<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/NCT03258632</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 15-298</org_study_id>
    <nct_id>NCT03258632</nct_id>
  </id_info>
  <brief_title>Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders</brief_title>
  <official_title>Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to help Veterans who are in medical treatment and have untreated alcohol&#xD;
      problems. First, the investigators adapted a Decision Aid that explains alcohol-related&#xD;
      treatment options and their risks and benefits. Then, the investigators are determining the&#xD;
      effectiveness of an intervention called DO-MoST (for Drinking Options-Motivate, Shared&#xD;
      Decisions, Telemonitor), whereby a Decision Coach helps Veterans make decisions about&#xD;
      alcohol-related behaviors and treatments they prefer, and keeps in contact by phone to&#xD;
      continue to help with drinking and treatment decisions. DO-MoST is designed to increase rates&#xD;
      at which Veterans decide to reduce or quit drinking, and begin and remain in treatment, and&#xD;
      to improve drinking- and medical-related outcomes over time. It may also decrease Veterans'&#xD;
      use of expensive health services such as hospitalizations and emergency visits. Finally, the&#xD;
      investigators will study how VA can use DO-MoST on an ongoing, more widespread basis. The&#xD;
      project should increase patient-centered health care for Veterans with alcohol problems to&#xD;
      benefit their recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In fiscal year 2014, over 57,000 Veterans with diagnosed alcohol use disorders (AUDs)&#xD;
      received VHA inpatient medical-surgical services. This likely underrepresents the prevalence&#xD;
      of AUDs among Veteran inpatients, because these conditions often go undiagnosed during&#xD;
      hospital stays. The high prevalence of AUDs among VHA medical and surgical patients is of&#xD;
      critical concern because AUDs and medical conditions exacerbate one another, and their&#xD;
      co-occurrence increases the use of costly health services. Yet, there are no evidence-based&#xD;
      strategies that improve outcomes in this patient population by means of increased utilization&#xD;
      (initiation, engagement) of AUD treatment services. The investigators have identified&#xD;
      Drinking Options: Motivate, Shared Decisions, Telemonitor (DO-MoST) as a potential solution&#xD;
      to the critical need for evidence-based strategies.&#xD;
&#xD;
      This project is evaluating DO-MoST as a new and innovative intervention to facilitate the&#xD;
      transition from medical-surgical care to AUD treatment in primary and specialty care&#xD;
      settings, thereby improving Veterans' AUD and medical outcomes. DO-MoST entails use of&#xD;
      motivational interviewing and a decision aid during the inpatient stay to facilitate informed&#xD;
      choices about drinking options and resources for help to change drinking, if desired,&#xD;
      followed by telephone calls with the patient to continue to motivate and support decisions.&#xD;
      In addition to determining the effectiveness of DO-MoST, this project includes a process&#xD;
      evaluation - that is, will gather information from providers and patients on DO-MoST's&#xD;
      implementation at the two project sites - to inform VA's potential widespread implementation&#xD;
      of DO-MoST with medical-surgical patients with AUDs.&#xD;
&#xD;
      Using an effectiveness/implementation Hybrid Type 1 design, incorporating a randomized&#xD;
      controlled trial (RCT) and process evaluation to facilitate future implementation, this&#xD;
      project has three Specific Aims.&#xD;
&#xD;
      Aim 1: Adapt a decision aid being implemented with AUD patients in non-VA primary care&#xD;
      settings to be appropriate for Veterans with AUDs in medical-surgical treatment settings.&#xD;
      With this prototype, the investigators will conduct alpha testing with patients and&#xD;
      providers, and adapt and pilot the decision aid to finalize it for use in the RCT.&#xD;
&#xD;
      Aim 2: Conduct DO-MoST at two VA facilities (Ann Arbor and Palo Alto) and evaluate its&#xD;
      effectiveness.&#xD;
&#xD;
      The primary hypotheses are: Patients in DO-MoST, compared to patients in usual care (UC),&#xD;
      will be more likely to (1) utilize AUD help (initiate, engage), (2) have better AUD (fewer&#xD;
      heavy drinking days) and medical (physical status) outcomes, and (3) have fewer and more&#xD;
      delayed acute care episodes (Emergency Department visits, rehospitalizations). Patients will&#xD;
      be assessed at baseline, and 3, 6, and 12 months post-baseline, for outcomes and non-VA&#xD;
      health care; VA health care will be assessed with VA databases. GLMM analyses will be&#xD;
      conducted to compare the UC and DO-MoST groups on course of outcomes.&#xD;
&#xD;
      Aim 3: Conduct a qualitative process evaluation to inform the wider implementation of&#xD;
      DO-MoST, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance)&#xD;
      framework. The purpose is to provide guidance for VA facilities' broader adoption of DO-MoST&#xD;
      in the future, including its possible adaptation for diverse subpopulations of Veterans, such&#xD;
      as patients with mental health diagnoses (e.g., PTSD).&#xD;
&#xD;
      In summary, this project will develop a decision aid and comprehensively examine DO-MoST as a&#xD;
      novel and groundbreaking approach to providing a bridge between medical-surgical treatment&#xD;
      and AUD treatment. Decision Aids have been used successfully in a number of contexts, but&#xD;
      never with medical-AUD patients. The investigator's operations partners from VHA Office of&#xD;
      Mental Health and Suicide Prevention, and Medical Service, are committed to directly&#xD;
      addressing the dangerous, costly pattern of Veterans obtaining medical-surgical services but&#xD;
      not receiving the AUD treatment they need. The project is focused on priorities in the VA&#xD;
      Blueprint for Excellence, of HSR&amp;D Service, and of the PIs' HSR&amp;D Centers of Innovation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 26, 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time Line Follow Back</measure>
    <time_frame>90 days</time_frame>
    <description>The investigators will use the Timeline Follow-Back (TLFB) to assess alcohol use during the 90 days preceding assessment. The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the primary outcome of percent of drinking days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TLFB</measure>
    <time_frame>90 days</time_frame>
    <description>The investigators will use the TLFB to assess percent of heavy drinking days (i.e., 4 or more standard drinks for women, 5 or more standard drinks for men, per day) during the past 90 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">292</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Under usual care, when a patient screens positive on the AUDIT-C administered at intake, a provider (social worker, nurse) provides Brief Intervention (BI), i.e., tells the patient that problems are associated with alcohol use, and about recommended drinking limits; notes the patient as ready to change drinking or not, and as agreeing to treatment or not. If the patient agrees to treatment, specialty addiction services are notified.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)</intervention_name>
    <description>Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Medical-surgical inpatients with alcohol use disorder at the Ann Arbor or Palo Alto VA.&#xD;
        Specifically:&#xD;
&#xD;
          -  in a current episode of medical-surgical care,&#xD;
&#xD;
          -  meet DSM 5 criteria for an AUD&#xD;
&#xD;
          -  no specialty addiction treatment or weekly mutual-help group attendance within 60 days&#xD;
             prior to the inpatient episode,&#xD;
&#xD;
          -  no restricted access due to infection control requirements (e.g., TB, MRSA, C. diff),&#xD;
&#xD;
          -  no significant cognitive impairment,&#xD;
&#xD;
          -  ongoing access to a cell or land line telephone,&#xD;
&#xD;
          -  at least one contact who will continue to know the patient's contact information, and&#xD;
             (8) not having participated in an interview for Aim 1 of this project.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        See inclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Timko, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Palo Alto Health Care System, Palo Alto, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System, Palo Alto, CA</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304-1290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Ann Arbor Healthcare System, Ann Arbor, MI</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol Use Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 24, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03258632
org study id: IIR 15-298
nct id: NCT03258632
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This project aims to help Veterans who are in medical treatment and have untreated alcohol
      problems. First, the investigators adapted a Decision Aid that explains alcohol-related
      treatment options and their risks and benefits. Then, the investigators are determining the
      effectiveness of an intervention called DO-MoST (for Drinking Options-Motivate, Shared
      Decisions, Telemonitor), whereby a Decision Coach helps Veterans make decisions about
      alcohol-related behaviors and treatments they prefer, and keeps in contact by phone to
      continue to help with drinking and treatment decisions. DO-MoST is designed to increase rates
      at which Veterans decide to reduce or quit drinking, and begin and remain in treatment, and
      to improve drinking- and medical-related outcomes over time. It may also decrease Veterans'
      use of expensive health services such as hospitalizations and emergency visits. Finally, the
      investigators will study how VA can use DO-MoST on an ongoing, more widespread basis. The
      project should increase patient-centered health care for Veterans with alcohol problems to
      benefit their recovery.
In fiscal year 2014, over 57,000 Veterans with diagnosed alcohol use disorders (AUDs)
      received VHA inpatient medical-surgical services. This likely underrepresents the prevalence
      of AUDs among Veteran inpatients, because these conditions often go undiagnosed during
      hospital stays. The high prevalence of AUDs among VHA medical and surgical patients is of
      critical concern because AUDs and medical conditions exacerbate one another, and their
      co-occurrence increases the use of costly health services. Yet, there are no evidence-based
      strategies that improve outcomes in this patient population by means of increased utilization
      (initiation, engagement) of AUD treatment services. The investigators have identified
      Drinking Options: Motivate, Shared Decisions, Telemonitor (DO-MoST) as a potential solution
      to the critical need for evidence-based strategies.

