Patient adherence with chronic therapy is the necessary link between effective, evidence-based treatments and improved patient outcomes. However, the frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. Many studies have linked medication non-adherence to treatment failure;unnecessary and dangerous intensification of therapy;and excess health care costs, hospitalizations, and deaths. Although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. Simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. The proposed PATIENT (Promoting Adherence To Improve the Effectiveness of CVD Therapies) study is a pragmatic RCT to compare the effectiveness of two health information technology-based, low-intensity, low-cost population-based interventions for increasing adherence to selected chronic CVD medications with known efficacy for preventing cardiovascular morbidity and mortality. An Interactive Voice Recognition (IVR) intervention will use automated speech-recognition phone calls, integrated with an electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions in a timely manner. An Enhanced IVR (IVR+) intervention will augment the IVR intervention with: EMR-based feedback to primary care providers, mailed educational material to all patients, and personalized and tailored mailed reminders to patients who fail to fill prescriptions. The target population includes adults aged 40-80 with diabetes or prevalent atherosclerotic cardiovascular disease, for whom the use of an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker (ACEI/ARB), a statin, and aspirin are all recommended therapy for secondary prevention. The primary aims of this study are to determine if, for current users of statins and ACEI/ARBs, the IVR and IVR+ interventions lead to greater adherence compared to usual care and, if so, to compare the relative effectiveness of the IVR vs. IVR+ interventions. The Practical Robust Implementation and Sustainability Model (PRISM) will serve as the guiding framework for evaluating these interventions which, if successful, could have significant Public Health applications as flexible and generalizable components of managed care and pharmacy benefits programs.

Public Health Relevance

The primary goal of the PATIENT study is to increase both initial use and ongoing adherence to three classes of medications used to treat diabetes or cardiovascular disease. The PATIENT interventions use interactive voice recognition, with and without supplemental personalized mailings to patients and messages to providers, to deliver medication refill reminders, educate members about their conditions, and connect members with pharmacists and their doctors. If PATIENT's methods are successful, this research should lead to reduced hospitalizations and deaths, and to increased quality of life for people with diabetes or cardiovascular disease. This research should also be broadly applicable to other diseases and treatments.

National Institute of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Research Project (R01)
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Special Emphasis Panel (ZHS1-HSR-C (01))
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Hsia, David
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Kaiser Foundation Research Institute
United States
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Smith, David H; O'Keeffe-Rosetti, Maureen; Owen-Smith, Ashli A et al. (2016) Improving Adherence to Cardiovascular Therapies: An Economic Evaluation of a Randomized Pragmatic Trial. Value Health 19:176-84
Vollmer, William M; Owen-Smith, Ashil A; Tom, Jeffrey O et al. (2014) Improving adherence to cardiovascular disease medications with information technology. Am J Manag Care 20:SP502-10