Using Telehealth to Improve Outcomes in Veterans at Risk for Suicide
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Change in Beck Scale for Suicidal Ideation (BSS). Aaron T. Beck, copyright 1991.
研究概览
简要总结
Overview. The investigators will randomize 120 Veterans in this 3-site trial over 16 months. Eligible Veterans will include those to be discharged for a hospitalization for suicidal ideation. Baseline data collection and randomization will occur at discharge. The 3 month intervention will have study assessments at 2, 4, 8, and 12 weeks post-discharge. The study's primary outcome measure is suicidal ideation (measured with the Beck Scale for Suicidal Ideation[BSS] and secondarily with the Columbia Scale for Suicidality C-SSRS).
Intervention Components. The control condition will consist of Veterans randomized to VHA-SRM (Suicide Risk Monitoring). The experimental condition will be the telehealth system (TES) + VHA-SRM (Suicide Risk Monitoring) intervention. Veterans randomized to the telehealth system will receive the Interactive Voice Response (IVR) system monitoring in addition to VHA-SRM and will receive training on how to use the TES from the research coordinator. Veterans can access the IVR as a telephonic device accessed by a local or toll-free number and can use a 'plain old telephone system' (POTS), Cellular phone or Internet phone connected to their phone service provider. Participants will be instructed to interact daily with the TES system daily. Because of safety concerns, questions pertaining to suicidal behavior will be asked daily; to avoid repetition, all other questions will be asked every 3rd day. Once participants complete the questions on the telehealth device, their responses will be automatically uploaded and checked by trained VA Pittsburgh Healthcare System (VAPHS) nurses every 4 hours, during regular daytime hours of 9-5. VAPHS will serve as the central site retrieving downloads for all sites. Color-coded risk triage level designations based on potential responses, provide guidance regarding next steps. The protocol for assessing suicidal patients will follow standard VA procedures, outlined in each medical center's safety plan for suicidal patients.
详细描述
A subject will be considered enrolled after they sign the consent form, but prior to the initiation of study procedures. After enrollment, subjects will undergo baseline assessments and will be randomized prior to discharge from index hospitalization. The study aims to randomize 120 Veterans in 3-sites over 16-20 months.
Once a Veteran has been identified and referred, a member of the study team will meet with the Veteran on the inpatient unit to obtain consent. The baseline visit may take place all at once or on different days while patients are on the inpatient service. The investigators will attempt to perform baseline assessments as close to discharge as possible in order to obtain a true baseline assessment. However, the investigators may not be able to be certain regarding time of discharge and if this is the case or if discharge is extended, the baseline will be repeated one or more times to ensure that we have baseline data close to the time of discharge.
To assess eligibility, the following will be administered:
- Folstein Mini Mental Status Exam to assess cognitive impairment.
- The Beck Scale for Suicidal Ideation (SSI) to assess suicidal ideation.
- The 17 item Hamilton Depression Rating Scale (HAM-17) to rate depressive symptoms.
- The Mini International Neuropsychiatric Interview (MINI) to determine diagnoses.
Also administered will be the Sociodemographics Form, Columbia Scale for Suicidality (C-SSRS), Beck Hopelessness Scale©, Brief Addiction Monitor (BAM), Brief Emotional Closeness Questionnaire (ECQ), Brief Medication Questionnaire (BMQ), Hamilton Depression Rating Scale (HAM-D17), Clinical Global Impressions (CGI), and the Medical Outcomes Studies Social Support Survey (MOS-36). Participants that have a diagnosis of Schizophrenia(SZ) or Schizoaffective(SZA) disorder will additionally receive the Scales for the Assessment of Positive and Negative Symptoms (SAPS and SANS). These may be completed any time during the inpatient hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Veterans > 18 years old;
- •any diagnosis as long as participants exhibit at least mild depressive symptoms, i.e., a Hamilton 17-item depression 30 score >8; this includes patients with schizophrenia/schizoaffective disorder;
- •score >1 on items 4 or 5 on the SSI ; which assesses active or passive suicidal ideation, respectively.-
排除标准
- •Cognitive problems that would interfere with Veterans' ability to manage the TES system (e.g., neurocognitive d/o, significant traumatic brain injury, or a Folstein Mini Mental Status Exam score <22) or serious motor dexterity problems;
- •Veterans without phone access.
结局指标
主要结局
Change in Beck Scale for Suicidal Ideation (BSS). Aaron T. Beck, copyright 1991.
时间窗: At every visit: screen, baseline(s), week 2,4,6,8,12; timeframe is the past week, including today.
Continuous scale assessing suicidal ideation. Scores will range from 0 to 42, with lower scores indicating less suicidal ideation.
次要结局
- Change in Columbia Suicide Severity Rating Scale (C-SSRS). Posner, K; Brent, D; Lucas, c; Gould, M; Stanley, B; Brown, G; Fisher, P; Zelazny, J; Burke, A; Oquendo, M; Mann, J.(At every visit: screen, baseline(s), week 2,4,6,8,12; time frame includes lifetime and since last visit.)
研究者
Gretchen L. Haas, PhD
PI
VA Pittsburgh Healthcare System