Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- High-risk Medications
- Sponsor
- Northwestern University
- Enrollment
- 1005
- Locations
- 1
- Primary Endpoint
- Medication Knowledge (0-100)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study evaluates the effectiveness of an electronic health record based educational intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk medications. Half of the participants will receive the intervention, while the other half will receive the usual amount of information (usual care).
Detailed Description
Research has repeatedly demonstrated that individuals lack essential information on how to safely take prescribed (Rx) medications. A risk communication and surveillance strategy is needed in primary care to ensure that patients are adequately informed about medication risks and are taking prescribed regimens safely. The investigators devised an Electronic health record-based Medication Complete Communication (EMC2) Strategy that leverages electronic health record (EHR) and interactive voice response (IVR) technologies to: 1. prompt and guide provider counseling, 2. automate the delivery of Medication Guides at prescribing, 3. follow patients post-visit to confirm prescription understanding and use, and 4. deliver a care alert back to providers to inform them of any potential harms.
Investigators
Michael S. Wolf
Associate Division Chief - Research Division of General Internal Medicine
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •21 and older
- •English or spanish speaking
- •Primarily responsible for administering own medications
- •New prescription of one of 66 study medications on day of recruitment
- •Has a personal mobile or land line phone
Exclusion Criteria
- •Severe, uncorrectable vision
- •Hearing or cognitive impairments
Outcomes
Primary Outcomes
Medication Knowledge (0-100)
Time Frame: Baseline to 3 Months post baseline
Adjusted Least-square means of Medication Knowledge are calculated based on patient's ability to identify each medication's purpose and side effects, risks, warnings and benefits using general linear mixed models, specifying the identity link (PROC GLIMMIX). Treatment assignment by time is the independent variable of interest and modeled as a fixed effect, and clinic as a random effect, with additional subject statement to model correlations with patient. Confounding variables, such as age, preferred language, race, education, health status, number of chronic diseases, drug class, and health literacy (Newest Vital Sign) are included as fixed effects in the model. Patients are asked 10 questions (a scale developed by our team), and each questions is scored as correct/incorrect, and percentage of correctly answered questions is calculated (0-100 with 100 as best). Results are presented as adjusted least square means with 95% Confidence Intervals
Secondary Outcomes
- Probability of Prescription Medication Proper Use(1 Month post baseline to 3 Months post baseline)