Emergency Room Firearm and Medication Safety Intervention

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.

Study Overview

• Status: Completed
• Conditions: Suicide; Overdose; Firearm Injury

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 Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

• Study Contact: Name: Joseph A Simonetti, MD MPH; Phone Number: (330) 714-1648; Email: Joseph.Simonetti@va.gov
• Study Contact Backup: Name: Kelly Stearns; Phone Number: 6103 (303) 399-8020; Email: kelly.stearns@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center, Aurora, CO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Veterans will be eligible who are seen for healthcare in the VA Emergency Department

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): February 16, 2023
• Study Completion (Actual): February 16, 2023

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: suicide
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: CDX 21-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No