing literature on the relationship between team processes and clinical performance. The purpose of this review is to summarize these articles and examine the impact of team process behaviours on clinical performance. We conducted a literature search in five major databases. Inclusion criteria were: English peer-reviewed papers published between January 2001 and May 2012, which showed or tried to show (i) a statistical relationship of a team process variable and clinical performance or (ii) an improvement of a performance variable through a team process intervention. Study quality was assessed using predefined quality indicators. For every study, we calculated the relevant effect sizes. We included 28 studies in the review, seven of which were intervention studies. Every study reported at least one significant relationship between team processes or an intervention and performance. Also, some non-significant effects were reported. Most of the reported effect sizes were large or medium. The study quality ranged from medium to high. The studies are highly diverse regarding the specific team process behaviours investigated and also regarding the methods used. However, they suggest that team process behaviours do influence clinical performance and that training results in increased performance. Future research should rely on existing theoretical frameworks, valid, and reliable methods to assess processes such as teamwork or coordination and focus on the development of adequate tools to assess process performance, linking them with outcomes in the clinical setting.

Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): A cluster randomised trial protocol

PubMed Central

2010-01-01

Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003). Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition. Aims This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia) compliance with a clinical practice guideline for acute non-specific low back pain (LBP), compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP. Methods The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters) to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The intervention primarily consisted of an educational symposium. Patients aged 18 years or older who visit a participating practitioner for acute non-specific LBP of less than three months duration over a two-week data collection period, three months post the intervention symposia, are eligible for inclusion. Sample size calculations are based on recruiting between 15 to 40 patients per practice. Outcome assessors will be blinded to group allocation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609001022257 (date registered 25th November 2009) PMID:21067614

Going beyond: an adventure- and recreation-based group intervention promotes well-being and weight loss in schizophrenia.

PubMed

Voruganti, Lakshmi N P; Whatham, Jeff; Bard, Eleanor; Parker, Gayle; Babbey, Candice; Ryan, Janet; Lee, Suganya; MacCrimmon, Duncan J

2006-08-01

To undertake a preliminary study to assess the feasibility of clinical implementation and evaluate the effectiveness of a novel adventure- and recreation-based group intervention in the rehabilitation of individuals with schizophrenia. In a 2-year, prospective, case-control study, 23 consecutively referred, clinically stabilized schizophrenia patients received the new intervention over an 8-month period; 31 patients on the wait list, considered the control group, received standard clinical care that included some recreational activities. Symptom severity, self-esteem, self-appraised cognitive abilities, and functioning were documented for both groups with standardized rating scales administered at baseline, on completion of treatment, and at 12 months posttreatment. Treatment adherence was 97%, and there were no dropouts. Patients in the study group showed marginal improvement in perceived cognitive abilities and on domain-specific functioning measures but experienced a significant improvement in their self-esteem and global functioning (P < 0.05), as well as a weight loss of over 12 lb. Improvement was sustained over 1 year with further occupational and social gains. In the context of overcoming barriers to providing early intervention for youth and preventing metabolic problems among older adults with schizophrenia, adventure- and recreation-based interventions could play a useful complementary role.

The intended and unintended consequences of communication systems on general internal medicine inpatient care delivery: a prospective observational case study of five teaching hospitals

PubMed Central

Wu, Robert C; Lo, Vivian; Morra, Dante; Wong, Brian M; Sargeant, Robert; Locke, Ken; Cavalcanti, Rodrigo; Quan, Sherman D; Rossos, Peter; Tran, Kim; Cheung, Mark

2013-01-01

Background Effective clinical communication is critical to providing high-quality patient care. Hospitals have used different types of interventions to improve communication between care teams, but there have been few studies of their effectiveness. Objectives To describe the effects of different communication interventions and their problems. Design Prospective observational case study using a mixed methods approach of quantitative and qualitative methods. Setting General internal medicine (GIM) inpatient wards at five tertiary care academic teaching hospitals. Participants Clinicians consisting of residents, attending physicians, nurses, and allied health (AH) staff working on the GIM wards. Methods Ethnographic methods and interviews with clinical staff (doctors, nurses, medical students, and AH professionals) were conducted over a 16-month period from 2009 to 2010. Results We identified four categories that described the intended and unintended consequences of communication interventions: impacts on senders, receivers, interprofessional collaboration, and the use of informal communication processes. The use of alphanumeric pagers, smartphones, and web-based communication systems had positive effects for senders and receivers, but unintended consequences were seen with all interventions in all four categories. Conclusions Interventions that aimed to improve clinical communications solved some but not all problems, and unintended effects were seen with all systems. PMID:23355461

The effect of spiritual interventions addressing existential themes using a narrative approach on quality of life of cancer patients: a systematic review and meta-analysis.

PubMed

Kruizinga, Renske; Hartog, Iris D; Jacobs, Marc; Daams, Joost G; Scherer-Rath, Michael; Schilderman, Johannes B A M; Sprangers, Mirjam A G; Van Laarhoven, Hanneke W M

2016-03-01

The aim of this study was to examine the effect of spiritual interventions on quality of life of cancer patients. We conducted our search on June 6, 2014 in Medline, PsycINFO, Embase, and PubMed. All clinical trials were included that compared standard care with a spiritual intervention that addressed existential themes using a narrative approach. Study quality was evaluated by the Cochrane Risk of Bias Tool. A total of 4972 studies were identified, of which 14 clinical trials (2050 patients) met the inclusion criteria, and 12 trials (1878 patients) were included in the meta-analysis. The overall risk of bias was high. When combined, all studies showed a moderate effect (d) 0.50 (95% CI = 0.20-0.79) 0-2 weeks after the intervention on overall quality of life in favor of the spiritual interventions. Meta-analysis at 3-6 months after the intervention showed a small insignificant effect (0.14, 95% CI = -0.08 to 0.35). Subgroup analysis including only the western studies showed a small effect of 0.17 (95% CI = 0.05-0.29). Including only studies that met the allocation concealment criteria showed an insignificant effect of 0.14 (95% CI = -0.05 to 0.33). Directly after the intervention, spiritual interventions had a moderate beneficial effect in terms of improving quality of life of cancer patients compared with that of a control group. No evidence was found that the interventions maintained this effect up to 3-6 months after the intervention. Further research is needed to understand how spiritual interventions could contribute to a long-term effect of increasing or maintaining quality of life. Copyright © 2015 John Wiley & Sons, Ltd.

Advances in Diagnosis and Treatment of Fetal Alcohol Spectrum Disorders

PubMed Central

Murawski, Nathen J.; Moore, Eileen M.; Thomas, Jennifer D.; Riley, Edward P.

2015-01-01

Prenatal alcohol exposure can cause a number of physical, behavioral, cognitive, and neural impairments, collectively known as fetal alcohol spectrum disorders (FASD). This article examines basic research that has been or could be translated into practical applications for the diagnosis or treatment of FASD. Diagnosing FASD continues to be a challenge, but advances are being made at both basic science and clinical levels. These include identification of biomarkers, recognition of subtle facial characteristics of exposure, and examination of the relation between face, brain, and behavior. Basic research also is pointing toward potential new interventions for FASD involving pharmacotherapies, nutritional therapies, and exercise interventions. Although researchers have assessed the majority of these treatments in animal models of FASD, a limited number of recent clinical studies exist. An assessment of this literature suggests that targeted interventions can improve some impairments resulting from developmental alcohol exposure. However, combining interventions may prove more efficacious. Ultimately, advances in basic and clinical sciences may translate to clinical care, improving both diagnosis and treatment. PMID:26259091

Value analysis of postoperative staging imaging for asymptomatic, early-stage breast cancer: implications of clinical variation on utility and cost.

PubMed

Pellet, Andrew C; Erten, Mujde Z; James, Ted A

2016-06-01

Routine staging imaging for early-stage breast cancer is not recommended. Despite this, there is clinical practice variation with imaging studies obtained for asymptomatic patients with a positive sentinel node (SN+). We characterize the utility, cost, and clinical implications of imaging studies obtained in asymptomatic SN+ patients. A retrospective review was performed of asymptomatic, clinically node-negative patients who were found to have a positive sentinel node after surgery. The type of imaging, subsequent tests/interventions, frequency of additional malignancy detected, and costs were recorded. From April 2009 to April 2013, a total of 50 of 113 (44%) asymptomatic patients underwent staging imaging for a positive sentinel node; 11 (22%) patients had at least 1 subsequent imaging study or diagnostic intervention. No instance of metastatic breast cancer was identified, with a total cost of imaging calculated at $116,905. Staging imaging for asymptomatic SN+ breast cancer demonstrates clinical variation. These tests were associated with low utility, increased costs, and frequent false positives leading to subsequent testing/intervention. Evidence-based standardization may help increase quality by decreasing unnecessary variation and cost. Copyright © 2015 Elsevier Inc. All rights reserved.

Facility-level intervention to improve attendance and adherence among patients on anti-retroviral treatment in Kenya--a quasi-experimental study using time series analysis.

PubMed

Boruett, Patrick; Kagai, Dorine; Njogo, Susan; Nguhiu, Peter; Awuor, Christine; Gitau, Lillian; Chalker, John; Ross-Degnan, Dennis; Wahlström, Rolf; Tomson, Göran

2013-07-01

Achieving high rates of adherence to antiretroviral therapy (ART) in resource-poor settings comprises serious, but different, challenges in both the first months of treatment and during the life-long maintenance phase. We measured the impact of a health system-oriented, facility-based intervention to improve clinic attendance and patient adherence. This was a quasi-experimental, longitudinal, controlled intervention study using interrupted time series analysis. The intervention consisted of (1) using a clinic appointment diary to track patient attendance and monitor monthly performance; (2) changing the mode of asking for self-reported adherence; (3) training staff on adherence concepts, intervention methods, and use of monitoring data; (4) conducting visits to support facility teams with the implementation.We conducted the study in 12 rural district hospitals (6 intervention, 6 control) in Kenya and randomly selected 1894 adult patients over 18 years of age in two cohorts: experienced patients on treatment for at least one year, and newly treated patients initiating ART during the study. Outcome measures were: attending the clinic on or before the date of a scheduled appointment, attending within 3 days of a scheduled appointment, reporting perfect adherence, and experiencing a gap in medication supply of more than 14 days. Among experienced patients, the percentage attending the clinic on or before a scheduled appointment increased in both level (average total increase immediately after intervention) (+5.7%; 95% CI=2.1, 9.3) and trend (increase per month) (+1.0% per month; 95% CI=0.6, 1.5) following the intervention, as did the level and trend of those keeping appointments within three days (+4.2%; 95% CI=1.6, 6.7; and +0.8% per month; 95% CI=0.6, 1.1, respectively). The relative difference between the intervention and control groups based on the monthly difference in visit rates increased significantly in both level (+6.5; 95% CI=1.4, 11.6) and trend (1.0% per month; 95% CI=0.2, 1.8) following the intervention for experienced patients attending the clinic within 3 days of their scheduled appointments.The decrease in the percentage of experienced patients with a medication gap greater than 14 days approached statistical significance (-11.3%; 95% CI=-22.7, 0.1), and the change seemed to persist over 11 months after the intervention. All facility staff used appointment-keeping data to calculate adherence and discussed outcomes regularly. The appointment-tracking system and monthly performance monitoring was strengthened, and patient attendance was improved. Scale-up to national level may be considered.

Clinical pharmacists in general practice: an initial evaluation of activity in one English primary care organisation.

PubMed

Bush, Joseph; Langley, Christopher A; Jenkins, Duncan; Johal, Jaspal; Huckerby, Clair

2017-12-27

This aim of this research was to characterise the breadth and volume of activity conducted by clinical pharmacists in general practice in Dudley Clinical Commissioning Group (CCG), and to provide quantitative estimates of both the savings in general practitioner (GP) time and the financial savings attributable to such activity. This descriptive observational study retrospectively analysed quantitative data collected by Dudley CCG concerning the activity of clinical pharmacists in GP practices during 2015. Over the 9-month period for which data were available, the 5.4 whole time equivalent clinical pharmacists operating in GP practices within Dudley CCG identified 23 172 interventions. Ninety-five per cent of the interventions identified were completed within the study period saving the CCG in excess of £1 000 000. During the 4 months for which resource allocation data were available, the clinical pharmacists saved 628 GP appointments plus an additional 647 h that GPs currently devote to medication review and the management of repeat prescribing. This research suggests that clinical pharmacists in general practice in Dudley CCG are able to deliver clinical interventions efficiently and in high volume. In doing so, clinical pharmacists were able to generate considerable financial returns on investment. Further work is recommended to examine the effectiveness and cost-effectiveness of clinical pharmacists in general practice in improving outcomes for patients. © 2017 Royal Pharmaceutical Society.

Multi-level assessment protocol (MAP) for adoption in multi-site clinical trials

PubMed Central

Guydish, J.; Manser, S.T.; Jessup, M.; Tajima, B.; Sears, C.; Montini, T.

2010-01-01

The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is intended to test promising drug abuse treatment models in multi-site clinical trials, and to support adoption of new interventions into clinical practice. Using qualitative research methods we asked: How might the technology of multi-site clinical trials be modified to better support adoption of tested interventions? A total of 42 participants, representing 8 organizational levels ranging from clinic staff to clinical trial leaders, were interviewed about their role in the clinical trial, its interactions with clinics, and intervention adoption. Among eight clinics participating in the clinical trial, we found adoption of the tested intervention in one clinic only. In analysis of interview data we identified four conceptual themes which are likely to affect adoption and may be informative in future multi-site clinical trials. We offer the conclusion that planning for adoption in the early stages of protocol development will better serve the aim of integrating new interventions into practice. PMID:20890376

Mentoring, coaching and action learning: interventions in a national clinical leadership development programme.

PubMed

McNamara, Martin S; Fealy, Gerard M; Casey, Mary; O'Connor, Tom; Patton, Declan; Doyle, Louise; Quinlan, Christina

2014-09-01

To evaluate mentoring, coaching and action learning interventions used to develop nurses' and midwives' clinical leadership competencies and to describe the programme participants' experiences of the interventions. Mentoring, coaching and action learning are effective interventions in clinical leadership development and were used in a new national clinical leadership development programme, introduced in Ireland in 2011. An evaluation of the programme focused on how participants experienced the interventions. A qualitative design, using multiple data sources and multiple data collection methods. Methods used to generate data on participant experiences of individual interventions included focus groups, individual interviews and nonparticipant observation. Seventy participants, including 50 programme participants and those providing the interventions, contributed to the data collection. Mentoring, coaching and action learning were positively experienced by participants and contributed to the development of clinical leadership competencies, as attested to by the programme participants and intervention facilitators. The use of interventions that are action-oriented and focused on service development, such as mentoring, coaching and action learning, should be supported in clinical leadership development programmes. Being quite different to short attendance courses, these interventions require longer-term commitment on the part of both individuals and their organisations. In using mentoring, coaching and action learning interventions, the focus should be on each participant's current role and everyday practice and on helping the participant to develop and demonstrate clinical leadership skills in these contexts. © 2014 John Wiley & Sons Ltd.

Social Support for Diabetes Self-Management via eHealth Interventions.

PubMed

Vorderstrasse, Allison; Lewinski, Allison; Melkus, Gail D'Eramo; Johnson, Constance

2016-07-01

eHealth interventions have been increasingly used to provide social support for self-management of type 2 diabetes. In this review, we discuss social support interventions, types of support provided, sources or providers of support, outcomes of the support interventions (clinical, behavioral, psychosocial), and logistical and clinical considerations for support interventions using eHealth technologies. Many types of eHealth interventions demonstrated improvements in self-management behaviors, psychosocial outcomes, and clinical measures, particularly HbA1c. Important factors to consider in clinical application of eHealth support interventions include participant preferences, usability of eHealth technology, and availability of personnel to orient or assist participants. Overall, eHealth is a promising adjunct to clinical care as it addresses the need for ongoing support in chronic disease management.

Exploring exercise as an avenue for the treatment of anxiety disorders.

PubMed

DeBoer, Lindsey B; Powers, Mark B; Utschig, Angela C; Otto, Michael W; Smits, Jasper A J

2012-08-01

Anxiety disorders constitute a significant public health problem. Current gold standard treatments are limited in their effectiveness, prompting the consideration of alternative approaches. In this review, we examine the evidence for exercise as an intervention for anxiety disorders. This evidence comes from population studies, studies of nonclinical anxiety reduction, as well as a limited number of studies of clinically anxious individuals. All of these studies provide converging evidence for consistent beneficial effects of exercise on anxiety, and are consistent with a variety of accounts of the mechanism of anxiety reduction with exercise. Further study of clinical populations is encouraged, as are studies of the mechanism of change of exercise interventions, which have the potential to help refine exercise intervention strategies. Likewise, studies that identify moderators of treatment efficacy will assist clinicians in deciding how and for whom to prescribe exercise.

Using video feedback to improve early father–infant interaction: A pilot study

PubMed Central

Davies, Beverley; Ramchandani, Paul G.

2013-01-01

Preventive interventions with parents of infants have tended to focus on mothers. Recent research focused on fathers suggests that their involvement in interventions might enhance effectiveness. One effective approach with mothers is the brief, home-based Video-feedback Intervention to promote Positive Parenting (VIPP). This paper is a report of a pilot study of VIPP with fathers to assess its feasibility. Five fathers were recruited from an existing longitudinal study of parents. The primary outcome was acceptability, assessed using a semi-structured questionnaire after completion of the intervention. All fathers completed all sessions of the intervention. Fathers rated the intervention as having had a significant impact on their understanding of their child’s thoughts and feelings, and as having improved their communication and relationship with their baby. Fathers’ feedback was generally positive. The flexibility to conduct sessions at home (or at fathers’ places of work) and the flexible timing of sessions were identified as fundamental to successful delivery. The results of this pilot study are encouraging, as VIPP with fathers was feasible. In light of the modest sample size, and the use of a non-clinical sample, the intervention must be evaluated with larger, clinical samples to evaluate its efficacy with fathers. PMID:22434935

Clinic-wide Intervention Lowers Financial Risk and Improves Revenue to HIV Clinics Through Fewer Missed Primary Care Visits

PubMed Central

Gardner, Lytt I.; Marks, Gary; Wilson, Tracey E.; Giordano, Thomas P.; Sullivan, Meg; Raper, James L.; Rodriguez, Allan E.; Keruly, Jeanne; Malitz, Faye

2016-01-01

We calculated the financial impact in 6 HIV clinics of a low-effort retention in care intervention involving brief motivational messages from providers, patient brochures, and posters. We used a linear regression model to calculate absolute changes in kept primary care visits from the preintervention year (2008–2009) to the intervention year (2009–2010). Revenue from patients’ insurance was also assessed by clinic. Kept visits improved significantly in the intervention year versus the preintervention year (P < 0.0001). We found a net-positive effect on clinic revenue of +$24,000/year for an average-size clinic (7400 scheduled visits/year). We encourage HIV clinic administrators to consider implementing this low-effort intervention. PMID:25559605

What's in a Trial? On the Importance of Distinguishing Between Experimental Lab Studies and Randomized Controlled Trials: The Case of Cognitive Bias Modification and Alcohol Use Disorders.

PubMed

Wiers, Reinout W; Boffo, Marilisa; Field, Matt

2018-05-01

Recently, the National Institutes of Health (NIH) redefined clinical trials to include any study involving behavioral or biomedical interventions. In line with a general framework from experimental medicine, we argue that it is crucial to distinguish between experimental laboratory studies aimed at revealing psychological mechanisms underlying behavior and randomized controlled trials (RCTs) in clinical samples aimed at testing the efficacy of an intervention. As an illustration, we reviewed the current state of the evidence on the efficacy of cognitive bias modification (CBM) interventions in alcohol use disorders. A recent meta-analysis "cast serious doubts on the clinical utility of CBM interventions for addiction." That analysis combined experimental laboratory studies and RCTs. We demonstrated that, when studies are differentiated regarding study type (experimental laboratory study or RCT), mode of delivery (controlled experiment or Internet), and population (healthy volunteers or patients), the following effects are found: (a) short-lived effects of CBM on drinking behavior in experimental laboratory studies in students, but only when the bias is successfully manipulated; (b) small but robust effects of CBM on treatment outcome when administered as an adjunct to established treatments in clinical settings in RCTs with alcohol-dependent patients; and (c) nonspecific effects (reduced drinking irrespective of condition) in RCTs of CBM administered online to problem drinkers. We discuss how CBM might be improved when it is better integrated into regular treatment, especially cognitive behavioral therapy, and we conclude that disregarding the difference between experimental laboratory studies and RCTs can lead to invalid conclusions.

A feasibility study of a psychoeducational intervention program for gynecological cancer patients.

PubMed

Chow, Ka Ming; Chan, Carmen W H; Chan, Joanne C Y; Choi, Kai K C; Siu, K Y

2014-08-01

This study aimed to test the feasibility of implementing a psychoeducational intervention program for gynecological cancer patients. A single-blinded randomized controlled trial and mixed-method design were used. Study subjects were newly diagnosed gynecological cancer patients with surgery as the first-line treatment. They were randomly assigned to the intervention group, in which a psychoeducational intervention program based on a thematic counseling model was offered, or to the attention control group. Quantitative data on sexual functioning, quality of life, uncertainty, anxiety, depression and social support were collected at recruitment, post-operative and during the in-hospital period, and eight weeks after the operation. Participants in the intervention group and three nurses working in the clinical setting were invited to have semi-structured interviews. Of the 30 eligible subjects, 26 were successfully recruited into the study. Following the psychoeducational intervention program, there was significant improvement in the level of inconsistent information about the illness within the category of uncertainty among participants in the intervention group. In addition, trends towards improvement were demonstrated in quality of life, uncertainty, depression and perceived social support with the provision of the interventions. Qualitative data indicated the interventions were desired and appreciated by the participants, as well as being feasible and practical to implement in Hong Kong clinical settings. The findings suggest that it is feasible to deliver the psychoeducational intervention program and it may have beneficial effects in gynecological cancer patients. A full-scale study is warranted to confirm the results. Copyright © 2014 Elsevier Ltd. All rights reserved.

Educational interventions to improve quality of life in people with chronic inflammatory skin diseases: systematic reviews of clinical effectiveness and cost-effectiveness.

