Evaluating a Low-Literacy Discharge Medication Education Tool

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: NCT00408733
Recruitment Status : Completed
First Posted : December 7, 2006
Last Update Posted : January 25, 2008
Information provided by:
University of California, Los Angeles

Brief Summary:

Recent studies have demonstrated that patients sub-optimally understand hospital discharge medication instructions Health literacy has been shown to be an important factor in patient understanding of medical information , and following medication instructions.

The primary aim of this project is to test the efficacy of a low-literacy discharge medication education tool on medication adherence, and patient knowledge and understanding of inpatient discharge medications, in a low-income population with low health literacy levels. This evaluation is a prospective trial with patients randomly assigned to either receiving this tool or receiving the current standard of care. Given the complexity of the discharge medication regimen for the conditions of congestive heart failure (CHF) and coronary artery disease (CAD), and the proven effectiveness of these medications in the post discharge period, this trial will focus on the subpopulation of patients hospitalized with these two conditions.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Coronary Artery Disease Other: Medication Education Tool Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Official Title: Evaluating a Low-Literacy Discharge Medication Education Tool
Study Start Date : January 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : August 2007

Arm Intervention/treatment
No Intervention: 1
Experimental: 2
Other: Medication Education Tool
Picture and Icon-based Customizable Educational Tool

Primary Outcome Measures :
  1. Self-Reported Medication Adherence [ Time Frame: 2 & 4 weeks post discharge ]

Secondary Outcome Measures :
  1. Medication Knowledge, Patient Satisfaction & Self-Efficacy, Readmissions and Emergency Department Visits [ Time Frame: 2weeks -8weeks post discharge ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patient inclusion criteria will be:

  • 18 years of age or greater
  • Admission to the internal medical or cardiology services at LAC/USC Medical Center
  • Discharge directly from the medical service to home
  • During admission, being evaluated or treated for congestive heart failure or coronary artery disease.

Patient Exclusion criteria :

  • Moderate or severe cognitive dysfunction
  • Severe psychiatric disability such that the patient has, or there is an application for, a conservator, or any psychiatric illness with current psychotic features
  • Not having speaking proficiency in either English or Spanish language.
  • If the patient was previously enrolled in the study on a prior hospitalization, he or she will also be excluded.

Nurse Inclusion Criteria:

  • Performing the patient education at hospital discharge for a patient enrolled in the study

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): NCT00408733

United States, California
Los Angeles County/ USC Medical Center
Los Angeles, California, United States
Sponsors and Collaborators
University of California, Los Angeles
Principal Investigator: Kristina M Cordasco, MD, MPH University of California, Los Angeles

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kristina Cordasco, UCLA Identifier: NCT00408733     History of Changes
Other Study ID Numbers: G06-09-104-01
First Posted: December 7, 2006    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: December 2007

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases