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Emergency Room Firearm and Medication Safety Intervention

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT04797221
Collaborator
(none)
20
Enrollment
1
Location
18
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Development and Testing of a Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)
    Actual Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Qualitative theme of patient perspectives on lethal means interventions [baseline]

      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.

    Secondary Outcome Measures

    1. Qualitative theme of patient perspectives on emergency room interventions [baseline]

      Perspectives on emergency room based suicide prevention efforts. Qualitative interviews will be conducted to identify themes related to these perspectives.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rocky Mountain Regional VA Medical Center, Aurora, CO Aurora Colorado United States 80045

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT04797221
    Other Study ID Numbers:
    • CDX 21-003
    First Posted:
    Mar 15, 2021
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by VA Office of Research and Development
    suicide
    Additional relevant MeSH terms:
    Suicide

    Study Results

    No Results Posted as of Mar 21, 2022