PMID- 37170367 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230514 IS - 2055-5784 (Print) IS - 2055-5784 (Electronic) IS - 2055-5784 (Linking) VI - 9 IP - 1 DP - 2023 May 11 TI - 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). PG - 79 LID - 10.1186/s40814-023-01304-3 [doi] LID - 79 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 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. 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 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 pound1519 for the intervention ( pound2043 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. 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). CI - (c) 2023. Crown. FAU - Ngaage, Dumbor L AU - Ngaage DL AUID- ORCID: 0000-0003-2378-7160 AD - Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Castle Road Cottingham, Hull, UK. dumbor.ngaage@nhs.net. FAU - Mitchell, Natasha AU - Mitchell N AUID- ORCID: 0000-0002-6904-2976 AD - Department of Health Sciences, University of York, ARRC Building, York, UK. FAU - Dean, Alexandra AU - Dean A AUID- ORCID: 0000-0003-4711-5609 AD - Department of Health Sciences, University of York, ARRC Building, York, UK. FAU - Mitchell, Alex AU - Mitchell A AUID- ORCID: 0000-0001-9311-2092 AD - Department of Health Sciences, University of York, ARRC Building, York, UK. FAU - Hinde, Sebastian AU - Hinde S AUID- ORCID: 0000-0002-7117-4142 AD - Centre for Health Economics, Alcuin A Block, University of York, York, UK. FAU - Akowuah, Enoch AU - Akowuah E AUID- ORCID: 0000-0002-2429-3579 AD - James Cook Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, UK. FAU - Doherty, Patrick AU - Doherty P AUID- ORCID: 0000-0002-1887-0237 AD - Department of Health Sciences, University of York, ARRC Building, York, UK. FAU - Nichols, Simon AU - Nichols S AUID- ORCID: 0000-0003-0377-6982 AD - Sport and Physical Activity Research Centre, Sheffield Hallam University, Collegiate Campus, Sheffield, UK. FAU - Fairhurst, Caroline AU - Fairhurst C AUID- ORCID: 0000-0003-0547-462X AD - Department of Health Sciences, University of York, ARRC Building, York, UK. FAU - Flemming, Kate AU - Flemming K AUID- ORCID: 0000-0002-0795-8516 AD - Department of Health Sciences, University of York, ARRC Building, York, UK. FAU - Hewitt, Catherine AU - Hewitt C AUID- ORCID: 0000-0002-0415-3536 AD - Department of Health Sciences, University of York, ARRC Building, York, UK. FAU - Ingle, Lee AU - Ingle L AUID- ORCID: 0000-0001-6155-5577 AD - Department of Sport, Health and Exercise Science, University of Hull, Hull, UK. FAU - Watson, Judith AU - Watson J AUID- ORCID: 0000-0003-0694-3854 AD - Department of Health Sciences, University of York, ARRC Building, York, UK. LA - eng GR - PB-PG-0317-20047/National Institute for Health Research - Research for Patient Benefit/ PT - Journal Article DEP - 20230511 PL - England TA - Pilot Feasibility Stud JT - Pilot and feasibility studies JID - 101676536 PMC - PMC10172724 OTO - NOTNLM OT - Cardiac rehabilitation OT - Cardiac surgery OT - Feasibility OT - Median sternotomy OT - Outpatient review COIS- The authors declare that they have no competing interests. EDAT- 2023/05/12 01:07 MHDA- 2023/05/12 01:08 PMCR- 2023/05/11 CRDT- 2023/05/11 23:54 PHST- 2022/09/29 00:00 [received] PHST- 2023/04/21 00:00 [accepted] PHST- 2023/05/12 01:08 [medline] PHST- 2023/05/12 01:07 [pubmed] PHST- 2023/05/11 23:54 [entrez] PHST- 2023/05/11 00:00 [pmc-release] AID - 10.1186/s40814-023-01304-3 [pii] AID - 1304 [pii] AID - 10.1186/s40814-023-01304-3 [doi] PST - epublish SO - Pilot Feasibility Stud. 2023 May 11;9(1):79. doi: 10.1186/s40814-023-01304-3.