<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/NCT03001024</url>
  </required_header>
  <id_info>
    <org_study_id>1R44MD010405-03</org_study_id>
    <secondary_id>0311</secondary_id>
    <nct_id>NCT03001024</nct_id>
  </id_info>
  <brief_title>WayToServe Español: Online Responsible Beverage Service Training for Spanish-Speaking Servers</brief_title>
  <acronym>WTS-E</acronym>
  <official_title>WayToServe Español: A Culturally-Appropriate Online Responsible Beverage Service Training for Spanish-Speaking Servers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klein Buendel, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Texas, El Paso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Klein Buendel, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Responsible Beverage Service Training (RBS) has been shown to be effective and recent&#xD;
      research by this research team has shown that online RBS training (WayToServe®) was more&#xD;
      effective, particularly over time, than usual and customary (UC) RBS training by live&#xD;
      trainers. However, one growing segment of alcohol servers and sellers has been neglected in&#xD;
      RBS training efforts: Hispanic primarily Spanish-speaking servers in predominantly&#xD;
      Spanish-speaking premises. This project will develop and test the first online RBS training&#xD;
      for predominantly Spanish-speaking servers, WayToServe Español, which is culturally and&#xD;
      linguistically appropriate and will fill a gap in evidence-based alcohol prevention&#xD;
      interventions for this underserved population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Among the measures against drunk driving available to policy makers and prevention&#xD;
      practitioners, Responsible Beverage Service (RBS) training has shown promise. In these&#xD;
      programs, alcohol servers are educated in a number of techniques, including correct&#xD;
      identification checking, recognizing signs of intoxication in patrons, and managing patrons&#xD;
      via drink counting techniques to safely keep them under Driving While Intoxicated blood&#xD;
      alcohol limits. Recent reviews of RBS programs have found evidence for effectiveness.&#xD;
      However, the diffusion of RBS training and practices has been limited: 18 U.S. states require&#xD;
      some form of RBS training, another 18 incentivize training in some way, and the other 14&#xD;
      states have no RBS regulations at all. As a result, while RBS training may be widely&#xD;
      available, it is not widely adopted. An overlooked limitation of all RBS training in the&#xD;
      U.S., and a limit to its dissemination, is that it is only offered in English and from a&#xD;
      mainstream U.S. culture point of view. Proposed here is the development and testing of a&#xD;
      Spanish-language version of an evidence-based online RBS training program (WayToServe®) that&#xD;
      will be culturally tailored to Hispanic cultural values, experiences, and circumstances:&#xD;
      WayToServe Español. The systematic development of WayToServe Español will meet the training&#xD;
      needs of an underserved and growing population segment of alcohol servers and sellers -&#xD;
      Hispanics who are predominant speakers of Spanish and who often work in premises with many&#xD;
      predominantly Spanish-speaking patrons. The proposed Direct-to-Phase II research will be&#xD;
      accomplished in two phases. The first phase will entail the iterative and systematic&#xD;
      development of WayToServe Español via Spanish-language focus groups and usability testing.&#xD;
      The second phase will involve the evaluation of WayToServe Español in Spanish-dominant&#xD;
      premises in New Mexico and West Texas via a randomized efficacy trial that randomly assigns&#xD;
      premises to either receive WayToServe Español training or Usual and Customary (UC) RBS&#xD;
      training. A variety of alcohol service refusal rates will be the primary outcome variable,&#xD;
      measured using a pseudo-intoxicated Pseudo-Patron (PP) buyer assessment protocol. Premises&#xD;
      will be assessed at baseline, post-training, and 9-month follow up intervals. Should&#xD;
      WayToServe Español prove effective, commercialization plans include efforts similar to those&#xD;
      for WayToServe® (English), now available in four states (New Mexico, Texas, California,&#xD;
      Washington, and under review for approval in Oregon) and having trained nearly 29,000 alcohol&#xD;
      servers and sellers. Overall, the project will bolster efforts to diffuse an effective RBS&#xD;
      training to underserved Spanish-speaking alcohol servers and sellers, benefitting both them&#xD;
      directly and the communities in which they live. WayToServe Español will be the first&#xD;
      culturally- and linguistically-appropriate evidence-based RBS training available online in&#xD;
      the U.S. for this underserved population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol Service Refusal</measure>
    <time_frame>9 Months</time_frame>
    <description>The Investigators will employ data forms completed by both PP buyer and observer to record server reactions during the PP buyer visit. These forms are filled out immediately after the visit and are checked by research staff for completeness and concordance before data entry. The PP buyer form contains fields that record if an alcohol sale was made. The alcohol service refusal rate is the ratio of the number of times the sale is refused to the number of purchase attempts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - Physical Layout/Decor of the Establishment</measure>
    <time_frame>9 Months</time_frame>
    <description>Descriptive data about the physical layout/decor of the premises</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - Approximate Number of Servers On Duty</measure>
    <time_frame>9 Months</time_frame>
    <description>Data about the approximate number of servers on duty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - Approximate number of patrons</measure>
    <time_frame>9 Months</time_frame>
    <description>Data about the approximate number of patrons in establishment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - Gender of Server Who Interacts with PP buyer</measure>
    <time_frame>9 Months</time_frame>
    <description>Data about the gender of server who interacts with PP buyer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer</measure>
    <time_frame>9 Months</time_frame>
    <description>Data about the approximate age of server who interacts with PP buyer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - Server and PP buyer Interaction - Duration</measure>
    <time_frame>9 Months</time_frame>
    <description>Data about the duration of the alcohol service request</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - Server and PP Buyer Interaction - Server Comments</measure>
    <time_frame>9 Months</time_frame>
    <description>Descriptive data about comments from server</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - Server and PP Buyer Interaction - Server Interference</measure>
    <time_frame>9 Months</time_frame>
    <description>Descriptive data about the attempts by server to intervene and not serve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - Onsite or Off-site Premise</measure>
    <time_frame>9 Months</time_frame>
    <description>Data regarding if premise is onsite vs. off-site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Moderator - New Mexico or Texas</measure>
    <time_frame>9 Months</time_frame>
    <description>Data regarding if premise is located in New Mexico or Texas</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Alcoholic Intoxication</condition>
  <arm_group>
    <arm_group_label>Implementation of WayToServe Español</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental design to be employed in the trial evaluation of WayToServe Español (WTS-E) in this direct-to-Phase II project is a two-arm randomized field trial design (WTS-E vs. Usual and Customary [UC] training) with three assessment points (pretest - immediate post-test - 9 month follow-up).This constitutes a 2 (level of RBS training intervention) x 3 (level of time assessment) mixed factorial design. Spanish dominant onsite and off-site licensed alcohol premises will be the unit of analysis, stratified by type of premise (onsite vs. off-site sales) and state (New Mexico vs. Texas).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual and Customary RBS Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Investigators have carefully considered the over-time assessment factor in this design, and have chosen two follow-up assessments over a 9 month-period because a) our prior WayToServe® trials have shown that an immediate post-training assessment will document intervention effects when training effects are at optimum levels immediately after the training; b) the sustained effect of WTS-E needs to be demonstrated to show long-term not just short-term impact (9 months being between our previous 6-month and 1-year follow-ups). Finally, c) all follow-ups can be completed within the approximately 2-year period of a Phase II project. The immediate post-training assessment will occur for both arms of the design, one month after premises in the intervention arm are given access to WTS-E.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Implementation of WayToServe Español</intervention_name>
    <description>Following baseline assessment and randomization to experimental condition, premises assigned to the intervention condition will be contacted and recruited to the trial. Managers will provide a list of all servers. All servers will be registered by project staff on the WTS-E website and provided a unique identification code, which will track their use of the training and associate it with the premise. Servers will complete a profile on the program during their first login. Servers will be asked to complete the training within four weeks from initial registration; email and text reminders will be sent to those who do not login within one week of initial registration.</description>
    <arm_group_label>Implementation of WayToServe Español</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual and Customary RBS Training</intervention_name>
    <description>The premises randomized to the UC training condition will be, in effect, blind to the investigation. Server training is mandatory for all servers in New Mexico. Server training is voluntary in Texas but heavily incentivized by TABC's Safe Harbor clause. Under this clause, liquor licensees are held harmless for any service infractions if all servers are trained and certified by an approved RBS trainer; instead, the server is cited for the infraction.</description>
    <arm_group_label>Usual and Customary RBS Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Speak Spanish Primarily or bilingual in Spanish and English&#xD;
