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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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

Treatment groups

772 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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).

Time frame
between baseline consultation and "day 90"

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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