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

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.

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).

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