Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Usual Care

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Usual Care (Control Period)Other 1 intervention
Group B: Opioid Stewardship Intervention (Intervention Period)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment through 6 months after completion of the 10-week intervention period
2

Proportion of training and learning sessions attended (Feasibility Measure 1)

Proportion of training and learning sessions attended by change team members

Time frame
From enrollment through 6 months after completion of the 10-week intervention period
3

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

Time frame
From enrollment through 6 months after completion of the 10-week intervention period
4

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)

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

Secondary outcomes

1

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

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: