Firearm Injury, Overdose, Suicide
Conditions
Keywords
firearm
Brief summary
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.
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.
Interventions
BEHAVIORALhousehold 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Number of Participants Recruited Within One Year | 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. |
| Feasibility: Number of Participants Who Attend Their 4 Week Follow Up | 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. |
| Acceptability: Number of Participants With CSQ Scores ≥24 | 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. |
| Acceptability: Number of Participants Who Reported the Intervention to be Acceptable | 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. |
| Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable | 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: * Very uncomfortable * Uncomfortable * Neither * Comfortable * Very comfortable |
| Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions | 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: * Not at all * Slightly helpful * Moderately helpful * Very helpful * Extremely helpful |
| Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions | 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: * Not at all * Slightly helpful * Moderately helpful * Very helpful * Extremely helpful |
| Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners | 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: * Very disrespectful * Disrespectful * Neither * Respectful * Very respectful |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Participant Trust in the VA Healthcare System | 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 |
| Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal | 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 |
| Average Participant Beliefs About Importance of Secure Medication Storage Always | 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 |
| Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal | 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 |
| Average Participant Beliefs About Importance of Secure Firearm Storage Always | 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 |
| Average Participant Beliefs About Importance of Unloaded Firearm Storage Always | 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 |
| Average Participant Readiness to Securely Store All Firearms | 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 |
| Average Participant Readiness to Securely Store All Medications | 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 |
| Average Number of Firearms in Household | Day of intervention delivery (day 0) and at 4 weeks | Number of firearms in household: Answer range: 0 to 10,000 |
| Number of Participants Who Forget to Take Their Medications Often/Always | 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: * Never * Rarely * Sometimes * Very Often * Always |
| Number of Participants With Firearms Present in the Home | 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. |
| Number of Participants Securely Storing All Firearms | 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: * Yes, all of them are locked * Yes, some of them are locked * None of them are locked * I'm not sure * Decline to respond |
| Number of Participants Securely Storing All Medications | 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: * 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 |
| Average Importance of Firearm Ownership for Protection | 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 |
| Average Participant Readiness to Store Firearms Outside of the Home With Someone They Trust | 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 |
| Number of Participants Who Do Not Have Access to Locked Firearm(s) | 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: * You * Your spouse or partner * Children under the age of 18 years * Children 18 years of age or older * A friend * A neighbor * Other:\_\_\_\_\_\_\_\_\_\_ |
| Number of Participants With Ammunition in the Home | 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. |
| Number of Participants With All Ammunition Locked | 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: * 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 |
| Number of Participants With Naloxone Prescription in Participant Electronic Health Record | at 8 weeks | Count of participants who have a naloxone prescription (yes/no). Verified through each participant's electronic health record. |
| Number of Participants With Verified Return of Medication Safety Envelope | at 8 weeks | Verification of returned medication safety envelope (yes/no). Count represents number of participants who utilized their medication return envelope. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoseph A Simonetti, MD MPH
Rocky Mountain Regional VA Medical Center, Aurora, CO
Participant flow
Recruitment details
The study used adaptive pilot testing in three phases. Phase 1 (Oct 2024-Mar 2025) recruited Veterans from the Rocky Mountain Regional VA. Phase 2 (Mar-Apr 2025) expanded to VHA VISN 19. No unique challenges were found, however interviews with participants suggested the intervention was too long. In Phase 3 (Apr-Jun 2025), focus shifted to firearm storage, reducing intervention time and increasing acceptability.
Pre-assignment details
40 veterans consented to participate in the study. 3 discontinued enrollment prior to their baseline visit (2 unable to contact after consent, 1 due to time).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.14 Years STANDARD_DEVIATION 15.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed