EHR-based medication support and nurse-led medication therapy management: Rationale and design for a three-arm clinic randomized trial

Background--Patients with chronic conditions often use complex medical regimens. A nurse-led strategy to support medication therapy management incorporated into primary care teams may lead to improved use of medications for disease control. Electronic health record (EHR) tools may offer a lower-cost, less intensive approach to improving medication management. Methods and Results--The Northwestern and Access Community Health Network Medication Education Study is a health center- level cluster-randomized trial being conducted within a network of federally qualified community health centers. Health centers have been enrolled in groups of 3 and randomized to (1) usual care, (2) EHR-based medication management tools alone, or (3) EHR tools plus nurse-led medication therapy management. Patients with uncontrolled hypertension who are prescribed ≥3 medications of any kind are recruited from the centers. EHR tools include a printed medication list to prompt review at each visit and automated plain-language medication information within the after-visit summary to encourage proper medication use. In the nurse-led intervention, patients receive one-on-one counseling about their medication regimens to clarify medication discrepancies and identify drug-related concerns, safety issues, and nonadherence. Nurses also provide follow-up telephone calls following new prescriptions and periodically to perform medication review. The primary study outcome is systolic blood pressure after 1 year. Secondary outcomes include measures of understanding of dosing instructions, discrepancies between patient-reported medications and the medical record, adherence, and intervention costs. Conclusions--The Northwestern and Access Community Health Network Medication Education Study will assess the effects of 2 approaches to support outpatient medication management among patients with uncontrolled hypertension in federally qualified health center settings.