<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/NCT01661517</url>
  </required_header>
  <id_info>
    <org_study_id>X110829003</org_study_id>
    <nct_id>NCT01661517</nct_id>
  </id_info>
  <brief_title>Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting</brief_title>
  <official_title>Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting (Screening and Brief Treatment for Substance Use Disorders in the Emergency Room Department)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a quality improvement project to review the effectiveness and barriers to&#xD;
      effectiveness of a new clinical program in the emergency room to provide substance use&#xD;
      screening followed by brief motivational interviewing and referral to treatment for patients&#xD;
      who meet criteria for problem substance use. This study will consist of a chart review of the&#xD;
      results of the screens performed by substance use counselors and correlating them to&#xD;
      institutional variables such as wait time in the emergency room and length of stay as well as&#xD;
      to patient variables obtained by chart review such as medical diagnosis and sociodemographic&#xD;
      variables.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    incomplete data&#xD;
  </why_stopped>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>substance use</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5271</enrollment>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>Lifestyle Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>motivational interviewer</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational interviewing and referral to treatment</intervention_name>
    <arm_group_label>Lifestyle Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19 and older Presentation to UAB Emergency Department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 19 Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>October 15, 2016</last_update_submitted>
  <last_update_submitted_qc>October 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>substance use treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01661517
org study id: X110829003
nct id: NCT01661517
lead sponsor: 
has dmc: No
This study will be a quality improvement project to review the effectiveness and barriers to
      effectiveness of a new clinical program in the emergency room to provide substance use
      screening followed by brief motivational interviewing and referral to treatment for patients
      who meet criteria for problem substance use. This study will consist of a chart review of the
      results of the screens performed by substance use counselors and correlating them to
      institutional variables such as wait time in the emergency room and length of stay as well as
      to patient variables obtained by chart review such as medical diagnosis and sociodemographic
      variables.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: substance use
time frame: 2 years
arm group label: Lifestyle Counseling
arm group type: Experimental
description: motivational interviewer
intervention type: Behavioral
intervention name: Motivational interviewing and referral to treatment
arm group label: Lifestyle Counseling
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Substance-Related Disorders