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A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01669473
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : September 22, 2016
University of Illinois at Chicago
Information provided by (Responsible Party):
Bruce Lambert, Northwestern University

Brief Summary:

This study seeks to evaluate a low-literacy strategy in a primary health care setting for promoting safe and effective prescription medication use among English and Spanish-speaking patients with diabetes.

The investigators hypothesize that in comparison with patients receiving standard care, the patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies in their medication lists; 3) take their medication regimen more efficiently; 4) have greater adherence to their medication regimen.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type I Diabetes Mellitus Type II Other: EHR Based Strategy to promote Safe and Appropriate Drug Use Not Applicable

Detailed Description:

The strategy takes advantage of health information technology to assist patients with Medication Therapy Management (MTM) tasks, intervening with a set of low-literacy MTM printed tools triggered by the Electronic Health Record (EHR) in a primary health care clinic. Patients at the University of Illinois at Chicago (UIC) Medicine Clinic who are randomized to the intervention arm will be given three printed tools, one when they check in to the clinic and the other two when they check out. The Electronic Health Record (EHR) triggers the printing of these tools, and the receptionist hands them to the patient. Patients receive either English or Spanish language materials depending on the preference determined in the screening process and stored in their EHR.

Specific Aims

  1. Refine and Field Test an EHR strategy for generating and distributing low literacy prescription information for English and Spanish-speaking patients
  2. Assess the process of the EHR intervention and its fidelity for providing prescription information for patients at the point of prescribing and dispensing medications.
  3. Evaluate the effectiveness of the EHR strategy to improve medication understanding, reconciliation, regimen consolidation, and adherence compared to standard care.

In addition, we will be powered to also investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure, HbA1c, and LDL cholesterol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
Study Start Date : June 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention Arm

EHR Based Strategy to promote Safe and Appropriate Drug Use

Patients randomized to the intervention arm will be given (3) print tools to assist in safe and appropriate medication use. These include a Medreview, Medsheet,and Medlist.

Other: EHR Based Strategy to promote Safe and Appropriate Drug Use

The printed tools presented in the intervention include:

  1. Medication Review: a consolidated list of the medications a patient is currently taking.
  2. Medication Sheet: a medication information sheet, including simplified prescription instructions, for each medication that a patient is newly prescribed.
  3. Medication List: a table that lists all medications taken by the patient and provides an orientation on how to best organize and simplify their medication regimen

No Intervention: Standard Care Arm
The control group will receive regular standard care at the Clinic. They will not receive any print tools.

Primary Outcome Measures :
  1. Medication adherence [ Time Frame: One month after patients receive intervention materials ]

    We will determine to what extent presenting low-literacy information about prescription medicines to patients with diabetes affects their adherence to a medication regimen compared to patients under standard care.

    Adherence for each prescription medication will be measured through multiple methodologies.

Secondary Outcome Measures :
  1. Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol. [ Time Frame: Baseline interview and after 6 months ]
    We will investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure for patients with hypertension, HbA1 for patients with diabetes, and LDL cholesterol for patients with hyperlipidemia, through chart extraction at pre and post-intervention.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-years old or older;
  • have a diagnosis of diabetes mellitus either by ICD-billing codes or indicative medications;
  • are prescribed at least (3) chronic condition medications according to the EHR medication list;
  • are English or Spanish-speaking;
  • have no imminent intention to move or change clinics within the next year;
  • score 4 or higher on the six-question screener based on the Mini-Mental Status Exam;
  • are primarily responsible for administering their own medications;
  • prescribed a new chronic condition medication (including refills, and change in titrations) during their clinic visit and day.

Exclusion Criteria:

  • under age of 18 years-old;
  • does not speak English or Spanish;
  • dependent on assistance for medication administration;
  • scored less than 4 on the six-question screener;
  • not prescribed a new medication or changed medication at clinical appointment;

Information from the National Library of Medicine

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 identifier (NCT number): NCT01669473

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Illinois at Chicago
Chicago, Illinois, United States, 60654
Sponsors and Collaborators
Northwestern University
University of Illinois at Chicago
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Principal Investigator: Bruce Lambert, PhD Northwestern University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bruce Lambert, Director, Center for Communication and Health, Northwestern University Identifier: NCT01669473     History of Changes
Other Study ID Numbers: 1U19HS021093-01 ( U.S. AHRQ Grant/Contract )
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Bruce Lambert, Northwestern University:

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases