<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/NCT01661465</url>
  </required_header>
  <id_info>
    <org_study_id>X110422001</org_study_id>
    <nct_id>NCT01661465</nct_id>
  </id_info>
  <brief_title>Routine Clinical Screening for Substance Use Disorders in the Emergency Room Setting</brief_title>
  <official_title>Routine Clinical Screening for Substance Use Disorders in the Emergency Room Setting</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>
      To ensure consistent documentation of alcohol and substance use, the emergency medicine is&#xD;
      initiating a new standard of care for substance use screening: the use of a brief&#xD;
      self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed&#xD;
      in triage. This questionnaire will allow emergency medicine patients presenting to the&#xD;
      emergency room. This study will also review medical records after one year of the index&#xD;
      emergency room visit to establish rates or re-presentation and hospitalization correlated&#xD;
      with different substance use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening for alcohol use and substances of abuse in the emergency and trauma settings is&#xD;
      critical for both effective current treatment of the presenting clinical issue and prevention&#xD;
      of future incidents. Identification, engagement and treatment of substance use disorders&#xD;
      decreased trauma and emergency department visits and medical comorbidities (Bertholet et al.,&#xD;
      2005; Kaner et al., 2007). To ensure consistent documentation of alcohol and substance use,&#xD;
      the emergency medicine is initiating a new standard of care for substance use screening: the&#xD;
      use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to&#xD;
      be completed in triage. This questionnaire will allow emergency medicine patients presenting&#xD;
      to the emergency room. This research study will perform a chart review on all self-evaluation&#xD;
      questionnaires on alcohol, tobacco and substance use to determine the prevalence of use of&#xD;
      specific substances in this patient population and associated demographic predictors and&#xD;
      medical comorbidities. This study will also review medical records after one year of the&#xD;
      index emergency room visit to establish rates or re-presentation and hospitalization&#xD;
      correlated with different substance use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The Principal Investigator left the site.&#xD;
  </why_stopped>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of subjects with re-presentation of drug or alcohol abuse 1 year after initial presentation to Emergency Department</measure>
    <time_frame>baseline to 12 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">9212</enrollment>
  <condition>Substance Use</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to University Hospital Emergency Department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to complete a questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 19 Unable or unwilling to complete a self-assessment form written in&#xD;
             English Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</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>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Cheryl McCullumsmith</investigator_full_name>
    <investigator_title>Division Director, Hospital Psychiatry</investigator_title>
  </responsible_party>
  <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/NCT01661465
org study id: X110422001
nct id: NCT01661465
lead sponsor: 
has dmc: No
To ensure consistent documentation of alcohol and substance use, the emergency medicine is
      initiating a new standard of care for substance use screening: the use of a brief
      self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed
      in triage. This questionnaire will allow emergency medicine patients presenting to the
      emergency room. This study will also review medical records after one year of the index
      emergency room visit to establish rates or re-presentation and hospitalization correlated
      with different substance use.
Screening for alcohol use and substances of abuse in the emergency and trauma settings is
      critical for both effective current treatment of the presenting clinical issue and prevention
      of future incidents. Identification, engagement and treatment of substance use disorders
      decreased trauma and emergency department visits and medical comorbidities (Bertholet et al.,
      2005; Kaner et al., 2007). To ensure consistent documentation of alcohol and substance use,
      the emergency medicine is initiating a new standard of care for substance use screening: the
      use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to
      be completed in triage. This questionnaire will allow emergency medicine patients presenting
      to the emergency room. This research study will perform a chart review on all self-evaluation
      questionnaires on alcohol, tobacco and substance use to determine the prevalence of use of
      specific substances in this patient population and associated demographic predictors and
      medical comorbidities. This study will also review medical records after one year of the
      index emergency room visit to establish rates or re-presentation and hospitalization
      correlated with different substance use.
observational model: Other
time perspective: Retrospective
measure: Percent of subjects with re-presentation of drug or alcohol abuse 1 year after initial presentation to Emergency Department
time frame: baseline to 12 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Cheryl McCullumsmith
investigator title: Division Director, Hospital Psychiatry
mesh term: Emergencies
mesh term: Substance-Related Disorders