Prevention of Suicide in Veterans Through Brief Intervention and Contact (VA-BIC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Beck Scale for Suicide Ideation (BSS)
研究概览
简要总结
The VA is committed to reducing suicide in the U.S. Veteran population. Over 6,000 Veterans die from suicide each year, and this risk is particularly high following a psychiatric hospitalization. This may be due to problems with engagement in care and poor social connectedness. Although the VA has implemented tools to address Veteran suicide risk, suicide after psychiatric discharge remains an ongoing problem. This has highlighted the need to develop new interventions and approaches to post-discharge mental health care within the VA. In response, this project is a randomized control trial of an intervention an intervention called Prevention of suicide: Education, Awareness, Connection, and Engagement (PEACE). This intervention is comprised of two synergistic and promising components to prevent suicide: 1) a mobile mental health app, which aims to improve social connectedness after discharge; and 2) a manual-based intervention called the Veterans Affairs Brief Intervention and Contact Program (VA-BIC), which promotes engagement in care. The overall goal of this study is to determine if the PEACE intervention combined with standard discharge care reduces suicidal ideation as compared to a control group receiving only standard discharge care.
详细描述
Background: Suicide is a major public health concern in the U.S., and even more so in the Veteran population. Furthermore, the period following psychiatric hospitalization is one of the highest risk periods for suicide. Based on current evidence, some of the most important contributing factors to post-hospitalization suicide risk include problems with engagement in care, fragmented care, and lack of social connectedness. Other studies in civilian populations have also raised similar concerns, highlighting the need to identify novel and effective interventions or approaches to post-discharge mental health care.
Objectives: This project aims to 1) Identify the effect of PEACE on suicidal ideation after psychiatric hospitalization, compared to standard care alone; 2) Identify the effect of PEACE on social connectedness and engagement in care after psychiatric hospitalization, compared to standard care alone; and 3) Compare the effect of PEACE on suicide attempts and suicide deaths after psychiatric hospitalization, compared to standard care alone.
Methods: This is a single-site, assessor-blinded, randomized control trial of PEACE plus standard psychiatric hospital discharge care compared to standard psychiatric hospital discharge care alone. The trial will enroll up to 160 participants aged 18 years and older who are being discharged from the White River Junction VA Medical Center inpatient mental health unit. Participants will be randomized to either the PEACE intervention plus standard psychiatric discharge care or standard psychiatric discharge care alone. Suicidal ideation, hopelessness, social connectedness, engagement in care, suicide attempts, and app engagement (only those randomized to PEACE) will be measured at baseline and one, three, and six months post-discharge. Participants randomized to PEACE will also receive eight additional intervention contacts as part of the VA-BIC protocol.
Hypothesis
Veterans receiving the PEACE intervention will report greater improvements in suicidal thoughts and behaviors, hopelessness, social connectedness, and engagement in care at follow-up contact visits compared to Veterans receiving standard care 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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.
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
- •Per the unit psychiatrist, hospitalization was due to concerns about acute risk for self-harm including suicidal ideation, suicide attempt, and/or admitting provider deemed the patient was at imminent risk for self-harm;
- •Be a Veteran eligible to receive VA services;
- •Be 18 years or older;
- •Be able to speak English;
- •Have access to a smart phone and express willingness to download a mobile app.
排除标准
- •Unable to provide informed consent;
- •The investigators do not plan to enroll any potentially vulnerable populations including prisoners, or involuntarily committed patients.
研究组 & 干预措施
PEACE
The PEACE intervention will be delivered by a trained mental health staff member, such as a study psychologist, mental health nurse, social worker, or psychiatrist. The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide. Patients in this arm will also continue to receive standard post-discharge psychiatric care.
干预措施: PEACE (Behavioral)
PEACE
The PEACE intervention will be delivered by a trained mental health staff member, such as a study psychologist, mental health nurse, social worker, or psychiatrist. The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide. Patients in this arm will also continue to receive standard post-discharge psychiatric care.
干预措施: Standard Psychiatric Hospital Discharge Care (Other)
Control
Those randomized to the control arm will receive standard psychiatric hospital discharge care alone. Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy.
干预措施: Standard Psychiatric Hospital Discharge Care (Other)
结局指标
主要结局
Beck Scale for Suicide Ideation (BSS)
时间窗: 1-month, 3-month, and 6- month post-discharge
The BSS is a self-reported questionnaire that assesses severity of suicidal ideation. The BSS measures attitudes, behaviors, and plans to die by suicide. Each item on the BSS is scored on a scale from 0 to 2 and the first 19 of the 21 items are used to calculate a total score ranging from 0 - 38. The BSS has high reliability and is a valid measure of suicidal ideation. There is also evidence that the BSS is measurement invariant across time. The BSS is widely used in clinical trials, is sensitive to clinical change, and unlike most other measures of suicidal ideation, higher scores on the BSS are associated with death by suicide. While there is no established BSS cutoff score to classify suicide risk as high, low, or none, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation.
次要结局
- Suicide-Related Coping Scale (SRCS)(1-month, 3-month, and 6- month post-discharge)
- The Partners in Health Scale (PIH): Self-Management(1-month, 3-months, and 6-months post discharge)
- Beck Hopelessness Scale (BHS)(1-month, 3-months and 6- months post-discharge)
- Interpersonal Needs Questionnaire-15 (INQ-15): Thwarted Belongingness(1 month, 3-months, and 6-months post discharge)
- Interpersonal Needs Questionnaire-15 (INQ-15): Perceived Burdensomeness(1-month, 3-months, and 6-months post discharge)
- The Multidimensional Scale of Perceived Social Support (MSPSS)(1-month, 3-months and 6- months post-discharge)
- App Engagement Scale (AES) for Mobile Applications(6- month post-discharge)
- Continuity of Care(3-months post discharge)
- Suicide Attempts: Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline to 6- months post-discharge)