NCT04564599

Brief Summary

This will be a retrospective study with data collected from the trauma registry. We plan to complete the data collection and analysis by 12/31/2020. Data on ride sharing will be obtained from the Uber and Lyft websites. Data pertaining to number of alcohol- and drug-related motor vehicle (and auto-ped) collisions will be obtained from the Texas Department of Transportation website, the National Highway Traffic Safety Administration, the Shared-Use Mobility Center (SUMC) and the Transformation of Public Transit, the Texas A\&M Transportation Institute, Texas Department of Public Safety, and the U.S. Department of Transportation website (or equivalent). Sexual assault data will be obtained as available the Sexual Assault Nurse Examiner (SANE) database as well as from Turning Point Rape Crisis Center and surrounding hospitals in the Dallas area as well as the Uber report for sexual assaults.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

July 6, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2025

Completed
Last Updated

March 23, 2026

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

September 21, 2020

Last Update Submit

March 19, 2026

Conditions

Outcome Measures

Primary Outcomes (15)

  • Results of alcohol screen and drug screens

    Results of alcohol screen and drug screens

    Data from January 1, 2000 to December 31, 2019

  • Mechanism of injury

    Identify the Mechanism of injury for each collision ( alcohol vs. drug related)

    Data from January 1, 2000 to December 31, 2019

  • Metrics indicative of ride sharing service presence, use, and public awareness

    self-reported usage and company reports

    Data from January 1, 2000 to December 31, 2019

  • Patient demographics

    Patient demographics

    Data from January 1, 2000 to December 31, 2019

  • injury characteristics

    injury characteristics

    Data from January 1, 2000 to December 31, 2019

  • injury severity score

    injury severity score

    Data from January 1, 2000 to December 31, 2019

  • abbreviated injury scale

    abbreviated injury scale

    Data from January 1, 2000 to December 31, 2019

  • hospital length of stay (LOS)

    hospital length of stay (LOS)

    Data from January 1, 2000 to December 31, 2019

  • emergency department vitals, diagnoses, procedures, insurance coverage, treatment cost

    emergency department vitals, diagnoses, procedures, insurance coverage, treatment cost

    Data from January 1, 2000 to December 31, 2019

  • ICU Length of Stay (LOS)

    ICU Length of Stay (LOS)

    Data from January 1, 2000 to December 31, 2019

  • blood product data

    blood product data

    Data from January 1, 2000 to December 31, 2019

  • vehicle type

    vehicle type

    Data from January 1, 2000 to December 31, 2019

  • number of sexual assaults

    number of sexual assaults

    Data from January 1, 2000 to December 31, 2019

  • miles traveled

    miles traveled

    Data from January 1, 2000 to December 31, 2019

  • mortality

    mortality

    Data from January 1, 2000 to December 31, 2019

Study Arms (2)

alcohol- and drug-related motor vehicle collisions

Number of alcohol- and drug-related motor vehicle collisions

auto-ped alcohol- and drug-related collisions

Number of auto-ped alcohol- and drug-related collisions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This will be a retrospective study with data collected from the trauma registry. Patient population that will be looked at will be Males and Females 18 years or older who have tested positive for blood alcohol or drug screen and were involved Motor vehicle collision (MVC) or auto-ped.

You may qualify if:

  • years or older
  • Positive blood alcohol or drug screen
  • Motor vehicle collision (MVC) or auto-ped

You may not qualify if:

  • Younger than 16 years
  • Younger than 18 years
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingAlcoholic Intoxication

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Crystee Cooper, DHEd

    Methodist Health System Clinical Research Institute

    STUDY DIRECTOR
  • Michael Truitt, MD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

July 6, 2023

Primary Completion

June 6, 2025

Study Completion

June 6, 2025

Last Updated

March 23, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

The source data will be collected with the assistance of the electronic medical/health record software, Premier, Midas or other medical/hospital data sources, paper records and/or electronic data collection methods. All data collected will be entered into an Excel sheet and recorded. All data collection methodologies will be maintained under strict surveillance, double locked doors or an encrypted, password protected Methodist Health System (MHS) approved server. All data capture and storage methods will be HIPAA compliant as per MHS policy.

Locations