SurgerySUPPORTNCT06182254

Personalized Perioperative Care Based on Patient Reported Outcomes Measures

A study testing Experimental group: OPTIMISTIC follow-up in people with Surgery and Perioperative Medicine, run by University Hospital, Strasbourg, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgery, Perioperative Medicine
What is being tested?: Experimental group: OPTIMISTIC follow-up
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 280 participants
Where: 1 siteFrance
Study dates: 14 Apr 2023to 23 Jan 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

EBER Manon
Strasbourg

Other trials in France

About this study

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

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.

Read the 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.

Conditions: Surgery, Perioperative Medicine
Being tested: Experimental group: OPTIMISTIC follow-up, Control group: Usual conventional follow-up
Keywords: perioperative, surgery, care Patient Reported Outcomes Measures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06182254
Study group	Role	What they receive
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...) Receives: 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). Receives: Other: Control group: Usual conventional follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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.
Measured: 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
Number of medical and paramedical consultations and number of hospitalization days between hospital discharge and D35 postoperative
Measured: 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
Opioid consommation at D35 postoperative
Measured: Day 35
Evaluate the safety
postoperative complication rate to postoperative D35
Measured: Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 202323 Jan 2025

First posted26 Dec 2023
Study start14 Apr 2023
Primary completion23 Jan 2025
Study completion23 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SurgeryStudies of the same condition, open and under way.
More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 280 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06182254
Sponsor's protocol ID: 8801
Acronym: SUPPORT
Status last verified: May 2025
First submitted: 6 Apr 2023
Last updated: 8 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Eber M, Perrin T, Reinbold N, Diemunsch S, Bonnomet F, Pottecher J, Bennett-Guerrero E, Chahard A, Meyer N, Noll E. Patient-reported outcome measures-guided perioperative care versus standard of care in postoperative recovery: Randomised controlled trial in orthopaedic surgery. Eur J Anaesthesiol. 2026 Jun 9. doi: 10.1097/EJA.0000000000002429. Online ahead of print.
PubMed 42290213

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized Perioperative Care Based on Patient Reported Outcomes Measures: Randomized Controlled Trial Based on the QoR-15
ClinicalTrials.gov ID: NCT06182254
Acronym / sponsor ID: SUPPORT / 8801
Conditions: Surgery, Perioperative Medicine
Keywords: perioperative, surgery, care Patient Reported Outcomes Measures
Study type: Interventional
Recruitment status: Completed
Enrolment: 280 participants (actual)
Lead sponsor: University Hospital, Strasbourg, FranceUniversity, hospital or other
Study start: 14 Apr 2023 (actual)
Primary completion: 23 Jan 2025 (actual)
Study completion: 23 Jan 2025 (actual)
First posted: 26 Dec 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In the perioperative setting, Patient Reported Outcomes Measures (PROMs) are important for both patients and clinicians.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental group: OPTIMISTIC follow-up	Experimental	Behavioral: Experimental group: OPTIMISTIC follow-upfollow-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	Active comparator	Other: Control group: Usual conventional follow-upusual conventional follow-up according to routine care (modified QoR-15f score will be administered to all patients at visit 0 and Day 35).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental group: OPTIMISTIC follow-upfollow-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...)	Behavioural	Experimental group: OPTIMISTIC follow-up
Control group: Usual conventional follow-upusual 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

Primary outcome

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

4 secondary outcomes

Describe postoperative functional recovery after osteoarticular surgery
Time frame: 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
Time frame: 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
Time frame: Day 35
Evaluate the safety
Time frame: Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35]

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
Derived from this study: PubMed 42290213Eber M, Perrin T, Reinbold N, Diemunsch S, Bonnomet F, Pottecher J, Bennett-Guerrero E, Chahard A, Meyer N, Noll E. Patient-reported outcome measures-guided perioperative care versus standard of care in postoperative recovery: Randomised controlled trial in orthopaedic surgery. Eur J Anaesthesiol. 2026 Jun 9. doi: 10.1097/EJA.0000000000002429. Online ahead of print.
Individual participant dataSharing planned: No

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Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

EBER Manon, Mme principal investigator

CHRU Strasbourg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental group: OPTIMISTIC follow-up in people with Surgery and Perioperative Medicine, run by University Hospital, Strasbourg, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06182254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.