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Background: This study is to identify, summarise and synthesise literature on the causes of the evidence to practice gap for complex interventions in primary care.Design: This study is a systematic review of reviews.Methods: MEDLINE, EMBASE, CINAHL, Cochrane Library and PsychINFO were searched, from inception to December 2013. Eligible reviews addressed causes of the evidence to practice gap in primary care in developed countries. Data from included reviews were extracted and synthesised using guidelines for meta-synthesis.Results: Seventy reviews fulfilled the inclusion criteria and encompassed a wide range of topics, e.g. guideline implementation, integration of new roles, technology implementation, public health and preventative medicine. None of the included papers used the term "cause" or stated an intention to investigate causes at all. A descriptive approach was often used, and the included papers expressed "causes" in terms of "barriers and facilitators" to implementation. We developed a four-level framework covering external context, organisation, professionals and intervention. External contextual factors included policies, incentivisation structures, dominant paradigms, stakeholders' buy-in, infrastructure and advances in technology. Organisation-related factors included culture, available resources, integration with existing processes, relationships, skill mix and staff involvement. At the level of individual professionals, professional role, underlying philosophy of care and competencies were important. Characteristics of the intervention that impacted on implementation included evidence of benefit, ease of use and adaptability to local circumstances. We postulate that the "fit" between the intervention and the context is critical in determining the success of implementation.Conclusions: This comprehensive review of reviews summarises current knowledge on the barriers and facilitators to implementation of diverse complex interventions in primary care. To maximise the uptake of complex interventions in primary care, health care professionals and commissioning organisations should consider the range of contextual factors, remaining aware of the dynamic nature of context. Future studies should place an emphasis on describing context and articulating the relationships between the factors identified here.Systematic Review Registration: PROSPERO CRD42014009410. [ABSTRACT FROM AUTHOR]

Background: The handling of laboratory, imaging and other test results in UK general practice is a high-volume organisational routine that is both complex and high risk. Previous research in this area has focused on errors and harm, but a complementary approach is to better understand how safety is achieved in everyday practice. This paper ethnographically examines the role of informal dimensions of test results handling routines in the achievement of safety in UK general practice and how these findings can best be developed for wider application by policymakers and practitioners.Methods: Non-participant observation was conducted of high-volume organisational routines across eight UK general practices with diverse organisational characteristics. Sixty-two semi-structured interviews were also conducted with the key practice staff alongside the analysis of relevant documents.Results: While formal results handling routines were described similarly across the eight study practices, the everyday structure of how the routine should be enacted in practice was informally understood. Results handling safety took a range of local forms depending on how different aspects of safety were prioritised, with practices varying in terms of how they balanced thoroughness (i.e. ensuring the high-quality management of results by the most appropriate clinician) and efficiency (i.e. timely management of results) depending on a range of factors (e.g. practice history, team composition). Each approach adopted created its own potential risks, with demands for thoroughness reducing productivity and demands for efficiency reducing handling quality. Irrespective of the practice-level approach adopted, staff also regularly varied what they did for individual patients depending on the specific context (e.g. type of result, patient circumstances).Conclusions: General practices variably prioritised a legitimate range of results handling safety processes and outcomes, each with differing strengths and trade-offs. Future safety improvement interventions should focus on how to maximise practice-level knowledge and understanding of the range of context-specific approaches available and the safeties and risks inherent in each within the context of wider complex system conditions and interactions. This in turn has the potential to inform new kinds of proactive, contextually appropriate approaches to intervention development and implementation focusing on the enhanced deliberation of the safety of existing high-volume routines. [ABSTRACT FROM AUTHOR]

Background: Despite strong evidence giving guidance for effective fall prevention interventions in community-residing older people, there is currently no clear model for engaging general medical practitioners in fall prevention and routine use of allied health professionals in fall prevention has been slow, limiting widespread dissemination. This protocol paper outlines an implementation-effectiveness study of the Integrated Solutions for Sustainable Fall Prevention (iSOLVE) intervention which has developed integrated processes and pathways to identify older people at risk of falls and engage a whole of primary care approach to fall prevention.Methods/design: This protocol paper presents the iSOLVE implementation processes and change strategies and outlines the study design of a blended type 2 hybrid design. The study consists of a two-arm cluster randomized controlled trial in 28 general practices and recruiting 560 patients in Sydney, Australia, to evaluate effectiveness of the iSOLVE intervention in changing general practitioner fall management practices and reducing patient falls and the cost effectiveness from a healthcare funder perspective. Secondary outcomes include change in medications known to increase fall risk. We will simultaneously conduct a multi-methodology evaluation to investigate the workability and utility of the implementation intervention. The implementation evaluation includes in-depth interviews and surveys with general practitioners and allied health professionals to explore acceptability and uptake of the intervention, the coherence of the proposed changes for those in the work setting, and how to facilitate the collective action needed to implement changes in practice; social network mapping will explore professional relationships and influences on referral patterns; and, a survey of GPs in the geographical intervention zone will test diffusion of evidence-based fall prevention practices. The project works in partnership with a primary care health network, state fall prevention leaders, and a community of practice of fall prevention advocates.Discussion: The design is aimed at providing clear direction for sustainability and informing decisions about generalization of the iSOLVE intervention processes and change strategies. While challenges exist in hybrid designs, there is a potential for significant outcomes as the iSOLVE pathways project brings together practice and research to collectively solve a major national problem with implications for policy service delivery.Trial Registration: Australian New Zealand Clinial Trials Registry ACTRN12615000401550. [ABSTRACT FROM AUTHOR]

