Medication non-adherence is a widespread problem with serious ramifications at every point in the human life cycle. Most of this burden is borne by adults 55 and older. Nationwide statistics make it clear that non- adherence presents a formidable problem for efforts to promote active lifestyles and increase health expectancy. Annually, non-adherence is responsible for 10 percent of hospitalizations, 125,000 deaths, and $100 B in healthcare costs. Most prior attempts to improve adherence have proven costly, labor-intensive, and overall minimally effective. The problem has been particularly refractory for chronic asymptomatic conditions such as hypercholesterolemia. ? ? The solution to be studied in this SBIR was developed by two physician-scientists who have first-hand familiarity with non-adherence. They have developed a low-cost, consumer- and pharmacist-tested, telemedicine intervention that empowers patients to practice better adherence. This informatics-powered intervention has demonstrated usability in multiple Focus Groups, a randomized crossover pilot study, and most recently a commercial trial at a local pharmacy. In the controlled pilot study, medication adherence rose 33 percent relative to controls (p < 0.0001). ? ? We now propose a randomized controlled trial of the intervention for a common and important application: statin use in adults 55 years and older with asymptomatic hypercholesterolemia. The main hypothesis to be tested is that the proprietary intervention can be used to boost and sustain medication adherence for senior adults with chronic asymptomatic illnesses. The study will randomize 100 subjects who already use atorvastatin to receive the intervention versus control (standard of care) and follow them over 8 months. Outcome measures will be daily adherence rates as measured by Medication Event Monitoring System (MEMS) caps, monthly refill rates, persistency, over-medication error rates, and serum lipid profiles.
Specific aims are to: (1) measure the effect of the intervention on atorvastatin adherence and persistency; and (2) assess the ability of the intervention to collect data on medication adherence, with MEMS caps as a reference. We anticipate that the intervention will (1) boost adherence and persistency; (2) reduce over-medication errors; and (3) provide an automated medication adherence database for patient care and public health surveys. ? ? Based on iterative Focus Groups, consumer tests, materials trials, and pharmacist-directed development, we expect the intervention to be clinically effective, economical, easy-to-use, and widely accessible to patients. If the results support these predictions, the system can be scaled up rapidly to benefit the American population. A detailed business plan is in place to market the system to health care payers and pharmaceutical companies. The company has partnered with a nationwide pharmaceutical distributor to distribute medications in specially labeled bottles, and with various health-oriented merchants to fulfill rewards. ? ? ?
