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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Illinois at Chicago
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Bruce L. Lambert, Ph.D., University of Illinois
ClinicalTrials.gov Identifier:
NCT01669473
First received: August 3, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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 Intervention
Diabetes Mellitus Type I
Diabetes Mellitus Type II
Other: EHR Based Strategy to promote Safe and Appropriate Drug Use

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: One month after patients receive intervention materials ] [ Designated as safety issue: No ]

    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:
  • Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol. [ Time Frame: Baseline interview and after 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (not including refills, but including 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;
  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: NCT01669473

Contacts
Contact: Neeha Shrestha, MPH 312-355-0711 neehas@uic.edu
Contact: Kamila Przytula 312-503-3390 kamila.przytula@northwestern.edu

Locations
United States, Illinois
University of Illinois at Chicago Not yet recruiting
Chicago, Illinois, United States, 60654
Contact: Neeha Shrestha, MPH    312-355-0711    neehas@uic.edu   
Principal Investigator: Bruce Lambert, PhD         
Sub-Investigator: William Galanter, MD         
Sub-Investigator: Suzanne Falck, MD         
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Kamila Przytula    312-503-3390    kamila.przytula@northwestern.edu   
Sub-Investigator: Michael Wolf, Phd         
Sub-Investigator: Stacy Bailey, PhD         
Sponsors and Collaborators
University of Illinois at Chicago
Northwestern University
Investigators
Principal Investigator: Bruce Lambert, PhD University of Illinois Chicago
  More Information

No publications provided

Responsible Party: Bruce L. Lambert, Ph.D., Professor, Dept. of Pharmacy Administration Director, Center for Education and Research on Therapeutics, University of Illinois
ClinicalTrials.gov Identifier: NCT01669473     History of Changes
Other Study ID Numbers: 1U19HS021093-01
Study First Received: August 3, 2012
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Diabetes

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

ClinicalTrials.gov processed this record on July 29, 2014