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

Overview

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.

Detailed 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.

Interventions

• Behavioral RAMP
  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
• Behavioral Active control
  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.

Primary outcome measures

• Screening [Time frame: through study completion, approximately 2 years]
• Recruitment [Time frame: through study completion, approximately 2 years]
• Retention [Time frame: approximately 30 days]
• Assessment of behavioral outcomes [Time frame: approximately 30 days]
• Veteran acceptability - Theoretical Framework of Acceptability [Time frame: At immediate follow up, within approximately 2 weeks of intervention]
• Veteran acceptability - Experience and Satisfaction with intervention [Time frame: At immediate follow up, within approximately 2 weeks of intervention]
• Clinician acceptability - Theoretical Framework of Acceptability [Time frame: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)]
• Clinician acceptability - Negative impact [Time frame: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven

Identifiers

NCT: NCT07247916 · HSR4-001-24W · 1IK2RD000503-01A2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