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

NCT07338188 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-01-13

No results posted yet for this study

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

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 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.

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2028-03-03
Completion
2028-04-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07338188 on ClinicalTrials.gov