Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina

April 28, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • Jessica Schumacher, PhD
      • Wilmington, North Carolina, United States, 28401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Usual Care
Existing opioid prescribing practices and guidelines at each participating hospital site, with no additional educational, benchmarking, or quality improvement activities.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the Intervention Assessed by Semi-Structured Interviews (Change Team Members)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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).
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Second opioid fill within 60-days of discharge (yes/no) using administative claims data
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Jessica Schumacher, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-1636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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