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)

TY - JOUR

T1 - 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)

AU - Ngaage, Dumbor L.

AU - Mitchell, Natasha

AU - Dean, Alexandra

AU - Mitchell, Alex Steven

AU - Hinde, Sebastian

AU - Akowuah, Enoch

AU - Doherty, Patrick Joseph

AU - Nichols, Simon

AU - Fairhurst, Caroline Marie

AU - Flemming, Kate

AU - Hewitt, Catherine Elizabeth

AU - Ingle, Lee

AU - Watson, Jude

N1 - © Crown 2023.

PY - 2023/5/11

Y1 - 2023/5/11

N2 - Objective: 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.Methods: A 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 postoperativeoutpatient 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.Results: 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 28-92% for ISWT and 68-94% 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 scoresincreased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1,519 for the intervention (£2,043 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 obtainingconsent for willing patients challenging due to discharge timings.Conclusion: 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.Trial registration: ISRCTN80441309 (prospectively registered on 24/01/2019)Word count: 347Keywords: cardiac surgery; cardiac rehabilitation; outpatient review; feasibility; median sternotomy

AB - Objective: 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.Methods: A 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 postoperativeoutpatient 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.Results: 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 28-92% for ISWT and 68-94% 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 scoresincreased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1,519 for the intervention (£2,043 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 obtainingconsent for willing patients challenging due to discharge timings.Conclusion: 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.Trial registration: ISRCTN80441309 (prospectively registered on 24/01/2019)Word count: 347Keywords: cardiac surgery; cardiac rehabilitation; outpatient review; feasibility; median sternotomy

U2 - 10.1186/s40814-023-01304-3

DO - 10.1186/s40814-023-01304-3

M3 - Article

SN - 2055-5784

VL - 9

JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

M1 - 79

ER -