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

Policy Points The implementation of large-scale health care interventions relies on a shared vision, commitment to change, coordination across sites, and a spanning of siloed knowledge. Enablers of the system should include building an authorizing environment; providing relevant, meaningful, transparent, and timely data; designating and distributing leadership and decision making; and fostering the emergence of a learning culture. Attention to these four enablers can set up a positive feedback loop to foster positive change that can protect against the loss of key staff, the presence of lone disruptors, and the enervating effects of uncertainty. CONTEXT: 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. METHODS: 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. FINDINGS: 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. CONCLUSIONS: 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.

How does mentoring occupational therapists improve intervention fidelity in a randomised controlled trial? A realist evaluation.

BACKGROUND: Integrating complex interventions within healthcare settings can be challenging. Mentoring can be embedded within a randomised controlled trial (RCT) to upskill and support those delivering the intervention. This study aimed to understand, from a realist perspective, how mentoring worked to support implementation fidelity for occupational therapists (OTs) delivering a vocational rehabilitation (VR) intervention within the context of an RCT. METHODS: A realist evaluation using secondary data (emails, mentoring record forms, interviews) collected as part of an RCT. Three researchers coded the data following content analysis, focused on refining or refuting an initial programme theory by exploring the interactions between context, mechanisms, and outcomes. The research team met to further refine the programme theories. RESULTS: Data from 584 emails, 184 mentoring record forms, and 25 interviews were analysed following a realist approach. We developed a programme theory consisting of two contexts (trial set-up, ongoing mentoring), nine mechanisms (collective understanding, monitoring, timely support, positive reinforcement, reflective practice, support data completeness, facilitation strategy, shared learning experience, management of research and clinical duties), and three outcomes (improved confidence, improved fidelity, reduced contamination). CONCLUSIONS: Offering mentoring support to OTs delivering a VR intervention as part of an RCT improves intervention fidelity and reduces the risk of contamination. It improves OTs' understanding of the differences between their clinical and research roles and increases their confidence and competence in trial paperwork completion and identification of potential contamination issues.

Realist evaluation of a community-based antiretroviral therapy (CBART) programme for key populations in Benue State in Nigeria.

BACKGROUND: World Health Organization recommended community-based ART (CBART) approaches to improve access to antiretroviral treatment (ART) and treatment outcomes among key populations living with (KPLHIV). Key populations (KP) are female sex workers, men who have sex with men, persons who inject drugs, and transgender people. How CBART for KP (KP-CBART) worked and why, for whom and in what circumstances it worked within KP communities or at community sites, are yet to be described. The aim of this study is to describe the different KP-CBART approaches or models in Nigeria, identifying the context conditions and mechanisms that are likely to produce the desired outcomes. METHOD: Building on our previous study eliciting an initial programme theory for KP-CBART, we used a multiple case design and cross-case analysis to evaluate 3 KP-CBART approaches, namely: One Stop Shop clinic; community drop-in centre; and outreach venue. Between 2021 and 2023, we conducted a retrospective cohort study, 99 indepth interviews and 5 focused group discussions with various actors. Using realist evaluation, we synthesised context-mechanism-outcome configurations (CMOCs) and developed programme theory for each of the cases and an overall theory. RESULT: The analysis showed the central importance of decentralizing ART service delivery to a safe place within the community for KPLHIV. The provision of ART in a KP friendly environment triggered a feeling of safety and trust in the healthcare workers among KPLHIV, resulting in KP-CBART acceptance and improved ART uptake, medication adherence and retention on ART. KP community engagement in ART delivery, peer support through support group meetings, and linkages with KP-led organizations improved self-efficacy, fostered solidarity and a sense of belonging among KP. These resources encouraged and motivated clients to engage with the KP-CBART model. However, fear of disclosure of HIV and KP status, and lack of trust between KP groups, demotivated and discouraged KPLHIV from initiating ART and continuing their treatment in KP-CBART. CONCLUSION: To optimise access to ART and treatment outcomes for KPLHIV, policy makers and health practitioners should ensure the provision of a safe place for ART service delivery that can be trusted by the clients and the KP communities.

Mental health stigma and health-seeking behaviors amongst pregnant women in Vietnam: a mixed-method realist study.

