Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04564599 |
| Other study ID # |
004.GME.2020.D |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 6, 2023 |
| Est. completion date |
July 6, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Methodist Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
1. INTRODUCTION 1.1.1. Background Over the last decade, ride sharing services such as Uber
and Lyft have become a popular transportation option, particularly for young people.
These services often market themselves as less expensive and/or safer alternatives to
taxis or driving while intoxicated (1). Whether ride sharing has a net benefit on rates
of driving while intoxicated, or on alcohol and/or drug related crashes is unclear
(2-6). Few studies have investigated this relationship, and a literature review showed
no studies targeting the question outside of an isolated geographic region.
Additionally, Uber has recently released its Safety Report bringing to light the issue
of sexual assault associated with ride sharing.
1.1.2. Aim Investigate the relationship between ride sharing services and alcohol- and
drug-related motor vehicle collisions within the state of Texas, and to develop
understanding of the relationship between ride sharing services and sexual assault.
1.1.3. Rationale for the study The results of this study may be useful in public health
initiatives to either incentivize or discourage ride sharing as a way to impact rates of
alcohol- and drug-related motor vehicle collisions. Further, hospitals and insurance
payors may be interested to note any calculated effect of ride sharing on hospital
costs, lengths of stay, etc.
1.1.4. Hypothesis 1.1.4.1. Primary Hypothesis The introduction of ride sharing services
such as Uber and Lyft to the state of Texas resulted in fewer alcohol- and drug-related
crashes and greater cost savings for hospitals and insurance payors.
1.2. OBJECTIVES AND STUDY OUTCOME MEASURES 1.2.1. Study Objectives 1.2.1.1. Primary
Objective(s)
- Determine the number and severity of alcohol- and/or drug-related motor vehicle
collisions.
- Determine the number of auto vs pedestrian (auto-ped) alcohol- and/or drug-related
collisions.
- Determine the correlation between the introduction of ride sharing services and the
number of alcohol- and drug-related crashers as well as with hospital and insurance
payor expenditures.
- Determine the relationship between ride sharing services and sexual assault. 1.2.2.
Study Outcome Measures 1.2.2.1. Primary Outcomes
- Number of alcohol- and drug-related motor vehicle collisions
- Number of auto-ped alcohol- and drug-related collisions
- Results of alcohol screen and drug screens
- Mechanism of injury
- Metrics indicative of ride sharing service presence, use, and public awareness
(i.e. self-reported usage and company reports)
- Additional information collected will include patient demographics, injury
characteristics, injury severity score, abbreviated injury scale, emergency
department vitals, diagnoses, procedures, insurance coverage, treatment cost,
hospital length of stay (LOS), ICU LOS, blood product data, vehicle type, number of
sexual assaults, miles traveled, and mortality.
2. STUDY DESIGN This will be a retrospective study with data collected from the trauma
registry. We plan to complete the data collection and analysis by 12/31/2021. 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.
3. STUDY ENROLLMENT AND WITHDRAWAL 3.1. Study Inclusion Criteria:
- 18 years or older
- Positive blood alcohol or drug screen
- Motor vehicle collision (MVC) or auto-ped 3.2. Study Exclusion Criteria:
- Younger than 16 years
- Younger than 18 years
- Pregnant women 3.3. Premature Termination or suspension of study
This study may be suspended or prematurely terminated if there is sufficient reasonable
cause. Written notification, documenting the reason for study suspension or termination,
will be provided by the suspending or terminating party. If the study is prematurely
terminated or suspended, the principal investigator will promptly inform the IRB and
will provide the reason(s) for suspension or termination. Circumstances that may warrant
termination include, but are not limited to:
- Determination of unexpected, significant, or unacceptable risk to subjects.
- Insufficient adherence to protocol requirements.
- Data that is not sufficiently complete and/or evaluable.
- Determination of futility.
- Favorable outcomes at smaller than expected sample size.
