Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial

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).

Study Overview

• Status: Completed
• Conditions: High-risk Medications
• Intervention / Treatment: Behavioral: EMC2 Strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 1005
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Near North Health Services Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Subjects will receive the current standard of care.
Experimental: EMC2 Strategy; Subjects will receive the EMC2 Strategy. See description of strategy below.	Behavioral: EMC2 Strategy; The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Knowledge (0-100)	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	Baseline to 3 Months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probability of Prescription Medication Proper Use	Subjects will be asked to demonstrate proper use of the medication by indicating the correct dose (amount of medication taken each time), frequency (times per day), and total pills/units per day. For non-PRN medications, all must be answered correctly to be considered proper use (yes/no) , whereas for PRN medications, proper use is determined if the patient indicated the correct dose or less, the correct frequency or less, and the correct total pills/units or less. Proper use is modelled as a binary outcome, and General linear mixed models are used, specifying the logit 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 factors, such as drug class and health literacy (Newest Vital Sign) are also included in the model as fixed effects. Results are presented as adjusted least square means with 95% CI	1 Month post baseline to 3 Months post baseline

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Illinois at Chicago; Boston Medical Center; University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Michael K Paasche-Orlow, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2017
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: STU00201638; 1R01DK103684 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No