Protocol for Prehabilitation Service Implementation in Catalonia

Chronic Disease Clinical Trial

Official title:

Protocol for Prehabilitation Service Implementation in Catalonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767387
• Other study ID #: NEXTCARE-PREHAB
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2020
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: October 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Barberan-Garcia A, Ubré M, Roca J, Lacy AM, Burgos F, Risco R, Momblán D, Balust J, Blanco I, Martínez-Pallí 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cost-effectiveness	Health care costs	4 weeks
Secondary	Complications	number of complications per patient	4 weeks
Secondary	Length of stay	hospital and intensive care unit length of stay,	4 weeks
Secondary	Number of hospital readmissions	30-day hospital readmissions rate	4 weeks
Secondary	Number of Emergency room visits	30-day emergency room visits rate	4 weeks
Secondary	Meters achieved in the six-minute walk test	Aerobic capacity	4 weeks
Secondary	Yale Physical Activity Survey (YPAS)	Physical activity assessed by the YPAS (Range 0-100) Higher values represent better	4 weeks
Secondary	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
Secondary	Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)	Psychological status (Range 0-21) Higher values represent worst	4 weeks