Clinical Trial

PROMs-guided Perioperative Care in Patients With Complex Care Needs: An Open-label Randomized Controlled Trial

Study acronym: OPTICAIRE
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07338188
Lead Sponsor University Hospital, Strasbourg, France
Conditions Postoperative Follow-up
Enrollment 276 participants
Start Date 2025-12-31
Primary Completion 2028-03-03 (estimated)
Study Completion 2028-04-03 (estimated)
Updated on ClinicalTrials.gov 2026-01-13