Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211, United States
NCT Number: NCT06216327
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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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045-7211, United States
The investigators will pilot the LMS intervention among up to 50 Veterans to assess feasibility and acceptability.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
->17 years
Exclusion criteria
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.
Time frame: through study completion, an average of one year
Ability to recruit 30 Veterans in one year
Time frame: approximately 30 days
>70% follow up
Time frame: day of intervention delivery - day 0; and at 4 weeks
>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.
Time frame: at 4 weeks
Qualitative evaluation of participant's experiences
Time frame: day of intervention delivery - day 0; and at 4 weeks
"How comfortable did you feel engaging in the discussion? " Likert responses: Very uncomfortable Uncomfortable Neither Comfortable Very comfortable
Time frame: day of intervention delivery - day 0; and at 4 weeks
"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
Time frame: day of intervention delivery - day 0; and at 4 weeks
"How helpful was your interaction in making decisions about firearm storage?" Likert responses: Not at all Slightly helpful Moderately helpful Very helpful Extremely helpful
Time frame: day of intervention delivery - day 0; and at 4 weeks
"To what extent was this intervention respectful of your values as a firearm owner? Likert responses: Very disrespectful Disrespectful Neither Respectful Very respectful
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?
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
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
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
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
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
Time frame: 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
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)
Time frame: 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
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)
Time frame: Day of intervention delivery (day 0) and at 4 weeks
Number of firearms in household: Answer range: 0 to 10,000
Time frame: at 4 weeks
"To what extent have you had difficulty remembering to take your medications in the past month?" Likert responses: Never Rarely Sometimes Very Often Always
Time frame: Day of intervention delivery (day 0) and at 4 weeks
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
Time frame: Day of intervention delivery (day 0) and at 4 weeks
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
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
Time frame: 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
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
Time frame: Day of intervention delivery (day 0) and at 4 weeks
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:__________
Time frame: at 8 weeks
Verification of naloxone prescription within the electronic health record (yes/no)
Time frame: Day of intervention delivery (day 0) and at 4 weeks
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
Time frame: at 8 weeks
Verification of returned medication safety envelope (yes/no)
VA Office of Research and Development
Fed
Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)
Acronym: HSI
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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