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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
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: EHMI
Behavioral: Nurse Educator + EHMI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: EHR-based Health Literacy Strategy to Promote Medication Therapy Management

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1680
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578577

Contacts
Contact: Elisha Friesema, BA, CCRP 312-503-2753 e-friesema@northwestern.edu
Contact: Stephen Persell, MD, MPH 312-503-6464 spersell@nmff.org

Locations
United States, Illinois
ACCESS Community Health Network Recruiting
Chicago, Illinois, United States, 60661
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Stephen Persell, MD, MPH Northwestern University
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen Persell, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01578577     History of Changes
Other Study ID Numbers: Medication Therapy Management, 1R01NR012745
Study First Received: April 12, 2012
Last Updated: September 26, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Northwestern University:
Medication Therapy Management
Hypertension
Health Literacy
Medication Reconciliation
Medication Adherence

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014