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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Intoxication Alcohol
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: S-STOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted1 Aug 2018
- Study start1 Sep 2017
- Primary completion30 Apr 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intoxication AlcoholStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- RRF Field Services LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Pacific Institute for Research and Evaluation
- Responsible party
- Sponsor
- Investigators
- Brad Krevor, Ph.D., Principal investigator, Responsible Retailing Forum
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop-Service to Obviously-Impaired Patrons
- ClinicalTrials.gov ID
- NCT03608787
- Acronym / sponsor ID
- SSTOP / R44AA024992
- Conditions
- Intoxication Alcohol
- Keywords
- Alcohol Intoxication, Alcohol Overservice, Prevention, Alcohol Serving Establishments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- RRF Field Services LLCUniversity, hospital or other
- Collaborators
- Pacific Institute for Research and Evaluation
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 1 Aug 2018 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-Early Intervention | Experimental | Behavioral: S-STOPFollowing 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). |
| Cohort 2-Delayed Intervention | Experimental | Behavioral: S-STOPFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be server/bartender in sampled on-premises alcohol serving establishment
Key exclusion criteria (1 listed)
- Establishment must have at least 3 servers/bartenders on staff.
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 |
|---|---|---|
| S-STOPPseudo-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. | Behavioural | Cohort 1-Early Intervention, Cohort 2-Delayed Intervention |
Primary outcome
Change in Refusal of Service
Time frame: Once monthly over 9 months (3 months baseline; 3 months Early Intervention; 3 months Delayed Intervention.
The primary outcome is service/refusal of service to a pseudo-intoxicated patron.
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 17 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Intoxication Alcohol
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
Not yet recruiting
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
Intoxication, Delirium Tremens (DTs)
RecruitingPhase 1
Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
Cannabis Intoxication, Alcohol Intoxication
Recruiting
Alcohol, Breast Cancer, and Metabolism
Alcohol Drinking, Ethanol Intoxication
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.
Brad Krevor, Ph.D. principal investigator
Responsible Retailing Forum
1 site in 1 country: see every site and its status.
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.