Preventing the next stroke: nurse-led decision and adherence coaching to empower people with stroke (StrokeCompass) versus usual care - study protocol for a stepped-wedge pilot trial.

Abstract

Recurrent stroke prevention is important for people who have suffered a stroke or transient ischaemic attack (TIA), as they are at increased risk of having another stroke. Nevertheless, treatment adherence is often low. Therefore, the StrokeCompass project was initiated to enhance medication adherence by empowering individuals who have had a stroke to take an active role in recurrent stroke prevention and medication management. In accordance with the UK Medical Research Council (MRC) guidelines, a complex intervention was developed that integrated evidence-based decision aids and a personalised, nurse-led coaching programme. The present stepped-wedge cluster-randomised controlled study addresses the second phase of the MRC framework by pilot testing the feasibility and acceptability of the intervention in a clinical setting. A total of 452 patients with a recent ischaemic stroke or TIA will be recruited over a period of 16 months from seven stroke units across Germany. The study centres will be randomised and sequentially crossed over from the control phase to the intervention phase in three time periods (4, 8 and 12 months after initiation) until all clusters have been exposed to both conditions. The intervention comprises four core elements: first, a decision coaching programme, second, a physician consultation to discuss treatment targets, third, an adherence coaching programme, and fourth, a web-based patient decision aid. Furthermore, we developed a preparatory training programme for nurses and physicians. Feasibility outcomes (eg, recruitment strategies, participation, implementation and utilisation of intervention) will be analysed descriptively, while preliminary estimates of effectiveness, measured by changes in risk factor targets (eg, blood pressure and low-density lipoprotein cholesterol levels), will be analysed according to the intention-to-treat principle. Furthermore, an economic evaluation will be conducted focusing on the implementation costs. These findings could prove pivotal in the subsequent planning and rationale for a full-powered effectiveness study. The study has received ethical approval from the Ethical Committee of the University of Lübeck (reference 2024-522). We will disseminate the findings in peer-reviewed journals, at conferences, and on relevant patient websites. DRKS00036091.