- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04069403
An Opioid Prescribing Nudge (OHS)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Investigators
- Principal Investigator: Charlene Wong, MD, Duke University
- Principal Investigator: Charles Scales, MD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00102219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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