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Completed

NCT Number: NCT06182254

Personalized Perioperative Care Based on Patient Reported Outcomes Measures

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.

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Key information

Conditions

Surgery Perioperative Medicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EBER Manon

Strasbourg, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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...)

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).

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

    Time frame: 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 outcomes

  1. Describe postoperative functional recovery after osteoarticular surgery

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: Day 35

    Opioid consommation at D35 postoperative

  4. Evaluate the safety

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

    postoperative complication rate to postoperative D35

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: SUPPORT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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