Improving follow-up care for people after minor stroke: development and feasibility testing of a complex intervention

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.