Penetrating InjuryNCT06135610
Social Determinants of Health in Patients With Penetrating Trauma Injuries Before and During the COVID-19 Pandemic
An observational study of Penetrating Injury and COVID-19, run by Kern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Penetrating Injury, COVID-19, Social Determinants of Health
- What is being tested?
- Postive SAR-CoV-2 PCR nasopharyngeal swab
- How many people
- 803 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- emergency department presentation with a gunshot wound (GSW), stab wound, or assault between March 2019 and February 2021.
Who cannot join
- All reported blunt injuries, motor vehicle incident-related injuries, suicide attempts, or unintentional injuries were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Social Determinants of Health in a Cohort of Patients With Penetrating Trauma Injuries Before and During the COVID-19 Pandemic
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.
Read the 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.
- Conditions
- Penetrating Injury, COVID-19, Social Determinants of Health
- Being tested
- Postive SAR-CoV-2 PCR nasopharyngeal swab
- Keywords
- Penetrating Trauma, Covid-19, Social Determinants of Health
- Medical subject headings
- Wounds, Penetrating, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postive SAR-CoV-2 PCR nasopharyngeal swabDiagnostic test
Diagnosed Covid-19 confirmed by a positive of SAR-CoV-2 PCR nasopharyngeal swab.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Postive SAR-CoV-2 PCR nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetrating injury rate
Penetrating injury rate including gunshot wounds, stab wounds or other penetrating assult
Measured: March 2019 - Februrary 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Mar 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penetrating InjuryStudies 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
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Jones, Kern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135610
- Sponsor's protocol ID
- 0001143
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Social Determinants of Health in a Cohort of Patients With Penetrating Trauma Injuries Before and During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT06135610
- Acronym / sponsor ID
- 0001143
- Conditions
- Penetrating Injury, COVID-19, Social Determinants of Health
- Keywords
- Penetrating Trauma, Covid-19, Social Determinants of Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Kern Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 18 Nov 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Postive SAR-CoV-2 PCR nasopharyngeal swabPatients 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- emergency department presentation with a gunshot wound (GSW), stab wound, or assault between March 2019 and February 2021.
Key exclusion criteria (1 listed)
- All reported blunt injuries, motor vehicle incident-related injuries, suicide attempts, or unintentional injuries were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postive SAR-CoV-2 PCR nasopharyngeal swabDiagnosed Covid-19 confirmed by a positive of SAR-CoV-2 PCR nasopharyngeal swab. | Diagnostic test | COVID |
Primary outcome
Penetrating injury rate
Time frame: March 2019 - Februrary 2021
Penetrating injury rate including gunshot wounds, stab wounds or other penetrating assult
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Penetrating Injury and COVID-19, run by Kern Medical Center 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetrating injury rate (time frame: March 2019 - Februrary 2021). 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 18 Nov 2023.