Postoperative Follow-upOPTICAIRENCT07338188
PROMs-guided Perioperative Care in Patients With Complex Care Needs: An Open-label Randomized Controlled Trial
A study testing Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus) in people with Postoperative Follow-up, run by University Hospital, Strasbourg, France.
Trial summary
This research aims to identify, as early as the preoperative phase, groups of patients likely to experience maximum clinical improvement through structured paramedical follow-up based on PROMs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Follow-up
- What is being tested?
- Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 3 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female
- Adult patient, with no upper age limit
- Undergoing scheduled or unscheduled surgery in a center participating in the research
- Presenting a care situation identified as complex, defined by a COMID score > 9
- Subject affiliated to a social health insurance scheme
- Subject able to understand the objectives and risks related to the research and to give informed consent, dated and signed
Who cannot join
- Inability to administer the mQoR-15f questionnaire (cognitive disorders, language barrier)
- Inability to provide the subject with informed information (subject in an emergency situation, difficulties in understanding, etc.)
- Patient who has already received previous follow-up by the OPTIMISTE team
- Patient enrolled in a therapeutic trial that may affect post-operative recovery quality
- Subject under legal protection, guardianship or curatorship
- Pregnant or breastfeeding woman
About this study
Official title: Optimization of the Perioperative Pathway Coordinated Through the Collection of Patient-reported Outcome Measures in Patients With Complex Care Needs: An Open-label Randomized Controlled Trial
This research aims to identify, as early as the preoperative phase, groups of patients likely to experience maximum clinical improvement through structured paramedical follow-up based on PROMs. However, the high heterogeneity of the included patients could have masked more pronounced effects in certain subgroups, particularly those at higher risk. Relying on a multicenter approach and a subgroup analysis, our study hypothesizes that certain patient profiles are more likely to significantly benefit from personalized follow-up based on PROMs. The objective is to validate the hypothesis that support through PROMs for patients in complex situations could allow for a more pronounced clinical effect. This follow-up will enable better targeting of interventions from the preoperative phase, optimize the use of healthcare resources, and improve quality, safety, and efficiency of perioperative pathways.
Read the detailed description
The study is an open-label, multicenter, randomized controlled trial comparing two groups:
- A control group receiving the usual conventional follow-up, notably by the surgeon and the attending physician.
- An experimental group receiving, in addition to the usual conventional follow-up, follow-up by dedicated nurses focusing on the patient's perspective regarding their health status (OPTIMISTE follow-up).
- Conditions
- Postoperative Follow-up
- Being tested
- Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)
- Keywords
- perioperative, surgery, Patient Reported Outcomes Mesuares (PROMs), Complex clinical situation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)Other
Description - Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus) The Patient-Reported Outcomes-based perioperative follow-up is a patient-centered approach that evaluates postoperative recovery using standardized questionnaires completed directly by the patient. This method highlights the patient's own perception of recovery-covering physical comfort, emotional state, independence, and pain control-rather than relying solely on clinical or physiological parameters.
The Quality of Recovery-15 (QoR-15) questionnaire is a validated, short-form tool designed to measure the quality of postoperative recovery from the patient's perspective. It consists of 15 items covering five key dimensions:
Physical comfort (pain, nausea, general well-being), Emotional state (anxiety, depression, feeling of support), Psychological support, Physical independence (ability to move or perform daily activities), Pain and symptom management.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group In addition to routine follow up by the perioperative team including the surgical team, dedicated nurses will conduct PROMs based patients interviews. These interviews are carried out systematically and in a standardized manner during pre-hospitalization on postoperative days 1, 3, 14, 28 During the interview they will assist the patient with completing the QoR-15 questionnaire, allowing a snapshot of the patient's health status.
If the nurse perceive an alteration of the patient healthstatus based on the interview, the patient may be refered to another healthcare professional (eg : surgeons, anesthesiologist, primary care physician for exemple) Preoperative contact by a nurse practitioner (NP) or registered nurse (RN) specialized in PROMs-based follow-up, and organization of perioperative follow-up on postoperative days 1, 3, 14, and 28. Receives: Other: Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus) |
| Control group | Active comparator | follow-up by the perioperative team including the surgical team without the intervention of the dedicated PROMs based interviews team.
Control groupe :
The control group, on the other hand, will receive standard follow-up coordinated by the surgeon and in collaboration with the primary care physician and other community healthcare professionals, without intervention by a nurse practitioner (NP) or registered nurse (RN) and without PROMs-based follow-up. Receives: Other: Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to evaluate the effectiveness of a perioperative follow-up integrating the patient's perspective based on their perceived health status.
Evolution of a modified version of the French Quality-Of-Recovery 15 score (QoR-15f) between the baseline consultation and postoperative "day 35" (depending on the groups: with or without the OPTISMISTE program).
The evoluation is scored from 0 to 150 (A higher score indicates better quality of recovery.)
