- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00408733
Evaluating a Low-Literacy Discharge Medication Education Tool
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States
- Los Angeles County/ USC Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Investigators
- Principal Investigator: Kristina M Cordasco, MD, MPH, University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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