The electronic medication complete communication (EMC²) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care

Background Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs. Objective To evaluate the effectiveness of the Electronic Medication Complete Communication (EMC²) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care. Methods The automated EMC² Strategy consists of: 1) provider alerts to counsel patients on medication risks, 2) the delivery of patient-friendly medication information via the electronic health record, and 3) an automated telephone assessment to identify potential medication concerns or ADEs. The study will take place in two community health centers in Chicago, IL. Adult, English or Spanish-speaking patients (N = 1200) who have been prescribed a high-risk medication will be enrolled and randomized to the intervention arm or usual care based upon practice location. The primary outcomes of the study are medication knowledge, proper medication use, and reporting of ADEs; these will be measured at baseline, 4 weeks, and three months. Intervention fidelity as well as barriers and costs of implementation will be evaluated. Conclusions The EMC² Strategy automates a patient-friendly risk communication and surveillance process to promote safe medication use while minimizing clinic burden. This trial seeks to evaluate the effectiveness and feasibility of this strategy in comparison to usual care.