<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/NCT02188043</url>
  </required_header>
  <id_info>
    <org_study_id>RESCueH_Relay</org_study_id>
    <nct_id>NCT02188043</nct_id>
  </id_info>
  <brief_title>Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals</brief_title>
  <acronym>Relay</acronym>
  <official_title>Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals - A Single-blind Pragmatic Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the Relay Model helping alcohol dependent patients&#xD;
      at a general hospital to start specialized alcohol treatment in order to assess i) efficacy,&#xD;
      ii) cost-effectiveness and iii) overall societal cost impacts.&#xD;
&#xD;
      The effect of the Relay Model will be investigated in a single-blind pragmatic randomised&#xD;
      controlled trial in which the control group consists of patients referred to treatment by&#xD;
      usual procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An increase in individuals with alcohol dependence receiving specialized alcohol treatment&#xD;
      will be of major importance for society's response to alcohol problems and its consequences.&#xD;
      The Danish population has a large intake of alcohol. Approximately 20% of the adult&#xD;
      population are heavy drinkers ( &gt;14/21 drinks/ week (women/men)), 14% are harmful users, and&#xD;
      3% are dependent drinkers. Untreated alcohol use disorders lead to frequent contacts to the&#xD;
      health care system associated with considerable human and societal costs. A first approach&#xD;
      would be to identify and recruit patients from general hospitals, where the proportion of&#xD;
      inpatients with alcohol use disorders range between 16 % and 26%. A referral model to ensure&#xD;
      treatment for alcohol dependent patients after discharge is needed.&#xD;
&#xD;
      The main objective of the study is to develop strategies which increase the likelihood that&#xD;
      patients report for outpatient alcohol treatment after discharge. It is likely that an&#xD;
      optimization of the transfer procedure between hospital and outpatient clinic will lead to&#xD;
      that more patients will be engage in psychosocial treatment for their alcohol abuse, which&#xD;
      will improve the prognosis, reduce re-admissions and the use of hospital beds and, thus have&#xD;
      positive economic consequences. We evaluate the Relay Model in order to assess i) efficacy,&#xD;
      ii) cost-effectiveness and iii) overall societal cost impacts.&#xD;
&#xD;
      The target group of the present study is patients suffering from alcohol dependence admitted&#xD;
      to a general hospital located in an urban area and a general hospital located in a rural&#xD;
      area.&#xD;
&#xD;
      A single-blind pragmatic randomised controlled trial including patients admitted to Hospital.&#xD;
      The study group(n=500) receive an Intervention and the control group(n=500) are referred to&#xD;
      treatment by usual procedures. All patients complete a lifestyle questionnaire with the&#xD;
      Danish self-report version of the Alcohol Use Disorders Identification Test (AUDIT) embedded&#xD;
      as a case identification strategy. The patients are informed that an alcohol therapist may&#xD;
      contact them and give feedback on their responses.&#xD;
&#xD;
      The completed forms are reviewed daily and an AUDIT score of 8+prompts a call to the Alcohol&#xD;
      therapist, who attends the departments on different days randomly drawn by a computer. The&#xD;
      RELAY MODEL intervention include a Brief Motivational Intervention. Patients who score AUDIT&#xD;
      16+ are also offered an appointment at the alcohol treatment clinic.&#xD;
&#xD;
      Primary measure is health care expenditures 12 months after discharge, according to the&#xD;
      International Classification of Health Accounts, extracted from population registers. The&#xD;
      analysis will be repeated on a yearly basis during the following 5 years.&#xD;
&#xD;
      Secondary outcome: The percentage of the target group, who, 30 days after discharge, reports&#xD;
      at the alcohol treatment clinics.&#xD;
&#xD;
      A multiple regression model will be used. Since non-treated alcohol disorders generate a high&#xD;
      number of societal costs annually for health care, social services, traffic accidents,&#xD;
      criminal activities and lost productions we believe the Relay Model to be either cost-neutral&#xD;
      or cost-effective, i.e. low net costs compared to effectiveness. We expect to establish&#xD;
      evidence that the Relay Model is either cost-neutral or cost-effective, compared to referral&#xD;
      by usual procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>health care expenditures</measure>
    <time_frame>12 - 60 months</time_frame>
    <description>Primary measure is Health care expenditures 12 months after discharge, according to the International Classification of Health Accounts, extracted from population registers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>report to alcohol clinic</measure>
    <time_frame>30 days</time_frame>
    <description>Secondary outcome is the percentage of the target group, who, 30 days after discharge, reports at the alcohol treatment clinics.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1000</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <condition>Alcohol Dependency</condition>
  <arm_group>
    <arm_group_label>Relay Model</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>AUDIT score 8+: Brief Motivational Intervention with alcohol therapist. AUDITscore16+:Brief Motivational Intervention and appointment at Alcohol Treatment Clinic&#xD;
-</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Referral Procedure</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Hospital staff refer patient to Alcohol Treatment Clinic according to usual procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relay Model</intervention_name>
    <description>The Clinical staff hand out and collect lifestyle - questionnaires to admitted patients, and screen by 10 alcohol questions (AUDIT) , and report score to outpatient Alcohol Clinic.&#xD;
Based on the questionnaire that the patient filled out, the Alcohol therapist perform a brief Motivational Intervention on patients with an AUDIT score of 8+, focusing the patients alcohol consumption habits and offer an appointment to patients with an AUDIT score of 16+.</description>
    <arm_group_label>Relay Model</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized for a minimum of 24 hours&#xD;
&#xD;
          -  Resident within the uptake area of the involved alcohol treatment centres&#xD;
&#xD;
          -  Willing to participate in the study&#xD;
&#xD;
          -  Cognitive and physical capable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In any alcohol-specific treatment for alcohol dependence&#xD;
&#xD;
          -  Psychotic&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Hospitalized less than 24 hours&#xD;
&#xD;
          -  Resident outside uptake areas&#xD;
&#xD;
          -  Not consenting on participation in the study&#xD;
&#xD;
          -  Cognitive and physical incapable&#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>Bent Nielsen, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>bent.nielsen@rsyd.dk</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark</name>
      <address>
        <city>Odense</city>
        <zip>DK - 5000 C</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Kjeld Andersen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Alcohol use disorder</keyword>
  <keyword>Motivational Intervention</keyword>
  <keyword>Health expenditures</keyword>
  <keyword>efficacy study</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>
  <!-- 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/NCT02188043
org study id: RESCueH_Relay
nct id: NCT02188043
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the Relay Model helping alcohol dependent patients
      at a general hospital to start specialized alcohol treatment in order to assess i) efficacy,
      ii) cost-effectiveness and iii) overall societal cost impacts.

      The effect of the Relay Model will be investigated in a single-blind pragmatic randomised
      controlled trial in which the control group consists of patients referred to treatment by
      usual procedures.
An increase in individuals with alcohol dependence receiving specialized alcohol treatment
      will be of major importance for society's response to alcohol problems and its consequences.
      The Danish population has a large intake of alcohol. Approximately 20% of the adult
      population are heavy drinkers ( >14/21 drinks/ week (women/men)), 14% are harmful users, and
      3% are dependent drinkers. Untreated alcohol use disorders lead to frequent contacts to the
      health care system associated with considerable human and societal costs. A first approach
      would be to identify and recruit patients from general hospitals, where the proportion of
      inpatients with alcohol use disorders range between 16 % and 26%. A referral model to ensure
      treatment for alcohol dependent patients after discharge is needed.

      The main objective of the study is to develop strategies which increase the likelihood that
      patients report for outpatient alcohol treatment after discharge. It is likely that an
      optimization of the transfer procedure between hospital and outpatient clinic will lead to
      that more patients will be engage in psychosocial treatment for their alcohol abuse, which
      will improve the prognosis, reduce re-admissions and the use of hospital beds and, thus have
      positive economic consequences. We evaluate the Relay Model in order to assess i) efficacy,
      ii) cost-effectiveness and iii) overall societal cost impacts.

      The target group of the present study is patients suffering from alcohol dependence admitted
      to a general hospital located in an urban area and a general hospital located in a rural
      area.

      A single-blind pragmatic randomised controlled trial including patients admitted to Hospital.
      The study group(n=500) receive an Intervention and the control group(n=500) are referred to
      treatment by usual procedures. All patients complete a lifestyle questionnaire with the
      Danish self-report version of the Alcohol Use Disorders Identification Test (AUDIT) embedded
      as a case identification strategy. The patients are informed that an alcohol therapist may
      contact them and give feedback on their responses.

      The completed forms are reviewed daily and an AUDIT score of 8+prompts a call to the Alcohol
      therapist, who attends the departments on different days randomly drawn by a computer. The
      RELAY MODEL intervention include a Brief Motivational Intervention. Patients who score AUDIT
      16+ are also offered an appointment at the alcohol treatment clinic.

      Primary measure is health care expenditures 12 months after discharge, according to the
      International Classification of Health Accounts, extracted from population registers. The
      analysis will be repeated on a yearly basis during the following 5 years.

      Secondary outcome: The percentage of the target group, who, 30 days after discharge, reports
      at the alcohol treatment clinics.

      A multiple regression model will be used. Since non-treated alcohol disorders generate a high
      number of societal costs annually for health care, social services, traffic accidents,
      criminal activities and lost productions we believe the Relay Model to be either cost-neutral
      or cost-effective, i.e. low net costs compared to effectiveness. We expect to establish
      evidence that the Relay Model is either cost-neutral or cost-effective, compared to referral
      by usual procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: health care expenditures
time frame: 12 - 60 months
description: Primary measure is Health care expenditures 12 months after discharge, according to the International Classification of Health Accounts, extracted from population registers.
measure: report to alcohol clinic
time frame: 30 days
description: Secondary outcome is the percentage of the target group, who, 30 days after discharge, reports at the alcohol treatment clinics.
arm group label: Relay Model
arm group type: Other
description: AUDIT score 8+: Brief Motivational Intervention with alcohol therapist. AUDITscore16+:Brief Motivational Intervention and appointment at Alcohol Treatment Clinic
-
arm group label: Usual Referral Procedure
arm group type: No Intervention
description: Hospital staff refer patient to Alcohol Treatment Clinic according to usual procedure
intervention type: Behavioral
intervention name: Relay Model
description: The Clinical staff hand out and collect lifestyle - questionnaires to admitted patients, and screen by 10 alcohol questions (AUDIT) , and report score to outpatient Alcohol Clinic.
Based on the questionnaire that the patient filled out, the Alcohol therapist perform a brief Motivational Intervention on patients with an AUDIT score of 8+, focusing the patients alcohol consumption habits and offer an appointment to patients with an AUDIT score of 16+.
arm group label: Relay Model
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bent Nielsen, Ph.D
role: Principal Investigator
affiliation: bent.nielsen@rsyd.dk
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Kjeld Andersen
investigator title: Professor
mesh term: Alcoholism
mesh term: Alcohol Drinking