The development and evaluation of two Prehab interventions for patients undergoing elective and urgent heart surgery

Research questions In people undergoing elective cardiac surgery, is prehabilitation effective and cost-effective? In people undergoing urgent cardiac surgery, is prehabilitation feasible? Background Cardiac surgery is performed in over 32,000 people per year. Poor outcomes are strongly linked with poor physical and mental fitness pre-surgery.

Prehabilitation is a complex intervention that aims to improve: i) physical fitness, ii) nutrition and iii) mental wellbeing. Despite the high uptake in other surgical specialties, few cardiac surgery patients are offered prehabilitation.

Aims and Objectives The aim of Fit4HeartOp is to develop and test two prehabilitation interventions: one each for urgent and elective cardiac surgery patients.

Specific objectives (with corresponding work packages, WP) are to: Identify barriers/ facilitators to prehabilitation before cardiac surgery (WP1). Co-produce prehabilitation interventions for the urgent and elective pathways (WP2). Test the feasibility of both interventions (WP3). Evaluate the effectiveness and cost-effectiveness of prehabilitation in the elective pathway (WP4).

Design a financial and operational framework to support the delivery of prehabilitation in the NHS (WP5). Methods WP1.

Semi-structured interviews with i) patients awaiting surgery (12 urgent and 12 elective), ii) healthcare professionals (HCPs) in cardiac surgery (20) and iii) HCPs who have implemented prehabilitation in other surgical specialities (10).

WP2. i) Co-production panels (PPI, PPI/HCP Stakeholder Intervention Development, Champions Network, NHS Delivery, Sustainability and Impact) will coproduce the programme theory, interventions and intervention materials, and post-trial dissemination through regular meetings, ii) Think-aloud interviews with patients and HCPs will optimise core implementation resources.

WP3.

Non-randomised mixed-methods feasibility trial in 24 urgent and 36 elective patients from 3 Cardiac Surgery Centres and their District General Hospitals. Focus groups and qualitative interviews with 40 patients and 16 HCPs. Feasibility outcomes: recruitment, follow-up, adherence and acceptability. WP4.

Pragmatic, parallel group randomised controlled trial, with internal pilot, economic and process evaluation. 982 elective patients randomised 1:1 to prehabilitation or usual care. Co-primary outcome: Quality of life (SF-36) and hospital free days 3 months after surgery.

Secondary outcomes: SF-36 individual components, EQ5D-5L, baseline and 3-months post-surgery; all cause and cardiovascular specific mortality; all cause and cardiovascular specific hospitalisations; resource use; adherence. Process evaluation: qualitative interviews with 32 patients and 24 staff. WP5.

Work with our Champions Network and stakeholder groups to develop an operational framework with materials for widespread NHS roll-out.

Timelines for delivery 61 months: WP1 13 months (0-13), WP2 14 months (6-19), WP3 15 months (15-29), WP4 37 months (22-61), WP5 throughout, finishing month 61.

Equality, diversity and inclusion We will use evidence-based inclusivity approaches to recruit interviewees, PPIE and stakeholders for WP1 and 2. Hospitals participating in WP3 (Leicester, Glasgow, Bristol) represent different under-served groups. Successful inclusivity approaches identified in WP1-3 will be transferred and refined in the main trial (WP4).

Anticipated Impact and Dissemination WP5 (Delivery, Sustainability, and Impact) will produce a strategy for dissemination and delivery in the post-research period.

Research outputs will be disseminated through journal publications and presentations at national and international conferences.