Background: Two to 4% of emergency hospital admissions are caused by preventable adverse drug events. The estimated costs of such avoidable admissions in England were £530 million in 2015. The data-driven quality improvement in primary care (DQIP) intervention was designed to prompt review of patients vulnerable from currently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and anti-platelets and was found to be effective at reducing this prescribing. A process evaluation was conducted parallel to the trial, and this paper reports the analysis which aimed to explore response to the intervention delivered to clusters in relation to participants' perceptions about which intervention elements were active in changing their practice.Methods: Data generation was by in-depth interview with key staff exploring participant's perceptions of the intervention components. Analysis was iterative using the framework technique and drawing on normalisation process theory.Results: All the primary components of the intervention were perceived as active, but at different stages of implementation: financial incentives primarily supported recruitment; education motivated the GPs to initiate implementation; the informatics tool facilitated sustained implementation. Participants perceived the primary components as interdependent. Intervention subcomponents also varied in whether and when they were active. For example, run charts providing feedback of change in prescribing over time were ignored in the informatics tool, but were motivating in some practices in the regular e-mailed newsletter. The high-risk NSAID and anti-platelet prescribing targeted was accepted as important by all interviewees, and this shared understanding was a key wider context underlying intervention effectiveness.Conclusions: This was a novel use of process evaluation data which examined whether and how the individual intervention components were effective from the perspective of the professionals delivering changed care to patients. These findings are important for reproducibility and roll-out of the intervention.Trial Registration: ClinicalTrials.gov, NCT01425502 . [ABSTRACT FROM AUTHOR]

Background: Effective implementation strategies might facilitate patient-centered medical home (PCMH) uptake and spread by targeting barriers to change. Evidence-based quality improvement (EBQI) is a multi-faceted implementation strategy that is based on a clinical-researcher partnership. It promotes organizational change by fostering innovation and the spread of those innovations that are successful. Previous studies demonstrated that EBQI accelerated PCMH adoption within Veterans Health Administration primary care practices, compared with standard PCMH implementation. Research to date has not documented fidelity to the EBQI implementation strategy, limiting usefulness of prior research findings. This paper develops and assesses clinical participants' fidelity to three core EBQI elements for PCMH (EBQI-PCMH), explores the relationship between fidelity and successful QI project completion and spread (the outcome of EBQI-PCMH), and assesses the role of the clinical-researcher partnership in achieving EBQI-PCMH fidelity.Methods: Nine primary care practice sites and seven across-sites, topic-focused workgroups participated (2010-2014). Core EBQI elements included leadership-frontlines priority-setting for QI, ongoing access to technical expertise, coaching, and mentoring in QI methods (through a QI collaborative), and data/evidence use to inform QI. We used explicit criteria to measure and assess EBQI-PCMH fidelity across clinical participants. We mapped fidelity to evaluation data on implementation and spread of successful QI projects/products. To assess the clinical-researcher partnership role in EBQI-PCMH, we analyzed 73 key stakeholder interviews using thematic analysis.Results: Seven of 9 sites and 3 of 7 workgroups achieved high or medium fidelity to leadership-frontlines priority-setting. Fidelity was mixed for ongoing technical expertise and data/evidence use. Longer duration in EBQI-PCMH and higher fidelity to priority-setting and ongoing technical expertise appear correlated with successful QI project completion and spread. According to key stakeholders, partnership with researchers, as well as bi-directional communication between leaders and QI teams and project management/data support were critical to achieving EBQI-PCMH fidelity.Conclusions: This study advances implementation theory and research by developing measures for and assessing fidelity to core EBQI elements in relationship to completion and spread of QI innovation projects or tools for addressing PCMH challenges. These results help close the gap between EBQI elements, their intended outcome, and the finding that EBQI-PCMH resulted in accelerated adoption of PCMH. [ABSTRACT FROM AUTHOR]

Background High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices. Methods The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: + educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study. Results Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2x). Conclusions The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings. Trial registration ClinicalTrials.gov: NCT01602705 [ABSTRACT FROM AUTHOR]

Background: 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.Methods: 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.Results: 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.Conclusions: 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.Trial Registration: ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015. [ABSTRACT FROM AUTHOR]

Background: We developed and evaluated a tailored programme to implement three evidence-based recommendations for multimorbid patients with polypharmacy into primary care practices: structured medication counselling including brown bag reviews, the use of medication lists and medication reviews. No effect on the primary outcome was found. This process evaluation aimed to identify factors associated with outcomes by exploring nine hypotheses specified in the logic model of the tailored programme.Methods: The tailored programme was developed with respect to identified determinants of practice and consisted of a workshop for practice teams, elaboration of implementation action plans, aids for medication reviews, a multilingual info-tool for patients on a tablet PC, posters and brown paper bags as reminders for patients. The tailored programme was evaluated in a cluster randomized trial. The process evaluation was based on various data sources: interviews with general practitioners and medical assistants of the intervention group and a survey with general practitioners of the intervention and control group, written reports on the implementation action plans, documentation forms for structured medication counselling and the log file of the info-tool.Results: We analyzed 12 interviews, 21 questionnaires, 120 documentation forms for medication counselling, 5 implementation action plans and one log file of the info-tool. The most frequently reported effect of the tailored programme was the increase of awareness for the health problem and the recommendations, while implementation of routine processes was only reported for structured medication counselling. The survey largely confirmed the usefulness of the applied strategies, yet the interviews provided a more detailed understanding of the actual use of the strategies and several suggestions for modifications of the tailored programme.Conclusions: The tailored programme seemed to have induced awareness as a first step of behaviour change. Several modifications of the tailored programme may enhance its effectiveness such as conducting outreach visits instead of a workshop, improved targeting, provision of evidence, integration of tools into the practice software and information materials in tailored formats.Trial Registration: This study is linked to an outcome evaluation study with the registration ISRCTN34664024 , assigned 14/08/2013. [ABSTRACT FROM AUTHOR]

