A randomised controlled, feasibility study to establish the acceptability of early outpatient review and early cardiac rehabilitation compared to standard practice after cardiac surgery and viability of a future large-scale trial (FARSTER).

Ngaage, Dumbor L.; Mitchell, Natasha; Dean, Alexandra; Mitchell, Alex; Hinde, Sebastian; Akowuah, Enoch; Doherty, Patrick; Nichols, Simon; Fairhurst, Caroline; Flemming, Kate; Hewitt, Catherine; Ingle, Lee; Watson, Judith

Abstract

The aim of this study was to determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable. The study utilised a randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruiting from two UK cardiac centres patients aged 18–80 years who had undergone elective or urgent cardiac surgery via a median sternotomy. Eligible, consenting participants were randomised 1:1 by a remote, centralised randomisation service to postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control), or postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention). The primary outcome measures related to trial feasibility including recruitment, retention, CR adherence, and acceptability to participants/staff. Secondary outcome measures included health-rated quality of life using EQ-5D-5L, NHS resource-use, Incremental Shuttle Walk Test (ISWT) distance, 30- and 90-day mortality, surgical site complications and hospital readmission rates. Fifty participants were randomised (25 per group) and 92% declared fit for CR. Participant retention at final follow-up was 74%; completion rates for outcome data time points ranged from 28 to 92% for ISWT and 68 to 94% for follow-up questionnaires. At each time point, the mean ISWT distance walked was greater in the intervention group compared to the control. Mean utility scores increased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1519 for the intervention (£2043 control). Fifteen participants and a research nurse were interviewed. Many control participants felt their outpatient review and CR could have happened sooner; intervention participants felt the timing was right. The research nurse found obtaining consent for willing patients challenging due to discharge timings. Recruitment and retention rates showed that it would be feasible to undertake a full-scale trial subject to some modifications to maximise recruitment. Lower than expected recruitment and issues with one of the clinical tests were limitations of the study. Most study procedures proved feasible and acceptable to participants, and professionals delivering early CR. This trial was prospectively registered on 24/01/2019 with reference ISRCTN80441309.

Citation

NGAAGE, D.L., MITCHELL, N., DEAN, A., MITCHELL, A., HINDE, S., AKOWUAH, E., DOHERTY, P., NICHOLS, S., FAIRHURST, C., FLEMMING, K., HEWITT, C., INGLE, L. and WATSON, J. 2023. A randomised controlled, feasibility study to establish the acceptability of early outpatient review and early cardiac rehabilitation compared to standard practice after cardiac surgery and viability of a future large-scale trial (FARSTER). Pilot and feasibility studies [online], 9, article number 79. Available from: https://doi.org/10.1186/s40814-023-01304-3

• Journal Article Type: Article
• Acceptance Date: Apr 21, 2023
• Online Publication Date: May 11, 2023
• Publication Date: Dec 31, 2023
• Deposit Date: Nov 27, 2023
• Publicly Available Date: Nov 27, 2023
• Journal: Pilot and feasibility studies
• Electronic ISSN: 2055-5784
• Publisher: Springer
• Peer Reviewed: Peer Reviewed
• Volume: 9
• Article Number: 79
• DOI: https://doi.org/10.1186/s40814-023-01304-3
• Keywords: Cardiac patients; Cardiac outpatients; Cardiac rehabilitation; Outpatient review
• Public URL: https://rgu-repository.worktribe.com/output/2079551