~ 22 million Americans have asthma, 6 million under 18. Annual cost of care is estimated at $19.7 billion, with 456,000 hospitalizations and 1.5 million ER visits. Inhaled corticosteroids effectively control symptoms and reduce morbidity, mortality and cost, but outpatient studies show that 28-56% of patients do not adhere to ICS regimens. A 1979 study of children in the ER with asthma found that only 2% had therapeutic levels of the controller medicine theophylline. Only 8%-13% of patients continue to fill prescriptions after 1 year. It is difficult for clinicians to determine if treatment failure is dueto non-adherence because self-reported adherence is unreliable. Non-adherent patients are at risk of excess morbidity, mortality and intervention due to the inability to diagnose and address the true cause of treatment failure. This project will integrate an innovative adherence telemonitoring device for inhaled medications with a new motivational interviewing strategy that will enable clinicians to determine the root cause(s) of asthma treatment failure and deliver tailored interventions to improve adherence and/or correct inadequate medical treatment. The product will differentiate two major causes of treatment failure: non-adherence and incorrect medication or dose. In a pilot study, the PI used medication monitoring and psycho-educational adherence programs in children with severe asthma to significantly reduce morbidity, ER use, hospitalization and cost. This research extends that work and addresses two important knowledge gaps. First, NHLBI Expert Panel Report 3 states that adherence monitoring is a key component of management, but notes that the supporting data is weak, and encourages trials of adherence monitoring. Second, 56% of American Academy of Allergy Asthma &Immunology members say they don't know how to manage nonadherence. The innovation of this product is the combined use of 1) the SmartInhaler(R) telemonitor that transmits the date and time that controller and rescue medications are dispensed from metered dose or dry powder inhalers;2) a peak flow telemonitor, 3) an interactive voice response system that collects symptoms and, 4) timely motivational interviewing adherence strategies (MIAS), delivered by telephone when adherence is low or the patient is symptomatic. There is no product currently in clinical use that monitors inhaled medication adherence, links the adherence data with symptoms to identify the root causes of treatment failure and enables clinicians to deliver timely MIAS interventions. Because the adherence and symptoms data are real time, clinicians can leverage that information to create 'teachable moments'that improve adherence. Upon completion of Phase 2, we will have a scalable, low-cost, web-based product that improves asthma care and reduces cost. We will market to disease management companies and entities with financial risk such as ACOs, patient-centered medical homes, at-risk provider networks, insurers and the VA.

Public Health Relevance

This project is designed to help providers correctly identify the cause of asthma symptoms. Patients will receive medication and lung function telemonitors to explain if asthma symptoms are due to failure to take medication or insufficient medication. Providers will counsel patients to help them be more consistent with their asthma medication.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-RPHB-C (10))
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Croxton, Thomas
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Asthma Management Systems, LLC
United States
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