SuicideNCT04797221
Emergency Room Firearm and Medication Safety Intervention
An observational study of Suicide and Firearm Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Seventeen United States Veterans die by suicide each day. Nearly three-fourths of those Veterans die from firearm injury or poisoning, and many seek care in VA Emergency Departments (ED) prior to suicide attempts. In 2019, the VA began screening all Veterans seeking ED care for increased suicide risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Firearm Injury, Overdose
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 16 Feb 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans will be eligible who are seen for healthcare in the VA Emergency Department
Who may be able to join
- Veteran
- Recent Emergency Room care
- Screen positive for elevated suicide risk
Who cannot join
- Severe cognitive impairment
- Lack decisional capacity
- Unable to provide informed consent
- Lack reliable phone access
- Admitted to the hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
About this study
Official title: Development and Testing of a Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)
Seventeen United States Veterans die by suicide each day. Nearly three-fourths of those Veterans die from firearm injury or poisoning, and many seek care in VA Emergency Departments (ED) prior to suicide attempts. In 2019, the VA began screening all Veterans seeking ED care for increased suicide risk. Interventions that promote firearm and medication safety are recommended for Veterans identified as at-risk. The investigators work will provide important information that will aid the development and testing of such an intervention for Veterans who seek care in VA EDs. The investigators will interview at-risk Veterans who recently sought VA ED care to identify factors relevant to developing the intervention, and work with Veterans and VA healthcare staff to develop and test an intervention.
Read the detailed description
Veterans will be recruited from the Rocky Mountain Regional VA Medical Center (RMRVAMC) ED who are identified as having elevated suicide risk by VHA's new suicide risk screening initiative. All Veterans visiting VHA EDs are screened using an eight-item version of the Columbia Suicide Severity Rating Scale (C-SSRS) Screener, a valid predictor of future suicidal behavior. The C-SSRS Screener assesses suicide risk using eight items about recent suicidal ideation and intent, preparatory behaviors, and action. Deductive and inductive content analysis of qualitative interviews will occur in parallel with recruitment, and participants will be recruited until thematic saturation is achieved.
Veterans' visits (approx. 90 minutes) will be scheduled at their preferred times at RMRVAMC within two weeks of discharge from the ED. Sociodemographic and military service data will be collected using the Rocky Mountain Mental Illness Research, Education, and Clinical Center (MIRECC) Demographics Survey. During this visit, individuals will participate in qualitative interviews to identify contextual factors that may inform development of VA-based lethal means safety interventions.
- Conditions
- Suicide, Firearm Injury, Overdose
- Keywords
- suicide
- Medical subject headings
- Suicide, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veteran study group | The investigators will recruit approximately 20 Veterans who were identified as having elevated suicide risk while being treated in a VA Emergency Department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Theme Among 28 Patients on Perspectives on Lethal Means Interventions
Perspectives on VA-based interventions that aim to reduce access to firearms and medications.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Jul 2021
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joseph A Simonetti, MD MPH, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797221
- Sponsor's protocol ID
- CDX 21-003
- Status last verified
- Jul 2024
- First submitted
- 10 Mar 2021
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)
- ClinicalTrials.gov ID
- NCT04797221
- Acronym / sponsor ID
- CDX 21-003
- Conditions
- Suicide, Firearm Injury, Overdose
- Keywords
- suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seventeen United States Veterans die by suicide each day. Nearly three-fourths of those Veterans die from firearm injury or poisoning, and many seek care in VA Emergency Departments (ED) prior to suicide attempts. In 2019, the VA began screening all Veterans seeking ED care for increased suicide risk. Interventions that promote firearm and medication safety are recommended for Veterans identified as at-risk. The investigators work will provide important information that will aid the development and testing of such an intervention for Veterans who seek care in VA EDs. The investigators will interview at-risk Veterans who recently sought VA ED care to identify factors relevant to developing the intervention, and work with Veterans and VA healthcare staff to develop and test an intervention.
Detailed description
Veterans will be recruited from the Rocky Mountain Regional VA Medical Center (RMRVAMC) ED who are identified as having elevated suicide risk by VHA's new suicide risk screening initiative. All Veterans visiting VHA EDs are screened using an eight-item version of the Columbia Suicide Severity Rating Scale (C-SSRS) Screener, a valid predictor of future suicidal behavior. The C-SSRS Screener assesses suicide risk using eight items about recent suicidal ideation and intent, preparatory behaviors, and action. Deductive and inductive content analysis of qualitative interviews will occur in parallel with recruitment, and participants will be recruited until thematic saturation is achieved.
Veterans' visits (approx. 90 minutes) will be scheduled at their preferred times at RMRVAMC within two weeks of discharge from the ED. Sociodemographic and military service data will be collected using the Rocky Mountain Mental Illness Research, Education, and Clinical Center (MIRECC) Demographics Survey. During this visit, individuals will participate in qualitative interviews to identify contextual factors that may inform development of VA-based lethal means safety interventions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veteran study group | – | –The investigators will recruit approximately 20 Veterans who were identified as having elevated suicide risk while being treated in a VA Emergency Department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans will be eligible who are seen for healthcare in the VA Emergency Department
Key inclusion criteria (3 listed)
- Veteran
- Recent Emergency Room care
- Screen positive for elevated suicide risk
Key exclusion criteria (5 listed)
- Severe cognitive impairment
- Lack decisional capacity
- Unable to provide informed consent
- Lack reliable phone access
- Admitted to the hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative Theme Among 28 Patients on Perspectives on Lethal Means Interventions
Time frame: baseline
Perspectives on VA-based interventions that aim to reduce access to firearms and medications.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Joseph A Simonetti, MD MPH principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
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 Suicide and Firearm Injury, run by VA Office of Research and Development 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 3 inclusion and 5 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 13 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Qualitative Theme Among 28 Patients on Perspectives on Lethal Means Interventions (time frame: baseline). 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 13 Aug 2024.