We will evaluate two primary care-based, medication therapy management strategies that leverage an electronic health record to promote, patient understanding, medication reconciliation, medication adherence and disease control among hypertensive and diabetic patients at safety net clinics. Patients with multiple chronic illnesses use complex medication regimens, yet many, especially those with limited literacy, have difficulty performing routine medication tasks. Introduced with Medicare Part D, medication therapy management (MTM) serves as a mandate to help many older patients safely use their regimen. As currently defined, MTM includes medication review, assembly of a personal medication record, development of medication-related action plans, and follow-up. However, initial models of MTM have mostly been performed separate from patients'usual source of care (i.e. pharmacies). This may limit its effectiveness;medication- related concerns would be discussed by clinicians not fully aware of the regimen intended by the patients'prescribers. Cost is yet another barrier to widespread use of MTM. Our team has field tested at one academic internal medicine practice various low literacy MTM tools embedded within the electronic health record (EHR). For this study, we combine these tools to address a full range of MTM tasks. In aggregate, we refer to this as an Electronic health record-based Health literacy Medication therapy management Intervention, or 'EHMI'. We will evaluate the effectiveness of the EHMI strategy to improve 1) patient medication understanding, 2) medication reconciliation, 3) regimen adherence, and 4) disease control among hypertensive + diabetic patients treated in federally qualified health centers (FQHCs). As the EHMI strategy may or may not be sufficient, we will also evaluate the inclusion of a nurse educator to help patients utilize EHMI tools, provide brief counseling, and track progress.
Our specific aims are to: 1) Test the effectiveness of the EHMI strategy, with and without a nurse educator, to improve patient understanding, medication reconciliation, adherence, and health outcomes compared to usual care, 2) Determine if the effects of these strategies vary by patients'literacy skills, 3) Evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the intervention, and 4) Assess the costs required to deliver this intervention, exclusive of system design. We will conduct a three-arm, clinic-randomized trial at 12 FQHCs to evaluate the EHMI and EHMI + Nurse Educator interventions. Patients with diabetes and uncontrolled hypertension will be recruited and assessed again at 3, 6, and 12 months. We will also assess the fidelity and economic impact of the interventions to inform future dissemination efforts.

Public Health Relevance

Many patients with chronic disease have difficulty performing routine medication management tasks, particularly individuals with limited literacy, and this can cause dangerous medication errors and jeopardize treatment efficacy. The overall study objective is to rigorously evaluate two primary care-based medication therapy management strategies-one using a nurse educator and one without-that leverage an electronic health record to promote patient understanding of how to use medications, reduce medication discrepancies, improve adherence and improve disease control among hypertensive diabetic patients at safety net clinics. The EHR-based tools used here could be widely disseminated to other sites that use commercial EHRs, and the results of the nurse-led intervention will directly inform clinic care team redesign to promote safe and effective medication use.

National Institute of Health (NIH)
National Institute of Nursing Research (NINR)
Research Project (R01)
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Special Emphasis Panel (ZRG1-RPHB-A (50))
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Marden, Susan F
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Northwestern University at Chicago
Internal Medicine/Medicine
Schools of Medicine
United States
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