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Northwestern University and Access Community Health Network Medication Education Study

EHR-based Health Literacy Strategy to Promote Medication Therapy Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01578577
Acronym
NAMES
Enrollment
920
Registered
2012-04-17
Start date
2012-04-30
Completion date
2016-06-30
Last updated
2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Medication Therapy Management, Hypertension, Health Literacy, Medication Reconciliation, Medication Adherence

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.

Interventions

BEHAVIORALEHMI

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.

BEHAVIORALNurse Educator + EHMI

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.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic Blood Pressureone yearThe primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.

Secondary

MeasureTime frameDescription
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 monthsThis will be assessed by measuring patient medication understanding, medication reconciliation, adherence, and health outcomes (diastolic blood pressure, and among the diabetic subgroup Hemoglobin A1c \<8.0 and LDL Cholesterol \<100). Reported here: HbA1c \<8 at 12 months. Full secondary outcomes have been published. Persell SD, Karmali KN, MD, 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;178:1069-1077.
Effects of These Strategies by Patients' Literacy SkillsBaseline, 3 months, 6 months,12 monthsWe will measure how the effects of the interventions vary based on the participants' literacy levels. SBP at 12 months reported below.

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard Care
This arm will serve as a control group and will not receive any intervention.
254
EHMI
Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components. The EHMI 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.
262
Nurse Educator + EHMI
Nurse Educator + EHMI: 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.
278
Total794

Baseline characteristics

CharacteristicStandard CareEHMINurse Educator + EHMITotal
Age, Continuous53 years
STANDARD_DEVIATION 9.5
53.6 years
STANDARD_DEVIATION 9.7
51.6 years
STANDARD_DEVIATION 9.5
52.7 years
STANDARD_DEVIATION 9.6
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants4 Participants23 Participants37 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
237 Participants250 Participants233 Participants720 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
7 Participants8 Participants22 Participants37 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
234 Participants243 Participants215 Participants692 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants8 Participants22 Participants37 Participants
Race (NIH/OMB)
White
13 Participants11 Participants41 Participants65 Participants
Sex: Female, Male
Female
183 Participants175 Participants187 Participants545 Participants
Sex: Female, Male
Male
71 Participants87 Participants91 Participants249 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 3050 / 3020 / 313
serious
Total, serious adverse events
0 / 3050 / 3020 / 313

Outcome results

Primary

Systolic Blood Pressure

The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.

Time frame: one year

ArmMeasureValue (MEAN)Dispersion
Standard CareSystolic Blood Pressure134.5 mm HgStandard Deviation 20.4
EHMISystolic Blood Pressure141.7 mm HgStandard Deviation 22.1
Nurse Educator + EHMISystolic Blood Pressure134.6 mm HgStandard Deviation 19.9
Secondary

Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care.

This will be assessed by measuring patient medication understanding, medication reconciliation, adherence, and health outcomes (diastolic blood pressure, and among the diabetic subgroup Hemoglobin A1c \<8.0 and LDL Cholesterol \<100). Reported here: HbA1c \<8 at 12 months. Full secondary outcomes have been published. Persell SD, Karmali KN, MD, 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;178:1069-1077.

Time frame: Baseline, 3 months, 6 months, 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard CareEffectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care.61 Participants
EHMIEffectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care.48 Participants
Nurse Educator + EHMIEffectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care.64 Participants
Secondary

Effects of These Strategies by Patients' Literacy Skills

We will measure how the effects of the interventions vary based on the participants' literacy levels. SBP at 12 months reported below.

Time frame: Baseline, 3 months, 6 months,12 months

ArmMeasureValue (MEAN)Dispersion
Standard CareEffects of These Strategies by Patients' Literacy Skills135.5 mm HgStandard Deviation 20.7
EHMIEffects of These Strategies by Patients' Literacy Skills141.7 mm HgStandard Deviation 20
Nurse Educator + EHMIEffects of These Strategies by Patients' Literacy Skills133.8 mm HgStandard Deviation 18.8
Standard Care Possibly Limited Health LiteracyEffects of These Strategies by Patients' Literacy Skills138.4 mm HgStandard Deviation 22.4
EHMI Possibly Limited Health LiteracyEffects of These Strategies by Patients' Literacy Skills138.4 mm HgStandard Deviation 22.4
Nurse Educator + EHMI Possibly Limited Health LiteracyEffects of These Strategies by Patients' Literacy Skills132.2 mm HgStandard Deviation 19.4
Standard Care Likely Adequate Health LiteracyEffects of These Strategies by Patients' Literacy Skills135.5 mm HgStandard Deviation 20.1
EHMI Likely Adequate Health LiteracyEffects of These Strategies by Patients' Literacy Skills148.1 mm HgStandard Deviation 25.7
Nurse Educator + EHMI Likely Adequate Health LiteracyEffects of These Strategies by Patients' Literacy Skills138.9 mm HgStandard Deviation 21.5

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026