NCT03821103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

February 6, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

January 25, 2019

Last Update Submit

March 16, 2020

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Training Attendance

    First week

  • Change in attitude about buprenorphine-naloxone Questionaire

    Three months

Other Outcomes (1)

  • Retained knowledge of buprenorphine-naloxone treatment Questionaire

    Three months

Study Arms (2)

Standard training arm

EXPERIMENTAL

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

Behavioral economic enhanced arm

EXPERIMENTAL

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: TrainingBehavioral: Behavioral economic enhanced arm

Interventions

TrainingBEHAVIORAL

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 armStandard training arm
Behavioral economic enhanced armBEHAVIORAL

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

Behavioral economic enhanced arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Khatri UG, Lee K, Lin T, D'Orazio JL, Patel MS, Shofer FS, Perrone J. A Brief Educational Intervention to Increase ED Initiation of Buprenorphine for Opioid Use Disorder (OUD). J Med Toxicol. 2022 Jul;18(3):205-213. doi: 10.1007/s13181-022-00890-7. Epub 2022 Apr 12.

    PMID: 35415804DERIVED

Study Officials

  • Jeanmarie Perrone, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 29, 2019

Study Start

February 6, 2019

Primary Completion

January 31, 2020

Study Completion

February 29, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)