Home Safety Intervention (HSI)

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

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.

Study Overview

• Status: Completed
• Conditions: Suicide; Overdose; Firearm Injury
• Intervention / Treatment: Behavioral: household safety intervention

Detailed Description

The investigators will pilot the LMS intervention among up to 50 Veterans to assess feasibility and acceptability.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045-7211
      • Rocky Mountain Regional VA Medical Center, Aurora, CO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; There is a single intervention arm with no comparator for this pilot study	Behavioral: household safety intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study recruitment	Ability to recruit 30 Veterans in one year	through study completion, an average of one year
Feasibility of study follow up	>70% follow up	approximately 30 days
participant intervention satisfaction	Qualitative evaluation of participant's experiences	at 4 weeks
participant intervention satisfaction	>70% 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.	day of intervention delivery - day 0; and at 4 weeks
Comfort with intervention discussion	"How comfortable did you feel engaging in the discussion? " Likert responses: Very uncomfortable Uncomfortable Neither Comfortable Very comfortable	day of intervention delivery - day 0; and at 4 weeks
Intervention helpfulness in medication decisions	"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	day of intervention delivery - day 0; and at 4 weeks
Intervention helpfulness in firearm decisions	"How helpful was your interaction in making decisions about firearm storage?" Likert responses: Not at all Slightly helpful Moderately helpful Very helpful Extremely helpful	day of intervention delivery - day 0; and at 4 weeks
Respectfulness of the intervention	"To what extent was this intervention respectful of your values as a firearm owner? Likert responses: Very disrespectful Disrespectful Neither Respectful Very respectful	day of intervention delivery - day 0; and at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Institutional Trust	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?	Day of intervention delivery (day 0) and at 4 weeks
Beliefs about importance of secure medication storage when someone is suicidal	"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	Day of intervention delivery (day 0) and at 4 weeks
Beliefs about importance of secure firearm storage when someone is suicidal	"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	Day of intervention delivery (day 0) and at 4 weeks
Number of firearms in household	Number of firearms in household: Answer range: 0 to 10,000	Day of intervention delivery (day 0) and at 4 weeks
Medication adherence	"To what extent have you had difficulty remembering to take your medications in the past month?" Likert responses: Never Rarely Sometimes Very Often Always	at 4 weeks
Change in firearm storage practices	Changes in whether household firearms are present, and whether present firearms are stored securely. Answers: Yes, all of them are locked Yes, some of them are locked None of them are locked I'm not sure	Day of intervention delivery (day 0) and at 4 weeks
Change in medication storage practices	Changes in whether household medication is present, and whether present medication is stored securely. 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	Day of intervention delivery (day 0) and at 4 weeks
Change in access to firearm storage combination	Changes in who has access to household locking combinations. 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:__________	Day of intervention delivery (day 0) and at 4 weeks
Change in ammunition storage practices	Changes in whether household ammunition is present, and whether present ammunition is stored securely. 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	Day of intervention delivery (day 0) and at 4 weeks
Beliefs about importance of secure medication storage always	"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	Day of intervention delivery (day 0) and at 4 weeks
Beliefs about importance of secure firearm storage always	"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	Day of intervention delivery (day 0) and at 4 weeks
Beliefs about importance of unloaded firearm storage always	"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	Day of intervention delivery (day 0) and at 4 weeks
Firearm storage storage Stage of Change	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? (range 0-10)	Day of intervention delivery at visit #1 (day 0); optional visit #2 (1-29 days); optional visit #3 (2-29 days); and at 4 weeks
Medication storage storage Stage of Change	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]? (range 0-10)	Day of intervention delivery at visit #1 (day 0); optional visit #2 (1-29 days); optional visit #3 (2-29 days); and at 4 weeks
Keeping firearms for protection	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	Day of intervention delivery (day 0) and at 4 weeks
Naloxone prescription	Verification of naloxone prescription within the electronic health record (yes/no)	at 8 weeks
Medication return envelope	Verification of returned medication safety envelope (yes/no)	at 8 weeks
Firearm removal stage of change	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	Day of intervention delivery at visit #1 (day 0); optional visit #2 (1-29 days); optional visit #3 (2-29 days); and at 4 weeks

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): June 27, 2024
• Primary Completion (Actual): July 18, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: firearm
• Additional Relevant MeSH Terms: Drug Misuse; Mental Disorders; Behavioral Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Self-Injurious Behavior; Prescription Drug Misuse; Behavior; Suicide; Drug Overdose
• Other Study ID Numbers: CDX 24-001; 1IK2HX002861-01A2 (U.S. NIH Grant/Contract)

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