Clinical trial NCT03767387: Protocol for Prehabilitation Service Implementation in Catalonia
Official title: Protocol for Prehabilitation Service Implementation in Catalonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Prehabilitation
Physical Activity
Integrated Care
Collaborative Self-management
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: cost-effectiveness
timeFrame: 4 weeks
Secondary outcomes:
measure: Complications
timeFrame: 4 weeks
measure: Length of stay
timeFrame: 4 weeks
measure: Number of hospital readmissions
timeFrame: 4 weeks
measure: Number of Emergency room visits
timeFrame: 4 weeks
measure: Meters achieved in the six-minute walk test
timeFrame: 4 weeks
measure: Yale Physical Activity Survey (YPAS)
timeFrame: 4 weeks
measure: Health status assessed by 36-Item Short Form Survey (SF-36)
timeFrame: 4 weeks
measure: Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es
state: Catalonia
Study officials:
affiliation: Hospital Clinic
name: Josep Roca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.