CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 280 enrolled
Drug / intervention
Experimental group: OPTIMISTIC follow-up +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06182254
NCT06182254N/ACompleted

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

University Hospital, Strasbourg, France·interventional·Posted Dec 26, 2023·Updated May 8, 2025

In Brief

A clinical study evaluating Experimental group: OPTIMISTIC follow-up and Control group: Usual conventional follow-up for Surgery and Perioperative Medicine. Completed, enrolled 280 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedDec 26, 2023
Enrollment StartApr 14, 2023
Primary CompletionJan 23, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 2.5 years ago

Interventions

Experimental group: OPTIMISTIC follow-upbehavioral

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-upother

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