Mixed Methods Realist Evaluation Research Articles

A Workplace Intervention to Strengthen Supervisor Support for Employees With Common Mental Health Problems: A Mixed-Methods Realist Evaluation

The purpose of this study is to obtain insight into whether, how and under which circumstances a novel workplace intervention works. This intervention aims to strengthen the supportive behaviour of Dutch supervisors in promoting the work participation of employees with common mental health problems (CMHPs), provided by occupational health professionals (OHPs). In a mixed-methods realist design, we evaluated changes over time, reasoning that supportive behaviour would be changed through motivation and skills and we explored how mechanisms of change may be triggered by personal, environmental and intervention factors. Compared to baseline (n = 92), self-reported supportive behaviour of supervisors increased post-intervention (n = 65, 3 months) and increased significantly post-follow-up (n = 56, 6 months). A statistically significant regression model (R2 = 0.29) indicated that factors such as increased self-efficacy and skills, being assessed as supervisor on sick leave numbers, previous collaboration between OHP and supervisor, and having dealt with CMHP before were positively related to the changes in supervisors’ supportive behaviour. According to supervisors, working mechanisms on the interpersonal level were the OHPs’ expertise and trust and the co-supervisors collective efficacy. On the individual level, mechanisms were self-efficacy, willing to improve and skills to act. Enabling circumstances to trigger those mechanisms were being given time and structural, low-key access to OHP expertise, in a safe learning climate. This preventive, multifaceted, action-oriented workplace intervention had a positive impact on supervisor support in promoting work participation among employees with CMHP. These findings may encourage employers to invest in supervisors’ capacity, thereby enabling employees with CMHP to keep working and perform well in their jobs.

A preventive integrated eHealth approach for individuals with a low socioeconomic position: protocol for a realist evaluation

BackgroundAdoption of standalone eHealth tools is low among persons in lower socioeconomic groups. The preventive integrated eHealth approach combines blended care with an active and personal approach to facilitate access to local care, tailored to the needs of the participant. We describe the four step preventive integrated eHealth approach for individuals with a low socioeconomic position and the realist evaluation protocol of the intervention and implementation. The realist evaluation centers around the question, ‘what works for whom in what circumstances and why’.MethodsThe study population will consist of adult individuals with a low socioeconomic position, who participate in the preventive integrated eHealth approach in one of the participating locations in the Netherlands. The four-step intervention consists of: (1) a proactive invitation of participants by care professionals, (2) the use of an eHealth tool that produces a personalized health report, (3) a personal consultation with a care professional to discuss the personalized health report and set a goal to work on, and (4) active referral to local social and health care. An initial program theory theorized from literature and stakeholder involvement is presented. Qualitative and quantitative data collection and analysis with participants (survey at zero, three and twelve months and focus groups at six months) and professionals (interviews at three months) will inform the realist evaluation and serves to test and refine the initial program theory.DiscussionOur mixed-methods realist evaluation on the effect and implementation of a personal and active blended care approach will elucidate what elements trigger the mechanisms and responses of how individuals with a low socioeconomic position experience the preventive integrated eHealth approach. This will inform the way a preventative health check incorporating eHealth can be used to its full potential for low socioeconomic positioned groups to help close the digital divide and contribute to reduce health disparities.

Dementia care coordinators in primary care: a realist evaluation.

A dementia care coordinator (DCC) service has recently been implemented across Kent and Medway Integrated Care Board (ICB). DCCs are provided at the primary care network (PCN) level and work closely with GP practice teams. The service is intended to help service users navigate the care system and provide proactive support to mitigate crisis points. However, the value of this service from key stakeholder perspectives is not yet known. To understand: 1) how the DCC service works, for whom, and in what circumstances; and 2) identify outcomes, resource implications, and costs. The study uses mixed-methods realist evaluation with an embedded economic component. Data collection includes: questionnaires, service provider metrics, and qualitative interviews with healthcare practitioners and service users. Interpretive comparative analysis and narrative synthesis including evaluation of service costs against outcomes will produce a refined final programme theory. Patient and public involvement have been consulted throughout. Preliminary results indicate that when embedded in a local practice, healthcare practitioners including GPs welcome DCC involvement. DCCs act as community lynchpins, bridging service users to appropriate care pathways. The service may be capable of increasing diagnosis rates and reducing crisis points. However, caseloads are currently untamed. Therefore, the service and its workforce are becoming over-stretched. This evaluation describes preliminary findings from a recently implemented DCC service in Kent and Medway ICB. There is a crucial need to enhance the support of this workforce in order to ensure sustainability of this service. These findings will inform service development and future investment decisions.

