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An Opioid Prescribing Nudge (OHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069403
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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
Opioid Use, Unspecified Prescription Drug Abuse (Not Dependent) Prescription Drug Abuse and Dependency Health Behavior Benzodiazepine Abuse Benzodiazepine Dependent Other: Automated Reports on prescription patterns for their patients Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.

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 : September 10, 2019
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : June 15, 2020

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



Primary Outcome Measures :
  1. 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

  2. number of prescriptions with concurrent benzo within reporting period [ Time Frame: 6 Months ]
    Identify the number of prescriptions with concurrent benzo over 6 months

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069403


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Charlene Wong, MD Duke University
Principal Investigator: Charles Scales, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04069403    
Other Study ID Numbers: Pro00102219
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders