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

University Hospital, Strasbourg, France

Status: Completed

Conditions: Perioperative Medicine; Surgery

Treatments: Behavioral: Experimental group: OPTIMISTIC follow-up; Other: Control group: Usual conventional follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT06182254

8801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Experimental group: OPTIMISTIC follow-up

Experimental group

Description:

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...)

Treatment:

Behavioral: Experimental group: OPTIMISTIC follow-up

Control group: Usual conventional follow-up

Active Comparator group

Description:

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

Treatment:

Other: Control group: Usual conventional follow-up