Alcoholic IntoxicationWTS-ENCT03001024
WayToServe Español: Online Responsible Beverage Service Training for Spanish-Speaking Servers
A study testing Implementation of WayToServe Español and Usual and Customary RBS Training in people with Alcoholic Intoxication, run by Klein Buendel, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Intoxication
- What is being tested?
- Implementation of WayToServe Español and Usual and Customary RBS Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have a family member who is participating in the project
- Speak English primarily
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas, El Paso
El Paso, Texas, 79968-0587
Klein Buendel, Inc.
Golden, Colorado, 80401
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcoholic Intoxication
- Being tested
- Implementation of WayToServe Español, Usual and Customary RBS Training
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of WayToServe EspañolBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Usual and Customary RBS Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 Months
Secondary outcomes (10)
Effect Moderator - Physical Layout/Decor of the Establishment
Descriptive data about the physical layout/decor of the premises
Measured: 9 Months
Effect Moderator - Approximate Number of Servers On Duty
Data about the approximate number of servers on duty
Measured: 9 Months
Effect Moderator - Approximate number of patrons
Data about the approximate number of patrons in establishment
Measured: 9 Months
Effect Moderator - Gender of Server Who Interacts with PP buyer
Data about the gender of server who interacts with PP buyer
Measured: 9 Months
Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer
Data about the approximate age of server who interacts with PP buyer
Measured: 9 Months
Effect Moderator - Server and PP buyer Interaction - Duration
Data about the duration of the alcohol service request
Measured: 9 Months
Effect Moderator - Server and PP Buyer Interaction - Server Comments
Descriptive data about comments from server
Measured: 9 Months
Effect Moderator - Server and PP Buyer Interaction - Server Interference
Descriptive data about the attempts by server to intervene and not serve
Measured: 9 Months
Effect Moderator - Onsite or Off-site Premise
Data regarding if premise is onsite vs. off-site
Measured: 9 Months
Effect Moderator - New Mexico or Texas
Data regarding if premise is located in New Mexico or Texas
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas, El Paso
- Responsible party
- Sponsor
- Investigators
- Gill Woodall, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001024
- Sponsor's protocol ID
- 1R44MD010405-03
- Other IDs
- 0311
- Acronym
- WTS-E
- Status last verified
- Feb 2022
- First submitted
- 21 Nov 2016
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WayToServe Español: A Culturally-Appropriate Online Responsible Beverage Service Training for Spanish-Speaking Servers
- ClinicalTrials.gov ID
- NCT03001024
- Acronym / sponsor ID
- WTS-E / 1R44MD010405-03
- Conditions
- Alcoholic Intoxication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Texas, El Paso
- Study start
- Dec 2016 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation of WayToServe Español | Experimental | Behavioral: Implementation of WayToServe EspañolThe 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). |
| Usual and Customary RBS Training | Active comparator | Behavioral: Usual and Customary RBS TrainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Have a family member who is participating in the project
- Speak English primarily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of WayToServe EspañolFollowing 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. | Behavioural | Implementation of WayToServe Español |
| Usual and Customary RBS TrainingThe 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. | Behavioural | Usual and Customary RBS Training |
Primary outcome
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.
10 secondary outcomes
Effect Moderator - Physical Layout/Decor of the Establishment
Time frame: 9 Months
Effect Moderator - Approximate Number of Servers On Duty
Time frame: 9 Months
Effect Moderator - Approximate number of patrons
Time frame: 9 Months
Effect Moderator - Gender of Server Who Interacts with PP buyer
Time frame: 9 Months
Effect Moderator - Approximate Age of Server Who Interacts with PP Buyer
Time frame: 9 Months
Effect Moderator - Server and PP buyer Interaction - Duration
Time frame: 9 Months
Effect Moderator - Server and PP Buyer Interaction - Server Comments
Time frame: 9 Months
Effect Moderator - Server and PP Buyer Interaction - Server Interference
Time frame: 9 Months
Effect Moderator - Onsite or Off-site Premise
Time frame: 9 Months
Effect Moderator - New Mexico or Texas
Time frame: 9 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gill Woodall, PhD principal investigator
Klein Buendel, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of WayToServe Español and Usual and Customary RBS Training in people with Alcoholic Intoxication, run by Klein Buendel, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Service Refusal (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.