&#xD;
          -  Serve alcohol in a Spanish-dominant premise in New Mexico or West Texas&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a family member who is participating in the project&#xD;
&#xD;
          -  Speak English primarily&#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>Gill Woodall, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klein Buendel, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klein Buendel, Inc.</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas, El Paso</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79968-0587</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>February 24, 2022</last_update_submitted>
  <last_update_submitted_qc>February 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholic Intoxication</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/NCT03001024
org study id: 1R44MD010405-03
secondary id: 0311
nct id: NCT03001024
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Responsible Beverage Service Training (RBS) has been shown to be effective and recent
      research by this research team has shown that online RBS training (WayToServe®) was more
      effective, particularly over time, than usual and customary (UC) RBS training by live
      trainers. However, one growing segment of alcohol servers and sellers has been neglected in
      RBS training efforts: Hispanic primarily Spanish-speaking servers in predominantly
      Spanish-speaking premises. This project will develop and test the first online RBS training
      for predominantly Spanish-speaking servers, WayToServe Español, which is culturally and
      linguistically appropriate and will fill a gap in evidence-based alcohol prevention
      interventions for this underserved population.
Among the measures against drunk driving available to policy makers and prevention
      practitioners, Responsible Beverage Service (RBS) training has shown promise. In these
      programs, alcohol servers are educated in a number of techniques, including correct
      identification checking, recognizing signs of intoxication in patrons, and managing patrons
      via drink counting techniques to safely keep them under Driving While Intoxicated blood
      alcohol limits. Recent reviews of RBS programs have found evidence for effectiveness.
      However, the diffusion of RBS training and practices has been limited: 18 U.S. states require
      some form of RBS training, another 18 incentivize training in some way, and the other 14
      states have no RBS regulations at all. As a result, while RBS training may be widely
      available, it is not widely adopted. An overlooked limitation of all RBS training in the
      U.S., and a limit to its dissemination, is that it is only offered in English and from a
      mainstream U.S. culture point of view. Proposed here is the development and testing of a
      Spanish-language version of an evidence-based online RBS training program (WayToServe®) that
      will be culturally tailored to Hispanic cultural values, experiences, and circumstances:
      WayToServe Español. The systematic development of WayToServe Español will meet the training
      needs of an underserved and growing population segment of alcohol servers and sellers -
      Hispanics who are predominant speakers of Spanish and who often work in premises with many
      predominantly Spanish-speaking patrons. The proposed Direct-to-Phase II research will be
      accomplished in two phases. The first phase will entail the iterative and systematic
      development of WayToServe Español via Spanish-language focus groups and usability testing.
      The second phase will involve the evaluation of WayToServe Español in Spanish-dominant
      premises in New Mexico and West Texas via a randomized efficacy trial that randomly assigns
      premises to either receive WayToServe Español training or Usual and Customary (UC) RBS
      training. A variety of alcohol service refusal rates will be the primary outcome variable,
      measured using a pseudo-intoxicated Pseudo-Patron (PP) buyer assessment protocol. Premises
      will be assessed at baseline, post-training, and 9-month follow up intervals. Should
      WayToServe Español prove effective, commercialization plans include efforts similar to those
      for WayToServe® (English), now available in four states (New Mexico, Texas, California,
      Washington, and under review for approval in Oregon) and having trained nearly 29,000 alcohol
      servers and sellers. Overall, the project will bolster efforts to diffuse an effective RBS
      training to underserved Spanish-speaking alcohol servers and sellers, benefitting both them
      directly and the communities in which they live. WayToServe Español will be the first
      culturally- and linguistically-appropriate evidence-based RBS training available online in
      the U.S. for this underserved population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Alcohol Service Refusal
time frame: 9 Months
description: The Investigators will employ data forms completed by both PP buyer and observer to record server reactions during the PP buyer visit. These forms are filled out immediately after the visit and are checked by research staff for completeness and concordance before data entry. The PP buyer form contains fields that record if an alcohol sale was made. The alcohol service refusal rate is the ratio of the number of times the sale is refused to the number of purchase attempts.