Background: Although there is evidence that tailored implementation strategies can be effective, there is little evidence on which methods of tailoring improve the effect. We designed and evaluated five tailored programs (TPs) each consisting of various strategies. The aim of this study was to examine (a) how determinants of practice prioritized in the design phase of the TPs were perceived by health care professionals who had been exposed to the TPs and whether they suggested other important determinants of practice and (b) how professionals used the offered strategies and whether they suggested other strategies that might have been more effective.Methods: We conducted a mixed-method process evaluation linked to five cluster-randomized trials carried out in five European countries to implement recommendations for five chronic conditions in primary care settings. The five TPs used a total of 28 strategies which aimed to address 38 determinants of practice. Interviews of professionals in the intervention groups and a survey of professionals in the intervention and control groups were performed. Data collection was conducted by each research team in the respective national language. The interview data were first analyzed inductively by each research team, and subsequently, a meta-synthesis was conducted. The survey was analyzed descriptively.Results: We conducted 71 interviews; 125 professionals completed the survey. The survey showed that 76 % (n = 29) of targeted determinants of practice were perceived as relevant and 95 % (n = 36) as being modified by the implementation interventions by 66 to 100 % of professionals. On average, 47 % of professionals reported using the strategies and 51 % considered them helpful, albeit with substantial variance between countries and strategies. In the interviews, 89 determinants of practice were identified, of which 70 % (n = 62) had been identified and 45 % (n = 40) had been prioritized in the design phase. The interviewees suggested 65 additional strategies, of which 54 % (n = 35) had been identified and 20 % (n = 13) had been prioritized, but not selected in the final programs.Conclusions: This study largely confirmed the perceived relevance of the targeted determinants of practice. This contrasts with the fact that no impact of the trials on the implementation of the recommendations could be observed. The findings suggest that better methods for prioritization of determinants and strategies are needed.Trial Registration: Each of the five trials was registered separately in recognized trial registries. Details are given in the respective trial outcome papers. [ABSTRACT FROM AUTHOR]

Background: Despite substantial evidence for physical activity (PA) as a management option for type 2 diabetes, there remains a lack of PA behavioural interventions suitable for delivery in primary care. This paper describes the systematic development of an evidence-informed PA behavioural intervention for use during routine primary care consultations.Methods: In accordance with the Medical Research Council Framework for the Development and Evaluation of Complex Interventions, a four-stage systematic development process was undertaken: (1) exploratory work involving interviews and workshop discussions identified training needs of healthcare professionals and support needs of adults with type 2 diabetes; (2) a systematic review with meta- and moderator analyses identified behaviour change techniques and optimal intervention intensity and duration; (3) usability testing identified strategies to increase implementation of the intervention in primary care and (4) an open pilot study in two primary care practices facilitated intervention optimisation.Results: Healthcare professional training needs included knowledge about type, intensity and duration of PA sufficient to improve glycaemic control and acquisition of skills to promote PA behaviour change. Patients lacked knowledge about type 2 diabetes and skills to enable them to make sustainable changes to their level of PA. An accredited online training programme for healthcare professionals and a professional-delivered behavioural intervention for adults with type 2 diabetes were subsequently developed. This multifaceted intervention was informed by the theory of planned behaviour and social cognitive theory and consisted of 15 behaviour change techniques. Intervention intensity and duration were informed by a systematic review. Usability testing resolved technical problems with the online training intervention that facilitated use on practice IT systems. An open pilot study of the intervention with fidelity of delivery assessment informed optimisation and identified mechanisms to enhance implementation of the intervention during routine diabetes consultations.Conclusions: Movement as Medicine for Type 2 diabetes represents an evidence-informed multifaceted behavioural intervention targeting PA for management of type 2 diabetes developed for delivery in primary care. The structured development process undertaken enhances transparency of intervention content, replicability and scalability. Movement as Medicine for Type 2 diabetes is currently undergoing evaluation in a pilot RCT.Trial Registration: ISRCTN67997502. [ABSTRACT FROM AUTHOR]

Background: The Agency for Healthcare Research and Quality (AHRQ) launched the EvidenceNOW Initiative to rapidly disseminate and implement evidence-based cardiovascular disease (CVD) preventive care in smaller primary care practices. AHRQ funded eight grantees (seven regional Cooperatives and one independent national evaluation) to participate in EvidenceNOW. The national evaluation examines quality improvement efforts and outcomes for more than 1500 small primary care practices (restricted to those with fewer than ten physicians per clinic). Examples of external support include practice facilitation, expert consultation, performance feedback, and educational materials and activities. This paper describes the study protocol for the EvidenceNOW national evaluation, which is called Evaluating System Change to Advance Learning and Take Evidence to Scale (ESCALATES).Methods: This prospective observational study will examine the portfolio of EvidenceNOW Cooperatives using both qualitative and quantitative data. Qualitative data include: online implementation diaries, observation and interviews at Cooperatives and practices, and systematic assessment of context from the perspective of Cooperative team members. Quantitative data include: practice-level performance on clinical quality measures (aspirin prescribing, blood pressure and cholesterol control, and smoking cessation; ABCS) collected by Cooperatives from electronic health records (EHRs); practice and practice member surveys to assess practice capacity and other organizational and structural characteristics; and systematic tracking of intervention delivery. Quantitative, qualitative, and mixed methods analyses will be conducted to examine how Cooperatives organize to provide external support to practices, to compare effectiveness of the dissemination and implementation approaches they implement, and to examine how regional variations and other organization and contextual factors influence implementation and effectiveness.Discussion: ESCALATES is a national evaluation of an ambitious large-scale dissemination and implementation effort focused on transforming smaller primary care practices. Insights will help to inform the design of national health care practice extension systems aimed at supporting practice transformation efforts in the USA.Clinical Trial Registration: NCT02560428 (09/21/15). [ABSTRACT FROM AUTHOR]

