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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
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 23, 2019
Last Updated
June 29, 2020
Sponsor
Duke University
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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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