PubMed

Pickett, Karen; Loveman, Emma; Kalita, Neelam; Frampton, Geoff K; Jones, Jeremy

2015-10-01

Inflammatory skin diseases include a broad range of disorders. For some people, these conditions lead to psychological comorbidities and reduced quality of life (QoL). Patient education is recommended in the management of these conditions and may improve QoL. To assess the clinical effectiveness and cost-effectiveness of educational interventions to improve health-related quality of life (HRQoL) in people with chronic inflammatory skin diseases. Twelve electronic bibliographic databases, including The Cochrane Library, MEDLINE and EMBASE, were searched to July 2014. Bibliographies of retrieved papers were searched and an Advisory Group contacted. Systematic reviews were conducted following standard methodologies. Clinical effectiveness studies were included if they were undertaken in people with a chronic inflammatory skin condition. Educational interventions that aimed to, or could, improve HRQoL were eligible. Studies were required to measure HRQoL, and other outcomes such as disease severity were also included. Randomised controlled trials (RCTs) or controlled clinical trials were eligible. For the review of cost-effectiveness, studies were eligible if they were full economic evaluations, cost-consequence or cost analyses. Seven RCTs were included in the review of clinical effectiveness. Two RCTs focused on children with eczema and their carers. Five RCTs were in adults. Of these, two were of people with psoriasis, one was of people with acne and two were of people with a range of conditions. There were few similarities in the interventions (e.g. the delivery mode, the topics covered, the duration of the education), which precluded any quantitative synthesis. Follow-up ranged from 4 weeks to 12 months, samples sizes were generally small and, overall, the study quality was poor. There appeared to be positive effects on HRQoL in participants with psoriasis in one trial, but no difference between groups in another trial in which participants had less severe psoriasis. Carers of children in one RCT of eczema showed improvement in HRQoL; however, in a RCT evaluating a website intervention there were no demonstrable effects on HRQoL. Neither the RCT in those adults with acne nor the RCT in those adults with mixed skin conditions demonstrated an effect on HRQoL. One RCT reported subgroups with atopic dermatitis or psoriasis and education was effective for psoriasis only. Other outcomes also showed mixed results. It is unclear how clinically meaningful any of the observed improvements are. Three studies of cost-effectiveness were included. The interventions, comparators and populations varied across the studies and, overall, the studies provided limited information on cost-effectiveness. The studies did provide detailed information on resources and costs that could be useful to inform a future cost-effectiveness evaluation in this area. The application of the inclusion criterion around whether the interventions were aimed at improving HRQoL or the inference that they could improve HRQoL was difficult as information was rarely reported. There is uncertainty regarding whether educational interventions addressing issues that could improve HRQoL in people with chronic skin conditions are effective. Tentative conclusions about the best approach to delivering these kinds of interventions are that face-to-face, group, sessions may be beneficial; however, text messages may also be effective. Delivery over a period of time and by a multidisciplinary team may also be associated with positive outcomes. There is uncertainty over whether or not educational interventions are cost-effective. This study is registered as PROSPERO CRD42014007426. The National Institute for Health Research Health Technology Assessment programme.

Acceptance and attitudes of healthcare staff towards the introduction of clinical pharmacy service: a descriptive cross-sectional study from a tertiary care hospital in Sri Lanka.

PubMed

Shanika, Lelwala Guruge Thushani; Wijekoon, Chandrani Nirmala; Jayamanne, Shaluka; Coombes, Judith; Coombes, Ian; Mamunuwa, Nilani; Dawson, Andrew Hamilton; De Silva, Hithanadura Asita

2017-01-18

Multidisciplinary patient management including a clinical pharmacist shows an improvement in patient quality use of medicine. Implementation of a clinical pharmacy service represents a significant novel change in practice in Sri Lanka. Although attitudes of doctors and nurses are an important determinant of successful implementation, there is no Sri Lankan data about staff attitudes to such changes in clinical practice. This study determines the level of acceptance and attitudes of doctors and nurses towards the introduction of a ward-based clinical pharmacy service in Sri Lanka. This is a descriptive cross-sectional sub-study which determines the acceptance and attitudes of healthcare staff about the introduction of a clinical pharmacy service to a tertiary care hospital in Sri Lanka. The level of acceptance of pharmacist's recommendations regarding drug-related problems (DRPs) was measured. Data regarding attitudes were collected through a pre-tested self-administered questionnaires distributed to doctors (baseline, N =13, post-intervention period, N = 12) and nurses (12) worked in professorial medical unit at baseline and post-intervention period. A total of 274 (272 to doctors and 2 to nurses) recommendations regarding DRPs were made. Eighty three percent (225/272) and 100% (2/2) of the recommendations were accepted by doctors and nurses, respectively. The rate of implementation of pharmacist's recommendations by doctors was 73.5% (200/272) (95% CI 67.9 - 78.7%; P < 0.001). The response rate of doctors was higher at the post-intervention period (92.3%; 12/13) compared to the baseline (66.7%; 8/12). At the post-intervention survey 91.6% of doctors were happy to work with competent clinical pharmacists and accepted the necessity of this service to improve standards of care. The nurses' rate of response at baseline and post-intervention surveys were 80.0 and 0.0% respectively. Their perceptions on the role of clinical pharmacist were negative at baseline survey. There was high acceptance and implementation of clinical pharmacist's recommendations regarding DRPs by the healthcare team. The doctors' views and attitudes were positive regarding the inclusion of a ward-based pharmacist to the healthcare team. However there is a need to improve liaison between clinical pharmacist and nursing staff. Sri Lanka Clinical Trials Registry SLCTR/2013/029 Date: 13 September 2013; retrospectively registered.

Video-based sexually transmitted disease patient education: its impact on condom acquisition.

PubMed Central

O'Donnell, L N; Doval, A S; Duran, R; O'Donnell, C

1995-01-01

OBJECTIVES. This study assessed the impact of video-based educational interventions on condom acquisition among men and women seeking services at a large sexually transmitted disease clinic in the South Bronx, New York. METHODS. During 1992, 3348 African American and Hispanic patients were enrolled in a clinical trial of video-based interventions designed to promote safer sex behaviors, including increased condom use. Patients were assigned to one of three groups: control, video, or video plus interactive group discussion. Subjects were given a coupon to redeem for free condoms at a pharmacy several blocks from the clinic. Rates of condom acquisition were assessed by level of intervention. RESULTS. In comparison with a control group, subjects who viewed videos were significantly more likely to redeem coupons for condoms (21.2% redemption rate vs 27.6%). However, participation in interactive sessions after video viewing augmented the positive effects of video viewing alone (27.6% redemption rate vs 36.9%). Gender and ethnicity were significantly associated with outcomes. CONCLUSIONS. The condom acquisition are almost doubled with the use of culturally appropriate, video-based interventions. Designed to present minimal disruption to clinical services, these interventions can be implemented in clinics servicing at-risk men and women. Images FIGURE 1 PMID:7762716

Assessment of Clinical Effect of Perioperative Comprehensive Nursing Intervention Pattern in 23G Minimally Invasive Vitreous Surgery.

PubMed

Shen, Jie; Li, Su-Yan; Wang, Jian-Yu; Chen, Jing; Wang, Wen

2016-01-01

We observed the clinical effects of comprehensive nursing intervention pattern in 23G minimally invasive vitreous surgery according to the comprehensive nursing intervention table developed by our hospital, which would supply a basis for its clinical application. In this prospective study, we followed 120 patients undergoing 23G minimally invasive vitreous surgery from Xuzhou First People's Hospital from February 2013 to February 2015 and divided them into control and observation groups by a random number table (60 patients in each group). A regular nursing pattern was adopted for the control group, and a comprehensive nursing intervention pattern was adopted for the observation group. After that, a comparative analysis was made to identify the differences between the clinical effects of the two groups. Scores of cognition ratio, patient compliance and comfort level of patients in the observation group were higher than those of the control group were, and there was significant difference between the groups (P< 0.05). Complication incidence of the observation group is significantly lower than that of the control group (P<0.05). The comprehensive nursing intervention pattern developed by our hospital can improve clinical effects notably, which is of application value .We recommend it to be applied in eye diseases.

Enablers and challenges to occupational therapists’ research engagement: A qualitative study

PubMed Central

Di Bona, Laura; Wenborn, Jennifer; Field, Becky; Hynes, Sinéad M; Ledgerd, Ritchard; Mountain, Gail; Swinson, Tom

2017-01-01

Introduction To develop occupational therapy’s evidence base and improve its clinical outcomes, occupational therapists must increase their research involvement. Barriers to research consumption and leadership are well documented, but those relating to delivering research interventions, less so. Yet, interventions need to be researched within practice to demonstrate their clinical effectiveness. This study aims to improve understanding of challenges and enablers experienced by occupational therapists who deliver interventions within research programmes. Method Twenty-eight occupational therapists who participated in the Valuing Active Life in Dementia (VALID) research programme reported their experiences in five focus groups. Data were analysed thematically to identify key and subthemes. Results Occupational therapists reported that overwhelming paperwork, use of videos, recruitment and introducing a new intervention challenged their research involvement, whereas support, protected time and a positive attitude enabled it. The impact of these challenges and enablers varied between therapists and organisations. Conclusion Challenges and enablers to research involvement can be identified but must be addressed within individual and organisational contexts. Multifaceted collective action to minimise challenges and maximise enablers can facilitate clinicians’ involvement in research. Using this approach should enable occupational therapists to increase their research involvement, thus demonstrating the clinical effectiveness of their interventions. PMID:29170592

A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease.

PubMed

Ezenwa, Miriam O; Yao, Yingwei; Engeland, Christopher G; Molokie, Robert E; Wang, Zaijie Jim; Suarez, Marie L; Wilkie, Diana J

2016-06-01

To test feasibility of a guided audio-visual relaxation intervention protocol for reducing stress and pain in adults with sickle cell disease. Sickle cell pain is inadequately controlled using opioids, necessitating further intervention such as guided relaxation to reduce stress and pain. Attention-control, randomized clinical feasibility pilot study with repeated measures. Randomized to guided relaxation or control groups, all patients recruited between 2013-2014 during clinical visits, completed stress and pain measures via a Galaxy Internet-enabled Android tablet at the Baseline visit (pre/post intervention), 2-week posttest visit and also daily at home between the two visits. Experimental group patients were asked to use a guided relaxation intervention at the Baseline visit and at least once daily for 2 weeks. Control group patients engaged in a recorded sickle cell discussion at the Baseline visit. Data were analysed using linear regression with bootstrapping. At baseline, 27/28 of consented patients completed the study protocol. Group comparison showed that guided relaxation significantly reduced current stress and pain. At the 2-week posttest, 24/27 of patients completed the study, all of whom reported liking the study. Patients completed tablet-based measures on 71% of study days (69% in control group, 72% in experiment group). At the 2-week posttest, the experimental group had significantly lower composite pain index scores, but the two groups did not differ significantly on stress intensity. This study protocol appears feasible. The tablet-based guided relaxation intervention shows promise for reducing sickle cell pain and warrants a larger efficacy trial. The ClinicalTrials.gov Identifier is: NCT02501447. © 2016 John Wiley & Sons Ltd.

Novel System for Real-Time Integration of 3-D Echocardiography and Fluoroscopy for Image-Guided Cardiac Interventions: Preclinical Validation and Clinical Feasibility Evaluation.

PubMed

Arujuna, Aruna V; Housden, R James; Ma, Yingliang; Rajani, Ronak; Gao, Gang; Nijhof, Niels; Cathier, Pascal; Bullens, Roland; Gijsbers, Geert; Parish, Victoria; Kapetanakis, Stamatis; Hancock, Jane; Rinaldi, C Aldo; Cooklin, Michael; Gill, Jaswinder; Thomas, Martyn; O'neill, Mark D; Razavi, Reza; Rhode, Kawal S

2014-01-01

Real-time imaging is required to guide minimally invasive catheter-based cardiac interventions. While transesophageal echocardiography allows for high-quality visualization of cardiac anatomy, X-ray fluoroscopy provides excellent visualization of devices. We have developed a novel image fusion system that allows real-time integration of 3-D echocardiography and the X-ray fluoroscopy. The system was validated in the following two stages: 1) preclinical to determine function and validate accuracy; and 2) in the clinical setting to assess clinical workflow feasibility and determine overall system accuracy. In the preclinical phase, the system was assessed using both phantom and porcine experimental studies. Median 2-D projection errors of 4.5 and 3.3 mm were found for the phantom and porcine studies, respectively. The clinical phase focused on extending the use of the system to interventions in patients undergoing either atrial fibrillation catheter ablation (CA) or transcatheter aortic valve implantation (TAVI). Eleven patients were studied with nine in the CA group and two in the TAVI group. Successful real-time view synchronization was achieved in all cases with a calculated median distance error of 2.2 mm in the CA group and 3.4 mm in the TAVI group. A standard clinical workflow was established using the image fusion system. These pilot data confirm the technical feasibility of accurate real-time echo-fluoroscopic image overlay in clinical practice, which may be a useful adjunct for real-time guidance during interventional cardiac procedures.

Retesting for genital Chlamydia trachomatis among visitors of a sexually transmitted infections clinic: randomized intervention trial of home- versus clinic-based recall.

PubMed

Götz, Hannelore M; Wolfers, Mireille E G; Luijendijk, Ad; van den Broek, Ingrid V F

2013-05-24

Reinfections of Chlamydia trachomatis (Ct) are common. In a two-armed intervention study at an urban STI clinic in the Netherlands, heterosexual Ct-positive visitors received an invitation for retesting after 4-5 months. Interventions were either home-based sampling by mailed test-kit, or clinic-based testing without appointment. Data collection included socio-demographic and sexual behavioural variables at first (T0) and repeat test (T1). Participation in retesting, prevalence and determinants of repeat infection among study participants are described and compared with findings from non-participants. Of the 216 visitors enrolled in the study, 75 accepted retesting (35%). The retest participation was 46% (50/109) in the home group versus 23% (25/107) in the clinic group (p = 0.001). Men were less often retested than women (15% versus 43%, p < 0.001). The overall chlamydia positivity rate at retest was 17.3% (13/75) compared to 12.4% seen at all visits at the STI clinic in 2011. Repeated infections were more frequent among non-Dutch than Dutch participants (27.0% versus 7.9%; p = 0.04) and in persons reporting symptoms (31.0% versus 7.0%; p = 0.01). Both untreated infections of current partners as well as unprotected sex with new partners contribute to repeated infections. The high rate of repeated infections indicates the need for interventions to increase retesting; improvement of partner-management and risk reduction counselling remain necessary. Home- based testing was more effective than clinic-based testing. However other strategies, including self-triage of patients, may also increase repeat testing rates and personal preferences should be taken into account.

A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov.

PubMed

Bell, Stuart A; Tudur Smith, Catrin

2014-11-26

To provide a comprehensive characterisation of rare disease clinical trials registered in ClinicalTrials.gov, and compare against characteristics of trials in non-rare diseases. Registry based study of ClinicalTrials.gov registration entries. The ClinicalTrials.gov registry comprised 133,128 studies registered to September 27, 2012. By annotating medical subject heading descriptors to condition terms we could identify rare and non-rare disease trials. A total of 24,088 Interventional trials registered after January 1, 2006, conducted in the United States, Canada and/or the European Union were categorised as rare or non-rare. Characteristics of the respective trials were extracted and summarised with comparative statistics calculated where appropriate. Characteristics of interventional trials reported in the database categorised by rare and non-rare conditions to allow comparison. Of the 24,088 trials categorised 2,759 (11.5%) were classified as rare disease trials and 21,329 (88.5%) related to non-rare conditions. Despite the limitations of the database we found that rare disease trials differed to non-rare disease trials across all characteristics that we examined. Rare disease trials enrolled fewer participants (median 29 vs. 62), were more likely to be single arm (63.0% vs. 29.6%), non-randomised (64.5% vs. 36.1%) and open label (78.7% vs. 52.2%). A higher proportion of rare disease trials were terminated early (13.7% vs. 6.3%) and proportionally fewer rare disease studies were actively pursuing, or waiting to commence, enrolment (15.9% vs. 38.5%). Rare disease interventional trials differ from those in non-rare conditions with notable differences in enrolment, design, blinding and randomisation. However, clinical trials should aim to implement the highest trial design standards possible, regardless of whether diseases are rare or not.

Applying Theory to Understand and Modify Nurse Intention to Adhere to Recommendations regarding the Use of Filter Needles: An Intervention Mapping Approach.

PubMed

Cassista, Julianne; Payne-Gagnon, Julie; Martel, Brigitte; Gagnon, Marie-Pierre

2014-01-01

The manipulation of glass ampoules involves risk of particle contamination of parenteral medication, and the use of filter needles has often been recommended in order to reduce the number of particles in these solutions. This study aims to develop a theory-based intervention to increase nurse intention to use filter needles according to clinical guideline recommendations produced by a large university medical centre in Quebec (Canada). Using the Intervention Mapping framework, we first identified the psychosocial determinants of nurse intention to use filter needles according to these recommendations. Second, we developed and implemented an intervention targeting nurses from five care units in order to increase their intention to adhere to recommendations on the use of filter needles. We also assessed nurse satisfaction with the intervention. In total, 270 nurses received the intervention and 169 completed the posttest questionnaire. The two determinants of intention, that is, attitude and perceived behavioral control, were significantly higher after the intervention, but only perceived behavioral control remained a predictor of intention. In general, nurses were highly satisfied with the intervention. This study provides support for the use of Intervention Mapping to develop, implement, and evaluate theory-based interventions in order to improve healthcare professional adherence to clinical recommendations.

The role of decision analytic modeling in the health economic assessment of spinal intervention.

PubMed

Edwards, Natalie C; Skelly, Andrea C; Ziewacz, John E; Cahill, Kevin; McGirt, Matthew J

2014-10-15

Narrative review. To review the common tenets, strengths, and weaknesses of decision modeling for health economic assessment and to review the use of decision modeling in the spine literature to date. For the majority of spinal interventions, well-designed prospective, randomized, pragmatic cost-effectiveness studies that address the specific decision-in-need are lacking. Decision analytic modeling allows for the estimation of cost-effectiveness based on data available to date. Given the rising demands for proven value in spine care, the use of decision analytic modeling is rapidly increasing by clinicians and policy makers. This narrative review discusses the general components of decision analytic models, how decision analytic models are populated and the trade-offs entailed, makes recommendations for how users of spine intervention decision models might go about appraising the models, and presents an overview of published spine economic models. A proper, integrated, clinical, and economic critical appraisal is necessary in the evaluation of the strength of evidence provided by a modeling evaluation. As is the case with clinical research, all options for collecting health economic or value data are not without their limitations and flaws. There is substantial heterogeneity across the 20 spine intervention health economic modeling studies summarized with respect to study design, models used, reporting, and general quality. There is sparse evidence for populating spine intervention models. Results mostly showed that interventions were cost-effective based on $100,000/quality-adjusted life-year threshold. Spine care providers, as partners with their health economic colleagues, have unique clinical expertise and perspectives that are critical to interpret the strengths and weaknesses of health economic models. Health economic models must be critically appraised for both clinical validity and economic quality before altering health care policy, payment strategies, or patient care decisions. 4.

Obstacles to Successful Implementation of eHealth Applications into Clinical Practice.

PubMed

Voogt, Marianne P; Opmeer, Brent C; Kastelein, Arnoud W; Jaspers, Monique W M; Peute, Linda W

2018-01-01

eHealth can improve healthcare worldwide, and scientific research should provide evidence on the efficacy, safety and added value of such interventions. For successful implementation of eHealth interventions into clinical practice, barriers need to be anticipated. We identified seven barriers by interviewing health professionals in the Dutch healthcare system. These barriers covered three topics: financing, human factors and organizational factors. This paper discusses their potential impact on eHealth uptake. Bridging the gap between studies to assess effective eHealth interventions and their value-based implementation in healthcare is much needed.

Interest in Health Behavior Intervention Delivery Modalities Among Cancer Survivors: A Cross-Sectional Study.

PubMed

Martin, Emily C; Basen-Engquist, Karen; Cox, Matthew G; Lyons, Elizabeth J; Carmack, Cindy L; Blalock, Janice A; Demark-Wahnefried, Wendy

2016-02-11

Effective, broad-reaching channels are important for the delivery of health behavior interventions in order to meet the needs of the growing population of cancer survivors in the United States. New technology presents opportunities to increase the reach of health behavior change interventions and therefore their overall impact. However, evidence suggests that older adults may be slower in their adoption of these technologies than the general population. Survivors' interest for more traditional channels of delivery (eg, clinic) versus new technology-based channels (eg, smartphones) may depend on a variety of factors, including demographics, current health status, and the behavior requiring intervention. The aim of this study was to determine the factors that predict cancer survivors' interest in new technology-based health behavior intervention modalities versus traditional modalities. Surveys were mailed to 1871 survivors of breast, prostate, and colorectal cancer. Participants' demographics, diet and physical activity behaviors, interest in health behavior interventions, and interest in intervention delivery modalities were collected. Using path analysis, we explored the relationship between four intervention modality variables (ie, clinic, telephone, computer, and smartphone) and potential predictors of modality interest. In total, 1053 respondents to the survey (56.3% response rate); 847 provided complete data for this analysis. Delivery channel interest was highest for computer-based interventions (236/847, 27.9% very/extremely interested) and lowest for smartphone-based interventions (73/847, 8.6%), with interest in clinic-based (147/847, 17.3%) and telephone-delivered (143/847, 16.9%) falling in between. Use of other technology platforms, such as Web cameras and social networking sites, was positively predictive of interest in technology-based delivery channels. Older survivors were less likely to report interest in smartphone-based diet interventions. Physical activity, fruit and vegetable consumption, weight status, and age moderated relationships between interest in targeted intervention behavior and modality. This study identified several predictors of survivor interest in various health behavior intervention delivery modalities. Overall, computer-based interventions were found to be most acceptable, while smartphones were the least. Factors related to survivors' current technology use and health status play a role in their interest for technology-based intervention versus more traditional delivery channels. Future health behavior change research in this population should consider participants' demographic, clinical, and lifestyle characteristics when selecting a delivery channel. Furthermore, current health behavior interventions for older cancer survivors may be best delivered over the Internet. Smartphone interventions may be feasible in the future following further adoption and familiarization by this particular population. ©Emily C Martin, Karen Basen-Engquist, Matthew G Cox, Elizabeth J Lyons, Cindy L Carmack, Janice A Blalock, Wendy Demark-Wahnefried. Originally published in JMIR Cancer (http://cancer.jmir.org), 11.02.2016.

Rationale and design of the Sodium Lowering In Dialysate (SoLID) trial: a randomised controlled trial of low versus standard dialysate sodium concentration during hemodialysis for regression of left ventricular mass

PubMed Central

2013-01-01

Background The current literature recognises that left ventricular hypertrophy makes a key contribution to the high rate of premature cardiovascular mortality in dialysis patients. Determining how we might intervene to ameliorate left ventricular hypertrophy in dialysis populations has become a research priority. Reducing sodium exposure through lower dialysate sodium may be a promising intervention in this regard. However there is clinical equipoise around this intervention because the benefit has not yet been demonstrated in a robust prospective clinical trial, and several observational studies have suggested sodium lowering interventions may be deleterious in some dialysis patients. Methods/design The Sodium Lowering in Dialysate (SoLID) study is funded by the Health Research Council of New Zealand. It is a multi-centre, prospective, randomised, single-blind (outcomes assessor), controlled parallel assignment 3-year clinical trial. The SoLID study is designed to study what impact low dialysate sodium has upon cardiovascular risk in dialysis patients. The study intends to enrol 118 home hemodialysis patients from 6 sites in New Zealand over 24 months and follow up each participant over 12 months. Key exclusion criteria are: patients who dialyse more frequently than 3.5 times per week, pre-dialysis serum sodium of <135 mM, and maintenance hemodiafiltration. In addition, some medical conditions, treatments or participation in other dialysis trials, which contraindicate the SoLID study intervention or confound its effects, will be exclusion criteria. The intervention and control groups will be dialysed using dialysate sodium 135 mM and 140 mM respectively, for 12 months. The primary outcome measure is left ventricular mass index, as measured by cardiac magnetic resonance imaging, after 12 months of intervention. Eleven or more secondary outcomes will be studied in an attempt to better understand the physiologic and clinical mechanisms by which lower dialysate sodium alters the primary end point. Discussion The SoLID study is designed to clarify the effect of low dialysate sodium upon the cardiovascular outcomes of dialysis patients. The study results will provide much needed information about the efficacy of a cost effective, economically sustainable solution to a condition which is curtailing the lives of so many dialysis patients. Trial registration Australian and New Zealand Clinical Trials Registry number: ACTRN12611000975998 PMID:23855560

Critical review on non-operative management of adolescent idiopathic scoliosis.

