NCT04797221

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

March 10, 2021

Results QC Date

January 12, 2024

Last Update Submit

July 23, 2024

Conditions

Keywords

suicide

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Veteran
  • Recent Emergency Room care
  • Screen positive for elevated suicide risk

You may not qualify if:

  • Severe cognitive impairment
  • Lack decisional capacity
  • Unable to provide informed consent
  • Lack reliable phone access
  • Admitted to the hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

SuicideDrug Overdose

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorPrescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Joseph Simonetti
Organization
Veterans Health Administration

Study Officials

  • Joseph A Simonetti, MD MPH

    Rocky Mountain Regional VA Medical Center, Aurora, CO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 15, 2021

Study Start

July 1, 2021

Primary Completion

February 16, 2023

Study Completion

February 16, 2023

Last Updated

August 13, 2024

Results First Posted

August 13, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations