Patient Empowerment for Major Surgery Preparation @ Home (Paprika)

Patient Empowerment for Major Surgery Preparation @ Home: Multimodal Prehabilitation in Major Elective Surgery

Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program (based on physical activity, nutritional support and mental preparation) for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Urologic Diseases; Orthopedic Disorder; Thoracic Diseases; Gastrointestinal Disease
• Intervention / Treatment: Other: multimodal prehabilitation

Detailed Description

Prehabilitation programs essentially based on physical activity improvement may reduce postoperative complications after major surgery. We hypothesize that a multimodal program based on physical activity, nutritional support and mental preparation may not only improve postoperative recovery and reduce costs but also improve health status beyond postoperative period.

Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery.

Other outcomes will be measured : length of hospital stay, hospital readmissions, direct costs, health status at 1 and 6 months.

Moreover, the feasibility and adherence of Paprika program will be evaluated. Inter-data centres relating to the implementation of the same prehabilitation program will be compared with the consortium Paprika (Hospital Clinic of Barcelona, University of Cologne, University of Gdansk)

• Study Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-France Vaillant; Phone Number: +33 4 76 76 89 13; Email: mfvaillant@chu-grenoble.fr
• Study Contact Backup: Name: Laura Albaladejo; Email: EXT-LAlbaladejo@chu-grenoble.fr

Study Locations

• France
  • La Tronche, France, 38700
    • Recruiting
    • Centre Hospitalier Universitaire Grenoble Alpes
    • Contact: Marie-France Vaillant; Phone Number: +33 4 76 76 89 13; Email: mfvaillant@chu-grenoble.fr
    • Contact: Laura Albaladejo; Email: EXT-LAlbaladejo@chu-grenoble.fr
    • Principal Investigator: Pierre Albaladejo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient eligible to elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)
• Age > 70 years and/or American Society of Anesthesiologists (ASA) score 3-4
• or Unfit patient according to appropriate scores (Two among 3 scores (HAD, Physical activity score, nutritional score) below threshold). Unfit patients will be defined by at least 2 criteria if 'YES' answers: Physical activity: Less than 50% of WHO recommendations = less than 5000 steps/day or less than 75 min moderate activity/week or less than 12 min moderate activity/day Yes/No Malnutrition: BMI < 20 kg/m2 if < 70 years (or <22 if >70y) = undernutrition Yes/No or BMI>25 kg/m2 (= overweight to obesity) or Loss of appetite? Mental evaluation HAD (Hospital Anxiety and Depression) >8 for A or D score Yes/No
• Diagnosis:

Elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)

- Regulatory aspects: Be legally able to give consent Patient affiliated to social security

Exclusion Criteria:

• Planned surgery (less than 4 weeks at inclusion)
• Urgent surgery
• Patient with, at baseline, good to excellent physical, nutritional, mental status as defined by appropriate scores.
• Patient considered not eligible to this program for physical or psychological reasons by the surgeon or the anesthetist
• Persons referred in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Paprika group; Patients coming for elective major surgery will participate to Paprika program	Other: multimodal prehabilitation; Paprika prehabilitation program content: patients will have choices for each activity. Messages and motivation will be reinforced by using a mobile app or leaflet advices, according to patient's preferences.; Physical activity promotion by discovering ebike, personalised gymnastics and encouragement to increase the number of daily steps of patients, measured by a wristband and a mobile App; An individualized nutritional optimization plan with dietary advices and protein supplementation (if necessary).; Psychological support will be proposed through auto-hypnosis sensibilisation or management of stress with Cognitive Behavior Stress Management technics
NO_INTERVENTION: Historical group; Patients previously operated with same characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of postoperative complications at Day-30	Rate of postoperative complications at Day-30 classified following the standards of the European Society of Anaesthesiology and European Society of intensive Care Medicine.	at Day-30 post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and severity of postoperative complications	Number and severity of postoperative complications using Dindo-Clavien classification within 30 days	within 30 days post surgery
Length of stay (ICU and Hospital)	Length of ICU stay and Length of hospital stay	within 30 days post surgery
Hospital readmission	Hospital readmission within 30 days	within 30 days post surgery
Direct cost	Valuation in euros of the direct cost from a 1-month hospital point of view (duration and type of stay, acts, GHM...) by integrating for the intervention group the cost of the pre-habilitation program. Care consumption at 6 months from a social security perspective (Probabilistic Matching National Health Data System)--> comparison of direct costs for the Prehab sessions (professional caregivers and materials costs) versus complication costs of control group	interventional group: 1 month-cost before surgery+1 month-post surgery / Control group: 1 month-cost post-surgery
Physical activity health status	Health status based on physical activity score:GPAQ and DASI scores	a baseline, presurgery and 6 months post surgery
Nutritional health status	Nutritional health status based on weight, appetite and ingesta measurements	at baseline, 1 month and 6 months
Psychological health status	Psychological health status based on HAD, Perceived Stress Scale scores	at baseline, 1 month and 6 months
Number of patient participation to program in relation to the number of eligible patients	Number of patient participation to program in relation to the number of eligible patients to assess faisability	During Paprika inclusion period
Ratio patient participation to each session	Ratio patient participation to each session to assess faisability and limitation to participation	During Paprika 1 month-sessions
Comparison with other centers	Comparison will be done with other cohorts using Paprika program (Barcelona, Gdansk and Köln) on common outcomes	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Hospital Clinic of Barcelona; University Clinical Centre, Gdansk; EIT Health; Universitätsklinikum Köln
• Investigators: Principal Investigator: Pierre Albaladejo, Prof., CHU Grenoble Alpes

Publications and helpful links

General Publications

• 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.
• Barberan-Garcia A, Ubre M, Pascual-Argente N, Risco R, Faner J, Balust J, Lacy AM, Puig-Junoy J, Roca J, Martinez-Palli G. Post-discharge impact and cost-consequence analysis of prehabilitation in high-risk patients undergoing major abdominal surgery: secondary results from a randomised controlled trial. Br J Anaesth. 2019 Oct;123(4):450-456. doi: 10.1016/j.bja.2019.05.032. Epub 2019 Jun 25.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2020
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (ACTUAL): December 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Cardiovascular Diseases; Gastrointestinal Diseases; Digestive System Diseases; Musculoskeletal Diseases; Thoracic Diseases; Urologic Diseases
• Other Study ID Numbers: 38RC19.182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be shared with Barcelona, Köln and Gdansk: all collected IPD
• IPD Sharing Time Frame: Data will be available at the end of the study: starting July 2021
• IPD Sharing Access Criteria: IPD will be shared with other sites in order to compare results coming from common questionnaires and data. Statistical analyses will be performed for Grenoble site separately and pooled with the other sites in a second step.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

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