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Evaluating a Low-Literacy Discharge Medication Education Tool

This study has been completed.
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00408733
First received: December 6, 2006
Last updated: January 24, 2008
Last verified: December 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: Evaluating a Low-Literacy Discharge Medication Education Tool

Resource links provided by NLM:


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
No Intervention: 1
Experimental: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristina Cordasco, UCLA
ClinicalTrials.gov Identifier: NCT00408733     History of Changes
Other Study ID Numbers: G06-09-104-01
Study First Received: December 6, 2006
Last Updated: January 24, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014