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Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina

28 aprile 2026 aggiornato da: University of North Carolina, Chapel Hill

Building an Implementation Science Network to Reduce Post-Operative Opioid Prescribing in Southeastern North Carolina

The goal of this stepped-wedge cluster randomized trial is to evaluate whether an opioid stewardship intervention improves post-operative opioid prescribing practices. Participants will include surgeon champions and identified change team members (e.g., pharmacists, hospitalists, nurses, advanced practice providers, anesthesiologists, etc.) and patient representatives at designated hospital sites in North Carolina.

The main questions it aims to answer are:

I. Does the intervention reduce postoperative opioid prescribing behavior at the surgeon and hospital level? II. Is the intervention acceptable, feasible, and effective for implementation among participating hospitals?

Researchers will compare opioid prescribing and implementation outcomes across sites before and after implementation using a stepped-wedge cluster randomized design, in which sites are randomly assigned to different intervention start times.

Participants will attend educational sessions delivered, introduce the Standard Opioid Prescribing (SOPS) Toolkit into their clinical practice, review benchmarked, deidentified opioid prescribing performance reports that use administrative claims data (secondary data source, data not collected or shared between hospitals), and complete surveys assessing intervention acceptability, feasibility, and effectiveness. Preliminary effectiveness will be assessed through reduction of opioid prescriptions using administrative claims data.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

A stepped-wedge cluster randomized trial will be conducted across participating hospital sites in Southeastern North Carolina. Sites will transition sequentially from the control condition to the intervention condition based on randomization, until all clusters have completed the opioid stewardship intervention over a 10-week period.

During the control phase, opioid prescribing will continue according to existing practices. During the intervention phase, sites will implement a multi-component site-specific opioid stewardship intervention. The intervention includes dissemination of the Standard Opioid Prescribing (SOPS) Toolkit, quality improvement (QI) educational sessions, and benchmarked opioid prescribing performance reports generated from administrative claims data. These reports provide deidentified surgeon- and site-level prescribing summaries so that sites are able to see their current opioid prescribing levels.

The primary outcomes are the acceptability, feasibility, and effectiveness of the intervention assessed during and after implementation as determined from semi-structured interviews and surveys. Secondary outcomes include additional provider and patient opioid prescribing outcomes related to post-operative opioid fills by patients. This information will be obtained from administrative claims data. No patient information will be collected and no patient will be enrolled int eh study. These measures evaluate whether tailoring the opioid stewardship intervention to each hospital improves routine clinical practice and provider opioid prescribing.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27514
        • University of North Carolina at Chapel Hill
        • Contatto:
        • Investigatore principale:
          • Jessica Schumacher, PhD
      • Wilmington, North Carolina, Stati Uniti, 28401

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

Surgeon champions and identified change team members must be currently practicing at one of the sites participating in this study.

Patient representatives must be:

Proficient in the English language Prescribed opioids following a qualifying general surgery procedure (inpatient or outpatient laparoscopic appendectomy, inguinal/femoral hernia repair, umbilical hernia, bariatric/weight loss surgery, mastectomy, laparoscopic cholecystectomy, laparoscopic colectomy, lipoma/soft tissue tumor excision, and anal/rectal procedures).

No patients will be enrolled for this trial. However, claims data will be used to assess the claims based outcome measure (opioid prescribing).

Inclusion criteria for the claims analysis includes:

Patients greater than or equal to 18 at the time of a qualifying general surgery procedure either inpatient or outpatient (laparoscopic appendectomy; umbilical/ventral/inguinal/femoral hernia repair; bariatric/weight loss surgery; mastectomy; laparoscopic cholecystectomy; laparoscopic colectomy; lipoma/soft tissue tumor excision; anal/rectal procedures) based on procedure codes Patients must have continuous insurance coverage (including prescription drug coverage), 6 months before to 60 days post discharge to assess comorbidities and prescription drug fills.

Exclusion Criteria:

Patients with an opioid fill 6 months before the procedure. Patients who undergo a significant operation during the stay associated with their index procedure that would require additional pain management.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Usual Care (Control Period)
During the control phase of the stepped wedge cluster randomized trial, participating hospitals continue opioid prescribing according to existing local practices. Clinicians do not receive any components of the opioid stewardship intervention during this period. Each hospital contributes data to this arm prior to crossing over to the intervention phase based on randomized timing.
Altro: Usual Care
Existing opioid prescribing practices and guidelines at each participating hospital site, with no additional educational, benchmarking, or quality improvement activities.
Sperimentale: Opioid Stewardship Intervention (Intervention Period)
During the intervention phase, hospitals implement a multi component opioid stewardship intervention after crossing over from the control condition according to randomized start time. Clinician participants at each site engage in the intervention for approximately 10 weeks. All hospitals eventually receive the intervention as part of the stepped wedge design.
Comportamentale: Opioid Stewardship Intervention
A multi component intervention consisting of dissemination of the Standard Opioid Prescribing (SOPS) Toolkit, quality improvement educational sessions for clinicians, and benchmarked opioid prescribing performance reports generated from administrative claims data. Reports provide deidentified surgeon and site level summaries of opioid prescribing patterns.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acceptability of the Intervention Assessed by Semi-Structured Interviews (Change Team Members)
Lasso di tempo: From enrollment through 6 months after completion of the 10-week intervention period
Acceptability will be assessed qualitatively using themes derived from semi-structured interviews conducted with change team members. Interviews will explore perceptions of the intervention and its fit within the hospital context. Themes identified after the 10-week implementation period will be compared with themes identified prior to implementation.
From enrollment through 6 months after completion of the 10-week intervention period
Proportion of training and learning sessions attended (Feasibility Measure 1)
Lasso di tempo: From enrollment through 6 months after completion of the 10-week intervention period
Proportion of training and learning sessions attended by change team members
From enrollment through 6 months after completion of the 10-week intervention period
percentage of change team member providers that completed pre- and post- assessments (Feasibility Measure 2)
Lasso di tempo: From enrollment through 6 months after completion of the 10-week intervention period
percentage of change team member providers that completed pre- and post- assessments
From enrollment through 6 months after completion of the 10-week intervention period
change team's ability to start the trial as randomized (Feasibility Measure 3)
Lasso di tempo: From enrollment through 6 months after completion of the 10-week intervention period
change team's ability to start the trial as randomized (yes/no)
From enrollment through 6 months after completion of the 10-week intervention period
proportion of intervention components implemented (Feasibility Measure 4)
Lasso di tempo: From enrollment through 6 months after completion of the 10-week intervention period
proportion of intervention components implemented using themes gathered from semi-structured interviews (intervention fidelity)
From enrollment through 6 months after completion of the 10-week intervention period
Change in Organizational Readiness to Change (ORIC) Measure (Effectiveness Measure 1- survey)
Lasso di tempo: From enrollment through 6 months after completion of the 10-week intervention period)
Change in ORIC score from pre- to post intervention. Change team members will complete the survey before the intervention start phase and after intervention completion.
From enrollment through 6 months after completion of the 10-week intervention period)
Audit and feedback effectiveness as assessed by learning sessions and semi structured interviews (Effectiveness Measure 2)
Lasso di tempo: Intervention Period
Audit and feedback effectiveness is defined as the extent change team members feel ownership and agreement, can make sense of the information provided, are motivated by the social influence that reviewing their performance shows (e.g., comparing their performance to other hospitals), and accept accountability for the proposed changes.
Intervention Period
Change in Milligram equivalents (MME) of the first post-operative fill pre- and post-intervention using administrative claims data (Effectiveness Measure 3).
Lasso di tempo: Comparing pre (6 months before enrollment) and 6 month period starting at the end of the 10-week intervention period.
Change in Milligram equivalents (MME) of the first opioid prescription filled (outpatient) by patients -3 days before admission for their qualifying procedure through 7 days post-discharge during the pre- and post-intervention time periods.
Comparing pre (6 months before enrollment) and 6 month period starting at the end of the 10-week intervention period.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Second opioid fill within 60-days of discharge (yes/no) using administative claims data
Lasso di tempo: From enrollment through 6 months after completion of the 10-week intervention period
For patients with one or more post-operative opioids filled, the proportion that filled a second prescription within 60 days of discharge from the qualifying procedure
From enrollment through 6 months after completion of the 10-week intervention period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Investigatori

  • Investigatore principale: Jessica Schumacher, PhD, University of North Carolina, Chapel Hill

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2026

Ultimo verificato

1 marzo 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 25-1636

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Claims data use are governed by separate data use agreements with data vendors and cannot be shared per those agreements. There is no plan to share qualitative or survey data as sharing risks identifying the small number of hospitals that are participating in the study.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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