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Background: Assessing the fidelity of an implementation strategy is important to understand why and how the strategy influences the uptake of evidence-based interventions. The present study aims to assess the fidelity of the two procedures for engaging primary care (PC) professionals and for the deployment of an implementation strategy for optimizing type 2 diabetes prevention in routine PC within the PREDIAPS randomized cluster implementation trial. Method: We conducted a mixed-method fidelity evaluation study of the PVS-PREDIAPS implementation strategy. Nine PC centers from the Basque Health Service (Osakidetza) were allocated to two different procedures to engage physicians and nurses and deploy a implementation strategy to model and adapt the clinical intervention and its implementation to their specific contexts: a Global procedure, promoting the cooperation of all healthcare professionals from the beginning; or a Sequential procedure, centered first on nurses who then pursued the pragmatic cooperation of physicians. Process indicators of the delivery and receipt of implementation strategy actions, documented modifications to the planned implementation strategy, and a structured group interview with centers' leaders were all used to assess the following components of fidelity: adherence, dose, quality of delivery, professionals' responsiveness and program differentiation. Results: Generally, the procedures compared for professionals engagement and deployment of the implementation strategy were carried out with the planned differentiation. Nonetheless, some unexpected between-group differences were observed, the initial rate of collaboration of nurses being higher in the Sequential (93%) than in the Global (67%) groups. Exposure rate to the programed implementation actions (% of hours received out of those delivered) were similar in both groups by professional category, with nurses (86%) having a higher rate of exposure than physicians (75%). Professionals identified half of the planned discrete strategies and their rating of strategies' perceived usefulness was overwhelmingly positive, with few differences between Sequential and Global centers. Conclusions: The PVS-PREDIAPS implementation strategy has been implemented with high fidelity and minor unplanned reactive modifications. Professionals' exposure to the implementation strategy was high in both groups. The centers' organizational context (i.e., work overload) led to small mismatches between groups in participation and exposure of professionals to implementation actions. Trial registration: Clinicaltrials.gov identifier: NCT03254979. Registered 16 August 2017. [ABSTRACT FROM AUTHOR]

Background: This study presents a way for health services to improve service access for hardly reached people through an exploration of how staff can find and collaborate with citizens (referred to as connectors) who span socio-cultural boundaries in their community. The study explored the local socio-cultural contexts of connectors' boundary spanning activities and if they are health related; boundary spanning occurring between connectors and health professionals at the interface of health systems and community; and the opportunities and barriers to actively seeking out and collaborating with community connectors to access marginalised and hardly reached people.Methods: We conducted a qualitative case comparison from rural Ireland and Australia. Following purposive snow-ball sampling techniques to recruit participants, semi-structured interviews were conducted with 34 community informants, 21 healthcare staff and 32 connectors. Transcripts were coded and analysed using an inductive approach to ascertain categories and overall themes.Results: We found a diverse sample of connectors relating to heterogenous, small and locally distinct groups of hardly reached people. Overall 26 connectors were active at the interface between health services and the community, with variation in how this occurred between cases. The majority (21) described one or more health related activities with hardly reached people. All connectors expressed a willingness to develop a relationship with local health services on issues they identified as relevant. Barriers to collaborations between connectors and health services related to bureaucracy, workload, and burnout.Conclusions: Collaborating with connectors has potential as one strategy to improve access to health services for hardly reached people. To enact this, health staff need to identify local socio-cultural boundaries and associated connectors, facilitate two-way connections at the boundary between health services and community and enable collaboration by attending to activities in the community, at the interface between health services and community, and within the health system. [ABSTRACT FROM AUTHOR]

Background: One of the key elements to enhance the uptake of evidence in public health policies is stimulating cross-sector collaboration. An intervention stimulating collaboration is a policy game. The aim of this study was to describe the design and methods of the development process of the policy game ‘In2Action’ within a real-life setting of public health policymaking networks in the Netherlands, Denmark and Romania.Methods: The development of the policy game intervention consisted of three phases, pre intervention, designing the game intervention and tailoring the intervention.Results: In2Action was developed as a role-play game of one day, with main focus to develop in collaboration a cross-sector implementation plan based on the approved strategic local public health policy.Conclusions: This study introduced an innovative intervention for public health policymaking. It described the design and development of the generic frame of the In2Action game focusing on enhancing collaboration in local public health policymaking networks. By keeping the game generic, it became suitable for each of the three country cases with only minor changes. The generic frame of the game is expected to be generalizable for other European countries to stimulate interaction and collaboration in the policy process. [ABSTRACT FROM AUTHOR]

Background: A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological, and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces.Methods/design: This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18-60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed.Discussion: The proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI and their workplaces will be provided.Trial Registration: ClinicalTrials.gov, NCT03092713 . Registered on 10 March 2017. [ABSTRACT FROM AUTHOR]

Background: Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection.Methods/design: The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis.Discussion: If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in general practice, with major benefit to patients and society. If case finding is shown to be superior to standard detection, it will be recommended as the detection method in future treatment according to the Collabri model.Trial Registration: ClinicalTrials.gov. NCT02678845 . Retrospectively registered on 7 February 2016. [ABSTRACT FROM AUTHOR]

Background: Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are limited by the use of surrogate outcomes or suboptimal design. Thus, the potential for clinically significant improvements from different interventions is still unclear. The main objective of this study is therefore to evaluate the effect upon patient-relevant endpoints of a cooperation between geriatricians and general practitioners on complex drug regimens in home-dwelling elderly people.Methods: This is a cluster randomised, single-blind, controlled trial where general practitioners are invited to participate with patients from their lists. The patients must be 70 years or older, use at least seven different medications and have their medications administered by the home nursing service. We plan to recruit 200 patients, with randomisation at physician level. The intervention consists of three main parts: (1) clinical geriatric assessment of the patient, combined with a thorough review of their medications; (2) a meeting between the geriatrician and general practitioner, where the two physicians combine their competence and knowledge and discuss the drug list systematically; (3) clinical follow-up, depending on the medication changes that have been done. The study period is 24 weeks, and the patients are assessed at baseline, 16 and 24 weeks. The primary outcome measure is health-related quality of life according to the 15D instrument. Secondary outcome measures include physical and cognitive functioning, medication appropriateness, falls, carer burden, use of health services (hospital or nursing home admissions, use of home nursing services) and mortality.Discussion: Our choice of patient-relevant outcome measures will hopefully provide new knowledge on the potential for clinical improvements after performing comprehensive medication reviews in home-dwelling elderly people receiving polypharmacy.Trial Registration: ClinicalTrials.gov, NCT02379455 . Registered on 27 February 2015. [ABSTRACT FROM AUTHOR]

