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NCT Number: NCT07338188

PROMs-guided Perioperative Care 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.

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Key information

Conditions

Postoperative Follow-up

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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 Quality of Recovery-15 (QoR-15) questionnaire is a validated, short-form tool designed to measure the quality of postoperative recovery from the patient's perspective. It consists of 15 items covering five key dimensions:

Physical comfort (pain, nausea, general well-being), Emotional state (anxiety, depression, feeling of support), Psychological support, Physical independence (ability to move or perform daily activities), Pain and symptom management.

Primary outcomes

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"

Evolution of a modified version of the French Quality-Of-Recovery 15 score (QoR-15f) between the baseline consultation and postoperative "day 35" (depending on the groups: with or without the OPTISMISTE program).

The evoluation is scored from 0 to 150 (A higher score indicates better quality of recovery.)

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study 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

Acronym: OPTICAIRE

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jan 13, 2026
Registry last updated: Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.