Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina

Conditions

• Opioid Prescribing

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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 Dates

Start date

May 1, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• 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.
• 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.

Primary Outcome Measure

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 ]

Central Contacts

• Jessica Schumacher, PhD
  (919) 966-4320
  [email protected]
• Meaghan Hazelet
  [email protected]

Locations (2)

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