Background: Proliferation of terms describing the science of effectively promoting and supporting the use of research evidence in healthcare policy and practice has hampered understanding and development of the field. To address this, an international Terminology Working Group developed and published a simplified framework of interventions to promote and integrate evidence into health practices, systems, and policies. This paper presents results of validation work and a second international workgroup meeting, culminating in the updated AIMD framework [Aims, Ingredients, Mechanism, Delivery].Methods: Framework validity was evaluated against terminology schemas (n = 51); primary studies (n = 37); and reporting guidelines (n = 10). Framework components were independently categorized as fully represented, partly represented, or absent by two researchers. Opportunities to refine the framework were systematically recorded. A meeting of the expanded international Terminology Working Group updated the framework by reviewing and deliberating upon validation findings and refinement proposals.Results: There was variation in representativeness of the components across the three types of literature, in particular for the component 'causal mechanisms'. Analysis of primary studies revealed that representativeness of this concept lowered from 92 to 68% if only explicit, rather than explicit and non-explicit references to causal mechanisms were included. All components were very well represented in reporting guidelines, however the level of description of these was lower than in other types of literature. Twelve opportunities were identified to improve the framework, 9 of which were operationalized at the meeting. The updated AIMD framework comprises four components: (1) Aims: what do you want your intervention to achieve and for whom? (2) Ingredients: what comprises the intervention? (3) Mechanisms: how do you propose the intervention will work? and (4) Delivery: how will you deliver the intervention?Conclusions: The draft simplified framework was validated with reference to a wide range of relevant literature and improvements have enhanced useability. The AIMD framework could aid in the promotion of evidence into practice, remove barriers to understanding how interventions work, enhance communication of interventions and support knowledge synthesis. Future work needs to focus on developing and testing resources and educational initiatives to optimize use of the AIMD framework in collaboration with relevant end-user groups. [ABSTRACT FROM AUTHOR]

Background: Falls among community-dwelling older adults are a serious public health concern. While evidence-based fall prevention strategies are available, their effective implementation requires broad cross-sector coordination that is beyond the capacity of any single institution or organization. Community groups comprised of diverse stakeholders that include public health, care providers from the public and private sectors and citizen volunteers are working to deliver locally-based fall prevention. These groups are examples of collective impact and are important venues for public health professionals (PHPs) to deliver their mandate to work collaboratively towards achieving improved health outcomes. This study explores the process of community-based group work directed towards fall prevention, and it focuses particular attention on the collaborative leadership practices of PHPs, in order to advance understanding of the competencies required for collective impact.Methods: Four community groups, located in Ontario, Canada, were studied using an exploratory, retrospective, multiple case study design. The criteria for inclusion were presence of a PHP, a diverse membership and the completion of an initiative that fit within the scope of the World Health Organization Fall Prevention Model. Data were collected using interviews (n = 26), focus groups (n = 4), and documents. Cross-case synthesis was conducted by a collaborative team of researchers.Results: The community groups differed by membership, the role of the PHP and the type of fall prevention initiatives. Seven practice themes emerged: (1) tailoring to address context; (2) making connections; (3) enabling communication; (4) shaping a vision; (5) skill-building to mobilize and take action; (6) orchestrating people and projects; and (7) contributing information and experience. The value of recognized leadership competencies was underscored and the vital role of institutional supports was highlighted.Conclusion: To align stakeholders working towards fall prevention for community-dwelling older adults and establish a foundation for collective impact, public health professionals employed practices that reflected a collaborative leadership style. Looking ahead, public health professionals will want to shift their focus to evaluating the effectiveness of their group work within communities. They will also need to assess outcomes and evaluate whether the anticipated reductions in fall rates among community-dwelling older adults is being achieved. [ABSTRACT FROM AUTHOR]

Background: Facilitating and enhancing interaction between stakeholders involved in the policymaking process to stimulate collaboration and use of evidence, is important to foster the development of effective Health Enhancing Physical Activity (HEPA) policies. Performing an analysis of real-world policymaking processes will help reveal the complexity of a network of stakeholders. Therefore, the main objectives were to unravel the stakeholder network in the policy process by conducting three systems analyses, and to increase insight into the similarities and differences in the policy processes of these European country cases.Methods: A systems analysis of the local HEPA policymaking process was performed in three European countries involved in the 'REsearch into POlicy to enhance Physical Activity' (REPOPA) project, resulting in three schematic models showing the main stakeholders and their relationships. The models were used to compare the systems, focusing on implications with respect to collaboration and use of evidence in local HEPA policymaking. Policy documents and relevant webpages were examined and main stakeholders were interviewed.Results: The systems analysis in each country identified the main stakeholders involved and their position and relations in the policymaking process. The Netherlands and Denmark were the most similar and both differed most from Romania, especially at the level of accountability of the local public authorities for local HEPA policymaking. The categories of driving forces underlying the relations between stakeholders were formal relations, informal interaction and knowledge exchange.Conclusions: A systems analysis providing detailed descriptions of positions and relations in the stakeholder network in local level HEPA policymaking is rather unique in this area. The analyses are useful when a need arises for increased interaction, collaboration and use of knowledge between stakeholders in the local HEPA network, as they provide an overview of the stakeholders involved and their mutual relations. This information can be an important starting point to enhance the uptake of evidence and build more effective public health policies. [ABSTRACT FROM AUTHOR]

Background: Paramedics make important and increasingly complex decisions at scene about patient care. Patient safety implications of influences on decision making in the pre-hospital setting were previously under-researched. Cutting edge perspectives advocate exploring the whole system rather than individual influences on patient safety. Ethnography (the study of people and cultures) has been acknowledged as a suitable method for identifying health care issues as they occur within the natural context. In this paper we compare multiple methods used in a multi-site, qualitative study that aimed to identify system influences on decision making.Methods: The study was conducted in three NHS Ambulance Trusts in England and involved researchers from each Trust working alongside academic researchers. Exploratory interviews with key informants e.g. managers (n = 16) and document review provided contextual information. Between October 2012 and July 2013 researchers observed 34 paramedic shifts and ten paramedics provided additional accounts via audio-recorded 'digital diaries' (155 events). Three staff focus groups (total n = 21) and three service user focus groups (total n = 23) explored a range of experiences and perceptions. Data collection and analysis was carried out by academic and ambulance service researchers as well as service users. Workshops were held at each site to elicit feedback on the findings and facilitate prioritisation of issues identified.Results: The use of a multi-method qualitative approach allowed cross-validation of important issues for ambulance service staff and service users. A key factor in successful implementation of the study was establishing good working relationships with academic and ambulance service teams. Enrolling at least one research lead at each site facilitated the recruitment process as well as study progress. Active involvement with the study allowed ambulance service researchers and service users to gain a better understanding of the research process. Feedback workshops allowed stakeholders to discuss and prioritise findings as well as identify new research areas.Conclusion: Combining multiple qualitative methods with a collaborative research approach can facilitate exploration of system influences on patient safety in under-researched settings. The paper highlights empirical issues, strengths and limitations for this approach. Feedback workshops were effective for verifying findings and prioritising areas for future intervention and research. [ABSTRACT FROM AUTHOR]

Background: In mental health services what is commonplace across international frontiers is that to prevent aggressive patients from harming themselves, other patients or staff, coercive measures and foremost, violence management strategies are required. There is no agreement, recommendations or direction from the EU on which measures of coercion should be practiced across EU countries, and there is no overall one best practice approach.Methods: The project was conceived through an expert group, the European Violence in Psychiatry Research Group (EViPRG). The study aimed to incorporate an EU and multidisciplinary response in the determination of violence management practices and related research and education priorities across 17 European countries. From the EVIPRG members, one member from each country agreed to act as the national project coordinator for their country. Given the international spread of respondents, an eDelphi survey approach was selected for the study design and data collection. A survey instrument was developed, agreed and validated through members of EVIPRG.Results: The results included a total of 2809 respondents from 17 countries with 999 respondents who self-selected for round 2 eDelphi. The majority of respondents worked in acute psychiatry, 54% (n = 1511); outpatient departments, 10.5% (n = 295); and Forensic, 9.3% (n = 262). Other work areas of respondents include Rehabilitation, Primary Care and Emergency. It is of concern that 19.5% of respondents had not received training on violence management. The most commonly used interventions in the management of violent patients were physical restraint, seclusion and medications. The top priorities for education and research included: preventing violence; the influence of environment and staff on levels of violence; best practice in managing violence; risk assessment and the aetiology and triggers for violence and aggression.Conclusion: In many European countries there is an alarming lack of clarity on matters of procedure and policy pertaining to violence management in mental health services. Violence management practices in Europe appear to be fragmented with no identified ideological position or collaborative education and research. In Europe, language differences are a reality and may have contributed to insular thinking, however, it must not be seen as a barrier to sharing best practice. [ABSTRACT FROM AUTHOR]

Background: The English health system experienced a large-scale reorganisation in April 2013. A national tri-partite delivery framework involving the Department of Health, NHS England and Public Health England was agreed and a new local operational model applied. Evidence about how health system re-organisations affect constituent public health programmes is sparse and focused on low and middle income countries. We conducted an in-depth analysis of how the English immunisation programme adapted to the April 2013 health system reorganisation, and what facilitated or hindered the delivery of immunisation services in this context.Methods: A qualitative case study methodology involving interviews and observations at national and local level was applied. Three sites were selected to represent different localities, varying levels of immunisation coverage and a range of changes in governance. Study participants included 19 national decision-makers and 56 local implementers. Two rounds of interviews and observations (immunisation board/committee meetings) occurred between December 2014 and June 2015, and September and December 2015. Interviews were audio recorded and transcribed verbatim and written accounts of observed events compiled. Data was imported into NVIVO 10 and analysed thematically.Results: The new immunisation programme in the new health system was described as fragmented, and significant effort was expended to regroup. National tripartite arrangements required joint working and accountability; a shift from the simpler hierarchical pre-reform structure, typical of many public health programmes. New local inter-organisational arrangements resulted in ambiguity about organisational responsibilities and hindered data-sharing. Whilst making immunisation managers responsible for larger areas supported equitable resource distribution and strengthened service commissioning, it also reduced their ability to apply clinical expertise, support and evaluate immunisation providers' performance. Partnership working helped staff adapt, but the complexity of the health system hindered the development of consistent approaches for training and service evaluation.Conclusion: The April 2013 health system reorganisation in England resulted in significant fragmentation in the way the immunisation programme was delivered. Some of this was a temporary by-product of organisational change, other more persistent challenges were intrinsic to the complex architecture of the new health system. Partnership working helped immunisation leaders and implementers reconnect and now the challenge is to assess how inter-agency collaboration can be strengthened. [ABSTRACT FROM AUTHOR]

Background: Increased health research capacity is needed in low- and middle-income countries to respond to local health challenges. Technology-aided teaching approaches, such as blended learning (BL), can stimulate international education collaborations and connect skilled scientists who can jointly contribute to the efforts to address local shortages of high-level research capacity. The African Regional Capacity Development for Health Systems and Services Research (ARCADE HSSR) was a European Union-funded project implemented from 2011 to 2015. The project consortium partners worked together to expand access to research training and to build the research capacity of post-graduate students. This paper presents a case study of the first course in the project, which focused on a meta-analysis of diagnostic accuracy studies and was delivered in 2013 through collaboration by universities in Uganda, Sweden and South Africa.Methods: We conducted a mixed-methods case study involving student course evaluations, participant observation, interviews with teaching faculty and student feedback collected through group discussion. Quantitative data were analysed using frequencies, and qualitative data using thematic analysis.Results: A traditional face-to-face course was adapted for BL using a mixture of online resources and materials, synchronous online interaction between students and teachers across different countries complemented by face-to-face meetings, and in-class interaction between students and tutors. Synchronous online discussions led by Makerere University were the central learning technique in the course. The learners appreciated the BL design and reported that they were highly motivated and actively engaged throughout the course. The teams implementing the course were small, with individual faculty members and staff members carrying out many extra responsibilities; yet, some necessary competencies for course design were not available.Conclusions: BL is a feasible approach to simultaneously draw globally available skills into cross-national, high-level skills training in multiple countries. This method can overcome access barriers to research methods courses and can offer engaging formats and personalised learning experiences. BL enables teaching and learning from experts and peers across the globe with minimal disruption to students' daily schedules. Transforming a face-to-face course into a blended course that fulfils its full potential requires concerted effort and dedicated technological and pedagogical support. [ABSTRACT FROM AUTHOR]

Background: Many patients with chronic physical illnesses have co-morbid psychological illnesses, which may respond to interprofessional collaborative care. Continuing education programs frequently focus on skills and knowledge relevant for individual illnesses, and unidisciplinary care. This study evaluates the impact of "Mind the Gap", an Australian interprofessional continuing education program about management of dual illnesses, on practitioners' knowledge, use of psychological strategies and collaborative practice.Methods: A 6-h module addressing knowledge and skills needed for patients with physical and psychological co-morbid illnesses was delivered to 837 practitioners from mixed health professional backgrounds, through locally-facilitated workshops at 45 Australian sites. We conducted a mixed-methods evaluation, incorporating observation, surveys and network analysis using data collected, before, immediately after, and three months after training.Results: Six hundred forty-five participants enrolled in the evaluation (58 % GPs, 17 % nurses, 15 % mental health professionals, response rate 76 %). Participants' knowledge and confidence to manage patients with psychological and physical illnesses improved immediately. Among the subset surveyed at three months (response rate 24 %), referral networks had increased across seven disciplines, improvements in confidence and knowledge were sustained, and doctors, but no other disciplines, reported an increase in use of motivational interviewing (85.9 % to 96.8 %) and mindfulness (58.6 % to 74 %).Conclusions: Interprofessional workshops had an immediate impact on the stated knowledge and confidence of participants to manage patients with physical and psychological comorbidities, which appears to have been sustained. For some attendees, there was a sustained improvement in the size of their referral networks and their use of some psychological strategies. [ABSTRACT FROM AUTHOR]

Background: Hospital discharge is a vulnerable transitional stage in patient care. This qualitative study investigated the views of healthcare professionals and patients about the threats to safe hospital discharge with aim of identifying contributory and latent factors. The study was undertaken in two regional health and social care systems in the English National Health Service, each comprising three acute hospitals, community and primary care providers and municipal social care services. The study focused on the threats to safe discharge for hip fracture and stroke patients as exemplars of complex care transitions.Methods: A qualitative study involving narrative interviews with 213 representative stakeholders and professionals involved in discharge planning and care transition activities. Narratives were analysed in line with 'systems' thinking to identify proximal (active) and distal (latent) factors, and the relationships between them.Results: Three linked categories of commonly and consistently identified threat to safe discharge were identified: (1) 'direct' patient harms comprising falls, infection, sores and ulceration, medicines-related issues, and relapse; (2) proximal 'contributing' factors including completion of tests, assessment of patient, management of equipment and medicines, care plan, follow-up care and patient education; and distal 'latent' factors including discharge planning, referral processes, discharge timing, resources constraints, and organisational demands.Conclusion: From the perspective of stakeholders, the study elaborates the relationship between patient harms and systemic factors in the context of hospital discharge. It supports the importance of communication and collaboration across occupational and organisational boundaries, but also the challenges to supporting such communication with the inherent complexity of the care system. [ABSTRACT FROM AUTHOR]

Background: Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries.Methods/design: The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally.Discussion: The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.Trial Registration: ClinicalTrials.gov NCT02655354 . Registered 27 July 2015. [ABSTRACT FROM AUTHOR]

Background: Healthcare professionals perform knowledge-intensive work in very specialized disciplines. Across the professional divide, collaboration becomes increasingly difficult. For effective teamwork and collaboration to occur, it is considered necessary for individuals to believe in their ability to draw on their expertise and provide what others need to perform their job well. To date, however, no instruments exist to measure such a construct.Methods: A two-study design is used to test the psychometric properties, factor structure and incremental validity of a five-item questionnaire measuring informational role self-efficacy.Results: Based on parallel analysis and exploratory factor analysis, Study 1 shows a robust and reliable one-dimensional construct. Study 2 cross-validates this factor structure using confirmatory factor analysis. Study 2 also shows that informational role self-efficacy predicts proactive teamwork behaviors over and above goal similarity, interdependence, coordination and intra-team trust.Conclusions: The instrument can be used in research to assess an individual's capability beliefs in communicating his/her informational characteristics that are pertinent to the task performance of others. The construct is also shown to have value in team-building exercises. [ABSTRACT FROM AUTHOR]

Background: Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was to explore how teamwork influences recruitment to a multicentre randomised controlled trial (RCT) involving interventions delivered by different clinical specialties.Methods: Semi-structured interviews were conducted in three centres with a purposeful sample of members of the surgical, oncology and research teams recruiting to a feasibility RCT comparing definitive chemoradiotherapy with chemoradiotherapy and surgery for oesophageal squamous cell carcinoma. Interviews explored factors known to influence healthcare team effectiveness and were audio-recorded and thematically analysed. Sampling, data collection and analysis were undertaken iteratively and concurrently.Results: Twenty-one interviews were conducted. Factors that influenced how team working impacted upon trial recruitment were centred on: (1) the multidisciplinary team (MDT) meeting, (2) leadership of the trial, and (3) the recruitment process. The weekly MDT meeting was reported as central to successful recruitment and formed the focus for creating a 'study team', bringing together clinical and research teams. Shared study leadership positively influenced healthcare professionals' willingness to participate. Interviewees perceived their clinical colleagues to have strong treatment preferences which led to scepticism regarding whether the treatments were being described to patients in a balanced manner.Conclusions: This study has highlighted a number of aspects of team functioning that are important for recruitment to RCTs that span different clinical specialties. Understanding these issues will aid the production of guidance on team-relevant issues that should be considered in trial management and the development of interventions that will facilitate teamwork and improve recruitment to these challenging RCTs.Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN): ISRCTN89052791 . [ABSTRACT FROM AUTHOR]

Background: Self-management of inflammatory arthritis (IA) requires patients to address the impact of symptoms, treatment, and the psychosocial consequences of a long term condition. There are several possible mechanisms for facilitating self-management, including patient-clinician interactions in routine consultations. This requires patients to collaborate in their healthcare, and clinicians to specifically encourage and help patients to do so. To design training that enables clinicians to support patients to be actively involved and self-manage requires understanding both patients' and clinicians' perspectives about what is important and feasible. Previous research explored the perspectives of clinicians who had undertaken brief training which they were putting into practice in their routine consultations. This study explored the perspectives of patients attending those routine consultations to identify aspects of the interaction that influenced collaboration and self-management.Methods: Nineteen patients with IA who had attended a routine consultation with a rheumatology clinician at one of four hospitals in England took part in semi-structured interviews. Interviews were transcribed, anonymised and analysed using inductive thematic analysis.Results: Three themes encompass participants' thoughts about interactions that facilitated collaboration in consultations and their ability to self-manage their IA: first, patients and clinicians viewing care as a shared endeavour, including patients responding actively to their IA and clinicians exploring and negotiating with patients; second, the need for clinicians to understand the challenges faced by patients, appreciate the impact of IA and focus on patients' priorities; and third, clinicians using an open communication style, including the use of non-didactic, patient-centred approaches. A fourth theme was perceived benefits of actively engaging in consultations, including increased confidence to deal with the impact of IA and greater acceptance of a long term condition.Conclusions: Patients perceive that self-management can be facilitated when clinicians and patients view healthcare as a shared responsibility, underpinned by clinicians as experts in the disease and patients as experts in living with it. Clinicians can support patients' self-management by using non-didactic communication skills to identify patients' priorities, and to prompt patients to problem-solve and share in setting the consultation agenda. This should inform skills-training for rheumatology clinicians. [ABSTRACT FROM AUTHOR]

Background: Ageing has become a worldwide reality and presents new challenges for the health-care system. Research has shown that potentially inappropriate prescribing, both potentially inappropriate medications and potentially prescribing omissions, is highly prevalent in older people, especially in the nursing home setting. The presence of potentially inappropriate medications/potentially prescribing omissions is associated with adverse drug events, hospitalisations, mortality and health-care costs. The Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON) study aims to evaluate the effect of a complex, multifaceted intervention, including interdisciplinary case conferences, on the appropriateness of prescribing of medicines for older people in Belgian nursing homes.Methods/design: A multicentre cluster-controlled trial is set up in 63 Belgian nursing homes (30 intervention; 33 control). In each of these nursing homes, 35 residents (≥65 years) are selected for participation. The complex, multifaceted intervention comprises (i) health-care professional education and training, (ii) local concertation (discussion on the appropriate use of at least one medication class at the level of the nursing home) and (iii) repeated interdisciplinary case conferences between general practitioner, nurse and pharmacist to perform medication review for each included nursing home resident. The control group works as usual. The study period lasts 15 months. The primary outcome measures relate to the appropriateness of prescribing and are defined as (1) among residents who had at least one potentially inappropriate medication/potentially prescribing omission at baseline, the proportion of them for whom there is a decrease of at least one of these potentially inappropriate medications/potentially prescribing omissions at the end of study, and (2) among all residents, the proportion of them for whom at least one new potentially inappropriate medication/potentially prescribing omission is present at the end of the study, compared to baseline. The secondary outcome measures include individual components of appropriateness of prescribing, medication use, outcomes of the case conferences, clinical outcomes and costs. A process evaluation (focusing on implementation, causal mechanisms and contextual factors) will be conducted alongside the study.Discussion: The COME-ON study will contribute to a growing body of knowledge concerning the effect of complex interventions on the use of medicines in the nursing home setting, and on factors influencing their effect. The results will inform policymakers on strategies to implement in the near future.Trial Registration: Current Controlled Trials ISRCTN66138978. [ABSTRACT FROM AUTHOR]

Background: In 2008, the National Institute for Health Research (NIHR) began funding a major 5-year pilot research programme of translational research in England, establishing nine 'Collaborations for Leadership in Applied Health Research and Care' (CLAHRCs). A number of evaluations were carried out to examine whether or not the various collaborations worked as intended and why. In this paper, we examine what the theory of co-production adds to understanding of processes of knowledge creation and translation we observed in one of the CLAHRCs.Methods: A case study of a successful knowledge translation project was identified from our wider realist evaluation of the mechanisms of closer collaboration at play in the CLAHRC. In the project, a computer simulation model of an emergency pathway for acute ischaemic stroke was built to explore if and how the time between the onset and treatment of the condition could be minimised by redesigning the pathway. The aim of the case study was to improve our understanding of the nature and workings of the mechanisms of closer collaboration that were associated with the more successful projects by examining the relevance of the theory of co-production. Qualitative methods of analysis were used to explore the fit between the mechanisms of closer collaboration we observed in the realist evaluation and the principles of co-production we identified from the literature.Results: We found a close fit between the nine mechanisms of closer collaboration at work in the project and the principles of co-production (active agents; equality of partners; reciprocity and mutuality; transformative; and facilitated). The successful style of collaborative working exemplified by the project was consistent with a strong form of co-production.Conclusions: In our view, the theory of co-production provides useful insights into what it is about the qualities of collaborative working that inspire the requisite mechanisms for generating knowledge that is translated into practice. The theory provides a potentially useful basis for future knowledge translation programmes and projects in applied health research in a range of contexts. [ABSTRACT FROM AUTHOR]

Background: In 2012 and 2013, we conducted a social network survey of a new translational research network (TRN) designed to deliver better care to cancer patients. Results of these two surveys showed that silos of researchers and clinicians existed before the TRN was established but that the network had mediated collaborative relationships. This paper reports on a third social network survey of the TRN and focusses on the structure of the collaborative arrangements among members.Methods: Members of the TRN were invited to complete an on-line, whole network survey in May 2015. The survey asked respondents to identify personal impacts, outputs and wider outcomes attributable to their TRN membership. The final question asked respondents to select the name of TRN members with whom they had collaborated either formally or informally. For each member nominated, they were asked to say whether they had known this person before joining the TRN.Results: Response rate was 70 %. Over 4 years, the TRN has grown in size from 68 to 244 members. Relationships within and across the TRN have become more collaborative and interactive, with 1658 collaborative ties between members and over 40 % of ties with people unknown to participants before they joined the TRN. This points to a well-functioning network which has retained its focus on the original goals of the TRN and has fostered collaboration between researchers, clinicians, managers, consumers and TRN operational staff. This survey shows that the TRN's impact goes beyond outcomes from formal TRN-funded projects. About one third of respondents could list projects not directly funded by the TRN but which are attributed to TRN membership. Examples of practice change brought about through the TRN were given by 77 % of respondents. A substantial risk factor for the future is the high levels of dependency on key or central TRN participants.Conclusions: The structure of the TRN with its active central actors and brokers has been able to foster collaboration on implementation initiatives that result in practice change. The role of a social professional network in driving this collaboration is shown. [ABSTRACT FROM AUTHOR]

Background: Increasingly, it is being suggested that translational gaps might be eradicated or narrowed by bringing research users and producers closer together, a theory that is largely untested. This paper reports a national study to fill a gap in the evidence about the conditions, processes and outcomes related to collaboration and implementation.Methods: A longitudinal realist evaluation using multiple qualitative methods case studies was conducted with three Collaborations for Leadership in Applied Health Research in Care (England). Data were collected over four rounds of theory development, refinement and testing. Over 200 participants were involved in semi-structured interviews, non-participant observations of events and meetings, and stakeholder engagement. A combined inductive and deductive data analysis process was focused on proposition refinement and testing iteratively over data collection rounds.Results: The quality of existing relationships between higher education and local health service, and views about whether implementation was a collaborative act, created a path dependency. Where implementation was perceived to be removed from service and there was a lack of organisational connections, this resulted in a focus on knowledge production and transfer, rather than co-production. The collaborations' architectures were counterproductive because they did not facilitate connectivity and had emphasised professional and epistemic boundaries. More distributed leadership was associated with greater potential for engagement. The creation of boundary spanning roles was the most visible investment in implementation, and credible individuals in these roles resulted in cross-boundary work, in facilitation and in direct impacts. The academic-practice divide played out strongly as a context for motivation to engage, in that 'what's in it for me' resulted in variable levels of engagement along a co-operation-collaboration continuum. Learning within and across collaborations was patchy depending on attention to evaluation.Conclusions: These collaborations did not emerge from a vacuum, and they needed time to learn and develop. Their life cycle started with their position on collaboration, knowledge and implementation. More impactful attempts at collective action in implementation might be determined by the deliberate alignment of a number of features, including foundational relationships, vision, values, structures and processes and views about the nature of the collaboration and implementation. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number one cause of death worldwide. From 1990 until today, more people died from coronary heart disease than from any other cause. CVD is regularly treated with minimally or non-minimally invasive off- or on-pump cardiothoracic surgery and several interventions related to the outcome of the surgical procedures have been evaluated in clinical trials, but heterogeneity in outcome reporting hinders comparison of interventions across trials and limits the ability of research synthesis. This problem is encountered with the introduction of core outcome sets (COSs), which should be measured and reported, as a minimum, in all clinical trials for a specific clinical field.Methods/design: This study protocol describes the methods used to develop a COS for all types of cardiac surgery effectiveness trials. We aim to reach consensus on what to measure in an international three-round eDelphi exercise involving adult patients in need or after cardiothoracic surgery, cardiothoracic surgeons, cardiologists, anaesthesiologists, nursing staff and researchers with expertise in this particular field of medical research. Subsequently, outcome measurement instruments (how to measure) will be determined. Recommendations on COS development given by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and the Outcome Measures in Rheumatology (OMERACT) Initiative were followed.Discussion: The proposed COS aims to provide methodological guidance for future cardiothoracic surgical trials to ensure the comparability of effects of interventions across studies and enable research synthesis. This does not imply that primary outcomes should always and exclusively be those of the COS. However, to ensure the comparability of results across trials, the outcomes included in this COS should be considered for inclusion besides measuring trial-specific clinical endpoints. [ABSTRACT FROM AUTHOR]