Background: Only 7.8 % of individuals meeting diagnostic criteria for alcohol use disorder (AUD) receive treatment in a given year. Most individuals with AUDs are identified in primary care (PC) settings and referred to substance use disorders (SUD) clinics; however, only a minority of those referred attend treatment services. Safe and effective pharmacological treatments for AUD exist, but they are rarely prescribed by PC providers. The objective of this study is to refine, implement, and evaluate an intervention to integrate pharmacological AUD treatment options into PC settings. This paper provides a detailed description of the intervention design and the evaluation components.Methods/design: Three large Veterans Health Administration (VHA) facilities are participating in the intervention. The intervention targets stakeholder groups with tailored strategies based on implementation theory and prior research identifying barriers to implementation of AUD pharmacotherapy. Local SUD providers and primary care mental health integration (PCMHI) providers are trained to serve as local implementation/clinical champions and receive external facilitation. PC providers receive access to consultation from local and national clinical champions, educational materials, and a dashboard of patients with AUD on their caseloads for case identification. Veterans with AUD diagnoses receive educational information in the mail just prior to a scheduled PC visit. Effectiveness of the intervention will be evaluated through an interrupted time series with matched controls to monitor change in facility level AUD pharmacotherapy prescribing rates. Following Stetler's four-phase formative evaluation (FE) strategy, FE methods include (1) developmental FE (pre-implementation interviews with champions, PC providers, and Veterans), (2) implementation-focused FE (tracking attendance at facilitation meetings, academic detailing efforts by local champions, and patient dashboard utilization), (3) progress-focused FE (tracking rates of AUD pharmacotherapy prescribing and rates of referral to PCMHI and SUD specialty care), and (4) interpretive FE (post-implementation interviews with champions and PC providers). Analysis of FE data will be guided by the Consolidated Framework for Implementation Research (CFIR).Discussion: If demonstrated to be successful, this implementation strategy will provide a replicable, feasible, and relative low-cost method for integrating AUD treatment services into PC settings, thereby increasing access to AUD treatment. [ABSTRACT FROM AUTHOR]

Background: Laboratory testing is an integral part of day-to-day primary care practice, with approximately 30 % of patient encounters resulting in a request. However, research suggests that a large proportion of requests does not benefit patient care and is avoidable. The aim of this systematic review was to comprehensively search the literature for studies evaluating the effectiveness of interventions to improve primary care physician use of laboratory tests.Methods: A search of PubMed, Cochrane Library, Embase and Scopus (from inception to 09/02/14) was conducted. The following study designs were considered: systematic reviews, randomised controlled trials (RCTs), controlled clinical trials (CCTs), controlled before and after studies (CBAs) and interrupted time series analysis (ITSs). Studies were quality appraised using a modified version of the Effective Practice and Organisation of Care (EPOC) checklist. The population of interest was primary care physicians. Interventions were considered if they aimed to improve laboratory testing in primary care. The outcome of interest was a volume of laboratory tests.Results: In total, 6,166 titles and abstracts were reviewed, followed by 87 full texts. Of these, 11 papers were eligible for inclusion in the systematic review. This included four RCTs, six CBAs and one ITS study. The types of interventions examined included education, feedback, guidelines, education with feedback, feedback with guidelines and changing order forms. The quality of included studies varied with seven studies deemed to have a low risk of bias, three with unclear risk of bias and one with high risk of bias. All but one study found significant reductions in the volume of tests following the intervention, with effect sizes ranging from 1.2 to 60 %. Due to heterogeneity, meta-analysis was not performed.Conclusions: Interventions such as educational strategies, feedback and changing test order forms may improve the efficient use of laboratory tests in primary care; however, the level of evidence is quite low and the quality is poor. The reproducibility of findings from different laboratories is also difficult to ascertain from the literature. Some standardisation of both interventions and outcome measures is required to enable formal meta-analysis. [ABSTRACT FROM AUTHOR]

Background: Hypertension and diabetes, key risk factors for cardiovascular disease, are significant health problems globally. As cardiovascular disease is one of the leading causes of mortality in Mongolia since 2000, clinical guidelines on arterial hypertension and diabetes were developed and implemented in 2011. This paper explores the barriers and enablers influencing the implementation of these guidelines in the primary care setting.Methods: A phenomenological qualitative study with semi-structured interviews was conducted to explore the implementation of the diabetes and hypertension guidelines at the primary care level, as well as to gain insight into how practitioners view the usability and practicality of the guidelines. Ten family health centres were randomly chosen from a list of all the family health centres (n = 136) located in Ulaanbaatar City. In each centre, a focus group discussion with nurses (n = 20) and individual interviews with practice doctors (n = 10) and practice managers (n = 10) were conducted. Data was analysed using a thematic approach utilising the Theoretical Domains Framework.Results: The majority of the study participants reported being aware of the guidelines and that they had incorporated them into their daily practice. They also reported having attended guideline training sessions which were focused on practice skill development. The majority of participants expressed satisfaction with the wide range of resources that had been supplied to them by the Mongolian Government to assist with the implementation of the guidelines. The resources, supplied from 2011 onwards, included screening devices, equipment for blood tests, medications and educational materials. Other enablers were the participants' commitment and passion for guideline implementation and their belief in the simplicity and practicality of the guidelines. Primary care providers reported a number of challenges in implementing the guidelines, including frustration caused by increased workload and long waiting times, time constraints, difficulties with conflicting tasks and low patient health literacy.Conclusions: This study provides evidence that comprehensive and rigorous dissemination and implementation strategies increase the likelihood of successful implementation of new guidelines in low resource primary care settings. It also offers some key lessons that might be carefully considered when other evidence-based clinical guidelines are to be put into effect in low resource settings and elsewhere. [ABSTRACT FROM AUTHOR]

Background: The use of developmental evaluation is increasing as a method for conducting implementation research. This paper describes the use of developmental evaluation to enhance an ongoing study. The study develops and implements evidence-based clinical guidelines for deprescribing medications in primary care and long-term care settings. A unique feature of our approach is our use of a rapid analytical technique. Methods/Design: The team will carry out two separate analytical processes: first, a rapid analytical process to provide timely feedback to the guideline development and implementation teams, followed by a meta-evaluation and second, a comprehensive qualitative analysis of data after the implementation of each guideline and a final cross-case analysis. Data will be gathered through interviews, through observational techniques leading to the creation of field notes and narrative reports, and through assembling team documents such as meeting minutes. Transcripts and documents will be anonymized and organized in NVIVO by case, by sector (primary care or long-term care), and by implementation site. A narrative case report, directed coding, and open coding steps will be followed. Clustering and theming will generate a model or action map reflecting the functioning of the participating social environments. Discussion: In this study, we will develop three deprescribing guidelines and will implement them in six sites (three family health teams and three long-term care homes), in a sequential iterative manner encompassing 18 implementation efforts. The processes of 11 distinct teams within four conceptual categories will be examined: a guideline priority-setting group, a guideline development methods committee, 3 guideline development teams, and 6 guideline implementation teams. Our methods will reveal the processes used to develop and implement the guidelines, the role and contribution of developmental evaluation in strengthening these processes, and the experience of six sites in implementing new evidence-based clinical guidelines. This research will generate new knowledge about team processes and the uptake and use of deprescribing guidelines in family health teams and long-term care homes, with a goal of addressing polypharmacy in Canada. Clinicians and researchers creating clinical guidelines to introduce improvements into daily practice may benefit from our developmental evaluation approach. [ABSTRACT FROM AUTHOR]

