Protocol for Prehabilitation Service Implementation in Catalonia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Protocol for Prehabilitation Service Implementation in Catalonia

Conditions
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Chronic Disease

Intervention / Treatment
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* Other: Trimodal Prehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Non-elective surgery Metastatic disease known preoperatively Unstable cardiac or respiratory disease Locomotor limitations precluding exercise performance Cognitive deterioration impeding adherence to the program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prehabilitation + standard care<br>Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery | Other: Trimodal Prehabilitation<br>* Prehabilitation before major surgery consisting of: i) motivational interview to assess patient's adherence profile and to co-design the characteristics of the physical activity program with the patient; ii) personalised program to promote daily physical activity; and iii) supervised high-intensity endurance exercise training program.<br>|
| No Intervention: Standard care<br>Standard care before major surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness | Health care costs | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | number of complications per patient | 4 weeks | 
| Length of stay | hospital and intensive care unit length of stay, | 4 weeks | 
| Number of hospital readmissions | 30-day hospital readmissions rate | 4 weeks | 
| Number of Emergency room visits | 30-day emergency room visits rate | 4 weeks | 
| Meters achieved in the six-minute walk test | Aerobic capacity | 4 weeks | 
| Yale Physical Activity Survey (YPAS) | Physical activity assessed by the YPAS (Range 0-100) Higher values represent better | 4 weeks | 
| Health status assessed by 36-Item Short Form Survey (SF-36) | Health status related quality of life (Range 0-100) Higher values represent better | 4 weeks | 
| Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD) | Psychological status (Range 0-21) Higher values represent worst | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Physical Activity, Integrated Care, Collaborative Self-management