We will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. Our research team previously introduced the concept of the UMS to standardize and simplify medication instructions to support safe and effective prescription (Rx) drug use. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. We recently tested the UMS in a clinical trial at the point of dispensing medication in pharmacy practice among adults with diabetes. Significant improvement was achieved in proper regimen use and adherence; those who were taking ? 5 Rx drugs and/or were lower literate received the greatest benefit. Yet pharmacy was not the ideal point of implementation, as we learned many patients use multiple pharmacies for cost or convenience, resulting in continued receipt of variable Rx information. Further, findings indicate patients 1) may benefit from direct guidance from their doctor on how to safely consolidate Rx regimens to the most efficient daily schedule, and 2) need basic reminders to support memory. In the proposed study, we will impart the UMS at the point of prescribing in primary care using electronic health records (EHRs). As its foundation, our new intervention will standardize prescribing within an EHR so all medication orders include UMS Rx instructions ('sigs') and patients receive both a medication information sheet and UMS-structured medication list with after-visit summaries. We have already successfully developed and pilot tested these tools (in English and Spanish) within the Epic EHR system. In addition, mobile tools may further improve regimen use. We will link a unidirectional short message service (SMS) text reminder service to the EHR, delivering medication reminders to patients around UMS intervals. We propose to conduct a 3-arm, physician-randomized controlled trial to evaluate the effectiveness of the UMS EHR-based strategy, with and without SMS text reminders, to improve patient understanding, safe use and adherence compared to usual care. 1200 (n=400 per arm) English and Spanish-speaking primary care patients living with type 2 diabetes and taking ? 5 Rx drugs will be enrolled from primary care practices in Chicago, IL and New York, NY, with outcomes assessed at baseline, 2 weeks, 3 and 6 months. We will also determine the fidelity and costs of the interventions to guide future dissemination efforts.
Our specific aims are to: 1) Test the effectiveness of the UMS and UMS + SMS text reminder strategies compared to usual care; 2) Determine if the effects of these UMS strategies vary by patients' literacy skills and language; 3) Evaluate the fidelity of the two strategies and explore patient, staff, physician, and health syste factors influencing the interventions; and 4) Assess the costs required to deliver either intervention from a health system perspective.
Studies have repeatedly documented that many patients have problems performing routine medication tasks, and this is a root cause of medication errors, adverse drug events, and poor adherence to multi-drug regimens. The Universal Medication Schedule (UMS) is a straightforward and feasible strategy in primary care to help standardize the prescribing and dispensing of prescription medications for the increasing number of adults living with diabetes. We will merge the UMS concept with increasingly available health and consumer technologies to help patients overcome common medication self-management barriers and achieve optimal health benefits.
