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OpenTrials
Completed

NCT Number: NCT06216327

Home Safety Intervention

Access to lethal methods of self-harm such as firearms and medications increases risk for suicide. As such, VA/DoD guidelines for the care of individuals with elevated suicide risk include recommendations that clinicians deliver interventions to reduce access to lethal methods of suicide among patients who are identified as having elevated suicide risk. However, no interventions have been developed or tested among Veterans with elevated suicide risk. The aim of this study is to pilot test a lethal means safety intervention developed specifically for Veterans who seek care in VHA clinical settings and are identified as having elevated suicide risk.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

About this study

The investigators will pilot the LMS intervention among up to 50 Veterans to assess feasibility and acceptability. The study was suspended from April to June 2024 due to low study enrollment; modification of recruitment procedures and study approach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Encounter at VHA ED or urgent care setting, outpatient mental health, women's health, or primary care
  • >17 years
  • Discharged home from the encounter (rather than hospital admission)
  • Positive Columbia Screener
  • Patient-reported access to self-owned firearms and/or medications

Exclusion criteria

  • Unable to consent due to cognitive impairment, severity of illness (including psychiatric symptoms), intoxication with drugs and/or alcohol
  • Unreliable telephone access
  • Unreliable video access (because remote intervention)
  • Those currently experiencing unsheltered homelessness
  • No mailing address
  • Active opioid or stimulant use disorder
  • Active alcohol use disorder with daily alcohol consumption

Treatment and study plan

household safety intervention

Behavioral

This intervention includes a household safety intervention that is delivered by an interventionist with specific training in facilitating lethal means safety discussions, and the provision of no-cost safety devices for medications and firearms.

Primary outcomes

  1. Feasibility: Number of Participants Recruited Within One Year

    Time frame: through study completion, an average of one year

    Ability to recruit 40 Veterans in one year. Count represents number of participants recruited within one year.

  2. Feasibility: Number of Participants Who Attend Their 4 Week Follow Up

    Time frame: approximately 4 weeks

    >80% of participants attend their 4 week follow up. Count represents number of participants who completed their 4 week follow up visit.

  3. Acceptability: Number of Participants With CSQ Scores ≥24

    Time frame: day of intervention delivery - day 0; and at 4 weeks

    >80% with score greater than 23 (Client Satisfaction Questionnaire 8). 8 items, each with 4 answer options (1-4) on a Likert Scale. Likert options are different for each item. Score range is 8 to 32. Higher scores indicate higher satisfaction.

  4. Acceptability: Number of Participants Who Reported the Intervention to be Acceptable

    Time frame: at 4 weeks

    Count of participants who deemed the intervention acceptable via a qualitative evaluation of participant's experiences during the intervention. Assessed using the Narrative Evaluation of Intervention Interview (NEII): A 16-item semi-structured qualitative interview that helps participants evaluate the process and outcome of interventions.

  5. Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable

    Time frame: day of intervention delivery - day 0; and at 4 weeks

    Count represent the number of participants who reported feeling "Comfortable" or "Very comfortable".

    "How comfortable did you feel engaging in the discussion?"

    Likert responses:

    • Very uncomfortable
    • Uncomfortable
    • Neither
    • Comfortable
    • Very comfortable
  6. Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions

    Time frame: day of intervention delivery - day 0; and at 4 weeks

    Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful".

    "How helpful was your interaction in making decisions about medication storage and safety?"

    Likert responses:

    • Not at all
    • Slightly helpful
    • Moderately helpful
    • Very helpful
    • Extremely helpful
  7. Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions

    Time frame: day of intervention delivery - day 0; and at 4 weeks

    Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful".

    "How helpful was your interaction in making decisions about firearm storage?"

    Likert responses:

    • Not at all
    • Slightly helpful
    • Moderately helpful
    • Very helpful
    • Extremely helpful
  8. Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners

    Time frame: day of intervention delivery - day 0; and at 4 weeks

    Count represents the number of participants who reported that their interaction was "Respectful" or "Very respectful".

    "To what extent was this intervention respectful of your values as a firearm owner?

    Likert responses:

    • Very disrespectful
    • Disrespectful
    • Neither
    • Respectful
    • Very respectful

Secondary outcomes

  1. Average Participant Trust in the VA Healthcare System

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    "On a scale from 0 to 10, where 10 indicates complete trust and 0 indicates complete distrust (so 5 would indicate that you neither trust, nor distrust), Please indicate your level of trust in the VA healthcare system?" Answer range: 0-10

  2. Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    "On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is important to securely store medications when I or someone in my household has had recent thoughts of suicide." Answer range: 0-10

  3. Average Participant Beliefs About Importance of Secure Medication Storage Always

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    "On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is always important to securely store medications even if someone is not at risk for suicide in the home." Answer range: 0-10

  4. Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    "On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is important to securely store firearms when I or someone in my household has had recent thoughts of suicide." Answer range: 0-10

