A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing (REDUCE)

In this study, the investigators will evaluate the effect of a health system initiative aiming to change clinician opioid prescribing behaviors using two behavioral economic interventions - individual audit feedback and peer comparison feedback of clinicians.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Behavioral: Individual audit feedback; Behavioral: Peer comparison feedback

Detailed Description

Opioid-related abuse and overdose represent a growing national epidemic in the United States. Clinician practice patterns play an important role: opioid prescriptions impact the likelihood that patients will misuse or become dependent on these medications, with longer prescriptions leading to greater sustained use. In this study, we will evaluate a Sutter Health System quality improvement initiative using monthly individual audit feedback and/or monthly peer comparison feedback to clinicians to change opioid prescribing patterns. In partnership with Sutter Health System, this will be conducted using randomization to evaluate its effect. We will also conduct a process evaluation to understand factors associated with better or worse performance at the clinician level.

• Study Type: Interventional
• Enrollment (Actual): 452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94596
      • Sutter Heath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinicians

  1. Practiced primarily at participating emergency department or urgent care center

• Patients

  1. Presented to a participating emergency department or urgent care center during the study period
  2. Discharged to home from the visit

Exclusion Criteria:

• Clinicians

  1. Saw less than 100 patients in the prior year
  2. Practiced primarily at another site that is not in the main trial
  3. Did not practice at Sutter Health in the prior 90 days

• Patients

  1. Currently pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: Individual Audit; Clinicians will receive individual audit feedback informing them of their performance.	Behavioral: Individual audit feedback; Practice sites randomly assigned to have individual audit feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. The email will inform the clinician that the health system is doing monthly audits and provide them the number of patients in the last month for whom they prescribed 30 opioid pills per prescription or higher.
Experimental: Peer Comparison; Clinicians will receive peer comparison feedback informing them of how their performance compares to their peers.	Behavioral: Peer comparison feedback; Practice sites randomly assigned to have peer comparison feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. Data on the mean number of opioid pills per prescription and the proportion of visits with an opioid prescription will be delivered using a 3-month rolling average as follows: a) If clinician is above median: informed how their data compares to the median; b) If clinician is below median but above 10th percentile: informed how their data compares to the 10th percentile; c) If clinician is 10th percentile or below: informed of their data and commended for being a "low prescriber."
Experimental: Individual Audit and Peer Comparison; Clinicians will receive individual audit feedback informing them of their performance and peer comparison feedback informing them of how their performance compares to their peers.	Behavioral: Individual audit feedback; Practice sites randomly assigned to have individual audit feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. The email will inform the clinician that the health system is doing monthly audits and provide them the number of patients in the last month for whom they prescribed 30 opioid pills per prescription or higher.; Behavioral: Peer comparison feedback; Practice sites randomly assigned to have peer comparison feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. Data on the mean number of opioid pills per prescription and the proportion of visits with an opioid prescription will be delivered using a 3-month rolling average as follows: a) If clinician is above median: informed how their data compares to the median; b) If clinician is below median but above 10th percentile: informed how their data compares to the 10th percentile; c) If clinician is 10th percentile or below: informed of their data and commended for being a "low prescriber."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the mean number of pills per opioid prescription	The primary outcome is the change in the mean number of pills prescribed per opioid prescription from baseline to the intervention period.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proportion of patient visits with an opioid prescription	The secondary outcome is the change in proportion of patient visits in which an opioid is prescribed from baseline to the intervention period.	Six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in morphine milligram equivalents per opioid prescription	The change in morphine milligram equivalents per opioid prescription from baseline to the intervention period.	Six months
Change in mean number of opioid pills per patient-visit	The change in the mean number of opioid pills per patient-visit from baseline to the intervention period.	Six months
Change in proportion of patient-visits with non-opioid pain prescription	The change in proportion of patient-visits with non-opioid pain prescriptions (e.g., ibuprofen, acetaminophen, celecoxib, or muscle relaxants such as cyclobenzaprine, baclofen or tizanidine) from baseline to the intervention period.	Six months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Sutter Health; Donaghue Medical Research Foundation
• Investigators: Principal Investigator: Amol Navathe, MD, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Emergency Medicine; Opioids; Feedback; Urgent Care; Nudges
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 829269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No