PROMs-guided Perioperative Care in Patients With Complex Care Needs: An Open-label Randomized Con… (NCT07338188) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PROMs-guided Perioperative Care in Patients With Complex Care Needs: An Open-label Randomized Controlled Trial
276 participantsStarted 2025-12-31
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The main objective is to evaluate the effectiveness of a perioperative follow-up integrating the patient's perspective based on their perceived health status.
Timeframe: Between the baseline consultation and "day 35"