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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1005 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2019-09-20

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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High-risk Medications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

Subjects will receive the current standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

EMC2 Strategy

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

Group Type EXPERIMENTAL

EMC2 Strategy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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