Evaluation of different models of general practitioners working in or alongside emergency departments: a mixed-methods realist evaluation.

Emergency healthcare services are under intense pressure to meet increasing patient demands. Many patients presenting to emergency departments could be managed by general practitioners in general practitioner-emergency department service models. To evaluate the effectiveness, safety, patient experience and system implications of the different general practitioner-emergency department models. Mixed-methods realist evaluation. Phase 1 (2017-8), to understand current practice: rapid realist literature review, national survey and follow-up key informant interviews, national stakeholder event and safety data analysis. Phase 2 (2018-21), to collect and analyse qualitative (observations, interviews) and quantitative data (time series analysis); cost-consequences analysis of routine data; and case site data for 'marker condition' analysis from a purposive sample of 13 case sites in England and Wales. Phase 3 (2021-2), to conduct mixed-methods analysis for programme theory and toolkit development. General practitioners commonly work in emergency departments, but delivery models vary widely in terms of the scope of the general practitioner role and the scale of the general practitioner service. We developed a taxonomy to describe general practitioner-emergency department service models (Integrated with the emergency department service, Parallel within the emergency department, Outside the emergency department on the hospital site) and present a programme theory as principal output of the study to describe how these service models were observed to operate. Routine data were of variable quality, limiting our analysis. Time series analysis demonstrated trends across intervention sites for: increased time spent in the emergency department; increased emergency department attendances and reattendances; and mixed results for hospital admissions. Evidence on patient experience was limited but broadly supportive; we identified department-level processes to optimise the safety of general practitioner-emergency department models. The quality, heterogeneity and extent of routine emergency department data collection during the study period limited the conclusions. Recruitment was limited by criteria for case sites (time series requirements) and individual patients (with 'marker conditions'). Pandemic and other pressures limited data collection for marker condition analysis. Data collected and analysed were pre pandemic; new approaches such as 'telephone first' and their relevance to our findings remains unexplored. Findings suggest that general practitioner-emergency department service models do not meet the aim of reducing the overall emergency department waiting times and improving patient flow with limited evidence of cost savings. Qualitative data indicated that general practitioners were often valued as members of the wider emergency department team. We have developed a toolkit, based on our findings, to provide guidance for implementing and delivering general practitioner-emergency department services. The emergency care data set has since been introduced across England to help standardise data collection to facilitate further research. We would advocate the systematic capture of patient experience measures and patient-reported outcome measures as part of routine care. More could be done to support the development of the general practitioner in emergency department role, including a core set of competencies and governance structure, to reflect the different general practitioner-emergency department models and to evaluate the effectiveness and cost effectiveness to guide future policy. This study is registered as PROSPERO CRD42017069741. This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/145/04) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 10. See the NIHR Funding and Awards website for further award information.

Implementation of large, multi-site hospital interventions: a realist evaluation of strategies for developing capability

BackgroundThis study presents guidelines for implementation distilled from the findings of a realist evaluation. The setting was local health districts in New South Wales, Australia that implemented three clinical improvement initiatives as part of a state-wide program. We focussed on implementation strategies designed to develop health professionals’ capability to deliver value-based care initiatives for multisite programs. Capability, which increases implementers’ ability to cope with unexpected scenarios is key to managing change.MethodsWe used a mixed methods realist evaluation which tested and refined program theories elucidating the complex dynamic between context (C), mechanism (M) and outcome (O) to determine what works, for whom, under what circumstances. Data was drawn from program documents, a realist synthesis, informal discussions with implementation designers, and interviews with 10 key informants (out of 37 identified) from seven sites. Data analysis employed a retroductive approach to interrogate the causal factors identified as contributors to outcomes.ResultsCMO statements were refined for four initial program theories: Making it Relevant– where participation in activities was increased when targeted to the needs of the staff; Investment in Quality Improvement– where engagement in capability development was enhanced when it was valued by all levels of the organisation; Turnover and Capability Loss– where the effects of staff turnover were mitigated; and Community-Wide Priority– where there was a strategy of spanning sites. From these data five guiding principles for implementers were distilled: (1) Involve all levels of the health system to effectively implement large-scale capability development, (2) Design capability development activities in a way that supports a learning culture, (3) Plan capability development activities with staff turnover in mind, (4) Increased capability should be distributed across teams to avoid bottlenecks in workflows and the risk of losing key staff, (5) Foster cross-site collaboration to focus effort, reduce variation in practice and promote greater cohesion in patient care.ConclusionsA key implementation strategy for interventions to standardise high quality practice is development of clinical capability. We illustrate how leadership support, attention to staff turnover patterns, and making activities relevant to current issues, can lead to an emergent learning culture.

