Evaluation of a Structured Hospital-Community Care Follow-up Based on Perceived Quality of Care After Surgery, Aimed at Reducing Persistent Opioid Use in Primary Care: a Pragmatic Randomized Controlled Trial

NCT07659730 | Not Yet Recruiting

• 2 other identifiers: RC26_00182025-A02738-41
• Study Type: interventional
• Target: 772
• Locations: 0 countries
• Sites: N/A

Brief Summary

The OPTIMISTE program is based on a structured postoperative follow-up centered on patients' subjective perception of recovery using validated Patient Reported Outcome Measures (PROMs), including the mQoR-15f score. Follow-up is delivered by specifically trained nurses and embedded in a decompartmentalized care model combining in-person and remote interactions, integrating hospital teams and primary care professionals within a coordinated pathway. OPTIMISTE was recently evaluated in a multicenter randomized controlled trial, the SUPPORT study (NCT06182254), which included 280 patients. The study demonstrated a significant impact of PROM-based follow-up on perceived recovery at postoperative day 35, and more importantly, an approximately 50% reduction in the proportion of patients with persistent opioid use at that time point. Although this was a secondary endpoint, the findings suggest that active postoperative monitoring centered on patient-reported outcomes and rapidly relayed to community care providers represents a major lever for preventing opioid misuse after surgery. However, these results require further confirmation and refinement. First, the effect on persistent opioid consumption needs to be validated as a primary endpoint. Second, despite the benefit observed, more than 12% of patients in the intervention group still exhibited persistent opioid use five weeks after surgery, compared with 21% in the control group. This residual persistence, although reduced, remains clinically concerning and indicates that the current OPTIMISTE model does not yet fully prevent unanticipated prolonged opioid exposure. The hypothesis of the present protocol is that the effectiveness of OPTIMISTE in reducing postoperative persistent opioid use can be strengthened through earlier, more individualized and primary-care-driven management. This enhancement relies on better mobilization of community healthcare professionals - general practitioners, community nurses and pharmacists - supported by digital health tools and reinforced coordination channels such as secure platforms, teleconsultations and structured transmission of PROM scores. By systematically integrating primary care providers into longitudinal postoperative follow-up guided by PROMs, the protocol aims to improve therapeutic responsiveness, reduce unjustified prolonged prescriptions and promote early tapering when clinically appropriate. The objective is to optimize hospital-community coordination in order to amplify the impact of the OPTIMISTE pathway on patient-perceived recovery and opioid stewardship. Ultimately, this research seeks to demonstrate that strengthening the role of primary care, combined with fine-grained assessment of patient-reported recovery, represents an effective, ethical and scalable strategy to improve the quality, safety and efficiency of postoperative care pathways while sustainably reducing persistent opioid use at both individual and population levels.

Conditions

Perioperatoire Medicine; Surgery

Keywords

Perioperative; Surgery; Patient Reported Outcomes Mesuares (PROMs); persistent opioid use

Outcome Measures

Primary Outcomes (1)

• The main objective is to Evaluate the impact of a structured hospital-community follow-up on persistent opioid use in primary care 90 days after a surgical procedure.

  Persistent opioid use at postoperative day 90 is defined as the use of a weak or strong opioid at least once per week. This definition includes all weak opioids (WHO class 2) and strong opioids (WHO class 3), regardless of dosage form (e.g., immediate-release or extended-release) or route of administration (e.g., oral or transdermal).

  between baseline consultation and "day 90"

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants in the experimental group receive, in addition to standard postoperative follow-up, a structured PROMs-based OPTIMISTE program assessing health status with the mQoR-15f at multiple predefined time points: preoperatively, and on postoperative days 1, 3, 14, and 28. Assessments are conducted by specially trained nurses, in hospital or via phone once patients return to primary care, and aim to detect incomplete recovery and persistent opioid use early, prevent prolonged pain, and strengthen coordination between hospital and community care providers. From postoperative day 14, if a risk of persistent opioid use is identified, a coordinated hospital-community intervention is triggered. This includes: 1\. A structured report to the patient's general practitioner, co-designed with participating GPs, summarizing surgical details, PROMs-based recovery evolution, type of persistent opioid use, proposed tapering strategy, and hospital care recommendations. This report is shared via t

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

Control group

ACTIVE COMPARATOR

Perioperative follow up will include routine follow-up by the perioperative team including the surgical team without the intervention of the dedicated PROMs based interviews team. 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. (modified QoR-15f score will be administered to all patients at visit 0 and Day 35 and Day 90).

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

Interventions

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

Tip: Ensure that this name matches the name used in the associated Arm Description. Patient Reported Outcomes based perioperative follow-up. 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) score 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: 1. Physical comfort (pain, nausea, general well-being) 2. Emotional state (anxiety, depression, feeling of support) 3. Psychological support

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
• 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)
• 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.
• Pregnant or breastfeeding woman
• Inability to provide the subject with informed information (subject in an emergency situation, difficulties in understanding, etc.)
• Subject under legal protection, guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Central Study Contacts

Monia BEN HADJ HAMED

CONTACT

+33388616711; monia.ben-hadj-hamed@chru-strasbourg.fr

Study Design

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

Model Details: The study is an open-label, multicenter, randomized controlled trial comparing two groups

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: July 2, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06