NCT02785458

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,005

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

June 8, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 23, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

April 12, 2016

Results QC Date

September 30, 2020

Last Update Submit

January 6, 2021

Conditions

High-risk Medications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Probability of Prescription Medication Proper Use

    1 Month post baseline to 3 Months post baseline

Study Arms (2)

Usual Care

NO INTERVENTION

Subjects will receive the current standard of care.

EMC2 Strategy

EXPERIMENTAL

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

Behavioral: EMC2 Strategy

Interventions

EMC2 StrategyBEHAVIORAL

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.

EMC2 Strategy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe, uncorrectable vision
  • Hearing or cognitive impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near North Health Services Corporation

Chicago, Illinois, 60610, United States

Location

Results Point of Contact

Title
Dr. Michael S. Wolf, PhD MPH
Organization
Northwestern University
mswolf@northwestern.edu
312-503-5592

Study Officials

  • Michael S Wolf, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • Stacy C Bailey, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • Michael K Paasche-Orlow, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Division Chief - Research Division of General Internal Medicine

Study Record Dates

First Submitted

April 12, 2016

First Posted

May 27, 2016

Study Start

June 8, 2017

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

January 27, 2021

Results First Posted

October 23, 2020

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)