A Patient Advocate and Literacy-Based Treatment of Asthma (HAP)
研究概览
详细说明
This application addresses broad Challenge Area (05), Comparative Effectiveness Research, and Specific Challenge Topic 05-MD105, Health Literacy. Half of US adults have no more than basic reading and numerical skills; inadequate health literacy is a consequence. It is associated with unsatisfactory patient-provider communication and poor health outcomes in chronic diseases including asthma. We found low numeracy to be associated with prior ED visits and hospitalizations for asthma and determined that numerical skill may attenuate the association of minority status with lower asthma-related quality of life. We propose a Patient Advocate Intervention (PAI) as the most practical immediate but sustainable method of achieving effective health literacy (EHL) (understanding of asthma management and the practice/health system). Adapted from the Patient Navigator of Harold P. Freeman, MD and informed by focus groups of asthma patients, the PAI addresses low literacy, facilitating patient-provider communication surrounding self-management and navigation of the practice and health system to ensure medical recommendations can be accomplished. The PA is a nonprofessional with guidance from a social worker who will assist with and model preparations for a visit with the asthma doctor, attend the visit, and afterwards confirm understanding as well as facilitate scheduling, obtaining insurance coverage, and overcoming other barriers to carrying out medical advice. The primary outcome is electronically-monitored use of inhaled corticosteroids (ICS), the treatment of choice for all but the mildest asthma. ICS use is a marker of successful patient-provider communication. Other outcomes are asthma-related: hospitalizations, ED visits, change in FEV1, and asthma-related quality of life. We hypothesize that the PAI will improve these outcomes by promoting EHL.
We will enroll 84 adults with a high prevalence of low numerical skills who are approximately 67% black and 10% Latino with moderate or severe asthma to carry out the following Specific Aims. Specific Aim 1: refine and evaluate the feasibility of PAI and Specific Aim 2: conduct a randomized comparison of PAI with standard asthma education to obtain effect size estimates for ICS adherence and asthma-related outcomes for a future R01 confirmatory randomized trial of the final version of PAI. Exploratory analyses will assess EHL as a mediator, various moderators, and estimate the incremental costs of PAI. This novel project fills several research gaps. It 1) compares and tests an intervention addressing literacy to improve health, one that can easily be incorporated into practice to better patient self-management and preventive care, 2) is a potentially long-lasting intervention which will benefit all patients, especially those with low health literacy, and 3) will potentially improve prevention of asthma exacerbations, reducing the need for ED use.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- physician's diagnosis of asthma
- prescribed inhaled steroid
- moderate or severe asthma according to NHLBI Guidelines
- evidence of reversible airflow obstruction and improvement with bronchodilator
- Did not participate in the experimental arm (problem-solving) of WIN Study, HL073932
Exclusion Criteria:
- significant other current pulmonary or cardiac disease
- severe psychiatric problems making it impossible to understand or carryout the protocol
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:patient advocate
Patient advocate works with patient before, during, and after a visit to asthma doctor. Patient receives video of asthma education materials |
patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication
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有源比较器:asthma education
Patient receives video of asthma education materials
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patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
adherence to prescribed inhaled corticosteroid regimen
大体时间:16 weeks
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16 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
change in FEV1
大体时间:16 weeks
|
16 weeks
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|
asthma-related quality of life
大体时间:16 weeks
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16 weeks
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asthma control
大体时间:16 weeks
|
16 weeks
|
|
emergency department visits for asthma
大体时间:16 weeks
|
16 weeks
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hospitalizations for asthma
大体时间:16 weeks
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16 weeks
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合作者和调查者
调查人员
- 首席研究员:Andrea J Apter, MD, MSc, MA、University of Pennsylvania
出版物和有用的链接
一般刊物
- Black HL, Priolo C, Gonzalez R, Geer S, Adam B, Apter AJ. An analysis of contextual information relevant to medical care unexpectedly volunteered to researchers by asthma patients. J Asthma. 2012 Sep;49(7):731-7. doi: 10.3109/02770903.2012.699988. Epub 2012 Jul 13.
- Black HL, Priolo C, Akinyemi D, Gonzalez R, Jackson DS, Garcia L, George M, Apter AJ. Clearing clinical barriers: enhancing social support using a patient navigator for asthma care. J Asthma. 2010 Oct;47(8):913-9. doi: 10.3109/02770903.2010.506681.
- Krishnan JA, Schatz M, Apter AJ. A call for action: Comparative effectiveness research in asthma. J Allergy Clin Immunol. 2011 Jan;127(1):123-7. doi: 10.1016/j.jaci.2010.08.032. Epub 2010 Sep 19.
- Apter AJ, Wang X, Bogen DK, Rand CS, McElligott S, Polsky D, Gonzalez R, Priolo C, Adam B, Geer S, Ten Have T. Problem solving to improve adherence and asthma outcomes in urban adults with moderate or severe asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011 Sep;128(3):516-23.e1-5. doi: 10.1016/j.jaci.2011.05.010. Epub 2011 Jun 25.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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