Realist evaluation of maternity waiting home intervention models in Inhambane, Mozambique: protocol for a comparative embedded case study, the Mozambique-Canada Maternal Health Project

IntroductionThis is a study protocol that tests and refines realist theories regarding the uptake and scale-up of the linked maternity waiting home (hereafter MWH) and facility birth intervention in the...

Developing and evaluating Compassionate Workplace Programs to promote health and wellbeing around serious illness, dying and loss in the workplace (EU-CoWork): a transdisciplinary, cross-national research project

Background: Most employees will experience serious illness, caregiving, dying and loss (End-of-Life (EoL) experiences) at multiple points throughout their working lives. These experiences impact affected employees but also their colleagues in terms of health and wellbeing, and the workplace as a whole in terms of workplace safety, productivity and labour relations. The impact of EoL experiences on employees means that workplaces are called to play a more active role in providing support for EoL experiences. Aim: To describe how the EU-CoWork (2024–2028) project addresses its main aims to (1) create Compassionate Workplace cultures, practices and policies and improve health and wellbeing for employees dealing with EoL experiences in different national work contexts in Europe; (2) describe and evaluate the process of co-creation and implementation of Compassionate Workplace Programs (CWPs) and how these influence the programs’ outcomes. Design: EU-CoWork employs a facilitated and co-creative Developmental Evaluation approach to the development of 12 tailored CWPs across four European countries (Belgium, Austria, Sweden and Greece). Methods: To evaluate the outcomes and processes leading to these outcomes, a mixed-methods Realist Evaluation methodology is applied, formulating and testing Context-Mechanism-Outcomes configurations and combining longitudinal quantitative and qualitative data collections. Results: EU-CoWork will generate evidence to support an expanded model of occupational health and safety risk factors sensitive to the specific challenges related to employees’ EoL experiences. In doing so, several challenges will have to be navigated: involving employees with EoL experiences while avoiding overburdening them, avoiding tokenistic engagement, managing power differentials, balancing the need for scientific rigour with the flexibility required in co-creation, reconciling different epistemologies and disciplinary traditions and organisational resistance to change. Conclusion: There are potential long-lasting broader societal impacts through the stimulation of open discourse on EoL topics, the reconciliation of work and care, and changes in gendered work and care patterns.

Four System Enablers of Large-System Transformation in Health Care: A Mixed Methods Realist Evaluation.

Large-scale transformative initiatives have the potential to improve the quality, efficiency, and safety of health care. However, change is expensive, complex, and difficult to implement and sustain. This paper advances system enablers, which will help to guide large-scale transformation in health care systems. A realist study of the implementation of a value-based health care program between 2017 and 2021 was undertaken in every public hospital (n = 221) in New South Wales (NSW), Australia. Four data sources were used to elucidate initial program theories beginning with a set of literature reviews, a program document review, and informal discussions with key stakeholders. Semistructured interviews were then conducted with 56 stakeholders to confirm, refute, or refine the theories. A retroductive analysis produced a series of context-mechanism-outcome (CMO) statements. Next, the CMOs were validated with three health care quality expert panels (n = 51). Synthesized data were interrogated to distill the overarching system enablers. Forty-two CMO statements from the eight initial program theory areas were developed, refined, and validated. Four system enablers were identified: (1) build an authorizing environment; (2) provide relevant, authentic, timely, and meaningful data; (3) designate and distribute leadership and decision making; and (4) support the emergence of a learning culture. The system enablers provide a nuanced understanding of large-system transformation that illustrates when, for whom, and in what circumstances large-system transformation worked well or worked poorly. System enablers offer nuanced guidance for the implementation of large-scale health care interventions. The four enablers may be portable to similar contexts and provide the empirical basis for an implementation model of large-system value-based health care initiatives. With concerted application, these findings can pave the way not just for a better understanding of greater or lesser success in intervening in health care settings but ultimately to contribute higher quality, higher value, and safer care.

Family carer experiences of hospice care at home: Qualitative findings from a mixed methods realist evaluation

Background: Hospice-at-home aims to enable patients approaching end-of-life to die at home and support their carers. A wide range of different service models exists but synthesised evidence on how best to support family carers to provide sustainable end-of-life care at home is limited. Aim: To explore what works best to promote family carers’ experiences of hospice-at-home. Design: Realist evaluation with mixed methods. This paper focuses on qualitative interviews with carers (to gain their perspective and as proxy for patients) and service providers from 12 case study sites in England. Interviews were coded and programme theories were refined by the research team including two public members. Setting/participants: Interviews with carers (involved daily) of patients admitted to hospice-at-home services (n = 58) and hospice-at-home staff (n = 78). Results: Post bereavement, 76.4% of carers thought that they had received as much help and support as they needed and most carers (75.8%) rated the help and support as excellent or outstanding. Of six final programme theories capturing key factors relevant to providing optimum services, those directly relevant to carer experiences were: integration and co-ordination of services; knowledge, skills and ethos of hospice staff; volunteer roles; support directed at the patient–carer dyad. Conclusions: Carers in hospice-at-home services identified care to be of a higher quality than generic community services. Hospice staff were perceived as having ‘time to care’, communicated well and were comfortable with dying and death. Hands-on care was particularly valued in the period close to death.

Understanding Whether and How a Digital Health Intervention Improves Transition Care for Emerging Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Realist Evaluation.

Emerging adults living with type 1 diabetes (T1D) face a series of challenges with self-management and decreased health system engagement, leading to an increased risk of acute complications and hospital admissions. Effective and scalable strategies are needed to support this population to transfer seamlessly from pediatric to adult care with sufficient self-management capability. While digital health interventions for T1D self-management are a promising strategy, it remains unclear which elements work, how, and for which groups of individuals. This study aims to evaluate the design and implementation of a multicomponent SMS text message-based digital health intervention to support emerging adults living with T1D in real-world settings. The objectives are to identify the intervention components and associated mechanisms that support user engagement and T1D health care transition experiences and determine the individual characteristics that influence the implementation process. We used a realist evaluation embedded alongside a randomized controlled trial, which uses a sequential mixed methods design to analyze data from multiple sources, including intervention usage data, patient-reported outcomes, and realist interviews. In step 1, we conducted a document analysis to develop a program theory that outlines the hypothesized relationships among "individual-level contextual factors, intervention components and features, mechanisms, and outcomes," with special attention paid to user engagement. Among them, intervention components and features depict 10 core characteristics such as transition support information, problem-solving information, and real-time interactivity. The proximal outcomes of interest include user engagement, self-efficacy, and negative emotions, whereas the distal outcomes of interest include transition readiness, self-blood glucose monitoring behaviors, and blood glucose. In step 2, we plan to conduct semistructured realist interviews with the randomized controlled trial's intervention-arm participants to test the hypothesized "context-intervention-mechanism-outcome" configurations. In step 3, we plan to triangulate all sources of data using a coincidence analysis to identify the necessary combinations of factors that determine whether and how the desired outcomes are achieved and use these insights to consolidate the program theory. For step 1 analysis, we have developed the initial program theory and the corresponding data collection plan. For step 2 analysis, participant enrollment for the randomized controlled trial started in January 2023. Participant enrollment for this realist evaluation was anticipated to start in July 2023 and continue until we reached thematic saturation or achieved informational power. Beyond contributing to knowledge on the multiple pathways that lead to successful engagement with a digital health intervention as well as target outcomes in T1D care transitions, embedding the realist evaluation alongside the trial may inform real-time intervention refinement to improve user engagement and transition experiences. The knowledge gained from this study may inform the design, implementation, and evaluation of future digital health interventions that aim to improve transition experiences. PRR1-10.2196/46115.

The Impact of Ex-Post Legislative Evaluations in Healthcare: A Mixed Methods Realist Evaluation Study Protocol for Conducting Case Studies.

Recent studies on the impact of ex-post legislative evaluations show that there are different types of impact and different factors that can influence it. These include the context of a legislative evaluation, research quality, and interactions between researchers and other actors within the evaluation process. However, thorough empirical research in this area is lacking. This warrants empirical research into the factors that influence the impact of ex-post legislative evaluations, so these insights can be used to increase the likelihood of ex-post legislative evaluations having an impact. In this protocol, we report on the realist evaluation methodology that will be used to evaluate the impact of three ex-post legislative evaluations in the Dutch healthcare sector. The mixed methods realist evaluation approach will facilitate this theory-driven, qualitative research. The study will consist of the following three steps: (1) Initial programme theory development, (2) theory validation, and (3) theory refinement. Knowledge from two scoping reviews conducted previously, and two subsequent expert meetings will form the basis for developing the initial programme theory. During this study, three case studies will be conducted, in which three individual ex-post legislative evaluations will be examined. Specificmethods for data collection will include: documentary review, observation, structured questionnaires and focus group discussions with purposefully identified key stakeholders. Using the framework approach, the data will be analysed thematically in a within-case analysis followed by a cross-case analysis. This protocol provides insight into how the study will be conducted. As this study uses multiple qualitative researchmethods to answer one question, this protocol supports refining data collection procedures. Careful consideration of the approach beforehand can minimise pitfalls, reduce publication bias and improve reproducibility. The protocol therefore specifies how the research question will be answered in detail, and this provides solid guidance for the research process.

Unravelling the potential of social prescribing in individual-level type 2 diabetes prevention: a mixed-methods realist evaluation

BackgroundSocial prescribing (SP) usually involves linking patients in primary care with services provided by the voluntary and community sector. Preliminary evidence suggests that SP may offer a means of connecting patients with community-based health promotion activities, potentially contributing to the prevention of long-term conditions, such as type 2 diabetes (T2D).MethodsUsing mixed-methods realist evaluation, we explored the possible contribution of SP to individual-level prevention of T2D in a multi-ethnic, socio-economically deprived population in London, UK. We made comparisons with an existing prevention programme (NHS Diabetes Prevention Programme (NDPP)) where relevant and possible. Anonymised primary care electronic health record data of 447,360 people 18+ with an active GP registration between December 2016 and February 2022 were analysed using quantitative methods. Qualitative data (interviews with 11 primary care clinicians, 11 social prescribers, 13 community organisations and 8 SP users at high risk of T2D; 36 hours of ethnographic observations of SP and NDPP sessions; and relevant documents) were analysed thematically. Data were integrated using visual means and realist methods.ResultsPeople at high risk of T2D were four times more likely to be referred into SP than the eligible general population (RR 4.31 (95% CI 4.17–4.46)), with adjustment for socio-demographic variables resulting in attenuation (RR 1.33 (95% CI 1.27–1.39)). More people at risk of T2D were referred to SP than to NDPP, which could be explained by the broad referral criteria for SP and highly supportive (proactive, welcoming) environments. Holistic and sustained SP allowed acknowledgement of patients’ wider socio-economic constraints and provision of long-term personalised care. The fact that SP was embedded within the local community and primary care infrastructure facilitated the timely exchange of information and cross-referrals across providers, resulting in enhanced service responsiveness.ConclusionsOur study suggests that SP may offer an opportunity for individual-level T2D prevention to shift away from standardised, targeted and short-term strategies to approaches that are increasingly personalised, inclusive and long-term. Primary care-based SP seems most ideally placed to deliver such approaches where practitioners, providers and commissioners work collectively to achieve holistic, accessible, sustained and integrated services.

Evaluating the implementation and impact of a new model of care for integrating children and young people’s acute mental healthcare in a paediatric setting: a protocol for a realist, mixed-methods approach

IntroductionThe mental health of children and young people in the UK has been declining and has continued to worsen throughout the pandemic, leading to an increase in mental health-related emergencies....

