Evaluating the implementation and impact of the HEart faiLure carer support Programme (HELP) in the United Kingdom: A study protocol for a multi-centre, mixed-method, implementation study

BACKGROUND: Informal carers (i.e., family members or friends) of patients with heart failure are ill-prepared and under-supported for their caregiving role. To address this issue, the HEart faiLure carer support Programme was co-designed with carers and healthcare professionals, with pilot testing demonstrating intervention feasibility and acceptability. In the current article, we present the study protocol for evaluating the implementation and impact of the HEart faiLure carer support Programme in real-world, clinical settings across the United Kingdom (ClinicalTrials.gov ID: NCT07373041). METHODS: A mixed-method, implementation study adopting a multi-centre, prospective cohort study design, with nested process and economic evaluations will be conducted. Nurses will deliver the HEart faiLure carer support Programme to 180 carers of patients with symptomatic heart failure across five sites spanning three nations of the United Kingdom (Northern Ireland, England, and Scotland). The patients (approximately 180) of carers enrolled in the project will be invited to provide outcome data. Recruited carers will receive weekly, nurse-led, online support group sessions and supplementary, self-directed educational resources (a booklet and website) for six weeks. Quantitative (i.e., questionnaires and logs) and qualitative (i.e., interviews) data will be collected from carers, patients, and healthcare professionals throughout the study. These data will evaluate the acceptability, fidelity, context, economic cost, and impact of HEart faiLure carer support Programme delivery in real-world clinical settings. An integrative analysis with mapping to the Consolidated Framework for Implementation Research and Normalisation Process Theory domains will be conducted, which will identify key synergies across quantitative and qualitative data sets. DISCUSSION: The results will elucidate the factors underpinning successful intervention translation to clinical practice and identify any required contextual adaptations, along with generating preliminary evidence of intervention impact. These findings will inform a large-scale, type 2 hybrid study, advancing the HEart faiLure carer support Programme towards routine rollout across the United Kingdom.