NCT03001024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 11, 2022

Status Verified

February 1, 2022

Enrollment Period

4.9 years

First QC Date

November 21, 2016

Last Update Submit

February 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Effect Moderator - Physical Layout/Decor of the Establishment

    9 Months

  • Effect Moderator - Approximate Number of Servers On Duty

    9 Months

  • Effect Moderator - Approximate number of patrons

    9 Months

  • Effect Moderator - Gender of Server Who Interacts with PP buyer

    9 Months

  • Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer

    9 Months

  • +5 more secondary outcomes

Study Arms (2)

Implementation of WayToServe Español

EXPERIMENTAL

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).

Behavioral: Implementation of WayToServe Español

Usual and Customary RBS Training

ACTIVE COMPARATOR

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.

Behavioral: Usual and Customary RBS Training

Interventions

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.

Implementation of WayToServe Español

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.

Usual and Customary RBS Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

University of Texas, El Paso

El Paso, Texas, 79968-0587, United States

Location

MeSH Terms

Conditions

Alcoholic Intoxication

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Gill Woodall, PhD

    Klein Buendel, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

December 22, 2016

Study Start

December 1, 2016

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

March 11, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations