Personalized Perioperative Care Based on Patient Reported Outcomes Measures

Study Overview
=================
Brief Summary
-----------------
In the perioperative setting, Patient Reported Outcomes Measures (PROMs) are important for both patients and clinicians. Reliable PROMs, like the Quality Of Recovery 15 (QoR-15) questionnaire, are available for patients experiencing surgery. These PROMs are significantly used as endoints for clinical interventions assessment. These PROMs may also be considered to monitor and assess patient health status as part of enhanced recovery after surgery pathway. However data about the efficacy of PROMs-based perioperative clinical follow up are lacking. The clinical hypothesis is that a PROMs (QoR-15) based perioperative clinical care is more efficient that the usual care non based on the QoR-15.

Detailed Description
-----------------
The study is a multicenter randomized controlled trial comparing 2 groups: A control group, including the usual conventional follow-up by the surgeon and the attending physician. An experimental group including, in addition to the usual conventional follow-up, the follow-up by nurses specialized in the evaluation of the PROMs using the french version of the QoR-15 questionnaire.

Official Title
-----------------
Personalized Perioperative Care Based on Patient Reported Outcomes Measures: Randomized Controlled Trial Based on the QoR-15

Conditions
-----------------
Surgery, Perioperative Medicine

Intervention / Treatment
-----------------
* Behavioral: Experimental group: OPTIMISTIC follow-up
* Other: Control group: Usual conventional follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patient Benefiting from an osteo-articular surgery Subject affiliated to a social health insurance plan Able to understand the objectives and risks of the research and to give a dated and signed informed consent Exclusion Criteria: Inability to administer the QoR-15f questionnaire (cognitive impairment, language barrier) Subject under court protection Subject under guardianship or curatorship Patient whose rehabilitation will be performed in a secondary hospital Patient having already benefited from a previous follow-up by the OPTIMISTE team Patient included in a therapeutic trial that may impact postoperative quality of recovery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group: OPTIMISTIC follow-up<br>follow-up by nurses specialized in collecting the patient's point of view concerning his or her state of health, in addition to the usual conventional follow-up according to routine care directive interviews carried out preoperatively and at Days 1, 3, 14 and 28 postoperatively (modified QoR-15f score, PROMS...) | Behavioral: Experimental group: OPTIMISTIC follow-up<br>* follow-up by nurses specialized in collecting the patient's point of view concerning his or her state of health, in addition to the usual conventional follow-up according to routine care directive interviews carried out preoperatively and at Days 1, 3, 14 and 28 postoperatively (modified QoR-15f score, PROMS...)<br>|
| Active Comparator: Control group: Usual conventional follow-up<br>usual conventional follow-up according to routine care (modified QoR-15f score will be administered to all patients at visit 0 and Day 35). | Other: Control group: Usual conventional follow-up<br>* usual conventional follow-up according to routine care (modified QoR-15f score will be administered to all patients at visit 0 and Day 35).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of a perioperative follow-up integrating the patient's point of view in osteoarticular surgery compared to a classic postoperative management | Evolution of a modified version of the French Quality-Of-Recovery 15 score (QoR-15f) between the intraoperative consultation and D35 postoperative | Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe postoperative functional recovery after osteoarticular surgery | Isolated and dimensional changes in the 15 items of the QoR-15f score from intraoperative consultation to postoperative D35. | Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35 | 
| Describe the consequences of a perioperative follow-up that integrates the patient's point of view on the patient pathway | Number of medical and paramedical consultations and number of hospitalization days between hospital discharge and D35 postoperative | Day 1, Day 3, Day 14, Day 28 and Day 35 | 
| Evaluate the effectiveness of perioperative monitoring that incorporates the patient's perspective on reducing postoperative opioid use | Opioid consommation at D35 postoperative | Day 35 | 
| Evaluate the safety | postoperative complication rate to postoperative D35 | Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perioperative, surgery, care Patient Reported Outcomes Measures