A Patient Advocate and Literacy-Based Treatment of Asthma

Study Overview
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Brief Summary
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Half of US adults have no more than basic reading and numerical skills. A consequence is inadequate health literacy, which is associated with unsatisfactory patient-provider communication and poor health outcomes in chronic diseases, including asthma. We have adapted a patient navigator intervention to address asthma in high risk communities as a practical, immediate, and sustainable method of achieving effective health literacy in patients low health literacy. This intervention will lead to improved adherence and asthma control, attenuating health disparities so marked in asthma. It is compared for efficacy and cost-effectiveness with asthma education.

Detailed Description
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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.

Official Title
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A Patient Advocate and Literacy-Based Treatment of Asthma

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: patient advocate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient advocate<br>Patient advocate works with patient before, during, and after a visit to asthma doctor. Patient receives video of asthma education materials | Behavioral: patient advocate<br>* patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication<br>|
| Active Comparator: asthma education<br>Patient receives video of asthma education materials | Behavioral: patient advocate<br>* patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to prescribed inhaled corticosteroid regimen |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in FEV1 |  | 16 weeks | 
| asthma-related quality of life |  | 16 weeks | 
| asthma control |  | 16 weeks | 
| emergency department visits for asthma |  | 16 weeks | 
| hospitalizations for asthma |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, adherence, quality of life, health literacy, health disparities