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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Klein Buendel, Inc.
    • Texas
      • El Paso, Texas, United States, 79968-0587
        • University of Texas, El Paso

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alcohol Service Refusal
Time Frame: 9 Months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect Moderator - Physical Layout/Decor of the Establishment
Time Frame: 9 Months
Descriptive data about the physical layout/decor of the premises
9 Months
Effect Moderator - Approximate Number of Servers On Duty
Time Frame: 9 Months
Data about the approximate number of servers on duty
9 Months
Effect Moderator - Approximate number of patrons
Time Frame: 9 Months
Data about the approximate number of patrons in establishment
9 Months
Effect Moderator - Gender of Server Who Interacts with PP buyer
Time Frame: 9 Months
Data about the gender of server who interacts with PP buyer
9 Months
Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer
Time Frame: 9 Months
Data about the approximate age of server who interacts with PP buyer
9 Months
Effect Moderator - Server and PP buyer Interaction - Duration
Time Frame: 9 Months
Data about the duration of the alcohol service request
9 Months
Effect Moderator - Server and PP Buyer Interaction - Server Comments
Time Frame: 9 Months
Descriptive data about comments from server
9 Months
Effect Moderator - Server and PP Buyer Interaction - Server Interference
Time Frame: 9 Months
Descriptive data about the attempts by server to intervene and not serve
9 Months
Effect Moderator - Onsite or Off-site Premise
Time Frame: 9 Months
Data regarding if premise is onsite vs. off-site
9 Months
Effect Moderator - New Mexico or Texas
Time Frame: 9 Months
Data regarding if premise is located in New Mexico or Texas
9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klein Buendel, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Texas, El Paso

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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