“When there's collective leadership, there's the power to make changes”: A realist evaluation of a collective leadership intervention (Co-Lead) in healthcare teams

There is accumulating evidence for collective approaches to leadership, where multiple individuals share leadership roles, but there remains a lack of theory-informed research on how collective leadership is fostered in practice. This study evaluated the impact of a collective leadership intervention, exploring what works for whom, how, and under what circumstances through a mixed-methods realist evaluation of four case studies. Eight context-mechanism-outcome configurations (theories) were extrapolated that elucidate the mechanisms triggered to drive outcomes in particular settings. This is the first study to apply a realist lens to understand collective leadership and articulate the generative mechanisms that enable/inhibit collective leadership in healthcare teams.

Telehealth delivery of paediatric rehabilitation for children with neurodisability: A mixed methods realist evaluation of contexts, mechanisms and outcomes.

Teledelivery of rehabilitation services has been proposed as a cost-effective option for supporting children with neurodisability and their families. However, little is understood of the conditions that support uptake of telehealth in paediatric rehabilitation, what is delivered during telehealth or perceptions of its outcomes. The aim of this study was to identify the context, process and outcomes of telehealth for children with neurodisability and their families. A secondary objective was to identify if variations in these aspects of telehealth occurred for Māori, the indigenous people of New Zealand. A mixed-methods, three phase, realist evaluation identified context-mechanism-outcome configurations (CMOcs) of telehealth. In Phase 1, the Determinants of Implementation Behaviour Questionnaire indicated factors affecting practitioner uptake of telehealth (Context). In Phase 2, a casenote audit identified 'practitioner input' during telehealth (Mechanism). Phase 3 interviews with practitioners and parents explored 'parent response' to telehealth and practitioner and parent perceptions of its value (Mechanism and Outcomes). Subgroup analyses for Māori were planned. From Phase 1, practitioners (29/37, 78%) intended to use telehealth; however, few did so regularly (7/37, 22%). Positive experiences of telehealth were described by all practitioners (n = 5) and families (n = 7) in Phase 3. CMOcs explained that practitioners' offering of telehealth occurred when practitioners were confident, valued access to therapy over the familiarity of in-person delivery, and when practitioners used coaching-style communication. Parents were receptive to telehealth when they trusted practitioners, felt listened to and were offered telehealth as a choice. When telehealth occurred, access to therapy was timely and more consistent than in-person delivery. Child outcomes appeared to be positive. Confidence in offering telehealth to Māori was low. Initiatives to improve uptake of telehealth in paediatric rehabilitation should focus on creating conditions for practitioner implementation. Training in telehealth should include engagement with Māori. Adequate workspace and workplace culture change are required if telehealth is to be offered beyond the current 'early adopters'.

Exploring two distinct gentamicin prescribing protocols in UK hospitals: a mixed-methods realist evaluation

ObjectivesGentamicin is the aminoglycoside antibiotic of choice in the UK. It has a narrow therapeutic index: underdosing results in inefficacy while overdosing is characterised by nephrotoxicity and ototoxicity. To improve...

A Mixed-Methods Realist Evaluation of the Implementation and Impact of Community Forensic CAMHS to Manage Risk for Young People With Forensic and Mental Health Needs: Study Protocol.

Introduction: Young people in contact with forensic child and adolescent mental health services present with more complex needs than young people in the general population. Recent policy has led to the implementation of new workstreams and programmes to improve service provision for this cohort. This paper aims to present the protocol for a national study examining the impact and implementation of Community Forensic Child and Adolescent Mental Health Services (F:CAMHS).Methods and analysis: The study will use a mixed-methods Realist Evaluation design. Quantitative service activity and feedback data will be collected from all 13 sites, as well as questionnaires from staff. Non-participant observations and qualitative interviews will be conducted with staff, young people and parents/guardians from four focus study sites. An economic evaluation will examine whether Community F:CAMHS provides good value for money. The results will be triangulated to gain an in-depth understanding of young people's, parents/guardians' and staff experiences of the service.Ethics and dissemination: Ethical approval was granted by the Health Research Association and UCL Ethics. The results will be disseminated via project reports, feedback to sites, peer-reviewed journal publications and conference presentations.

