Perioperative Medicine, Surgery
Conditions
Keywords
perioperative, surgery, care Patient Reported Outcomes Measures
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.
Interventions
BEHAVIORALExperimental 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...)
OTHERControl 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).
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of a perioperative follow-up integrating the patient's point of view in osteoarticular surgery compared to a classic postoperative management | Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35 | Evolution of a modified version of the French Quality-Of-Recovery 15 score (QoR-15f) between the intraoperative consultation and D35 postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe postoperative functional recovery after osteoarticular surgery | Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35 | Isolated and dimensional changes in the 15 items of the QoR-15f score from intraoperative consultation to postoperative D35. |
| 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 | Number of medical and paramedical consultations and number of hospitalization days between hospital discharge and D35 postoperative |
| Evaluate the effectiveness of perioperative monitoring that incorporates the patient's perspective on reducing postoperative opioid use | Day 35 | Opioid consommation at D35 postoperative |
| Evaluate the safety | Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35] | postoperative complication rate to postoperative D35 |
Countries
France
Outcome results
None listed