Evaluating a Low-Literacy Discharge Medication Education Tool - Full Text View

Sponsored by:	University of California, Los Angeles
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00408733

Purpose

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	Intervention
Congestive Heart Failure Coronary Artery Disease	Other: Medication Education Tool

MedlinePlus related topics: Coronary Artery Disease Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study
Official Title:	Evaluating a Low-Literacy Discharge Medication Education Tool

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Self-Reported Medication Adherence [ Time Frame: 2 & 4 weeks post discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Medication Knowledge, Patient Satisfaction & Self-Efficacy, Readmissions and Emergency Department Visits [ Time Frame: 2weeks -8weeks post discharge ] [ Designated as safety issue: No ]

Enrollment:	287
Study Start Date:	January 2007
Study Completion Date:	August 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention
2: Experimental Intervention	Other: Medication Education Tool Picture and Icon-based Customizable Educational Tool

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408733

Locations

United States, California
Los Angeles County/ USC Medical Center
Los Angeles, California, United States

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Principal Investigator:

Kristina M Cordasco, MD, MPH

University of California, Los Angeles

More Information

No publications provided

Responsible Party:	UCLA ( Kristina Cordasco )
Study ID Numbers:	G06-09-104-01
Study First Received:	December 6, 2006
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00408733 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Failure
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Failure
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009