PubMed

Wong, M S; Liu, W C

2003-12-01

There are a number of different non-operative interventions which aim to control moderate adolescent idiopathic scoliosis (AIS) from progression. Clinicians may find difficulties in the selection of appropriate interventions for AIS. A comprehensive literature review was carried out to study all contemporary non-operative interventions, it was noted that rigid spinal orthoses apparently give more curve control; however, it would compromise the patient's quality of life via those inevitable factors--physical constraint, poor acceptance and psychological disturbance. There is a trend to develop more effective, acceptable and user-friendly interventions. Under such an aspiration, the theories and clinical evidence of different interventions should be developed along the clinical pathway of early intervention with reliable indicators/predictors, patient's active participation, dynamic control mechanism, holistic psychological and psychosocial considerations, and effective and long-lasting outcome.

Combined Clinic-Home Approach for Upper Limb Robotic Therapy After Stroke: A Pilot Study.

PubMed

Kim, Grace J; Rivera, Lisa; Stein, Joel

2015-12-01

To investigate the feasibility of a combined clinic-home intervention using a robotic elbow brace and, secondarily, to collect preliminary data on the efficacy of this clinic-home intervention. Nonrandomized pre-/postinterventional study. Outpatient clinic and participants' homes. Individuals at least 6 months after stroke (N=11; 5 women and 6 men; mean age, 51.7y; mean time since stroke, 7.6y; mean Fugl-Meyer Assessment of the Upper Extremity [FMA-UE] score, 22 of 66) were enrolled from the community. Participants received training in an outpatient clinic from an experienced occupational therapist to gain independence with use of the device (3-9 sessions) followed by a 6-week home program using the device at home. Five instruments were administered before and after the study intervention: Modified Ashworth Scale, Box and Blocks test, FMA-UE, Arm Motor Ability Test, and Motor Activity Log-Amount of Use and Motor Activity Log-How Well subscales (MAL-AOU, MAL-HW). Nine participants completed the study. Participants used the device on average 42.9min/d, 5.3d/wk. The FMA-UE (t=3.32; P=.01), MAL-AOU (t=4.40; P=.002), and MAL-HW (t=4.02; P=.004) scores showed statistically significant improvement from baseline to discharge; the MAL-AOU (t=2.61; P=.035) and MAL-HW (t=2.47; P=.043) scores were also significantly improved from baseline to 3-month follow-up. This combined clinic-home intervention was feasible and effective. Participants demonstrated improvements in arm impairment and self-reported use of the arm from baseline to discharge; they continued to report significant improvement in actual use of the arm at 3-month follow-up. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov.

PubMed

Chen, Junchao; Huang, Jihan; Li, Jordan V; Lv, Yinghua; He, Yingchun; Zheng, Qingshan

2017-01-01

The aim of this review is to characterize current status of global TCM clinical trials registered in ClinicalTrials.gov. We examined all the trials registered within ClinicalTrials.gov up to 25 September 2015, focusing on study interventions to identify TCM-related trials, and extracted 1,270 TCM trials from the data set. Overall, 691 (54.4%) trials were acupuncture, and 454 (35.8%) trials were herbal medicines. Differences in TCM trial intervention types were also evident among the specific therapeutic areas. Among all trials, 55.7% that were small studies enrolled <100 subjects, and only 8.7% of completed studies had reported results of trials. As for the location, the United States was second to China in conducting the most TCM trials. This review is the first snapshot of the landscape of TCM clinical trials registered in ClinicalTrials.gov, providing the basis for treatment and prevention of diseases within TCM and offering useful information that will guide future research on TCM.

The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov

PubMed Central

Huang, Jihan; Li, Jordan V.; Lv, Yinghua; He, Yingchun

2017-01-01

Objective The aim of this review is to characterize current status of global TCM clinical trials registered in ClinicalTrials.gov. Methods We examined all the trials registered within ClinicalTrials.gov up to 25 September 2015, focusing on study interventions to identify TCM-related trials, and extracted 1,270 TCM trials from the data set. Results Overall, 691 (54.4%) trials were acupuncture, and 454 (35.8%) trials were herbal medicines. Differences in TCM trial intervention types were also evident among the specific therapeutic areas. Among all trials, 55.7% that were small studies enrolled <100 subjects, and only 8.7% of completed studies had reported results of trials. As for the location, the United States was second to China in conducting the most TCM trials. Conclusion This review is the first snapshot of the landscape of TCM clinical trials registered in ClinicalTrials.gov, providing the basis for treatment and prevention of diseases within TCM and offering useful information that will guide future research on TCM. PMID:29138646

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

PubMed Central

2012-01-01

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

A Bereavement Support Group Intervention Is Longitudinally Associated with Salutary Effects on the CD4 Cell Count and Number of Physician Visits

PubMed Central

Goodkin, Karl; Feaster, Daniel J.; Asthana, Deshratn; Blaney, Nancy T.; Kumar, Mahendra; Baldewicz, Teri; Tuttle, Raymond S.; Maher, Kevin J.; Baum, Marianna K.; Shapshak, Paul; Fletcher, Mary Ann

1998-01-01

A randomized, controlled, clinical trial was conducted to examine the impact of a semistructured, 10-week, once weekly, 90-min/session bereavement support group intervention on immunological, neuroendocrine, and clinical health status in human immunodeficiency virus type 1-seropositive (HIV-1+) and HIV-1-seronegative (HIV-1−) homosexual men, compared to a standard of care control condition. A total of 119 homosexual men (74 HIV-1+ and 45 HIV-1−) were assessed at baseline, 10 weeks, and 6 months follow-up. At the 6-month follow-up assessment, the intervention groups exhibited significant beneficial effects compared to controls on changes in CD4 cell, total T-lymphocyte, and total lymphocyte counts, when baseline levels, antiretroviral medication use, CDC stage of disease, and other potentially confounding factors were accounted for. There was no statistically significant effect on the CD4/CD8 ratio or on the CD8 cell count. The effect on CD4 cell count was associated with group attendance and with changes in plasma cortisol level. Plasma cortisol levels decreased significantly among intervention subjects, compared to controls. A significantly reduced number of health care visits over the 6-month follow-up period among the intervention subjects supported the clinical relevance of the immunological changes observed for both HIV-1+ and HIV-1− individuals. These results indicate that behavioral interventions may have salutary immunological and clinical health effects following bereavement among HIV-1-infected individuals. The effect in HIV-1− individuals suggests that this bereavement support group intervention might have similar salutary effects in the general population. Potential effects of such interventions on clinical HIV disease progression are of interest and should be studied. PMID:9605995

Evaluation of Interventions in Clinical Pharmacist-Led Annual Medicare Wellness Visits Compared with Usual Care.

PubMed

Beliard, Regine C; Merrey, Jessica W

2017-11-01

Evaluate and compare the number and types of medication and non-medication-related interventions by clinical pharmacists and nonpharmacists conducting an Annual Medicare Wellness Visit (MWV). Multi-center, retrospective case-control study. Two community primary care internal medicine clinics in urban Maryland. Patients who had a MWV performed January 2014 through October 2015. Pharmacists conducted required components of a MWV and addressed medication or non-medication-related concerns identified while completing the patient health risk assessment. Number and types of medication-related interventions identified by clinical pharmacists compared with nonpharmacists completing the MWV. Patients in the pharmacist-led MWV group more often had medication-related interventions than those in the nonpharmacist group (median 2 vs. 0, respectively; P < 0.00001). Pharmacists tended to identify at least 1 to 2 medication interventions for each patient (30.4% and 34.8%, respectively), and nonpharmacists often did not intervene on medications (62.79% of the time). There were 37 medication-related interventions made by the pharmacist group in a cohort of 23 patients, and 20 medication-related interventions by the nonpharmacist group in a cohort of 43 patients. The pharmacist group most often addressed medication without indication (17 occurrences) followed by nonadherence (6 occurrences). Providers in the nonpharmacist group most often recognized subtherapeutic dosage (7 occurrences) and indication without medication (5 occurrences). Pharmacists completing the MWV had a higher rate of medication-related and non-medication-related interventions than the nonpharmacist group. Pharmacist-led MWVs may lead to more appropriate medication use in elderly patients and serve as a financially sustainable care model to provide clinical pharmacy services in the outpatient setting.

Effects of a Problem-Solving Intervention (COPE) on Quality of Life for Patients with Advanced Cancer on Clinical Trials and their Caregivers: Simultaneous Care Educational Intervention (SCEI): Linking Palliation and Clinical Trials

PubMed Central

Carducci, Michael; Loscalzo, Matthew J.; Linder, John; Greasby, Tamara; Beckett, Laurel A.

2011-01-01

Abstract Context Patients on investigational clinical trials and their caregivers experience poor quality of life (QOL), which declines as the disease progresses. Objective To examine the effect of a standardized cognitive–behavioral problem-solving educational intervention on the QOL of patients enrolled on investigational clinical trials and their caregivers. Design Prospective, multi-institution, randomized trial. QOL was measured repeatedly over 6 months. Participants Patients were simultaneously enrolled onto phase 1, 2, or 3 Institutional Review Board (IRB)-approved cancer clinical trials. Intervention Intervention arm dyads participated in three conjoint educational sessions during the first month, learning the COPE problem solving model. Nonintervention arm dyads received usual care. Outcome Measures Global QOL was measured by the City of Hope Quality of Life Instruments for Patients or Caregivers; problem solving skills were measured by the Social Problem Solving Inventory-Revised. Results The results are reported using the CONSORT statement. The analytic data set included 476 dyads including 1596 patient data points and 1576 care giver data points. Patient QOL showed no significant difference in the rate of change between the intervention and usual care arms (p = 0.70). Caregiver QOL scores in the intervention arm declined, but at less than half the rate in the control arm (p = 0.02). Conclusions The COPE intervention enabled the average caregiver to come much closer to stable QOL over the 6-month follow-up. Future studies should enroll subjects much earlier in the cancer illness trajectory, a common patient/caregiver theme. The maximum effect was seen in caregivers who completed the 6-month follow-up, suggesting that the impact may increase over time. PMID:21413846

Using simulation to improve the capability of undergraduate nursing students in mental health care.

PubMed

Kunst, Elicia L; Mitchell, Marion; Johnston, Amy N B

2017-03-01

Mental health care is an increasing component of acute patient care and yet mental health care education can be limited in undergraduate nursing programs. The aim of this study was to establish if simulation learning can be an effective method of improving undergraduate nurses' capability in mental health care in an acute care environment. Undergraduate nursing students at an Australian university were exposed to several high-fidelity high-technology simulation activities that incorporated elements of acute emergency nursing practice and acute mental health intervention, scaffolded by theories of learning. This approach provided a safe environment for students to experience clinical practice, and develop their skills for dealing with complex clinical challenges. Using a mixed method approach, the primary domains of interest in this study were student confidence, knowledge and ability. These were self-reported and assessed before and after the simulation activities (intervention) using a pre-validated survey, to gauge the self-rated capacity of students to initiate and complete effective care episodes. Focus group interviews were subsequently held with students who attended placement in the emergency department to explore the impact of the intervention on student performance in this clinical setting. Students who participated in the simulation activity identified and reported significantly increased confidence, knowledge and ability in mental health care post-intervention. They identified key features of the intervention included the impact of its realism on the quality of learning. There is some evidence to suggest that the intervention had an impact on the performance and reflection of students in the clinical setting. This study provides evidence to support the use of simulation to enhance student nurses' clinical capabilities in providing mental health care in acute care environments. Nursing curriculum development should be based on best-evidence to ensure that future nursing graduates have the skills and capability to provide high-quality, holistic care. Copyright © 2016 Elsevier Ltd. All rights reserved.

HPV vaccination: Population approaches for improving rates.

PubMed

Oliver, Kristin; Frawley, Alean; Garland, Elizabeth

2016-06-02

To review the literature on interventions to increase HPV vaccinations and assess whether The Community Preventive Services Task Force recommendations are supported by current evidence. We used a PubMed search to identify studies that assessed interventions that looked at provider assessment and feedback, provider reminders, client reminder and recall, and clinic based education programs. Of the 13 studies identified, 8 included client reminder and recall interventions, 4 included provider assessment and feedback and/or provider reminders and 2 included clinic based education. 11 of the 13 studies demonstrated a positive effect on HPV vaccine initiation or completion. Provider assessment and feedback studies were more likely to report a positive effect on HPV vaccine initiation than on series completion, while client reminder recall interventions more frequently produced an effect on series completion than on initiation. There is evidence to support the application of the Community Preventive Services Task Force recommendations specifically to HPV vaccination both for client reminder and recall programs and for provider assessment and feedback interventions. Multiple targeted approaches will be needed to substantially impact HPV vaccine rates.

Mental exercises for cognitive function: clinical evidence.

PubMed

Kawashima, Ryuta

2013-01-01

The purpose of this study was to examine the beneficial effects of a new cognitive intervention program designed for the care and prevention of dementia, namely Learning Therapy. The training program used systematized basic problems in arithmetic and Japanese language as training tasks. In study 1, 16 individuals in the experimental group and 16 in the control group were recruited from a nursing home. In both groups, all individuals were clinically diagnosed with senile dementia of the Alzheimer type. In study 2, we performed a single-blind, randomized controlled trial in our cognitive intervention program of 124 community-dwelling seniors. In both studies, the daily training program using reading and arithmetic tasks was carried out approximately 5 days a week, for 15 to 20 minutes a day in the intervention groups. Neuropsychological measures were determined simultaneously in the groups both prior to and after six months of the intervention. The results of our investigations indicate that our cognitive intervention using reading and arithmetic problems demonstrated a transfer effect and they provide convincing evidence that cognitive training maintains and improves the cognitive functions of dementia patients and healthy seniors.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

Effects of reflection on clinical decision-making of intensive care unit nurses.

PubMed

Razieh, Shahrokhi; Somayeh, Ghafari; Fariba, Haghani

2018-07-01

Nurses are one of the most influential factors in overcoming the main challenges faced by health systems throughout the world. Every health system should, hence, empower nurses in clinical judgment and decision-making skills. This study evaluated the effects of implementing Tanner's reflection method on clinical decision-making of nurses working in an intensive care unit (ICU). This study used an experimental, pretest, posttest design. The setting was the intensive care unit of Amin Hospital Isfahan, Iran. The convenience sample included 60 nurses working in the ICU of Amin Hospital (Isfahan, Iran). This clinical trial was performed on 60 nurses working in the ICU of Amin Hospital (Isfahan, Iran). The nurses were selected by census sampling and randomly allocated to either the case or the control group. Data were collected using a questionnaire containing demographic characteristics and the clinical decision-making scale developed by Laurie and Salantera (NDMI-14). The questionnaire was completed before and one week after the intervention. The data were analyzed using SPSS 21.0. The two groups were not significantly different in terms of the level and mean scores of clinical decision-making before the intervention (P = 0.786). Based on the results of independent t-test, the mean score of clinical decision-making one week after the intervention was significantly higher in the case group than in the control group (P = 0.009; t = -2.69). The results of Mann Whitney test showed that one week after the intervention, the nurses' level of clinical decision-making in the case group rose to the next level (P = 0.001). Reflection could improve the clinical decision-making of ICU nurses. It is, thus, recommended to incorporate this method into the nursing curriculum and care practices. Copyright © 2018. Published by Elsevier Ltd.

Emergency department-based interventions for women suffering domestic abuse: a critical literature review.

PubMed

Ansari, Sereena; Boyle, Adrian

2017-02-01

Domestic abuse represents a serious public health and human rights concern. Interventions to reduce the risk of abuse include staff training and standardized documentation improving detection and adherence to referral pathways. Interventional studies have been conducted in primary care, maternity and outpatient settings. Women disclosing abuse in emergency departments differ from women attending other healthcare settings, and it is unclear whether these interventions can be transferred to the emergency care setting. This review examines interventional studies to evaluate the effectiveness of emergency department-based interventions in reducing domestic abuse-related morbidity. Medline, EMBASE, CINAHL, PsycINFO and Cochrane Library were searched, according to prespecified selection criteria. Study quality was assessed using the Jadad scale. Of 273 search results, nine were eligible for review. Interventions involving staff training demonstrated benefits in subjective measures, such as staff knowledge regarding abuse, but no changes in clinical practice, based on detection and referral rates. When staff training was implemented in conjunction with supporting system changes - for example, standardized documentation for assessment and referral - clinically relevant improvements were noted. Interventions centred around staff training are insufficient to bring about improvements in the management and, thus, outcome of patients suffering abuse. Instead, system changes, such as standardized documentation and referral pathways, supported by training, may bring about beneficial changes. It remains uncertain whether surrogate outcomes employed by most studies translate to changes in abuse-related morbidity: the ultimate goal.

An exploration of clinical interventions provided by pharmacists within a complex asthma service

PubMed Central

Lemay, Kate S.; Saini, Bandana; Bosnic-Anticevich, Sinthia; Smith, Lorraine; Stewart, Kay; Emmerton, Lynne; Burton, Deborah L.; Krass, Ines; Armour, Carol L.

2014-01-01

Background: Pharmacists in Australia are accessible health care professionals, and their provision of clinical pharmacy interventions in a range of areas has been proven to improve patient outcomes. Individual clinical pharmacy interventions in the area of asthma management have been very successful. An understanding of the nature of these interventions will inform future pharmacy services. What we do not know is when pharmacists provide a complex asthma service, what elements of that service (interventions) they choose to deliver. Objective: To explore the scope and frequency of asthma-related clinical interventions provided by pharmacists to patients in an evidence-based complex asthma service. Methods: Pharmacists from 4 states/territories of Australia were trained in asthma management. People with asthma had 3 or 4 visits to the pharmacy. Guided by a structured patient file, the pharmacist assessed the patient’s asthma and management and provided interventions where and when considered appropriate, based on their clinical decision making skills. The interventions were recorded in a checklist in the patient file. They were then analysed descriptively and thematically. Results: Pharmacists provided 22,909 clinical pharmacy interventions over the service to 570 patients (398 of whom completed the service). The most frequently delivered interventions were in the themes ’Education on asthma’, ’Addressing trigger factors’, ’Medications - safe and effective use’ and ’Explore patient perspectives’. The patients had a high and ongoing need for interventions. Pharmacists selected interventions based on their assessment of perceived need then revisited and reinforced these interventions. Conclusion: Pharmacists identified a number of areas in which patients required interventions to assist with their asthma management. Many of these were perceived to require continuing reinforcement over the duration of the service. Pharmacists were able to use their clinical judgement to assess patients and provide clinical pharmacy interventions across a range of asthma management needs. PMID:25883692

Occupational Therapy in the Intensive Care Unit: A Systematic Review.

PubMed

Weinreich, Mark; Herman, Jennifer; Dickason, Stephanie; Mayo, Helen

2017-07-01

This paper is a synthesis of the available literature on occupational therapy interventions performed in the adult intensive care unit (ICU). The databases of Ovid MEDLINE, Embase, the Cochrane Library, ClinicalTrials.gov and CINAHL databases were systematically searched from inception through August 2016 for studies of adults who received occupational therapy interventions in the ICU. Of 1,938 citations reviewed, 10 studies met inclusion criteria. Only one study explicitly discussed occupational therapy interventions performed and only one study specifically tested the efficacy of occupational therapy. Future research is needed to clarify the specific interventions and role of occupational therapy in the ICU and the efficacy of these interventions.

Randomized Trial of a Social Networking Intervention for Cancer-Related Distress.

PubMed

Owen, Jason E; O'Carroll Bantum, Erin; Pagano, Ian S; Stanton, Annette

2017-10-01

Web and mobile technologies appear to hold promise for delivering evidence-informed and evidence-based intervention to cancer survivors and others living with trauma and other psychological concerns. Health-space.net was developed as a comprehensive online social networking and coping skills training program for cancer survivors living with distress. The purpose of this study was to evaluate the effects of a 12-week social networking intervention on distress, depression, anxiety, vigor, and fatigue in cancer survivors reporting high levels of cancer-related distress. We recruited 347 participants from a local cancer registry and internet, and all were randomized to either a 12-week waiting list control group or to immediate access to the intervention. Intervention participants received secure access to the study website, which provided extensive social networking capabilities and coping skills training exercises facilitated by a professional facilitator. Across time, the prevalence of clinically significant depression symptoms declined from 67 to 34 % in both conditions. The health-space.net intervention had greater declines in fatigue than the waitlist control group, but the intervention did not improve outcomes for depression, trauma-related anxiety symptoms, or overall mood disturbance. For those with more severe levels of anxiety at baseline, greater engagement with the intervention was associated with higher levels of symptom reduction over time. The intervention resulted in small but significant effects on fatigue but not other primary or secondary outcomes. Results suggest that this social networking intervention may be most effective for those who have distress that is not associated with high levels of anxiety symptoms or very poor overall psychological functioning. The trial was registered with the ClinicalTrials.gov database ( ClinicalTrials.gov #NCT01976949).

Impact of high-fidelity simulation on the development of clinical judgment and motivation among Lebanese nursing students.

PubMed

Fawaz, Mirna A; Hamdan-Mansour, Ayman M

2016-11-01

High-fidelity simulation (HFS) offers a strategy to facilitate cognitive, affective, and psychomotor outcomes and motivate the new generation of students. The purpose of this study was to examine the impact of using high-fidelity simulation on the development of clinical judgment and motivation among Lebanese nursing students. A post-test, quasi-experimental design was used. Two private universities in Lebanon were targeted to implement the intervention. A convenience sample of 56 nursing students from two private universities in Lebanon were recruited. Data were collected using the Lasater Clinical Judgment Rubric and the Motivated Strategies for Learning questionnaires. Nursing students exhibited significant improvement in clinical judgment and motivation due to exposure to HFS. There was a significant difference post HFS between the intervention group and the control group in clinical judgment intervention (t=5.23, p<0.001) and motivation for academic achievement (t=-6.71, p<0.001). The intervention group had a higher mean score of clinical judgment (29.5, SD=5.4) than the control group (22.1, SD=5.7) and, similarly, students had higher mean scores of motivation (198.6, SD=10.5) in the intervention group than in the control group (161.6, SD=20). The analysis related to differences between the intervention and control groups in motivation and clinical judgment; controlling for previous experience in health care services, the analysis showed no significant difference (Wilk's lambda =0.77, F=1.09, p=0.374). There is a need for nursing educators to implement HFS in nursing curricula, where its integration can bridge the gap between theoretical knowledge and nursing practice and enhance critical thinking and motivation among nursing students. Copyright © 2016 Elsevier Ltd. All rights reserved.

