NCT03608787

Brief Summary

The Responsible Retailing Forum ("RRF") seeks to develop a new intervention, Stop Service to Obviously- Impaired Patrons ("S-STOP"), to reduce the incidence and harm associated with overservice of alcohol. Modeled after RRF's effective program to reduce alcohol sales to minors using Mystery Shopper feedback on staff ID-checking conduct, SSTOP would (1) conduct "Pseudo-Intoxicated" Mystery Shop" ("P-I/MS") inspections of serving establishments, employing actors who seek to purchase an alcohol beverage while showing obvious signs of intoxication, (2) provide licensees with confidential feedback on actual staff conduct and a video link to view the behavior of the P-I/MS that visited their establishments, (3) provide staff with brief online training in the recognition and skillful refusal of service to intoxicated patrons, and (4) provide communities with a measure of the prevalence of overservice. The proposed study will: (1) determine the effectiveness of S-STOP in improving recognition and refusal to serve an obviously- impaired customer. To do this, we will implement S-STOP in 10 pairs of demographically matched college and university communities, employing a cross-over design. After a 3-month baseline, we will implement S- STOP in one community in each pair (Cohort 1), while the second community serves as a control (Cohort 2). After 6 months, we will end S-STOP in Cohort 1 communities but continue inspections to measure the effects of decay; and we will begin S-STOP in Cohort 2. (2) examine how licensees utilize the S-STOP program and the extent to which utilization moderates the effectiveness of the program. To do this, we will measure the number and percentage of managers who visit the S-STOP website and register their staff for training, measure the number of staff that complete the training, and conduct analyses to investigate the dose-response relationship between utilization of the S-STOP program and likelihood of overservice. (3) investigate why some owner/managers did not participate in S-STOP. To achieve this, we will interview 20 owner-managers who did not access the S-STOP website.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

July 18, 2018

Last Update Submit

November 13, 2020

Conditions

Keywords

Alcohol IntoxicationAlcohol OverservicePreventionAlcohol Serving Establishments

Outcome Measures

Primary Outcomes (1)

  • Change in Refusal of Service

    The primary outcome is service/refusal of service to a pseudo-intoxicated patron.

    Once monthly over 9 months (3 months baseline; 3 months Early Intervention; 3 months Delayed Intervention.

Study Arms (2)

Cohort 1-Early Intervention

EXPERIMENTAL

Following baseline, participating outlets in this arm will receive the S-STOP program consisting of Pseudo-Intoxicated Mystery Shops (P-I/MS) with performance feedback for 3 months. After 3 months they will receive no further intervention, but will continue to receive Pseudo-Intoxicated Mystery Shops (P-I/MS).

Behavioral: S-STOP

Cohort 2-Delayed Intervention

EXPERIMENTAL

Following baseline, participating outlets in this arm will receive receive Pseudo-Intoxicated Mystery Shops (P-I/MS) with no feedback. After 3 months they will receive the S-STOP program consisting of Pseudo-Intoxicated Mystery Shops (P-I/MS) with performance feedback.

Behavioral: S-STOP

Interventions

S-STOPBEHAVIORAL

Pseudo-intoxicated patrons will enter each participating establishment and attempt to be served an alcoholic beverage. In the intervention phases, feedback on staff performance will be provided to owners/managers along with supporting materials and a link to a website with a video of a typical pseudo-intoxicated patron. Staff will be provided with a link to a website providing tips for preventing overservice.

Cohort 1-Early InterventionCohort 2-Delayed Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be server/bartender in sampled on-premises alcohol serving establishment

You may not qualify if:

  • Establishment must have at least 3 servers/bartenders on staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RRForum

Waltham, Massachusetts, 02451-0621, United States

Location

MeSH Terms

Conditions

Alcoholic Intoxication

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Brad Krevor, Ph.D.

    Responsible Retailing Forum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: We will: (a) identify ten pairs of matched college/university communities for a total of 20 communities; (b) recruit a minimum of 12 on-premises serving establishments in each community for participation in the project; (c) conduct 3 Pseudo-Intoxicated Mystery Shop (P-I/MS) baseline inspections in all participating outlets in all 20 communities to observe pre-intervention over-service conduct; (d) randomly assign one community from each pair to receive S-STOP immediately (Cohort 1) and the other (Cohort 2) to serve as a control group and then to receive S-STOP later; (e) implement S-STOP in Cohort 1 communities for 3 months and conduct P-I MS in Cohort 2 control communities with no feedback to the licensees or community; (f) at the end of the 3 months, end S-STOP in Cohort 1 communities, but continue unreported P-I/MS and begin S-STOP in Cohort 2 communities for 3 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 1, 2018

Study Start

September 1, 2017

Primary Completion

April 30, 2019

Study Completion

August 31, 2019

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations