NCT03652272

Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy

Completed NA Results posted Last updated 7 March 2025

What this trial tests

NA trial testing EMC2 in Medication Adherence in 301 participants. Completed in 27 September 2021.

Timeline

8 February 2019

Primary endpoint
27 September 2021

27 September 2021

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	301
Start date	8 February 2019
Primary completion	27 September 2021
Estimated completion	27 September 2021
Sites	1 location across United States

Drugs / interventions tested

• EMC2

Conditions studied

• Medication Adherence — all drugs for Medication Adherence →

Sponsor

Northwestern University

Who can join

18 and older, any sex, with Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medication Specific Knowledge Primary · Baseline

Patients are asked about their medication's 1) indication, 2) risks or warnings (knowledge of risk/warnings, correct or incorrect per item) and 3) side effects (knowledge of at least two side effects, correct or incorrect per item). Correct answers were graded blindly by 2 reviewers and any discordance was resolved by a third pharmacist. Total scores ranged from 0-100, with a higher value associated with a better outcome, that reflects the percent correct of possible points.

Group	Value	95% CI
EMC2	63.82	59.53 – 68.11
Usual Care	62.80	58.80 – 66.80

Medication Adherence- Ask 12 Secondary · Baseline-3 Months

The ASK-12 survey covers three adherence domains: inconvenience/forgetfulness, treatment beliefs and behavior. Scores range from 12-60, with higher scores translating to greater barriers to adherence.

Group	Value	95% CI
EMC2	22.33	21.33 – 23.32
Usual Care	21.56	20.64 – 22.48

Medication Adherence - Proper Use Secondary · Baseline- 3 Months

Patients will be asked the last day they took their medication and how. A patient's proper timing (last day and # of times per day), dosing (number of pills per dose), and spacing between doses (for BID, TID medications only) will be coded as correct or incorrect. Patients will be classified as having properly used their medication if they correctly reported all components.

Group	Value	95% CI
EMC2	0.78	0.62 – 0.88
Usual Care	0.62	0.45 – 0.76

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Event data was collected post 3.5 months from EMC2 intervention.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

EMC2

Serious: 0/143 (0%)

Deaths: 0/143

Usual Care

Serious: 0/158 (0%)

Deaths: 0/158

Other adverse events (1 terms — click to expand)

Reaction	System	EMC2	Usual Care
Medication Side Effects	General disorders	—	—

Data from ClinicalTrials.gov NCT03652272 adverse events section.

Sponsor's own description

There is a well-documented need for effective interventions that can help patients understand and safely adhere to prescribed medications, particularly those with greater potential for harm if not taken correctly. The investigators will leverage health and consumer technologies with their EHR-based Medication Complete Communication (EMC2) Strategy to: 1) inform patients about medication risks and safe use, 2) promote provider education and counseling about prescribed drugs and 3) monitor patient adherence outside of visits. The EMC2 Strategy could be feasible, sustainable, and readily available to ambulatory care practices.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.