  5. Average Participant Beliefs About Importance of Secure Firearm Storage Always

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    "On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is always important to store firearms securely in a locked space, or with a locking device, even if someone is not at risk for suicide in the home." Answer range: 0-10

  6. Average Participant Beliefs About Importance of Unloaded Firearm Storage Always

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    "On a scale of 0 to 10, I want to ask you about whether you find the following safety measures to be important. Someone who answers 0 does not consider them to be important at all, while someone who answers 10 considers them to be extremely important. It is always important to securely store firearms unloaded even if someone is not at risk for suicide in the home." Answer range: 0-10

  7. Average Participant Readiness to Securely Store All Firearms

    Time frame: Day of intervention delivery - day 0

    "One thing some people consider doing to reduce risk of suicide or injury for themselves and others in their household is to securely store all firearms. On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change] like that?" Answer range: 0-10

  8. Average Participant Readiness to Securely Store All Medications

    Time frame: Day of intervention delivery at visit #1 (day 0)

    "One thing some people consider doing to reduce risk of suicide or injury for themselves and others in their household is to securely store all medications. On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change]?" Answer range: 0-10

  9. Average Number of Firearms in Household

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    Number of firearms in household: Answer range: 0 to 10,000

  10. Number of Participants Who Forget to Take Their Medications Often/Always

    Time frame: at 4 weeks

    Count represents number of participants who said 'very often' or 'always'. "To what extent have you had difficulty remembering to take your medications in the past month?"

    Likert responses:

    • Never
    • Rarely
    • Sometimes
    • Very Often
    • Always
  11. Number of Participants With Firearms Present in the Home

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    Changes in whether household firearms are present in a participant's home from day of intervention delivery (day 0) to 4 weeks. Count represents the number of participants who reported having at least 1 firearm in their home.

  12. Number of Participants Securely Storing All Firearms

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    Changes in whether household firearms are stored securely. Count represents number of participants who had 'all' firearms locked.

    "Are any firearms in or around your home currently stored locked?"

    Answers:

    • Yes, all of them are locked
    • Yes, some of them are locked
    • None of them are locked
    • I'm not sure
    • Decline to respond
  13. Number of Participants Securely Storing All Medications

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    Changes in whether present medication are all stored securely. Count represents the number of participants who stored 'all' of their medications locked.

    "Are the medications in your home currently stored locked? (Examples include using a locked cabinet or box)"

    Answer options:

    • Yes, all of the medications in my home are locked up
    • Yes, some of the medications in my home are locked up
    • None of the medications in my home are locked up
    • I'm not sure
  14. Average Importance of Firearm Ownership for Protection

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    "On a scale of 0 to 10, to what extent do you keep your firearms to protect yourself or your loved ones from other people? Someone who answers 0 does not consider themselves to keep firearms for protection, while someone who answers 10 considers that their firearms are absolutely required for protection." Answer range: 0-10

  15. Average Participant Readiness to Store Firearms Outside of the Home With Someone They Trust

    Time frame: Day of intervention delivery (day 0)

    "One of the safest things someone can do while they're going through a difficult time is to store their firearms outside of the home with someone they trust. On a scale from 0 to 10, where 0 is not at all, and 10 is completely, how would you rate your readiness to [make a change] like that?" Answer range: 0-10

  16. Number of Participants Who Do Not Have Access to Locked Firearm(s)

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    Count of people who said they do not have access to the key/combination for their locked firearm.

    "For the firearms in your home that are locked, who has access to the keys or number combinations that would be needed to access them?"

    Answer options:

    • You
    • Your spouse or partner
    • Children under the age of 18 years
    • Children 18 years of age or older
    • A friend
    • A neighbor
    • Other:__________
  17. Number of Participants With Ammunition in the Home

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    Changes from day of intervention delivery (day 0) to 4 weeks in whether household ammunition is present. The presence of ammunition in the home was only asked to participants who stated there were firearms in the home and that they were the owner of at least 1 of the firearms in the home. Count represents number of participants who reported having ammunition in the home.

  18. Number of Participants With All Ammunition Locked

    Time frame: Day of intervention delivery (day 0) and at 4 weeks

    Count of participants who reported having 'all' ammunition in the home securely locked. This measure was only asked to participants who reported that there were firearms in the home, that they were the owner of at least 1 of the firearms in the home, and that there was ammunition in the home.

    "Is ammunition in or around your home currently stored in a locked place, such as a locked cabinet?"

    Answer options:

    • Yes, all of the ammunition is locked
    • Yes, some of the ammunition is locked
    • None of the ammunition is locked
    • I'm not sure
    • No ammunition is in my home
  19. Number of Participants With Naloxone Prescription in Participant Electronic Health Record

    Time frame: at 8 weeks

    Count of participants who have a naloxone prescription (yes/no). Verified through each participant's electronic health record.

  20. Number of Participants With Verified Return of Medication Safety Envelope

    Time frame: at 8 weeks

    Verification of returned medication safety envelope (yes/no). Count represents number of participants who utilized their medication return envelope.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)

Acronym: HSI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2024
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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