Northwestern University and Access Community Health Network Medication Education Study
NAMES
EHR-based Health Literacy Strategy to Promote Medication Therapy Management
2 other identifiers
interventional
920
1 country
1
Brief Summary
Many patients have difficulty performing routine medication management tasks. Individuals with limited literacy are at high risk for these problems. The overall study objective is to rigorously evaluate two primary care-based medication therapy management strategies that leverage an electronic health record (EHR) to promote patient understanding, medication reconciliation, medication adherence and disease control among hypertensive patients at safety net clinics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Apr 2012
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 12, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
June 28, 2019
CompletedJune 28, 2019
June 1, 2019
4.2 years
April 12, 2012
June 4, 2019
June 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic Blood Pressure
The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.
one year
Secondary Outcomes (2)
Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care.
Baseline, 3 months, 6 months, 12 months
Effects of These Strategies by Patients' Literacy Skills
Baseline, 3 months, 6 months,12 months
Study Arms (3)
Standard Care
NO INTERVENTIONThis arm will serve as a control group and will not receive any intervention.
EHMI
EXPERIMENTALElectronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components, all leveraged by the Epic EHR platform (Verona, WI). The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.
Nurse Educator + EHMI
EXPERIMENTALInterventions
The EHMI intervention consists of multiple components, all leveraged by the Epic EHR platform (Verona, WI). The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.
This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.
Eligibility Criteria
You may qualify if:
- age is 18 years or older
- at least 3 medications are prescribed by their physician
- standardized mean blood pressure measurement ≥130 mm Hg systolic or ≥ 80 mm Hg diastolic if they are diabetic or mean blood pressure measurement ≥ 135 mm Hg systolic or ≥ 85 mm Hg diastolic if they are not
- a Mini-Cog Exam score of ≥ 3
- the patient is the person primarily responsible for administering their medication
- the patient does not intend to move or change their usual source of medical care during the next year.
You may not qualify if:
- the patient's usual source of medical care is not a participating ACCESS Community Health Center
- is non-English language speaking
- does not meet mean blood pressure criteria
- has a Mini-Cog Exam score of \< 3
- is not the person primarily responsible for administering medication
- intends to move or change their usual source of medical care during the next year.
- Is not prescribed at least 3 medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ACCESS Community Health Network
Chicago, Illinois, 60661, United States
Related Publications (2)
Persell SD, Karmali KN, Lazar D, Friesema EM, Lee JY, Rademaker A, Kaiser D, Eder M, French DD, Brown T, Wolf MS. Effect of Electronic Health Record-Based Medication Support and Nurse-Led Medication Therapy Management on Hypertension and Medication Self-management: A Randomized Clinical Trial. JAMA Intern Med. 2018 Aug 1;178(8):1069-1077. doi: 10.1001/jamainternmed.2018.2372.
PMID: 29987324DERIVEDPersell SD, Eder M, Friesema E, Connor C, Rademaker A, French DD, King J, Wolf MS. EHR-based medication support and nurse-led medication therapy management: rationale and design for a three-arm clinic randomized trial. J Am Heart Assoc. 2013 Oct 24;2(5):e000311. doi: 10.1161/JAHA.113.000311.
PMID: 24157649DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Stephen Persell
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Persell, MD, MPH
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 12, 2012
First Posted
April 17, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 28, 2019
Results First Posted
June 28, 2019
Record last verified: 2019-06