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

University Hospital, Strasbourg, France

Status: Not yet enrolling

Conditions: Postoperative Follow-up

Treatments: Other: Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)

Study type: Interventional

Funder types: Other

Identifiers

NCT07338188

9965

2025-A02288-41 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 276 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

Experimental group

Experimental group

Description:

Experimental group In addition to routine follow up by the perioperative team including the surgical team, dedicated nurses will conduct PROMs based patients interviews. These interviews are carried out systematically and in a standardized manner during pre-hospitalization on postoperative days 1, 3, 14, 28 During the interview they will assist the patient with completing the QoR-15 questionnaire, allowing a snapshot of the patient's health status. If the nurse perceive an alteration of the patient healthstatus based on the interview, the patient may be refered to another healthcare professional (eg : surgeons, anesthesiologist, primary care physician for exemple) Preoperative contact by a nurse practitioner (NP) or registered nurse (RN) specialized in PROMs-based follow-up, and organization of perioperative follow-up on postoperative days 1, 3, 14, and 28.

Treatment:

Other: Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)

Control group

Active Comparator group

Description:

follow-up by the perioperative team including the surgical team without the intervention of the dedicated PROMs based interviews team. Control groupe : The control group, on the other hand, will receive standard follow-up coordinated by the surgeon and in collaboration with the primary care physician and other community healthcare professionals, without intervention by a nurse practitioner (NP) or registered nurse (RN) and without PROMs-based follow-up.

Treatment:

Other: Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)