Personalized Perioperative Care Based on Patient Reported Outcomes Measures

Surgery Clinical Trial

— SUPPORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182254
• Other study ID #: 8801
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: July 5, 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: EBER Manon, Mme
• Phone: +33368765377
• Email: manon.eber[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 5, 2025
• Est. primary completion date: July 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

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).

Locations

Country	Name	City	State
France	EBER Manon	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effectiveness of a perioperative follow-up integrating the patient's point of view in osteoarticular surgery compared to a classic postoperative management	Evolution of a modified version of the French Quality-Of-Recovery 15 score (QoR-15f) between the intraoperative consultation and D35 postoperative	Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35
Secondary	Describe postoperative functional recovery after osteoarticular surgery	Isolated and dimensional changes in the 15 items of the QoR-15f score from intraoperative consultation to postoperative D35.	Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35
Secondary	Describe the consequences of a perioperative follow-up that integrates the patient's point of view on the patient pathway	Number of medical and paramedical consultations and number of hospitalization days between hospital discharge and D35 postoperative	Day 1, Day 3, Day 14, Day 28 and Day 35
Secondary	Evaluate the effectiveness of perioperative monitoring that incorporates the patient's perspective on reducing postoperative opioid use	Opioid consommation at D35 postoperative	Day 35
Secondary	Evaluate the safety	postoperative complication rate to postoperative D35	Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35]