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临床试验/NCT03551015
NCT03551015已完成不适用

Feasibility Study of Early Outpatient Review and Early Cardiac Rehabilitation After Coronary Artery Bypass Grafting: Mixed Methods Research Design

Hull University Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Physical fitness

研究概览

简要总结

Current care after coronary artery bypass grafting (CABG) involves a check-up 6 weeks after hospital discharge followed by an exercise programme called cardiac rehabilitation (CR) from 8 weeks. This practice is not evidence-based; it is therefore uncertain if earlier check-up and CR would promote quicker recovery. The proposed research will examine the feasibility of having check-up at 3 weeks and CR from 4 weeks after hospital discharge, and the associated advantages.

The investigators plan to recruit 100 patients undergoing planned CABG through a median sternotomy, at 2 NHS hospitals over 5 months. They will include 18 to 75 year olds, capable of giving Informed consent and fit for CR exercises.

Patients will be approached before surgery and given study information to read. Four days after surgery, patients who are willing to take part will have their routine clinical examination, blood tests, chest x-rays and heart tracings reviewed to determine suitability for the study. The investigators will obtain informed consent, do breathing tests and, ask the patients to complete a general health questionnaire. A computer will allocate patients equally to the proposed care (intervention group) or current care (control group). After discharge, patients will attend check-up and semi-structured interview at 3 weeks (intervention group) or 6 weeks (control group) before starting CR from 4 weeks (intervention group) or 8 weeks (control group). CR will involve exercise classes once or twice a week for 8 weeks, and fitness tests. Patients will have a final assessment at 26 weeks, with clinical examination, fitness and breathing tests, and completion of general health questionnaire.

The investigators will analyse patients' and staff experiences, patient fitness levels, quality of life and costs, associated with each pathway. They will report potential benefits of proposed care, if any. This study findings will be used to design a larger trial to determine the best practice.

详细描述

Rationale and Background

Currently following CABG, patients attend their first outpatient review six weeks after hospital discharge, where recovery is assessed and fitness to commence CR is determined. CR is then started from eight weeks. In a survey conducted in May/June 2017 by the investigators, 35 of 42 UK cardiac centres responded, and confirmed this as current practice. The long interval before postoperative review and CR extends the period of vulnerability and inactivity for patients, with patients often seeking medical attention for surgery-related complications during this period. In a prospective observational study (FORCAST6), the investigators found that 44% of patients sought further medical help during this 6 week period, and 41% would like an earlier review. This feasibility study will examine the feasibility of bringing forward outpatient review and CR in order to facilitate recovery.

CABG is usually performed through a cut in the breastbone (median sternotomy) and patients are required to refrain from upper body exercises, lifting of heavy objects and usual strenuous activities for 12 weeks. These restrictions, called "sternal precautions" (SP), are intended to aid healing of the cut breastbone. CR which has significant short- and long-term benefits after CABG is therefore delayed. The delay can mitigate the benefits of CR, contribute to physical deconditioning, and hinder the ability of CR to facilitate timely recovery of fitness and physical activity status. According to the 2013 UK national audit of CR, late CR commencement contributes to a substantial number of heart surgery patients declining to participate in CR. Current time frames for postoperative review and CR are not evidence-based and may prolong recovery after CABG, and be placing unnecessary limitations on patient activity.

The standard access for heart operations is through a median sternotomy. In the UK, heart operations have steadily increased since 2010. Of 36,134 operations performed in 2013, 17,630 were isolated CABG. Following CABG, the recovery pathway after hospital discharge has two important elements, namely; outpatient review and CR.

First postoperative outpatient review: It is routine practice to undertake the first postoperative review six weeks after hospital discharge. However, high rates of hospital readmissions for surgery-related complications within this period have been reported. The investigators conducted a prospective observational study (FORCAST6) to investigate postoperative morbidity during, as well as patient opinion about, the six-week interval between hospital discharge and first review. This study showed that 44% of patients reported surgery-related complications; 17.5% required hospital readmission. Although majority of patients who did not have complication were satisfied with the six weeks interval, 41% felt it was too long. Early contact with patients has been associated with reduction in hospital readmissions. Non-randomised studies have also shown lower 30-day adverse outcomes with early review, for heart and other surgical patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing elective and urgent CABG
  • Having full median sternotomy
  • Capable of giving Informed consent.

排除标准

  • Body Mass Index greater than 40kg/m2
  • Heart failure with left ventricular ejection fraction of <30%
  • Early postoperative sternal wound complications such as infection and sternal instability
  • Postoperative complications resulting in prolonged hospital stay greater than 14 days after surgery.

结局指标

主要结局

Physical fitness

时间窗: 6 months

Change in physical fitness assessed by incremental shuttle walk test

次要结局

  • A standardized health questionnaire for measuring generic health status.(6 months)
  • Morbidity(6 months)
  • Costs(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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