Efficacy of Pharmacist Based Diabetes Educational Interventions on Clinical Outcomes of Adults With Type 2 Diabetes Mellitus: A Network Meta-Analysis

PubMed Central

Bukhsh, Allah; Khan, Tahir M.; Lee, Shaun W. H.; Lee, Learn-Han; Chan, Kok-Gan; Goh, Bey-Hing

2018-01-01

Background: Comparative efficacy of different pharmacist based interventions on glycemic control of type 2 diabetes patients is unclear. This review aimed to evaluate and compare the efficacy of different pharmacist based interventions on clinical outcomes of type 2 diabetes patients. Methods: A systematic search was conducted across five databases from date of database inception to September 2017. All randomized clinical trials evaluating the efficacy of pharmacist based interventions on type 2 diabetes patients were included for network meta-analysis (NMA). The protocol is available with PROSPERO (CRD42017078854). Results: A total of 43 studies, involving 6259 type 2 diabetes patients, were included. NMA demonstrated that all interventions significantly lowered glycosylated hemoglobin (HbA1c) levels compared to usual care, but there was no statistical evidence from this study that one intervention was significantly better than the other for reducing HbA1c levels. Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy for reducing HbA1c levels [−0.86, 95% CI −0.983, −0.727; p < 0.001]. Pharmacist based diabetes education plus pharmaceutical care was observed to be statistically significant in lowering levels of systolic blood pressure [−4.94; 95%CI −8.65, −1.23] and triglycerides levels [−0.26, 95%CI −0.51, −0.01], as compared to the interventions which involved diabetes education by pharmacist, and for body mass index (BMI) [−0.57; 95%CI −1.25, −0.12] in comparison to diabetes education by health care team involving pharmacist as member. Conclusion: The findings of this review demonstrate that all interventions had a significantly positive effect on HbA1c, but there was no statistical evidence from this study that one intervention was significantly better than the other for achieving glycemic control.Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy on HbA1c and rest of the clinical outcomes. PMID:29692730

Measuring the Effectiveness of Mentoring as a Knowledge Translation Intervention for Implementing Empirical Evidence: A Systematic Review

PubMed Central

Abdullah, Ghadah; Rossy, Dianne; Ploeg, Jenny; Davies, Barbara; Higuchi, Kathryn; Sikora, Lindsey; Stacey, Dawn

2014-01-01

Background Mentoring as a knowledge translation (KT) intervention uses social influence among healthcare professionals to increase use of evidence in clinical practice. Aim To determine the effectiveness of mentoring as a KT intervention designed to increase healthcare professionals’ use of evidence in clinical practice. Methods A systematic review was conducted using electronic databases (i.e., MEDLINE, CINAHL), grey literature, and hand searching. Eligible studies evaluated mentoring of healthcare professionals responsible for patient care to enhance the uptake of evidence into practice. Mentoring is defined as (a) a mentor more experienced than mentee; (b) individualized support based on mentee's needs; and (c) involved in an interpersonal relationship as indicated by mutual benefit, engagement, and commitment. Two reviewers independently screened citations for eligibility, extracted data, and appraised quality of studies. Data were analyzed descriptively. Results Of 10,669 citations from 1988 to 2012, 10 studies were eligible. Mentoring as a KT intervention was evaluated in Canada, USA, and Australia. Exposure to mentoring compared to no mentoring improved some behavioral outcomes (one study). Compared to controls or other multifaceted interventions, multifaceted interventions with mentoring improved practitioners’ knowledge (four of five studies), beliefs (four of six studies), and impact on organizational outcomes (three of four studies). There were mixed findings for changes in professionals’ behaviors and impact on practitioners’ and patients’ outcomes: some outcomes improved, while others showed no difference. Linking Evidence to Action Only one study evaluated the effectiveness of mentoring alone as a KT intervention and showed improvement in some behavioral outcomes. The other nine studies that evaluated the effectiveness of mentoring as part of a multifaceted intervention showed mixed findings, making it difficult to determine the added effect of mentoring. Further research is needed to identify effective mentoring as a KT intervention. PMID:25252002

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 systematic review of educational interventions to change behaviour of prescribers in hospital settings, with a particular emphasis on new prescribers

PubMed Central

Brennan, Nicola; Mattick, Karen

2013-01-01

Aims Prescribing is a complex task and a high risk area of clinical practice. Poor prescribing occurs across staff grades and settings but new prescribers are attributed much of the blame. New prescribers may not be confident or even competent to prescribe and probably have different support and development needs than their more experienced colleagues. Unfortunately, little is known about what interventions are effective in this group. Previous systematic reviews have not distinguished between different grades of staff, have been narrow in scope and are now out of date. Therefore, to inform the design of educational interventions to change prescribing behaviour, particularly that of new prescibers, we conducted a systematic review of existing hospital-based interventions. Methods Embase, Medline, SIGLE, Cinahl and PsychINFO were searched for relevant studies published 1994–2010. Studies describing interventions to change the behaviour of prescribers in hospital settings were included, with an emphasis on new prescibers. The bibliographies of included papers were also searched for relevant studies. Interventions and effectiveness were classified using existing frameworks and the quality of studies was assessed using a validated instrument. Results Sixty-four studies were included in the review. Only 13% of interventions specifically targeted new prescribers. Most interventions (72%) were deemed effective in changing behaviour but no particular type stood out as most effective. Conclusion Very few studies have tailored educational interventions to meet needs of new prescribers, or distinguished between new and experienced prescribers. Educational development and research will be required to improve this important aspect of early clinical practice. PMID:22831632

A Two-Week Psychosocial Intervention Reduces Future Aggression and Incarceration in Clinically Aggressive Juvenile Offenders.

PubMed

Kendall, Ashley D; Emerson, Erin M; Hartmann, William E; Zinbarg, Richard E; Donenberg, Geri R

2017-12-01

There is a largely unmet need for evidence-based interventions that reduce future aggression and incarceration in clinically aggressive juvenile offenders serving probation. We addressed this gap using a group randomized controlled trial. Offenders both with and without clinical aggression were included, enabling comparison of intervention effects. Juveniles 13 to 17 years old (N = 310, mean = 16 years, 90% African-American, 66% male) on probation were assigned to a 2-week intervention targeting psychosocial factors implicated in risky behavior (e.g., learning strategies to manage "hot" emotions that prompt risk taking) or to an equally intensive health promotion control. Participants completed aggression measures at baseline, 6-, and 12-month follow-up and reported on incarceration at 12 months. Spline regression tested symptom change. Among clinically aggressive offenders (n = 71), the intervention arm showed significantly greater reductions in aggression over the first 6 months compared with controls. Juveniles from the intervention no longer met clinical criteria, on average, but clinically significant symptoms persisted in the control group. By 12 months, participants from the intervention appeared to maintain treatment gains, but their symptom levels no longer differed significantly from those in the control. However, the intervention group was nearly 4 times less likely than controls to report incarceration. Intervention effects were significantly stronger for offenders with clinical than with nonclinical (n = 239) baseline aggression. A 2-week intervention expedited improvements in aggression and reduced incarceration in clinically aggressive juvenile offenders. The findings underscore the importance of directing intervention resources to the most aggressive youth. Clinical trial registration information-PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice (PHAT Life); http://clinicaltrials.gov/; NCT02647710. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

A multifaceted intervention to improve sepsis management in general hospital wards with evaluation using segmented regression of interrupted time series.

PubMed

Marwick, Charis A; Guthrie, Bruce; Pringle, Jan E C; Evans, Josie M M; Nathwani, Dilip; Donnan, Peter T; Davey, Peter G

2014-12-01

Antibiotic administration to inpatients developing sepsis in general hospital wards was frequently delayed. We aimed to reproduce improvements in sepsis management reported in other settings. Ninewells Hospital, an 860-bed teaching hospital with quality improvement (QI) experience, in Scotland, UK. The intervention wards were 22 medical, surgical and orthopaedic inpatient wards. A multifaceted intervention, informed by baseline process data and questionnaires and interviews with junior doctors, evaluated using segmented regression analysis of interrupted time series (ITS) data. MEASURES FOR IMPROVEMENT: Primary outcome measure: antibiotic administration within 4 hours of sepsis onset. Secondary measures: antibiotics within 8 hours; mean and median time to antibiotics; medical review within 30 min for patients with a standardised early warning system score .4; blood cultures taken before antibiotic administration; blood lactate level measured. The intervention included printed and electronic clinical guidance, educational clinical team meetings including baseline performance data, audit and monthly feedback on performance. Performance against all study outcome measures improved postintervention but differences were small and ITS analysis did not attribute the observed changes to the intervention. Rigorous analysis of this carefully designed improvement intervention could not confirm significant effects. Statistical analysis of many such studies is inadequate, and there is insufficient reporting of negative studies. In light of recent evidence, involving senior clinical team members in verbal feedback and action planning may have made the intervention more effective. Our focus on rigorous intervention design and evaluation was at the expense of iterative refinement, which likely reduced the effect. This highlights the necessary, but challenging, requirement to invest in all three components for effective QI.

Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature.

PubMed

Tofighi, Babak; Nicholson, Joseph M; McNeely, Jennifer; Muench, Frederick; Lee, Joshua D

2017-07-01

Mobile phone use has increased dramatically and concurrent with rapid developments in mobile phone-based health interventions. The integration of text messaging interventions promises to optimise the delivery of care for persons with substance dependence with minimal disruption to clinical workflows. We conducted a systematic review to assess the acceptability, feasibility and clinical impact of text messaging interventions for persons with illicit drug and alcohol dependence. Studies were required to evaluate the use of text messaging as an intervention for persons who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition criterion for a diagnosis of illicit drug and/or alcohol dependence. Authors searched for articles published to date in MEDLINE (pubmed.gov), the Cochrane Library, EMBASE, CINAHL, Google Scholar and PsychINFO. Eleven articles met the search criteria for this review and support the acceptability and feasibility of text messaging interventions for addressing illicit drug and alcohol dependence. Most studies demonstrated improved clinical outcomes, medication adherence and engagement with peer support groups. Text messaging interventions also intervened on multiple therapeutic targets such as appointment attendance, motivation, self-efficacy, relapse prevention and social support. Suggestions for future research are described, including intervention design features, clinician contact, privacy measures and integration of behaviour change theories. Text messaging interventions offer a feasible platform to address a range of substances (i.e. alcohol, methamphetamine, heroin and alcohol), and there is increasing evidence supporting further larger-scale studies. [Tofighi B, Nicholson JM, McNeely J, Muench F, Lee JD. Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. Drug Alcohol Rev 2017;36:477-491]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

PubMed

Beukes, Eldré W; Baguley, David M; Allen, Peter M; Manchaiah, Vinaya; Andersson, Gerhard

2017-04-21

Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

Interventional Radiology Clinical Practice Guideline Recommendations for Neurovascular Disorders Are Not Based on High-Quality Systematic Reviews.

PubMed

Chong, A B; Taylor, M; Schubert, G; Vassar, M

2017-04-01

In recent years, clinical practice guidelines have been criticized for biased interpretations of research evidence, and interventional radiology is no exception. Our aim was to evaluate the methodologic quality and transparency of reporting in systematic reviews used as evidence in interventional radiology clinical practice guidelines for neurovascular disorders from the Society of Interventional Radiology. Our sources were 9 neurovascular disorder clinical practice guidelines from the Society of Interventional Radiology. We selected 65 systematic reviews and meta-analyses. A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) tools were used to assess the methodologic quality and reporting transparency of systematic reviews. Radial plots were created on the basis of average scores for PRISMA and AMSTAR items. On the basis of AMSTAR scores, 3 (4.62%) reviews were high-quality, 28 reviews (43.08%) were moderate-quality, and 34 reviews (52.31%) were low-quality, with an average quality score of 3.66 (34.32%; minimum, 0%; maximum, 81.82%). The average PRISMA score was 18.18 (69.41%). We were unable to obtain previous versions for 8 reviews, 7 of which were from the Cochrane Database of Systematic Reviews. The methodologic quality of systematic reviews needs to be improved. Although reporting clarity was much better than the methodologic quality, it still has room for improvement. The methodologic quality and transparency of reporting did not vary much among clinical practice guidelines. This study can also be applied to other medical specialties to examine the quality of studies used as evidence in their own clinical practice guidelines. © 2017 by American Journal of Neuroradiology.

Recent Internet Use and Associations with Clinical Outcomes among Patients Entering Addiction Treatment Involved in a Web-Delivered Psychosocial Intervention Study.

PubMed

Tofighi, B; Campbell, A N C; Pavlicova, M; Hu, M C; Lee, J D; Nunes, E V

2016-10-01

The acceptability and clinical impact of a web-based intervention among patients entering addiction treatment who lack recent internet access are unclear. This secondary analysis of a national multisite treatment study (NIDA Clinical Trials Network-0044) assessed for acceptability and clinical impact of a web-based psychosocial intervention among participants enrolling in community-based, outpatient addiction treatment programs. Participants were randomly assigned to 12 weeks of a web-based therapeutic education system (TES) based on the community reinforcement approach plus contingency management versus treatment as usual (TAU). Demographic and clinical characteristics, and treatment outcomes were compared among participants with recent internet access in the 90 days preceding enrollment (N = 374) and without internet access (N = 133). Primary outcome variables included (1) acceptability of TES (i.e., module completion; acceptability of web-based intervention) and (2) clinical impact (i.e., self-reported abstinence confirmed by urine drug/breath alcohol tests; retention measured as time to dropout). Internet use was common (74 %) and was more likely among younger (18-49 years old) participants and those who completed high school (p < .001). Participants randomized to TES (n = 255) without baseline internet access rated the acceptability of TES modules significantly higher than those with internet access (t = 2.49, df = 218, p = .01). There was a near significant interaction between treatment, baseline abstinence, and internet access on time to dropout (χ 2 (1) = 3.8089, p = .051). TES was associated with better retention among participants not abstinent at baseline who had internet access (X 2 (1) = 6.69, p = .01). These findings demonstrate high acceptability of this web-based intervention among participants that lacked recent internet access.

Evaluation of a pilot parent-delivered play-based intervention for children with attention deficit hyperactivity disorder.

PubMed

Wilkes-Gillan, Sarah; Bundy, Anita; Cordier, Reinie; Lincoln, Michelle

2014-01-01

OBJECTIVE. This study evaluated a parent-delivered intervention aiming to address the social difficulties of children with attention deficit hyperactivity disorder (ADHD). The intervention was evaluated from three perspectives: effectiveness, feasibility, and appropriateness. METHOD. This one-group pretest-posttest study included 5 children with ADHD and their parents, who had previously participated in a therapist-delivered play-based intervention. The 7-wk parent-delivered intervention involved home modules (including a DVD, manual, and play dates with a typically developing playmate) and three therapist-led clinic-based play sessions. The Test of Playfulness was used as a pre- and postintervention and follow-up measure. Parents were interviewed 1 mo following the intervention, and data were analyzed for recurring themes. RESULTS. Children's social play outcomes improved significantly from pretest to 1-mo follow-up (Z = 2.02, p = .04, d = 1.0). Three themes emerged: the clinic play environment as a sanctuary, parental barriers to intervention delivery, and tools for repeating learned lessons. CONCLUSION. The parent-delivered intervention demonstrated preliminary evidence for feasibility and effectiveness. Further research is warranted regarding appropriateness. Copyright © 2014 by the American Occupational Therapy Association, Inc.

Group intervention for siblings of children with disabilities: a pilot study in a clinical setting.

PubMed

Granat, Tina; Nordgren, Ingrid; Rein, George; Sonnander, Karin

2012-01-01

To study the effectiveness of a group intervention in a clinical setting designed to increase knowledge of disability and improve sibling relationship among siblings of children with disabilities. A self-selected sample of 54 younger and older siblings with typical development (ages 8-12 years) of children with attention deficit hyperactivity disorder (ADHD) (9), Asperger syndrome (7), autistic disorder (13), physical disability (8) and intellectual disability (17) participated in collateral sibling groups. The Sibling Knowledge Interview (SKI) and Sibling Relationship Questionnaire (SRQ) were administered pre- and post-intervention. SKI scores increased (p < 0.001) from pre- to post-intervention when merged diagnostic groups were compared. Comparisons of SRQ pre- and post-intervention scores across diagnostic sibling groups showed significantly different (p < 0.05) score patterns. The results were encouraging and contribute to further development of interventions meeting the needs of siblings of children with disabilities. In view of the limited empirical research on group interventions for siblings of children with disabilities future work is needed to investigate the effectiveness of such interventions. Particular attention should be given to siblings of children with autism and siblings of children with intellectual disability.

Systematic review of peer education intervention programmes among individuals with type 2 diabetes.

PubMed

Gatlin, Tricia K; Serafica, Reimund; Johnson, Michael

2017-12-01

To systematically review published randomised controlled trials of peer education interventions among adults with type 2 diabetes. Systematic reviews have shown mixed results for peer support interventions to improve diabetes self-management. Given the effectiveness of diabetes education by healthcare professionals, peer education interventions may be a useful alternative approach. This review addressed that gap. Systematic review. A systematic search of published randomised controlled trials between 2006-2016 was conducted using the keywords diabetes, type 2 diabetes, randomised controlled trials, self-management, peer education and peer support. The methodological quality of each study was assessed using the Jadad scale. Seven studies were included in the final review, and the Jadad scores ranged from 8-10 of a possible 13 points. There was no consistent design, setting, or outcome measurement among the studies. There were two types of peer education interventions compared to traditional diabetes education: face-to-face or a combination of face-to-face and telephone/texting. The most common clinical outcome measure was HbA1c. Two of six studies showed statistically significant improvement in HbA1c between intervention and control groups. An increase in diabetes knowledge was also statistically significant in two of five studies. Peer education could be successful in improving clinical outcomes. No evidence was found indicating that healthcare provider education was superior in regard to clinical knowledge or behavioural or psychological outcome measures than peer education. HbA1c was statistically significantly lower in some peer education groups compared to control groups. There is evidence that peer education can be useful in achieving positive clinical outcomes such as decreasing HbA1c levels and increasing diabetes knowledge. A certified diabetes educator or a trained healthcare professional should not be overlooked though when using peer educators. © 2017 John Wiley & Sons Ltd.

A qualitative study of clinic and community member perspectives on intervention toolkits: "Unless the toolkit is used it won't help solve the problem".

PubMed

Davis, Melinda M; Howk, Sonya; Spurlock, Margaret; McGinnis, Paul B; Cohen, Deborah J; Fagnan, Lyle J

2017-07-18

Intervention toolkits are common products of grant-funded research in public health and primary care settings. Toolkits are designed to address the knowledge translation gap by speeding implementation and dissemination of research into practice. However, few studies describe characteristics of effective intervention toolkits and their implementation. Therefore, we conducted this study to explore what clinic and community-based users want in intervention toolkits and to identify the factors that support application in practice. In this qualitative descriptive study we conducted focus groups and interviews with a purposive sample of community health coalition members, public health experts, and primary care professionals between November 2010 and January 2012. The transdisciplinary research team used thematic analysis to identify themes and a cross-case comparative analysis to explore variation by participant role and toolkit experience. Ninety six participants representing primary care (n = 54, 56%) and community settings (n = 42, 44%) participated in 18 sessions (13 focus groups, five key informant interviews). Participants ranged from those naïve through expert in toolkit development; many reported limited application of toolkits in actual practice. Participants wanted toolkits targeted at the right audience and demonstrated to be effective. Well organized toolkits, often with a quick start guide, with tools that were easy to tailor and apply were desired. Irrespective of perceived quality, participants experienced with practice change emphasized that leadership, staff buy-in, and facilitative support was essential for intervention toolkits to be translated into changes in clinic or public -health practice. Given the emphasis on toolkits in supporting implementation and dissemination of research and clinical guidelines, studies are warranted to determine when and how toolkits are used. Funders, policy makers, researchers, and leaders in primary care and public health are encouraged to allocate resources to foster both toolkit development and implementation. Support, through practice facilitation and organizational leadership, are critical for translating knowledge from intervention toolkits into practice.

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

PubMed

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

2017-04-01

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

Impact of an educational intervention and clinical performance dashboard on neonatal bloodstream infections.

PubMed

Raban, Moegammad Shukri; Bamford, Colleen; Joolay, Yaseen; Harrison, Michael C

2015-09-21

Blood cultures are the most direct method of detecting bacteraemia. Reducing contamination rates improves the specificity and positive predictive value of the blood culture. Clinical performance dashboards have been shown to be powerful tools in improving patient care and outcomes. To determine whether prospective surveillance of bloodstream infections (BSIs), introduction of an educational intervention and the use of a clinical performance dashboard could reduce BSIs and blood culture contamination rates in a neonatal nursery. We compared two time periods, before and after an intervention. Blood culture data were extracted from the local microbiology laboratory database. The educational intervention included the establishment of hand-washing protocols, blood culture techniques and video tools. A clinical performance dashboard was developed to demonstrate the monthly positive blood culture and contamination rates, and this was highlighted and referred to weekly at the unit staff meeting. Before the intervention, 1 460 blood cultures were taken; 206 (14.1%) were positive, of which 104 (7.1% of the total) were contaminants. In the period following the intervention, 1 282 blood cultures were taken; 131 (10.2%) were positive, of which 42 (3.3% of the total) were contaminants. The number of positive blood cultures and contamination rates after the intervention were both statistically significantly reduced (p=0.002 and p<0.001, respectively). This study demonstrates that adopting a relatively simple educational tool, making use of a clinical performance dashboard indicator and benchmarking practice can significantly reduce the level of neonatal sepsis while also reducing contaminated blood cultures.

What is a clinical pathway? Refinement of an operational definition to identify clinical pathway studies for a Cochrane systematic review.

PubMed

Lawal, Adegboyega K; Rotter, Thomas; Kinsman, Leigh; Machotta, Andreas; Ronellenfitsch, Ulrich; Scott, Shannon D; Goodridge, Donna; Plishka, Christopher; Groot, Gary

2016-02-23

Clinical pathways (CPWs) are a common component in the quest to improve the quality of health. CPWs are used to reduce variation, improve quality of care, and maximize the outcomes for specific groups of patients. An ongoing challenge is the operationalization of a definition of CPW in healthcare. This may be attributable to both the differences in definition and a lack of conceptualization in the field of clinical pathways. This correspondence article describes a process of refinement of an operational definition for CPW research and proposes an operational definition for the future syntheses of CPWs literature. Following the approach proposed by Kinsman et al. (BMC Medicine 8(1):31, 2010) and Wieland et al. (Alternative Therapies in Health and Medicine 17(2):50, 2011), we used a four-stage process to generate a five criteria checklist for the definition of CPWs. We refined the operational definition, through consensus, merging two of the checklist's criteria, leading to a more inclusive criterion for accommodating CPW studies conducted in various healthcare settings. The following four criteria for CPW operational definition, derived from the refinement process described above, are (1) the intervention was a structured multidisciplinary plan of care; (2) the intervention was used to translate guidelines or evidence into local structures; (3) the intervention detailed the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol or other 'inventory of actions' (i.e. the intervention had time-frames or criteria-based progression); and (4) the intervention aimed to standardize care for a specific population. An intervention meeting all four criteria was considered to be a CPW. The development of operational definitions for complex interventions is a useful approach to appraise and synthesize evidence for policy development and quality improvement.

Reduction of hypoglycaemic events with a behavioural intervention: a randomized clinical trial for paediatric patients with Type 1 diabetes mellitus.

PubMed

Gee, B T; Nansel, T R; Liu, A

2017-03-01

To determine if a low-intensity, clinic-integrated behavioural intervention reduced the incidence of hypoglycaemic events in children with Type 1 diabetes. A total of 390 families with children with Type 1 diabetes were enrolled in a 2-year, randomized clinical trial of a behavioural intervention. The intervention was designed to improve diabetes management practices by targeting the family's diabetes problem-solving skills. Hypoglycaemic events were categorized in two groups: those treated by oral ingestion and those treated by parenteral therapy. Events were self-reported by participants at each clinic visit, which occurred approximately every 3-4 months. Analyses included two-sample t-tests, the mean cumulative function test, and the Cox proportional hazards model for recurrent events to compare the incidence between groups. Across the entire 2-year study period, the incidence of hypoglycaemic events treated by oral ingestion of glucose-rich foods and events requiring parenteral therapy did not significantly differ between study conditions; however, during the second year of participant enrolment, the incidence of events treated by oral ingestion in the intervention group was 13.6 per 100 person-years compared with 27.3 per 100 patient-years in the control group (P = 0.02). The hazard ratio of these events during the second year was 0.49 (95% CI 0.27-0.90; P = 0.02). Our findings suggest the need for a long-term (> 1 year) focus on the implementation of interventions targeting diabetes management in young people. Behavioural interventions targeting problem-solving skills could be considered as practical, non-pharmacological strategies to reduce hypoglycaemia in adolescents with Type 1 diabetes. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

Broadening Our Understanding of Evidence-Based Practice: Effective and Discredited Interventions

ERIC Educational Resources Information Center

Zaboski, Brian A.; Schrack, Anna P.; Joyce-Beaulieu, Diana; MacInnes, Jann W.

2017-01-01

The proliferation of unsubstantiated or discredited interventions underscores the importance of the evidence-based practice (EBP) movement in school psychology. Although researchers have conducted several surveys on discredited interventions in counseling and clinical psychology, no studies have investigated the use of these treatments in school…

Mapping the Early Intervention System in Ontario, Canada

ERIC Educational Resources Information Center

Underwood, Kathryn

2012-01-01

This study documents the wide range of early intervention services across the province of Ontario. The services are mapped across the province showing geographic information as well as the scope of services (clinical, family-based, resource support, etc.), the range of early intervention professionals, sources of funding and the populations served…

Clinical Inertia in a Randomized Trial of Telemedicine-Based Chronic Disease Management: Lessons Learned.

PubMed

Barton, Anna Beth; Okorodudu, Daniel E; Bosworth, Hayden B; Crowley, Matthew J

2018-01-17

Treatment nonadherence and clinical inertia perpetuate poor cardiovascular disease (CVD) risk factor control. Telemedicine interventions may counter both treatment nonadherence and clinical inertia. We explored why a telemedicine intervention designed to reduce treatment nonadherence and clinical inertia did not improve CVD risk factor control, despite enhancing treatment adherence versus usual care. In this analysis of a randomized trial, we studied recipients of the 12-month telemedicine intervention. This intervention comprised two nurse-administered components: (1) monthly self-management education targeting improved treatment adherence; and (2) quarterly medication management facilitation designed to support treatment intensification by primary care (thereby reducing clinical inertia). For each medication management facilitation encounter, we ascertained whether patients met treatment goals, and if not, whether primary care recommended treatment intensification following the encounter. We assessed disease control associated with encounters, where intensification was/was not recommended. We examined 455 encounters across 182 intervention recipients (100% African Americans with type 2 diabetes). Even after accounting for valid reasons for deferring intensification (e.g., treatment nonadherence), intensification was not recommended in 67.5% of encounters in which hemoglobin A1c was above goal, 72.5% in which systolic blood pressure was above goal, and 73.9% in which low-density lipoprotein cholesterol was above goal. In each disease state, treatment intensification was more likely with poorer control. Despite enhancing treatment adherence, this intervention was unsuccessful in countering clinical inertia, likely explaining its lack of effect on CVD risk factors. We identify several lessons learned that may benefit investigators and healthcare systems.

Exercise and physical activity in mental disorders: clinical and experimental evidence.

PubMed

Zschucke, Elisabeth; Gaudlitz, Katharina; Ströhle, Andreas

2013-01-01

Several epidemiological studies have shown that exercise (EX) and physical activity (PA) can prevent or delay the onset of different mental disorders, and have therapeutic benefits when used as sole or adjunct treatment in mental disorders. This review summarizes studies that used EX interventions in patients with anxiety, affective, eating, and substance use disorders, as well as schizophrenia and dementia/mild cognitive impairment. Despite several decades of clinical evidence with EX interventions, controlled studies are sparse in most disorder groups. Preliminary evidence suggests that PA/EX can induce improvements in physical, subjective and disorder-specific clinical outcomes. Potential mechanisms of action are discussed, as well as implications for psychiatric research and practice.

A gesture-controlled projection display for CT-guided interventions.

PubMed

Mewes, A; Saalfeld, P; Riabikin, O; Skalej, M; Hansen, C

2016-01-01

The interaction with interventional imaging systems within a sterile environment is a challenging task for physicians. Direct physician-machine interaction during an intervention is rather limited because of sterility and workspace restrictions. We present a gesture-controlled projection display that enables a direct and natural physician-machine interaction during computed tomography (CT)-based interventions. Therefore, a graphical user interface is projected on a radiation shield located in front of the physician. Hand gestures in front of this display are captured and classified using a leap motion controller. We propose a gesture set to control basic functions of intervention software such as gestures for 2D image exploration, 3D object manipulation and selection. Our methods were evaluated in a clinically oriented user study with 12 participants. The results of the performed user study confirm that the display and the underlying interaction concept are accepted by clinical users. The recognition of the gestures is robust, although there is potential for improvements. The gesture training times are less than 10 min, but vary heavily between the participants of the study. The developed gestures are connected logically to the intervention software and intuitive to use. The proposed gesture-controlled projection display counters current thinking, namely it gives the radiologist complete control of the intervention software. It opens new possibilities for direct physician-machine interaction during CT-based interventions and is well suited to become an integral part of future interventional suites.

Patient-centeredness and quality management in Dutch diabetes care organizations after a 1-year intervention.

PubMed

Campmans-Kuijpers, Marjo Je; Lemmens, Lidwien C; Baan, Caroline A; Rutten, Guy Ehm

2016-01-01

More focus on patient-centeredness in care for patients with type 2 diabetes requests increasing attention to diabetes quality management processes on patient-centeredness by managers in primary care groups and outpatient clinics. Although patient-centered care is ultimately determined by the quality of interactions between patients and clinicians at the practice level, it should be facilitated at organizational level too. This nationwide study aimed to assess the state of diabetes quality management on patient-centeredness at organizational level and its possibilities to improve after a tailored intervention. This before-after study compares the quality management on patient-centeredness within Dutch diabetes care groups and outpatient clinics before and after a 1-year stepwise intervention. At baseline, managers of 51 diabetes primary care groups and 28 outpatient diabetes clinics completed a questionnaire about the organization's quality management program. Patient-centeredness (0%-100%) was operationalized in six subdomains: facilitating self-management support, individualized care plan support, patients' access to medical files, patient education policy, safeguarding patients' interests, and formal patient involvement. The intervention consisted of feedback and benchmark and if requested a telephone call and/or a consultancy visit. After 1 year, the managers completed the questionnaire again. The 1-year changes were examined by dependent (non) parametric tests. Care groups improved significantly on patient-centeredness (from 47.1% to 53.3%; P =0.002), and on its subdomains "access to medical files" (from 42.0% to 49.4%), and "safeguarding patients' interests" (from 58.1% to 66.2%). Outpatient clinics, which scored higher at baseline (66.7%) than care groups, did not improve on patient-centeredness (65.6%: P =0.54) or its subdomains. "Formal patient involvement" remained low in both care groups (23.2%) and outpatient clinics (33.9%). After a simple intervention, care groups significantly improved their quality management on patient-centeredness, but outpatient clinics did not. Interventions to improve quality management on patient-centeredness in diabetes care organizations should differ between primary and secondary care.

Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting.

PubMed

Bouça-Machado, Raquel; Rosário, Madalena; Alarcão, Joana; Correia-Guedes, Leonor; Abreu, Daisy; Ferreira, Joaquim J

2017-01-25

Over the past decades there has been a significant increase in the number of published clinical trials in palliative care. However, empirical evidence suggests that there are methodological problems in the design and conduct of studies, which raises questions about the validity and generalisability of the results and of the strength of the available evidence. We sought to evaluate the methodological characteristics and assess the quality of reporting of clinical trials in palliative care. We performed a systematic review of published clinical trials assessing therapeutic interventions in palliative care. Trials were identified using MEDLINE (from its inception to February 2015). We assessed methodological characteristics and describe the quality of reporting using the Cochrane Risk of Bias tool. We retrieved 107 studies. The most common medical field studied was oncology, and 43.9% of trials evaluated pharmacological interventions. Symptom control and physical dimensions (e.g. intervention on pain, breathlessness, nausea) were the palliative care-specific issues most studied. We found under-reporting of key information in particular on random sequence generation, allocation concealment, and blinding. While the number of clinical trials in palliative care has increased over time, methodological quality remains suboptimal. This compromises the quality of studies. Therefore, a greater effort is needed to enable the appropriate performance of future studies and increase the robustness of evidence-based medicine in this important field.

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

PubMed Central

van den Ende, Cornelia H. M.; Houterman, Anne E. J.; Heemskerk, Charlotte P. M.; van Dulmen, Sandra; van den Bemt, Bart J. F.

2017-01-01

Objective This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. Methods A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Results Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Conclusion Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF. PMID:28991903

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

PubMed

van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

2017-01-01

This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

Cost Effectiveness of Adopted Quality Requirements in Hospital Laboratories

PubMed Central

HAMZA, Alneil; AHMED-ABAKUR, Eltayib; ABUGROUN, Elsir; BAKHIT, Siham; HOLI, Mohamed

2013-01-01

Background The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. Methods: The quality management intervention based on ISO 15189 was conceded through three phases; pre – intervention phase, Intervention phase and Post-intervention phase. Results: In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen’s d) of (0.00) in pre-intervention phase and (0.99) in post – intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. Conclusion: The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure. PMID:23967422

Effects and moderators of psychosocial interventions on quality of life, and emotional and social function in patients with cancer: An individual patient data meta‐analysis of 22 RCTs

PubMed Central

Kalter, J.; Verdonck‐de Leeuw, I.M.; Sweegers, M.G.; Aaronson, N.K.; Jacobsen, P.B.; Newton, R.U.; Courneya, K.S.; Aitken, J.F.; Armes, J.; Arving, C.; Boersma, L.J.; Braamse, A.M.J.; Brandberg, Y.; Chambers, S.K.; Dekker, J.; Ell, K.; Ferguson, R.J.; Gielissen, M.F.M.; Glimelius, B.; Goedendorp, M.M.; Graves, K.D.; Heiney, S.P.; Horne, R.; Hunter, M.S.; Johansson, B.; Kimman, M.L.; Knoop, H.; Meneses, K.; Northouse, L.L.; Oldenburg, H.S.; Prins, J.B.; Savard, J.; van Beurden, M.; van den Berg, S.W.; Brug, J.

2018-01-01

Abstract Objective This individual patient data (IPD) meta‐analysis aimed to evaluate the effects of psychosocial interventions (PSI) on quality of life (QoL), emotional function (EF), and social function (SF) in patients with cancer, and to study moderator effects of demographic, clinical, personal, and intervention‐related characteristics. Methods Relevant studies were identified via literature searches in 4 databases. We pooled IPD from 22 (n = 4217) of 61 eligible randomized controlled trials. Linear mixed‐effect model analyses were used to study intervention effects on the post‐intervention values of QoL, EF, and SF (z‐scores), adjusting for baseline values, age, and cancer type. We studied moderator effects by testing interactions with the intervention for demographic, clinical, personal, and intervention‐related characteristics, and conducted subsequent stratified analyses for significant moderator variables.Results: PSI significantly improved QoL (β = 0.14,95%CI = 0.06;0.21), EF (β = 0.13,95%CI = 0.05;0.20), and SF (β = 0.10,95%CI = 0.03;0.18). Significant differences in effects of different types of PSI were found, with largest effects of psychotherapy. The effects of coping skills training were moderated by age, treatment type, and targeted interventions. Effects of psychotherapy on EF may be moderated by cancer type, but these analyses were based on 2 randomized controlled trials with small sample sizes of some cancer types. Conclusions PSI significantly improved QoL, EF, and SF, with small overall effects. However, the effects differed by several demographic, clinical, personal, and intervention‐related characteristics. Our study highlights the beneficial effects of coping skills training in patients treated with chemotherapy, the importance of targeted interventions, and the need of developing interventions tailored to the specific needs of elderly patients. PMID:29361206

Implementing personal digital assistant documentation of pharmacist interventions in a military treatment facility.

PubMed

Ford, Stephen; Illich, Stan; Smith, Lisa; Franklin, Arthur

2006-01-01

To describe the use of personal digital assistants (PDAs) in documenting pharmacists' clinical interventions. Evans Army Community Hospital (EACH), a 78-bed military treatment facility, in Colorado Springs. Pharmacists on staff at EACH. All pharmacists at EACH used PDAs with the pilot software to record interventions for 1 month. The program underwent final design changes and then became the sole source for recording pharmacist interventions. The results of this project are being evaluated every 3 months for the first year and yearly thereafter. Visual CE (Syware Inc. Cambridge, Mass.) software was selected to develop fields for the documentation tool. This software is simple and easy to use, and users can retrieve reports of interventions from both inpatient and outpatient sections. The software needed to be designed so that data entry would only take a few minutes and ad hoc reports could be produced easily. Number of pharmacist interventions reported, time spent in clinical interventions, and outcome of clinical intervention. Implementing a PDA-based system for documenting pharmacist interventions across ambulatory, inpatient, and clinical services dramatically increased reporting during the first 6 months after implementation (August 2004-February 2005). After initial fielding, clinical pharmacists in advanced practice settings (such as disease management clinic, anticoagulation clinic) recognized a need to tailor the program to their specific activities, which resulted in a spin-off program unique to their practice roles. A PDA-based system for documenting clinical interventions at a military treatment facility increased reporting of interventions across all pharmacy points of service. Pharmacy leadership used these data to document the impact of pharmacist interventions on safety and quality of pharmaceutical care provided.

Using the core curriculum on childhood trauma to strengthen clinical knowledge in evidence-based practitioners.

PubMed

Layne, Christopher M; Strand, Virginia; Popescu, Marciana; Kaplow, Julie B; Abramovitz, Robert; Stuber, Margaret; Amaya-Jackson, Lisa; Ross, Leslie; Pynoos, Robert S

2014-01-01

The high prevalence of trauma exposure in mental health service-seeking populations, combined with advances in evidence-based practice, competency-based training, common-elements research, and adult learning make this an opportune time to train the mental health workforce in trauma competencies. The Core Curriculum on Childhood Trauma (CCCT) utilizes a five-tiered conceptual framework (comprising Empirical Evidence, Core Trauma Concepts, Intervention Objectives, Practice Elements, and Skills), coupled with problem-based learning, to build foundational trauma knowledge and clinical reasoning skills. We present findings from three studies: Study 1 found that social work graduate students' participation in a CCCT course (N = 1,031) was linked to significant pre-post increases in self-reported confidence in applying core trauma concepts to their clinical work. Study 2 found significant pre-post increases in self-reported conceptual readiness (N = 576) and field readiness (N = 303) among social work graduate students participating in a "Gold Standard Plus" educational model that integrated classroom instruction in core trauma concepts, training in evidence-based trauma treatment (EBTT), and implementation of that EBTT in a supervised field placement. Students ranked the core concepts course as an equivalent or greater contributor to field readiness compared to standard EBTT training. Study 3 used qualitative methods to "distill" common elements (35 intervention objectives, 59 practice elements) from 26 manualized trauma interventions. The CCCT is a promising tool for educating "next-generation" evidence-based practitioners who possess competencies needed to implement modularized, individually tailored trauma interventions by strengthening clinical knowledge, clinical reasoning, and familiarity with common elements.

Comparison of the efficacy of three PubMed search filters in finding randomized controlled trials to answer clinical questions.

PubMed

Yousefi-Nooraie, Reza; Irani, Shirin; Mortaz-Hedjri, Soroush; Shakiba, Behnam

2013-10-01

The aim of this study was to compare the performance of three search methods in the retrieval of relevant clinical trials from PubMed to answer specific clinical questions. Included studies of a sample of 100 Cochrane reviews which recorded in PubMed were considered as the reference standard. The search queries were formulated based on the systematic review titles. Precision, recall and number of retrieved records for limiting the results to clinical trial publication type, and using sensitive and specific clinical queries filters were compared. The number of keywords, presence of specific names of intervention and syndrome in the search keywords were used in a model to predict the recalls and precisions. The Clinical queries-sensitive search strategy retrieved the largest number of records (33) and had the highest recall (41.6%) and lowest precision (4.8%). The presence of specific intervention name was the only significant predictor of all recalls and precisions (P = 0.016). The recall and precision of combination of simple clinical search queries and methodological search filters to find clinical trials in various subjects were considerably low. The limit field strategy yielded in higher precision and fewer retrieved records and approximately similar recall, compared with the clinical queries-sensitive strategy. Presence of specific intervention name in the search keywords increased both recall and precision. © 2010 John Wiley & Sons Ltd.

Implementation of a cystic fibrosis lung transplant referral patient decision aid in routine clinical practice: an observational study.

PubMed

Stacey, Dawn; Vandemheen, Katherine L; Hennessey, Rosamund; Gooyers, Tracy; Gaudet, Ena; Mallick, Ranjeeta; Salgado, Josette; Freitag, Andreas; Berthiaume, Yves; Brown, Neil; Aaron, Shawn D

2015-02-07

The decision to have lung transplantation as treatment for end-stage lung disease from cystic fibrosis (CF) has benefits and serious risks. Although patient decision aids are effective interventions for helping patients reach a quality decision, little is known about implementing them in clinical practice. Our study evaluated a sustainable approach for implementing a patient decision aid for adults with CF considering referral for lung transplantation. A prospective pragmatic observational study was guided by the Knowledge-to-Action Framework. Healthcare professionals in all 23 Canadian CF clinics were eligible. We surveyed participants regarding perceived barriers and facilitators to patient decision aid use. Interventions tailored to address modifiable identified barriers included training, access to decision aids, and conference calls. The primary outcome was >80% use of the decision aid in year 2. Of 23 adult CF clinics, 18 participated (78.2%) and 13 had healthcare professionals attend training. Baseline barriers were healthcare professionals' inadequate knowledge for supporting patients making decisions (55%), clarifying patients' values for outcomes of options (58%), and helping patients handle conflicting views of others (71%). Other barriers were lack of time (52%) and needing to change how transplantation is discussed (42%). Baseline facilitators were healthcare professionals feeling comfortable discussing bad transplantation outcomes (74%), agreeing the decision aid would be easy to experiment with (71%) and use in the CF clinic (87%), and agreeing that using the decision aid would not require reorganization of the CF clinic (90%). After implementing the decision aid with interventions tailored to the barriers, decision aid use increased from 29% at baseline to 85% during year 1 and 92% in year 2 (p < 0.001). Compared to baseline, more healthcare professionals at the end of the study were confident in supporting decision-making (p = 0.03) but continued to feel inadequate ability with supporting patients to handle conflicting views (p = 0.01). Most Canadian CF clinics agreed to participate in the study. Interventions were used to target identified modifiable barriers to using the patient decision aid in routine CF clinical practice. CF clinics reported using it with almost all patients in the second year.

Reduction of missed appointments at an urban primary care clinic: a randomised controlled study.

PubMed

Perron, Noelle Junod; Dao, Melissa Dominicé; Kossovsky, Michel P; Miserez, Valerie; Chuard, Carmen; Calmy, Alexandra; Gaspoz, Jean-Michel

2010-10-25

Missed appointments are known to interfere with appropriate care and to misspend medical and administrative resources. The aim of this study was to test the effectiveness of a sequential intervention reminding patients of their upcoming appointment and to identify the profile of patients missing their appointments. We conducted a randomised controlled study in an urban primary care clinic at the Geneva University Hospitals serving a majority of vulnerable patients. All patients booked in a primary care or HIV clinic at the Geneva University Hospitals were sent a reminder 48 hrs prior to their appointment according to the following sequential intervention: 1. Phone call (fixed or mobile) reminder; 2. If no phone response: a Short Message Service (SMS) reminder; 3. If no available mobile phone number: a postal reminder. The rate of missed appointment, the cost of the intervention, and the profile of patients missing their appointment were recorded. 2123 patients were included: 1052 in the intervention group, 1071 in the control group. Only 61.7% patients had a mobile phone recorded at the clinic. The sequential intervention significantly reduced the rate of missed appointments: 11.4% (n = 122) in the control group and 7.8% (n = 82) in the intervention group (p < 0.005), and allowed to reallocate 28% of cancelled appointments. It also proved to be cost effective in providing a total net benefit of 1846. - EUR/3 months. A satisfaction survey conducted with 241 patients showed that 93% of them were not bothered by the reminders and 78% considered them to be useful. By multivariate analysis, the following characteristics were significant predictors of missed appointments: younger age (OR per additional decade 0.82; CI 0.71-0.94), male gender (OR 1.72; CI 1.18-2.50), follow-up appointment >1 year (OR 2.2; CI: 1.15-4.2), substance abuse (2.09, CI 1.21-3.61), and being an asylum seeker (OR 2.73: CI 1.22-6.09). A practical reminder system can significantly increase patient attendance at medical outpatient clinics. An intervention focused on specific patient characteristics could further increase the effectiveness of appointment reminders.

Reduction of missed appointments at an urban primary care clinic: a randomised controlled study

PubMed Central

2010-01-01

Background Missed appointments are known to interfere with appropriate care and to misspend medical and administrative resources. The aim of this study was to test the effectiveness of a sequential intervention reminding patients of their upcoming appointment and to identify the profile of patients missing their appointments. Methods We conducted a randomised controlled study in an urban primary care clinic at the Geneva University Hospitals serving a majority of vulnerable patients. All patients booked in a primary care or HIV clinic at the Geneva University Hospitals were sent a reminder 48 hrs prior to their appointment according to the following sequential intervention: 1. Phone call (fixed or mobile) reminder; 2. If no phone response: a Short Message Service (SMS) reminder; 3. If no available mobile phone number: a postal reminder. The rate of missed appointment, the cost of the intervention, and the profile of patients missing their appointment were recorded. Results 2123 patients were included: 1052 in the intervention group, 1071 in the control group. Only 61.7% patients had a mobile phone recorded at the clinic. The sequential intervention significantly reduced the rate of missed appointments: 11.4% (n = 122) in the control group and 7.8% (n = 82) in the intervention group (p < 0.005), and allowed to reallocate 28% of cancelled appointments. It also proved to be cost effective in providing a total net benefit of 1846. - EUR/3 months. A satisfaction survey conducted with 241 patients showed that 93% of them were not bothered by the reminders and 78% considered them to be useful. By multivariate analysis, the following characteristics were significant predictors of missed appointments: younger age (OR per additional decade 0.82; CI 0.71-0.94), male gender (OR 1.72; CI 1.18-2.50), follow-up appointment >1year (OR 2.2; CI: 1.15-4.2), substance abuse (2.09, CI 1.21-3.61), and being an asylum seeker (OR 2.73: CI 1.22-6.09). Conclusion A practical reminder system can significantly increase patient attendance at medical outpatient clinics. An intervention focused on specific patient characteristics could further increase the effectiveness of appointment reminders. PMID:20973950

Evaluating the Efficacy of a Short Aging Simulation Workshop for an Interdisciplinary Group of Health-Care Employees at a Veterans Affairs Medical Center

ERIC Educational Resources Information Center

Halpin, Sean N.