measure: Effect Moderator - Physical Layout/Decor of the Establishment
time frame: 9 Months
description: Descriptive data about the physical layout/decor of the premises
measure: Effect Moderator - Approximate Number of Servers On Duty
time frame: 9 Months
description: Data about the approximate number of servers on duty
measure: Effect Moderator - Approximate number of patrons
time frame: 9 Months
description: Data about the approximate number of patrons in establishment
measure: Effect Moderator - Gender of Server Who Interacts with PP buyer
time frame: 9 Months
description: Data about the gender of server who interacts with PP buyer
measure: Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer
time frame: 9 Months
description: Data about the approximate age of server who interacts with PP buyer
measure: Effect Moderator - Server and PP buyer Interaction - Duration
time frame: 9 Months
description: Data about the duration of the alcohol service request
measure: Effect Moderator - Server and PP Buyer Interaction - Server Comments
time frame: 9 Months
description: Descriptive data about comments from server
measure: Effect Moderator - Server and PP Buyer Interaction - Server Interference
time frame: 9 Months
description: Descriptive data about the attempts by server to intervene and not serve
measure: Effect Moderator - Onsite or Off-site Premise
time frame: 9 Months
description: Data regarding if premise is onsite vs. off-site
measure: Effect Moderator - New Mexico or Texas
time frame: 9 Months
description: Data regarding if premise is located in New Mexico or Texas
arm group label: Implementation of WayToServe Español
arm group type: Experimental
description: The experimental design to be employed in the trial evaluation of WayToServe Español (WTS-E) in this direct-to-Phase II project is a two-arm randomized field trial design (WTS-E vs. Usual and Customary [UC] training) with three assessment points (pretest - immediate post-test - 9 month follow-up).This constitutes a 2 (level of RBS training intervention) x 3 (level of time assessment) mixed factorial design. Spanish dominant onsite and off-site licensed alcohol premises will be the unit of analysis, stratified by type of premise (onsite vs. off-site sales) and state (New Mexico vs. Texas).
arm group label: Usual and Customary RBS Training
arm group type: Active Comparator
description: The Investigators have carefully considered the over-time assessment factor in this design, and have chosen two follow-up assessments over a 9 month-period because a) our prior WayToServe® trials have shown that an immediate post-training assessment will document intervention effects when training effects are at optimum levels immediately after the training; b) the sustained effect of WTS-E needs to be demonstrated to show long-term not just short-term impact (9 months being between our previous 6-month and 1-year follow-ups). Finally, c) all follow-ups can be completed within the approximately 2-year period of a Phase II project. The immediate post-training assessment will occur for both arms of the design, one month after premises in the intervention arm are given access to WTS-E.
intervention type: Behavioral
intervention name: Implementation of WayToServe Español
description: Following baseline assessment and randomization to experimental condition, premises assigned to the intervention condition will be contacted and recruited to the trial. Managers will provide a list of all servers. All servers will be registered by project staff on the WTS-E website and provided a unique identification code, which will track their use of the training and associate it with the premise. Servers will complete a profile on the program during their first login. Servers will be asked to complete the training within four weeks from initial registration; email and text reminders will be sent to those who do not login within one week of initial registration.
arm group label: Implementation of WayToServe Español
intervention type: Behavioral
intervention name: Usual and Customary RBS Training
description: The premises randomized to the UC training condition will be, in effect, blind to the investigation. Server training is mandatory for all servers in New Mexico. Server training is voluntary in Texas but heavily incentivized by TABC's Safe Harbor clause. Under this clause, liquor licensees are held harmless for any service infractions if all servers are trained and certified by an approved RBS trainer; instead, the server is cited for the infraction.
arm group label: Usual and Customary RBS Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gill Woodall, PhD
role: Principal Investigator
affiliation: Klein Buendel, Inc.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholic Intoxication
sharing ipd: No