Northwestern University and Access Community Health Network Medication Education Study (NAMES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Persell, Northwestern University
ClinicalTrials.gov Identifier:
NCT01578577
First received: April 12, 2012
Last updated: September 26, 2014
Last verified: September 2014

April 12, 2012
September 26, 2014
April 2012
April 2016   (final data collection date for primary outcome measure)
Systolic Blood Pressure [ Time Frame: one year ] [ Designated as safety issue: No ]
The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.
Same as current
Complete list of historical versions of study NCT01578577 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We will measure how the effects of the interventions vary based on the participants' literacy levels.
Same as current
Not Provided
Not Provided
 
Northwestern University and Access Community Health Network Medication Education Study
EHR-based Health Literacy Strategy to Promote Medication Therapy Management

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hypertension
  • Behavioral: 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.
  • 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.
  • No Intervention: Standard Care
    This arm will serve as a control group and will not receive any intervention.
  • Experimental: EHMI
    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.
    Intervention: Behavioral: EHMI
  • Experimental: Nurse Educator + EHMI
    Intervention: Behavioral: Nurse Educator + EHMI
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1680
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Elisha Friesema, BA, CCRP 312-503-2753 e-friesema@northwestern.edu
Contact: Stephen Persell, MD, MPH 312-503-6464 spersell@nmff.org
United States
 
NCT01578577
Medication Therapy Management, 1R01NR012745
Yes
Stephen Persell, Northwestern University
Northwestern University
National Institute of Nursing Research (NINR)
Principal Investigator: Stephen Persell, MD, MPH Northwestern University
Northwestern University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP