Title: Improving follow-up care for people after minor stroke: development and feasibility testing of a complex intervention
Funder: Health Education England

Abstract: Background: Stroke is the largest cause of adult disability with more than 1.2million stroke survivors in the UK(1). Between a third(2) to almost half(3) of people with stroke experience 'mild' or 'minor' stroke. Minor stroke survivors are deemed 'too good' for existing post-discharge stroke pathways and frequently report unmet information needs and feeling abandoned on discharge(7,14). This lack of knowledge and understanding is associated with increased risk of stroke recurrence(8,9). Critically, hidden impairments, not apparent in hospital, become evident after discharge. If unaddressed these affect return to work, quality of life and well-being(30-33). This study aims to develop an intervention to address these unmet needs. Key Aim: To develop a theory-based, personalised, follow-up intervention for people after minor stroke that addresses their information needs and provides them with support to manage the ongoing effects of stroke. Objectives: To utilise evidence from a scoping review, behaviour change theory and stakeholder engagement to inform and develop a post-discharge follow-up intervention (year 1). To develop, with stakeholder input, training material, resources to operationalise implementation of the intervention and participant resources (year 1). To conduct a feasibility study with embedded qualitative interviews to determine whether the intervention can be delivered within the NHS and is acceptable to participants (year 2). To review feasibility outcomes, analysis and write up (year 3).Methods: Complex intervention development: The revised guidance from the Medical Research Council (currently in draft)(49) will be used alongside the framework of actions described by O'Cathain and colleagues(50) to systematically develop this complex intervention that targets a diverse population with differing stroke aetiologies and personal contexts. The behaviour change theory has been identified to further inform intervention development; it considers both the behaviour of participants and professionals and provides a structure to identify techniques that can be used to bring about behaviour change(51). Feasibility study and embedded qualitative interviews: This will be a two-armed randomised, single-centre study. The recruitment target is 60 participants (30 control/30 intervention). Mixed methods will be used to analyse intervention feasibility. The specific outcome measures to be utilised will be confirmed in the development phase. Patient reported quantitative measures of stroke knowledge, medication compliance, self-efficacy, participation and quality of life will be gathered. Health economic data will be gathered alongside cognition, fatigue and mood scores. Qualitative interviews will be conducted with participants from both groups to explore acceptability, experience and perceived benefits of both follow-up approaches. Data will be analysed using thematic analysis(52). Anticipated impact and dissemination: Improvement in patient experience through access to theory-based personalised follow-up care, onward referrals and stroke specialists. Increased healthcare professional awareness of the unmet needs of the minor stroke population. Feasibility findings will inform the design of a multi-site RCT to establish the effectiveness of the intervention. A lay summary of study findings will be sent to study participants. Study results will be disseminated to the stroke team and stakeholder groups. Wider dissemination of results through national and international stroke conferences, publication in peer reviewed journals, the Stroke Association, professional networks and social media.

Lay abstract: Background to the research: The term 'minor stroke' refers to a stroke that has caused damage that is visible on a brain scan but has not caused any obvious physical difficulties. People admitted to hospital with a minor stroke typically have a short stay in hospital, are thought to have made a full recovery at the time of discharge, and return home with no follow-up except for routine medical appointments. However, minor stroke survivors tell us that they are not provided with enough information whilst in hospital and often have unanswered questions about their stroke, medication and ongoing investigations. In addition, after returning home they may experience less obvious difficulties such as problems with their thinking and memory or changes in their mood; these together with fatigue and reduced confidence can impact on returning to work and to their full pre-stroke lives. Aims of my research project are: To develop a personalised, theory-based, follow-up programme of care for minor stroke survivors that improves their knowledge and understanding of their stroke, how to reduce the risk of another stroke and how to manage less obvious difficulties they may experience. To test if this follow-up programme of care can be implemented in the NHS, is acceptable and understandable to minor stroke survivors and improves outcomes that matter to them. To conduct interviews with participants who receive the programme of care and those that do not to try and understand in greater detail how it helps, and whether there is a positive impact on those that do receive it.Public Involvement and Engagement: Previous minor stroke patients have told me that they needed personalised follow-up that focussed on their risk factors and the particular difficulties they experienced. They also needed a named contact person in the hospital stroke team, for questions that arose after returning home. They described a frustrating breakdown in communication between the hospital and their GP and difficulty accessing support for the less obvious difficulties once back at home. I have convened a patient, public involvement (PPI) group of six minor stroke survivors who are contributing to the development of this follow-up programme of care. They described how their information needs changed over time and that follow-up care needs to happen at more than one particular time point. Initially, their focus was on medical questions, medications and ongoing tests. In contrast, later on when they started getting back to their normal daily activities, they found that support with thinking and memory difficulties, mood issues and managing fatigue was needed. Going forward the PPI group will continue to shape the intervention development work, will support with identifying meaningful outcome measures and the preparation of information provided to patients. Design and methods used: The follow-up programme of care will have multiple parts and be planned using guidance provided by the Medical Research Council for developing complex interventions. The follow-up care itself will be based on well-known behavioural theories which focus on supporting people to feel able to make changes and to manage their new circumstances. A combination of methods will be used to understand whether the programme of care works in practice and helps people adjust and recover. Dissemination: Results of this study will be shared with study participants, the PPI group and other professionals who look after stroke patients in hospitals and the wider community. Results will be published in scientific journals and presented at national and international stroke conferences. If this research project is successful then funding will be sought to run a large-scale trial covering many hospitals to test the clinical and cost-effectiveness of this follow-up programme of care.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: STROKE