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临床试验/NCT03767387
NCT03767387已完成不适用

Protocol for Prehabilitation Service Implementation in Catalonia

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2018年11月1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
750
试验地点
2
主要终点
cost-effectiveness

研究概览

简要总结

Trimodal prehabilitation consists of a short-term (~ four to six weeks) preventive intervention to: i) enhance aerobic capacity and daily physical activity; ii) nutritional optimization; and, iii) psychological support before a major surgical procedure. The final aim of prehabilitation is to decrease surgical complications and speed-up postoperative functional recovery.

详细描述

This is a preventive intervention addressed to high risk candidates for major surgical procedures carried out for a period of approximately four weeks before surgery aiming at reducing complications and enhancing post-surgical recovery. It combines: i) high-intensity endurance exercise training and promotion of daily physical activity; ii) nutritional balance; and, iii) psychological support.

The intervention is currently deployed as mainstream service at Hospital Clinic in several types of major surgeries. During fall 2017, three multidisciplinary workshops using a design-thinking approach were carried out to refine the service workflow and to explore the potential for service scalability. The outcomes of the co-design process provided a robust background for the design of a future personalized perioperative care service at regional level covering three phases: prehabilitation, in-patient care, and, post-discharge care.

The current study protocol aims to assess cost-effectiveness of prehabilitation as mainstream service in the ongoing deployment at Hospital Clinic, as well as to generate a roadmap for regional scalability of the service. It is planned as a quasi-experimental case-control study including 500 patients undertaking prehabilitation, as intervention group, and 250 patients following standard conventional care before surgery. The patients will be included from the following type of surgeries (2:1 intervention to control ratio): major digestive surgery (n, 525), lung volume reduction (n, 30), radical cystectomy (n, 30), major cardiovascular surgery (n, 165). Study groups will be made comparable using propensity score matching with the following matching variables: type of surgery, age, sex and adjusted morbidity groups (GMA) scoring.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Adult patients (>18 years old) candidates to colorectal surgery, esophagectomy, gastrectomy, gastric bypass, major liver resection, pancreas resection, lung volume resection, radical cystectomy, cardiac valve surgery or cardiac revascularization.
  • Patients at high-risk for surgical complications defined by age > 70 years old and/or American Society of Anesthesiologists 3-4.

排除标准

  • Non-elective surgery
  • Metastatic disease known preoperatively
  • Unstable cardiac or respiratory disease
  • Locomotor limitations precluding exercise performance
  • Cognitive deterioration impeding adherence to the program

结局指标

主要结局

cost-effectiveness

时间窗: 4 weeks

Health care costs

次要结局

  • Meters achieved in the six-minute walk test(4 weeks)
  • Yale Physical Activity Survey (YPAS)(4 weeks)
  • Number of Emergency room visits(4 weeks)
  • Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)(4 weeks)
  • Complications(4 weeks)
  • Length of stay(4 weeks)
  • Health status assessed by 36-Item Short Form Survey (SF-36)(4 weeks)
  • Number of hospital readmissions(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Roca

Clinical Professor

Hospital Clinic of Barcelona

研究点 (2)

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