Intervention to reduce sedentary behaviour and improve outcomes after stroke (Get Set Go): a study protocol for the process evaluation of a pilot cluster randomised controlled trial (RECREATE).

INTRODUCTION: Stroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB ('Get Set Go') will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes. METHODS AND ANALYSIS: This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model. ETHICS AND DISSEMINATION: The study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN82280581.

Unpacking the Cinderella black box of complex intervention development through the Partners at Care Transitions (PACT) programme of research.

INTRODUCTION: Complex intervention development has been described as the 'Cinderella' black box in health services research. Greater transparency in the intervention development process is urgently needed to help reduce research waste. METHODS: We applied a new consensus-based framework for complex intervention development to our programme of research, in which we developed an intervention to improve the safety and experience of care transitions for older people. Through this process, we aimed to reflect on the framework's utility for intervention development and identify any important gaps within it to support its continued development. FINDINGS: The framework was a useful tool for transparent reporting of the process of complex intervention development. We identified potential 'action' gaps in the framework including 'consolidation of evidence' and 'development of principles' that could bracket and steer decision-making in the process. CONCLUSIONS: We consider that the level of transparency demonstrated in this report, aided through use of the framework, is essential in the quest for reducing research waste. PATIENT OR PUBLIC CONTRIBUTION: We have involved our dedicated patient and public involvement group in all work packages of this programme of research. Specifically, they attended and contributed to co-design workshops and contributed to finalizing the intervention for the pilot evaluation. Staff also participated by attending co-design workshops, helping us to prioritize content ideas for the intervention and supporting the development of intervention components outside of the workshops.

A qualitative formative evaluation of a patient facing intervention to improve care transitions for older people moving from hospital to home.

BACKGROUND: The Partners at Care Transitions (PACTs) intervention was developed to support older people's involvement in hospital to improve outcomes at home. A booklet, question card, record sheet, induction leaflet, and patient-friendly discharge letter support patients to be more involved in their health and wellbeing, medications, activities of daily living and post-discharge care. We aimed to assess intervention acceptability, identify implementation tools, and further develop the intervention. METHODS: This was a qualitative formative evaluation involving three wards from one hospital. We recruited 25 patients aged 75 years and older. Ward staff supported intervention delivery. Data were collected in wards and patients' homes, through semi-structured interviews, observation, and documentary analysis. Data were analysed inductively and iteratively with findings sorted according to the research aims. RESULTS: Patients and staff felt there was a need for, and understood the purpose of, the PACT intervention. Most patients read the booklet but other components were variably used. Implementation challenges included time, awareness, and balancing intervention benefits against risks. Changes to the intervention and implementation included clarifying the booklet's messages, simplifying the discharge letter to reduce staff burden, and using prompts and handouts to promote awareness. CONCLUSION: The PACT intervention offers a promising new way to improve care transitions for older people by supporting patient involvement in their care. After further development of the intervention and implementation package, it will undergo further testing. PATIENT OR PUBLIC CONTRIBUTION: This study regularly consulted a panel representing the local patient community, who supported the development of this intervention and its implementation.

Doing involvement: A qualitative study exploring the 'work' of involvement enacted by older people and their carers during transition from hospital to home.

CONTEXT: Being involved in one's care is prioritised within UK healthcare policy to improve care quality and safety. However, research suggests that many older people struggle with this. DESIGN: We present focused ethnographic research exploring older peoples' involvement in healthcare from hospital to home. RESULTS: We propose that being involved in care is a dynamic form of labour, which we call 'involvement work' (IW). In hospital, many patients 'entrust' IW to others; indeed, when desired, maintaining control, or being actively involved, was challenging. Patient and professionals' expectations, alongside hospital processes, promoted delegation; staff frequently did IW on patients' behalf. Many people wanted to resume IW postdischarge, but struggled because they were out of practice. DISCUSSION: Preference and capacity for involvement was dynamic, fluctuating over time, according to context and resource accessibility. The challenges of resuming IW were frequently underestimated by patients and care providers, increasing dependence on others post-discharge and negatively affecting peoples' sense and experience of (in)dependence. CONCLUSIONS: A balance needs to be struck between respecting peoples' desire/capacity for non-involvement in hospital while recognising that 'delegating' IW can be detrimental. Increasing involvement will require patient and staff roles to be reframed, though this must be done acknowledging the limits of patient desire, capability,and resources. Hospital work should be (re)organised to maximise involvement where possible and desired. PATIENT/PUBLIC CONTRIBUTION: Our Patient and Public Involvement and Engagement Panel contributed to research design, especially developing interview guides and patient-facing documentation. Patients were key participants within the study; it is their experiences represented.

A qualitative exploration of self-reported unmet need one year after stroke.

PURPOSE: Stroke survivors consistently report longer-term problems after stroke, suggesting their needs are not being met. We developed a questionnaire to identify stroke-survivor unmet needs. Preliminary questionnaire testing showed that despite residual impairment, nearly one third of respondents reported no/low unmet need. This qualitative study aims to gain insight into why stroke survivors report low/no unmet needs. METHOD: People who self-reported zero or one unmet need were purposively sampled and semi-structured interviews were conducted with 10 participants. Identification and management of current problems were discussed and thematic analysis was undertaken. RESULTS: Participants did not report having unmet need. Despite this, all participants identified current issues or problems. Living with problems while reporting no/low unmet need is explained through: acceptance of changed circumstances; making comparisons with other people and circumstances; valuing pride, determination or independence; and viewing issues in the context of their expectations and experiences of services. Additionally, all participants were receiving some support. CONCLUSIONS: Self-identification of unmet needs is complex. Further investigation could explore the factors which enable stroke survivors to appropriately identify and experience no unmet needs, and whether these could be applied to reduce unmet needs of others. Implications for Rehabilitation Despite self-reporting no/low unmet need, survivors of stroke may still be experiencing difficulties in their daily lives. Stroke-survivor-identified low unmet need is influenced by complex factors including: acceptance; expectations of services; and comparisons with other people, which Health and Social Care professionals have a role in understanding. Health professionals could assess unmet need by using tools as a guide, supported by individual conversation. Factors which enable some stroke survivors to appropriately identify and experience no/low unmet need could be further explored, and considered as strategies to reduce unmet needs of others.