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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03001024
Other study ID # 1R44MD010405-03
Secondary ID 0311
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date October 31, 2021

Study information

Verified date February 2022
Source Klein Buendel, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Implementation of WayToServe Español
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.
Usual and Customary RBS Training
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.

Locations

Country Name City State
United States University of Texas, El Paso El Paso Texas
United States Klein Buendel, Inc. Golden Colorado

Sponsors (2)

Lead Sponsor Collaborator
Klein Buendel, Inc. University of Texas, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 9 Months
Secondary Effect Moderator - Physical Layout/Decor of the Establishment Descriptive data about the physical layout/decor of the premises 9 Months
Secondary Effect Moderator - Approximate Number of Servers On Duty Data about the approximate number of servers on duty 9 Months
Secondary Effect Moderator - Approximate number of patrons Data about the approximate number of patrons in establishment 9 Months
Secondary Effect Moderator - Gender of Server Who Interacts with PP buyer Data about the gender of server who interacts with PP buyer 9 Months
Secondary Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer Data about the approximate age of server who interacts with PP buyer 9 Months
Secondary Effect Moderator - Server and PP buyer Interaction - Duration Data about the duration of the alcohol service request 9 Months
Secondary Effect Moderator - Server and PP Buyer Interaction - Server Comments Descriptive data about comments from server 9 Months
Secondary Effect Moderator - Server and PP Buyer Interaction - Server Interference Descriptive data about the attempts by server to intervene and not serve 9 Months
Secondary Effect Moderator - Onsite or Off-site Premise Data regarding if premise is onsite vs. off-site 9 Months
Secondary Effect Moderator - New Mexico or Texas Data regarding if premise is located in New Mexico or Texas 9 Months
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