This SBIR Phase I application proposes development of the MedicaSafe ChemoCareRx, a technology- enabled specialty pharmacy service for oral oncology patients built around MedicaSafe's proprietary Medication Therapy Optimization (MTO) technology. The increased use of oral oncology chemotherapy regimens has led to a paradigm shift in the treatment of cancer. Patients are no longer required to receive treatment at infusion centers, but instead can complete treatments at home on their own. Although this new treatment option provides patients with increased flexibility and control, it also poses significan challenges and risks. With increased patient responsibility and reduced clinical oversight, treatment adherence and side-effect management have become major concerns for this patient population. As a result, specialty pharmacies focused specifically on oral oncolytics are becoming increasingly more common place in the U.S. and elsewhere. The goal of these programs are to maximize adherence to therapy, educate patients about medication tolerance and adverse effects, and actively monitor regimen adherence, persistency, and length of therapy, usually through treatment counseling services delivered via the phone. Although specialty pharmacy programs have been shown to increase adherence rates and reduce overall healthcare costs relative to their retail counterparts, there is significant room for improvement, as the average adherence rates of cancer patients who utilize these services still remain significantly below the minimally desirable adherence threshold. Moreover, the "high-touch" approach usually employed by specialty pharmacy programs is also extremely time and resource intensive, as it requires groups of specially trained clinicians to devote extensive amounts of time to patient assessments, education, and follow-up. As a result of these and other operational costs, it is extremely hard for specialty pharmacies to remain profitable in the current marketplace. Development of ChemoCareRx will directly address this marketplace opportunity. Key components of the system include a 3G-connected, Android based Electronic Adherence Device (EAD) with a "smartphone like" touchscreen interface designed for tracking and dispensing complex, multi-drug treatment regimens;an adapted multimedia version of an empirically-validated Symptom Management Guide (SMG) for use by patients on the EAD touchscreen;a set of Treatment Optimization Algorithms for optimizing patient medication regimens with respect to lifestyle and safety, and real-time Treatment Reports with detailed medication adherence data and symptom severity levels able to be automatically integrated into physician and pharmacy Electronic Medical Records (EMRs). Phase I will involve empirical development and proof of concept testing of ChemoCareRx utilizing a user- centered design approach. Activities with patients, oncologists, clinical pharmacists, adherence researchers and key opinion leaders in the healthcare industry will include interviews to explore challenges and requirements of the approach;a task analysis to identify potential use-related hazards and improve task performance;low fidelity prototype testing and development activities to refine the conceptual design of the system;high-fidelity testing and development with "looks like, work likes" physical prototypes of core system components to test system stability and usability;a pilot adherence study to compare performance of the ChemoCareRx relative to standard care (SC) in real-world clinical environment, and an acceptance study to test acceptance of the system from the patient and provider point of view.
The increased use of oral oncology chemotherapy regimens has led to a paradigm shift in the treatment of cancer. Although this new treatment option provides patients with increased flexibility and control, treatment adherence and side-effect management have become major concerns as clinical oversight is reduced for this patient population. This research will develop a technology-enabled treatment adherence intervention for oral oncology chemotherapy regimens that will increase adherence rates while reducing time and resource costs.