Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study.

Background: Of the 150 000 people per year in the UK who have strokes, third to half will experience a so-called 'minor stroke'. Although appearing benign these strokes put a person at increased risk of further strokes and survivors are usually considered 'too good' for referral onto community stroke services. When back at home the hidden effects of stroke like fatigue and changes in mood and cognition become apparent and impact return to work, relationships and everyday activities. Alongside this, managing the risk of recurrence, highest early after an initial stroke, is a priority. People with stroke report feeling abandoned after discharge with unmet information and support needs.

Methods: To address this issue, we reviewed the literature, met with people with stroke and other stakeholders to develop an early, personalised follow-up programme of care for those who currently only receive routine medical follow-up appointments. The design of this complex intervention is informed by the NIHR/MRC framework for complex intervention development and the framework of action described by O'Cathain and colleagues. The intervention is underpinned by self-determination theory. We will be conducting a randomised, mixed methods, single-centre feasibility study to explore the acceptability and feasibility of the intervention. Sixty participants will be recruited from a Hyperacute Stroke Unit and Rapid Assessment Clinic and randomised to the intervention or control group. The intervention group will receive personalised follow-up appointments at two- and six-weeks post-discharge. All participants will have outcome measures taken at baseline and twelve-weeks post-stroke. Patient reported outcomes will be reviewed to assess their suitability for a later definitive trial. Qualitative interviews will be conducted to gain a deeper understanding of life after stroke from those who did and did not receive the intervention.

Conclusions: Study findings will be used to further refine the intervention, methods and outcome measurements used. These refinements will inform a future multicentre randomised controlled trial.