We will impart a Universal Medication Schedule (UMS) via increasingly available health and consumer technologies to promote patient adherence to complex prescription (Rx) drug regimens. Our team devised the UMS to simplify Rx use and help improve regimen adherence for the increasing number of adults taking complex, multi-drug regimens. 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 concept was highlighted by the Institute of Medicine, U.S. Pharmacopeia, and National Council for Prescription Drug Programs as a best practice. Despite considerable evidence and support for the UMS, how it may be optimally embedded in practice remains unclear. We recently tested the UMS in a clinical trial at the point of dispensing medication in pharmacy practice. Significant improvement was achieved in proper regimen use and adherence; those who were taking e 5 Rx drugs and/or were lower literate received the greatest benefit. But pharmacy was not the ideal point of implementation. Many patients use multiple pharmacies for cost or convenience, resulting in continued receipt of variable Rx information. In addition, patients would have benefited from direct guidance from their doctor on how to safely consolidate Rx regimens. Many also required basic reminders to aid memory, while others had multifaceted adherence concerns warranting periodic monitoring. We will now evaluate the independent and combined contributions of low cost, highly disseminable technologies to impart the UMS and promote adherence to multi- drug regimens at the point of prescribing in primary care. This includes: 1) leveraging an EHR to prescribe all medications with UMS Rx instructions and to provide patients with a UMS-informed medication list [EHR]; 2) sending SMS text reminders around UMS intervals [SMS]; 3) implementing a periodic regimen adherence assessment via a web-based, EHR patient portal to provide access to Rx information, monitor patient medication behaviors, and notify a clinic nurse when problems are identified [Portal]. In the proposed study, we will conduct a physician-randomized controlled trial using a 2x2 factorial design + usual care arm to compare the effectiveness of each of the above interventions, alone or in combination, to usual care and to one another. English and Spanish-speaking patients 50 and older from 1 of 3 federally qualified health centers in Chicago who take e 5 Rx drugs for chronic conditions will be randomized to receive: 1) Usual Care, 2) EHR only, 3) EHR + SMS, 4) EHR + Portal, or 5) EHR + SMS + Portal. Outcomes will be measured at baseline, 2 weeks, 1, 3, and 6 months (chart reviews at baseline and 6 months).
Our specific aims are to: 1) test and compare the effectiveness of the UMS EHR tools, with or without SMS and/or Portal interventions; 2) evaluate the fidelity of each strategy and explore patient, staff, physician, and health system factors influencing the delivery of UMS interventions, alone and in combination; 3) assess the costs required to deliver the interventions.
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. 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.
| Bailey, Stacy Cooper; Wismer, Guisselle A; Parker, Ruth M et al. (2017) Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults. Contemp Clin Trials 62:21-26 |
