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临床试验/NCT02084979
NCT02084979已完成不适用

A Controlled Trial of Patient Centered Telepsychiatry Interventions

University of California, Davis6 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2014年4月最近更新:
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
185
试验地点
6
主要终点
Global Assessment of Functioning (GAF)

研究概览

简要总结

This two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.

详细描述

This project addresses a critical public mental health problem: the need to improve access to high quality, mental health services for diverse populations through improving the flow of clinical work across care settings (primary care and specialty care) by implementing an efficient, provider compatible, administratively simple health IT solution: Asynchronous Telepsychiatry. To assess the impact of this novel approach, this two-year randomized controlled trial of clinical outcomes seeks to evaluate the superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality, cost and outcomes of care over the usual care for adults referred from primary care clinics for psychiatric evaluation and treatment.

Aim 1: To assess whether the ATP delivery model improves clinical OUTCOMES in adult patients referred for psychiatric treatment by their PCPs; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:

H1: Higher scores over the course of treatment (better clinical trajectory) on the Short-Form-12 Health Survey (SF12- the primary outcome measure), the Clinical Global Impressions scale (CGI), the Who Disability Schedule (WHODAS) and the Global Assessment of Functioning (GAF) score.

H2 (Exploratory): Improved clinical trajectories on specific disorder scales, such as the PSQ9, the Hamilton Anxiety Scale (HAMA), the GAD7 and the AUDIT substance abuse scale over the those in the "usual care" arm.

Aim 2: To assess whether ATP improves the QUALITY of care for adult patients referred for psychiatric treatment by their PCPs and for PCP providers; Hypotheses: Compared to the participants in the 'usual care" arm, participants in the ATP arm will show:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • aged 18 or older
  • diagnosis of a mood disorder, anxiety disorder, or substance/alcohol abuse disorder(s)
  • referred by PCP at participating site.

排除标准

  • less than 18 years
  • imminent suicidal ideation and/or plans
  • immediate violent intentions or plans
  • incarceration
  • significant cognitive deficits
  • patient who's PCP recommends not participating.
  • PCP not at participating site

研究组 & 干预措施

Asynchronous telepsychiatry

Experimental

Experimental Arm: Asynchronous telepsychiatry evaluation and consultation

干预措施: telepsychiatry evaluation (Behavioral)

Synchronous telepsychiatry

Active Comparator

Control Arm: Synchronous telepsychiatry evaluation and consultation

干预措施: telepsychiatry evaluation (Behavioral)

结局指标

主要结局

Global Assessment of Functioning (GAF)

时间窗: every 6 months for a 2 year follow-up period

The GAF is used by clinicians to rate patients' social, occupational and psychological functioning Scale from 0-100 with 100 being the superior functioning and 1 being poor functioning (0 not enough info)

The Clinical Global Impression (CGI)

时间窗: every 6 months for a 2 year follow-up period

The CGI is a widely used clinician rated scale that assesses a patient's response to mental health treatment.

次要结局

  • PCL(every 6 months for a 2 year follow-up period)
  • The Alcohol Use Disorders Identification Test (AUDIT)(Every 6 months- 2 year follow-up period)
  • The Patient Telemedicine Satisfaction Questionnaire(every 6 months- 2 year follow-up period)
  • PHQ-9(every 6 months for a 2 year follow-up period)
  • Provider Telepsychiatry Satisfaction Questionnaire(every 6 months for a 2 year follow-up period)
  • The Generalized Anxiety Disorder 7 item (GAD-7)(every 6 months for a 2 year follow-up period)
  • SF12(every 6 months for a 2 year follow-up period)
  • Manual for WHO Disability Assessment Schedule - WHODAS 2.0(every 6 months for a 2 year follow-up period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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