Measured: Between the baseline consultation and "day 35"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start31 Dec 2025 (estimated)
- Primary completion3 Mar 2028 (estimated)
- Study completion3 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Follow-upStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338188
- Sponsor's protocol ID
- 9965
- Other IDs
- 2025-A02288-41
- Acronym
- OPTICAIRE
- Status last verified
- Oct 2025
- First submitted
- 8 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Perioperative Pathway Coordinated Through the Collection of Patient-reported Outcome Measures in Patients With Complex Care Needs: An Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07338188
- Acronym / sponsor ID
- OPTICAIRE / 9965
- Conditions
- Postoperative Follow-up
- Keywords
- perioperative, surgery, Patient Reported Outcomes Mesuares (PROMs), Complex clinical situation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 3 Mar 2028 (estimated)
- Study completion
- 3 Apr 2028 (estimated)
- First posted
- 13 Jan 2026 (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.
This research aims to identify, as early as the preoperative phase, groups of patients likely to experience maximum clinical improvement through structured paramedical follow-up based on PROMs. However, the high heterogeneity of the included patients could have masked more pronounced effects in certain subgroups, particularly those at higher risk. Relying on a multicenter approach and a subgroup analysis, our study hypothesizes that certain patient profiles are more likely to significantly benefit from personalized follow-up based on PROMs. The objective is to validate the hypothesis that support through PROMs for patients in complex situations could allow for a more pronounced clinical effect. This follow-up will enable better targeting of interventions from the preoperative phase, optimize the use of healthcare resources, and improve quality, safety, and efficiency of perioperative pathways.
Detailed description
The study is an open-label, multicenter, randomized controlled trial comparing two groups:
- A control group receiving the usual conventional follow-up, notably by the surgeon and the attending physician.
- An experimental group receiving, in addition to the usual conventional follow-up, follow-up by dedicated nurses focusing on the patient's perspective regarding their health status (OPTIMISTE follow-up).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)Experimental group In addition to routine follow up by the perioperative team including the surgical team, dedicated nurses will conduct PROMs based patients interviews. These interviews are carried out systematically and in a standardized manner during pre-hospitalization on postoperative days 1, 3, 14, 28 During the interview they will assist the patient with completing the QoR-15 questionnaire, allowing a snapshot of the patient's health status. If the nurse perceive an alteration of the patient healthstatus based on the interview, the patient may be refered to another healthcare professional (eg : surgeons, anesthesiologist, primary care physician for exemple) Preoperative contact by a nurse practitioner (NP) or registered nurse (RN) specialized in PROMs-based follow-up, and organization of perioperative follow-up on postoperative days 1, 3, 14, and 28. |
| Control group | Active comparator | Other: Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)follow-up by the perioperative team including the surgical team without the intervention of the dedicated PROMs based interviews team. Control groupe : The control group, on the other hand, will receive standard follow-up coordinated by the surgeon and in collaboration with the primary care physician and other community healthcare professionals, without intervention by a nurse practitioner (NP) or registered nurse (RN) and without PROMs-based follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Adult patient, with no upper age limit
- Undergoing scheduled or unscheduled surgery in a center participating in the research
- Presenting a care situation identified as complex, defined by a COMID score > 9
- Subject affiliated to a social health insurance scheme
Key exclusion criteria (6 listed)
- Inability to administer the mQoR-15f questionnaire (cognitive disorders, language barrier)
- Inability to provide the subject with informed information (subject in an emergency situation, difficulties in understanding, etc.)
- Patient who has already received previous follow-up by the OPTIMISTE team
- Patient enrolled in a therapeutic trial that may affect post-operative recovery quality
- Subject under legal protection, guardianship or curatorship
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 |
|---|---|---|
| Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)Description - Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus) The Patient-Reported Outcomes-based perioperative follow-up is a patient-centered approach that evaluates postoperative recovery using standardized questionnaires completed directly by the patient. This method highlights the patient's own perception of recovery-covering physical comfort, emotional state, independence, and pain control-rather than relying solely on clinical or physiological parameters. The Quality of Recovery-15 (QoR-15) questionnaire is a validated, short-form tool designed to measure the quality of postoperative recovery from the patient's perspective. It consists of 15 items covering five key dimensions: Physical comfort (pain, nausea, general well-being), Emotional state (anxiety, depression, feeling of support), Psychological support, Physical independence (ability to move or perform daily activities), Pain and symptom management. | Other | Control group, Experimental group |
Primary outcome
The main objective is to evaluate the effectiveness of a perioperative follow-up integrating the patient's perspective based on their perceived health status.
Time frame: Between the baseline consultation and "day 35"
Evolution of a modified version of the French Quality-Of-Recovery 15 score (QoR-15f) between the baseline consultation and postoperative "day 35" (depending on the groups: with or without the OPTISMISTE program). The evoluation is scored from 0 to 150 (A higher score indicates better quality of recovery.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus) in people with Postoperative Follow-up, run by University Hospital, Strasbourg, 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 6 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The main objective is to evaluate the effectiveness of a perioperative follow-up integrating the patient's perspective based on their perceived health status. (time frame: Between the baseline consultation and "day 35"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.