2015-01-01

Several interventions aimed at increasing positive attitudes towards older adults among health-care professionals have been introduced. These interventions tend to focus on a small subset of clinical employees, ignoring other clinical and nonclinical hospital staff. The objective of this study was to evaluate the efficacy of a short aging…

Clinical Practice Guideline Selection, Development, Implementation, and Evaluation

DTIC Science & Technology

2000-02-01

interventions for a particular diagnosis” (Henning, 1997) developed by members of the hospital staff. They can be Clinical Practice Guidelines6 conceptualized...health care environment , it is more important than ever for health care organizations to select the most cost-effective procedures, and to continuously...of the studies regarding the targeted illness/injury will enable this team to identify those interventions strongly supported by significant

Comparative study between ultrasonography and optical coherence tomography in interventional cardiology

NASA Astrophysics Data System (ADS)

Fanjul-Vélez, Félix; de la Torre-Hernández, José María; Ortega-Quijano, Noé; Zueco-Gil, José Javier; Arce-Diego, José Luis

2009-07-01

In this work, we present clinical images of IVUS and OCT in the evaluation of pharmacological stent endothelization. These preliminary imaging results are analyzed and compared in order to determine the ability of these technologies to visualize relevant intravascular features of interest in interventional cardiology. The results enable to compare the performance of both techniques and to evaluate their potential for clinical purposes.

The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women.

PubMed

Duval, Karine; Langlois, Marie-France; Carranza-Mamane, Belina; Pesant, Marie-Hélène; Hivert, Marie-France; Poder, Thomas G; Lavoie, Hélène B; Ainmelk, Youssef; St-Cyr Tribble, Denise; Laredo, Sheila; Greenblatt, Ellen; Sagle, Margaret; Waddell, Guy; Belisle, Serge; Riverin, Daniel; Jean-Denis, Farrah; Belan, Matea; Baillargeon, Jean-Patrice

2015-01-01

Obesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5-10 % of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study will evaluate clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. We hypothesize that the intervention will: 1) improve fertility, efficacy of fertility treatments, and health of mothers and their children; and 2) reduce the cost per live birth, including costs of fertility treatments and pregnancy outcomes. Obese infertile women (age: 18-40 years; BMI ≥30 kg/m(2) or ≥27 kg/m(2) with polycystic ovary syndrome) will be randomised to either a lifestyle intervention followed by standard fertility treatments after 6 months if no conception has been achieved (intervention group) or standard fertility treatments only (control group). The intervention and/or follow-up will last for a maximum of 18 months or up to the end of pregnancy. Evaluation visits will be planned every 6 months where different outcome measures will be assessed. The primary outcome will be live-birth rates at 18 months. The secondary outcomes will be sub-divided into four categories: lifestyle and anthropometric, fertility, pregnancy complications, and neonatal outcomes. Outcomes and costs will be also compared to similar women seen in three fertility clinics across Canada. Qualitative data will also be collected from both professionals and obese infertile women. This study will generate new knowledge about the implementation, impacts and costs of a lifestyle management program in obese infertile women. This information will be relevant for decision-makers and health care professionals, and should be generalizable to North American fertility clinics. ClinicalTrials.gov NCT01483612. Registered 25 November 2011.

Patient-oriented education and medication management intervention for people with decompensated cirrhosis: study protocol for a randomized controlled trial.

PubMed

Hayward, Kelly L; Martin, Jennifer H; Cottrell, W Neil; Karmakar, Antara; Horsfall, Leigh U; Patel, Preya J; Smith, David D; Irvine, Katharine M; Powell, Elizabeth E; Valery, Patricia C

2017-07-20

People with decompensated cirrhosis require complex medical care and are often prescribed an intricate and frequently changing medication and lifestyle regimen. However, many patients mismanage their medications or have poor comprehension of their disease and self-management tasks. This can lead to harm, hospitalization, and death. A patient-oriented education and medication management intervention has been developed for implementation at a tertiary hospital hepatology outpatient center in Queensland, Australia. Consenting patients with decompensated cirrhosis will be randomly allocated to education intervention or usual care treatment arms when they attend routine follow-up appointments. In the usual care arm, participants will be reviewed by their hepatologist according to the current model of care in the hepatology clinic. In the intervention arm, participants will be reviewed by a clinical pharmacist to receive the education and medication management intervention at baseline in addition to review by their hepatologist. Intervention participants will also receive three further educational contacts from the clinical pharmacist within the following 6-month period, in addition to routine hepatologist review that is scheduled within this time frame. All participants will be surveyed at baseline and follow-up (approximately 6 months post-enrollment). Validated questionnaire tools will be used to determine participant adherence, medication beliefs, illness perceptions, and quality of life. Patients' knowledge of dietary and lifestyle modifications, their current medications, and other clinical data will be obtained from the survey, patient interview, and medical records. Patient outcome data will be collected at 52 weeks. The intervention described within this protocol is ready to adapt and implement in hepatology ambulatory care centers globally. Investigation of potentially modifiable variables that may impact medication management, in addition to the effect of a clinical pharmacist-driven education and medication management intervention on modifying these variables, will provide valuable information for future management of these patients. Australian and New Zealand Clinical Trial Registry identifier: ACTRN12616000780459 . Registered on 15 June 2016.

Identifying Nursing Interventions in a Cancer Screening Program Using Nursing Interventions Classification Taxonomy.

PubMed

Benito, Llucia; Lluch, María Teresa; Falcó, Anna Marta; García, Montse; Puig, Montse

2017-04-01

This study aimed to investigate which Nursing Interventions Classification (NIC) labels correspond to specific nursing interventions provided during cancer screening to establish a nursing documentation system. This descriptive study was conducted to identify and classify the interventions that cancer screening nurses perform based on an initial list. The initial list was grouped into 15 interventions that corresponded to four domains and eight classes. The study found expert consensus regarding the duties of cancer screening nurses and identified 15 interventions that should be implemented in clinical practice for cancer screening care, according to the NIC taxonomy. This study is the first step in developing indicators to assess nursing performance in cancer screening, and it helps to establish the core competency requirements for cancer screening nurses. © 2015 NANDA International, Inc.

Computer-generated reminders and quality of pediatric HIV care in a resource-limited setting.

PubMed

Were, Martin C; Nyandiko, Winstone M; Huang, Kristin T L; Slaven, James E; Shen, Changyu; Tierney, William M; Vreeman, Rachel C

2013-03-01

To evaluate the impact of clinician-targeted computer-generated reminders on compliance with HIV care guidelines in a resource-limited setting. We conducted this randomized, controlled trial in an HIV referral clinic in Kenya caring for HIV-infected and HIV-exposed children (<14 years of age). For children randomly assigned to the intervention group, printed patient summaries containing computer-generated patient-specific reminders for overdue care recommendations were provided to the clinician at the time of the child's clinic visit. For children in the control group, clinicians received the summaries, but no computer-generated reminders. We compared differences between the intervention and control groups in completion of overdue tasks, including HIV testing, laboratory monitoring, initiating antiretroviral therapy, and making referrals. During the 5-month study period, 1611 patients (49% female, 70% HIV-infected) were eligible to receive at least 1 computer-generated reminder (ie, had an overdue clinical task). We observed a fourfold increase in the completion of overdue clinical tasks when reminders were availed to providers over the course of the study (68% intervention vs 18% control, P < .001). Orders also occurred earlier for the intervention group (77 days, SD 2.4 days) compared with the control group (104 days, SD 1.2 days) (P < .001). Response rates to reminders varied significantly by type of reminder and between clinicians. Clinician-targeted, computer-generated clinical reminders are associated with a significant increase in completion of overdue clinical tasks for HIV-infected and exposed children in a resource-limited setting.

SYRCLE’s risk of bias tool for animal studies

PubMed Central

2014-01-01

Background Systematic Reviews (SRs) of experimental animal studies are not yet common practice, but awareness of the merits of conducting such SRs is steadily increasing. As animal intervention studies differ from randomized clinical trials (RCT) in many aspects, the methodology for SRs of clinical trials needs to be adapted and optimized for animal intervention studies. The Cochrane Collaboration developed a Risk of Bias (RoB) tool to establish consistency and avoid discrepancies in assessing the methodological quality of RCTs. A similar initiative is warranted in the field of animal experimentation. Methods We provide an RoB tool for animal intervention studies (SYRCLE’s RoB tool). This tool is based on the Cochrane RoB tool and has been adjusted for aspects of bias that play a specific role in animal intervention studies. To enhance transparency and applicability, we formulated signalling questions to facilitate judgment. Results The resulting RoB tool for animal studies contains 10 entries. These entries are related to selection bias, performance bias, detection bias, attrition bias, reporting bias and other biases. Half these items are in agreement with the items in the Cochrane RoB tool. Most of the variations between the two tools are due to differences in design between RCTs and animal studies. Shortcomings in, or unfamiliarity with, specific aspects of experimental design of animal studies compared to clinical studies also play a role. Conclusions SYRCLE’s RoB tool is an adapted version of the Cochrane RoB tool. Widespread adoption and implementation of this tool will facilitate and improve critical appraisal of evidence from animal studies. This may subsequently enhance the efficiency of translating animal research into clinical practice and increase awareness of the necessity of improving the methodological quality of animal studies. PMID:24667063

[The effects of case-based learning using video on clinical decision making and learning motivation in undergraduate nursing students].

PubMed

Yoo, Moon-Sook; Park, Jin-Hee; Lee, Si-Ra

2010-12-01

The purpose of this study was to examine the effects of case-base learning (CBL) using video on clinical decision-making and learning motivation. This research was conducted between June 2009 and April 2010 as a nonequivalent control group non-synchronized design. The study population was 44 third year nursing students who enrolled in a college of nursing, A University in Korea. The nursing students were divided into the CBL and the control group. The intervention was the CBL with three cases using video. The controls attended a traditional live lecture on the same topics. With questionnaires objective clinical decision-making, subjective clinical decision-making, and learning motivation were measured before the intervention, and 10 weeks after the intervention. Significant group differences were observed in clinical decision-making and learning motivation. The post-test scores of clinical decision-making in the CBL group were statistically higher than the control group. Learning motivation was also significantly higher in the CBL group than in the control group. These results indicate that CBL using video is effective in enhancing clinical decision-making and motivating students to learn by encouraging self-directed learning and creating more interest and curiosity in learning.

An educational video to increase clinical trials enrollment among breast cancer patients.

PubMed

Du, Wei; Mood, Darlene; Gadgeel, Shirish; Simon, Michael S

2009-09-01

Only 3% of women with breast cancer participate in cancer clinical trials nationwide. The lack of awareness about clinical trials is a significant barrier towards clinical trials participation. A study was conducted at a large urban Comprehensive Cancer Center to test (1) the effectiveness of an 18-min educational video on improving attitudes toward clinical trials and trials enrollment among new breast cancer patients seen at the Karmanos Cancer Institute, and (2) to assess racial differences in attitudes regarding clinical trials. Participants were randomized to either the educational intervention prior to their first oncology clinic appointment or to standard care. A baseline and 2-week post-intervention survey to assess attitudes toward clinical trials participation was completed by participants. Of 218 subjects recruited, 196 (55% white vs. 45% African American (AA)) eligible patients were included in the analysis. A small increase in therapeutic clinical trial enrollment was observed in the intervention arm but was not statistically significant (10.4% vs. 6.1%; P = 0.277). The intervention also did not result in a clear improvement in patients' attitudes toward clinical trials at posttest. However, a lower enrollment rate for the AA women was noted after adjusting for stage (OR = 0.282, P = 0.049). Significantly more negative scores were noted in 3 out of the 5 baseline attitudinal scales for AA women. The educational video did not significantly increase enrollment in breast cancer clinical trials. The findings that AA women had significantly more negative attitudes toward clinical trials than white women may partially explain the racial disparity in enrollment. An educational video remains a simple and cost-effective way to educate patients. Future studies should focus on designing a new educational video to specifically target cultural and attitudinal barriers in the AA population to more effectively change attitudes and increase trial enrollment.

An educational video to increase clinical trials enrollment among breast cancer patients

PubMed Central

Du, Wei; Mood, Darlene; Gadgeel, Shirish; Simon, Michael S.

2013-01-01

Only 3% of women with breast cancer participate in cancer clinical trials nationwide. The lack of awareness about clinical trials is a significant barrier towards clinical trials participation. A study was conducted at a large urban Comprehensive Cancer Center to test (1) the effectiveness of an 18-min educational video on improving attitudes toward clinical trials and trials enrollment among new breast cancer patients seen at the Karmanos Cancer Institute, and (2) to assess racial differences in attitudes regarding clinical trials. Participants were randomized to either the educational intervention prior to their first oncology clinic appointment or to standard care. A baseline and 2-week post-intervention survey to assess attitudes toward clinical trials participation was completed by participants. Of 218 subjects recruited, 196 (55% white vs. 45% African American (AA)) eligible patients were included in the analysis. A small increase in therapeutic clinical trial enrollment was observed in the intervention arm but was not statistically significant (10.4% vs. 6.1%; P = 0.277). The intervention also did not result in a clear improvement in patients’ attitudes toward clinical trials at posttest. However, a lower enrollment rate for the AA women was noted after adjusting for stage (OR = 0.282, P = 0.049). Significantly more negative scores were noted in 3 out of the 5 baseline attitudinal scales for AA women. The educational video did not significantly increase enrollment in breast cancer clinical trials. The findings that AA women had significantly more negative attitudes toward clinical trials than white women may partially explain the racial disparity in enrollment. An educational video remains a simple and cost-effective way to educate patients. Future studies should focus on designing a new educational video to specifically target cultural and attitudinal barriers in the AA population to more effectively change attitudes and increase trial enrollment. PMID:19152024

Digital Interventions for Problematic Cannabis Users in Non-Clinical Settings: Findings from a Systematic Review and Meta-Analysis.

PubMed

Hoch, Eva; Preuss, Ulrich W; Ferri, Marica; Simon, Roland

2016-01-01

Existing cannabis treatment programs reach only a very limited proportion of people with cannabis-related problems. The aim of this systematic review and meta-analysis was to assess the effectiveness of digital interventions applied outside the health care system in reducing problematic cannabis use. We systematically searched the Cochrane Central Register of Controlled Trials (2015), PubMed (2009-2015), Medline (2009-2015), Google Scholar (2015) and article reference lists for potentially eligible studies. Randomized controlled trials examining the effects of internet- or computer-based interventions were assessed. Study effects were estimated by calculating effect sizes (ESs) using Cohen's d and Hedges' g bias-corrected ES. The primary outcome assessed was self-reported cannabis use, measured by a questionnaire. Fifty-two studies were identified. Four studies (including 1,928 participants) met inclusion criteria. They combined brief motivational interventions and cognitive behavioral therapy delivered online. All studies were of good quality. The pooled mean difference (x0394; = 4.07) and overall ES (0.11) give evidence of small effects at 3-month follow-up in favor of digital interventions. Digital interventions can help to successfully reduce problematic cannabis use outside clinical settings. They have some potential to overcome treatment barriers and increase accessibility for at-risk cannabis users. © 2016 S. Karger AG, Basel.

Prebiotics, Prosynbiotics and Synbiotics: Can They Reduce Plasma Oxidative Stress Parameters? A Systematic Review.

PubMed

Salehi-Abargouei, Amin; Ghiasvand, Reza; Hariri, Mitra

2017-03-01

This study assessed the effectiveness of presybiotics, prosybiotics and synbiotics on reducing serum oxidative stress parameters. PubMed/Medline, Ovid, Google Scholar, ISI Web of Science and SCOPUS were searched up to September 2016. English language randomized clinical trials reporting the effect of presybiotics, prosybiotics or synbiotic interventions on serum oxidative stress parameters in human adults were included. Twenty-one randomized clinical trials met the inclusion criteria for systematic review. Two studies investigated prebiotics, four studies synbiotics and fifteen studies probiotics. According to our systematic review, prebiotic could decrease malondialdehyde and increase superoxidative dismutase, but evidence is not enough. In comparison with fructo-oligosaccharide, inulin is much more useful for oxidative stress reduction. Using probiotics with dairy products could reduce oxidative stress significantly, but probiotic in form of supplementation did not have any effect on oxidative stress. There is limited but supportive evidence that presybiotics, prosybiotics and synbiotics are effective for reducing oxidative stress parameters. Further randomized clinical trials with longer duration of intervention especially on population with increased oxidative stress are needed to provide more definitive results before any recommendation for clinical use of these interventions.

Routine health insurance data for scientific research: potential and limitations of the Agis Health Database.

PubMed

Smeets, Hugo M; de Wit, Niek J; Hoes, Arno W

2011-04-01

Observational studies performed within routine health care databases have the advantage of their large size and, when the aim is to assess the effect of interventions, can offer a completion to randomized controlled trials with usually small samples from experimental situations. Institutional Health Insurance Databases (HIDs) are attractive for research because of their large size, their longitudinal perspective, and their practice-based information. As they are based on financial reimbursement, the information is generally reliable. The database of one of the major insurance companies in the Netherlands, the Agis Health Database (AHD), is described in detail. Whether the AHD data sets meet the specific requirements to conduct several types of clinical studies is discussed according to the classification of the four different types of clinical research; that is, diagnostic, etiologic, prognostic, and intervention research. The potential of the AHD for these various types of research is illustrated using examples of studies recently conducted in the AHD. HIDs such as the AHD offer large potential for several types of clinical research, in particular etiologic and intervention studies, but at present the lack of detailed clinical information is an important limitation. Copyright © 2011 Elsevier Inc. All rights reserved.

Clinical tube weaning supported by hunger provocation in fully-tube-fed children.

PubMed

Hartdorff, Caroline M; Kneepkens, C M Frank; Stok-Akerboom, Anita M; van Dijk-Lokkart, Elisabeth M; Engels, Michelle A H; Kindermann, Angelika

2015-04-01

Children with congenital malformations, mental retardation, and complex early medical history frequently have feeding problems. Although tube feeding is effective in providing the necessary energy and nutrients, it decreases the child's motivation to eat and may lead to oral aversion. In this study, we sought to confirm our previous results, showing that a multidisciplinary clinical hunger provocation program may lead to quick resumption of oral feeding. In a crossover study, 22 children of 9 to 24 months of age who were fully dependent on tube feeding were randomly assigned to one of two groups: group A, intervention group (2-week multidisciplinary clinical hunger provocation program); and group B, control group (4-week outpatient treatment by the same multidisciplinary team). Patients failing one treatment were reassigned to the other treatment group. Primary outcome measures were at least 75% orally fed at the conclusion of the intervention and fully orally fed and gaining weight 6 months after the intervention. In group A, 9/11 patients were successfully weaned from tube feeding (2 failures: 1 developed ulcerative colitis, 1 drop-out). In group B, only 1 patient was weaned successfully; 10/11 were reassigned to the clinical hunger provocation program, all being weaned successfully. Six months after the intervention, 1 patient had to resume tube feeding. In total, in the control group, 1/11 (9%) was weaned successfully as compared with 18/21 (86%) in the hunger provocation group (P < 0.001). Multidisciplinary clinical hunger provocation is an effective short-term intervention for weaning young children from tube feeding.

Patients' perspectives of a multifaceted intervention with a focus on technology: a qualitative analysis.

PubMed

Lambert-Kerzner, Anne; Havranek, Edward P; Plomondon, Mary E; Albright, Karen; Moore, Ashley; Gryniewicz, Kelsey; Magid, David; Ho, P Michael

2010-11-01

Few studies have investigated the effectiveness of multifaceted interventions from the study participants' perspective. We conducted qualitative interviews to understand patients' experiences with a multifaceted blood pressure (BP) control intervention involving interactive voice response technology, home BP monitoring, and pharmacist-led BP management. In the randomized study, the intervention resulted in clinically significant decreases in BP. We used insights generated from in-depth interviews from all study participants randomly assigned to the multifaceted intervention or usual care (n=146) to create a model explaining the observed improvements in health behavior and clinical outcomes. The data were analyzed using qualitative content analysis methods and consultative and reflexive team analysis. Six explanatory factors emerged from the patients' interviews: (1) improved relationships with medical personnel; (2) increased knowledge of hypertension; (3) increased participation in their health care and personal empowerment; (4) greater understanding of the impact of health behavior on BP; (5) high satisfaction with technology used in the intervention; and, for some patients, (6) increased health care utilization. Eighty-six percent of the intervention patients and 62% of the usual care patients stated that study participation had a positive effect on them. Of those expressing a positive effect, 68% (intervention) and 55% (usual care) reached their systolic BP goal. Establishing bidirectional conversations between patients and providers is a key element of successful hypertension management. Home BP monitoring coupled with interactive voice response technology reporting facilitates such conversations.

Diabetes and cardiovascular disease interventions by community pharmacists: a systematic review.

PubMed

Evans, Charity D; Watson, Erin; Eurich, Dean T; Taylor, Jeff G; Yakiwchuk, Erin M; Shevchuk, Yvonne M; Remillard, Alfred; Blackburn, David

2011-05-01

To systematically review and assess the quality of studies evaluating community pharmacist interventions for preventing or managing diabetes or cardiovascular disease (CVD) and/or their major risk factors. A comprehensive literature search was performed using MEDLINE (1950-February 2011), EMBASE (1980-February 2011), International Pharmaceutical Abstracts (1970-February 2011), Cumulative Index to Nursing and Allied Health Literature (1982-June 2007), and Cochrane Central Register of Controlled Trials (1898-February 2011). Search terms included: community pharmacy(ies), community pharmacist(s), cardiovascular, diabetes, and intervention. The grey literature was searched using the ProQuest Dissertations and Theses, Theses Canada, and OAlster databases. Articles published in English or French with all study designs were considered for the review. Studies were included if they contained interventions designed to reduce the incidence, risk, or mortality of CVD or diabetes; affect clinical indicators of CVD or diabetes mellitus (including hypertension, dyslipidemia, or hemoglobin A(1c)); and/or improve adherence to treatment strategies. Only studies involving interventions carried out primarily by pharmacists in community pharmacy settings were included. Study quality was assessed using a checklist validated for both randomized and nonrandomized studies. A total of 4142 studies were initially identified, with 40 meeting our inclusion criteria. Eleven studies were randomized controlled trials, 4 were cluster randomized trials, and 2 studies had randomized before-after designs. The remaining studies were controlled before-after (n = 2), cohort (n = 4), and uncontrolled before-after (n = 17) designs. Interventions focused on diabetes (n = 12), hypertension (n = 9), medication adherence (n = 9), lipids (n = 5), evidence-based medication initiation or optimization (n = 3), risk factor prediction scores (n = 1), and body mass index (n = 1). All studies contained interventions focused at the patient level and the majority of studies (34/40) involved interventions directed at both the physician and patient. No specific intervention emerged as superior, and study quality was generally poor, making it difficult to determine the true effect of the interventions. Poor study quality, time-intensive interventions, and unproven clinical significance warrant the need for further high-quality studies of community pharmacist interventions for preventing or managing diabetes or CVD and/or their major risk factors.

