- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05779774
WayToServePlus: Improving Responsible Alcohol Service Ph II
April 11, 2024 updated by: Klein Buendel, Inc.
WayToServe Plus: In-service Professional Development Component to Improve Responsible Alcohol Service Ph II
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
The research 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 Type
Interventional
Enrollment (Estimated)
1172
Phase
- 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 Contact
- Name: David Buller, PhD
- Phone Number: 3035654321
- Email: dbuller@kleinbuendel.com
Study Contact Backup
- Name: Lila Martinez
- Email: lmartinez@kleinbuendel.com
Study Locations
-
-
Colorado
-
Golden, Colorado, United States, 80401
- Recruiting
- Klein Buendel, Inc
-
Contact:
- David Buller, PhD
- Phone Number: 303-565-4321
- Email: dbuller@kleinbuendel.com
-
-
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
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Have a family/household member already participating in project • Younger than 19 years old (18 and younger cannot legally serve alcohol in either state)
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: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WayToServe Plus In-service Component
Intervention group of servers to participate in Facebook group.
|
Investigators will test WayToServe Plus in-service component's ability to increase refusal of service to intoxicated patrons in a randomized trial.
A two-group randomized field trial (WayToServe training only [comparison control] v. WayToServe training plus WayToServe Plus in-service component [intervention]) with 2 assessment rounds (Baseline, Posttest) will yield a 2 factorial design.
Investigators will randomly assign premises to WayToServe training and WayToServe Plus after baseline in Month 18, stratified by state and location.
Remaining premises will receive WayToServe Training Only.
All premises will be recruited to have servers complete WayToServe training.
Servers in intervention group will be accepted into a Facebook private group after WayToServe training to receive in-service component with ~3 posts per week for 12 months.
In Months 30-32, all premises will be posttested with PiP assessments (blind to condition).
|
Experimental: WayToServe Training Only
Control group of servers who do not participate in Facebook group and receive WayToServe Training only.
|
Investigators will test WayToServe Plus in-service component's ability to increase refusal of service to intoxicated patrons in a randomized trial.
A two-group randomized field trial (WayToServe Training Only [comparison control] v. WayToServe Plus In-service Component [intervention]) with 2 assessment rounds (Baseline, Posttest) will yield a 2 factorial design.
Investigators will randomly assign premises to WayToServe Traiing Only after baseline in Month 18, stratified by state and location.
In Months 30-32, all premises will be posttested with PiP assessments (blind to condition).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Refusal rate of alcohol service to apparently-intoxicated patrons
Time Frame: Change in refusal rate between baseline and 1 year posttest assessments
|
Primary outcome measure, refusal rate of alcohol service to apparently-intoxicated patrons, will be obtained via a pseudo-intoxicated patron (PiP) assessment.
Confederate buyers will feign intoxication and record if servers agree to serve them an alcoholic beverage.
PiP protocol presents a server with the most overt situation in which alcohol service should be refused, (i.e., when a patron is showing clear signs of intoxication), models behavior of patrons most at risk, and is relatively low cost.
|
Change in refusal rate between baseline and 1 year posttest assessments
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Buller, PhD, Klein Buendel, Inc.
- Principal Investigator: Gill Woodall, PhD, Klein Buendel, Inc.
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)
June 25, 2023
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
May 30, 2025
Study Registration Dates
First Submitted
February 7, 2023
First Submitted That Met QC Criteria
March 9, 2023
First Posted (Actual)
March 22, 2023
Study Record Updates
Last Update Posted (Estimated)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 11, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0338
- 4R44AA029364-02 (U.S. NIH Grant/Contract)
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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