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

Northwestern University

Status: Completed

Conditions: High-risk Medications

Treatments: Behavioral: EMC2 Strategy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02785458

STU00201638

1R01DK103684 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,005 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,005 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Subjects will receive the current standard of care.

EMC2 Strategy

Experimental group

Description:

Subjects will receive the EMC2 Strategy. See description of strategy below.

Treatment:

Behavioral: EMC2 Strategy