A Patient Advocate and Literacy-Based Treatment of Asthma
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| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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Asthma |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT01128348 |
| Primary Contact: |
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Principal Investigator
Andrea J Apter, MD, MSc, MA
University of Pennsylvania
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| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19104
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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