- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03001024
WayToServe Español: Online Responsible Beverage Service Training for Spanish-Speaking Servers (WTS-E)
February 24, 2022 updated by: Klein Buendel, Inc.
WayToServe Español: A Culturally-Appropriate Online Responsible Beverage Service Training for Spanish-Speaking Servers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Golden, Colorado, United States, 80401
- Klein Buendel, Inc.
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Texas
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El Paso, Texas, United States, 79968-0587
- University of Texas, El Paso
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Implementation of WayToServe Español
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).
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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.
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Active Comparator: Usual and Customary RBS Training
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Alcohol Service Refusal
Time Frame: 9 Months
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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.
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9 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect Moderator - Physical Layout/Decor of the Establishment
Time Frame: 9 Months
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Descriptive data about the physical layout/decor of the premises
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9 Months
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Effect Moderator - Approximate Number of Servers On Duty
Time Frame: 9 Months
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Data about the approximate number of servers on duty
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9 Months
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Effect Moderator - Approximate number of patrons
Time Frame: 9 Months
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Data about the approximate number of patrons in establishment
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9 Months
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Effect Moderator - Gender of Server Who Interacts with PP buyer
Time Frame: 9 Months
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Data about the gender of server who interacts with PP buyer
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9 Months
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Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer
Time Frame: 9 Months
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Data about the approximate age of server who interacts with PP buyer
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9 Months
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Effect Moderator - Server and PP buyer Interaction - Duration
Time Frame: 9 Months
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Data about the duration of the alcohol service request
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9 Months
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Effect Moderator - Server and PP Buyer Interaction - Server Comments
Time Frame: 9 Months
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Descriptive data about comments from server
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9 Months
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Effect Moderator - Server and PP Buyer Interaction - Server Interference
Time Frame: 9 Months
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Descriptive data about the attempts by server to intervene and not serve
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9 Months
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Effect Moderator - Onsite or Off-site Premise
Time Frame: 9 Months
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Data regarding if premise is onsite vs. off-site
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9 Months
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Effect Moderator - New Mexico or Texas
Time Frame: 9 Months
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Data regarding if premise is located in New Mexico or Texas
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9 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
November 21, 2016
First Submitted That Met QC Criteria
December 19, 2016
First Posted (Estimate)
December 22, 2016
Study Record Updates
Last Update Posted (Actual)
March 11, 2022
Last Update Submitted That Met QC Criteria
February 24, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R44MD010405-03 (U.S. NIH Grant/Contract)
- 0311 (Other Identifier: Klein Buendel, Inc.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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