Protocol for Prehabilitation Service Implementation in Catalonia
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|ClinicalTrials.gov Identifier: NCT03767387|
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Disease||Other: Trimodal Prehabilitation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Protocol for Prehabilitation Service Implementation in Catalonia|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
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
- cost-effectiveness [ Time Frame: 4 weeks ]Health care costs
- Complications [ Time Frame: 4 weeks ]number of complications per patient
- Length of stay [ Time Frame: 4 weeks ]hospital and intensive care unit length of stay,
- Number of hospital readmissions [ Time Frame: 4 weeks ]30-day hospital readmissions rate
- Number of Emergency room visits [ Time Frame: 4 weeks ]30-day emergency room visits rate
- Meters achieved in the six-minute walk test [ Time Frame: 4 weeks ]Aerobic capacity
- Yale Physical Activity Survey (YPAS) [ Time Frame: 4 weeks ]Physical activity assessed by the YPAS
- Health status assessed by 36-Item Short Form Survey (SF-36) [ Time Frame: 4 weeks ]Health status related quality of life
- Psychological status assessed by the The Hospital Anxiety And Depression Scale (HAD) [ Time Frame: 4 weeks ]Psychological status
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767387
|Hospital Clinic. Prehabilitation Unit D +34932275747 firstname.lastname@example.org|
|Barcelona, Catalonia, Spain, 08036|
|Principal Investigator:||Josep Roca, MD||Hospital Clinic|