Developing and Piloting an Implementation Strategy for a Brief, Motivational Interviewing-based Lethal Means Safety Counseling Intervention in Primary Care Settings (CDA-2)

VA Office of Research and Development

Status: Begins enrollment in a year or more

Conditions: Suicide Prevention

Treatments: Behavioral: Active control; Behavioral: RAMP

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07247916

1IK2RD000503-01A2%9 (Other Grant/Funding Number)

HSR4-001-24W

Details and patient eligibility

About

Suicide prevention remains a significant priority and nearly three-quarters of Veteran suicides result from firearm injury. Since access to lethal means of self-harm increases the risk of injury, the VA/DoD Clinical Practice Guidelines recommend that Veterans with elevated suicide risk receive lethal means safety (LMS) counseling to reduce access to lethal means, including firearms. However, no LMS counseling interventions have been tested within VA. Thus, the aim of this study is to conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of a tailored LMS counseling intervention compared to an active control condition.

Full description

This is a pilot randomized controlled trial of up to 50 Veterans to assess the feasibility and acceptability of a LMS intervention and testing procedures.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For Veterans:

• Has access to a firearm
• Referred to PCMHI care

For clinicians (delivering intervention):

• deliver care in PCMHI
• trained in RAMP and study procedures

Exclusion criteria

For Veterans:

• Unable to consent due to cognitive impairment, severity of illness (including psychiatric symptoms), intoxication with drugs and/or alcohol
• Unreliable telephone access
• Inability to read English or communicate in spoken and written English

For clinicians (delivering intervention):

- Did not participate in training

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Active control

Active Comparator group

Description:

The control condition will entail a 5-minute review of a pamphlet on suicide prevention with the PCMHI clinician. This pamphlet is produced by the Veteran's Crisis Line and is widely available on the OSP suicide prevention website as a VHA resource. This condition will control for time and attention, subject matter, mode of delivery, and setting.

Treatment:

Behavioral: Active control

RAMP

Experimental group

Description:

Participants randomized to the intervention condition will receive a brief, motivational interviewing-based intervention called RAMP (Raise the subject, Assess current storage, Motivate change, and Plan next steps) in the context of their clinical care. RAMP incorporates evidence-informed intervention components to facilitate secure firearm storage

Treatment:

Behavioral: RAMP