Clinical trial NCT06216327: Home Safety Intervention
Official title: Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Firearm Injury
Overdose
Keywords: firearm
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of study recruitment
timeFrame: through study completion, an average of one year
measure: Feasibility of study follow up
timeFrame: approximately 30 days
measure: participant intervention satisfaction
timeFrame: day of intervention delivery - day 0; and at 4 weeks
measure: participant intervention satisfaction
timeFrame: at 4 weeks
measure: Comfort with intervention discussion
timeFrame: day of intervention delivery - day 0; and at 4 weeks
measure: Intervention helpfulness in medication decisions
timeFrame: day of intervention delivery - day 0; and at 4 weeks
measure: Intervention helpfulness in firearm decisions
timeFrame: day of intervention delivery - day 0; and at 4 weeks
measure: Respectfulness of the intervention
timeFrame: day of intervention delivery - day 0; and at 4 weeks
Secondary outcomes:
measure: Institutional Trust
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Beliefs about importance of secure medication storage when someone is suicidal
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Beliefs about importance of secure medication storage always
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Beliefs about importance of secure firearm storage when someone is suicidal
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Beliefs about importance of secure firearm storage always
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Beliefs about importance of unloaded firearm storage always
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Firearm storage storage Stage of Change
timeFrame: 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
measure: Medication storage storage Stage of Change
timeFrame: 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
measure: Number of firearms in household
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Medication adherence
timeFrame: at 4 weeks
measure: Change in firearm storage practices
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Change in medication storage practices
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Keeping firearms for protection
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Firearm removal stage of change
timeFrame: 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
measure: Change in access to firearm storage combination
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Naloxone prescription
timeFrame: at 8 weeks
measure: Change in ammunition storage practices
timeFrame: Day of intervention delivery (day 0) and at 4 weeks
measure: Medication return envelope
timeFrame: at 8 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Joseph A Simonetti, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: