Abstract
Background/Aims The frequent failure of patients with diabetes and cardiovascular disease to adhere to long-term medications remains one of the greatest challenges for chronic-disease management. Simple interventions designed to make small but significant improvements to adherence at the population-level may offer cost-effective and easily-disseminated options for enhancing adherence.We describe the design and implementation of a pragmatic clinical trial, PATIENT, designed to improve adherence to selected medications with known efficacy for preventing cardiovascular disease morbidity and mortality.
Methods We will recruit adults aged 40–80 with diabetes or cardiovascular disease, for whom the use of ACEI/ARBs and statins are recommended therapy for secondary prevention. The 3 arms of the study include 1) usual care; 2) an Interactive Voice Recognition (IVR) intervention, integrated with an electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions and 3) an Enhanced IVR (IVR+) intervention with EMR-based feedback to primary care providers, mailed educational material to patients, and personalized and tailored mailed reminders to patients who fail to fill prescriptions. The Practical Robust Implementation and Sustainability Model (PRISM) will serve as the guiding framework for evaluating these interventions. The study will take place within the Northwest, Hawaii, and Southeast regions of Kaiser Permanente and will be an illustration of how to conduct a large pragmatic trial in collaboration with care delivery systems.
Results As part of the first phase of this 3-year study, key stakeholders and advisors have been actively engaged, including individuals in health IT, care management, pharmacy, and health care providers. Input is being obtained through ongoing meetings with local advisory boards and a series of patient focus groups and in-depth, individual interviews with patients, providers, and health plan managers. The presentation will describe the finalized design of the intervention and highlight the findings from the ongoing developmental work.
Conclusions The PATIENT study interventions, if successful, could have significant public health applications as flexible and generalizable components of managed care and pharmacy benefits programs. Understanding systems-level and patient-level barriers to, and facilitators of, successful implementation is therefore critical to widespread implementation and development of these interventions.
