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)
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.
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
The study is an open-label, multicenter, randomized controlled trial comparing two groups:
- Control group Participants in the control group receive the usual conventional postoperative follow-up, notably by the surgeon and the attending physician.
- Experimental group
In addition to the usual conventional follow-up, participants in the experimental group benefit from a comprehensive, closely coordinated care pathway between hospital and primary care, based on active collaboration with community healthcare professionals. This enhanced follow-up includes:
- Establishment of a personalized recovery trajectory,
- Early identification of any delay or difficulty in the recovery process,
- Adaptation of follow-up and adjustment of the care pathway in response to potential complications,
- Generation of a personalized report transmitted to the general practitioner to facilitate ongoing care,
- Simplified access to specialist consultations if clinically required, and
- a pharmaceutical consultation with the community pharmacist to optimize and secure medication use.
The program also integrates specially trained nurses who assess patients' health status according to their own perception (OPTIMISTE follow-up). From postoperative day 14 onward, if a risk of persistent opioid use is identified, a coordinated intervention between hospital and community care is initiated to ensure timely therapeutic adjustments, promote appropriate tapering, and prevent unjustified prolonged opioid exposure.
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Monia BEN HADJ HAMED
- Puhelinnumero: +33388616711
- Sähköposti: monia.ben-hadj-hamed@chru-strasbourg.fr
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Kokeellinen: Experimental group
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 |
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:
|
|
Active Comparator: Control group
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). |
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:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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.
Aikaikkuna: between baseline consultation and "day 90"
|
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"
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- RC26_0018
- 2025-A02738-41 (Muu tunniste: N° IDRCB)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .