Neurology · Medical Literature
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
Introduction 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. Methods and analysis 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 focusin
Clinical relevance
Recurrent stroke and TIA represent a high-stakes clinical challenge: globally, over 25% of strokes are recurrent events, and medication non-adherence — a key modifiable driver — affects a substantial proportion of survivors, with up to 21% discontinuing antihypertensive therapy within the first year post-stroke. StrokeCompass addresses the critical gap between evidence-based secondary prevention recommendations and real-world patient adherence by embedding shared decision-making and personalised nurse-led coaching directly into the acute stroke unit pathway. Neurologists and stroke clinicians should attend to this trial as it tests a scalable, structured empowerment model — developed under the UK MRC complex intervention framework — that integrates patient decision aids with individualized coaching across a multi-centre German network.
Key findings
NOTE: This is a study protocol publication; no efficacy or adherence outcome data are yet available. The following findings reflect the pre-specified design parameters and feasibility targets as reported in the protocol: 1. TARGET SAMPLE: 452 patients with recent ischaemic stroke or TIA will be recruited across 7 stroke units in Germany over a 16-month enrolment period. 2. TRIAL DESIGN: Stepped-wedge cluster-randomised controlled design with 3 sequential crossover time points (at 4, 8, and 12 months post-initiation), ensuring all clusters contribute both control-phase and intervention-phase data — a design that strengthens internal validity while accommodating real-world implementation constraints. 3. INTERVENTION COMPONENTS: The StrokeCompass intervention comprises 4 core elements: (1) nurse-led decision coaching, (2) a structured physician consultation to negotiate individualised risk factor targets, (3) a personalised nurse-led adherence coaching programme, and (4) a web-based patient decision aid — operationalised through a preparatory training programme for both nurses and physicians. 4. PRIMARY FEASIBILITY OUTCOMES: Outcomes include recruitment rate, participation rate, implementation fidelity, and utilisation of intervention components, all to be analysed descriptively — consistent with MRC Phase II pilot methodology. 5. PRELIMINARY EFFECTIVENESS OUTCOMES: Preliminary estimates of intervention effectiveness will be assessed by changes in modifiable risk factor targets, specifically blood pressure and LDL-cholesterol levels, analysed on an intention-to-treat basis. 6. ECONOMIC EVALUATION: The protocol includes a formal health economic evaluation component focusing on cost-effectiveness, acknowledging the resource implications of scaling nurse-delivered coaching in routine stroke care. No quantitative effect size estimates, confidence intervals, p-values, or NNT/NNH are pre-specified in the published protocol abstract.
Practice implications
Pending trial results, the StrokeCompass protocol signals that stroke units should anticipate integrating structured nurse-led decision and adherence coaching into post-stroke care pathways, particularly for patients with recent ischaemic stroke or TIA who are at highest risk of recurrence and most susceptible to early medication discontinuation. Clinicians should note that the intervention explicitly pairs shared decision-making tools (decision aids) with individually tailored adherence support and a dedicated physician consultation to set blood pressure and LDL targets — suggesting that no single component alone may be sufficient, and that programmatic, multi-element approaches are required. Stroke teams considering adoption of similar models should plan for dedicated nurse training programmes and anticipate the operational challenges of releasing clinical staff for structured coaching delivery, as highlighted in analogous stepped-wedge feasibility trials in this space.