Protocol for Prehabilitation Service Implementation in Catalonia

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Other: Trimodal Prehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prehabilitation + standard care; Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery	Other: Trimodal Prehabilitation; 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.
No Intervention: Standard care; Standard care before major surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Josep Roca, MD, Hospital Clínic

Publications and helpful links

General Publications

• Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Physical Activity; Integrated Care; Prehabilitation; Collaborative Self-management
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: NEXTCARE-PREHAB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No