      This project is evaluating DO-MoST as a new and innovative intervention to facilitate the
      transition from medical-surgical care to AUD treatment in primary and specialty care
      settings, thereby improving Veterans' AUD and medical outcomes. DO-MoST entails use of
      motivational interviewing and a decision aid during the inpatient stay to facilitate informed
      choices about drinking options and resources for help to change drinking, if desired,
      followed by telephone calls with the patient to continue to motivate and support decisions.
      In addition to determining the effectiveness of DO-MoST, this project includes a process
      evaluation - that is, will gather information from providers and patients on DO-MoST's
      implementation at the two project sites - to inform VA's potential widespread implementation
      of DO-MoST with medical-surgical patients with AUDs.

      Using an effectiveness/implementation Hybrid Type 1 design, incorporating a randomized
      controlled trial (RCT) and process evaluation to facilitate future implementation, this
      project has three Specific Aims.

      Aim 1: Adapt a decision aid being implemented with AUD patients in non-VA primary care
      settings to be appropriate for Veterans with AUDs in medical-surgical treatment settings.
      With this prototype, the investigators will conduct alpha testing with patients and
      providers, and adapt and pilot the decision aid to finalize it for use in the RCT.

      Aim 2: Conduct DO-MoST at two VA facilities (Ann Arbor and Palo Alto) and evaluate its
      effectiveness.

      The primary hypotheses are: Patients in DO-MoST, compared to patients in usual care (UC),
      will be more likely to (1) utilize AUD help (initiate, engage), (2) have better AUD (fewer
      heavy drinking days) and medical (physical status) outcomes, and (3) have fewer and more
      delayed acute care episodes (Emergency Department visits, rehospitalizations). Patients will
      be assessed at baseline, and 3, 6, and 12 months post-baseline, for outcomes and non-VA
      health care; VA health care will be assessed with VA databases. GLMM analyses will be
      conducted to compare the UC and DO-MoST groups on course of outcomes.

      Aim 3: Conduct a qualitative process evaluation to inform the wider implementation of
      DO-MoST, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance)
      framework. The purpose is to provide guidance for VA facilities' broader adoption of DO-MoST
      in the future, including its possible adaptation for diverse subpopulations of Veterans, such
      as patients with mental health diagnoses (e.g., PTSD).

      In summary, this project will develop a decision aid and comprehensively examine DO-MoST as a
      novel and groundbreaking approach to providing a bridge between medical-surgical treatment
      and AUD treatment. Decision Aids have been used successfully in a number of contexts, but
      never with medical-AUD patients. The investigator's operations partners from VHA Office of
      Mental Health and Suicide Prevention, and Medical Service, are committed to directly
      addressing the dangerous, costly pattern of Veterans obtaining medical-surgical services but
      not receiving the AUD treatment they need. The project is focused on priorities in the VA
      Blueprint for Excellence, of HSR&D Service, and of the PIs' HSR&D Centers of Innovation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Time Line Follow Back
time frame: 90 days
description: The investigators will use the Timeline Follow-Back (TLFB) to assess alcohol use during the 90 days preceding assessment. The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the primary outcome of percent of drinking days.
measure: TLFB
time frame: 90 days
description: The investigators will use the TLFB to assess percent of heavy drinking days (i.e., 4 or more standard drinks for women, 5 or more standard drinks for men, per day) during the past 90 days.
arm group label: Usual Care
arm group type: No Intervention
description: Under usual care, when a patient screens positive on the AUDIT-C administered at intake, a provider (social worker, nurse) provides Brief Intervention (BI), i.e., tells the patient that problems are associated with alcohol use, and about recommended drinking limits; notes the patient as ready to change drinking or not, and as agreeing to treatment or not. If the patient agrees to treatment, specialty addiction services are notified.
arm group label: Intervention
arm group type: Experimental
description: Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.
intervention type: Behavioral
intervention name: Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)
description: Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine Timko, PhD
role: Principal Investigator
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Alcohol Drinking
sharing ipd: No
submitted: February 24, 2023