Rapid Personalization of Safety Plans for Psychiatrically Hospitalized Veterans at High-Risk for Suicide
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Beck Scale for Suicide Ideation
研究概览
简要总结
Veterans psychiatrically hospitalized face significantly elevated suicide risk, particularly in the three months post-discharge. While Safety Planning is a required component of discharge planning, many safety plans lack personalization thereby reducing their effectiveness. The proposed intervention, Personalized Safety Plans (PSP), will be developed for rapid delivery on acute inpatient psychiatry units. PSP is a single-session intervention followed by twice monthly brief, personalized coaching sessions during the three-month high-risk discharge period. PSP will be iteratively refined and finalized in a case series (N = 15) then evaluated in a pilot randomized controlled trial (N = 96) comparing PSP to Safety Plans as Usual among psychiatrically hospitalized Veterans. Overall, the study aims to: 1) iteratively refine PSP; 2) examine PSP's preliminary effectiveness in reducing suicide ideation and increasing adaptive coping; 3) identify barriers and facilitators to implementation; and 4) develop a fidelity measure to support future personalization monitoring.
详细描述
Veterans hospitalized in inpatient psychiatry units are eight times more likely to die by suicide than all Veterans who use VA services, with the highest risk period being the first three months post-discharge. Safety Planning is a required component of discharge planning for psychiatrically hospitalized Veterans, yet many safety plans (SPs) are often poorly personalized which significantly limits their effectiveness. Clinicians need better training to personalize SPs and Veterans prefer a personalized intervention that identifies their specific suicide warning signs and adaptive coping skills. Improvements in SP application are critically needed. To address this gap, the proposed intervention, Personalized Safety Plans (PSP), will be developed for rapid delivery on acute inpatient psychiatry units. PSP is a single-session intervention followed by twice monthly brief, personalized coaching sessions during the three-month high-risk discharge period. PSP will be iteratively refined in a case series (N = 15) and then, consistent with a hybrid I effectiveness-implementation design, evaluated in a pilot randomized controlled trial (RCT; N = 96) comparing PSP to SP as Usual among psychiatrically hospitalized Veterans. In the case series, Veterans will complete assessments at baseline, post-treatment, and at 1 month post-discharge. In the pilot RCT, Veterans will complete assessments at baseline, post-treatment, and at 1, 3, and 6 months post-discharge. The primary goal is to determine PSP's preliminary effectiveness; the secondary goal is to understand the implementation context through feedback from Veterans, clinicians, and stakeholders. The proposed study will provide a foundation for a larger RCT through four aims: 1) iteratively refine PSP, guided by Veteran, clinician, and stakeholder feedback; 2) examine PSP's preliminary effectiveness in reducing suicide ideation, increasing adaptive coping, and increasing SP personalization compared to SP as Usual; 3) identify barriers and facilitators to implementation; and 4) develop a fidelity measure to support future personalization monitoring. The proposed study will be conducted in the Behavioral Science Division of the National Center for PTSD at the VA Boston Healthcare System with support from a collaborative and expert mentorship team. The candidate will pursue five training aims: 1) obtain expertise in treatment adaptation and conducting RCTs with psychiatrically hospitalized Veterans; 2) gain analytic skills to evaluate RCTs; 3) refine clinical expertise in treating suicidal Veterans; 4) acquire fundamentals of implementation science; and 5) engage in professional development to support the transition to an independently funded VA investigator. The proposed study and training directly aligns with the candidate's career goal of becoming a VA clinical trialists who develops, adapts, and tests personalized and implementable interventions to reduce Veteran suicide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome Assessors will be independent from the Study Team and will be masked to participants' treatment 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
- •Participants will be Veterans who are:
- •admitted to VABHS inpatient psychiatry for suicide risk
- •display sufficient English comprehension and cognitive capacity to understand the study and provide informed consent
- •have been medically cleared by attending physician
排除标准
- •The exclusion criteria for Veterans in this study are:
- •current psychosis
- •current mania
- •dementia or other significant cognitive impairment
- •being inaccessible and discharged from the unit less than 48 hours after being identified by study staff
- •prisoner status
研究组 & 干预措施
Personalized Safety Plans
Personalized Safety Plans is a single-session (up to 90min) inpatient intervention followed by twice-monthly coaching sessions (up to 30min each) over the three-month high-risk discharge period. The inpatient session uses chain and solution analyses from Dialectical Behavior Therapy to build a shared understanding of the suicide crisis, including vulnerability factors, prompting events, behavioral links, consequences, and solutions. Veterans also identify distal patterns of suicide risk, supporting proactive risk reduction. Chain and solution analyses populate a personalized, actionable safety plan. Follow-up coaching sessions focus on the Veteran's safety plan, including reviewing its personalization, addressing barriers to in-home use, and making necessary updates. Participants will continue to receive inpatient and outpatient treatment as usual.
干预措施: Personalized Safety Plans (Behavioral)
Safety Plans as Usual + Calls
The comparator condition is Safety Plan as Usual plus attentional control phone calls. Safety Plan as Usual reflect standard clinical practice on the inpatient psychiatry of how safety plans are created. Per VHA Directives and clinical requirements, all at-risk patients must collaboratively develop a SP and receive a copy prior to discharge. Providers use the suicide narrative alongside questions from the Safety Planning Intervention Manual. Attentional control phone calls are twice-monthly supportive check-ins, matched in frequency to the Personalized Safety Plans coaching sessions, designed to control for time and attention differences between conditions. Participants will continue to receive inpatient and outpatient treatment as usual.
干预措施: Safety Plans as Usual + Calls (Behavioral)
结局指标
主要结局
Beck Scale for Suicide Ideation
时间窗: Baseline and 1, 3, and 6-month follow-up
In Part 2 (pilot RCT), suicide ideation severity will be measured with the Beck Scale for Suicide Ideation. The Beck Scale for Suicide Ideation has a minimum score of 0 and a maximum of 38. Higher total scores indicate greater suicide ideation severity. Longitudinal mixed-effects models with random effects will examine the effect of treatment condition (Personalized Safety Plans, Safey Plans as Usual + Calls) on the primary outcome of suicide ideation severity. A time by treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) interaction will be used to examine if Personalized Safety Plans is associated with greater reductions in suicide ideation severity relative to Safety Plans as Usual + Calls. The investigators will examine if these differences are immediately present at the 1-month follow-up and maintained through the 6-month follow-up.
Columbia-Suicide Severity Rating Scale - Suicide Ideation Duration
时间窗: Baseline and 1, 3, and 6-month follow-up, an average of 6 months
In Part 2 (pilot RCT), suicide ideation duration will be measured using the Columbia-Suicide Severity Rating Scale. Suicide ideation duration is measured on a 1 to 5 scale, with higher scores meaning longer suicide ideation duration. The Columbia-Suicide Severity Rating Scale is a widely used interview measure in suicide prevention clinical trials. Longitudinal mixed-effects models with random effects will examine the effect of treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) on the primary outcome of suicide ideation duration. A time by treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) interaction will be used to examine if Personalized Safety Plans is associated with greater reductions in suicide ideation duration relative to Safety Plans as Usual + Calls. The investigators will examine if these differences are immediately present at the 1-month follow-up and maintained through the 6-month follow-up.
Columbia-Suicide Severity Rating Scale - Suicide Ideation Frequency
时间窗: Baseline and 1, 3, and 6-month follow-up, an average of 6 months
In Part 2 (pilot RCT), suicide ideation frequency will be measured using the Columbia-Suicide Severity Rating Scale. Suicide ideation frequency is measured on a 1 to 5 scale, with higher scores meaning greater suicide ideation frequency. The Columbia-Suicide Severity Rating Scale is a widely used interview measure in suicide prevention clinical trials. Longitudinal mixed-effects models with random effects will examine the effect of treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) on the primary outcome of suicide ideation frequency. A time by treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) interaction will be used to examine if Personalized Safety Plans is associated with greater reductions in suicide ideation frequency relative to Safety Plans as Usual + Calls. The investigators will examine if these differences are immediately present at the 1-month follow-up and maintained through the 6-month follow-up.
Feasibility of PSP Intervention
时间窗: Throughout Part 1 of study completion, an average of 1 month
In Part 1 (case series), Personalized Safety Plans feasibility will be assessed in the following way: Percent of patients approached and who agree to enroll Given that Part 1 (case series) is focused on iterative refinement of Personalized Safety Plans, there are no hypotheses related to feasibility. This information will inform Personalized Safety Plans refinement and finalization.
Acceptability of PSP Intervention - Patient Satisfaction
时间窗: Throughout Part 1 of study completion, an average of 1 month
In Part 1 (case series), Personalized Safety Plans acceptability will be assessed in the following way: Client Satisfaction Questionnaire-8 will assess patient satisfaction Given that Part 1 (case series) is focused on iterative refinement of Personalized Safety Plans, there are no hypotheses related to acceptability. This information will inform Personalized Safety Plans refinement and finalization.
Acceptability of PSP Intervention
时间窗: Throughout Part 1 of study completion, an average of 1 month
In Part 1 (case series), Personalized Safety Plans acceptability will be assessed in the following ways: Percent of patients who complete Personalized Safety Plans Percent of patients who drop out of Personalized Safety Plans Given that Part 1 (case series) is focused on iterative refinement of Personalized Safety Plans, there are no hypotheses related to acceptability. This information will inform Personalized Safety Plans refinement and finalization.
次要结局
- Suicide-Related Coping Scale(Baseline and 1, 3, and 6-month follow-up)
- Safety Plan Rating Scale(Baseline and 1, 3, and 6-month follow-up)
- Safety Plan Use Scale(Baseline and 1, 3, and 6-month follow-up)