Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments

March 16, 2020 updated by: University of Pennsylvania
This study seeks to test standard and behavioral economic-enhanced training strategies to bolster first-time Emergency Department-initiated buprenorphine-naloxone administration among Emergency Department providers.

Study Overview

Status

Completed

Conditions

Detailed Description

Philadelphia is experiencing a significant opioid crisis. Through this novel pilot study, critical training about opioid use disorder and medication-assisted treatment with buprenorphine-naloxone will be provided to emergency providers and changes in clinical practice will be incentivized in order to optimize treatment engagement for patients with opioid use disorder in the Emergency Department.

Participants will be invited to participate in a brief in-person training session, will receive a pre- and post-session knowledge and attitude assessment, and will be invited to self-report first-time buprenorphine-naloxone Emergency Department administration within the 3 month study period.

Participants will be randomized to one of two arms: standard training arm and behavioral economic enhanced arm. The standard training arm will receive the aforementioned intervention. The behavioral economic enhanced arm will additionally receive an opt-out invitation, loss-framed incentivization, and weekly tailored text message-based reminders.

Endpoints of interest include retained knowledge and change in provider attitudes regarding Emergency department buprenorphine-naloxone administration and treatment following training and again at 3 months, and first-time Emergency department administration of buprenorphine-naloxone.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Residents and Advanced Practice Providers and attending clinicians working in emergency departments in Pennsylvania.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard training arm
The standard training arm will consist of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department administration within 3 month study period.
The training includes of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department (ED) administration within 3 month study period
Experimental: Behavioral economic enhanced arm
The behavioral economic enhanced training arm will consist of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department administration within 3 month study period in addition to an opt-out invitation, loss-framed incentivization, and weekly tailored text message-based reminders
The training includes of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department (ED) administration within 3 month study period
Behavioral economic enhancement includes an opt-out invitation, loss-framed incentivization, weekly tailored text based reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Emergency Department initiated buprenorphine-naloxone treatment
Time Frame: One year
Measuring number of providers who have initiated at least one first dose of buprenorphine-naloxone
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Training Attendance
Time Frame: First week
Measure the number of clinicians who attend the training with the incentive.
First week
Change in attitude about buprenorphine-naloxone Questionaire
Time Frame: Three months

The scale is not a validated tool. It is a construct to measure attitudes about buprenorphine-naloxone.

It is a Likert scale 1-5, 1 being strongly disagree and 5 being strongly agree. Higher values signify more favorable outcomes.

Three months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retained knowledge of buprenorphine-naloxone treatment Questionaire
Time Frame: Three months

Compare retention of knowledge and assessment from before and after the training in the two arms.The scale is not a validated tool. It is a construct of questions to measure retained knowledge about buprenorphine-naloxone initiation.

The scale is a percentage of questions answered correctly. Minimum score is 0% and maximum score is 100%.

Higher values signify more favorable outcomes.

Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeanmarie Perrone, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 832359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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