Clinical trial NCT01578577: Northwestern University and Access Community Health Network Medication Education Study
Official title: EHR-based Health Literacy Strategy to Promote Medication Therapy Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Medication Therapy Management
Hypertension
Health Literacy
Medication Reconciliation
Medication Adherence
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2012-04-17
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Medication therapy management (MTM) has been described as a set of procedures that include: medication review, assembly of a personal medication record, development of action plans, intervention when necessary, and follow-up. However, evidence showing the effectiveness of general MTM interventions is scant. MTM has often been performed separately from patients' usual sources of care (i.e., at pharmacies). This could limit its effectiveness since medication-related concerns would be discussed by clinicians who are not aware of the regimen intended by patients' prescribers. Cost is another barrier to widespread use of MTM.

Health information technology in primary care could be leveraged to assist with MTM tasks. The investigators have field tested low literacy MTM tools embedded within an EHR to 1) activate patients to review medications, 2) automate the provision of plain language, medication information, and 3) provide print tools to help patients engage providers, and consolidate their regime. These tools were developed with patient, physician, and pharmacist feedback.

For this study, the investigators combine tools to address the range of MTM tasks. In aggregate, the study refers to this as an Electronic health record-based Health literacy Medication therapy management Intervention, or 'EHMI'. The investigators will evaluate the effects of this approach among patients with uncontrolled hypertension treated in federally qualified health centers (FQHCs). This may be a relatively low-cost strategy ideal for safety net practices that use EHRs and whose patients may be at greater risk for limited literacy. It is also possible that the EHMI strategy may not result in a significant change. Therefore, the investigators will also evaluate using a nurse educator to help patients utilize EHMI tools, provide brief counseling, and track progress.

This three-arm, clinic-randomized, controlled trial conducted within a network of FQHCs will evaluate the EHMI and EHMI + Nurse Educator interventions compared to usual care. Recruited patients will be followed for 12 months. The investigators will test the impact of these two strategies on blood pressure levels, with an anticipated power to detect a 4 mm Hg difference in systolic blood pressure as the primary outcome. The investigators will also assess the impact on diastolic blood pressure, as well as HbA1c and LDL cholesterol control in the subgroup with diabetes. The investigators will determine the interventions' effects on: 1) medication understanding, 2) discrepancies, and 3) adherence. The investigators will specifically examine intervention effects among groups with different literacy levels. The investigators will also assess the fidelity and cost of the interventions to guide future dissemination efforts.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: one year
Secondary outcomes:
measure: Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care.
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Effects of These Strategies by Patients' Literacy Skills
timeFrame: Baseline, 3 months, 6 months,12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: ACCESS Community Health Network
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephen Persell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Persell 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.