Northwestern University and Access Community Health Network Medication Education Study (NAMES)
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|ClinicalTrials.gov Identifier: NCT01578577|
Recruitment Status : Unknown
Verified March 2015 by Stephen Persell, Northwestern University.
Recruitment status was: Active, not recruiting
First Posted : April 17, 2012
Last Update Posted : March 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: EHMI Behavioral: Nurse Educator + EHMI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1680 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||EHR-based Health Literacy Strategy to Promote Medication Therapy Management|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
No Intervention: Standard Care
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.
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.
|Experimental: Nurse Educator + EHMI||
Behavioral: 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.
- Systolic Blood Pressure [ Time Frame: one year ]The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.
- Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy management strategy (EHMI), with and without a nurse educator, compared to standard care. [ Time Frame: Baseline, 3 months, 6 months, 12 months ]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).
- Effects of these strategies by patients' literacy skills [ Time Frame: Baseline, 3 months, 6 months,12 months ]We will measure how the effects of the interventions vary based on the participants' literacy levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578577
|United States, Illinois|
|ACCESS Community Health Network|
|Chicago, Illinois, United States, 60661|
|Principal Investigator:||Stephen Persell, MD, MPH||Northwestern University|