Clinical trial NCT06182254: Personalized Perioperative Care Based on Patient Reported Outcomes Measures
Official title: Personalized Perioperative Care Based on Patient Reported Outcomes Measures: Randomized Controlled Trial Based on the QoR-15
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Perioperative Medicine
Keywords: perioperative
surgery
care Patient Reported Outcomes Measures
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Evaluate the effectiveness of a perioperative follow-up integrating the patient's point of view in osteoarticular surgery compared to a classic postoperative management
timeFrame: Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35
Secondary outcomes:
measure: Describe postoperative functional recovery after osteoarticular surgery
timeFrame: Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35
measure: Describe the consequences of a perioperative follow-up that integrates the patient's point of view on the patient pathway
timeFrame: Day 1, Day 3, Day 14, Day 28 and Day 35
measure: Evaluate the effectiveness of perioperative monitoring that incorporates the patient's perspective on reducing postoperative opioid use
timeFrame: Day 35
measure: Evaluate the safety
timeFrame: Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35]
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: EBER Manon
Study officials:
affiliation: CHRU Strasbourg
name: EBER Manon, Mme
role: PRINCIPAL_INVESTIGATOR
References: