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WayToServePlus: Improving Responsible Alcohol Service Ph II

Primary Purpose

Alcohol Drinking, Alcohol Intoxication, Alcohol Use, Unspecified

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WayToServe Plus In-service Component
WayToServe Training Only
Sponsored by
Klein Buendel, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring Alcohol service, Driving under influence, DWI prevention, Safe alcohol service

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Klein Buendel, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

WayToServe Plus In-service Component

WayToServe Training Only

Arm Description

Intervention group of servers to participate in Facebook group.

Control group of servers who do not participate in Facebook group and receive WayToServe Training only.

Outcomes

Primary Outcome Measures

Refusal rate of alcohol service to apparently-intoxicated patrons
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.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2023
Last Updated
July 26, 2023
Sponsor
Klein Buendel, Inc.
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Pacific Institute for Research and Evaluation
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1. Study Identification

Unique Protocol Identification Number
NCT05779774
Brief Title
WayToServePlus: Improving Responsible Alcohol Service Ph II
Official Title
WayToServe Plus: In-service Professional Development Component to Improve Responsible Alcohol Service Ph II
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2023 (Actual)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klein Buendel, Inc.
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Pacific Institute for Research and Evaluation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Intoxication, Alcohol Use, Unspecified
Keywords
Alcohol service, Driving under influence, DWI prevention, Safe alcohol service

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Masking Description
Premises are unaware of the pseudo patrons sent in for data collection.
Allocation
Randomized
Enrollment
1172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WayToServe Plus In-service Component
Arm Type
Experimental
Arm Description
Intervention group of servers to participate in Facebook group.
Arm Title
WayToServe Training Only
Arm Type
Experimental
Arm Description
Control group of servers who do not participate in Facebook group and receive WayToServe Training only.
Intervention Type
Behavioral
Intervention Name(s)
WayToServe Plus In-service Component
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
WayToServe Training Only
Intervention Description
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).
Primary Outcome Measure Information:
Title
Refusal rate of alcohol service to apparently-intoxicated patrons
Description
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.
Time Frame
Change in refusal rate between baseline and 1 year posttest assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Buller, PhD
Phone
3035654321
Email
dbuller@kleinbuendel.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lila Martinez
Email
lmartinez@kleinbuendel.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Buller, PhD
Organizational Affiliation
Klein Buendel, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gill Woodall, PhD
Organizational Affiliation
Klein Buendel, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klein Buendel, Inc
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Buller, PhD
Phone
303-565-4321
Email
dbuller@kleinbuendel.com

12. IPD Sharing Statement

Learn more about this trial

WayToServePlus: Improving Responsible Alcohol Service Ph II

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