Reducing Post-Operative Opioid Prescribing in Southeastern North Carolina

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other Usual Care
  Existing opioid prescribing practices and guidelines at each participating hospital site, with no additional educational, benchmarking, or quality improvement activities.
• Behavioral Opioid Stewardship Intervention
  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 outcome measures

• 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]
• 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]
• 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]
• 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]
• proportion of intervention components implemented (Feasibility Measure 4) [Time frame: 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) [Time frame: 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) [Time frame: Intervention Period]
• 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.]

Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• University of North Carolina at Chapel Hill — Chapel Hill
• Novant Health New Hanover Regional Medical Center — Wilmington

Identifiers

NCT: NCT07566182 · 25-1636

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