NCT00408733

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2006

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 25, 2008

Status Verified

December 1, 2007

Enrollment Period

6 months

First QC Date

December 6, 2006

Last Update Submit

January 24, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-Reported Medication Adherence

    2 & 4 weeks post discharge

Secondary Outcomes (1)

  • Medication Knowledge, Patient Satisfaction & Self-Efficacy, Readmissions and Emergency Department Visits

    2weeks -8weeks post discharge

Study Arms (2)

1

NO INTERVENTION

2

EXPERIMENTAL

Intervention

Other: Medication Education Tool

Interventions

Picture and Icon-based Customizable Educational Tool

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Performing the patient education at hospital discharge for a patient enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles County/ USC Medical Center

Los Angeles, California, United States

Location

Related Publications (1)

  • Cordasco KM, Asch SM, Bell DS, Guterman JJ, Gross-Schulman S, Ramer L, Elkayam U, Franco I, Leatherwood CL, Mangione CM. A low-literacy medication education tool for safety-net hospital patients. Am J Prev Med. 2009 Dec;37(6 Suppl 1):S209-16. doi: 10.1016/j.amepre.2009.08.018.

MeSH Terms

Conditions

Heart FailureCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kristina M Cordasco, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2006

First Posted

December 7, 2006

Study Start

January 1, 2007

Primary Completion

July 1, 2007

Study Completion

August 1, 2007

Last Updated

January 25, 2008

Record last verified: 2007-12

Locations