Background Computerized decision support systems (CDSSs) are increasingly used to improve quality of care. There is evidence for moderate to large effects from randomized controlled trials (RCTs), but evidence on their effectiveness when implemented at a national level is lacking. In the Netherlands, the Dutch College of General Practitioners (NHG) initiated their successful guideline program already 30 years ago. NHGDoc, a CDSS based on these NHG guidelines, covering multiple disease areas for general practice, was developed in 2006 with the aim to improve quality of primary care. In this paper, a protocol is presented to evaluate the uptake and effects of NHGDoc. Methods A cluster RCT will be conducted among 120 general practices in the Netherlands. Eligible general practices will be randomized to receive either the regular NHGDoc decision support modules (control arm) or the regular modules plus an additional module on heart failure (intervention arm). The heart failure module consists of patient-specific alerts concerning the treatment of patients with heart failure. The effect evaluation will focus on performance indicators (e.g., prescription behavior) as well as on patient outcomes (e.g., hospital admissions) relevant in the domain of heart failure. Additionally, a process evaluation will be conducted to gain insight into the barriers and facilitators that affect the uptake and impact of NHGDoc. Discussion Results of this study will provide insight in the uptake and impact of a multipledomain covering CDSS for primary care implemented by a national guideline organization to improve the quality of primary care. Whereas the trial focuses on a specific domain of care-heart failure-conclusions of this study will shed light on the functioning of CDSSs covering multiple disease areas for primary care, particularly as this study also explores the factors contributing to the system's uptake and effectiveness. [ABSTRACT FROM AUTHOR]

Background The objectives of this paper are to describe the planned implementation and evaluation of the Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Primary Care (BETTER 2) program which originated from the BETTER trial. The pragmatic trial, informed by the Chronic Care Model, demonstrated the effectiveness of an approach to Chronic Disease Prevention and Screening (CDPS) involving the use of a new role, the prevention practitioner. The desired goals of the program are improved clinical outcomes, reduction in the burden of chronic disease, and improved sustainability of the health-care system through improved CDPS in primary care. Methods/design The BETTER 2 program aims to expand the implementation of the intervention used in the original BETTER trial into communities across Canada (Alberta, Ontario, Newfoundland and Labrador, the Northwest Territories and Nova Scotia). This proactive approach provides atrisk patients with an intervention from the prevention practitioner, a health-care professional. Using the BETTER toolkit, the prevention practitioner determines which CDPS actions the patient is eligible to receive, and through shared decision-making and motivational interviewing, develops a unique and individualized 'prevention prescription' with the patient. This intervention is 1) personalized; 2) addressing multiple conditions; 3) integrated through linkages to local, regional, or national resources; and 4) longitudinal by assessing patients over time. The BETTER 2 program brings together primary care providers, policy/decision makers and researchers to work towards improving CDPS in primary care. The target patient population is adults aged 40-65. The reach, effectiveness, adoption, implementation, maintain (RE-AIM) framework will inform the evaluation of the program through qualitative and quantitative methods. A composite index will be used to quantitatively assess the effectiveness of the prevention practitioner intervention. The CDPS actions comprising the composite index include the following: process measures, referral/treatment measures, and target/change outcome measures related to cardiovascular disease, diabetes, cancer and associated lifestyle factors. Discussion The BETTER 2 program is a collaborative approach grounded in practice and built from existing work (i.e., integration not creation). The program evaluation is designed to provide an understanding of issues impacting the implementation of an effective approach for CDPS within primary care that may be adapted to become sustainable in the non-research setting. [ABSTRACT FROM AUTHOR]

Background Implementation of long-term condition management interventions rests on the notion of whole systems re-design, where incorporating wider elements of health care systems are integral to embedding effective and integrated solutions. However, most self-management support (SMS) evaluations still focus on particular elements or outcomes of a sub-system. A randomised controlled trial of a SMS intervention (WISE-Whole System Informing Selfmanagement Engagement) implemented in primary care showed no effect on patient-level outcomes. This paper reports on a parallel process evaluation to ascertain influences affecting WISE implementation at patient, clinical and organisational levels. Normalisation Process Theory (NPT) provided a sensitising background and analytical framework. Methods A multi-method approach using surveys and interviews with organisational stakeholders, practice staff and trial participants about impact of training and use of tools developed for WISE. Analysis was sensitised by NPT (coherence, cognitive participation, collective action and reflective monitoring). The aim was to identify what worked and what did not work for who and in what context. Results Interviews with organisation stakeholders emphasised top-down initiation of WISE by managers who supported innovation in self-management. Staff from 31 practices indicated engagement with training but patchy adoption of WISE tools; SMS was neither prioritised by practices nor fitted with a biomedically focussed ethos, so little effort was invested in WISE techniques. Interviews with 24 patients indicated no awareness of any changes following the training of practice staff; furthermore, they did not view primary care as an appropriate place for SMS. Conclusion The results contribute to understanding why SMS is not routinely adopted and implemented in primary care. WISE was not embedded because of the perceived lack of relevance and fit to the ethos and existing work. Enacting SMS within primary care practice was not viewed as a legitimate activity or a professional priority. There was failure to, in principle, engage with and identify patients' support needs. Policy presumptions concerning SMS appear to be misplaced. Implementation of SMS within the health service does not currently account for patient circumstances. Primary care priorities and support for SMS could be enhanced if they link to patients' broader systems of implementation networks and resources. [ABSTRACT FROM AUTHOR]

Background: The 'Facilitating Implementation of Research Evidence' study found no significant differences between sites that received two types of facilitation support and those that did not on the primary outcome of documented compliance with guideline recommendations. Process evaluation highlighted factors that influenced local, internal facilitators' ability to enact the roles as envisaged. In this paper, the external facilitators responsible for designing and delivering the two types of facilitation intervention analyse why the interventions proved difficult to implement as expected, including the challenge of balancing fidelity and adaptation.Methods: Qualitative data sources included notes from monthly internal-external facilitator teleconference meetings, from closing events for the two facilitation interventions and summary data analyses from repeated interviews with 16 internal facilitators. Deductive and inductive data analysis was led by an independent researcher to evaluate how facilitation in practice compared to the logic pathways designed to guide fidelity in the delivery of the interventions.Results: The planned facilitation interventions did not work as predicted. Difficulties were encountered in each of the five elements of the logic pathway: recruitment and selection of appropriate internal facilitators, preparation for the role, ability to apply facilitation knowledge and skills at a local level, support and mentorship from external facilitators via monthly teleconferences, working collaboratively and enabling colleagues to implement guideline recommendations. Moreover, problems were cumulative and created tensions for the external facilitators in terms of balancing the logic pathway with a more real-world, flexible and iterative approach to facilitation.Conclusion: Evaluating an intervention that is fluid and dynamic within the methodology of a randomised controlled trial is complex and challenging. At a practical level, relational aspects of facilitation are critically important. It is essential to recruit and retain individuals with the appropriate set of skills and characteristics, explicit support from managerial leaders and accessible mentorship from more experienced facilitators. At a methodological level, there is a need for attention to the balance between fidelity and adaptation of interventions. For future studies, we suggest a theoretical approach to fidelity, with a focus on mechanisms, informed by prospective use of process evaluation data and more detailed investigation of the context-facilitation dynamic. [ABSTRACT FROM AUTHOR]

Background: The US continues to face public health crises related to both chronic pain and opioid overdoses. Thirty percent of Americans suffer from chronic noncancer pain at an estimated yearly cost of over $600 billion. Most patients with chronic pain turn to primary care clinicians who must choose from myriad treatment options based on relative risks and benefits, patient history, available resources, symptoms, and goals. Recently, with attention to opioid-related risks, prescribing has declined. However, clinical experts have countered with concerns that some patients for whom opioid-related benefits outweigh risks may be inappropriately discontinued from opioids. Unfortunately, primary care clinicians lack usable tools to help them partner with their patients in choosing pain treatment options that best balance risks and benefits in the context of patient history, resources, symptoms, and goals. Thus, primary care clinicians and patients would benefit from patient-centered clinical decision support (CDS) for this shared decision-making process.Methods: The objective of this 3-year project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in new clinical settings in the OneFlorida Clinical Research Consortium. Our central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making. We further hypothesize that increases in shared decision making will lead to improved patient outcomes, specifically pain and physical function. The CDS implementation will be guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. The evaluation will be organized by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. We will adapt and tailor PainManager, an open source interoperable CDS tool, for implementation in primary care clinics affiliated with the OneFlorida Clinical Research Consortium. We will evaluate the effect of tailored implementation support on PainManager's adoption for pain treatment shared decision making. This evaluation will establish the feasibility and obtain preliminary data in preparation for a multi-site pragmatic trial targeting the effectiveness of PainManager and tailored implementation support on shared decision making and patient-reported pain and physical function.Discussion: This research will generate evidence on strategies for implementing interoperable CDS in new clinical settings across different types of electronic health records (EHRs). The study will also inform tailored implementation strategies to be further tested in a subsequent hybrid effectiveness-implementation trial. Together, these efforts will lead to important new technology and evidence that patients, clinicians, and health systems can use to improve care for millions of Americans who suffer from pain and other chronic conditions.Trial Registration: ClinicalTrials.gov, NCT05256394 , Registered 25 February 2022. [ABSTRACT FROM AUTHOR]

Background: Audit and feedback (A&F) that shows how health professionals compare to those of their peers, can be an effective intervention to reduce unnecessary antibiotic prescribing among family physicians. However, the most impactful design approach to A&F to achieve this aim is uncertain. We will test three design modifications of antibiotic A&F that could be readily scaled and sustained if shown to be effective: (1) inclusion of case-mix-adjusted peer comparator versus a crude comparator, (2) emphasizing harms, rather than lack of benefits, and (3) providing a viral prescription pad.Methods: We will conduct two interrelated pragmatic randomized trials in January 2021. One trial will include family physicians in Ontario who have signed up to receive their MyPractice: Primary Care report from Ontario Health ("OH Trial"). These physicians will be cluster-randomized by practice, 1:1 to intervention or control. The intervention group will also receive a Viral Prescription Pad mailed to their office as well as added emphasis in their report on use of the pad. Ontario family physicians who have not signed up to receive their MyPractice: Primary Care report will be included in the other trial administered by Public Health Ontario ("PHO Trial"). These physicians will be allocated 4:1 to intervention or control. The intervention group will be further randomized by two factors: case-mix adjusted versus unadjusted comparator and emphasis or not on harms of antibiotics. Physicians in the intervention arm of this trial will receive one of four versions of a personalized antibiotic A&F letter from PHO. For both trials, the primary outcome is the antibiotic prescribing rate per 1000 patient visits, measured at 6 months post-randomization, the primary analysis will use Poisson regression and we will follow the intention to treat principle. A mixed-methods process evaluation will use surveys and interviews with family physicians to explore potential mechanisms underlying the observed effects, exploring targeted constructs including intention, self-efficacy, outcome expectancies, descriptive norms, and goal prioritization.Discussion: This protocol describes the rationale and methodology of two interrelated pragmatic trials testing variations of theory-informed components of an audit and feedback intervention to determine how to optimize A&F interventions for antibiotic prescribing in primary care.Trial Registration: NCT04594200, NCT05044052. CIHR Grant ID: 398514. [ABSTRACT FROM AUTHOR]

Background: Audit and feedback has been shown to be instrumental in improving quality of care, particularly in outpatient settings. The mental model individuals and organizations hold regarding audit and feedback can moderate its effectiveness, yet this has received limited study in the quality improvement literature. In this study we sought to uncover patterns in mental models of current feedback practices within high- and low-performing healthcare facilities.Methods: We purposively sampled 16 geographically dispersed VA hospitals based on high and low performance on a set of chronic and preventive care measures. We interviewed up to 4 personnel from each location (n = 48) to determine the facility's receptivity to audit and feedback practices. Interview transcripts were analyzed via content and framework analysis to identify emergent themes.Results: We found high variability in the mental models of audit and feedback, which we organized into positive and negative themes. We were unable to associate mental models of audit and feedback with clinical performance due to high variance in facility performance over time. Positive mental models exhibit perceived utility of audit and feedback practices in improving performance; whereas, negative mental models did not.Conclusions: Results speak to the variability of mental models of feedback, highlighting how facilities perceive current audit and feedback practices. Findings are consistent with prior research  in that variability in feedback mental models is associated with lower performance.; Future research should seek to empirically link mental models revealed in this paper to high and low levels of clinical performance. [ABSTRACT FROM AUTHOR]

Background: Involving patients in their healthcare using shared decision-making (SDM) is promoted through policy and research, yet its implementation in routine practice remains slow. Research into SDM has stemmed from primary and secondary care contexts, and research into the implementation of SDM in tertiary care settings has not been systematically reviewed. Furthermore, perspectives on SDM beyond those of patients and their treating clinicians may add insights into the implementation of SDM. This systematic review aimed to review literature exploring barriers and facilitators to implementing SDM in hospital settings from multiple stakeholder perspectives.Methods: The search strategy focused on peer-reviewed qualitative studies with the primary aim of identifying barriers and facilitators to implementing SDM in hospital (tertiary care) settings. Studies from the perspective of patients, clinicians, health service administrators, and decision makers, government policy makers, and other stakeholders (for example researchers) were eligible for inclusion. Reported qualitative results were mapped to the Theoretical Domains Framework (TDF) to identify behavioural barriers and facilitators to SDM.Results: Titles and abstracts of 8724 articles were screened and 520 were reviewed in full text. Fourteen articles met inclusion criteria. Most studies (n = 12) were conducted in the last four years; only four reported perspectives in addition to the patient-clinician dyad. In mapping results to the TDF, the dominant themes were Environmental Context and Resources, Social/Professional Role and Identity, Knowledge and Skills, and Beliefs about Capabilities. A wide range of barriers and facilitators across individual, organisational, and system levels were reported. Barriers specific to the hospital setting included noisy and busy ward environments and a lack of private spaces in which to conduct SDM conversations.Conclusions: SDM implementation research in hospital settings appears to be a young field. Future research should build on studies examining perspectives beyond the clinician-patient dyad and further consider the role of organisational- and system-level factors. Organisations wishing to implement SDM in hospital settings should also consider factors specific to tertiary care settings in addition to addressing their organisational and individual SDM needs.Trial Registration: The protocol for the review is registered on the Open Science Framework and can be found at https://osf.io/da645/ , DOI https://doi.org/10.17605/OSF.IO/DA645 . [ABSTRACT FROM AUTHOR]

Background: Knowledge brokering is a knowledge translation approach that has been gaining popularity in Canada although the effectiveness is unknown. This study evaluated the effectiveness of generalised, exclusively email-based prompts versus a personalised remote knowledge broker for delivering evidence-based mood management interventions within an existing smoking cessation programme in primary care settings.Methods: The study design is a cluster randomised controlled trial of 123 Ontario Family Health Teams participating in the Smoking Treatment for Ontario Patients programme. They were randomly allocated 1:1 for healthcare providers to receive either: a remote knowledge broker offering tailored support via phone and email (group A), or a generalised monthly email focused on tobacco and depression treatment (group B), to encourage the implementation of an evidence-based mood management intervention to smokers presenting depressive symptoms. The primary outcome was participants' acceptance of a self-help mood management resource. The secondary outcome was smoking abstinence at 6-month follow-up, measured by self-report of smoking abstinence for at least 7 previous days. The tertiary outcome was the costs of delivering each intervention arm, which, together with the effectiveness outcomes, were used to undertake a cost minimisation analysis.Results: Between February 2018 and January 2019, 7175 smokers were screened for depression and 2765 (39%) reported current/past depression. Among those who reported current/past depression, 29% (437/1486) and 27% (345/1277) of patients accepted the mood management resource in group A and group B, respectively. The adjusted generalised estimating equations showed that there was no significant difference between the two treatment groups in patients' odds of accepting the mood management resource or in the patients' odds of smoking abstinence at follow-up. The cost minimisation analysis showed that the email strategy was the least costly option.Conclusions: Most participants did not accept the resource regardless of remote knowledge broker strategy. In contexts with an existing KT infrastructure, decision-makers should consider an email strategy when making changes to a programme given its lower cost compared with other strategies. More research is required to improve remote knowledge broker strategies.Trial Registration: ClinicalTrials.gov, NCT03130998 . Registered April 18, 2017, (Archived on WebCite at www.webcitation.org/6ylyS6RTe ). [ABSTRACT FROM AUTHOR]

Background: Alcohol is a leading risk factor contributing to the global burden of disease. Several national and international agencies recommend that screening and brief interventions (SBI) should be routinely delivered in primary care settings to reducing patients' alcohol consumption. However, evidence shows that such activities are seldom implemented in practice. A review of the barriers and facilitators mediating implementation, and how they fit with theoretical understandings of behaviour change, to inform the design of implementation interventions is lacking. This study aimed to conduct a theory-informed review of the factors influencing general practitioners' and primary care nurses' routine delivery of alcohol SBI in adults.Methods: A systematic literature search was carried out in four electronic databases (Medline, CINAHL, CENTRAL, PsycINFO) using comprehensive search strategies. Both qualitative and quantitative studies were included. Two authors independently abstracted and thematically grouped the data extracted. The barriers and facilitators identified were mapped to the domains of the Capability-Opportunity-Motivation-Behaviour system/Theoretical Domains Framework (TDF).Results: Eighty-four out of the 258 studies identified met the selection criteria. The majority of the studies reported data on the views of general practitioners (n = 60) and used a quantitative design (n = 49). A total of 660 data items pertaining to barriers and 253 data items pertaining to facilitators were extracted and thematically grouped into 46 themes. The themes mapped to at least one of the 14 domains of the TDF. The three TDF domains with the highest number of data units coded were 'Environmental Context and Resources' (n = 158, e.g. lack of time), 'Beliefs about Capabilities' (n = 134, e.g. beliefs about the ability to deliver screening and brief advice and in helping patients to cut down) and 'Skills' (n = 99, e.g. lack of training).Conclusions: This study identified a range of potential barriers and facilitators to the implementation of alcohol SBI delivery in primary care and adds to the scarce body of literature that identifies the barriers and facilitators from a theoretical perspective. Given that alcohol SBI is seldom implemented, this review provides researchers with a tool for designing novel theory-oriented interventions to support the implementation of such activity.Systematic Review Registration: PROSPERO CRD42016052681. [ABSTRACT FROM AUTHOR]