A realist evaluation exploring simulated patient role-play in pharmacist undergraduate communication training

BackgroundEffective communication between pharmacists and patients is essential and improves health outcomes. Simulated patients (SPs) are trained to reproduce real-life situations and can help pharmacy students to develop and adapt their communication skills in a safe, learner-centred environment. The aim of this research was to explore how SP and pharmacy student role-play supports communication training.MethodsA mixed methods realist evaluation approach was adopted to test an initial theory relating to SP role-play for pharmacy students. The intervention tested involved complex communication cases in a men’s and women’s health module in year three of a new MPharm programme. This SP session was the first such session, of the programme which exclusively focused on complex communication skills for the students. Data collected comprised video-recordings of both training and mock OSCE sessions, and from student focus groups. Communication videos were scored using the Explanation and Planning Scale (EPSCALE) tool. Scores from SP and mock OSCE sessions were compared using the Wilcoxon-signed rank test. Focus groups were conducted with students about their experience of the training and analysed thematically, through a realist lens. Data was analysed for Context-Mechanism-Outcome configurations to produce modified programme theories.ResultsForty-six students (n = 46/59, 78 %) consented to their video-recorded interactions to be used. Students identified contextual factors relating to the timing within the course and the setting of the intervention, the debrief and student individual contexts. Mechanisms included authenticity, feedback, reflection, self-awareness and confidence. Negative responses included embarrassment and nervousness. They distinguished outcomes including increased awareness of communication style, more structured communication and increased comfort. However quantitative data showed a decrease (p < 0.001) in communication scores in the mock OSCE compared with scores from training sessions. Modified programme theories relating to SP training for pharmacy students were generated.ConclusionsSP role-play is a valuable communication skills training approach. Emphasis should be placed on multiple stakeholder feedback and promotion of reflection. Time limits need to be considered in this context and adjusted to meet student needs, especially for students with lower levels of communication comfort and those communicating in languages different to their first language.

Evaluation of a health-related intervention to reduce overweight, obesity and increase employment in France and the United Kingdom: a mixed-methods realist evaluation protocol

BackgroundObesity, overweight and unemployment are interlinked, with debilitating effects on mortality, health, wellbeing and quality of life. Existing interventions to reduce overweight, obesity and unemployment have addressed these challenges independent of each other with limited success. The Adding to Social capital and individual Potential In disadvantaged REgions (ASPIRE) project will develop an innovative model using a combination of skills training and health and wellbeing interventions to improve health, wellbeing, quality of life and reduce overweight, obesity and unemployment in England and France. The aim of this paper is to outline the protocol for evaluating the ASPIRE project to examine the effectiveness of the intervention and clarify the mechanisms and contextual factors which interact to achieve outcomes.MethodsA mixed-method realist evaluation using a single-group before-and-after design will be used. The evaluation will consist of development of an initial programme theory, theory validation and refinement using quantitative and qualitative data to understand the causal mechanisms, contexts of implementation and their interactions that result in outcomes observed in ASPIRE. Primary outcomes that will be assessed are change in body weight and body mass index, reemployment and a rise on the ASPIRE participation ladder. The ASPIRE participation ladders consists of a series of 5 steps to engage participants in the project. The first step on the ladder is joining an ASPIRE hub with paid employment as the final step on the ladder. Secondary outcomes will be physical activity, diet quality, self-efficacy and health-related quality of life. Both quantitative and qualitative approaches are appropriate in this study because the use of validated questionnaires and objective measures will demonstrate how much the intervention addressed outcomes related to weight loss and reemployment and the qualitative data (photovoice) will provide insights into the contexts and experiences that are unique to participants in the project.DiscussionThe results from this evaluation will provide an understanding of how a model of health-related interventions which improve health, wellbeing and maintenance of a healthy lifestyle could reduce overweight, obesity and unemployment. The findings will enable the adaptation of this model for effective implementation in different contexts and circumstances.Trial registrationISRCTN registry: Study ID: ISRCTN17609001, 24th February 2021 (Retrospectively registered).

Study protocol: a mixed-methods realist evaluation of the Universal Health Visiting Pathway in Scotland

IntroductionThe growing political emphasis on the early years reflects the importance of these formative years of life. Health visitors in the UK are uniquely positioned to improve health outcomes for...