Emergency Room Firearm and Medication Safety Intervention

Suicide Clinical Trial

Official title:

Development and Testing of a Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797221
• Other study ID #: CDX 21-003
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: February 16, 2023

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 16, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veteran

• Recent Emergency Room care

• Screen positive for elevated suicide risk

Exclusion Criteria:

• Severe cognitive impairment

• Lack decisional capacity

• Unable to provide informed consent

• Lack reliable phone access

• Admitted to the hospital

Related Conditions & MeSH terms

• Firearm Injury
• Overdose
• Suicide

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative theme of patient perspectives on lethal means interventions	Perspectives on VA-based interventions that aim to reduce access to firearms and medications. Qualitative interviews will be conducted to identify themes related to these perspectives.	baseline
Secondary	Qualitative theme of patient perspectives on emergency room interventions	Perspectives on emergency room based suicide prevention efforts. Qualitative interviews will be conducted to identify themes related to these perspectives.	baseline