Personalized Perioperative Care Based on Patient Reported Outcomes Measures

Not Applicable

Completed

• Conditions: Perioperative Medicine; Surgery

• Registration Number: NCT06182254
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Study Timeline

• Study First Submitted: 2023-04-06
• Study Start: 2023-04-14
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2023-12-26
• Primary Completion: 2025-01-23
• Study Completion: 2025-01-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

EBER Manon; 🇫🇷 Strasbourg, France