Driving While IntoxicatedNCT05146024
WayToServePlus: Improving Responsible Alcohol Service Ph I
An observational study of Driving While Intoxicated, run by Klein Buendel, Inc. at 2 sites in United States.
Trial summary
Responsible beverage service (RBS) training for alcohol servers is a promising intervention for reducing driving while intoxicated (DWI) by alcohol. Training, certification, and in-service contact improves professionalism and effectiveness of prevention interventions delivered by community members such as alcohol… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Driving While Intoxicated
- What is being tested?
- Way To Serve Plus: Improving Responsible Alcohol Service
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 183 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2021to 30 Jun 2022
- Phase
- Observational
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Owners, managers, and employees of alcohol-serving establishments in New Mexico and Washington State.
Who may be able to join
- 19 years of age or older
- Own/manage a licensed premises or be an alcohol server (waitress, waiter or bartender)
- Have completed the WayToServe responsible beverage service training (Phase I only)
- Be proficient in English
- Consent to participate
Who cannot join
- Have a family/household member already participating in project
- Younger than 19 years old (18 and younger cannot legally serve alcohol in either state)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pacific Institute for Research and Evaluation
Berkeley, California, 94704-1365
Klein Buendel, Inc.
Golden, Colorado, 80401
About this study
Official title: WayToServe Plus: In-service Professional Development Component to Improve Responsible Alcohol Service Ph I
Responsible beverage service (RBS) training for alcohol servers is a promising intervention for reducing driving while intoxicated (DWI) by alcohol. Training, certification, and in-service contact improves professionalism and effectiveness of prevention interventions delivered by community members such as alcohol servers. This SBIR Fast-track project will develop and test an in-service professional development component to the WayToServe® online RBS training to improve the effectiveness of RBS training in order to make further gains in reducing problem alcohol behavior in communities.
Read the detailed description
Among the interventions targeting driving while intoxicated (DWI) by alcohol, Responsible Beverage Service (RBS) training of alcohol servers has shown promise. RBS training is currently required or incentivized by 36 U.S. states and California will require it starting in 2022. Our team has shown that an online RBS training, named WayToServe®, was effective in two randomized trials. These results filled a gap in the literature on RBS training that is limited by the lack of randomized trials, poor measurement of training implementation, and almost exclusive focus on live training when online training predominates. The goal of this SBIR Fast-track research is to develop and test an in-service professional development component for alcohol servers trained by WayToServe to improve its effectiveness. It is intended to motivate servers to implement the RBS skills in the face of common barriers, provide support for RBS actions from a "community" of alcohol servers, and prevent natural degradation of skills over time. Rationale for this product is provided by past research showing that training, certification, and in-service contact improves professionalism and efficacy of community prevention interventions. Scientific premise is provided by the positive results of our trials on the WayToServe® training. The in-service component will be delivered through the WayToServe Facebook page that currently is "followed" by over 20,000 alcohol servers trained by WayToServe. The specific aims of Phase I are to: 1) develop content of in-service professional development on RBS skills with a) premises owners/ managers interviews and b) alcohol servers in New Mexico and Washington State trained by the WayToServe online RBS training through focus group discussions; 2) produce a prototype WayToServe Plus in-service professional development component in flowcharts and an initial library of Facebook posts, including text, graphics, and interactive elements and evaluate it for acceptability, usability, and engagement in focus groups and field pilot trial with alcohol servers in New Mexico and Washington State trained by the WayToServe online RBS training, and 3) determine feasibility of WayToServe Plus in-service professional development component and develop evaluation plans for Phase II research. Milestones will be an EAB-approved Phase I research plans and development of the content outline and WayToServe Plus prototype, evaluation of WayToServe Plus prototype, and feasibility assessment of the WayToServe Plus in-service professional development component. Phase II specific aims will achieve the milestones of full production of WayToServe Plus and a randomized trial testing its effectiveness by: 4) producing the full WayToServe Plus in-service professional development component and 5) conducting a randomized trial with 160 alcohol premises in New Mexico and Washington State evaluating effectiveness of WayToServe Plus on refusal of sales to PiP (primary outcome). The SBIR research is innovative as WayToServe Plus will be the first continuous in-service professional development for RBS and will increase the WayToServe training's effectiveness and commercial advantage with alcohol servers and corporate clients.
