Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT03821103

Collaborator

American College of Medical Toxicology (Other), Blue Cross Blue Shield (Other)

104

Enrollment

Location

Arms

12.7

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use	Behavioral: Training Behavioral: Behavioral economic enhanced arm	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments

Actual Study Start Date :

Feb 6, 2019

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Feb 29, 2020

Arms and Interventions

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.	Behavioral: Training 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	Behavioral: Training 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: Behavioral economic enhanced arm Behavioral economic enhancement includes an opt-out invitation, loss-framed incentivization, weekly tailored text based reminders

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.

Behavioral: Training

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

Behavioral: Training

Behavioral: Behavioral economic enhanced arm

Behavioral economic enhancement includes an opt-out invitation, loss-framed incentivization, weekly tailored text based reminders

Outcome Measures

Primary Outcome Measures

Change in Emergency Department initiated buprenorphine-naloxone treatment [One year]
Measuring number of providers who have initiated at least one first dose of buprenorphine-naloxone

Secondary Outcome Measures

Training Attendance [First week]
Measure the number of clinicians who attend the training with the incentive.
Change in attitude about buprenorphine-naloxone Questionaire [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.

Other Outcome Measures

Retained knowledge of buprenorphine-naloxone treatment Questionaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania
American College of Medical Toxicology
Blue Cross Blue Shield

Investigators

Principal Investigator: Jeanmarie Perrone, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT03821103

Other Study ID Numbers:

832359

First Posted:

Jan 29, 2019

Last Update Posted:

Mar 17, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emergencies

Study Results

No Results Posted as of Mar 17, 2020