Background: The number of people with one or more chronic diseases is increasing, but this trend could be reduced by promoting physical activity. Therefore, in 2012, the Dutch Ministry of Health, Welfare, and Sport introduced Care Sport Connectors (CSCs), to whom a broker role has been ascribed. The defined outcome of CSCs role is an increased number of residents participating in local sports facilities and being physically active in their own neighbourhood. To realize this, primary care and sports professionals need to collaborate, and local sports facilities and neighbourhoods need to offer accessible physical activities for people in the locality, including people with one or more chronic diseases or at increased risk of chronic disease(s). Adequate scientific research is needed to assess CSCs' impact on: 1) connecting primary care, sport, and physical activity and 2) increasing the number of residents who engage in physical activity to promote their health.Methods and Design: To study the role and the impact of CSCs, a longitudinal multiple case study will be conducted, in nine municipalities spread over the Netherlands, from 2014 until 2017. A mixed methodology will be used to perform action research and process evaluation. Study I focuses on the expected alliances of CSCs and the preconditions that facilitate or hinder CSCs in the formation of these alliances. The study population will consist of intermediary target groups. A literature review, interviews, focus groups, and document analysis will be undertaken. Study II will concentrate on lifestyle program participants to identify health and physical activity behavior changes. For this purpose, interviews, literature studies, a Delphi study, fitness tests, and questionnaires will be used.Discussion: Linking and integrating results gained by multiple methods, at different levels, will provide a validated assessment of CSCs' impact on connecting the primary care and sports sectors. This will reveal changes in residents' physical activity behavior, and also the circumstances under which this will happen. The assessment in combination with general lessons learned from the different case studies will make it possible to determine whether CSCs are able to fulfill the policy aspiration and whether it would be beneficial to extend this function.Trial Registration: Nederlands Trialregister NTR4986 . Registered 14 December 2014. [ABSTRACT FROM AUTHOR]

Introduction: Due to a limited health workforce, many health care providers in Africa must take on health leadership roles with minimal formal training in leadership. Hence, the need to equip health care providers with practical skills required to lead high-impact health care programs. In Uganda, the Afya Bora Global Health Leadership Fellowship is implemented through the Makerere University College of Health Sciences (MakCHS) and her partner institutions. Lessons learned from the program, presented in this paper, may guide development of in-service training opportunities to enhance leadership skills of health workers in resource-limited settings.Methods: The Afya Bora Consortium, a consortium of four African and four U.S. academic institutions, offers 1-year global health leadership-training opportunities for nurses and doctors. Applications are received and vetted internationally by members of the consortium institutions in Botswana, Kenya, Tanzania, Uganda, and the USA. Fellows have 3 months of didactic modules and 9 months of mentored field attachment with 80% time dedicated to fellowship activities. Fellows' projects and experiences, documented during weekly mentor-fellow meetings and monthly mentoring team meetings, were compiled and analyzed manually using pre-determined themes to assess the effect of the program on fellows' daily leadership opportunities.Results: Between January 2011 and January 2015, 15 Ugandan fellows (nine doctors and six nurses) participated in the program. Each fellow received 8 weeks of didactic modules held at one of the African partner institutions and three online modules to enhance fellows' foundation in leadership, communication, monitoring and evaluation, health informatics, research methodology, grant writing, implementation science, and responsible conduct of research. In addition, fellows embarked on innovative projects that covered a wide spectrum of global health challenges including critical analysis of policy formulation and review processes, bottlenecks in implementation of national HIV early infant diagnosis and prevention of mother-to-child HIV-transmission programs, and use of routine laboratory data about antibiotic resistance to guide updates of essential drug lists.Conclusion: In-service leadership training was feasible, with ensured protected time for fellows to generate evidence-based solutions to challenges within their work environment. With structured mentorship, collaborative activities at academic institutions and local health care programs equipped health care providers with leadership skills. [ABSTRACT FROM AUTHOR]

Background: Tobacco consumption is a preventable risk factor for chronic disease and complicates the treatment of medical conditions. Therefore, the German health insurance company AOK NORDWEST has developed a collaborative smoking cessation intervention for individuals with cardiovascular disease, chronic obstructive pulmonary disease and heavy smokers, with the aim of reducing tobacco consumption. The objective of the study ENTER is to evaluate the effectiveness of the collaborative smoking cessation intervention and determine its cost-effectiveness.Methods/design: This study is a cluster-randomized controlled trial conducted with 40 medical practices that are being selected from different geographic regions in Germany. Participating medical practices will be randomly allocated to either the intervention or control group. Within the medical practices, a total of 800 patients will be recruited for participation in the study and blinded to group assignment. Patients are included in the study if they are 18 years or older, insured by AOK, heavy smokers (smoke at least 20 cigarettes per day) and/or suffer from chronic obstructive pulmonary disease or cardiovascular disease. Exclusion criteria are patients who are nonsmokers, who have cognitive impairments or who are illiterate. Physicians from medical practices in the intervention group will motivate patients to participate in a smoking cessation program offered by the health insurance, refer them to the program and ask about their program participation. Physicians from medical practices in the control group will provide usual care. Data collection will take place on the date of study inclusion and after 6 and 12 months. The primary outcome is the amount of cigarettes consumed during the past 30 days, 12 months after the initial medical consultation. Secondary outcomes are abstinence from smoking, health-related quality of life and respiratory complaints. Moreover, a process evaluation and health economic analysis will be performed.Discussion: The results of this study will help to determine whether the collaborative smoking cessation intervention is an effective and feasible way to promote smoking cessation in the primary care setting and provide evidence regarding its cost-effectiveness.Trial Registration: German Clinical Trials Register DRKS00006079 . Registered 4 June 2014. [ABSTRACT FROM AUTHOR]

Background: Collaborative partnerships are considered an essential strategy for integrating local disjointed health and social services. Currently, little evidence is available on how integrated care arrangements between professionals and organisations are achieved through the evolution of collaboration processes over time. The first aim was to develop a typology of integrated care projects (ICPs) based on the final degree of integration as perceived by multiple stakeholders. The second aim was to study how types of integration differ in changes of collaboration processes over time and final perceived effectiveness.Methods: A longitudinal mixed-methods study design based on two data sources (surveys and interviews) was used to identify the perceived degree of integration and patterns in collaboration among 42 ICPs in primary care in The Netherlands. We used cluster analysis to identify distinct subgroups of ICPs based on the final perceived degree of integration from a professional, organisational and system perspective. With the use of ANOVAs, the subgroups were contrasted based on: 1) changes in collaboration processes over time (shared ambition, interests and mutual gains, relationship dynamics, organisational dynamics and process management) and 2) final perceived effectiveness (i.e. rated success) at the professional, organisational and system levels.Results: The ICPs were classified into three subgroups with: 'United Integration Perspectives (UIP)', 'Disunited Integration Perspectives (DIP)' and 'Professional-oriented Integration Perspectives (PIP)'. ICPs within the UIP subgroup made the strongest increase in trust-based (mutual gains and relationship dynamics) as well as control-based (organisational dynamics and process management) collaboration processes and had the highest overall effectiveness rates. On the other hand, ICPs with the DIP subgroup decreased on collaboration processes and had the lowest overall effectiveness rates. ICPs within the PIP subgroup increased in control-based collaboration processes (organisational dynamics and process management) and had the highest effectiveness rates at the professional level.Conclusions: The differences across the three subgroups in terms of the development of collaboration processes and the final perceived effectiveness provide evidence that united stakeholders' perspectives are achieved through a constructive collaboration process over time. Disunited perspectives at the professional, organisation and system levels can be aligned by both trust-based and control-based collaboration processes. [ABSTRACT FROM AUTHOR]

Background: Evidence-based treatments (EBTs) are available for treating childhood behavioral health challenges. Despite EBTs' potential to help children and families, they have primarily remained in university settings. Little empirical evidence exists regarding how specific, commonly used training and quality control models are effective in changing practice, achieving full implementation, and supporting positive client outcomes.Methods/design: This study (NIMH RO1 MH095750; ClinicalTrials.gov Identifier: NCT02543359), which is currently in progress, will evaluate the effectiveness of three training models (Learning Collaborative (LC), Cascading Model (CM), and Distance Education (DE)) to implement a well-established EBT , Parent-Child Interaction Therapy, in real-world, community settings. The three models differ in their costs, skill training, quality control methods, and capacity to address broader implementation challenges. The project is guided by three specific aims: (1) to build knowledge about training outcomes, (2) to build knowledge about implementation outcomes, and (3) to test the differential impact of training clinicians using LC, CM, and DE models on key client outcomes. Fifty (50) licensed psychiatric clinics across Pennsylvania were randomized to one of the three training conditions: (1) LC, (2) CM, or (3) DE. The impact of training on practice skills (clinician level) and implementation/sustainment outcomes (clinic level) are being evaluated at four timepoints coinciding with the training schedule: baseline, 6 (mid), 12 (post), and 24 months (1 year follow-up). Immediately after training begins, parent-child dyads (client level) are recruited from the caseloads of participating clinicians. Client outcomes are being assessed at four timepoints (pre-treatment, 1, 6, and 12 months after the pre-treatment).Discussion: This proposal builds on an ongoing initiative to implement an EBT statewide. A team of diverse stakeholders including state policy makers, payers, consumers, service providers, and academics from different, but complementary areas (e.g., public health, social work, psychiatry), has been assembled to guide the research plan by incorporating input from multidimensional perspective.Trial Registration: ClinicalTrials.gov: NCT02543359. [ABSTRACT FROM AUTHOR]

Background: Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial.Methods: In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model.Results: We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed.Conclusion: Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial.Trial Registration: Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009. [ABSTRACT FROM AUTHOR]

Background: Competing health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Guideline implementation interventions rarely acknowledge this, leaving both patients and providers feeling overwhelmed by the volume of recommended actions. Interprofessional (IP) shared decision-making (SDM) with the use of decision aids may help to set treatment priorities. We developed an evidence-based SDM intervention for patients with diabetes and other conditions that was framed by the IP-SDM model and followed a user-centered approach. Our objective in the present study is to pilot an IP-SDM and goal-setting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care.Methods/design: A two-step, parallel-group, clustered randomized controlled trial (RCT) will be conducted, with the primary goal being to assess intervention fidelity and the feasibility of conducting a larger RCT. The first step is a provider-directed implementation only; the second (after a 6-month delay) involves both provider- and patient-directed implementation. Half of the clusters will be assigned to receive the IP-SDM toolkit, and the other will be assigned to be mailed a diabetes guidelines summary. Individual interviews with patients, their family members and health care providers will be conducted upon trial completion to explore toolkit use. A secondary purpose of this trial is to gather estimates of the toolkit's impact on decisional conflict. Secondary outcomes include diabetes distress, quality of life and chronic illness care, which will be assessed on the basis of patient-completed questionnaires of validated scales at baseline and at 6 and 12 months. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.Discussion: An individualized approach to patients with multiple chronic conditions using SDM and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion. Our pilot trial will provide insights regarding strategies for the routine implementation of such interventions in clinical practice, and it will offer an assessment of the impact of this approach.Trial Registration: Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015. [ABSTRACT FROM AUTHOR]

Background: We aimed to make individual patient data from the International Stroke Trial (IST), one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.Methods: For each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point (14-days after randomisation or prior discharge) and at 6-months and provide them as an analysable database.Results: The IST dataset includes data on 19 435 patients with acute stroke, with 99% complete follow-up. Over 26.4% patients were aged over 80 years at study entry. Background stroke care was limited and none of the patients received thrombolytic therapy.Conclusions: The IST dataset provides a source of primary data which could be used for planning further trials, for sample size calculations and for novel secondary analyses. Given the age distribution and nature of the background treatment given, the data may be of value in planning trials in older patients and in resource-poor settings. [ABSTRACT FROM AUTHOR]

Background: Early identification and management of mental illness in childhood and adolescence helps to avert debilitating mental illness in adulthood but the attention given to Child and Adolescent Mental Health (CAMH) has until recently been low. Traditional healers are often consulted by patients with mental illness and in Uganda, up to 60% of patients attending traditional healers have moderate to severe mental illness. Poor access to CAMH care in Uganda creates a treatment gap that could be met through enhanced collaboration between traditional healers and biomedical health systems. The aim of this study was to explore traditional healers' views on their collaboration with biomedical health systems so as to inform the implementation of strategies to improve access to CAMH services in Uganda.Methods: In-depth interviews with 20 purposively selected traditional healers were conducted in November 2015. A semi-structured interview guide was used to explore: 1) The experiences of traditional healers with mental ill-health in children and adolescents; 2) their willingness to collaborate with the formal health system; and 3) their perception of clinicians' willingness to collaborate with them. Interviews were conducted in local languages and tape recorded. Data were analysed using thematic analysis.Results: Traditional healers described several experiences managing children and adolescents with mental illness, which they ascribed to spiritual and physical causes. The spiritual explanations were a consequence of unhappy ancestral spirits, modern religions and witchcraft, while physical causes mentioned included substance abuse and fevers. No traditional healer had received a patient referred to them from a medical clinic although all had referred patients to clinics for non-mental health reasons. Traditional healers expressed distrust in biomedical health systems and believed their treatments were superior to medical therapies in alleviating mental suffering. They expressed willingness to collaborate with biomedical providers. However, traditional healers believe clinicians disregard them and would not be willing to collaborate with them.Conclusion: Potential for collaboration between traditional healers and biomedical health systems for improving access to CAMH services in Uganda exists, but is undermined by mutual mistrust and competition between traditional healers and clinicians. [ABSTRACT FROM AUTHOR]

Rare disease represents one of the most significant issues facing the medical community and health care providers worldwide, yet the majority of these disorders never emerge from their obscurity, drawing little attention from the medical community or the pharmaceutical industry. The challenge therefore is how best to mobilize rare disease stakeholders to enhance basic, translational and clinical research to advance understanding of pathogenesis and accelerate therapy development. Here we describe a rare, fatal brain disorder known as Niemann-Pick type C (NPC) and an innovative research collaborative known as Support of Accelerated Research for NPC (SOAR-NPC) which illustrates one pathway through which knowledge of a rare disease and its possible treatments are being successfully advanced. Use of the "SOAR" mechanism, we believe, offers a blueprint for similar advancement for many other rare disorders. [ABSTRACT FROM AUTHOR]

Background: BETTER (Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Primary Care) is a patient-based intervention to improve chronic disease prevention and screening (CDPS) for cardiovascular disease, diabetes, cancer, and associated lifestyle factors in patients aged 40 to 65. The key component of BETTER is a prevention practitioner (PP), a health care professional with specialized skills in CDPS who meets with patients to develop a personalized prevention prescription, using the BETTER toolkit and Brief Action Planning. The purpose of this qualitative study was to understand facilitators and barriers of the implementation of the BETTER 2 program among clinicians, patients, and stakeholders in three (urban, rural, and remote) primary care settings in Newfoundland and Labrador, Canada.Methods: We collected and analyzed responses from 20 key informant interviews and 5 focus groups, as well as memos and field notes. Data were organized using Nvivo 10 software and coded using constant comparison methods. We then employed the Consolidated Framework for Implementation Research (CFIR) to focus our analysis on the domains most relevant for program implementation.Results: The following key elements, within the five CFIR domains, were identified as impacting the implementation of BETTER 2: (1) intervention characteristics-complexity and cost of the intervention; (2) outer setting-perception of fit including lack of remuneration, lack of resources, and duplication of services, as well as patients' needs as perceived by physicians and patients; (3) characteristics of prevention practitioners-interest in prevention and ability to support and motivate patients; (4) inner setting-the availability of a local champion and working in a team versus working as a team; and (5) process-planning and engaging, collaboration, and teamwork.Conclusions: The implementation of a novel CDPS program into new primary care settings is a complex, multi-level process. This study identified key elements that hindered or facilitated the implementation of the BETTER approach in three primary care settings in Newfoundland and Labrador. Employing the CFIR as an overarching typology allows for comparisons with other contexts and settings, and may be useful for practices, researchers, and policy-makers interested in the implementation of CDPS programs. [ABSTRACT FROM AUTHOR]

Background: Education Outside the Classroom (EOTC) is a teaching method that aims to promote schoolchildren's learning, physical activity (PA), social relations, motivation, and well-being. EOTC activities are characterized by teachers using the local environment in their teaching, and involve innovative teaching methods, child-led approaches to problem-solving, experimentation, cooperation, PA, and play. EOTC has become common practice for many teachers in Scandinavia; however, only case studies have evaluated its impacts. The TEACHOUT study aims to evaluate the impacts of EOTC on Danish schoolchildren's PA, social relations, motivation, well-being, and learning.Methods: TEACHOUT is a quasi-experimental, cross-disciplinary study. Sixteen schools participated, containing 19 EOTC school classes and 19 parallel non-EOTC classes, with a total of 834 children aged 9 to 13 years. Measures of the children's social relations, motivation for school, well-being, and academic performance were collected at the beginning and end of the school year. Data on PA levels were collected over ten-day periods during the school year using accelerometers. The amount and characteristics of the actual EOTC provided in both EOTC and non-EOTC classes were monitored day-to-day throughout the school year, using an online teacher survey platform. The effects of EOTC are mainly analysed by comparing EOTC pupils to non-EOTC (i.e. control) pupils based on their scores on the outcome variables (i.e. school performance, well-being, motivation, and social relations) at the end of the school year, adjusting for the baseline values (from the beginning of the year). The impacts of EOTC on PA are evaluated by comparing the total as well as context-specific amounts of PA of children participating in EOTC to those of children in their parallel non-EOTC classes. Furthermore, the interdependencies between PA, social relations, well-being, motivation, and learning are explored using path analysis. To help describe and understand the processes that have led to the quantitative outcomes, qualitative case observations of children's practices and interactions in EOTC as well as classroom teaching were carried out and combined with qualitative interviews about children's perceptions of these practices.Discussion: The TEACHOUT study represents a holistic multidisciplinary approach to educational and school health-promotion research through its study design and combination of scientific disciplines and methods, as well as its focus on the interdependent relations between learning, PA, social relations, well-being, and motivation. This will result in a comprehensive picture of school health promotion and children's health and well-being, which will broaden the understanding of the potential benefits of EOTC in school health promotion and primary education. These results can be used to inform and guide future policy and practice. [ABSTRACT FROM AUTHOR]

Background: Service delivery innovation is at the heart of efforts to combat the growing burden of chronic disease and escalating healthcare expenditure. Small-scale, locally-led service delivery innovation is a valuable source of learning about the complexities of change and the actions of local change agents. This exploratory qualitative study captures the perspectives of clinicians and managers involved in a general practitioner-led integrated diabetes care innovation.Methods: Data on these change agents' perspectives on the local innovation and how it works in the local context were collected through focus groups and semi-structured interviews at two primary health care sites. Transcribed data were analysed thematically. Normalization Process Theory provided a framework to explore perspectives on the individual and collective work involved in putting the innovation into practice in local service delivery contexts.Results: Twelve primary health care clinicians, hospital-based medical specialists and practice managers participated in the study, which represented the majority involved in the innovation at the two sites. The thematic analysis highlighted three main themes of local innovation work: 1) trusting and embedding new professional relationships; 2) synchronizing services and resources; and 3) reconciling realities of innovation work. As a whole, the findings show that while locally-led service delivery innovation is designed to respond to local problems, convincing others to trust change and managing the boundary tensions is core to local work, particularly when it challenges taken-for-granted practices and relationships. Despite this, the findings also show that local innovators can and do act in both discretionary and creative ways to progress the innovation.Conclusions: The use of Normalization Process Theory uncovered some critical professional, organizational and structural factors early in the progression of the innovation. The key to local service delivery innovation lies in building coalitions of trust at the point of service delivery and persuading organizational and institutional mindsets to consider the opportunities of locally-led innovation. [ABSTRACT FROM AUTHOR]

Background: The objective of Heart Health NOW (HHN) is to determine if primary care practice support-a comprehensive evidence-based quality improvement strategy involving practice facilitation, academic detailing, technology support, and regional learning collaboratives-accelerates widespread dissemination and implementation of evidence-based guidelines for cardiovascular disease (CVD) prevention in small- to medium-sized primary care practices and, additionally, increases practices' capacity to incorporate other evidence-based clinical guidelines in the future.Methods/design: HHN is a stepped wedge, stratified, cluster randomized trial to evaluate the effect of primary care practice support on evidence-based CVD prevention, organizational change process measures, and patient outcomes. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after the start of the intervention. The intervention will be randomized to practices in one of four strata defined by region of the state (east or west) and degree of practice readiness for change. Seventy-five practices in each region with a high degree of readiness will be randomized 1:1:1 in blocks of 3 sometime prior to month 8 to receive the intervention at month 9, 11, or 12. An additional 75 practices within each region that have a low degree of readiness or are recruited later will be randomized 1:1 in blocks of 2 prior to month 13 to receive the intervention at month 14 or 16. The sites will be ordered within each strata based on time of enrollment with the blocking based on this ordering. Evaluation will examine the effect of primary care practice support on (1) practice-level delivery of evidence-based CVD prevention, (2) patient-level health outcomes, (3) practice-level implementation of clinical and organizational changes that support delivery of evidence-based CVD prevention, and (4) practice-level capacity to implement future evidence-based clinical guidelines.Discussion: Results will indicate whether primary care practice support is an effective strategy for widespread dissemination and implementation of evidence-based clinical guidelines in primary care practices. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.Trial Registration: ClinicalTrials.gov NCT02585557. [ABSTRACT FROM AUTHOR]