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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

Tracking Information
First Submitted Date  ICMJE August 23, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE September 10, 2019
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
  • 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
  • number of prescriptions with concurrent benzo within reporting period [ Time Frame: 6 Months ]
    Identify the number of prescriptions with concurrent benzo over 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Opioid Prescribing Nudge
Official Title  ICMJE An Opioid Prescribing Nudge: Leveraging Behavioral Economics to Reduce Opioid Harms Within Health Systems
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Opioid Use, Unspecified
  • Prescription Drug Abuse (Not Dependent)
  • Prescription Drug Abuse and Dependency
  • Health Behavior
  • Benzodiazepine Abuse
  • Benzodiazepine Dependent
Intervention  ICMJE Other: Automated Reports on prescription patterns for their patients
de-identified aggregate reports
Other Names:
  • de-identified reports
  • prescribers' prescribing patterns
Study Arms  ICMJE
  • Experimental: Intervention Arm- Automated Reports
    Receives automated reports on prescription patterns monthly
    Intervention: Other: Automated Reports on prescription patterns for their patients
  • No Intervention: Control Arm: Usual clinical education and feedback
    Receive no reports
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2020)
427
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2019)
2000
Actual Study Completion Date  ICMJE June 15, 2020
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04069403
Other Study ID Numbers  ICMJE Pro00102219
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charlene Wong, MD Duke University
Principal Investigator: Charles Scales, MD Duke University
PRS Account Duke University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP