<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/NCT02968186</url>
  </required_header>
  <id_info>
    <org_study_id>ASBI-2017</org_study_id>
    <nct_id>NCT02968186</nct_id>
  </id_info>
  <brief_title>Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care</brief_title>
  <official_title>Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Agrupamento de Centros de Saúde de Dão Lafões</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cambridge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Stirling</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Agrupamento de Centros de Saúde de Dão Lafões</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the efficacy of an implementation program&#xD;
      specifically designed to increase alcohol screening and brief intervention rates in primary&#xD;
      health care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol is an important risk factor for several diseases, even when consumed moderately.&#xD;
      Screening and advising at-risk drinkers to cut-down is a highly effective and cost-effective&#xD;
      intervention when conducted in primary healthcare settings. However, these interventions are&#xD;
      seldom implemented at the primary care level.&#xD;
&#xD;
      Twelve out of the 26 primary health care units of the Dão Lafões Grouping of Primary Health&#xD;
      Care Centres will be randomized to two groups: the intervention arm will receive the new&#xD;
      implementation program; the control group will be on a waiting list for receiving the&#xD;
      implementation program and will receive the intervention after the testing phase of the trial&#xD;
      is completed. The study will last for one year, starting in January 2017. The implementation&#xD;
      program was designed in order to overcome known barriers for implementing alcohol screening&#xD;
      and brief advice in primary health care. The Behaviour Change Wheel and the Theoretical&#xD;
      Domains Framework were used to pinpoint the constructs and behaviour change techniques most&#xD;
      suited to address the barriers in order to achieve practice changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol screening rate</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of eligible patients visiting the primary health care centre for an appointment with a general practitioner or nurse who were screened for alcohol use with the Alcohol Use Disorders Identification Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of general practitioners attitudes toward at-risk drinkers</measure>
    <time_frame>12 months</time_frame>
    <description>Short Alcohol and Alcohol Problems Perception Questionnaire given before and after intervention. General practitioners are classified into a more positive or more negative attitudes group based on the answers given. The groups will be compared before and after.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in knowledge related to alcohol screening and brief intervention</measure>
    <time_frame>12 months</time_frame>
    <description>Four multiple choice questions. These questions will measure the theoretical knowledge of health professionals to key concepts related to alcohol screening and brief intervention. The groups will be compared before and after.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in barriers for implementing alcohol screening and brief intervention</measure>
    <time_frame>12 months</time_frame>
    <description>Level of agreement with 33 statements. Each statement can be mapped to a specific domain of the Theoretical Domains Framework. The groups will be compared before and after.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility of materials used in the trial</measure>
    <time_frame>Through study completion, an average of 12 months</time_frame>
    <description>Level of agreement with 6 statements. Participants (intervention arm only) will be asked to rate the impact of the materials that were specifically produced to be used during the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief intervention rate</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of patients who screened positive that were offered at least one brief intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">222</enrollment>
  <condition>Alcohol-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Implementation program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health professionals will receive a training and support implementation program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Health professionals will be assigned to a waiting list to receive the implementation program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Implementation program</intervention_name>
    <description>Health professionals in the intervention arm will receive up to four training sessions in the first three months of the implementation period. Practice support will be continuously available throughout the project. Posters specifically designed for this project will be added to the primary health care units aiming to facilitate eliciting alcohol issues during the consultations, and to help professionals remembering to conduct alcohol screening and brief intervention. Leaflets to be handed-in to patients were also specifically produced for this project, aiming to aid professionals in advising at-risk drinkers to cut down. The research team will schedule with each primary health care unit regular visits for feedback on the progress of the program.</description>
    <arm_group_label>Implementation program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary health care units of the Dão Lafões Grouping of Primary Health Care Centres&#xD;
             (family physicians/general practitioners, family medicine residents, practice nurses&#xD;
             and receptionists)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary health care units with four or less general practitioners&#xD;
&#xD;
          -  Primary health care units that have a specific alcohol program already implemented&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederico M Rosário, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dão Lafões Grouping of Primary Health Care Centres</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dão Lafões Grouping of Primary Health Care Centres</name>
      <address>
        <city>Viseu</city>
        <state>Dão Lafões</state>
        <zip>3514-511</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <reference>
    <citation>Rosario F, Vasiljevic M, Pas L, Fitzgerald N, Ribeiro C. Implementing alcohol screening and brief interventions in primary health care: study protocol for a pilot cluster randomized controlled trial. Fam Pract. 2019 Mar 20;36(2):199-205. doi: 10.1093/fampra/cmy062.</citation>
    <PMID>29939239</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Agrupamento de Centros de Saúde de Dão Lafões</investigator_affiliation>
    <investigator_full_name>Frederico Rosário</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Mass Screening</keyword>
  <keyword>Counseling</keyword>
  <keyword>Primary Health Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02968186
org study id: ASBI-2017
nct id: NCT02968186
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The objective of this study is to investigate the efficacy of an implementation program
      specifically designed to increase alcohol screening and brief intervention rates in primary
      health care.
Alcohol is an important risk factor for several diseases, even when consumed moderately.
      Screening and advising at-risk drinkers to cut-down is a highly effective and cost-effective
      intervention when conducted in primary healthcare settings. However, these interventions are
      seldom implemented at the primary care level.

      Twelve out of the 26 primary health care units of the Dão Lafões Grouping of Primary Health
      Care Centres will be randomized to two groups: the intervention arm will receive the new
      implementation program; the control group will be on a waiting list for receiving the
      implementation program and will receive the intervention after the testing phase of the trial
      is completed. The study will last for one year, starting in January 2017. The implementation
      program was designed in order to overcome known barriers for implementing alcohol screening
      and brief advice in primary health care. The Behaviour Change Wheel and the Theoretical
      Domains Framework were used to pinpoint the constructs and behaviour change techniques most
      suited to address the barriers in order to achieve practice changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Alcohol screening rate
time frame: 12 months
description: Percentage of eligible patients visiting the primary health care centre for an appointment with a general practitioner or nurse who were screened for alcohol use with the Alcohol Use Disorders Identification Test
measure: Improvement of general practitioners attitudes toward at-risk drinkers
time frame: 12 months
description: Short Alcohol and Alcohol Problems Perception Questionnaire given before and after intervention. General practitioners are classified into a more positive or more negative attitudes group based on the answers given. The groups will be compared before and after.
measure: Improvement in knowledge related to alcohol screening and brief intervention
time frame: 12 months
description: Four multiple choice questions. These questions will measure the theoretical knowledge of health professionals to key concepts related to alcohol screening and brief intervention. The groups will be compared before and after.
measure: Improvement in barriers for implementing alcohol screening and brief intervention
time frame: 12 months
description: Level of agreement with 33 statements. Each statement can be mapped to a specific domain of the Theoretical Domains Framework. The groups will be compared before and after.
measure: Utility of materials used in the trial
time frame: Through study completion, an average of 12 months
description: Level of agreement with 6 statements. Participants (intervention arm only) will be asked to rate the impact of the materials that were specifically produced to be used during the trial.
measure: Brief intervention rate
time frame: 12 months
description: Percentage of patients who screened positive that were offered at least one brief intervention
arm group label: Implementation program
arm group type: Experimental
description: Health professionals will receive a training and support implementation program
arm group label: Waiting list
arm group type: No Intervention
description: Health professionals will be assigned to a waiting list to receive the implementation program
intervention type: Behavioral
intervention name: Implementation program
description: Health professionals in the intervention arm will receive up to four training sessions in the first three months of the implementation period. Practice support will be continuously available throughout the project. Posters specifically designed for this project will be added to the primary health care units aiming to facilitate eliciting alcohol issues during the consultations, and to help professionals remembering to conduct alcohol screening and brief intervention. Leaflets to be handed-in to patients were also specifically produced for this project, aiming to aid professionals in advising at-risk drinkers to cut down. The research team will schedule with each primary health care unit regular visits for feedback on the progress of the program.
arm group label: Implementation program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frederico M Rosário, MD
role: Principal Investigator
affiliation: Dão Lafões Grouping of Primary Health Care Centres
facility: 
country: Portugal
citation: Rosario F, Vasiljevic M, Pas L, Fitzgerald N, Ribeiro C. Implementing alcohol screening and brief interventions in primary health care: study protocol for a pilot cluster randomized controlled trial. Fam Pract. 2019 Mar 20;36(2):199-205. doi: 10.1093/fampra/cmy062.
PMID: 29939239
responsible party type: Principal Investigator
investigator affiliation: Agrupamento de Centros de Saúde de Dão Lafões
investigator full name: Frederico Rosário
investigator title: Dr.
mesh term: Alcohol-Related Disorders
sharing ipd: No