PROMs-guided Perioperative Care in Patients With Complex Care Needs: An Open-label Randomized Controlled Trial
Starting soon · Not applicable
Conditions studied: Postoperative Follow-up
In brief
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.
Key facts
- Study ID
- NCT07338188
- Run by
- University Hospital, Strasbourg, France
- People needed
- 276
- Starts
- 2025-12-31
- Expected to finish
- 2028-04-03
- Last updated by the study team
- 2026-01-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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