Feasibility and Process Evaluation of CArdiac Brief INtervention (CABIN) in Patients with ST-Elevation Myocardial Infarction: A Mixed-Method, Pilot Randomised Controlled Trial.
Gareth Thompson, Gemma Caughers, Judy Bradley, Patrick Donnelly, Maria Mooney, Lana Dixon, Donna FitzsimonsAbstract
Aims
To conduct feasibility testing and a process evaluation of CArdiac Brief INtervention (CABIN), with a preliminary assessment of impact in patients with ST-Elevation Myocardial Infarction (STEMI).
Methods and Results
A two-arm, parallel group, pilot randomised controlled trial with a concurrent, mixed-method design was conducted. Forty patients were recruited post-STEMI from two hospital centres in the United Kingdom (UK). Participants were randomly assigned to the intervention (CABIN) or control (usual care) group using a 1:1 allocation ratio. CABIN delivered psychoeducational support via a single, one-to-one session (approximately 20 minutes) with patients post-STEMI before hospital discharge. Feasibility and process evaluation data were collected from patients and cardiology staff. Patient-related outcomes were assessed at four timepoints (TPs): baseline, post-intervention, four weeks from diagnosis, and fourteen weeks from diagnosis. The findings demonstrated favourable recruitment (13.3 patients per month), data completeness (≥ 87.5% at each TP), and acceptability (positive feedback with no major revisions identified). Larger, favourable changes (Hedges’ g > 0.8) were documented for all patient-related outcomes (disease knowledge; illness perception; anxiety and depression; and health status and confidence) in the intervention group across the TPs. All participants (100%) of the intervention sub-group enrolled in cardiac rehabilitation (CR) compared to 50% of the control sub-group.
Conclusion
CABIN was feasible and acceptable to patients. Preliminary evidence suggests a potential, positive impact on disease knowledge, psychological wellbeing, and CR enrolment. CABIN will progress to an effectiveness and implementation evaluation, informing potential integration with routine clinical practice in the UK.
Registration
ClinicalTrials.gov: NCT05848674.