Home Safety Intervention

NCT ID: NCT06216327

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-27

Study Completion Date

2025-08-18

Brief Summary

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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.

Detailed Description

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The investigators will pilot the LMS intervention among up to 50 Veterans to assess feasibility and acceptability.

Conditions

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Suicide Firearm Injury Overdose

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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intervention arm

There is a single intervention arm with no comparator for this pilot study

Group Type EXPERIMENTAL

household safety intervention

Intervention Type 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.

Interventions

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household 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph A Simonetti, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Regional VA Medical Center, Aurora, CO

Locations

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Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1IK2HX002861-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDX 24-001

Identifier Type: -

Identifier Source: org_study_id

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