PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home (PAPRIKA)

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Surgical Procedure, Unspecified
• Intervention / Treatment: Behavioral: Usual care; Behavioral: Prehabilitation

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Recruiting
      • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Prospective sample of risk patients who are candidates for major surgery attended in the outpatient offices of the Hospital Clínic de Barcelona.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Usual care; The preoperative standard measures consist of physical activity recommendation and advice on both smoking cessation and alcohol intake reduction. Moreover, in patients presenting with anemia, the anesthesiologists will assess its etiology and treat it accordingly, and nutritional intervention will be performed by a registered dietitian in to those patients at risk of malnutrition (Malnutrition Universal Screening Tool ≥2).
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.	Behavioral: Prehabilitation; i) Exercise training: Ambulatory exercise training sessions with two main components, namely: high-intensity endurance exercise training and strength muscular training. ii) Promotion of physical activity: Pedometer-based program using a physical activity tracker linked to a mobile app. iv) Nutritional optimization: Recommendations of a healthy balanced diet or adapted to their digestive symptoms. Daily amount of protein intake will be close to 2 g•Kg-1•day-1. iv) Smoking cessation: Use of both cognitive behavioral intervention and pharmacological therapy by varenicline or nicotine replacement therapies. v) Cognitive behavioral therapy: Weekly group sessions conducted by a clinical health psychologist, including psychoeducation, motivational and behavioral change, self-efficacy and adherence enhancement, coping strategies acquisition and patient empowerment.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test	Distance covered during the six-minute walk test	At program inclusion and at program discharge (on average at 6 weeks)
Physical activity	Physical activity measured by the Yale Physical Activity Survey (YPAS) (range 0 to 142; the lowest the worst)	At program inclusion and at program discharge (on average at 6 weeks)
Psycho-emotional status	Psycho-emotional status measured by the Hospital Anxiety and Depression (HAD) scale (range 0-21; the highest the worst)	At program inclusion and at program discharge (on average at 6 weeks)

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Study Director: Josep Roca, Prof, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): June 30, 2020
• Study Completion (ANTICIPATED): July 30, 2020

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (ACTUAL): March 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Nutrition; Physical activity; Smoking cessation; eHealth; Exercise training; Cognitive behavioural therapy; Prehabilitation
• Other Study ID Numbers: HCB/2019/1030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No