Blood Alcohol ConcentrationNCT06695416
Community-based Partnership's Efficacy in Decreasing Injury Rates At Night in Dallas, TX
An observational study of Blood Alcohol Concentration and Drunk Driving, run by Methodist Health System at 1 site in United States.
Trial summary
According to the Centers for Disease Control and Prevention (CDC), "88,000 people die every year due to alcohol-related issues including homicide, sexual assault, intimate partner violence, and suicide". In the city of Dallas, violent crimes have decreased by roughly 4% in 2022 compared to 2021. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blood Alcohol Concentration, Drunk Driving
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2023to 28 Apr 2025
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chief complaint or diagnosis associated with a trauma mechanism of injury: assault (i.e., gunshot wounds, knife wounds, general assault, or sexual assault), MVC, motorcycle/all-terrain vehicle collision (MCC), or auto-ped/bicycle collision * Injury occurred between 6pm-6am * Injury occurred in City of Dallas, TX
Who may be able to join
- • Chief complaint or diagnosis associated with a trauma mechanism of injury: assault (i.e., gunshot wounds, knife wounds, general assault, or sexual assault), MVC, motorcycle/all-terrain vehicle collision (MCC), or auto-ped/bicycle collision
- Injury occurred between 6pm-6am
- Injury occurred in City of Dallas, TX
Who cannot join
- • Injuries from mechanism other than assault, MVC, MCC, or auto-ped/bicycle
- Assault occurs outside of 6pm-6am window
- Assault occurred outside of Dallas city limits
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Colette Ngo Ndjom, MS, (214) 947-4680 ext. 71280, mhsirb@mhd.com
Loretta W Bedell, MPH, 217-947-4681 ext. 74681, mhsirb@mhd.com
About this study
According to the Centers for Disease Control and Prevention (CDC), "88,000 people die every year due to alcohol-related issues including homicide, sexual assault, intimate partner violence, and suicide". In the city of Dallas, violent crimes have decreased by roughly 4% in 2022 compared to 2021. Dallas Police Department (DPD) implemented changes in May 2021 to combat violent crimes.
Read the detailed description
To address these issues, 24Hour Dallas, a community-based non-profit organization, has utilized public health approaches at the business and city level. Their overarching goals are to reduce drunk driving, violence against women, human trafficking, and general violence or injuries related to alcohol use, all within the nighttime hours of 6pm and 6am through the application of their Good Neighbor initiative and Copper Star certification for businesses. Both the Good Neighbor initiative and the Copper Star certification follow a model from Safe Night LLC, an organization that was built on the premise of The Arlington Restaurant Initiative in Arlington, Virginia.
- Conditions
- Blood Alcohol Concentration, Drunk Driving
- Medical subject headings
- Driving Under the Influence
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ED visits with implementation of 24HourDallas Copper Star Certification
Number of ED visits that are associated with a mechanism of injury of assault or MVC with either a positive BAC level or a positive Audit C screen between 6pm and 6am before and after implementation of 24HourDallas Copper Star Certification in Dallas.
Measured: 12 hours
Number of Sexual Assault with implementation of Copper Star Certification in Dallas
Number of Sexual Assault Nurse Examiner (SANE) examinations done between 6pm and 6am before and after implementation of Copper Star Certification in Dallas.
Measured: 12 hours
Number of ED Visits caused by Assault Injuries
Number of ED Visits by females with a chief complaint of diagnosis associated with a mechanism of injury related to assault
Measured: 12 hours
Number of human trafficking cases with implementation of Copper Star Certification in Dallas
Number of human trafficking cases between 6pm and 6am before and after implementation of Copper Star Certification in Dallas.
Measured: 12 hours
Secondary outcomes (1)
Location of assaults
Locations of assaults between 6pm-6am
- Mechanism of injury of assaults between 6pm-6am
- Injury rates between 6pm-6am
- Mortality rates between 6pm-6am
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start28 Apr 2023
- Primary completion28 Apr 2025 (estimated)
- Study completion28 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Alcohol ConcentrationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695416
- Sponsor's protocol ID
- 003.TRA.2023.D
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Partnership's Efficacy in Decreasing Injury Rates At Night in Dallas, TX
- ClinicalTrials.gov ID
- NCT06695416
- Acronym / sponsor ID
- 003.TRA.2023.D
- Conditions
- Blood Alcohol Concentration, Drunk Driving
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 28 Apr 2025 (estimated)
- First posted
- 19 Nov 2024 (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.
According to the Centers for Disease Control and Prevention (CDC), "88,000 people die every year due to alcohol-related issues including homicide, sexual assault, intimate partner violence, and suicide". In the city of Dallas, violent crimes have decreased by roughly 4% in 2022 compared to 2021. Dallas Police Department (DPD) implemented changes in May 2021 to combat violent crimes.
Detailed description
To address these issues, 24Hour Dallas, a community-based non-profit organization, has utilized public health approaches at the business and city level. Their overarching goals are to reduce drunk driving, violence against women, human trafficking, and general violence or injuries related to alcohol use, all within the nighttime hours of 6pm and 6am through the application of their Good Neighbor initiative and Copper Star certification for businesses. Both the Good Neighbor initiative and the Copper Star certification follow a model from Safe Night LLC, an organization that was built on the premise of The Arlington Restaurant Initiative in Arlington, Virginia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chief complaint or diagnosis associated with a trauma mechanism of injury: assault (i.e., gunshot wounds, knife wounds, general assault, or sexual assault), MVC, motorcycle/all-terrain vehicle collision (MCC), or auto-ped/bicycle collision * Injury occurred between 6pm-6am * Injury occurred in City of Dallas, TX
Key inclusion criteria (3 listed)
- • Chief complaint or diagnosis associated with a trauma mechanism of injury: assault (i.e., gunshot wounds, knife wounds, general assault, or sexual assault), MVC, motorcycle/all-terrain vehicle collision (MCC), or auto-ped/bicycle collision
Key exclusion criteria (3 listed)
- • Injuries from mechanism other than assault, MVC, MCC, or auto-ped/bicycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of ED visits with implementation of 24HourDallas Copper Star Certification
Time frame: 12 hours
Number of ED visits that are associated with a mechanism of injury of assault or MVC with either a positive BAC level or a positive Audit C screen between 6pm and 6am before and after implementation of 24HourDallas Copper Star Certification in Dallas.
Number of Sexual Assault with implementation of Copper Star Certification in Dallas
Time frame: 12 hours
Number of Sexual Assault Nurse Examiner (SANE) examinations done between 6pm and 6am before and after implementation of Copper Star Certification in Dallas.
Number of ED Visits caused by Assault Injuries
Time frame: 12 hours
Number of ED Visits by females with a chief complaint of diagnosis associated with a mechanism of injury related to assault
Number of human trafficking cases with implementation of Copper Star Certification in Dallas
Time frame: 12 hours
Number of human trafficking cases between 6pm and 6am before and after implementation of Copper Star Certification in Dallas.
1 secondary outcome
Location of assaults
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Alcohol Concentration and Drunk Driving, run by Methodist Health System 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colette Ngo Ndjom, MS (214-947-1280 ext. 74681, MHSIRB@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ED visits with implementation of 24HourDallas Copper Star Certification (time frame: 12 hours). The study lists 4 primary outcomes in all. 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 19 Nov 2024.