4. STATISTICAL CONSIDERATIONS 4.1. Sample Size Considerations This protocol is intended to
be an observational study dependent on occurrence data. No formal sample size
calculations were completed as this is limited by reported occurrences and retrospective
analysis.
4.2. Statistical Analysis Plan Descriptive analysis will be performed for all variables.
Frequencies, percentages, sensitivity, and specificity will be presented to summarize
the categorical variables such as patient demographics and the outcomes of the different
conditions associated with diaphragmatic injury. Mean and standard deviation will be
presented for normally distributed continuous variables and median and interquartile
range will be presented for non-normal continuous variables. The categorical outcome
variables between the samples will be compared with chi square test or Fisher's exact
test (if any cell value ≤ 5). The normally distributed continuous outcome variables will
be analyzed with a two-sample t-test and non-normally distributed continuous outcomes
will be analyzed with a nonparametric Wilcoxon-Mann-Whitney test. Because there might be
potential for confounding patient characteristic variables to influence the outcome, a
multiple regression and logistic model will be used to compensate for these factors.
Odds ratio along with the confidence interval and p-value will be reported for both the
adjusted and unadjusted model. A p-value <0.05 will be considered statistically
significant.
5. ETHICS/PROTECTION OF HUMAN SUBJECTS 5.1. Ethical Standard The investigator will ensure
that this study is conducted in full conformity with the principles set forth in The
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects
of Research, as drafted by the US National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR
Part 46 and/or the ICH E6. If the study is conducted at international sites, the
statement could be as above and/or could reference compliance with the Declaration of
Helsinki, CIOMS, International Ethical Guidelines for Biomedical Research Involving
Human Subjects (2002), or another country's ethical policy statement, whichever provides
the most protection to human subjects.
5.2. Institutional Review Board The protocol will be submitted to the IRB for review and
approval. Approval of the protocol must be obtained before any participant is enrolled.
Any amendment to the protocol will require review and approval by the IRB before the
changes are implemented in the study.
5.3. Informed Consent Waiver Acquiring informed consent is not applicable. This study
proposal is requesting a waiver of informed consent. This research only involves the
collection or study of existing data, documents, and records and the investigators are
recording information in such a manner that patients cannot be identified or possess any
identifiers which could somehow be linked back to the patient. This research could not
practicably be conducted without the waiver of informed consent because this is a
retrospective chart review and it would be extremely time consuming to attempt contact
for consent.
Waiver of the HIPAA Authorization has been requested. The following reasons apply to our
proposal: the use of the protected health information involves no more than the minimal
risk of the privacy of the individuals, the research could not practicably be conducted
without the waiver, and the research could not practicably be conducted without access
to, and use of, the protected health information.
5.4. Participant Confidentiality All patient records and/or information will be kept
under double locked doors or under password protection at all times. Only authorized
study personnel as stated in the delegation of responsibility will have access to
patient records and/or information.
6. DATA MANAGEMENT PLAN 6.1. Source Document Management 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.
6.2. Data Capture Methods The 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 MHS approved server. All data capture and storage methods will be HIPAA
compliant as per MHS policy.
7. RECORD RETENTION/ARCHIVING All records pertaining to the study will be kept on site at
Methodist Dallas Medical Center for three years upon study completion.
8. PUBLICATION PLAN All studies must comply with GCP of blinding all protected health
information of all patients prior to presentation and/or publication. The data obtained
will be de-identified prior to sharing via presentation and/or publication in relevant
research mediums. The data will be published and/or presented at national, regional,
local and international sites. The research gathered will be analyzed and submitted to
relevant medical journals for publication to add to the body of knowledge in the science
community, as well as to improve on existing policies in trauma. This information may be
presented at major surgical and trauma conferences including AAST (American Association
for the Surgery of Trauma), SWSC (Southwest Surgical Congress), EAST (Eastern
Association for the Surgery of Trauma), WTA (Western Trauma Association), etc.
