PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Surgical Procedure, Unspecified; Cancer

Treatments: Behavioral: Prehabilitation; Behavioral: Usual care

Study type: Observational

Funder types: Other

Identifiers

NCT04295668

HCB/2019/1030

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Usual care

Description:

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.

Treatment:

Behavioral: Usual care

Prehabilitation

Description:

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.

Treatment:

Behavioral: Prehabilitation