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
OPIOID CITY FR
Other study identifiers
Sponsor study identifier
Secondary identifiers
OTHER · N° IDRCB
interventional
772
0 countries
N/A
Study Start
July 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- not yet recruiting
- Estimated enrollment
- 772 participants
- Study completion date
December 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 0 countries · 0 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
June 15, 2026
Actual (reported)First Posted
June 22, 2026
Actual (reported)Study Start
July 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- June 22, 2026
- Status Verified
- June 2026
- Last Update Submitted
- June 15, 2026