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Feasibility Study of Early Outpatient Review and Early Cardiac Rehabilitation After Cardiac Surgery: Mixed Methods Research Design – a study protocol

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JournalBMJ Open
DateAccepted/In press - 2 Dec 2019
DatePublished (current) - 29 Dec 2019
Number of pages8
Original languageEnglish

Abstract

Introduction: Following cardiac surgery, patients currently attend an outpatient review six weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from eight weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier.

Methods and analyses: This is a multi-centre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18 to 80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7 month period across two centres. Feasibility will be measured by consent, recruitment, retention rates, and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial (RCT).

Ethics and dissemination: Ethics approval was granted by East Midlands - Derby Research Ethics Committee on 10th January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders.

Trial registration: ISRCTN80441309

Keywords: cardiac surgery; cardiac rehabilitation; outpatient review; feasibility; median sternotomy

Protocol version: Version 2.0, 26th September 2019

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© Author(s) (or their employer(s)) 2019

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