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

Research

Dumbor L. Ngaage¹  Sebastian Hinde²  Patrick Doherty³  Alexandra Dean³  Alex Mitchell³  Caroline Fairhurst³  Catherine Hewitt³  Kate Flemming³  Natasha Mitchell³  Judith Watson³  Lee Ingle⁴  Enoch Akowuah⁵  Simon Nichols⁶ 

[1] Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Castle Road Cottingham, Hull, UK;Centre for Health Economics, Alcuin A Block, University of York, York, UK;Department of Health Sciences, University of York, ARRC Building, York, UK;Department of Sport, Health and Exercise Science, University of Hull, Hull, UK;James Cook Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, UK;Sport and Physical Activity Research Centre, Sheffield Hallam University, Collegiate Campus, Sheffield, UK;

关键词: Cardiac surgery;    Cardiac rehabilitation;    Outpatient review;    Feasibility;    Median sternotomy;   

DOI  :  10.1186/s40814-023-01304-3

 received in 2022-09-29, accepted in 2023-04-21,  发布年份 2023

来源: Springer

【 摘 要 】

ObjectiveTo 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.MethodsA randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18–80 years from two UK cardiac centres 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.ResultsFifty 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.ConclusionRecruitment 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.Trial registrationISRCTN80441309 (prospectively registered on 24/01/2019).

【 授权许可】

CC BY   
© Crown 2023

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