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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03821103
Other study ID # 832359
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2019
Est. completion date February 29, 2020

Study information

Verified date March 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date February 29, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Pennsylvania Health System Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
University of Pennsylvania American College of Medical Toxicology, Blue Cross Blue Shield

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Retained knowledge of buprenorphine-naloxone treatment Questionaire 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
Primary Change in Emergency Department initiated buprenorphine-naloxone treatment Measuring number of providers who have initiated at least one first dose of buprenorphine-naloxone One year
Secondary Training Attendance Measure the number of clinicians who attend the training with the incentive. First week
Secondary Change in attitude about buprenorphine-naloxone Questionaire 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
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