Developing and Piloting an Implementation Strategy for a Brief, Motivational Interviewing-based Lethal Means Safety Counseling Intervention in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Screening
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research assistant (outcomes assessor) will be blinded to study condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Active control (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
干预措施: RAMP (Behavioral)
结局指标
主要结局
Screening
时间窗: through study completion, approximately 2 years
Investigators will assess the number of new PCMHI patients seen in PCMHI and the number who were approached about potential study participation per month
Recruitment
时间窗: through study completion, approximately 2 years
Investigators will track the number of eligible Veterans who enrolled in the study per month
Retention
时间窗: approximately 30 days
Investigators will calculate the number of Veterans who received RAMP who were willing to complete immediate and one-month follow up assessments.
Assessment of behavioral outcomes
时间窗: approximately 30 days
Investigators will assess the percentage of participants who completed behavioral outcome measures within the time allotted at each timepoint
Veteran acceptability - Theoretical Framework of Acceptability
时间窗: At immediate follow up, within approximately 2 weeks of intervention
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.
Veteran acceptability - Experience and Satisfaction with intervention
时间窗: At immediate follow up, within approximately 2 weeks of intervention
Investigators will conduct qualitative evaluation of the participant's experience and satisfaction receiving the intervention.
Clinician acceptability - Theoretical Framework of Acceptability
时间窗: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)
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.
Clinician acceptability - Negative impact
时间窗: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)
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).
次要结局
未报告次要终点