<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03821103</url>
  </required_header>
  <id_info>
    <org_study_id>832359</org_study_id>
    <nct_id>NCT03821103</nct_id>
  </id_info>
  <brief_title>Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments</brief_title>
  <official_title>Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American College of Medical Toxicology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Blue Cross Blue Shield</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to test standard and behavioral economic-enhanced training strategies to&#xD;
      bolster first-time Emergency Department-initiated buprenorphine-naloxone administration among&#xD;
      Emergency Department providers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Philadelphia is experiencing a significant opioid crisis. Through this novel pilot study,&#xD;
      critical training about opioid use disorder and medication-assisted treatment with&#xD;
      buprenorphine-naloxone will be provided to emergency providers and changes in clinical&#xD;
      practice will be incentivized in order to optimize treatment engagement for patients with&#xD;
      opioid use disorder in the Emergency Department.&#xD;
&#xD;
      Participants will be invited to participate in a brief in-person training session, will&#xD;
      receive a pre- and post-session knowledge and attitude assessment, and will be invited to&#xD;
      self-report first-time buprenorphine-naloxone Emergency Department administration within the&#xD;
      3 month study period.&#xD;
&#xD;
      Participants will be randomized to one of two arms: standard training arm and behavioral&#xD;
      economic enhanced arm. The standard training arm will receive the aforementioned&#xD;
      intervention. The behavioral economic enhanced arm will additionally receive an opt-out&#xD;
      invitation, loss-framed incentivization, and weekly tailored text message-based reminders.&#xD;
&#xD;
      Endpoints of interest include retained knowledge and change in provider attitudes regarding&#xD;
      Emergency department buprenorphine-naloxone administration and treatment following training&#xD;
      and again at 3 months, and first-time Emergency department administration of&#xD;
      buprenorphine-naloxone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Emergency Department initiated buprenorphine-naloxone treatment</measure>
    <time_frame>One year</time_frame>
    <description>Measuring number of providers who have initiated at least one first dose of buprenorphine-naloxone</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Training Attendance</measure>
    <time_frame>First week</time_frame>
    <description>Measure the number of clinicians who attend the training with the incentive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attitude about buprenorphine-naloxone Questionaire</measure>
    <time_frame>Three months</time_frame>
    <description>The scale is not a validated tool. It is a construct to measure attitudes about buprenorphine-naloxone.&#xD;
It is a Likert scale 1-5, 1 being strongly disagree and 5 being strongly agree. Higher values signify more favorable outcomes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Retained knowledge of buprenorphine-naloxone treatment Questionaire</measure>
    <time_frame>Three months</time_frame>
    <description>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.&#xD;
The scale is a percentage of questions answered correctly. Minimum score is 0% and maximum score is 100%.&#xD;
Higher values signify more favorable outcomes.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Standard training arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral economic enhanced arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training</intervention_name>
    <description>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</description>
    <arm_group_label>Behavioral economic enhanced arm</arm_group_label>
    <arm_group_label>Standard training arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral economic enhanced arm</intervention_name>
    <description>Behavioral economic enhancement includes an opt-out invitation, loss-framed incentivization, weekly tailored text based reminders</description>
    <arm_group_label>Behavioral economic enhanced arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residents and Advanced Practice Providers and attending clinicians working in&#xD;
             emergency departments in Pennsylvania.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeanmarie Perrone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03821103
org study id: 832359
nct id: NCT03821103
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Emergency Department initiated buprenorphine-naloxone treatment
time frame: One year
description: Measuring number of providers who have initiated at least one first dose of buprenorphine-naloxone
measure: Training Attendance
time frame: First week
description: Measure the number of clinicians who attend the training with the incentive.
measure: Change in attitude about buprenorphine-naloxone Questionaire
time frame: Three months
description: 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.
measure: Retained knowledge of buprenorphine-naloxone treatment Questionaire
time frame: Three months
description: 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.
arm group label: Standard training arm
arm group type: Experimental
description: 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.
arm group label: Behavioral economic enhanced arm
arm group type: Experimental
description: 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
intervention type: Behavioral
intervention name: Training
description: 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
arm group label: Behavioral economic enhanced arm
arm group label: Standard training arm
intervention type: Behavioral
intervention name: Behavioral economic enhanced arm
description: Behavioral economic enhancement includes an opt-out invitation, loss-framed incentivization, weekly tailored text based reminders
arm group label: Behavioral economic enhanced arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jeanmarie Perrone, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No