An interventional study of EHMI and Nurse Educator + EHMI in Hypertension, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-28.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 920 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
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Exclusion Criteria:
This arm will serve as a control group and will not receive any intervention.
Electronic 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.
Behavioral: EHMI
Behavioral: Nurse Educator + EHMI
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.
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
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
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
| Milestone | Standard Care | EHMI | Nurse Educator + EHMI |
|---|---|---|---|
| Started | 305 | 302 | 313 |
| Completed | 254 | 262 | 278 |
| Not completed | 51 | 40 | 35 |
The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.
| mm Hg | Standard Care | EHMI | Nurse Educator + EHMI |
|---|---|---|---|
| Systolic Blood Pressure | 134.5 ± 20.4 | 141.7 ± 22.1 | 134.6 ± 19.9 |
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.
| Participants | Standard Care | EHMI | Nurse Educator + EHMI |
|---|---|---|---|
| Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care. | 61 | 48 | 64 |
We will measure how the effects of the interventions vary based on the participants' literacy levels. SBP at 12 months reported below.
| mm Hg | Standard Care Likely Limited Health Literacy | EHMI Likely Limited Health Literacy | Nurse Educator + EHMI Likely Limted Health Literacy | Standard Care Possibly Limited Health Literacy | EHMI Possibly Limited Health Literacy | Nurse Educator + EHMI Possibly Limited Health Literacy | Standard Care Likely Adequate Health Literacy | EHMI Likely Adequate Health Literacy | Nurse Educator + EHMI Likely Adequate Health Literacy |
|---|---|---|---|---|---|---|---|---|---|
| Effects of These Strategies by Patients' Literacy Skills | 135.5 ± 20.7 | 141.7 ± 20 | 133.8 ± 18.8 | 138.4 ± 22.4 | 138.4 ± 22.4 | 132.2 ± 19.4 | 135.5 ± 20.1 | 148.1 ± 25.7 | 138.9 ± 21.5 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Care | — | 0/305 (0%) | 0/305 (0%) |
| EHMI | — | 0/302 (0%) | 0/302 (0%) |
| Nurse Educator + EHMI | — | 0/313 (0%) | 0/313 (0%) |
| Age, Continuous(years) | Standard Care | EHMI | Nurse Educator + EHMI | Total |
|---|---|---|---|---|
| Mean | 53 ± 9.5 | 53.6 ± 9.7 | 51.6 ± 9.5 | 52.7 ± 9.6 |
| Sex: Female, Male(Participants) | Standard Care | EHMI | Nurse Educator + EHMI | Total |
|---|---|---|---|---|
| Female | 183 | 175 | 187 | 545 |
| Male | 71 | 87 | 91 | 249 |
| Ethnicity (NIH/OMB)(Participants) | Standard Care | EHMI | Nurse Educator + EHMI | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 4 | 23 | 37 |
| Not Hispanic or Latino | 237 | 250 | 233 | 720 |
| Unknown or Not Reported | 7 | 8 | 22 | 37 |
| Race (NIH/OMB)(Participants) | Standard Care | EHMI | Nurse Educator + EHMI | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 234 | 243 | 215 | 692 |
| White | 13 | 11 | 41 | 65 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 8 | 22 | 37 |
The record gives a start of Apr 2012, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2019, 3 years after primary completion.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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