Background: 'Implementation interventions' refer to methods used to enhance the adoption and implementation of clinical interventions such as diabetic retinopathy screening (DRS). DRS is effective, yet uptake is often suboptimal. Despite most routine management taking place in primary care and the central role of health care professionals (HCP) in referring to DRS, few interventions have been developed for primary care. We aimed to develop a multifaceted intervention targeting both professionals and patients to improve DRS uptake as an example of a systematic development process combining theory, stakeholder involvement, and evidence.Methods: First, we identified target behaviours through an audit in primary care of screening attendance. Second, we interviewed patients (n = 47) and HCP (n = 30), to identify determinants of uptake using the Theoretical Domains Framework, mapping these to behaviour change techniques (BCTs) to develop intervention content. Thirdly, we conducted semi-structured consensus groups with stakeholders, specifically users of the intervention, i.e. patients (n = 15) and HCPs (n = 16), regarding the feasibility, acceptability, and local relevance of selected BCTs and potential delivery modes. We consulted representatives from the national DRS programme to check intervention 'fit' with existing processes. We applied the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects, and equity) to select the final intervention components, drawing on findings from the previous steps, and a rapid evidence review of operationalised BCT effectiveness.Results: We identified potentially modifiable target behaviours at the patient (consent, attendance) and professional (registration) level. Patient barriers to consent/attendance included confusion between screening and routine eye checks, and fear of a negative result. Enablers included a recommendation from friends/family or professionals and recognising screening importance. Professional barriers to registration included the time to register patients and a lack of readily available information on uptake in their local area/practice. Most operationalised BCTs were acceptable to patients and HCPs while the response to feasibility varied. After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients.Conclusions: Using the example of an intervention to improve DRS uptake, this study illustrates an approach to integrate theory with user involvement. This process highlighted tensions between theory-informed and stakeholder suggestions, and the need to apply the Theoretical Domains Framework (TDF)/BCT structure flexibly. The final intervention draws on the trusted professional-patient relationship, leveraging existing services to enhance implementation of the DRS programme. Intervention feasibility in primary care will be evaluated in a randomised cluster pilot trial. [ABSTRACT FROM AUTHOR]

Background: The EBMeDS system is the computerized clinical decision support (CCDS) system of EBPNet, a national computerized point-of-care information service in Belgium. There is no clear evidence of more complex CCDS systems to manage chronic diseases in primary care practices (PCPs). The objective of this study was to assess the effectiveness of EBMeDS use in improving diabetes care.Methods: A cluster-randomized trial with before-and-after measurements was performed in Belgian PCPs over 1 year, from May 2017 to May 2018. We randomly assigned 51 practices to either the intervention group (IG), to receive the EBMeDS system, or to the control group (CG), to receive usual care. Primary and secondary outcomes were the 1-year pre- to post-implementation change in HbA1c, LDL cholesterol, and systolic and diastolic blood pressure. Composite patient and process scores were calculated. A process evaluation was added to the analysis. Results were analyzed at 6 and 12 months. Linear mixed models and logistic regression models based on generalized estimating equations were used where appropriate.Results: Of the 51 PCPs that were enrolled and randomly assigned (26 PCPs in the CG and 25 in the IG), 29 practices (3815 patients) were analyzed in the study: 2464 patients in the CG and 1351 patients in the IG. No change differences existed between groups in primary or secondary outcomes. Change difference between CG and IG after 1-year follow-up was - 0.09 (95% CI - 0.18; 0.01, p-value = 0.06) for HbA1c; 1.76 (95% CI - 0.46; 3.98, p-value = 0.12) for LDL cholesterol; and 0.13 (95% CI - 0.91; 1.16, p-value = 0.81) and 0.12 (95% CI - 1.25;1.49, p-value = 0.86) for systolic and diastolic blood pressure respectively. The odds ratio of the IG versus the CG for the probability of no worsening and improvement was 1.09 (95% CI 0.73; 1.63, p-value = 0.67) for the process composite score and 0.74 (95% CI 0.49; 1.12, p-value = 0.16) for the composite patient score. All but one physician was satisfied with the EBMeDS system.Conclusions: The CCDS system EBMeDS did not improve diabetes care in Belgian primary care. The lack of improvement was mainly caused by imperfections in the organizational context of Belgian primary care for chronic disease management and shortcomings in the system requirements for the correct use of the EBMeDS system (e.g., complete structured records). These shortcomings probably caused low-use rates of the system.Trial Registration: ClinicalTrials.gov, NCT01830569, Registered 12 April 2013. [ABSTRACT FROM AUTHOR]

Background: Pediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations.Methods: This (type II) hybrid effectiveness-implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children's hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption, feasibility, appropriateness, fidelity, and cost), we use a multi-method and multi-informant assessment strategy including electronic health record data, behavioral observation, questionnaires, interviews, and cost capture methods.Discussion: This study has the potential to prevent excess weight gain, obesity, and health disparities in children by establishing the effectiveness of the FCU4Health and collecting information critical for healthcare decision makers to support sustainable implementation of family-based programs in primary care.Trial Registration: NCT03013309 ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]