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Trial record 2 of 189 for:    BUPRENORPHINE AND NALOXONE

Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821103
Recruitment Status : Enrolling by invitation
First Posted : January 29, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
American College of Medical Toxicology
Blue Cross Blue Shield
Information provided by (Responsible Party):
University of Pennsylvania

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : February 6, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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 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 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Training Attendance [ Time Frame: First week ]
    Measure the number of clinicians who attend the training with the incentive.

  2. 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.



Other Outcome Measures:
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821103


Locations
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United States, Pennsylvania
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
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Principal Investigator: Jeanmarie Perrone, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03821103     History of Changes
Other Study ID Numbers: 832359
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Emergencies
Disease Attributes
Pathologic Processes
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists