The REACH-HF feasibility study was a multicentre single-arm feasibility study with parallel process evaluation to assess the feasibility and acceptability of the REACH-HF manual for systolic HF patients, their caregivers and facilitators delivering the intervention. The feasibility study was conducted in preparation for a fully powered randomised controlled trial assessing the clinical effectiveness and cost effectiveness of the HF Manual vs usual care in patients with systolic HF and a separate single centre pilot trial in patients with heart failure with preserved ejection fraction (HFpEF).
- To assess the feasibility and acceptability of the addition of the HF Manual to usual care for systolic HF patients, caregivers and intervention facilitators.
- To assess the fidelity of HF Manual delivery by intervention facilitators.
- To evaluate components of the study process to inform the main randomised controlled trial design: feasibility of outcome data collection processes, and outcome burden and completion/attrition rates for patients and caregivers.
Intervention development aims:
- To identify any further training needs for the intervention facilitators.
- To identify any changes needed in the HF Manual.
- To finalise the content and format of the HF Manual and training materials
The study used a four centre (Birmingham, Cornwall, South Glamorgan and York) single-arm design with a parallel process evaluation. Following identification and recruitment, patients with systolic HF received the HF manual intervention which was delivered over a period of 12 weeks by trained intervention facilitators, in addition to their usual care.
The parallel process evaluation utilised a range of qualitative methods including recordings of intervention sessions, satisfaction questionnaires and interviews with both patients and caregivers, in addition to an observed structured clinical assessment using an intervention fidelity checklist in the context of delivering the REACH-HF Manual to people with systolic HF. Multiple rounds of data collection and interaction with the intervention facilitators delivering the intervention generated feedback that informed both changes to the HF Manual, and changes to the training materials (i.e. the way the HF Manual is delivered by the intervention facilitators). The patient and caregiver outcome measures for the main trial of clinical effectiveness and cost-effectiveness were collected pre- and post- intervention in this study, in order to test procedures for collection, burden for patients, completeness of data collection and the rate of patient attrition/loss to follow up.
Recruitment of patients and their caregivers took place over the 12 week period from 1 March 2014 to 31 May 2014, a one-month extension on the planned 2-month period due to delayed Excess Treatment Costs (ETC) agreement and delayed recruitment start at one centre (York). A total of 23 patients and 12 caregivers were recruited – meeting the recruitment target for the study. A total of eight intervention facilitators were recruited.
- REACH-HF manuals appear to have been well accepted by patients, caregivers and facilitators.
- Patients and caregivers were highly satisfied with REACH-HF intervention.
- There was a need for some modifications to the manual content and format & facilitator training.
- Fidelity scoring indicated adequate delivery for most aspects of the intervention by all the facilitators
- Two items (addressing emotional consequences of being a caregiver and caregiver health and well-being) need reinforcement in future intervention delivery.
- There were generally excellent levels of outcome completion and patients/caregivers perceived relatively low outcome burden.
- A number of patient and caregiver outcomes following REACH-HF intervention showed evidence of improvement (with all caveats of a small population of selected participants and the study design of pre-post comparison with no control group).
- No safety issues were identified.
- The Incremental Shuttle Walk Test (ISWT) was not universally popular with patients and failed to show change over time
- Following the feasibility study and discussion with the Programme Steering Committee (PSC), a small number of revisions to the main trial processes were implemented.This article presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-1210-12004). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.