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WayToServe Español: Online Responsible Beverage Service Training for Spanish-Speaking Servers (WTS-E)

Primary Purpose

Alcoholic Intoxication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implementation of WayToServe Español
Usual and Customary RBS Training
Sponsored by
Klein Buendel, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcoholic Intoxication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Speak Spanish Primarily or bilingual in Spanish and English
  • Serve alcohol in a Spanish-dominant premise in New Mexico or West Texas
  • Age 18 or older

Exclusion Criteria:

  • Have a family member who is participating in the project
  • Speak English primarily

Sites / Locations

  • Klein Buendel, Inc.
  • University of Texas, El Paso

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Implementation of WayToServe Español

Usual and Customary RBS Training

Arm 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).

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.

Outcomes

Primary Outcome Measures

Alcohol Service Refusal
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.

Secondary Outcome Measures

Effect Moderator - Physical Layout/Decor of the Establishment
Descriptive data about the physical layout/decor of the premises
Effect Moderator - Approximate Number of Servers On Duty
Data about the approximate number of servers on duty
Effect Moderator - Approximate number of patrons
Data about the approximate number of patrons in establishment
Effect Moderator - Gender of Server Who Interacts with PP buyer
Data about the gender of server who interacts with PP buyer
Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer
Data about the approximate age of server who interacts with PP buyer
Effect Moderator - Server and PP buyer Interaction - Duration
Data about the duration of the alcohol service request
Effect Moderator - Server and PP Buyer Interaction - Server Comments
Descriptive data about comments from server
Effect Moderator - Server and PP Buyer Interaction - Server Interference
Descriptive data about the attempts by server to intervene and not serve
Effect Moderator - Onsite or Off-site Premise
Data regarding if premise is onsite vs. off-site
Effect Moderator - New Mexico or Texas
Data regarding if premise is located in New Mexico or Texas

Full Information

First Posted
November 21, 2016
Last Updated
February 24, 2022
Sponsor
Klein Buendel, Inc.
Collaborators
University of Texas, El Paso
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1. Study Identification

Unique Protocol Identification Number
NCT03001024
Brief Title
WayToServe Español: Online Responsible Beverage Service Training for Spanish-Speaking Servers
Acronym
WTS-E
Official Title
WayToServe Español: A Culturally-Appropriate Online Responsible Beverage Service Training for Spanish-Speaking Servers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klein Buendel, Inc.
Collaborators
University of Texas, El Paso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Intoxication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implementation of WayToServe Español
Arm Type
Experimental
Arm 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 Title
Usual and Customary RBS Training
Arm Type
Active Comparator
Arm 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(s)
Implementation of WayToServe Español
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Usual and Customary RBS Training
Intervention 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.
Primary Outcome Measure Information:
Title
Alcohol Service Refusal
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.
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
Effect Moderator - Physical Layout/Decor of the Establishment
Description
Descriptive data about the physical layout/decor of the premises
Time Frame
9 Months
Title
Effect Moderator - Approximate Number of Servers On Duty
Description
Data about the approximate number of servers on duty
Time Frame
9 Months
Title
Effect Moderator - Approximate number of patrons
Description
Data about the approximate number of patrons in establishment
Time Frame
9 Months
Title
Effect Moderator - Gender of Server Who Interacts with PP buyer
Description
Data about the gender of server who interacts with PP buyer
Time Frame
9 Months
Title
Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer
Description
Data about the approximate age of server who interacts with PP buyer
Time Frame
9 Months
Title
Effect Moderator - Server and PP buyer Interaction - Duration
Description
Data about the duration of the alcohol service request
Time Frame
9 Months
Title
Effect Moderator - Server and PP Buyer Interaction - Server Comments
Description
Descriptive data about comments from server
Time Frame
9 Months
Title
Effect Moderator - Server and PP Buyer Interaction - Server Interference
Description
Descriptive data about the attempts by server to intervene and not serve
Time Frame
9 Months
Title
Effect Moderator - Onsite or Off-site Premise
Description
Data regarding if premise is onsite vs. off-site
Time Frame
9 Months
Title
Effect Moderator - New Mexico or Texas
Description
Data regarding if premise is located in New Mexico or Texas
Time Frame
9 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Speak Spanish Primarily or bilingual in Spanish and English Serve alcohol in a Spanish-dominant premise in New Mexico or West Texas Age 18 or older Exclusion Criteria: Have a family member who is participating in the project Speak English primarily
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gill Woodall, PhD
Organizational Affiliation
Klein Buendel, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klein Buendel, Inc.
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
University of Texas, El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79968-0587
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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WayToServe Español: Online Responsible Beverage Service Training for Spanish-Speaking Servers

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