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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06135610
Other study ID # 0001143
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date February 1, 2021

Study information

Verified date November 2023
Source Kern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigators report on the impact of the COVID-19 stay-at-home order concerning penetrating violence and its association within different socioeconomic regions within the county. The distribution and volume of violent offenses prior to the stay-at-home order was compared to during the stay-at-home order. This bears a crucial significance in our injury prevention and education efforts within our community.


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.


Recruitment information / eligibility

Status Completed
Enrollment 803
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Diagnostic Test:
Postive SAR-CoV-2 PCR nasopharyngeal swab
Diagnosed Covid-19 confirmed by a positive of SAR-CoV-2 PCR nasopharyngeal swab.

Locations

Country Name City State
United States Kern Medical Center Bakersfield California

Sponsors (1)

Lead Sponsor Collaborator
Kern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Penetrating injury rate Penetrating injury rate including gunshot wounds, stab wounds or other penetrating assult March 2019 - Februrary 2021
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