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Intoxication AlcoholSSTOPNCT03608787

Stop-Service to Obviously-Impaired Patrons

A study testing S-STOP in people with Intoxication Alcohol, run by RRF Field Services LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Intoxication Alcohol
What is being tested?
S-STOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
1 siteUnited States
Study dates
1 Sep 2017to 31 Aug 2019
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • RRForum

    Waltham, Massachusetts, 02451-0621

Other trials in United States

About this study

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.

Read the detailed description

The Responsible Retailing Forum (RRF) has developed a community-based program - S-STOP (Stop Service To Obviously-Impaired Patrons) - that assists communities and their on-premises alcohol establishments to address the problems of over-service of alcoholic beverages. S-STOP is a six-month program, administered by RRF, which:

  • Conducts Pseudo-Intoxicated Mystery Shop (P-I/MS) visits at on-premises establishments employing actors who seek to be served an alcoholic beverage while showing obvious signs of intoxication;
  • Provides on-premises owner-operators and managers with confidential feedback on staff conduct and an Internet link to a video that shows how the P-I/MS that visited their establishments typically would have behaved;
  • Provides resources to licensees to assist them in complying with over-service laws;
  • Provides on-premises staff with a brief online training module on how to recognize and skillfully refuse service to potentially intoxicated patrons;
  • Provides community stakeholders with aggregated data on the prevalence of alcohol over-service in their communities.

In this project, we will conduct and evaluate S-STOP in selected college and university communities in California.

Specific Aim 1 of this project is to demonstrate the effectiveness of S-STOP in reducing over-service. To achieve this, RRF will conduct a randomized control trial using a cross-over design. We will:

  • Identify ten pairs of demographically matched college/university communities for a total of 20 communities and, in each community, recruit a minimum of 12 on-premises serving establishments for participation in the project;
  • Conduct 3 P-I/MS baseline inspections in all 20 communities to observe pre-intervention over-service conduct;
  • 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;
  • 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. At the end of the 3 months, we will end S-STOP in Cohort 1 communities, but continue unreported P-I/MS and begin S-STOP in Cohort 2 communities for 3 months;

Specific Aim 2 is to examine how licensees utilize the S-STOP program within their establishments and the extent to which utilization moderates the effectiveness of the program. To achieve this aim, we will:

  • Measure the number and percentage of owner-operators and managers who visit the S-STOP website to view the typical behavior of P-I/MS inspectors and register their staff for training;
  • Measure the number of staff who complete the S-STOP online training;
  • Investigate the dose-response relationship between utilization of the S-STOP program (number of owner-manager visits to S-STOP website; percentage of staff completing S-STOP training) and likelihood of over-service as assessed by the P-I/MS.

Specific Aim 3 is to investigate why some owner/managers did not participate in S-STOP in order to improve the program. We will:

  • Interview 20 owner-managers who did not access the S-STOP website to find out why and determine how the program might be modified to encourage their use of it.

The S-STOP program has three key components:

  • Pseudo-Intoxicated Mystery Shops (P-I/MS). S-STOP conducts P-I/MS inspections by actors who seek to be served an alcoholic beverage while showing obvious signs of impairment. In order to appear realistic, the P-I/MSs act out levels of intoxication that staff of bars, clubs, and restaurants are likely to encounter in the course of their jobs. Owner-operators and managers are notified by mail that the S-STOP inspections recently occurred and are provided with the results (refused service/did not refuse service) of inspections in their own establishment. In addition, the mailings include materials describing best practices for on-premises serving establishments, providing guidance on what steps staff should take if a customer is obviously impaired and describing the potential legal consequences for licensees and staff who serve alcohol to an obviously-impaired customer. The mailings also provide a link to an internet site with a video showing the typical behavior of actors during the P-I/MS visits and for registration of staff for online training.
  • Online refresher training in over-service recognition and refusal. S-STOP provides a brief online training module for staff on how to recognize and skillfully refuse service to potentially intoxicated patrons. The online training presents staff with scenarios involving customers who have been drinking and models several ways in which staff can firmly, but respectfully decline to serve. The video also reinforces the importance of management supervision and reinforcement of responsible beverage service practices. The online training lasts under 4 minutes and can be accessed using a mobile device, tablet, or computer. Owners/managers will be notified when their staff members complete the training.
  • Community engagement. S-STOP also reports aggregated community-level P-I/MS results to licensees, their industry partners, and public health, safety, and licensing agencies to provide these community stakeholders with a measure of over-service prevalence and changes in refusal rates in their communities over time.
Being tested
S-STOP
Keywords
Alcohol Intoxication, Alcohol Overservice, Prevention, Alcohol Serving Establishments
Medical subject headings
Alcoholic Intoxication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-STOPBehavioural

    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.

Study groups in NCT03608787
Study groupRoleWhat they receive
Cohort 1-Early InterventionExperimentalFollowing 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).
Receives: Behavioral: S-STOP
Cohort 2-Delayed InterventionExperimentalFollowing 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.
Receives: Behavioral: S-STOP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Refusal of Service

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start1 Sep 2017
  3. Primary completion30 Apr 2019
  4. Study completion31 Aug 2019

Resources

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
Crossover
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03608787
Sponsor's protocol ID
R44AA024992
Acronym
SSTOP
Status last verified
Nov 2020
First submitted
18 Jul 2018
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing S-STOP in people with Intoxication Alcohol, run by RRF Field Services LLC at 1 site 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 1 inclusion and 1 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Change in Refusal of Service (time frame: Once monthly over 9 months (3 months baseline; 3 months Early Intervention; 3 months Delayed Intervention.). 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 17 Nov 2020; AzTrials last refreshed its copy on 27 Oct 2026.

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