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

Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy (Phase 2)

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Behavioral: EMC2

Detailed Description

This is a 2-arm, multi-site, physician-randomized pragmatic trial to evaluate the impact and scalability of the EMC2 strategy to promote safe medication use and adherence.

Treatment Arms and Duration:

Usual Care. Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.

Intervention: EMC2 Strategy.

In brief, there are several components to this strategy that will be embedded into the workflow via EHR/patient portal platforms, mostly automating their implementation. Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:

1. Physician Medication Alert: If a prescribing physician attempts to place a new order or change to an existing study medication prescription, an EHR-generated alert will notify the provider that the medication requires patient counseling. Physicians can opt to ignore this alert.
2. Provider Counseling Support: Content from the 1-page, Med Guide Summary will appear on the screen, if selected by the provider, to orient and inform provider-patient discussion.
3. Automated Delivery of Med Guide + Summary: When patients leave an encounter, the medication order in Epic will automatically cue printing of both the 1-page, health literate Med Guide Summary for study medications and a full Med Guide, if applicable (latter is required by FDA for certain medications only, the former designed to enhance comprehension).

4. Follow-Up Portal Questionnaire: Within 1 week post-visit, patients will receive an automated email prompting them to log on to the patient portal. Patients' will be asked to fill out a short set of questions related to medication adherence, and other medication-related concerns (i.e. cost, side effects). If patients have not completed the questionnaire within 2 days, another email reminder will be sent. The information submitted back by the patient will be stored in the EHR. A second questionnaire will be sent 1 month later.

   The addition of the patient portal will provide opportunities to have ongoing communications with their clinic, access to regimen-specific medication information, and to provide a feedback loop informing healthcare providers of safety and adherence-related behaviors and concerns.

5. EHR Inbox Message to Clinic: The results of the patient portal questionnaire will be sent back to the EHR, populating an inbox message notifying the nurse/clinic staff and/or physician if a patient has a medication risk alert, detailing the nature of the issue (i.e. education needed, adherence problem, side effect concerns, etc.). The system will be flexible and allow the clinic to specify actions to be taken according to their workflow preferences; the default plan is that patient contact will be undertaken by nurses/clinic staff involved with care management.
6. Clinic Counseling: If a problem/concern is flagged during the review of the portal questionnaire, there will be an expectation for a clinic staff member to respond to the concern by calling the patient. A general orientation to staff at the clinic will provide guidance on how to perform brief counseling based on each specific clinic protocol.

Number of Patients:

While the expected sample size for this pragmatic study is 300, the investigators will recruit 330 patients (n=165 per site, the investigators anticipate 90% retention among the recruited sample by 3 months (n=297). The investigators therefore will over sample to accommodate some attrition.

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient is age 18 and older
• Patient is English speaking
• Patient is primarily responsible for administering their own medication
• Patient must have received a new or changed prescription for a product(s), identified by Eli Lilly and the study team, within 7 days of recruitment
• Patient must have access to the internet
• Patient must have a patient portal account

Exclusion Criteria:

• Severe, uncorrectable vision
• Severe hearing impairments
• Severe cognitive impairment
• No access to the internet or patient portal account

Providers must meet the following eligibility criteria:

• Resident, Attending Physician or Mid-level provider (NP, PA) working in the NMHC Endocrinology clinic or other study sites during study dates.

*Adults unable to consent, individuals under the age of 18, and prisoners will be excluded from this research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMC2; Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications: Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks; Patients will receive a Medication Guide + Summary with their After Visit Summary; Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study); Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.	Behavioral: EMC2; Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks; Patients will receive a Medication Guide + Summary with their After Visit Summary; Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study); Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
No Intervention: Usual Care; Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Specific Knowledge	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence- Ask 12	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.	Baseline-3 Months
Medication Adherence - Proper Use	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.	Baseline- 3 Months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Michael S Wolf, PhD MPH, Northwestern University; Principal Investigator: Stacy C Bailey, PhD MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: adherence; medication safety; electronic health record
• Other Study ID Numbers: STU00207507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No