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

August 3, 2012
August 21, 2012
September 22, 2016
June 2013
August 2016   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01669473 on Archive Site
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.
Same as current
Not Provided
Not Provided
A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use

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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Diabetes Mellitus Type I
  • Diabetes Mellitus Type II
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
  • 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.

    Intervention: Other: EHR Based Strategy to promote Safe and Appropriate Drug Use
  • No Intervention: Standard Care Arm
    The control group will receive regular standard care at the Clinic. They will not receive any print tools.
Przytula K, Bailey SC, Galanter WL, Lambert BL, Shrestha N, Dickens C, Falck S, Wolf MS. A primary care, electronic health record-based strategy to promote safe drug use: study protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:17. doi: 10.1186/s13063-014-0524-x.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2016
August 2016   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1U19HS021093-01( U.S. AHRQ Grant/Contract )
Not Provided
Not Provided
Bruce Lambert, Northwestern University
Northwestern University
University of Illinois at Chicago
Principal Investigator: Bruce Lambert, PhD Northwestern University
Northwestern University
September 2016

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