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

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

Overview

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).

Interventions

• Other 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 Quali

Primary outcome measures

• 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"]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07338188 · 9965 · 2025-A02288-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