An Opioid Prescribing Nudge (OHS)
Primary Purpose
Opioid Use, Unspecified, Prescription Drug Abuse (Not Dependent), Prescription Drug Abuse and Dependency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated Reports on prescription patterns for their patients
Sponsored by
About this trial
This is an interventional health services research trial for Opioid Use, Unspecified focused on measuring Opioids, Prescription, Patterns, Nudge, Practices
Eligibility 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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm- Automated Reports
Control Arm: Usual clinical education and feedback
Arm Description
Receives automated reports on prescription patterns monthly
Receive no reports
Outcomes
Primary Outcome Measures
Change in Opioid prescribing habits
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
Identify the number of prescriptions with concurrent benzo over 6 months
number of prescriptions with concurrent muscle relaxants within reporting period
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
Identify the number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis over 6 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04069403
Brief Title
An Opioid Prescribing Nudge
Acronym
OHS
Official Title
An Opioid Prescribing Nudge: Leveraging Behavioral Economics to Reduce Opioid Harms Within Health Systems
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Unspecified, Prescription Drug Abuse (Not Dependent), Prescription Drug Abuse and Dependency, Health Behavior, Benzodiazepine Abuse, Benzodiazepine Dependent
Keywords
Opioids, Prescription, Patterns, Nudge, Practices
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
427 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm- Automated Reports
Arm Type
Experimental
Arm Description
Receives automated reports on prescription patterns monthly
Arm Title
Control Arm: Usual clinical education and feedback
Arm Type
No Intervention
Arm Description
Receive no reports
Intervention Type
Other
Intervention Name(s)
Automated Reports on prescription patterns for their patients
Other Intervention Name(s)
de-identified reports, prescribers' prescribing patterns
Intervention Description
de-identified aggregate reports
Primary Outcome Measure Information:
Title
Change in Opioid prescribing habits
Description
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
Time Frame
Baseline, 6 Months
Title
number of prescriptions with concurrent benzo within reporting period
Description
Identify the number of prescriptions with concurrent benzo over 6 months
Time Frame
6 Months
Title
number of prescriptions with concurrent muscle relaxants within reporting period
Description
Identify the number of prescriptions with concurrent muscle relaxants over 6 months
Time Frame
6 Months
Title
number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period
Description
Identify the number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis over 6 months
Time Frame
6 Months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlene Wong, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Scales, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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An Opioid Prescribing Nudge
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