Clinical trial NCT00408733: Evaluating a Low-Literacy Discharge Medication Education Tool
Official title: Evaluating a Low-Literacy Discharge Medication Education Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Coronary Artery Disease
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2006-12-07
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Self-Reported Medication Adherence
timeFrame: 2 & 4 weeks post discharge
Secondary outcomes:
measure: Medication Knowledge, Patient Satisfaction & Self-Efficacy, Readmissions and Emergency Department Visits
timeFrame: 2weeks -8weeks post discharge
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County/ USC Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kristina M Cordasco, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.