Personalized Perioperative Care Based on Patient Reported Outcomes Measures (SUPPORT)

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Perioperative Medicine
• Intervention / Treatment: Behavioral: Experimental group: OPTIMISTIC follow-up; Other: Control group: Usual conventional follow-up

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 Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France
    • EBER Manon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group: OPTIMISTIC follow-up; 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; 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...)
Active Comparator: Control group: Usual conventional follow-up; 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; usual conventional follow-up according to routine care (modified QoR-15f score will be administered to all patients at visit 0 and Day 35).

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]

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: EBER Manon, Mme, CHRU Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: surgery; perioperative; care Patient Reported Outcomes Measures
• Other Study ID Numbers: 8801 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No