Dataset Information

Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial.

ABSTRACT:

Introduction

Frailty is a geriatric syndrome characterised by reductions in muscle mass, strength, endurance and activity level. The frailty syndrome, prevalent in 25-50% of patients undergoing cardiac surgery, is associated with increased rates of mortality and major morbidity as well as function decline postoperatively. This trial will compare a preoperative, interdisciplinary exercise and health promotion intervention to current standard of care (StanC) for elective coronary artery bypass and valvular surgery patients for the purpose of determining if the intervention improves 3-month and 12-month clinical outcomes among a population of frail patients waiting for elective cardiac surgery.

Methods and analysis

This is a multicentre, randomised, open end point, controlled trial using assessor blinding and intent-to-treat analysis. Two-hundred and forty-four elective cardiac surgical patients will be recruited and randomised to receive either StanC or StanC plus an 8-week exercise and education intervention at a certified medical fitness facility. Patients will attend two weekly sessions and aerobic exercise will be prescribed at 40-60% of heart rate reserve. Data collection will occur at baseline, 1-2 weeks preoperatively, and at 3 and 12 months postoperatively. The primary outcome of the trial will be the proportion of patients requiring a hospital length of stay greater than 7 days.

Potential impact of study

The healthcare team is faced with an increasingly complex older adult patient population. As such, this trial aims to provide novel evidence supporting a health intervention to ensure that frail, older adult patients thrive after undergoing cardiac surgery.

Ethics and dissemination

Trial results will be published in peer-reviewed journals, and presented at national and international scientific meetings. The University of Manitoba Health Research Ethics Board has approved the study protocol V.1.3, dated 11 August 2014 (H2014:208).

Trial registration number

The trial has been registered on ClinicalTrials.gov, a registry and results database of privately and publicly funded clinical studies (NCT02219815).

SUBMITTER: Stammers AN

PROVIDER: S-EPMC4360727 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Publications

Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial.

Stammers Andrew N AN Kehler D Scott DS Afilalo Jonathan J Avery Lorraine J LJ Bagshaw Sean M SM Grocott Hilary P HP Légaré Jean-Francois JF Logsetty Sarvesh S Metge Colleen C Nguyen Thang T Rockwood Kenneth K Sareen Jitender J Sawatzky Jo-Ann JA Tangri Navdeep N Giacomantonio Nicholas N Hassan Ansar A Duhamel Todd A TA Arora Rakesh C RC

BMJ open 20150309 3

<h4>Introduction</h4>Frailty is a geriatric syndrome characterised by reductions in muscle mass, strength, endurance and activity level. The frailty syndrome, prevalent in 25-50% of patients undergoing cardiac surgery, is associated with increased rates of mortality and major morbidity as well as function decline postoperatively. This trial will compare a preoperative, interdisciplinary exercise and health promotion intervention to current standard of care (StanC) for elective coronary artery by ...[more]

PMID: 25753362

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Project description:IntroductionPatients undergoing coronary artery bypass graft surgery often experience a range of symptoms. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation have a positive physiological and psychological effect in early outpatient rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial.Methods/analysisSheppHeartCABG is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, employing 1:1 central randomisation to rehabilitation plus usual care versus usual care alone. On the basis of a sample size calculation, 326 patients undergoing coronary artery bypass grafting will be included from two clinical sites. All patients receive usual care and patients allocated to the experimental intervention follow 4 weeks rehabilitation consisting of an exercise programme, psycho-educative consultations and a compact mindfulness programme. The primary outcome is physical function measured by the 6-min walk test. The secondary outcomes are mental health and physical activity measured by the Medical Outcome Study Short Form (SF-12), anxiety and depression measured by the Hospital Anxiety and Depression Scale questionnaire, physical, emotional and global scores by the HeartQoL questionnaire, sleep measured by the Pittsburgh Sleep Quality Index, pain measured by the Örebro Musculoskeletal Screening Questionnaire and muscle endurance measured by the sit-to-stand test. A number of explorative analyses will also be conducted.Ethics and disseminationSheppHeartCABG is approved by the regional ethics committee (no. H-4-2014-109) and the Danish Data Protection Agency (no. 30-1309) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Positive, neutral and negative results of the trial will be submitted to international peer-reviewed journals. Furthermore, results will be presented at national and international conferences relevant to the subject fields.Trial registration numberNCT02290262; pre-results.

Project description:BackgroundStudies have shown that Black patients die more frequently following coronary artery bypass grafting than their White counterparts for reasons not fully explained by disease severity or comorbidity. To examine whether provider care team segregation within hospitals contributes to this inequity, we analyzed national Medicare data.MethodsUsing national Medicare data, we identified beneficiaries who underwent coronary artery bypass grafting at hospitals where this procedure was performed on at least 10 Black and 10 White patients between 2008 and 2014 (n=12 646). After determining the providers who participated in their perioperative care, we examined the extent to which Black and White patients were cared for by unique networks of provider care teams within the same hospital. We then evaluated whether a lack of overlap in composition of the provider care teams treating Black versus White patients (ie, high segregation) was associated with higher 90-day operative mortality among Black patients.ResultsThe median level of provider care team segregation was high (0.89) but varied across hospitals (interquartile range, 0.85-0.90). On multivariable analysis, after controlling for patient-, hospital-, and community-level differences, mortality rates for White patients were comparable at hospitals with high and low levels of provider care segregation (5.4% [95% CI, 4.7%-6.1%] versus 5.8% [95% CI, 4.7%-7.0%], respectively; P=0.601), while Black patients treated at high-segregation hospitals had significantly higher mortality than those treated at low-segregation hospitals (8.3% [95% CI, 5.4%-12.4%] versus 3.3% [95% CI, 2.0%-5.4%], respectively; P=0.017). The difference in mortality rates for Black and White patients treated at low-segregation hospitals was nonsignificant (-2.5%; P=0.098).ConclusionsBlack patients who undergo coronary artery bypass grafting at a hospital with a higher level of provider care team segregation die more frequently after surgery than Black patients treated at a hospital with a lower level.

Project description:ImportanceIt has been reported that women undergoing coronary artery bypass have higher mortality and morbidity compared with men but it is unclear if the difference has decreased over the last decade.ObjectiveTo evaluate trends in outcomes of women undergoing coronary artery bypass in the US from 2011 to 2020.Design, setting, and participantsThis retrospective cohort study at hospitals contributing to the Adult Cardiac Surgery Database of the Society of Thoracic Surgeons included 1 297 204 patients who underwent primary isolated coronary artery bypass from 2011 to 2020.ExposureCoronary artery bypass.Main outcomes and measuresThe primary outcome was operative mortality. The secondary outcome was the composite of operative mortality and morbidity (including operative mortality, stroke, kidney failure, reoperation, deep sternal wound infection, prolonged mechanical ventilation, and prolonged hospital stay). The attributable risk (the association of female sex with coronary artery bypass grafting outcomes) for the primary and secondary outcomes was calculated.ResultsBetween 2011 and 2020, 1 297 204 patients underwent primary isolated coronary artery bypass grafting with a mean age of 66.0 years, 317 716 of which were women (24.5%). Women had a higher unadjusted operative mortality (2.8%; 95% CI, 2.8-2.9 vs 1.7%; 95% CI, 1.7-1.7; P < .001) and overall unadjusted incidence of the composite of operative mortality and morbidity compared with men (22.9%; 95% CI, 22.7-23.0 vs 16.7%; 95% CI, 16.6-16.8; P < .001). The attributable risk of female sex for operative mortality varied from 1.28 in 2011 to 1.41 in 2020, with no significant change over the study period (P for trend = 0.38). The attributable risk for the composite of operative mortality and morbidity was 1.08 in both 2011 and 2020 with no significant change over the study period (P for trend = 0.71).Conclusions and relevanceWomen remain at significantly higher risk for adverse outcomes following coronary artery bypass grafting and no significant improvement has been seen over the course of the last decade. Further investigation into the determinants of operative outcomes in women is urgently needed.

Dataset Information

Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial.

Introduction

Methods and analysis

Potential impact of study

Ethics and dissemination

Trial registration number

Publications

Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial.

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