PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

• Conditions: Cancer; Surgical Procedure, Unspecified
• Interventions: Behavioral: Usual care; Behavioral: Prehabilitation

• Registration Number: NCT04295668
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

PAPRIKA establishes a technologically enabled and personalized prehabilitation and follow-up after surgical intervention program for patients undergoing elective major surgery Program creates close collaboration between the medical environment and the patients empowering them to co-create their own care.

It is at the first stage aimed to high-risk patients undergoing major surgery. Better condition before the surgery is proved to reduce the perioperative complications and to improve patients' health-related quality of life while cutting the associated costs. The concept integrates short-term (average 4 weeks) preoperative interventions including endurance training, promotion of physical activity and nutritional and psychological support. Interventions are planned both at community and at hospital reducing unnecessary interactions between patients and tertiary care.

PAPRIKA tackles three major drivers: i) human perspective ii) organizational challenges and iii) technical aspects. The project is based on previous experience on prehabilitation and the already refined service using design thinking methodologies. It will be also based on the proven reduction of associated costs for the healthcare system.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-02-27
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-03
• Last Update Submitted: 2020-03-03
• Study First Posted: 2020-03-04
• Last Update Posted: 2020-03-04
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age > 70 years old and/or American Society of Anesthesiologist (ASA) index 3-4 and/or highly aggressive surgery or solid organ transplantation.

Exclusion Criteria

• Non-elective surgery; metastatic disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	A contemporaneous control group of patients was build using propensity score matching (PSM) methodologies taking into account the following matching variables: type of surgery, age, sex, American Society of Anesthesiologists Index (ASA) and adjusted morbidity groups (GMA) grading.
Prehabilitation	Prehabilitation	Prospective sample of risk patients who are candidates for major surgery attended in the outpatient offices of the Hospital Clínic de Barcelona. Inclusion criteria: i) American Society of Anesthesiologists Index (ASA) 3-4; and / or, ii) age ≥ 75 years; and / or iii) major aggressive surgery; and, iv) solid organ transplant candidate. Exclusion criteria: i) Non-elective surgery; ii) Known metastatic disease before surgery; iii) Unstable respiratory or heart disease; or, iv) Locomotive or cognitive limitations that prevent adherence to the program.

Primary Outcome Measures

Name	Time	Method
Postoperative complications	Duration of the initial hospitalization for surgery	Number of postoperative complications during the initial hospitalization for surgery
Severity of postoperative complications	Duration of the initial hospitalization for surgery	Severity of postoperative complications during the initial hospitalization for surgery using the Clavien-Dindo classification
Hospital length of stay	Duration of the initial hospitalization for surgery	Number of days of hospital length of stay during the initial hospitalization for surgery

Secondary Outcome Measures

Name	Time	Method
Hospital readmissions at 30 days	From initial hospital discharge to 30 days follow-up	Number of postoperative complications during a 30-day period after surgery
Emergency room visits at 30 days	From initial hospital discharge to 30 days follow-up	Number of emergency room visits during a 30-day period after surgery
Surgical reinterventions at 30 days	From initial hospital discharge to 30 days follow-up	Number of surgical reinterventions during a 30-day period after surgery
Mortality at 30 days	From initial hospital discharge to 30 days follow-up	Number of exitus during a 30-day period after surgery

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Catalonia, Spain