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

NCT03652272 | Completed Results

• 1 other identifier: STU00207507
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medication Adherence

Keywords

medication safety; adherence; electronic health record

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Medication Adherence- Ask 12

  Baseline-3 Months

• Medication Adherence - Proper Use

  Baseline- 3 Months

Study Arms (2)

EMC2

EXPERIMENTAL

Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications: 1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks 2. Patients will receive a Medication Guide + Summary with their After Visit Summary 3. 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) 4. 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

Usual Care

NO INTERVENTION

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.

Interventions

EMC2 BEHAVIORAL

1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks 2. Patients will receive a Medication Guide + Summary with their After Visit Summary 3. 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) 4. 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.

EMC2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Michael Wolf
• Organization: Northwestern University

mswolf@northwestern.edu

(312) 503-5592

Study Officials

• Michael S Wolf, PhD MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Stacy C Bailey, PhD MPH

  Northwestern University

  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 Vice Chair for Research, Department of Medicine

Model Details: 2-arm, multi-site, physician-randomized pragmatic trial to evaluate the impact and scalability of the Phase I EMC2 strategy to promote safe medication use and adherence.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 29, 2018
• Study Start: February 8, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)