Patient Empowerment for Major Surgery Preparation @ Home

Study Overview
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Brief Summary
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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

Detailed Description
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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)

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

Conditions
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Urologic Diseases, Cardiovascular Diseases, Thoracic Diseases, Orthopedic Disorder, Gastrointestinal Disease

Intervention / Treatment
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* Other: multimodal prehabilitation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional group: Patients with Paprika program Historical group: Patients with same characteristics operated in 2018-2019
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paprika group<br>Patients coming for elective major surgery will participate to Paprika program | Other: multimodal prehabilitation<br>* 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<br>|
| No Intervention: Historical group<br>Patients previously operated with same characteristics | |

What is the study measuring?
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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 |