An Opioid Prescribing Nudge (OHS)

June 29, 2020 updated by: Duke University

An Opioid Prescribing Nudge: Leveraging Behavioral Economics to Reduce Opioid Harms Within Health Systems

Analyze baseline concurrent opioid prescribing metrics at the individual prescriber level in the Duke Health System on the identified three main outcome measures.

Test the impact of reports on opioid prescriber behaviors with the following primary measures: number of prescriptions with concurrent benzo within reporting period, number of prescriptions with concurrent muscle relaxants within reporting period, and number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period.

Create a blueprint to implement the concurrent opioid prescribing nudge intervention in other settings.

Study Overview

Detailed Description

The Concurrent Opioid Prescribing Nudge project intends to address multiple points within the opioid-use cycle through the development of standardized and scalable reporting mechanisms to provide social comparisons and feedback to physicians across the Duke Health System regarding their concurrent and co- opioid, benzodiazepines, and muscle relaxant prescribing practices. Concurrent are hereby defined as:

  • writing a new opioid prescription for a patient with a benzodiazepine prescription within the last 3 months,
  • writing a new benzodiazepine prescription for a patient with a opioid prescription within the last 3 months,
  • writing a new muscle relaxant prescription for a patient with an opioid prescription within the last 3 months,
  • writing a new opioid prescription for a patient with muscle relaxant prescription within the last 3 months, or
  • writing a new prescription for both an opioid and benzodiazepine or opioid and muscle relaxant.

The proposed project will leverage insights from behavioral economics to design informational and social incentives to reduce concurrent practices and mitigate opioid harm. Opioid prescribers (attending physicians, residents, and advanced practice providers) at participating departments and clinics in the Duke Health System will be randomized to a control or intervention arm. Over six month reporting periods beginning fall 2019, providers in the intervention arms will receive monthly reports with their individual prescribing patterns and comparison to peer prescribing patterns for the following measures: number of prescriptions with concurrent opioid active prescriptions of opioid/ benzodiazepines, number of prescriptions with concurrent opioid active prescriptions of opioid/muscle relaxants, and number of missed opportunities to prescribe naloxone to patients with any opioid-related diagnosis. The control arm will receive usual clinical education and feedback. Interventions will be implemented at participating departments and clinics utilizing a stepped-wedge timeline.

Study Type

Interventional

Enrollment (Actual)

427

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

The primary population of focus for this study is:

  • attending physicians
  • residents
  • advanced practice providers

hereby referred to as opioid prescribers in Duke University Health System and may include these departments and clinics:

  • Emergency Department
  • Neurology, Pain Management
  • Primary Care
  • Psychiatry, Sleep Disorder Clinic
  • Spine

All opioid prescribers in these settings will be identified in partnership with Duke University Health System.

Exclusion Criteria:

  • Providers not identified above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm- Automated Reports
Receives automated reports on prescription patterns monthly
de-identified aggregate reports
Other Names:
  • de-identified reports
  • prescribers' prescribing patterns
No Intervention: Control Arm: Usual clinical education and feedback
Receive no reports

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Opioid prescribing habits
Time Frame: Baseline, 6 Months
Using baseline concurrent opioid prescribing metrics obtained (at the individual prescriber level) during their initial month and month prior in the Duke Health System, measure changes in Opioid n prescription orders as measured by provider prescriptions
Baseline, 6 Months
number of prescriptions with concurrent benzo within reporting period
Time Frame: 6 Months
Identify the number of prescriptions with concurrent benzo over 6 months
6 Months
number of prescriptions with concurrent muscle relaxants within reporting period
Time Frame: 6 Months
Identify the number of prescriptions with concurrent muscle relaxants over 6 months
6 Months
number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period
Time Frame: 6 Months
Identify the number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis over 6 months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Charlene Wong, MD, Duke University
  • Principal Investigator: Charles Scales, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Actual)

June 15, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00102219

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Health Behavior

Clinical Trials on Automated Reports on prescription patterns for their patients

3
Subscribe