Evaluating a Low-Literacy Discharge Medication Education Tool

Coronary Artery Disease Clinical Trial

Official title:

Evaluating a Low-Literacy Discharge Medication Education Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408733
• Other study ID #: G06-09-104-01
• Status: Completed
• Phase: N/A
• First received: December 6, 2006
• Last updated: January 24, 2008
• Start date: January 2007
• Est. completion date: August 2007

Study information

• Verified date: December 2007
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: August 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Congestive Heart Failure
• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia

Intervention

Other:
• Medication Education Tool
Picture and Icon-based Customizable Educational Tool

Locations

Country	Name	City	State
United States	Los Angeles County/ USC Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Reported Medication Adherence		2 & 4 weeks post discharge	No
Secondary	Medication Knowledge, Patient Satisfaction & Self-Efficacy, Readmissions and Emergency Department Visits		2weeks -8weeks post discharge	No