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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2HX002861-01A2 | U.S. NIH Grant/Contract | View source |
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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.
The investigators will pilot the LMS intervention among up to 50 Veterans to assess feasibility and acceptability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention arm | Experimental | There is a single intervention arm with no comparator for this pilot study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 | >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 |
| participant intervention satisfaction | Qualitative evaluation of participant's experiences | 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 |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph A Simonetti, MD MPH | Rocky Mountain Regional VA Medical Center, Aurora, CO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045-7211 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 30, 2024 | Sep 10, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D063487 | Prescription Drug Misuse |
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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.
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| 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 |
"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 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Naloxone prescription | Verification of naloxone prescription within the electronic health record (yes/no) | at 8 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 |
| Medication return envelope | Verification of returned medication safety envelope (yes/no) | at 8 weeks |
| D000076064 |
| Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |