Opioid Stewardship Intervention for Opioid Prescribing
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jessica Schumacher, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Control Phase
Hospitals continue opioid prescribing according to existing local practices without receiving any components of the opioid stewardship intervention.
Intervention Phase
Hospitals implement a multi-component opioid stewardship intervention, including the SOPS Toolkit, educational sessions, and performance reports.
Follow-up
Participants are monitored for the effectiveness of the intervention through surveys and interviews assessing acceptability, feasibility, and effectiveness.
What Are the Treatments Tested in This Trial?
Interventions
- Opioid Stewardship Intervention
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
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