SBIR-STTR Award

Medication nonadherence is a costly healthcare problem, adding $177 billion annually to the nation's healthcare expenditures. Three out of four Americans do not take their medicine as prescribed, and the ramifications affect virtually every aspect of the health care system. It is called America's other drug problem for good reason. Nonadherence issues are particularly troublesome with oral chemotherapeutic medications, which are increasingly entering the market, and which often have severe toxicities and narrow therapeutic indices. A review of adherence published in the Journal of the National Cancer Institute found that up to 80 percent of cancer patients failed to follow their prescriptions. There is not a ""one size fits all"" solution to the adherence problem. Thus, this Fast Track application aims to facilitate widespread adoption of promising telemonitoring technology for improving medication adherence by extending it to additional wireless platforms to make it accessible to broad sociodemographic groups. It fosters partnerships among collaborators from academia, healthcare, and industry working together toward this aim. The proposed RandD would enable us to make very promising technology available to more people who could benefit from it by acknowledging their age, lifestyle, disease state, and preference for a particular communication strategy and platform. The existing technology was developed through a Small Business Innovation Research (SBIR) grant from the National Institute on Aging. It integrates cell phones, radio frequency identification (RFID), and health and behavioral informatics to optimize medication compliance, track medication use, and extend patient care to the ambulatory setting. It has consistently demonstrated adherence rates of 96 percent to 98 percent, along with clinically significant improvements in self efficacy, in randomized control studies among elderly chronic disease and cancer patients taking from 1 to 11 medications/day. Usability testing was conducted by an independent third party at NCI's User-Centered Informatics Research Lab with outstanding success. Patients reported that the technology makes them feel more confident that they will be able to manage their medications. Clinicians participating in the usability testing gave the clinical interface and Web service high marks, calling it ""a great boon for the research nurse or clinical trial coordinator."" We will extend the existing telemonitoring technology, which runs on a cellphone/PDA, to three new platforms: a low-cost smartphone, the Apple iPhone, and an Internet appliance called Chumby. Work will proceed through six stages. In Phase I we will: (1) develop functional prototypes on three new platforms (2) conduct focus groups to evaluate acceptance by patient end-users, and end-user demographics relative to preference for a particular platform. In Phase II we will: (3) develop full functionality on three new platforms based on focus group input (4) integrate and aggregate adherence and patient reported outcomes data from all platforms through a single web service and user interface (5) conduct a pilot study to demonstrate technical feasibility and assess usability and efficacy (6) assess acceptance of the web service and clinical interface among a sample of clinicians, physicians, providers, and stakeholders in the pharmaceutical supply chain.

Public Health Relevance:
This Fast Track application aims to facilitate widespread adoption of promising telemonitoring technology for improving medication adherence by extending it to additional wireless platforms to make it accessible to broad sociodemographic groups. Three out of four Americans do not take their medicine as prescribed, and the ramifications affect virtually every aspect of the health care system. Lack of medication compliance leads to unnecessary disease progression and complications, additional doctor visits and hospitalizations, reduced functional abilities, early admission to assisted-care facilities, lower quality of life, and even death. It is called America's other drug problem for good reason. The current telemonitoring technology has consistently demonstrated adherence rates of 96 percent to 98 percent in randomized control studies among elderly chronic disease and cancer patients taking from 1 to 11 medications/day. There is not a ""one size fits all"" solution to the adherence problem. The proposed RandD would enable us to make very promising technology available to more people who could benefit from it by acknowledging their age, lifestyle, and preference for a particular communication strategy and platform. Telemonitoring such as that proposed here may facilitate patient self-efficacy and improve adherence to recommended dosing to optimize outcomes and enable ""aging in place."" It fosters partnerships among collaborators from academia, healthcare, and industry working together toward this aim.

Thesaurus Terms:
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Medication nonadherence is a costly healthcare problem, adding $177 billion annually to the nation's healthcare expenditures. Three out of four Americans do not take their medicine as prescribed, and the ramifications affect virtually every aspect of the health care system. It is called America's other drug problem for good reason. Nonadherence issues are particularly troublesome with oral chemotherapeutic medications, which are increasingly entering the market, and which often have severe toxicities and narrow therapeutic indices. A review of adherence published in the Journal of the National Cancer Institute found that up to 80 percent of cancer patients failed to follow their prescriptions. There is not a ""one size fits all"" solution to the adherence problem. Thus, this Fast Track application aims to facilitate widespread adoption of promising telemonitoring technology for improving medication adherence by extending it to additional wireless platforms to make it accessible to broad sociodemographic groups. It fosters partnerships among collaborators from academia, healthcare, and industry working together toward this aim. The proposed RandD would enable us to make very promising technology available to more people who could benefit from it by acknowledging their age, lifestyle, disease state, and preference for a particular communication strategy and platform. The existing technology was developed through a Small Business Innovation Research (SBIR) grant from the National Institute on Aging. It integrates cell phones, radio frequency identification (RFID), and health and behavioral informatics to optimize medication compliance, track medication use, and extend patient care to the ambulatory setting. It has consistently demonstrated adherence rates of 96 percent to 98 percent, along with clinically significant improvements in self efficacy, in randomized control studies among elderly chronic disease and cancer patients taking from 1 to 11 medications/day. Usability testing was conducted by an independent third party at NCI's User-Centered Informatics Research Lab with outstanding success. Patients reported that the technology makes them feel more confident that they will be able to manage their medications. Clinicians participating in the usability testing gave the clinical interface and Web service high marks, calling it ""a great boon for the research nurse or clinical trial coordinator."" We will extend the existing telemonitoring technology, which runs on a cellphone/PDA, to three new platforms: a low-cost smartphone, the Apple iPhone, and an Internet appliance called Chumby. Work will proceed through six stages. In Phase I we will: (1) develop functional prototypes on three new platforms (2) conduct focus groups to evaluate acceptance by patient end-users, and end-user demographics relative to preference for a particular platform. In Phase II we will: (3) develop full functionality on three new platforms based on focus group input (4) integrate and aggregate adherence and patient reported outcomes data from all platforms through a single web service and user interface (5) conduct a pilot study to demonstrate technical feasibility and assess usability and efficacy (6) assess acceptance of the web service and clinical interface among a sample of clinicians, physicians, providers, and stakeholders in the pharmaceutical supply chain.