Protocol for Prehabilitation Service Implementation in Catalonia
Primary Purpose
Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Trimodal Prehabilitation
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Disease focused on measuring Prehabilitation, Physical Activity, Integrated Care, Collaborative Self-management
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
Sites / Locations
- Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Prehabilitation + standard care
Standard care
Arm Description
Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery
Standard care before major surgery
Outcomes
Primary Outcome Measures
cost-effectiveness
Health care costs
Secondary Outcome Measures
Complications
number of complications per patient
Length of stay
hospital and intensive care unit length of stay,
Number of hospital readmissions
30-day hospital readmissions rate
Number of Emergency room visits
30-day emergency room visits rate
Meters achieved in the six-minute walk test
Aerobic capacity
Yale Physical Activity Survey (YPAS)
Physical activity assessed by the YPAS (Range 0-100) Higher values represent better
Health status assessed by 36-Item Short Form Survey (SF-36)
Health status related quality of life (Range 0-100) Higher values represent better
Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)
Psychological status (Range 0-21) Higher values represent worst
Full Information
NCT ID
NCT03767387
First Posted
December 3, 2018
Last Updated
February 11, 2020
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT03767387
Brief Title
Protocol for Prehabilitation Service Implementation in Catalonia
Official Title
Protocol for Prehabilitation Service Implementation in Catalonia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Prehabilitation, Physical Activity, Integrated Care, Collaborative Self-management
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation + standard care
Arm Type
Active Comparator
Arm Description
Trimodal Prehabilitation consisting on motivation, personalisation and supervision of physical activity before major surgery
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care before major surgery
Intervention Type
Other
Intervention Name(s)
Trimodal Prehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
cost-effectiveness
Description
Health care costs
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Complications
Description
number of complications per patient
Time Frame
4 weeks
Title
Length of stay
Description
hospital and intensive care unit length of stay,
Time Frame
4 weeks
Title
Number of hospital readmissions
Description
30-day hospital readmissions rate
Time Frame
4 weeks
Title
Number of Emergency room visits
Description
30-day emergency room visits rate
Time Frame
4 weeks
Title
Meters achieved in the six-minute walk test
Description
Aerobic capacity
Time Frame
4 weeks
Title
Yale Physical Activity Survey (YPAS)
Description
Physical activity assessed by the YPAS (Range 0-100) Higher values represent better
Time Frame
4 weeks
Title
Health status assessed by 36-Item Short Form Survey (SF-36)
Description
Health status related quality of life (Range 0-100) Higher values represent better
Time Frame
4 weeks
Title
Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD)
Description
Psychological status (Range 0-21) Higher values represent worst
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Roca, MD
Organizational Affiliation
Hospital Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic. Prehabilitation Unit D +34932275747 chernan@clinic.ub.es
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28489682
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.
Results Reference
background
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Protocol for Prehabilitation Service Implementation in Catalonia
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