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NCT Number: NCT07566182

Reducing 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.

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Key information

Conditions

Opioid Prescribing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual Care

Other

Existing opioid prescribing practices and guidelines at each participating hospital site, with no additional educational, benchmarking, or quality improvement activities.

Opioid Stewardship Intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Schumacher, PhD

CONTACT

[email protected]

(919) 966-4320

Meaghan Hazelet

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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