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

NCT02785458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1005

Last updated 2021-01-27

Study results available
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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).

Conditions

  • High-risk Medications

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Boston Medical Center

    collaborator OTHER
  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • University of Illinois at Chicago

    collaborator OTHER
  • Northwestern University

    lead OTHER

Principal Investigators

  • Michael S Wolf, PhD · Northwestern University

  • Stacy C Bailey, PhD · Northwestern University

  • Michael K Paasche-Orlow, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2019-09-20
Completion
2019-09-20

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02785458 on ClinicalTrials.gov