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临床试验/NCT03347552
NCT03347552已完成不适用

Home-Based Mental Health Evaluation (HOME): A Multi-Site Trial

University of Colorado, Denver3 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2014年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
323
试验地点
3
主要终点
Treatment Engagement 1

研究概览

简要总结

The purpose of this project is to investigate the effectiveness of the Home-Based Mental Health Evaluation (HOME) program, which is an innovative and culturally-relevant suicide prevention intervention for Veterans aimed at increasing treatment engagement and decreasing suicide risk following psychiatric hospitalization, a period of heightened suicide risk.

详细描述

The purpose of this project is to investigate the effectiveness of the Home-Based Mental Health Evaluation (HOME) program, which is an innovative and culturally-relevant suicide prevention intervention for Veterans aimed at increasing treatment engagement and decreasing suicide risk following psychiatric hospitalization, a period of heightened suicide risk. The research project employs a multi-site two-arm interventional trial design to study the effectiveness of the HOME program. Effectiveness of the treatment will be evaluated by comparing Veterans receiving the HOME program at two active treatment sites, Denver and Philadelphia Department of Veterans Affairs Medical Centers (VAMCs), to with those receiving care at two control sites, Houston and Portland VAMCs. The current protocol describes procedures as they will occur at all sites, including those completed locally at the Denver VAMC, which is the lead site for the study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The blind assessor will administer follow up measures. In order to keep the assessor blind to participant status (active vs. control), research staff will facilitate phone calls. To monitor blinding, the blind assessor will record if participants inadvertently un-blind themselves during the assessment and also record their guess to which treatment condition (active versus E-CARE)participants were allocated.

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age between 18-89
  • •Able to provide a phone number and the location of a residence at which they can be reached
  • •Planned location of discharge is a safe environment for the HOME provider to visit*
  • •Agree to receive the HOME program intervention (active site participants only)
  • •Ability to adequately respond to questions regarding the informed consent procedure

排除标准

  • •Receiving services from the Mental Health Intensive Case Management (MHICM) or Domiciliary program or being directly transferred to further inpatient or residential treatment
  • •Enrolled in other intervention studies that may affect the outcome of this study, or where this study may affect the outcome of the other study, until the subject has completed their participation in the other study
  • •Current involvement in the criminal justice system as a prisoner or ward of the state.

研究组 & 干预措施

Active Treatment

Experimental

Participants in the active arm will be enrolled in the HOME Program.

干预措施: HOME (Behavioral)

E-CARE

No Intervention

Receiving enhanced care as usual. Participants at these sites are described as receiving "enhanced care as usual" or "E-CARE" because they will be recruited, enrolled and complete baseline and follow-up assessments in addition to care as usual.

结局指标

主要结局

Treatment Engagement 1

时间窗: From discharge from the hospital through 90 days post discharge

Access to participants' VA electronic medical record will be utilized to address the hypothesis that Veterans participating in the HOME program will be significantly more likely to engage in treatment and or care more quickly. Data collection may be facilitated by VA's Compensation and Pension Record Interchange (CAPRI) and VA's Corporate Data Warehouse (CDW).

Treatment Engagement 3

时间窗: From discharge from the hospital through 90 days post discharge

Access to participants' VA electronic medical record will be utilized to address the hypothesis that Veterans participating in the HOME program will be significantly more likely to attend more outpatient appointments. Data collection may be facilitated by VA's Compensation and Pension Record Interchange (CAPRI) and VA's Corporate Data Warehouse (CDW).

次要结局

  • Lower Suicidal Ideation scores(3 months post-discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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