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临床试验/NCT02263742
NCT02263742已完成不适用

Increasing Health Care Choices and Improving Health Outcomes Among Persons With Serious Mental Illness

Yale University4 个研究点 分布在 1 个国家目标入组 204 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
204
试验地点
4
主要终点
Effectiveness of a Co-located Primary Health Care Center in a Local mental health center

研究概览

简要总结

This project aims to study health outcomes of individuals with mental illness attending a co-located primary health care center in a mental health center. This study uses mixed methods to collect a range of information about who chooses to use what Wellness Center services and in what combinations, with what short and longer-term effects and with what outcomes.

Based on participant interviews, identify barriers to and facilitators of access, service, and improvements in person-centered outcomes and elicit suggestions for enhancing health care outcomes and choice.

Collaborate with persons in recovery in using the data collected through Aims 1 and 2 to develop and pilot the effectiveness of a new peer-led community based intervention in enhancing access and choice and improving person-centered health outcomes.

详细描述

Background: Americans with serious mental illnesses (SMI) die an average of 25 years earlier due to modifiable risk factors, medical conditions, and lack of access to quality, coordinated care. Strategies for addressing this disparity have amassed evidence. What remains to be determined is who will choose to use these evidence-based practices (EBPs) when implemented in routine practice, in what combinations, with what short term effects and health outcomes, and what else might be needed for persons for whom these strategies are not effective.

Objectives: The proposed research builds upon the investigators receipt of a SAMHSA grant that established an integrated Wellness Center (WC) within the local mental health center that provides four EBPs: a) on-site primary care; b) screening of clients for modifiable risk factors and medical conditions; c) care coordination; and d) peer health navigation. Through PCORI, the investigators propose to add a comparative effectiveness dimension and a focus on patient-centered outcomes. The investigators specific aims are:

  1. to assess patient preferences and use of services, short-term effects, and longer term outcomes associated with various practices for the population and subpopulations;
  2. to identify barriers to and facilitators of access, service use, and improvements in traditional and patient-centered health outcomes; and
  3. to develop and pilot a peer-led, community-based intervention in enhancing access and choice, and improving patient-centered health outcomes, among 40 treatment-refractory clients of the WC.

The investigators long-term objectives are to: a) identify which practices work for which persons with SMI in improving health and patient-centered outcomes, and b) provide stakeholders around the nation with the knowledge and tools to replicate this model efficiently, effectively, and broadly.

Methods: The sample includes 360 poor, urban adults with SMI who are at risk for or have co-morbid medical conditions. Using participatory and mixed methodology, the investigators will assess Specific Aims 1 & 2 by collecting health and patient-centered outcome data on patients entering the WC and at 6 month follow-up intervals and analyze the data using Linear Mixed Models and logistic regression. Outcome data from the pilot intervention (Aim 3; N=40) will be compared to outcomes of a propensity matched sample of WC patients. Qualitative data will be collected each year through focus groups (N=48 agency stakeholders, year 1) and individual interviews (50 WC patients, years 2 & 3).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

  • 18 years or older
  • Clients receiving services from CMHC and the Wellness Center.
  • Research staff will verify with CMHC staff that the potential participant is receiving services currently at CMHC.
  • Provider research subjects will be included if they are a mental health provider at CMHC or if they are members of the staff for the Wellness Center
  • Adults with serious mental illness and physical illness

排除标准

  • Participant research subjects not receiving services at CMHC and the Wellness Center
  • Provider research subjects of other agencies will be excluded
  • Children and youth under 18 years of age

研究组 & 干预措施

Peer whole health

Experimental

Peer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes

干预措施: Peer whole health intervention (Behavioral)

EBPs at Wellness Center

Active Comparator

EBPs at Wellness Center will be the active comparative to measure healthcare choice and outcomes with the peer whole health intervention

干预措施: EBPs at Wellness Center (Behavioral)

结局指标

主要结局

Effectiveness of a Co-located Primary Health Care Center in a Local mental health center

时间窗: up to 30 months

Use mixed methods to collect a rage of information about who chooses to use Using quantitative and qualitative measures by looking at the number of participants, follow up rates, improvement in health indices

次要结局

  • Effectiveness of health care navigation in improving health outcomes for people with mental illness(up to 30 months)
  • Universal Health screening(up to 30 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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