SAFEGUARD Phase 2 Pathfinding Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Suicide-related behaviors
研究概览
简要总结
This study evaluates the effectiveness of Pathfinding, a 6-month, remotely-delivered case management intervention designed to decrease suicidal behavior among active-duty Regular Army soldiers recently discharged from inpatient psychiatric treatment. Soldiers discharged from military treatment facilities across the U.S. will be identified and recruited to participate. Those who consent will be randomly assigned to receive either Treatment As Usual (TAU), which is the Army's standard post-discharge care, or TAU plus Pathfinding. Participants will complete a baseline assessment and follow-up assessments 6 months and 12 months later. The 6- and 12-month follow-up periods will also include examination of participants' electronic healthcare data and Army administrative data. The overall goals of the study are: (1) to evaluate whether Pathfinding decreases suicidal behaviors among soldiers transitioning from psychiatric hospitalization back to the community; and (2) to determine which discharged soldiers are most likely to benefit from the Pathfinding intervention versus TAU alone.
详细描述
Discharge from psychiatric hospitalization is the highest risk period for death by suicide. Intensive case management programs have been effective in reducing post-discharge suicidal behavior, but such programs are too resource-intensive to implement for all psychiatric inpatients. It would be more scalable to target the intervention to those most likely to benefit and implement it remotely with centralized training & management. This study evaluates the effectiveness of Pathfinding, a 6-month, adjunctive, telehealth case management intervention, in decreasing suicide-related behaviors among active-duty Regular Army soldiers over the 12 months following discharge from inpatient psychiatric treatment. The Pathfinding intervention combines elements from two case management programs that have been found to reduce suicidal behavior and other negative outcomes among individuals transitioning out of the hospital and back to the community-Coping with Long-Term Active Suicide Program (CLASP) and Critical Time Intervention (CTI)-and adapts them for the unique needs of an active-duty military population. The intervention is delivered remotely by "Guides," masters-level mental health professionals who are centrally trained and supervised.
Soldiers hospitalized for inpatient psychiatric care at military treatment facilities (MTFs) across the U.S. will be identified in the electronic health record (EHR) as soon as possible after being discharged. A previously developed machine learning model based on EHR and Army administrative data will be used to stratify discharged soldiers based on their predicted probability of suicidal behavior. Soldiers will be recruited from across the distribution of predicted risk via emails, text messages, and phone calls. Consenting soldiers will complete a baseline assessment of their health, experiences, and characteristics. They will then be randomized to receive either Treatment As Usual (TAU), which is the Army's standard post-discharge care, or TAU plus the 6-month Pathfinding case management intervention. All participants will be administered follow-up assessments 6 and 12 months after baseline to identify self-reported suicide-related events and other outcomes. Outcomes will also be tracked through EHR data.
The study will examine: (1) whether Pathfinding decreases suicide-related behaviors among soldiers transitioning from psychiatric hospitalization back to the community; and (2) whether certain soldiers are more likely than others to benefit from the Pathfinding intervention versus TAU alone.
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
- None
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
- •Active duty Regular Army soldiers recently discharged from inpatient psychiatric care at a military treatment facility in the US
- •Access to telephone and computer (including smartphone)
排除标准
- •Impaired ability to provide informed consent
- •Terminal illness
- •Failure to complete baseline survey within 30 days of discharge
- •Positive screen for post-discharge suicide-related behaviors
研究组 & 干预措施
Treatment As Usual (TAU)
Treatment As Usual (TAU) is the Army's standard care for soldiers discharged from inpatient psychiatric treatment. It involves discharge planning, risk assessment, and referrals (as detailed in the TAU intervention description).
干预措施: Treatment As Usual (TAU) (Behavioral)
Pathfinding intervention plus Treatment As Usual (TAU)
Pathfinding is a 6-month, adjunctive, telehealth intervention that integrates 2 evidence-based case management programs and adapts them for active duty soldiers: Coping Long Term with Active Suicide Program (CLASP), a case management intervention for suicidal patients transitioning out of psychiatric hospitals; and Critical Time Intervention (CTI), a more general case management intervention for high-risk transitions out restrictive environments. Administered remotely by a centrally trained & supervised team of "Guides." Focuses on key suicide risk factors (e.g., treatment engagement, social connection, problem-solving) and unmet needs across life domains (e.g., legal, financial, housing, and relationships). Participants receive Pathfinding in addition to standard post-discharge care (see TAU intervention description for details).
干预措施: Pathfinding (Behavioral)
结局指标
主要结局
Suicide-related behaviors
时间窗: Within the 12 months following completion of the baseline assessment
Suicide-related behaviors are defined as: suicide death (administratively documented or informant reported), nonfatal suicide attempt (self-reported or administratively documented), and interrupted suicide attempt, aborted suicide attempt, and preparatory behaviors for suicide (the latter 3 are all self-reported).
次要结局
- Number of suicide attempts(Within the 12 months following completion of the baseline assessment)
- Rehospitalization(Within the 12 months following completion of the baseline assessment)
- Non-suicide death(Within the 12 months following completion of the baseline assessment)
- Risky behaviors(Within the 12 months following completion of the baseline assessment)
- Suicide ideation(Within the 12 months following completion of the baseline assessment)
- Low psychological resilience(Within the 12 months following completion of the baseline assessment)