Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation (G2P)
2015年5月8日 更新者：Public Health - Seattle and King County
The primary hypothesis the investigators will test is that that improving asthma guideline implementation and providing patients with a unified asthma management plan using a multi-component and multilevel intervention will improve patient-centered asthma outcomes compared to health plan case management, passive guideline dissemination and provider education.
研究概览
地位
未知
条件
详细说明
The study will use a factorial randomized controlled design to assess the comparative effectiveness of the following interventions among 8 community health centers and 550 patients with:
- Health plan enhanced intervention plus traditional provider education: Health plans will enhance case management support, monitor medication fills, and increase passive guideline dissemination. Traditional provider education will consist of implementation of the PACE asthma education program. Note that all participants and clinics will receive this intervention. In effect, this will be the base active comparator arm of the study.
- Home visit intervention: Community health workers will provide in-home tailored asthma support: assess asthma self-management knowledge and skills, conduct a home environmental assessment focused on asthma triggers, and conduct follow-up visits to support patient actions to improve asthma control based on unified asthma management plan.
- Enhanced clinic intervention with system integration: Clinics will implement a multi-component intervention that includes decision support, audit and feedback, provider and staff education, team-based care, and training and feedback in implementing office spirometry and allergy testing. EHR enhancements and clinic systems redesign will support this work. The EHR will also provide a platform for sharing a common asthma management plan and enhancing communications among care team members (clinicians, CHWs, plan case managers).
All four intervention groups will receive enhanced health plan intervention + provider education. The four study arms will receive the following additional different interventions: (a) usual clinic care; (b) a + home visit, (c) enhanced clinic care + system integration, and (d) c + home visit.
研究类型
介入性
注册 (预期的)
550
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Washington
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Seattle、Washington、美国、98104
- Public Health -- Seattle & King County
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
5年 至 75年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 5-75
- Provider-verified diagnosis of asthma
- Have uncontrolled asthma
- Primary language of English,Spanish or Vietnamese
- Patient of Neighborcare or HealthPoint Health
- Insured by Molina Healthcare or Community Health Plan of Washington
Exclusion Criteria:
- Patient planning to leave Neighborcare or Healthpoint Health within the next 12 months
- Household appearing to be unsafe for a visit by a community health worker
- Co-existing medical conditions that make asthma control a low priority for patient management or that confound outcome measurement or that preclude participation in self-management
- Participation in another asthma research study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Enhanced Clinic+ Unified Management Plan
Patients in study arm will receive:
|
其他名称：
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有源比较器：CHW Home Visit Only
Patients in study arm will receive:
|
-Home visit intervention: Community health workers will provide in-home tailored asthma support: assess asthma self-management knowledge and skills, conduct a home environmental assessment focused on asthma triggers, and conduct follow-up visits to support patient actions to improve asthma control based on unified asthma management plan.
其他名称：
|
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有源比较器：Enhanced Clinic+ Unified Plan+ CHW
Patients in study arm will receive:
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其他名称：
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无干预：Usual Care
-Usual clinic care with enhanced healthplan
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Symptom free days
大体时间：12 Months
|
Measured by questionnaire: Days without cough, wheeze, chest tightness, shortness of breath, nocturnal wakening from symptoms or activity limitation due to asthma in past 2 weeks.
|
12 Months
|
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Asthma control
大体时间：12 Months
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Measured by questionnaire and spirometry.
Asthma Control Adults: Asthma Control Test and EPR3 categories Asthma Control Children: cACT and EPR3 categories
|
12 Months
|
|
Asthma-related Quality of Life
大体时间：12 Months
|
Measured by questionnaire. Adults:
Children 7-17:
Children 5-6:
|
12 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Nocturnal wakening
大体时间：12 Months
|
Measured by questionnaire: Nights wakened in the past two weeks due to asthma.
|
12 Months
|
|
Asthma exacerbations
大体时间：12 Months
|
Measured by questionnaire: Need for oral steroids (3+ day course), hospitalization, ED visit or unscheduled clinic visit for worsening asthma in past 12 months
|
12 Months
|
|
Pulmonary function
大体时间：12 Months
|
Measured by spirometry: Post-bronchodilator FEV1 and FEV1 /FVC and change in pre-post bronchodilator FEV1 and FEV1 /FVC182 using EasyOne Diagnostic spirometer
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12 Months
|
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FeNO (Fractional exhaled Nitric Oxide)
大体时间：12 Months
|
Measured by portable handheld device: Online measurement of ppb in exhaled breath at 50 L/s (<25 ppb indicates normal value.)
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12 Months
|
|
Beta-agonist use
大体时间：12 Months
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Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks
|
12 Months
|
|
Oral steroid use
大体时间：12 Months
|
Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months
|
12 Months
|
|
Controller use
大体时间：12 Months
|
Measured by claims data: Controller to total asthma medication ratio > 0.5
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12 Months
|
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Asthma-related urgent health services utilization
大体时间：12 Month
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Measured by questionnaire and administrative data: Urgent clinic visits, emergency department visits, and hospitalizations during past three months and past year
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12 Month
|
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Missed work or school days
大体时间：12 Months
|
Measured by questionnaire: Number of school or work days missed in past two weeks.
|
12 Months
|
|
General Health Status
大体时间：12 Months
|
Measured by questionnaire: Adults: SF-12 Health Survey Children: SF -10 Health Survey |
12 Months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：James Stout, MD、University of Washington
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年12月1日
初级完成 (预期的)
2016年10月1日
研究完成 (预期的)
2016年10月1日
研究注册日期
首次提交
2014年7月11日
首先提交符合 QC 标准的
2014年7月14日
首次发布 (估计)
2014年7月15日
研究记录更新
最后更新发布 (估计)
2015年5月12日
上次提交的符合 QC 标准的更新
2015年5月8日
最后验证
2014年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.