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

N/ANot Yet RecruitingNCT07247916

VA Office of Research and Development50 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Suicide Prevention

Interventions

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

Active controlBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Screening

Investigators will assess the number of new PCMHI patients seen in PCMHI and the number who were approached about potential study participation per month

Time frame: through study completion, approximately 2 years

Recruitment

Investigators will track the number of eligible Veterans who enrolled in the study per month

Time frame: through study completion, approximately 2 years

Retention

Investigators will calculate the number of Veterans who received RAMP who were willing to complete immediate and one-month follow up assessments.

Time frame: approximately 30 days

Assessment of behavioral outcomes

Investigators will assess the percentage of participants who completed behavioral outcome measures within the time allotted at each timepoint

Time frame: approximately 30 days

Veteran acceptability - Theoretical Framework of Acceptability

Investigators will assess Veteran acceptability using the eight Likert-style items from the Theoretical Framework of Acceptability questionnaire, which assess seven component constructs of acceptability including Veteran's experience of the lethal means safety intervention. Each item has 5 answer options (1-5) on a Likert Scale. Score range is 8 to 40, with a higher score indicating more higher reported acceptability.

Time frame: At immediate follow up, within approximately 2 weeks of intervention

Veteran acceptability - Experience and Satisfaction with intervention

Investigators will conduct qualitative evaluation of the participant's experience and satisfaction receiving the intervention.

Time frame: At immediate follow up, within approximately 2 weeks of intervention

Clinician acceptability - Theoretical Framework of Acceptability

Investigators will invite clinicians to respond to the eight-item Theoretical Framework of Acceptability questionnaire eliciting clinician acceptability of the lethal means safety intervention. Each item has 5 answer options (1-5) on a Likert Scale. Score range is 8 to 40, with a higher score indicating more higher reported acceptability.

Time frame: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)

Clinician acceptability - Negative impact

Investigators will assess to what extent PCMHI clinicians agree that study recruitment negatively impacted clinical care, using Likert-type items where '1' indicates "strongly disagree" and '5' indicates "strongly agree." For those responding \>3 ("don't know"), an open-ended question will elicit detailed information (e.g., interfered with delivery of clinical care, led to Veteran frustration).