Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina

Starting soon · Not applicable

Conditions studied: Opioid Prescribing

In brief

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.

Key facts

Study ID

NCT07566182

Run by

University of North Carolina, Chapel Hill

People needed

40

Starts

2026-05-01

Expected to finish

2027-12-31

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Novant Health New Hanover Regional Medical Center — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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