Personalized Perioperative Care Based on Patient Reported Outcomes Measures

NCT06182254 | Completed DMC

• 1 other identifier: 8801
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Perioperative Medicine

Keywords

perioperative; surgery; care Patient Reported Outcomes Measures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Describe postoperative functional recovery after osteoarticular surgery

  Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35

• Describe the consequences of a perioperative follow-up that integrates the patient's point of view on the patient pathway

  Day 1, Day 3, Day 14, Day 28 and Day 35

• Evaluate the effectiveness of perioperative monitoring that incorporates the patient's perspective on reducing postoperative opioid use

  Day 35

• Evaluate the safety

  Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35]

Study Arms (2)

Experimental group: OPTIMISTIC follow-up

EXPERIMENTAL

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...)

Behavioral: Experimental group: OPTIMISTIC follow-up

Control group: Usual conventional follow-up

ACTIVE COMPARATOR

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

Other: Control group: Usual conventional follow-up

Interventions

Experimental group: OPTIMISTIC follow-up BEHAVIORAL

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...)

Experimental group: OPTIMISTIC follow-up

Control group: Usual conventional follow-up OTHER

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

Control group: Usual conventional follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

EBER Manon

Strasbourg, France

Location

Study Officials

• EBER Manon, Mme

  CHRU Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: December 26, 2023
• Study Start: April 14, 2023
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)