Evaluating a Low-Literacy Discharge Medication Education Tool

January 24, 2008 updated by: University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

287

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-Reported Medication Adherence
Time Frame: 2 & 4 weeks post discharge
2 & 4 weeks post discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Medication Knowledge, Patient Satisfaction & Self-Efficacy, Readmissions and Emergency Department Visits
Time Frame: 2weeks -8weeks post discharge
2weeks -8weeks post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Kristina M Cordasco, MD, MPH, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

December 6, 2006

First Submitted That Met QC Criteria

December 6, 2006

First Posted (Estimate)

December 7, 2006

Study Record Updates

Last Update Posted (Estimate)

January 25, 2008

Last Update Submitted That Met QC Criteria

January 24, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G06-09-104-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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