Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina

NCT07566182 | Not Yet Recruiting

• 1 other identifier: 25-1636
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Opioid Prescribing

Keywords

Opioid Stewardship; Postoperative opioid prescribing; Cluster randomized trial; Implementation science; Audit and feedback; Performance reporting; Quality Improvement

Outcome Measures

Primary Outcomes (8)

• Acceptability of the Intervention Assessed by Semi-Structured Interviews (Change Team Members)

  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)

  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)

  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)

  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)

  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)

  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)

  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).

  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 Outcomes (1)

• Second opioid fill within 60-days of discharge (yes/no) using administative claims data

  From enrollment through 6 months after completion of the 10-week intervention period

Study Arms (2)

Usual Care (Control Period)

OTHER

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

Opioid Stewardship Intervention (Intervention Period)

EXPERIMENTAL

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

Interventions

Usual Care OTHER

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

Usual Care (Control Period)

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.

Opioid Stewardship Intervention (Intervention Period)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Study Officials

• Jessica Schumacher, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Schumacher, PhD

CONTACT

(919) 966-4320; Jessica_Schumacher@med.unc.edu

Meaghan Hazelet

CONTACT

meaghan.hazelet@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster randomized trial

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)