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

NCT07338188 | Not Yet Recruiting

• 2 other identifiers: 99652025-A02288-41
• Study Type: interventional
• Target: 276
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Follow-up

Keywords

perioperative; surgery; Patient Reported Outcomes Mesuares (PROMs); Complex clinical situation

Outcome Measures

Primary Outcomes (1)

• The main objective is to evaluate the effectiveness of a perioperative follow-up integrating the patient's perspective based on their perceived health status.

  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.)

  Between the baseline consultation and "day 35"

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

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

Control group

ACTIVE COMPARATOR

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.

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

Interventions

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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 13, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): March 3, 2028
• Study Completion (Estimated): April 3, 2028
• Last Updated: January 13, 2026

Record last verified: 2025-10