<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/NCT02236494</url>
  </required_header>
  <id_info>
    <org_study_id>13-3446</org_study_id>
    <secondary_id>R03AG048090</secondary_id>
    <nct_id>NCT02236494</nct_id>
  </id_info>
  <brief_title>Study of an Emergency Department-based Intervention to Reduce Alcohol Misuse in Older Adults</brief_title>
  <official_title>Pilot Trial of Emergency Department Intervention and Referral for Alcohol Misuse in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The American Geriatrics Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Society for Academic Emergency Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Carolina Translational and Clinical Sciences Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized trial to assess the value of an emergency department-based intervention&#xD;
      to reduce hazardous alcohol use among older adults. We hypothesize that the intervention will&#xD;
      result in a 25% reduction in the prevalence of hazardous alcohol use while the control group&#xD;
      will only have a 5% reduction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this project is to perform a pilot, randomized, controlled trial of a brief&#xD;
      intervention and referral for treatment among older adults in the emergency department (ED)&#xD;
      with alcohol misuse. The pilot data would then be used to design a larger study. The&#xD;
      intervention for this trial will consist of a Brief Negotiation Interview (BNI) with a&#xD;
      stratified referral for further treatment, compared with usual care. The BNI is a&#xD;
      standardized, well-described intervention that has been implemented in a broad range of&#xD;
      clinical settings but has not been specifically tested in older adults in the ED. Following&#xD;
      the BNI, we will provide a referral for further care for the patient that is stratified by&#xD;
      severity of alcohol misuse. Patients with hazardous or harmful alcohol use will follow-up&#xD;
      with a primary care physician; patients with alcohol abuse or dependence will follow-up with&#xD;
      an outpatient alcohol and substance abuse program; those at risk for complicated withdrawal&#xD;
      will be recommended for inpatient treatment. In all cases we will contact the referral&#xD;
      physician to help transition the patient's care, and ensure the patient receives a consistent&#xD;
      message regarding their alcohol use across the different care settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">July 10, 2017</completion_date>
  <primary_completion_date type="Actual">July 10, 2017</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol misuse</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported alcohol misuse is defined as patient self-report of either drinking &gt;7 drinks per week or &gt;3 drinks per occasion in the past month.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subgroup analysis of patients who met hazardous alcohol use criteria based on time-line follow back method of assessing alcohol consumption</measure>
    <time_frame>6 months</time_frame>
    <description>Analysis of rate of hazardous alcohol use in the control and intervention arms within the subgroup of patients who met hazardous drinking criteria of &gt;7 drinks in the past 7 days, or &gt;3 drinks per occasion within the last 28 days using the time-line follow back method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol misuse</measure>
    <time_frame>3 months, 12 months</time_frame>
    <description>Alcohol misuse is defined as patient self-report of either drinking &gt;7 drinks per week or &gt;3 drinks per day in the past month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function</measure>
    <time_frame>6,12 months</time_frame>
    <description>Activities of Daily Living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol consumption</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Average drinks per week and episodes of &gt;3 drinks in past 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol abuse</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>AUDIT Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Health</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Mobility, depression, and presence of chronic pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk-taking behavior</measure>
    <time_frame>6,12 months</time_frame>
    <description>Driving after drinking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trauma</measure>
    <time_frame>6,12 months</time_frame>
    <description>Injuries, falls, and motor vehicle collisions within the last 6 months, alcohol use preceding and medical care following the injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>6,12 months</time_frame>
    <description>Number of primary care, urgent care, and ED visits, and hospitalization days within the last 6 months, and any relation of these visits to alcohol use.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">222</enrollment>
  <condition>Alcohol Abuse</condition>
  <arm_group>
    <arm_group_label>General Health Information Pamphlet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will not receive a brief intervention in the ED. They will receive a pamphlet with general health information for older adults, as well as contact information for an outpatient alcohol treatment center where they have the option to follow-up for alcohol treatment at their discretion. The patient's readiness to change their alcohol habits will be measured using a 1-10 scale with a visual cue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brief Negotiated Interview</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The BNI will follow standard steps (7, 63): 1. The research assistant (RA) will ask permission to discuss the patient's alcohol use with them. 2. They will provide feedback regarding the patient's alcohol use, and will review guidelines drinking in older adults. Where relevant, the RA will discuss how the patient's current visit may relate to their alcohol use. 3. The RA will assess the patient's readiness to change using a 1-10 scale, and will enhance motivation. 4. The RA will negotiate a goal for the patient's drinking and give advice. The patient will be asked to sign a drinking agreement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Negotiated Interview</intervention_name>
    <description>As per arm</description>
    <arm_group_label>Brief Negotiated Interview</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>General Health Information</intervention_name>
    <description>As per arm (this is the active comparator)</description>
    <arm_group_label>General Health Information Pamphlet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 and older&#xD;
&#xD;
          -  Receiving care in the emergency department&#xD;
&#xD;
          -  Hazardous alcohol use, defined as reporting drinking more than 7 drinks per week on an&#xD;
             average week during the three months prior to the visit, and whether they have&#xD;
             consumed more than three drinks on any given occasion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prisoner&#xD;
&#xD;
          -  psychosis or psychiatric hold&#xD;
&#xD;
          -  nursing home&#xD;
&#xD;
          -  life-threatening condition&#xD;
&#xD;
          -  current hospice care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Shenvi, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Timothy F Platts-Mills, MD,MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Hospitals Emergency Department</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>July 10, 2017</last_update_submitted>
  <last_update_submitted_qc>July 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>alcoholism</keyword>
  <keyword>dangerous behavior</keyword>
  <keyword>aged</keyword>
  <keyword>emergency medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Alcoholism</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/NCT02236494
org study id: 13-3446
secondary id: R03AG048090
nct id: NCT02236494
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a randomized trial to assess the value of an emergency department-based intervention
      to reduce hazardous alcohol use among older adults. We hypothesize that the intervention will
      result in a 25% reduction in the prevalence of hazardous alcohol use while the control group
      will only have a 5% reduction.
The goal of this project is to perform a pilot, randomized, controlled trial of a brief
      intervention and referral for treatment among older adults in the emergency department (ED)
      with alcohol misuse. The pilot data would then be used to design a larger study. The
      intervention for this trial will consist of a Brief Negotiation Interview (BNI) with a
      stratified referral for further treatment, compared with usual care. The BNI is a
      standardized, well-described intervention that has been implemented in a broad range of
      clinical settings but has not been specifically tested in older adults in the ED. Following
      the BNI, we will provide a referral for further care for the patient that is stratified by
      severity of alcohol misuse. Patients with hazardous or harmful alcohol use will follow-up
      with a primary care physician; patients with alcohol abuse or dependence will follow-up with
      an outpatient alcohol and substance abuse program; those at risk for complicated withdrawal
      will be recommended for inpatient treatment. In all cases we will contact the referral
      physician to help transition the patient's care, and ensure the patient receives a consistent
      message regarding their alcohol use across the different care settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Alcohol misuse
time frame: 6 months
description: Self-reported alcohol misuse is defined as patient self-report of either drinking >7 drinks per week or >3 drinks per occasion in the past month.
measure: Subgroup analysis of patients who met hazardous alcohol use criteria based on time-line follow back method of assessing alcohol consumption
time frame: 6 months
description: Analysis of rate of hazardous alcohol use in the control and intervention arms within the subgroup of patients who met hazardous drinking criteria of >7 drinks in the past 7 days, or >3 drinks per occasion within the last 28 days using the time-line follow back method.
measure: Alcohol misuse
time frame: 3 months, 12 months
description: Alcohol misuse is defined as patient self-report of either drinking >7 drinks per week or >3 drinks per day in the past month.
measure: Function
time frame: 6,12 months
description: Activities of Daily Living
measure: Alcohol consumption
time frame: 3,6,12 months
description: Average drinks per week and episodes of >3 drinks in past 3 months
measure: Alcohol abuse
time frame: 3,6,12 months
description: AUDIT Score
measure: General Health
time frame: 3,6,12 months
description: Mobility, depression, and presence of chronic pain
measure: Risk-taking behavior
time frame: 6,12 months
description: Driving after drinking
measure: Trauma
time frame: 6,12 months
description: Injuries, falls, and motor vehicle collisions within the last 6 months, alcohol use preceding and medical care following the injury
measure: Healthcare Utilization
time frame: 6,12 months
description: Number of primary care, urgent care, and ED visits, and hospitalization days within the last 6 months, and any relation of these visits to alcohol use.
arm group label: General Health Information Pamphlet
arm group type: Active Comparator
description: This group will not receive a brief intervention in the ED. They will receive a pamphlet with general health information for older adults, as well as contact information for an outpatient alcohol treatment center where they have the option to follow-up for alcohol treatment at their discretion. The patient's readiness to change their alcohol habits will be measured using a 1-10 scale with a visual cue.
arm group label: Brief Negotiated Interview
arm group type: Experimental
description: The BNI will follow standard steps (7, 63): 1. The research assistant (RA) will ask permission to discuss the patient's alcohol use with them. 2. They will provide feedback regarding the patient's alcohol use, and will review guidelines drinking in older adults. Where relevant, the RA will discuss how the patient's current visit may relate to their alcohol use. 3. The RA will assess the patient's readiness to change using a 1-10 scale, and will enhance motivation. 4. The RA will negotiate a goal for the patient's drinking and give advice. The patient will be asked to sign a drinking agreement.
intervention type: Behavioral
intervention name: Brief Negotiated Interview
description: As per arm
arm group label: Brief Negotiated Interview
intervention type: Behavioral
intervention name: General Health Information
description: As per arm (this is the active comparator)
arm group label: General Health Information Pamphlet
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Christina Shenvi, MD,PhD
role: Principal Investigator
affiliation: UNC Chapel Hill
last name: Timothy F Platts-Mills, MD,MSc
role: Principal Investigator
affiliation: UNC Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Alcoholism