- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06135610
Social Determinants of Health in Patients With Penetrating Trauma Injuries Before and During the COVID-19 Pandemic
The Impact of Social Determinants of Health in a Cohort of Patients With Penetrating Trauma Injuries Before and During the COVID-19 Pandemic
Study Overview
Status
Intervention / Treatment
Detailed Description
Investigators hypothesized that the COVID-19 'Stay At Home" order contributed to an increase in the incidence of violent traumatic injuries, particularly in areas with lower socioeconomic status in Kern County, as measured by census data, which was previously shown to be true in other areas of America. Investigators conducted a retrospective analysis of injuries sustained before and during the pandemic and further explored the median income of the area of injury to determine if socioeconomic status was a determinant of violent crime incidence rates. This study aims to better understand the causality of the increase in crime, further analyze the results, and identify trends in future public health crises.
This retrospective cross-sectional minimal risk study utilized the Kern Medical's trauma registry to identify patients in Kern County who presented to the emergency department with a gunshot wound (GSW), stab wound, or assault between March 2019 and February 2021. All reported blunt injuries, motor vehicle incident-related injuries, suicide attempts, or unintentional injuries were excluded. Each case was categorized as pre-COVID (March 2019 - February 2020) or COVID (March 2020 - February 2021) and further subclassified based on the incident zip code. Kern County zip codes were combined into urban regions as NW (zip codes:93312, 93314), NE (93301, 93305, 93306, 93308), SW (93311, 93313), and SE (93304, 93307, 93309, 93241), with a separate category defined as rural (outside Bakersfield city limits). These regions were also defined by median income as lower income (≤$50k: NW and SW) and higher income (>$50k: NE, SE, Rural) based on California census data. This study was approved by the Institutional Review board of Kern Medical Hospital.
Tabulated data were analyzed using odds ratios, chi-square tests of Independence, Woolf's test for homogeneity of Odds Ratios, Fisher's exact test, and the Generalized Cochran-Mantel-Haenszel test. Regions were identified with median incomes of ≤$50k and >$50K then were analyzed using a Cochran-Mantel-Haenszel test with an ad hoc analysis looking at the occurrence of GSWs and stab wounds pre-COVID and during COVID. A Bonferroni p-value adjustment was performed for all multiple comparison p-values. Additional demographic variables were collected, including patient demographics, follow-up, and death, but they were not included in these analyses.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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California
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Bakersfield, California, United States, 93306
- Kern Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- emergency department presentation with a gunshot wound (GSW), stab wound, or assault between March 2019 and February 2021.
Exclusion Criteria:
- All reported blunt injuries, motor vehicle incident-related injuries, suicide attempts, or unintentional injuries were excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pre-COVID
Patients identified in Kern County who presented to the emergency department with a gunshot wound (GSW), stab wound, or assault between March 2019 and February 2020 The group was further sub-classified based on the incident zip code.
Kern County zip codes were combined into urban regions as NW (zip codes:93312, 93314), NE (93301, 93305, 93306, 93308), SW (93311, 93313), and SE (93304, 93307, 93309, 93241), with a separate category defined as rural (outside Bakersfield city limits).
|
|
COVID
Patients identified in Kern County who presented to the emergency department with a gunshot wound (GSW), stab wound, or assault between March 2020 - February 2021.
The group was then further sub-classified based on the incident zip code.
Kern County zip codes were combined into urban regions as NW (zip codes:93312, 93314), NE (93301, 93305, 93306, 93308), SW (93311, 93313), and SE (93304, 93307, 93309, 93241), with a separate category defined as rural (outside Bakersfield city limits).
|
Diagnosed Covid-19 confirmed by a positive of SAR-CoV-2 PCR nasopharyngeal swab.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Penetrating injury rate
Time Frame: March 2019 - Februrary 2021
|
Penetrating injury rate including gunshot wounds, stab wounds or other penetrating assult
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March 2019 - Februrary 2021
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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