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OHS: An Opioid Prescribing Nudge

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT04069403
Collaborator
(none)
427
Enrollment
1
Location
2
Arms
9.2
Actual Duration (Months)
46.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Automated Reports on prescription patterns for their patients
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
427 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 or 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.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 or 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.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
An Opioid Prescribing Nudge: Leveraging Behavioral Economics to Reduce Opioid Harms Within Health Systems
Actual Study Start Date :
Sep 10, 2019
Actual Primary Completion Date :
Jun 15, 2020
Actual Study Completion Date :
Jun 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Arm- Automated Reports

Receives automated reports on prescription patterns monthly

Other: Automated Reports on prescription patterns for their patients
de-identified aggregate reports
Other Names:
  • de-identified reports
  • prescribers' prescribing patterns

    		•
    No Intervention: Control Arm: Usual clinical education and feedback

    Receive no reports

    Outcome Measures

    Primary Outcome Measures

    1. Change in Opioid prescribing habits [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

    2. number of prescriptions with concurrent benzo within reporting period [6 Months]

      Identify the number of prescriptions with concurrent benzo over 6 months

    3. number of prescriptions with concurrent muscle relaxants within reporting period [6 Months]

      Identify the number of prescriptions with concurrent muscle relaxants over 6 months

    4. number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period [6 Months]

      Identify the number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis over 6 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27705

    Sponsors and Collaborators

    • Duke University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT04069403
    Other Study ID Numbers:
    • Pro00102219
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Jun 30, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Duke University
    Opioids
    Prescription
    Patterns
    Nudge
    Practices
    Additional relevant MeSH terms:
    Substance-Related Disorders

    Study Results

    No Results Posted as of Jun 30, 2020