BACKGROUND: Approximately 15% of women in low-and middle-income countries experience common perinatal mental disorders. Yet, many women, even if diagnosed with mental health conditions, are untreated due to poor quality care, limited accessibility, limited knowledge, and stigma. This paper describes how mental health-related stigma influences pregnant women's decisions not to disclose their conditions and to seek treatment in Vietnam, all of which exacerbate inequitable access to maternal mental healthcare. METHODS: A mixed-method realist study was conducted, comprising 22 in-depth interviews, four focus group discussions (total participants n = 44), and a self-administered questionnaire completed by 639 pregnant women. A parallel convergent model for mixed methods analysis was employed. Data were analyzed using the realist logic of analysis, an iterative process aimed at refining identified theories. Survey data underwent analysis using SPSS 22 and descriptive analysis. Qualitative data were analyzed using configurations of context, mechanisms, and outcomes to elucidate causal links and provide explanations for complexity. RESULTS: Nearly half of pregnant women (43.5%) would try to hide their mental health issues and 38.3% avoid having help from a mental health professional, highlighting the substantial extent of stigma affecting health-seeking and accessing care. Four key areas highlight the role of stigma in maternal mental health: fear and stigmatizing language contribute to the concealment of mental illness, rendering it unnoticed; unconsciousness, normalization, and low literacy of maternal mental health; shame, household structure and gender roles during pregnancy; and the interplay of regulations, referral pathways, and access to mental health support services further compounds the challenges. CONCLUSION: Addressing mental health-related stigma could influence the decision of disclosure and health-seeking behaviors, which could in turn improve responsiveness of the local health system to the needs of pregnant women with mental health needs, by offering prompt attention, a wide range of choices, and improved communication. Potential interventions to decrease stigma and improve access to mental healthcare for pregnant women in Vietnam should target structural and organizational levels and may include improvements in screening and referrals for perinatal mental care screening, thus preventing complications.

Women's engagement with community perinatal mental health services: a realist evaluation.

BACKGROUND: In recognition of the burden of Perinatal Mental Health problems, NHS England invested £365 million to transform women's access to mental health care, including investment in Community Perinatal Mental Health Services. This study examined how elements of provider care affected women's engagement with these services. METHODS: Semi-structured interviews were conducted with 139 women and explored their experiences of care from 10 different Community Perinatal Mental Health Teams; including which service components participants believed made a difference to their initial and continued engagement. Realist analysis was used to create context-mechanism-outcome configurations (CMOCs) across interviews, since not all parts of the configurations were always articulated within singular interviews. RESULTS: Four key pillars for engagement were identified: perinatal competence, relationship building, accurate reassurance, and reliability. The way perinatal competencies were relayed to women mattered; compassion, understanding and consistency were critical interactional styles. The extent to which these factors affected women's engagement varied by their context and personal characteristics. CONCLUSIONS: As mental health problems increase, disproportionately affecting vulnerable populations, it is critical to continue to ensure support is not only available, but appropriately meets the needs of those individuals. Our findings suggest that key staff behaviours applied at the right time can support women's engagement and potentially contribute to better treatment outcomes.

Translating global evidence into local implementation through technical assistance: a realist evaluation of the Bloomberg philanthropies initiative for global Road safety.

