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Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina

28. dubna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • North Carolina
      • Chapel Hill, North Carolina, Spojené státy, 27514
        • University of North Carolina at Chapel Hill
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Jessica Schumacher, PhD
      • Wilmington, North Carolina, Spojené státy, 28401

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: 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.
Jiný: Usual Care
Existing opioid prescribing practices and guidelines at each participating hospital site, with no additional educational, benchmarking, or quality improvement activities.
Experimentální: 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.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Acceptability of the Intervention Assessed by Semi-Structured Interviews (Change Team Members)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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).
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Second opioid fill within 60-days of discharge (yes/no) using administative claims data
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of North Carolina, Chapel Hill

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jessica Schumacher, PhD, University of North Carolina, Chapel Hill

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. května 2026

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

28. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

28. dubna 2026

První zveřejněno (Aktuální)

4. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. dubna 2026

Naposledy ověřeno

1. března 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 25-1636

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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