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. The study was suspended from April to June 2024 due to low study enrollment; modification of recruitment procedures and study approach.

• 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: Number of Participants Recruited Within One Year	Ability to recruit 40 Veterans in one year. Count represents number of participants recruited within one year.	through study completion, an average of one year
Feasibility: Number of Participants Who Attend Their 4 Week Follow Up	>80% of participants attend their 4 week follow up. Count represents number of participants who completed their 4 week follow up visit.	approximately 4 weeks
Acceptability: Number of Participants With CSQ Scores ≥24	>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.	day of intervention delivery - day 0; and at 4 weeks
Acceptability: Number of Participants Who Reported the Intervention to be Acceptable	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.	at 4 weeks
Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable	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	day of intervention delivery - day 0; and at 4 weeks
Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions	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	day of intervention delivery - day 0; and at 4 weeks
Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions	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	day of intervention delivery - day 0; and at 4 weeks
Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners	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	day of intervention delivery - day 0; and at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Participant Trust in the VA Healthcare System	"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	Day of intervention delivery (day 0) and at 4 weeks
Average Participant 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
Average Participant 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
Average Participant 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
Average Participant 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
Average Participant 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
Average Participant Readiness to Securely Store All Firearms	"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	Day of intervention delivery - day 0
Average Participant Readiness to Securely Store All Medications	"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	Day of intervention delivery at visit #1 (day 0)
Average 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
Number of Participants Who Forget to Take Their Medications Often/Always	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	at 4 weeks
Number of Participants With Firearms Present in the Home	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.	Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Securely Storing All Firearms	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	Day of intervention delivery (day 0) and at 4 weeks
Number of Participants Securely Storing All Medications	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	Day of intervention delivery (day 0) and at 4 weeks
Average Importance of Firearm Ownership 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
Average Participant Readiness to Store Firearms Outside of the Home With Someone They Trust	"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 (day 0)
Number of Participants Who Do Not Have Access to Locked Firearm(s)	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:__________	Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With Ammunition in the Home	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.	Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With All Ammunition Locked	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	Day of intervention delivery (day 0) and at 4 weeks
Number of Participants With Naloxone Prescription in Participant Electronic Health Record	Count of participants who have a naloxone prescription (yes/no). Verified through each participant's electronic health record.	at 8 weeks
Number of Participants With Verified Return of Medication Safety Envelope	Verification of returned medication safety envelope (yes/no). Count represents number of participants who utilized their medication return envelope.	at 8 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): October 8, 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 (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: August 1, 2026

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