- Conditions
- Driving While Intoxicated
- Being tested
- Way To Serve Plus: Improving Responsible Alcohol Service
- Keywords
- Alcohol Use, Prevention
- Medical subject headings
- Driving Under the Influence, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Way To Serve Plus: Improving Responsible Alcohol ServiceBehavioural
Improving responsible alcohol service of owners, managers, and employees of alcohol-serving establishments by developing professional development components to enhance their responsible beverage service skills.
| Study group | Role | What they receive |
|---|---|---|
| Formative Research | Alcohol-serving establishment owners, managers, and servers in New Mexico and Washington State. Receives: Behavioral: Way To Serve Plus: Improving Responsible Alcohol Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formative Research
Focus Groups, Semi-structured Interviews, Field Pilot Test
Measured: Baseline Only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start10 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Driving While IntoxicatedStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pacific Institute for Research and Evaluation, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- David Buller, PHD, Principal investigator, Klein Buendel, Inc.Gill Woodall, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146024
- Sponsor's protocol ID
- 0332
- Other IDs
- 1R44AA029364-01
- Status last verified
- Jun 2023
- First submitted
- 23 Nov 2021
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WayToServe Plus: In-service Professional Development Component to Improve Responsible Alcohol Service Ph I
- ClinicalTrials.gov ID
- NCT05146024
- Acronym / sponsor ID
- 0332
- Conditions
- Driving While Intoxicated
- Keywords
- Alcohol Use, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pacific Institute for Research and Evaluation, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Dec 2021 (actual)
- 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 (RBS) training for alcohol servers is a promising intervention for reducing driving while intoxicated (DWI) by alcohol. Training, certification, and in-service contact improves professionalism and effectiveness of prevention interventions delivered by community members such as alcohol servers. This SBIR Fast-track project will develop and test an in-service professional development component to the WayToServe® online RBS training to improve the effectiveness of RBS training in order to make further gains in reducing problem alcohol behavior in communities.
Detailed description
Among the interventions targeting driving while intoxicated (DWI) by alcohol, Responsible Beverage Service (RBS) training of alcohol servers has shown promise. RBS training is currently required or incentivized by 36 U.S. states and California will require it starting in 2022. Our team has shown that an online RBS training, named WayToServe®, was effective in two randomized trials. These results filled a gap in the literature on RBS training that is limited by the lack of randomized trials, poor measurement of training implementation, and almost exclusive focus on live training when online training predominates. The goal of this SBIR Fast-track research is to develop and test an in-service professional development component for alcohol servers trained by WayToServe to improve its effectiveness. It is intended to motivate servers to implement the RBS skills in the face of common barriers, provide support for RBS actions from a "community" of alcohol servers, and prevent natural degradation of skills over time. Rationale for this product is provided by past research showing that training, certification, and in-service contact improves professionalism and efficacy of community prevention interventions. Scientific premise is provided by the positive results of our trials on the WayToServe® training. The in-service component will be delivered through the WayToServe Facebook page that currently is "followed" by over 20,000 alcohol servers trained by WayToServe. The specific aims of Phase I are to: 1) develop content of in-service professional development on RBS skills with a) premises owners/ managers interviews and b) alcohol servers in New Mexico and Washington State trained by the WayToServe online RBS training through focus group discussions; 2) produce a prototype WayToServe Plus in-service professional development component in flowcharts and an initial library of Facebook posts, including text, graphics, and interactive elements and evaluate it for acceptability, usability, and engagement in focus groups and field pilot trial with alcohol servers in New Mexico and Washington State trained by the WayToServe online RBS training, and 3) determine feasibility of WayToServe Plus in-service professional development component and develop evaluation plans for Phase II research. Milestones will be an EAB-approved Phase I research plans and development of the content outline and WayToServe Plus prototype, evaluation of WayToServe Plus prototype, and feasibility assessment of the WayToServe Plus in-service professional development component. Phase II specific aims will achieve the milestones of full production of WayToServe Plus and a randomized trial testing its effectiveness by: 4) producing the full WayToServe Plus in-service professional development component and 5) conducting a randomized trial with 160 alcohol premises in New Mexico and Washington State evaluating effectiveness of WayToServe Plus on refusal of sales to PiP (primary outcome). The SBIR research is innovative as WayToServe Plus will be the first continuous in-service professional development for RBS and will increase the WayToServe training's effectiveness and commercial advantage with alcohol servers and corporate clients.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formative Research | – | Behavioral: Way To Serve Plus: Improving Responsible Alcohol ServiceAlcohol-serving establishment owners, managers, and servers in New Mexico and Washington State. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Owners, managers, and employees of alcohol-serving establishments in New Mexico and Washington State.
Key inclusion criteria (5 listed)
- 19 years of age or older
- Own/manage a licensed premises or be an alcohol server (waitress, waiter or bartender)
- Have completed the WayToServe responsible beverage service training (Phase I only)
- Be proficient in English
- Consent to participate
Key exclusion criteria (2 listed)
- Have a family/household member already participating in project
- Younger than 19 years old (18 and younger cannot legally serve alcohol in either state)
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 |
|---|---|---|
| Way To Serve Plus: Improving Responsible Alcohol ServiceImproving responsible alcohol service of owners, managers, and employees of alcohol-serving establishments by developing professional development components to enhance their responsible beverage service skills. | Behavioural | Formative Research |
Primary outcome
Formative Research
Time frame: Baseline Only
Focus Groups, Semi-structured Interviews, Field Pilot Test
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 12 Jun 2023.
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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.
David Buller, PHD principal investigator
Klein Buendel, Inc.
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?
An observational study of Driving While Intoxicated, 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 5 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 12 Jun 2023. 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?
Formative Research (time frame: Baseline Only). 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 12 Jun 2023.