Combining a leadership course and multi-source feedback has no effect on leadership skills of leaders in postgraduate medical education. An intervention study with a control group.

PubMed

Malling, Bente; Mortensen, Lene; Bonderup, Thomas; Scherpbier, Albert; Ringsted, Charlotte

2009-12-10

Leadership courses and multi-source feedback are widely used developmental tools for leaders in health care. On this background we aimed to study the additional effect of a leadership course following a multi-source feedback procedure compared to multi-source feedback alone especially regarding development of leadership skills over time. Study participants were consultants responsible for postgraduate medical education at clinical departments. pre-post measures with an intervention and control group. The intervention was participation in a seven-day leadership course. Scores of multi-source feedback from the consultants responsible for education and respondents (heads of department, consultants and doctors in specialist training) were collected before and one year after the intervention and analysed using Mann-Whitney's U-test and Multivariate analysis of variances. There were no differences in multi-source feedback scores at one year follow up compared to baseline measurements, either in the intervention or in the control group (p = 0.149). The study indicates that a leadership course following a MSF procedure compared to MSF alone does not improve leadership skills of consultants responsible for education in clinical departments. Developing leadership skills takes time and the time frame of one year might have been too short to show improvement in leadership skills of consultants responsible for education. Further studies are needed to investigate if other combination of initiatives to develop leadership might have more impact in the clinical setting.

[Breast-feeding training programme as intervention approach at the hospital level: results of evaluation of the first phase of the STELLA study].

PubMed

Meyer, N; Spegel, H; Hendrowarsito, L; Schwegler, U; Fromme, H; Bolte, G

2012-01-01

The health-promoting short- and long-term effects of breast-feeding are supported by a vast scientific literature. The Bavarian prospective cohort study 2005/2006 showed regional variations of breast-feeding rates. Furthermore, improvement in counselling mothers, particularly with regard to prevention and handling of breast-feeding problems, has a great potential for health promotion. The objective of this study is to promote breast-feeding in maternity clinics by improving the surrounding conditions. A clinic-based and community-related intervention trial was carried out in Lower Bavaria as a model region with below average breast-feeding rates. (1) INTERVENTION: an advanced training of maternity ward professionals of 10 hospitals and after-care midwives was performed from May until December 2008. The training programme was based on the WHO/UNICEF criteria of the "Ten Steps to Successful Breastfeeding" to deepen the breast-feeding knowledge and to improve the breast-feeding management. (2) EVALUATION: A singular assessment of the advanced training programme was undertaken concerning an increase of knowledge and the practicability in clinical everyday life by participants; improvements of the maternity wards were assessed via structural interviews with maternity ward staff before and after intervention. Approximately 85% (n=378) of the staff of the 10 maternity clinics attended the training course. The survey after the training programme (response rate 83%) indicated that more than 80% of the participants stated to have learned something new and to be able to use the knowledge acquired for their own practice. Results of the clinic interviews showed a transfer of training contents into clinical work routines. Improvements at interview date were shown best for bonding (all 10 maternity clinics), for additional feeding (8 maternity clinics) as well as for 24-h rooming-in and mother counselling (7 maternal clinics each). Training of maternity ward professionals accounts for baby-friendly conditions in maternity clinics. Most willingness for improvements was shown by maternity ward staff particularly for bonding between mother and child as well as for additional feeding. Considerable differences between the hospitals were observed for the promotion of infant formulas before and after the intervention. © Georg Thieme Verlag KG Stuttgart · New York.

Measures for assessing practice change in medical practitioners

PubMed Central

Hakkennes, Sharon; Green, Sally

2006-01-01

Background There are increasing numbers of randomised trials and systematic reviews examining the efficacy of interventions designed to bring about a change in clinical practice. The findings of this research are being used to guide strategies to increase the uptake of evidence into clinical practice. Knowledge of the outcomes measured by these trials is vital not only for the interpretation and application of the work done to date, but also to inform future research in this expanding area of endeavour and to assist in collation of results in systematic reviews and meta-analyses. Methods The objective of this review was to identify methods used to measure change in the clinical practices of health professionals following an intervention aimed at increasing the uptake of evidence into practice. All published trials included in a recent, comprehensive Health Technology Assessment of interventions to implement clinical practice guidelines and change clinical practice (n = 228) formed the sample for this study. Using a standardised data extraction form, one reviewer (SH), extracted the relevant information from the methods and/or results sections of the trials. Results Measures of a change of health practitioner behaviour were the most common, with 88.8% of trials using these as outcome measures. Measures that assessed change at a patient level, either actual measures of change or surrogate measures of change, were used in 28.8% and 36.7% of studies (respectively). Health practitioners' knowledge and attitudes were assessed in 22.8% of the studies and changes at an organisational level were assessed in 17.6%. Conclusion Most trials of interventions aimed at changing clinical practice measured the effect of the intervention at the level of the practitioner, i.e. did the practitioner change what they do, or has their knowledge of and/or attitude toward that practice changed? Less than one-third of the trials measured, whether or not any change in practice, resulted in a change in the ultimate end-point of patient health status. PMID:17150111

Measures for assessing practice change in medical practitioners.

PubMed

Hakkennes, Sharon; Green, Sally

2006-12-06

There are increasing numbers of randomised trials and systematic reviews examining the efficacy of interventions designed to bring about a change in clinical practice. The findings of this research are being used to guide strategies to increase the uptake of evidence into clinical practice. Knowledge of the outcomes measured by these trials is vital not only for the interpretation and application of the work done to date, but also to inform future research in this expanding area of endeavour and to assist in collation of results in systematic reviews and meta-analyses. The objective of this review was to identify methods used to measure change in the clinical practices of health professionals following an intervention aimed at increasing the uptake of evidence into practice. All published trials included in a recent, comprehensive Health Technology Assessment of interventions to implement clinical practice guidelines and change clinical practice (n = 228) formed the sample for this study. Using a standardised data extraction form, one reviewer (SH), extracted the relevant information from the methods and/or results sections of the trials. Measures of a change of health practitioner behaviour were the most common, with 88.8% of trials using these as outcome measures. Measures that assessed change at a patient level, either actual measures of change or surrogate measures of change, were used in 28.8% and 36.7% of studies (respectively). Health practitioners' knowledge and attitudes were assessed in 22.8% of the studies and changes at an organisational level were assessed in 17.6%. Most trials of interventions aimed at changing clinical practice measured the effect of the intervention at the level of the practitioner, i.e. did the practitioner change what they do, or has their knowledge of and/or attitude toward that practice changed? Less than one-third of the trials measured, whether or not any change in practice, resulted in a change in the ultimate end-point of patient health status.

Interventions for the prevention of nutritional rickets in term born children.

PubMed

Lerch, C; Meissner, T

2007-10-17

Nutritional rickets is a disease of growing children leading to bone deformities, bone pain, convulsions or delayed motor development. Today, high-incidence of nutritional rickets is mainly found in low-income countries. To assess the effects of various interventions on the prevention of nutritional rickets in term born children. Studies were obtained from computerised searches of The Cochrane Library, MEDLINE, EMBASE, LILACS and reference lists of relevant articles. We contacted authors of studies or reviews to obtain further studies. Studies were included if they were randomised controlled clinical trials, controlled clinical trials or prospective cohort studies comparing any intervention for the prevention of nutritional rickets in term born children with placebo or no intervention. Minimum duration of the intervention was three months for children under 12 months or six months for children over 12 months. Two authors independently extracted data and assessed study quality. Authors of studies were contacted to obtain missing information. Four studies enrolled approximately 1700 participants. Trials lasted between nine months to two years. Three studies were randomised controlled trials, two of which showed a cluster randomised design; one trial probably was a controlled trial with researcher controlled group assignment. In children up to three years of age in Turkey, Vitamin D compared to no intervention showed a relative risk of 0.04 (95% confidence interval (CI) 0 to 0.71). Despite a marked non-compliance, a Chinese trial in children up to three years of age comparing a combined intervention of supplementation of vitamin D, calcium and nutritional counseling showed a relative risk of 0.76 (95% CI 0.61 to 0.95) compared to no intervention. In two studies conducted in older children in China and in France no rickets occurred in both the intervention and control group. There a only few studies on the prevention of nutritional rickets in term born children. Until new data become available, it appears sound to offer preventive measures (vitamin D or calcium) to groups of high risk, like infants and toddlers; children living in Africa, Asia or the Middle East or migrated children from these regions into areas where rickets is not frequent. Due to a marked clinical heterogeneity and the scarcity of data, the main and adverse effects of preventive measures against nutritional rickets should be investigated in different countries, different age groups and in children of different ethnic origin.

Assessment of Clinical Pharmacy Interventions to Reduce Outpatient Use of High-Risk Medications in the Elderly.

PubMed

Weddle, Sarah C; Rowe, A Shaun; Jeter, Julie W; Renwick, Rachel C; Chamberlin, Shaunta' M; Franks, Andrea S

2017-05-01

Use of high-risk medications in the elderly (HRME) and drug-disease (Rx-DIS) interactions in the elderly, as defined by the Healthcare Effectiveness Data and Information Set (HEDIS) Measures, are significantly associated with mortality, hospital admission, and need for emergency care. No published studies to date evaluate interventions to reduce the use of HEDIS-defined HRME, although many studies have postulated a beneficial effect of such interventions. To evaluate the effect of pharmacist interventions on use of HRME and Rx-DIS interactions in the outpatient elderly population. This retrospective cohort study was conducted in a resident-based family medicine clinic. Patients aged ≥ 65 years were prospectively screened for the use of HRME and Rx-DIS interactions before their visits with their primary care providers. If HRME or Rx-DIS interactions were noted, the clinical pharmacist sent messages to the physicians through the electronic medical record, alerting them of the findings with suggestions of safer alternative agents, if applicable. The recommendation acceptance rate was assessed and then compared with a historical control from a similar time frame. The primary outcome was assessed with a chi square analysis. Secondary outcomes were assessed with descriptive statistics, chi square test, and Fisher's exact test. HRME and/or Rx-DIS interactions were changed 25.9% of the time in the pharmacist intervention group compared with only 2.0% of the time in the historical control group (P = 0.001). The most frequently changed medication classes included skeletal muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs. Over 85% of the medication changes were preserved at the end of the study period. There was no difference between groups in the number of patients with HRME or Rx-DIS interactions. Clinical pharmacy interventions result in significant reductions in use of HRME and Rx-DIS interactions in the outpatient elderly population. Using electronic communication allows pharmacists to provide meaningful interventions for numerous patients receiving care in a high-volume family medicine clinic setting. There was no funding or sponsorship for this study. Rowe reports personal fees from The Medicines Company, outside the submitted work. The other authors have nothing to disclose. Study concept and design were contributed by Jeter, Chamberlin, and Weddle, with assistance from Rowe and Franks. Weddle and Renwick collected the data, and data interpretation was performed by Weddle and Rowe, with assistance from Franks. The manuscript was written by Weddle and Rowe and revised by Weddle and Franks, assisted by Chamberlin. The abstract for the completed study was presented at the American College of Clinical Pharmacy Global Conference, San Francisco, California, October 2015, and the Southeastern Residency Conference, Athens, Georgia, April 2015 (platform presentation). The research-in-progress abstract was presented at the Tennessee Society of Health System Pharmacists, Nashville, Tennessee, February 2015; the American Society of Health System Pharmacists Midyear Clinical Meeting, Anaheim, California, December 2014; and the University HealthSystem Consortium Pharmacy Council, Anaheim, California, December 2014.

Bioresorbable scaffolds: talking about a new interventional revolution [corrected].

PubMed

Hassell, M E C J; Grundeken, M J D; Delewi, R; Wykrzykowska, J J; Piek, J J

2013-04-01

After the introduction of coronary balloon angioplasty, bare-metal, and drug-eluting stents, fully bioresorbable scaffolds (BRS) could be the fourth revolution in interventional cardiology. The BRS technology shares the advantages of metallic stents regarding acute gain and prevention of acute vessel occlusion by providing transient scaffolding, while potentially overcoming many of the safety concerns of drug-eluting stents. Furthermore, without a permanent metallic cage, the vessel could remodel favourably and atherosclerotic plaques could regress in the long-term. This attracted increased interest and several BRS have been developed. In this review we will describe all BRS which are thus far clinically evaluated and provide an overview of ongoing clinical studies. Although the technology seems to be very promising, more studies including patients with more complex lesions are needed to evaluate whether the BRS can be used in daily clinical practice and if it is indeed becoming a new interventional revolution.

No Medication for My Child! A Naturalistic Study on the Treatment Preferences for and Effects of Cogmed Working Memory Training Versus Psychostimulant Medication in Clinically Referred Youth with ADHD.

PubMed

Muris, Peter; Roodenrijs, Dorien; Kelgtermans, Lut; Sliwinski, Sonja; Berlage, Ulrike; Baillieux, Hanna; Deckers, Anne; Gunther, Marieke; Paanakker, Bertien; Holterman, Ida

2018-05-16

In this naturalistic clinical study, we explored the applicability and clinical effectiveness of Cogmed WMT, pharmacotherapy, and their combination for clinically referred children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Ninety youth with ADHD (ages 6-16 years) and their parents were offered the possibility to choose one of the three interventions. The motives for choosing various interventions were quite different. Medication was chosen because this treatment was expected to be most effective, but also because the Cogmed WMT program was regarded as too taxing. The choice for Cogmed WMT was mainly negatively motivated: participants tended to be strongly against the use of medication, found it a too rigorous step, or feared side effects and addiction problems. The choice for the combination treatment was strongly positively motivated: parents and youth indicated that they wanted to receive the best possible intervention and part of them also had high expectations of Cogmed WMT. In terms of clinical effectiveness, pharmacotherapy with stimulant medication and the combination treatment produced larger reductions in ADHD symptomatology than Cogmed WMT. Further, results indicated that Cogmed WMT selectively enhanced working memory performance. Finally, after conducting Cogmed WMT, youths and parents were more 'open' to accept pharmacotherapy as intervention, probably because the training increased greater insight in and awareness of the problematic features of ADHD.

Measuring the quality of life of the elderly in health promotion intervention clinical trials.

PubMed Central

Kutner, N G; Ory, M G; Baker, D I; Schechtman, K B; Hornbrook, M C; Mulrow, C D

1992-01-01

The Multicenter Trials of Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT) is a series of clinical trials of biomedical, behavioral, and environmental interventions to reduce the risks of frailty and injury among the elderly. Reliable assessment of the quality of life reported by the subjects is a central issue in evaluating the interventions. An intervention may have a significant impact on an elderly person's sense of well-being, even though significant improvement is not observed in selected physical outcome measures. Elderly persons' compliance with particular intervention regimens may be influenced by the quality of life effects that they perceive in relation to the intervention. The researchers review the definition and measurement of quality of life in the trials, with particular attention to issues in determining common measures used at all study locations. Practical considerations in the selection and use of quality of life measures in both community and institutional populations are addressed. Topics discussed include the interrelation of aging, functional capacities, and quality of life; the multi-dimensionality of quality of life in relation to differential intervention effects; and age-related issues in the collection of quality of life data. Preliminary observations are reviewed, and potential contributions of FICSIT to intervention-sensitive quality of life assessments among the elderly are noted. PMID:1410233

Effectiveness of an individual school-based intervention for children with aggressive behaviour: a randomized controlled trial.

PubMed

Stoltz, Sabine; van Londen, Monique; Deković, Maja; de Castro, Bram O; Prinzie, Peter; Lochman, John E

2013-10-01

For elementary school-children with aggressive behaviour problems, there is a strong need for effective preventive interventions to interrupt the developmental trajectory towards more serious behaviour problems. The aim of this RCT-study was to evaluate a school-based individual tailor-made intervention (Stay Cool Kids), designed to reduce aggressive behaviour in selected children by enhancing cognitive behavioural skills. The sample consisted of 48 schools, with 264 fourth-grade children selected by their teachers because of elevated levels of externalizing behaviour (TRF T-score>60), randomly assigned to the intervention or no-intervention control condition. The intervention was found to be effective in reducing reactive and proactive aggressive behaviour as reported by children, mothers, fathers or teachers, with effect sizes ranging from .11 to .32. Clinically relevant changes in teacher-rated externalizing behaviour were found: the intervention reduced behaviour problems to (sub) clinical or normative levels for significantly more children than the control condition. Some aspects of problems in social cognitive functioning were reduced and children showed more positive self-perception. Ethnic background and gender moderated intervention effects on child and teacher reported aggression and child response generation. The results of this study demonstrate the effectiveness on outcome behaviour and child cognitions of an individual tailor-made intervention across informants under real-world conditions.

Systematic review: Effective home support in dementia care, components and impacts - Stage 2, effectiveness of home support interventions.

PubMed

Clarkson, Paul; Hughes, Jane; Roe, Brenda; Giebel, Clarissa M; Jolley, David; Poland, Fiona; Abendstern, Michele; Chester, Helen; Challis, David

2018-03-01

The aim of this study was to explicate the outcomes of home support interventions for older people with dementia and/or their carers to inform clinical practice, policy and research. Most people with dementia receive support at home. However, components and effectiveness of home support interventions have been little explored. Systematic review with narrative summary. Electronic searches of published studies in English using PubMed, Cochrane Central Register of Controlled Trials, PsychINFO, CINAHL, Applied Social Science Index and CSA Social Services Abstracts. Databases and sources were searched from inception to April 2014 with no date restrictions to locate studies. The PRISMA statement was followed and established systematic review methods used. Using 14 components of care for people with dementia and their carers, identified previously, data across studies were synthesized. Interventions were grouped and described and effectiveness ratings applied. Qualitative studies were synthesized using key themes. Seventy studies (four qualitative) were included. Most were directed to carers and of high quality. Seven interventions for carers and two for people with dementia were identified, covering 81% of studies. Those relating to daily living, cognitive training and physical activity for people with dementia were absent. Measures of effectiveness were influenced mainly by the intensity (duration and frequency) of interventions. Those containing education, social support and behaviour management appeared most effective. These interventions reflect emergent patterns of home support. Research is required to identify effective interventions linked to the stage of dementia, which can be applied as part of routine clinical care. © 2017 John Wiley & Sons Ltd.

An Intervention Using Gamification to Increase Human Immunodeficiency Virus and Sexually Transmitted Infection Screening Among Young Men Who Have Sex With Men in California: Rationale and Design of Stick To It

PubMed Central

Mejia, Christopher M; Acland, Daniel; Buzdugan, Raluca; Grimball, Reva; Natoli, Lauren; McGrath, Mark R; Klausner, Jeffrey D

2017-01-01

Background In the United States, young men who have sex with men (YMSM) remain disproportionately affected by human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Although routine HIV/STI screening is pivotal to the timely diagnosis of HIV and STIs, initiation of appropriate treatment, and reduced onward disease transmission, repeat screening is underused. Novel interventions that incorporate elements of games, an approach known as gamification, have the potential to increase routinization of HIV/STI screening among YMSM. Objective The study aims to test the hypothesis that an incentive-based intervention that incorporates elements of gamification can increase routine HIV/STI screening among YMSM in California. Methods The study consists of a formative research phase to develop the intervention and an implementation phase where the intervention is piloted in a controlled research setting. In the formative research phase, we use an iterative development process to design the intervention, including gathering information about the feasibility, acceptability, and expected effectiveness of potential game elements (eg, points, leaderboards, rewards). These activities include staff interviews, focus group discussions with members of the target population, and team meetings to strategize and develop the intervention. The final intervention is called Stick To It and consists of 3 components: (1) online enrollment, (2) Web-based activities consisting primarily of quizzes and a countdown “timer” to facilitate screening reminders, and (3) in-person activities that occur at 2 sexual health clinics. Participants earn points through the Web-based activities that are then redeemed for chances to win various prizes during clinic visits. The pilot study is a quasi-experimental study with a minimum of 60 intervention group participants recruited at the clinics, at community-based events, and online. We will compare outcomes in the intervention group with a historical control group consisting of individuals meeting the inclusion criteria who attended study clinics in the 12 months prior to intervention implementation. Eligible participants in the pilot study (1) are 18 to 26 years old, (2) were born or identify as male, 3) report male sexual partners, and 4) have a zip code of residence within defined areas in the vicinity of 1 of the 2 implementation sites. The primary outcome is repeat HIV/STI screening within 6 months. Results This is an ongoing research study with initial results expected in the fourth quarter of 2017. Conclusions We will develop and pilot test a gamification intervention to encourage YMSM to be regularly screened for HIV/STIs. The results from this research will provide preliminary evidence about the potential effectiveness of using gamification to amplify health-related behavioral change interventions. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions. Trial Registration Clinicaltrials.gov NCT02946164; https://clinicaltrials.gov/ct2/show/NCT02946164 (Archived by WebCite at http://www.webcitation.org/6ri3G4HwD) PMID:28716771

Effectiveness of Evidence-Based Asthma Interventions.

PubMed

Kennedy, Suzanne; Bailey, Ryan; Jaffee, Katy; Markus, Anne; Gerstein, Maya; Stevens, David M; Lesch, Julie Kennedy; Malveaux, Floyd J; Mitchell, Herman

2017-06-01

Researchers often struggle with the gap between efficacy and effectiveness in clinical research. To bridge this gap, the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) study adapted an efficacious, randomized controlled trial that resulted in evidence-based asthma interventions in community health centers. Children (aged 5-12 years; N = 590) with moderate to severe asthma were enrolled from 3 intervention and 3 geographically/capacity-matched control sites in high-risk, low-income communities located in Arizona, Michigan, and Puerto Rico. The asthma intervention was tailored to the participant's allergen sensitivity and exposure, and it comprised 4 visits over the course of 1 year. Study visits were documented and monitored prospectively via electronic data capture. Asthma symptoms and health care utilization were evaluated at baseline, and at 6 and 12 months. A total of 314 intervention children and 276 control children were enrolled in the study. Allergen sensitivity testing (96%) and home environmental assessments (89%) were performed on the majority of intervention children. Overall study activity completion (eg, intervention visits, clinical assessments) was 70%. Overall and individual site participant symptom days in the previous 4 weeks were significantly reduced compared with control findings (control, change of -2.28; intervention, change of -3.27; difference, -0.99; P < .001), and this result was consistent with changes found in the rigorous evidence-based interventions. Evidence-based interventions can be successfully adapted into primary care settings that serve impoverished, high-risk populations, reducing the morbidity of asthma in these high-need populations. Copyright © 2017 by the American Academy of Pediatrics.

Theory-Based Interventions to Improve Medication Adherence in Older Adults Prescribed Polypharmacy: A Systematic Review.

PubMed

Patton, Deborah E; Hughes, Carmel M; Cadogan, Cathal A; Ryan, Cristín A

2017-02-01

Previous interventions have shown limited success in improving medication adherence in older adults, and this may be due to the lack of a theoretical underpinning. This review sought to determine the effectiveness of theory-based interventions aimed at improving medication adherence in older adults prescribed polypharmacy and to explore the extent to which psychological theory informed their development. Eight electronic databases were searched from inception to March 2015, and extensive hand-searching was conducted. Interventions delivered to older adults (populations with a mean/median age of ≥65 years) prescribed polypharmacy (four or more regular oral/non-oral medicines) were eligible. Studies had to report an underpinning theory and measure at least one adherence and one clinical/humanistic outcome. Data were extracted independently by two reviewers and included details of intervention content, delivery, providers, participants, outcomes and theories used. The theory coding scheme (TCS) was used to assess the extent of theory use. Five studies cited theory as the basis for intervention development (social cognitive theory, health belief model, transtheoretical model, self-regulation model). The extent of theory use and intervention effectiveness in terms of adherence and clinical/humanistic outcomes varied across studies. No study made optimal use of theory as recommended in the TCS. The heterogeneity observed and inclusion of pilot designs mean conclusions regarding effectiveness of theory-based interventions targeting older adults prescribed polypharmacy could not be drawn. Further primary research involving theory as a central component of intervention development is required. The review findings will help inform the design of future theory-based adherence interventions.

COMmunication with Families regarding ORgan and Tissue donation after death in intensive care (COMFORT): protocol for an intervention study.

PubMed

Potter, Julie E; Herkes, Robert G; Perry, Lin; Elliott, Rosalind M; Aneman, Anders; Brieva, Jorge L; Cavazzoni, Elena; Cheng, Andrew T H; O'Leary, Michael J; Seppelt, Ian M; Gebski, Val

2017-01-17

Discussing deceased organ donation can be difficult not only for families but for health professionals who initiate and manage the conversations. It is well recognised that the methods of communication and communication skills of health professionals are key influences on decisions made by families regarding organ donation. This multicentre study is being performed in nine intensive care units with follow-up conducted by the Organ and Tissue Donation Service in New South Wales (NSW) Australia. The control condition is pre-intervention usual practice for at least six months before each site implements the intervention. The COMFORT intervention consists of six elements: family conversations regarding offers for organ donation to be led by a "designated requester"; family offers for donation are deferred to the designated requester; the offer of donation is separated from the end-of-life discussion that death is inevitable; it takes place within a structured family donation conversation using a "balanced" approach. Designated requesters may be intensivists, critical care nurses or social workers prepared by attending the three-day national "Family Donation Conversation" workshops, and the half-day NSW Simulation Program. The design is pre-post intervention to compare rates of family consent for organ donation six months before and under the intervention. Each ICU crosses from using the control to intervention condition after the site initiation visit. The primary endpoint is the consent rate for deceased organ donation calculated from 140 eligible next of kin families. Secondary endpoints are health professionals' adherence rates to core elements of the intervention; identification of predictors of family donation decision; and the proportion of families who regret their final donation decision at 90 days. The pragmatic design of this study may identify 'what works' in usual clinical settings when requesting organ donation in critical care areas, both in terms of changes in practice healthcare professionals are willing and able to adopt, and the effect this may have on desired outcomes. The findings of this study will be indicative of the potential benefits of the intervention and be relevant and transferrable to clinical settings in other states and countries. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000815763 (24 July 2013). ClinicalTrials.gov: NCT01922310 (14 August 2013) (retrospectively registered).

Reporting of Telehealth-Delivered Dietary Intervention Trials in Chronic Disease: Systematic Review.

PubMed

Warner, Molly M; Kelly, Jaimon T; Reidlinger, Dianne P; Hoffmann, Tammy C; Campbell, Katrina L

2017-12-11

Telehealth-delivered dietary interventions are effective for chronic disease management and are an emerging area of clinical practice. However, to apply interventions from the research setting in clinical practice, health professionals need details of each intervention component. The aim of this study was to evaluate the completeness of intervention reporting in published dietary chronic disease management trials that used telehealth delivery methods. Eligible randomized controlled trial publications were identified through a systematic review. The completeness of reporting of experimental and comparison interventions was assessed by two independent assessors using the Template for Intervention Description and Replication (TIDieR) checklist that consists of 12 items including intervention rationale, materials used, procedures, providers, delivery mode, location, when and how much intervention delivered, intervention tailoring, intervention modifications, and fidelity. Where reporting was incomplete, further information was sought from additional published material and through email correspondence with trial authors. Within the 37 eligible trials, there were 49 experimental interventions and 37 comparison interventions. One trial reported every TIDieR item for their experimental intervention. No publications reported every item for the comparison intervention. For the experimental interventions, the most commonly reported items were location (96%), mode of delivery (98%), and rationale for the essential intervention elements (96%). Least reported items for experimental interventions were modifications (2%) and intervention material descriptions (39%) and where to access them (20%). Of the 37 authors, 14 responded with further information, and 8 could not be contacted. Many details of the experimental and comparison interventions in telehealth-delivered dietary chronic disease management trials are incompletely reported. This prevents accurate interpretation of trial results and implementation of effective interventions in clinical practice. ©Molly M Warner, Jaimon T Kelly, Dianne P Reidlinger, Tammy C Hoffmann, Katrina L Campbell. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 11.12.2017.

Exploring exercise as an avenue for the treatment of anxiety disorders

PubMed Central

DeBoer, Lindsey B; Powers, Mark B; Utschig, Angela C; Otto, Michael W; Smits, Jasper AJ

2012-01-01

Anxiety disorders constitute a significant public health problem. Current gold standard treatments are limited in their effectiveness, prompting the consideration of alternative approaches. In this review, we examine the evidence for exercise as an intervention for anxiety disorders. This evidence comes from population studies, studies of nonclinical anxiety reduction, as well as a limited number of studies of clinically anxious individuals. All of these studies provide converging evidence for consistent beneficial effects of exercise on anxiety, and are consistent with a variety of accounts of the mechanism of anxiety reduction with exercise. Further study of clinical populations is encouraged, as are studies of the mechanism of change of exercise interventions, which have the potential to help refine exercise intervention strategies. Likewise, studies that identify moderators of treatment efficacy will assist clinicians in deciding how and for whom to prescribe exercise. PMID:23002943

Clinical and neurobiological effects of aerobic exercise in dental phobia: A randomized controlled trial.

PubMed

Lindenberger, Brigitt L; Plag, Jens; Schumacher, Sarah; Gaudlitz, Katharina; Bischoff, Sophie; Bobbert, Thomas; Dimeo, Fernando; Petzold, Moritz B; Kirschbaum, Clemens; Dudás, Zsuzsa; Ströhle, Andreas

2017-11-01

Physical activity has shown to be effective in anxiety disorders. For specific phobia, no studies are available that systematically examined the effects of an aerobic exercise intervention on phobic fear within a randomized-controlled design. Therefore, we investigated the acute effect of a standardized aerobic training on clinical symptoms of dental phobia as well as on stress-related neurobiological markers. Within a crossover design, 30 patients with dental phobia (mean age: 34.1 years; mean score of the Dental Anxiety Scale: 18.8) underwent two minor dental interventions separated by 7 days. Dental treatment was performed after 30 min of physical activity at either 20% VO 2 max (control) or 70% VO 2 max (intervention), respectively. To control for habituation, patients were randomly assigned to one of the two conditions prior to the first intervention. Moreover, saliva samples were collected at five times in order to determine changes in salivary cortisol (sC) and alpha-amylase (sAA) due to treatment. In comparison to baseline, aerobic exercise within 70% VO 2 max significantly reduced clinical anxiety and sC concentrations before, during, and after the dental treatment. In contrast, the control condition led to decreased sAA levels at different time points of measurement. Habituation occurred at the second study day, independent of the order. Our study provides evidence for an effect of moderate-intense exercise on clinical symptoms and sC in patients with dental phobia. Therefore, acute aerobic exercise might be a simple and low-cost intervention to reduce disorder-specific phobic fear. © 2017 Wiley Periodicals, Inc.

Intervention Fidelity: Aspects of Complementary and Alternative Medicine (CAM) Research

PubMed Central

Wyatt, Gwen; Sikorskii, Alla; Rahbar, Mohammad Hossein; Victorson, David; Adams, Lora

2010-01-01

Background The Treatment Fidelity Workgroup (TFW) established by the National Institutes of Health (NIH) provides a 5-point structure for intervention fidelity: dosing, interventionists’ consistency, intervention delivery, receipt and enactment of the intervention. Using our reflexology trial, we apply the first three points. Objectives Study objectives are to: 1) evaluate key dosage dimensions associated with CAM research; 2) evaluate approaches to interventionists’ consistency of delivery of CAM protocols; and 3) evaluate and discuss data that reflect CAM intervention fidelity. Intervention Women with late stage breast cancer (N=318) were randomly assigned to either 4 weeks of reflexology, placebo, or standard care. Results Dosing consists of three dimensions: frequency (4-sessions), duration (30 minutes), and interval between sessions (5–9 days). Interventionist consistency revealed over a 90% accuracy rate in following the protocol; 84% and 89% completion rate of the 4 session in the reflexology and placebo groups respectively; and no differences in attrition after randomization between reflexology and placebo groups (17% and 15%, respectively). Intervention delivery, examined through debriefing data, indicated a significantly higher rate of correct guesses on group assignment in the reflexology group as compared to the placebo (82% versus 46%, p-value=.0002). Conclusions This study points out the relevance of dosing, interventionists’ consistency, and delivery data within a CAM clinical trial, as well as the challenges of blinding. Implications Monitoring intervention fidelity by using the key areas identified by the BCC ensures that findings from a clinical trial are meaningful and have the potential to be translated to clinical practice. PMID:20467309

Clinical and cost outcomes of multifactorial, cardiovascular risk management interventions in worksites: a comprehensive review and analysis.

PubMed

Pelletier, K R

1997-12-01

This paper is a critical review of the clinical and cost outcome evaluation studies of multifactorial, comprehensive, cardiovascular risk management programs in worksites. A comprehensive international literature search conducted under the auspices of the National Heart, Lung and Blood Institute identified 17 articles based on 12 studies that examined the clinical outcomes of multifactorial, comprehensive programs. These articles were identified through MEDLINE, manual searches of recent journals, and through direct inquiries to worksite health promotion researchers. All studies were conducted between 1978 and 1995, with 1978 being the date of the first citation of a methodologically rigorous evaluation. Of the 12 research studies, only 8 utilized the worksite as both the unit of assignment and as the unit of analysis. None of the studies analyzed adequately for cost effectiveness. Given this limitation, this review briefly considers the relevant worksite research that has demonstrated cost outcomes. Worksite-based, multifactorial cardiovascular intervention programs reviewed for this article varied widely in the comprehensiveness, intensity, and duration of both the interventions and evaluations. Results from randomized trials suggest that providing opportunities for individualized, cardiovascular risk reduction counseling for high-risk employees within the context of comprehensive programming may be the critical component of an effective worksite intervention. Despite the many limitations of the current methodologies of the 12 studies, the majority of the research to date indicates the following: (1) favorable clinical and cost outcomes; (2) that more recent and more rigorously designed research tends to support rather than refute earlier and less rigorously designed studies; and (3) that rather than interpreting the methodological flaws and diversity as inherently negative, one may consider it as indicative of a robust phenomena evident in many types of worksites, with diverse employees, differing interventions, and varying degrees of methodological sophistication. Results of these studies reviewed provide both cautious optimism about the effectiveness of these worksite programs and insights regarding the essential components and characteristics of successful programs.

Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial.

PubMed

Russell, Lahiru; Ugalde, Anna; Milne, Donna; Krishnasamy, Meinir; O Seung Chul, Eric; Austin, David W; Chambers, Richard; Orellana, Liliana; Livingston, Patricia M

2018-04-13

People with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant in this group of patients and, if not addressed, can lead to distress. Mindfulness-based interventions have been shown to alleviate symptoms of anxiety and depression among various groups of cancer patients. Online mindfulness-based interventions have the potential to reach people unable to attend face-to-face interventions due to limitations such as cancer-related illness, transportation or time constraints. This study aims to (1) examine whether individuals with a melanoma diagnosis are willing to participate and adhere to a 6-week online mindfulness-based intervention and (2) explore potential benefits of the program on fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness to inform the design of a clinical trial. This is a single-site randomised controlled trial of a feasibility study. Seventy-five participants with stage 2c or 3 melanoma will be recruited from a melanoma outpatient clinic and randomised (2:1) either to an online mindfulness-based program (intervention) or to usual care (control). The intervention is a 6-week program specifically developed for this study. It consists of videos describing the concept of mindfulness, short daily guided meditation practices (5-10 min), automated meditation reminders and instructions for applying mindfulness in daily life to enhance wellbeing. All participants will complete questionnaires at baseline and at 6-week post-randomisation. Participants in the control group will be given access to the online program at the end of the study. Primary outcomes are overall recruitment; retention; extent of questionnaire completion; and usability and acceptability of, and adherence to, the program. The secondary outcomes are fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness measured using validated instruments. This feasibility study will evaluate participants' satisfaction with the program and identify barriers to recruitment and adherence. The recruitment and data collection process will highlight methodological aspects to address in the planning of a larger scale study assessing the impact of an online mindfulness-based intervention on fear of cancer recurrence and wellbeing. Australian New Zealand Clinical Trials Registry, ACTRN12617000081314 . Registered on 16 January 2017.

Sudden cardiac death in haemodialysis: clinical epidemiology and mechanisms.

PubMed

Banerjee, Debasish

Sudden cardiac death, which causes premature loss of lives on haemodialysis of the elderly, youths and even children; cannot be prevented, because the aetiology is poorly understood and effective interventions are yet unknown. Improving our knowledge of mechanisms causing sudden cardiac death in haemodialysis patients may help us to design better interventions; and clinical epidemiology of sudden cardiac death could be an important tool to further guide human and animal studies. This review researches the clinical epidemiology of sudden cardiac death to suggest possible mechanisms, although they require further studies. The research shows how traditional cardiovascular risk factors such as age, diabetes and smoking have an impact; non-traditional risk factors such as inflammation, mineral-bone disease and even uraemia itself have higher impact; and how cardiac structural, functional and electrocardiographic markers predict sudden cardiac death in dialysis patients. More in-depth human and animal studies, guided with existing knowledge, are necessary to better understand the mechanisms and design successful interventions. Copyright © 2016 Elsevier Inc. All rights reserved.

Prevalence of intradialytic hypotension, clinical symptoms and nursing interventions--a three-months, prospective study of 3818 haemodialysis sessions.

PubMed

Kuipers, Johanna; Oosterhuis, Jurjen K; Krijnen, Wim P; Dasselaar, Judith J; Gaillard, Carlo A J M; Westerhuis, Ralf; Franssen, Casper F M

2016-02-27

Intradialytic hypotension (IDH) is considered one of the most frequent complications of haemodialysis with an estimated prevalence of 20-50 %, but studies investigating its exact prevalence are scarce. A complicating factor is that several definitions of IDH are used. The goal of this study was, to assess the prevalence of IDH, primarily in reference to the European Best Practice Guideline (EBPG) on haemodynamic instability: A decrease in systolic blood pressure (SBP) ≥20 mmHg or in mean arterial pressure (MAP) ≥10 mmHg associated with a clinical event and the need for nursing intervention. During 3 months we prospectively collected haemodynamic data, clinical events, and nursing interventions of 3818 haemodialysis sessions from 124 prevalent patients who dialyzed with constant ultrafiltration rate and dialysate conductivity. Patients were considered as having frequent IDH if it occurred in >20 % of dialysis sessions. Decreases in SBP ≥20 mmHg or MAP ≥10 mmHg occurred in 77.7 %, clinical symptoms occurred in 21.4 %, and nursing interventions were performed in 8.5 % of dialysis sessions. Dialysis hypotension according to the full EBPG definition occurred in only 6.7 % of dialysis sessions. Eight percent of patients had frequent IDH. The prevalence of IDH according to the EBPG definition is low. The dominant determinant of the EBPG definition was nursing intervention since this was the component with the lowest prevalence. IDH seems to be less common than indicated in the literature but a proper comparison with previous studies is complicated by the lack of a uniform definition.

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.

[Consensus on nursing diagnoses, interventions and outcomes for home care of patients with heart failure].

PubMed

Azzolin, Karina; de Souza, Emiliane Nogueira; Ruschel, Karen Brasil; Mussi, Cláudia Motta; de Lucena, Amália Fátima; Rabelo, Eneida Rejane

2012-12-01

This was a consensus study with six cardiology nurses with the objective of selecting nursing diagnoses, outcomes and interventions described by NANDA International (NANDA-I), Nursing Outcomes Classification (NOC), Nursing Intervention Classification (NIC), for home care of patients with heart failure (HF). Eight nursing diagnoses (NDs) were pre-selected and a consensus was achieved in three stages, during which interventions/activities and outcomes/indicators of each NDs were validated and those considered valid obtained 70% to 100% consensus. From the eight pre-selected NDs, two were excluded due to the lack of consensus on appropriate interventions for the clinical home care scenario. Eleven interventions were selected from a total of 96 pre-selected ones and seven outcomes were validated out of 71. The practice of consensus among expert nurses provides assistance to the qualifications of the care process and deepens the knowledge about the use of tazonomies in nursing clinical practice.

Systematic Review and Meta-analysis of the Effectiveness of Implementation Strategies for Non-communicable Disease Guidelines in Primary Health Care.

PubMed

Kovacs, Eva; Strobl, Ralf; Phillips, Amanda; Stephan, Anna-Janina; Müller, Martin; Gensichen, Jochen; Grill, Eva

2018-05-04

As clinical practice guidelines represent the most important evidence-based decision support tool, several strategies have been applied to improve their implementation into the primary health care system. This study aimed to evaluate the effect of intervention methods on the guideline adherence of primary care providers (PCPs). The studies selected through a systematic search in Medline and Embase were categorised according to intervention schemes and outcome indicator categories. Harvest plots and forest plots were applied to integrate results. The 36 studies covered six intervention schemes, with single interventions being the most effective and distribution of materials the least. The harvest plot displayed 27 groups having no effect, 14 a moderate and 21 a strong effect on the outcome indicators in the categories of knowledge transfer, diagnostic behaviour, prescription, counselling and patient-level results. The forest plot revealed a moderate overall effect size of 0.22 [0.15, 0.29] where single interventions were more effective (0.27 [0.17, 0.38]) than multifaceted interventions (0.13 [0.06, 0.19]). Guideline implementation strategies are heterogeneous. Reducing the complexity of strategies and tailoring to the local conditions and PCPs' needs may improve implementation and clinical practice.

Metabolism and catabolism in hip fracture patients: nutritional and anabolic intervention--a review.

PubMed

Hedström, Margareta; Ljungqvist, Olle; Cederholm, Tommy

2006-10-01

Patients suffering from hip fracture are known to be at risk of catabolism and protein-energy malnutrition. In this review we discuss the pathogenesis of hip fracture-related catabolism per- and postoperatively. We also describe the consequences of malnutrition after a hip fracture and summarize studies that have evaluated the effect of nutritional or anabolic treatment of these patients. There has been relatively little published on the effects of nutritional and anabolic pharmacological interventions for improvement of nutritional status and on the role of nutritional status in clinical outcomes. Even so, there have been 19 randomized studies in this field. 12 studies evaluated nutritional supplementation or protein supplementation. 6 found improved clinical outcome with fewer complications, faster recovery and shorter length of hospital stay, whereas the others reported no difference in clinical outcome. For pharmacological interventions, the outcomes have been even less clear. Supplementation studies in general appear to be underpowered or suffer logistic problems. Studies of higher scientific quality are needed, and enteral feeding, anabolic treatment and multimodal approaches need to be evaluated in greater depth.

A combination SMS and transportation reimbursement intervention to improve HIV care following abnormal CD4 test results in rural Uganda: a prospective observational cohort study.

PubMed

Siedner, Mark J; Santorino, Data; Lankowski, Alexander J; Kanyesigye, Michael; Bwana, Mwebesa B; Haberer, Jessica E; Bangsberg, David R

2015-07-06

Up to 50 % of HIV-infected persons in sub-Saharan Africa are lost from care between HIV diagnosis and antiretroviral therapy (ART) initiation. Structural barriers, including cost of transportation to clinic and poor communication systems, are major contributors. We conducted a prospective, pragmatic, before-and-after clinical trial to evaluate a combination mobile health and transportation reimbursement intervention to improve care at a publicly operated HIV clinic in Uganda. Patients undergoing CD4 count testing were enrolled, and clinicians selected a result threshold that would prompt early return for ART initiation or further care. Participants enrolled in the pre-intervention period (January - August 2012) served as a control group. Participants in the intervention period (September 2012 - November 2013) were randomized to receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading "ABCDEFG" to confidentially convey an abnormal result. Participants returning within seven days of their first message received transportation reimbursements (about $6USD). Our primary outcomes of interest were time to return to clinic and time to ART initiation. There were 45 participants in the pre-intervention period and 138 participants in the intervention period (46, 49, and 43 in the direct, PIN, and coded groups, respectively) with low CD4 count results. Median time to clinic return was 33 days (IQR 11-49) in the pre-intervention period and 6 days (IQR 3-16) in the intervention period (P < 0.001); and median time to ART initiation was 47 days (IQR 11-75) versus 12 days (IQR 5-19), (P < 0.001). In multivariable models, participants in the intervention period had earlier return to clinic (AHR 2.32, 95 %CI 1.53 to 3.51) and earlier time to ART initiation (AHR 2.27, 95 %CI 1.38 to 3.72). All three randomized message formats improved time to return to clinic and time to ART initiation (P < 0.01 for all comparisons versus the pre-intervention period). A combination of an SMS laboratory result communication system and transportation reimbursements significantly decreased time to clinic return and time to ART initiation after abnormal CD4 test results. Clinicaltrials.gov NCT01579214 , approved 13 April 2012.

Patterns of User Engagement with Mobile- and Web-Delivered Self-Care Interventions for Adults with T2DM: A Review of the Literature.

PubMed

Nelson, Lyndsay A; Coston, Taylor D; Cherrington, Andrea L; Osborn, Chandra Y

2016-07-01

Technology-delivered interventions can improve the health behaviors and clinical outcomes of persons with diabetes, but only if end users engage with these interventions. To summarize the current knowledge on engagement with technology-based interventions, we conducted a review of recent mobile- and web-delivered intervention studies for adults with type 2 diabetes published from 2011 to 2015. Among 163 identified studies, 24 studies satisfied our inclusion criteria. There was substantial variation in how intervention engagement was reported across studies. Engagement rates were lower among interventions with a longer duration, and engagement decreased over time. In several studies, older age and lower health literacy were associated with less engagement, and more engagement was associated with intervention improvement in at least one outcome, including glycemic control. Future technology-based intervention studies should report on engagement, examine and report on associations between user characteristics and engagement, and aim to standardize how this is reported, particularly in longer trials.