Personalized Perioperative Care Based on Patient Reported Outcomes Measures

NCT ID: NCT06182254

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-14
• Study Completion Date: 2025-01-23

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.

Conditions

Surgery; Perioperative Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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...)

Group Type: EXPERIMENTAL

Experimental group: OPTIMISTIC follow-up

Intervention Type: BEHAVIORAL

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...)

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).

Group Type: ACTIVE_COMPARATOR

Control group: Usual conventional follow-up

Intervention Type: OTHER

usual conventional follow-up according to routine care (modified QoR-15f score will be administered to all patients at visit 0 and Day 35).

Interventions

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...)

Intervention Type: BEHAVIORAL

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EBER Manon, Mme

Role: PRINCIPAL_INVESTIGATOR

CHRU Strasbourg

Locations

EBER Manon

Strasbourg, , France

Countries

France

Other Identifiers

8801

Identifier Type: -

Identifier Source: org_study_id