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. The study was suspended from April to June 2024 due to low study enrollment; modification of recruitment procedures and study approach.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 40 Veterans in one year. Count represents number of participants recruited within one year.
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.
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.
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.
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:
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:
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:
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:
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
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 - 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
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
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
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:
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.
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:
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:
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 (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
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:
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.
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:
Time frame: at 8 weeks
Count of participants who have a naloxone prescription (yes/no). Verified through each participant's electronic health record.
Time frame: at 8 weeks
Verification of returned medication safety envelope (yes/no). Count represents number of participants who utilized their medication return envelope.
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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