BACKGROUND: Traffic-related crashes are a leading cause of premature death and disability. The safe systems approach is an evidence-informed set of innovations to reduce traffic-related injuries and deaths. First developed in Sweden, global health actors are adapting the model to improve road safety in low- and middle-income countries via technical assistance (TA) programs; however, there is little evidence on road safety TA across contexts. This study investigated how, why, and under what conditions technical assistance influenced evidence-informed road safety in Accra (Ghana), Bogotá (Colombia), and Mumbai (India), using a case study of the Bloomberg Philanthropies Initiative for Global Road Safety (BIGRS). METHODS: We conducted a realist evaluation with a multiple case study design to construct a program theory. Key informant interviews were conducted with 68 government officials, program staff, and other stakeholders. Documents were utilized to trace the evolution of the program. We used a retroductive analysis approach, drawing on the diffusion of innovation theory and guided by the context-mechanism-outcome approach to realist evaluation. RESULTS: TA can improve road safety capabilities and increase the uptake of evidence-informed interventions. Hands-on capacity building tailored to specific implementation needs improved implementers' understanding of new approaches. BIGRS generated novel, city-specific analytics that shifted the focus toward vulnerable road users. BIGRS and city officials launched pilots that brought evidence-informed approaches. This built confidence by demonstrating successful implementation and allowing government officials to gauge public perception. But pilots had to scale within existing city and national contexts. City champions, governance structures, existing political prioritization, and socio-cultural norms influenced scale-up. CONCLUSION: The program theory emphasizes the interaction of trust, credibility, champions and their authority, governance structures, political prioritization, and the implement-ability of international evidence in creating the conditions for road safety change. BIGRS continues to be a vehicle for improving road safety at scale and developing coalitions that assist governments in fulfilling their role as stewards of population well-being. Our findings improve understanding of the complex role of TA in translating evidence-informed interventions to country-level implementation and emphasize the importance of context-sensitive TA to increase impact.

Centring participant experience: a realist evaluation of a menstruator-friendly facility design project in a refugee settlement, Lebanon.

INTRODUCTION: Menstrual health in humanitarian contexts is a neglected topic. Its taboo nature presents difficulties for participants in menstrual health projects in these particularly challenging settings. Namely, their experiences may be concealed or overlooked in projects that are typically outcome focused. Realist Evaluation is a useful method to unearth and explore the hidden mechanisms and their causes, which lead to positive or negative participant experiences. The authors have applied this approach to a robust humanitarian menstrual health project to explore how to centre the emotional wellbeing of participants at all stages: prior to, during, and post-participation. STUDY SETTING: The project studied was led by the International Federation of Red Cross and Red Crescent Societies who piloted their adaptable manual for menstruator-friendly water, sanitation and hygiene (WaSH) facility design in humanitarian contexts. It was conducted by the Lebanese Red Cross in an informal tented settlement hosting Syrian refugees in Qaa, Lebanon. METHODS: The authors collected interview and focus group data on the contextual factors and processes within the project from nine project staff and 16 settlement inhabitants. They used a realist process of theory development, testing, and consolidation to understand how and under what circumstances the project inputs affected participants' wellbeing. RESULTS: The contextual factors and causal mechanisms promoting participant experience comprised individual (choices influencing and experience during participation), interpersonal (group dynamics and the role of non-menstruators), and organisational (expertise and knowledge, relationship to participants and cultural differences) factors. IMPLICATIONS: The research uses a case study from a renowned humanitarian organisation who provided a well-delivered project in a conducive environment to explore the mechanisms and contexts that can promote wider learning and refine understanding and programming in this under-researched and -theorised space. Specifically, it informs which contextual factors and project inputs must be present within a menstrual health project to ensure participant satisfaction whilst efficiently delivering well-designed menstruator-friendly WaSH facilities.

Social participation in the promoting activity, independence and stability in early dementia (PrAISED), a home-based therapy intervention for people living with dementia: a realist evaluation.

BACKGROUND: Interventions promoting social activity may reduce behavioural psychological symptoms and improve quality of life in people living with dementia. This study aimed to identify social benefits for participants living with dementia in the context of Promoting Activity, Independence and Stability in Early Dementia (PrAISED), an exercise intervention programme promoting physical activity and independence in participants living with dementia in England. METHODS: This was a multi-method realist evaluation undertaking secondary analysis of data collected during the PrAISED process evaluation, including qualitative interviews with participants with dementia, caregivers and therapists, personal notes of researchers, and video recordings of therapy sessions. The study consisted of four phases: (1) Setting operational definition of social outcomes in PrAISED; (2) Developing Context, Mechanisms, Outcome (CMO) configurations; (3) Testing and refining CMOs; and (4) Synthesising definitive CMOs into a middle range theory. RESULTS: Two CMOs were identified. (1) When therapists were able to make therapy sessions engaging and had the caregivers' support, the participants experienced therapy sessions as an opportunity to achieve goals in areas they were interested in. They also found the sessions enjoyable. This all led to the participants being highly engaged in their social interactions with the therapists. (2) When the participants realised that they were gaining benefits and progress through the PrAISED intervention, such as increased balance, this boosted their confidence in physical ability. It might also reduce caregivers' risk-aversion/gatekeeping attitude, which in turn would lead to participants' increased participation in social activities. CONCLUSION: The PrAISED intervention supported social participation in participants living with dementia. Under certain circumstances, home-based therapy interventions can be beneficial for social health (regardless of physical health gains). Given the limitations of currently available outcome measures to assess social participation, qualitative methods should be used to explore social health outcomes.

Local government interventions for improving the health and wellbeing of tenants in private rented housing: developing initial program theory to inform evaluation in the United Kingdom.

BACKGROUND: Housing is an important wider determinant of health. Private Rented Sector (PRS) housing is generally the worst quality of housing stock across tenures. Although a wide range of interventions are available to local governments to manage and improve the quality of PRS housing and therefore the health of tenants, there is limited evidence about the extent to which these are used. This study aims to explore what drives the use of different interventions in different local governments, to better understand and inform local strategies. METHODS: As the first realist evaluation on this topic, the range of available interventions was informed by a Local Government Association toolkit. Consistent with realist approaches, retroductive analysis of intervention-context-mechanism-outcome configurations helped to develop and refine Initial Programme Theories (IPTs). Data sources included local government housing documents, a survey and eleven semi-structured interviews with housing officers. RESULTS: Using data for 22 out of the 30 local governments in the South West region of the United Kingdom, eight IPTs were developed which act on different levels from individual PRS team leaders to system wide. The IPTs include a belief in market forces, risk adverse to legal challenge, attitude to enforcement, relational approaches to partnership working, job security and renumeration, financial incentives drive action, and system-level understanding of the drivers of poor health, inequalities and opportunities for cost-savings. The findings suggest that limited objective health outcomes are being used to understand impact, which hinders interpretation of the effectiveness of all mechanisms. CONCLUSION: Interventions that bring about positive outcomes in managing PRS housing are unlikely to be universal; they depend on the context which differs across place and over time. The proposed IPTs highlight the need for strategies to be tailored considering the local context and should be evaluated in subsequent phases of study.

Key elements and contextual factors that influence successful implementation of large-system transformation initiatives in the New Zealand health system: a realist evaluation.

BACKGROUND: Despite three decades of policy initiatives to improve integration of health care, delivery of health care in New Zealand remains fragmented, and health inequities persist for Maori and other high priority populations. An evidence base is needed to increase the chances of success with implementation of large-system transformation (LST) initiatives in a complex adaptive system. METHODS: This research aimed to identify key elements that support implementation of LST initiatives, and to investigate contextual factors that influence these initiatives. The realist logic of enquiry, nested within the macro framing of complex adaptive systems, formed the overall methodology for this research and involved five phases: theory gleaning from a local LST initiative, literature review, interviews, workshop, and online survey. NVivo software programme was used for thematic analysis of the interview, workshop, and the survey data. We identified key elements and explained variations in success (outcomes) by identifying mechanisms triggered by various contexts in which LST initiatives are implemented. RESULTS: The research found that a set of 10 key elements need to be present in the New Zealand health system to increase chances of success with implementation of LST initiatives. These are: (i) an alliancing way of working; (ii) a commitment to te Tiriti o Waitangi; (iii) an understanding of equity; (iv) clinical leadership and involvement; (v) involved people, whanau, and community; (vi) intelligent commissioning; (vii) continuous improvement; (viii) integrated health information; (ix) analytic capability; and (x) dedicated resources and time. The research identified five contextual factors that influenced implementation of LST initiatives: a history of working together, distributed leadership from funders, the maturity of Alliances, capacity and capability for improvement, and a continuous improvement culture. The research found that the key mechanism of trust is built and nurtured over time through sharing of power by senior health leaders by practising distributed leadership, which then creates a positive history of working together and increases the maturity of Alliances. DISCUSSION: Two authors (KMS and PBJ) led the development and implementation of the local LST initiative. This prior knowledge and experience provided a unique perspective to the research but also created a conflict of interest and introduced potential bias, these were managed through a wide range of data collection methods and informed consent from participants. The evidence-base for successful implementation of LST initiatives produced in this research contains knowledge and experience of senior system leaders who are often in charge of leading these initiatives. This evidence base enables decision makers to make sense of complex processes involved in the successful implementation of LST initiatives. CONCLUSIONS: Use of informal trust-based networks provided a critical platform for successful implementation of LST initiatives in the New Zealand health system. Maturity of these networks relies on building and sustaining high-trust relationships among the network members. The role of local and central agencies and the government is to provide the policy settings and conditions in which trust-based networks can flourish. OTHER: This study was approved by the Victoria University of Wellington Human Ethics Committee (Ethics Approval Number 27,356). The research was supported by the Victoria University of Wellington research grant (222,809) and from the University of Auckland Department of Medicine research fund (H10779).

The role of provincial health administration in supporting district health management teams in the Democratic Republic of Congo: eliciting an initial programme theory of a realist evaluation.

BACKGROUND: In 2006, the Ministry of Health in the Democratic Republic of Congo designed a strategy to strengthen the health system by developing health districts. This strategy included a reform of the provincial health administration to provide effective technical support to district health management teams in terms of leadership and management. The provincial health teams were set up in 2014, but few studies have been done on how, for whom, and under what circumstances their support to the districts works. We report on the development of an initial programme theory that is the first step of a realist evaluation seeking to address this knowledge gap. METHODS: To inform the initial programme theory, we collected data through a scoping review of primary studies on leadership or management capacity building of district health managers in sub-Saharan Africa, a review of policy documents and interviews with the programme designers. We then conducted a two-step data analysis: first, identification of intervention features, context, actors, mechanisms and outcomes through thematic content analysis, and second, formulation of intervention-context-actor-mechanism-outcome (ICAMO) configurations using a retroductive approach. RESULTS: We identified six ICAMO configurations explaining how effective technical support (i.e. personalised, problem-solving centred and reflection-stimulating) may improve the competencies of the members of district health management teams by activating a series of mechanisms (including positive perceived relevance of the support, positive perceived credibility of provincial health administration staff, trust in provincial health administration staff, psychological safety, reflexivity, self-efficacy and perceived autonomy) under specific contextual conditions (including enabling learning environment, integration of vertical programmes, competent public health administration staff, optimal decision space, supportive work conditions, availability of resources and absence of negative political influences). CONCLUSIONS: We identified initial ICAMO configurations that explain how provincial health administration technical support for district health management teams is expected to work, for whom and under what conditions. These ICAMO configurations will be tested in subsequent empirical studies.

A realist evaluation of how, why and when objective structured clinical exams (OSCEs) are experienced as an authentic assessment of clinical preparedness.

INTRODUCTION: Whilst rarely researched, the authenticity with which Objective Structured Clinical Exams (OSCEs) simulate practice is arguably critical to making valid judgements about candidates' preparedness to progress in their training. We studied how and why an OSCE gave rise to different experiences of authenticity for different participants under different circumstances. METHODS: We used Realist evaluation, collecting data through interviews/focus groups from participants across four UK medical schools who participated in an OSCE which aimed to enhance authenticity. RESULTS: Several features of OSCE stations (realistic, complex, complete cases, sufficient time, autonomy, props, guidelines, limited examiner interaction etc) combined to enable students to project into their future roles, judge and integrate information, consider their actions and act naturally. When this occurred, their performances felt like an authentic representation of their clinical practice. This didn't work all the time: focusing on unavoidable differences with practice, incongruous features, anxiety and preoccupation with examiners' expectations sometimes disrupted immersion, producing inauthenticity. CONCLUSIONS: The perception of authenticity in OSCEs appears to originate from an interaction of station design with individual preferences and contextual expectations. Whilst tentatively suggesting ways to promote authenticity, more understanding is needed of candidates' interaction with simulation and scenario immersion in summative assessment.

Leadership practices that enable healthful cultures in clinical practice: A realist evaluation.

AIM: To generate, test and refine programme theories that emerged from a rapid realist review investigating practising UK Nurses' and Midwives' experiences of effective leadership strategies during the COVID-19 pandemic. BACKGROUND: The realist review of literature generated six tentative theories of healthful leadership practices reflecting, working with people's beliefs and values; being facilitative; multiple means of communication and; practical support. The review yielded little insight into the actual impact of the leadership approaches advocated. METHODS: A realist study, informed by person-centredness using mixed-methods. Online survey (n = 328) and semi-structured interviews (n = 14) of nurses and midwives across the UK in different career positions/specialities. Quantitative data analysed using descriptive statistics and exploratory factor analysis. Framework analysis for qualitative data using context (C), mechanism (M), outcome (O) configurations of the tentative theories. RESULTS: Three refined theories were identified concerning: Visibility and availability; embodying values and; knowing self. Healthful leadership practices are only achievable within organisational cultures that privilege well-being. CONCLUSIONS: Leaders should intentionally adopt practices that promote well-being. 'Knowing self' as a leader, coaching and mentoring practice development is important for leadership development. IMPLICATIONS FOR CLINICAL PRACTICE: Nurses who feel valued, heard, cared for and safe are more likely to remain in clinical practice. Job satisfaction and being motivated to practice with confidence and competence will impact positively on patient outcomes. IMPACT: The study addresses the role of leadership in developing healthful workplace cultures. The main findings were six leadership practices that promote healthful cultures. The research will have an impact on strategic and clinical leaders, nurses and midwives. REPORTING METHOD: This study used EQUATOR checklist, RAMASES II as reporting standards for realist evaluations. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

The Use of Vignettes to Improve the Validity of Qualitative Interviews for Realist Evaluation.

Although realist evaluation (RE) requires multiple data collection methods, qualitative interviews are considered most valuable and are most frequently used. The guiding principles of RE may limit the emergence of new Context-Mechanism-Outcome (CMO) configurations by evoking particular underlying mechanisms. This paper proposes a new method for conducting semi-structured interviews in the RE context by drawing on the literature and examining the ability of vignettes to explore perceptions about specific situations. Vignettes are developed based on researchers' knowledge of the setting and program theory and are updated through an iterative process throughout data collection. Interviews focus on situations illustrated in the vignette to capture variations in interviewees' perceptions. This method constrains interviewees to using retroduction to identify the hidden underlying mechanisms that link contextual elements to outcomes based on their experiences. This method allows researchers to focus on CMO configurations without evoking mechanisms, which contributes to the rigor of the method.

A realist evaluation of devices used for the prevention of heel pressure ulcers: An ethnographic study of clinical practice.

BACKGROUND: It is known that heel offloading devices are widely used in clinical practice for the prevention of heel pressure ulcers, even though there is a lack of robust, good quality evidence to inform their use. OBJECTIVE: To explore how and why heel offloading devices are used (or not used) and reasoning behind their use in population at high risk of developing heel pressure ulcers. METHODS: An ethnographic study was conducted as part of a realist evaluation in three orthopaedic wards in a large English hospital. Twelve observations took place, with 49 h and 35 min of patient care observed. A total of 32 patients were observed and 19 members of the nursing team were interviewed and in-depth interviews with the three ward managers were conducted. RESULTS: Although the focus of the study was on offloading devices, constant low pressure heel specific devices were also observed in use for pressure ulcer prevention, whilst offloading devices were perceived to be for higher risk patients or those already with a heel pressure ulcer. Nursing staff viewed leadership from the ward manager and the influence of the Tissue Viability Nurse Specialists as key mechanisms for the proactive use of devices. CONCLUSIONS: This study informs trial design as it has identified that a controlled clinical trial of both types of heel specific devices is required to inform evidence-based practice. Involving the ward managers and Tissue Viability Nurse Specialists during set up phase for clinical equipoise could improve recruitment. Tweetable abstract How, for whom, and in what circumstances do devices work to prevent heel pressure ulcers? Observations of clinical practice.

Using PURPOSE-T in clinical practice: A realist evaluation.

AIM: To explain how the clinical and organisational context influenced the way the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE-T) is used by nursing staff to support their clinical judgement and decision making about care planning and delivery. METHODS: A realist process evaluation was undertaken in a large acute hospital trust using mixed methods incorporating organisational policy review, staff semi-structured, ethnographic observation of clinical care and patient record review. Approximately 75 h of ethnographic field work involving 72 patients, 15 patient record reviews and 16 staff interviews were undertaken on 4 wards. FINDINGS: Findings suggest PURPOSE-T assisted nurses differently depending on their level of experience. Those with less experience use it as an educational guide, while those with more experience made an initial clinical judgement and used PURPOSE-T as a safety net to ensure they hadn't missed anything. Nurses were concerned about demonstrating good documentation of assessment, care planning and delivery in order to underpin consistent communication about care and because they had an underlying fear of being blamed if things went wrong. There is an array of other contextual features that impact the planning and delivery of pressure area care that go beyond the use of PURPOSE-T alone, including systematic equipment provision, competing patient safety initiatives and rehabilitation requirements. CONCLUSION: The findings reinforce the assertion that PU-RAIs are complex interventions and could inform the development of a more integrated system of care which takes into account the contextual features associated with PU prevention in modern hospitals.

How do health system factors (funding and performance) impact on access to healthcare for populations experiencing homelessness: a realist evaluation.

BACKGROUND: People experiencing long-term homelessness face significant difficulties accessing appropriate healthcare at the right time and place. This study explores how and why healthcare performance management and funding arrangements contribute to healthcare accessibility or the lack thereof using long-term homeless adults as an example of a population experiencing social exclusion. METHODS: A realist evaluation was undertaken. Thirteen realist interviews were conducted after which data were transcribed, coded, and analysed. RESULTS: Fourteen CMOCs were created based on analysis of the data collected. These were then consolidated into four higher-level CMOCs. They show that health systems characterised by fragmentation are designed to meet their own needs above the needs of patients, and they rely on practitioners with a special interest and specialised services to fill the gaps in the system. Key contexts identified in the study include: health system fragmentation; health service fragmentation; bio-medical, one problem at a time model; responsive specialised services; unresponsive mainstream services; national strategy; short health system funding cycles; and short-term goals. CONCLUSION: When health services are fragmented and complex, the needs of socially excluded populations such as those experiencing homelessness are not met. Health systems focus on their own metrics and rely on separate actors such as independent NGOs to fill gaps when certain people are not accommodated in the mainstream health system. As a result, health systems lack a comprehensive understanding of the needs of all population groups and fail to plan adequately, which maintains fragmentation. Policy makers must set policy and plan health services based on a full understanding of needs of all population groups.

A realist evaluation of the feasibility of a randomised controlled trial of a digital music and movement intervention for older people living in care homes.

BACKGROUND: Low physical activity in care home residents brings about negative mental health consequences, such as higher levels of depression and loneliness. With advancements in communication technology, particularly during the COVID-19 pandemic, the feasibility and effectiveness of a randomised controlled trial (RCT) of a digital Physical Activity (PA) resource in care homes deserve more research attention. A realist evaluation was used to uncover influencing factors of a feasibility study implementation to inform how a digital music and movement programme would work and under what circumstances this would be most effective. METHODS: Participants were 49 older adults (aged 65 years +) recruited across ten care homes in Scotland. Surveys were administered at baseline and post-intervention comprising psychometric questionnaires on multidimensional health markers validated in older adults with possible cognitive impairment. The intervention comprised 12 weeks of four prescribed digitally delivered movement (n = 3) and music-only (n = 1) sessions per week. An activity coordinator delivered these online resources in the care home. Post-intervention focus groups with staff and interviews with a sub-sample of participants were conducted to gain qualitative data on the acceptability of the intervention. RESULTS: Thirty three care home residents started the intervention, but only 18 residents (84% female) completed both pre- and post-intervention assessments. Activity coordinators (AC) offered 57% of the prescribed sessions, with an average residents' adherence of 60%. Delivery of the intervention did not go as planned due to Covid restrictions in care homes and delivery challenges, including (1) motivation and engagement, (2) changes in cognitive impairment and disabilities of the participants, (3) death or hospitalisation of the participants and (4) limited staffing and technology resources to deliver the programme as intended. Despite this, group participation and encouragement of residents supported the delivery and acceptance of the intervention, with ACs and residents reporting improved mood, physical health, job satisfaction and social support. Improvements with large effect sizes were found for anxiety, depression, loneliness, perceived stress and sleep satisfaction, but no changes in fear of falling, domains of general health or appetite. CONCLUSION: This realist evaluation suggested that this digitally delivered movement and music intervention is feasible. From the findings, the initial programme theory was refined for future implementation of an RCT in other care homes but future research exploring how to tailor the intervention to those with cognitive impairment and/or lacking capacity to consent is needed. TRIAL REGISTRATION: Retrospectively registered at ClinicalTrials.gov NCT05559203.

How to collaborate for health throughout the project timeline - a longitudinal study reflecting on implemented strategies in three projects for a healthy living environment.

BACKGROUND: When improving the health of local and regional populations, cross-sector collaboration between different policy domains, non-governmental organisations and citizens themselves is needed. Previously, enabling factors and strategies have been identified to improve cross-sector collaboration for health. However, few longitudinal studies have been conducted to understand how the implementation of strategies for cross-sector collaboration changes throughout the collaboration process. The aim of this study is therefore to learn more about the different strategies that were implemented throughout three cross-sector collaboration projects for a healthy living environment. METHODS: The realist evaluation approach was used to understand how the implemented strategies worked, in which context, why and with what outcomes. Project partners were asked to reflect on their implemented strategies at two different moments in the project timelines, and quarterly updates with project leaders were held. In addition two reference panels were organised for data triangulation. RESULTS: Three key insights for successful cross-sector collaboration throughout projects for a healthy living environment were identified, namely 1. Investing in trust among the partners and faith in the project has a positive influence on continuing the collaboration throughout the project; 2. Making stakeholders actively participate throughout the project requires additional strategies after the onset of the project, and 3. Defining roles, tasks, and other prerequisites at the start of the project helps in pursuing the project over time, but needs re-examination throughout the project. These key insights were based on multiple examples of implemented strategies, linked to context, mechanisms and outcomes. CONCLUSIONS: This study shows the different strategies that can be employed as the collaboration in projects for a healthy living environment progresses. We found that 'trust' does not merely include the relationships built between the partners, but at the onset of projects can also be based on faith in the project itself. In addition, as it can be difficult to foresee the right investments and strategies at the onset of the project, frequent reflection moments to choose fitting strategies might benefit regional partners in their cross-sector collaboration for health.

What works in advocating for food advertising policy change across an english region - a realist evaluation.

BACKGROUND: With increasing recognition of the role of commercial determinants of health, local areas in England have sought to restrict the advertising of products high in fat, salt and sugar (HFSS) on council-owned spaces, as part of wider strategies to reduce obesity. While there is some evidence of the impact of such policy change on behaviour, little is known about what works in the process of implementing this policy change. METHODS: Guided by a realist evaluation framework that explores the interaction between context, mechanism and outcomes, this study aims to investigate the factors that influence the restriction of outdoor advertising of HFSS products in one region in England. It refines a programme theory co-produced with stakeholders from 14 local authorities within a region and uses multiple data sources from each area with an in-depth examination of four case study sites. Data sources include longitudinal realist interviews, focus groups and surveys with policy advocates and policy stakeholders. Data were analysed retroductively to understand the causal link between context, mechanism and outcomes. RESULTS: Outcomes were driven by five dominant mechanisms: a strategic and staggered approach to stakeholder engagement, gathering intelligence, identifying policy champions, building relationships, reframing the issue; and two secondary mechanisms of amplifying the issue and increasing public will. These led to varied outcomes with no changes in formal policy position within the evaluation period but draft policy guidance in place and changes in political will demonstrated. Dominant context factors influencing change included having a named and resourced policy advocate in place supported by an external Community of Improvement and having existing aligned local objectives. Organisational complexity and change, financial concerns, lack of local examples, ideological positions and the pandemic were also influencing contextual factors. CONCLUSION: Effecting policy change in this area requires the commitment of an extended period and the valuing of short-term policy outcomes, such as increasing political will. The importance of a resourced and well-supported policy advocate to lead this work is fundamental and the commercially sensitive nature of this policy change means that a complex interplay of mechanisms is required which may be dominated by a strategically staggered approach to stakeholder engagement.