NCT06182254

Personalized Perioperative Care Based on Patient Reported Outcomes Measures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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...)
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).

Timeline

• Start date: 2023-04-14
• Primary completion: 2025-01-23
• Completion: 2025-01-23
• First posted: 2023-12-26
• Last updated: 2025-05-08

Locations

1 site across 1 country: France