Decreasing Medication Errors by Caregivers Using a Health Literacy Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01294501
Recruitment Status : Terminated (PI left the institution)
First Posted : February 11, 2011
Last Update Posted : April 24, 2015
Information provided by (Responsible Party):
Columbia University

Brief Summary:
Giving medications to children can be confusing; studies have shown that caregivers make dosing administration errors up to 50% of the time. There are many reasons that there are so many errors, including the fact that dosing for children is based on their weight, liquid medications come in many different forms, and caregivers often give medicines using kitchen teaspoons and tablespoons. Caregivers who have difficulty reading have even more difficulty understanding medication instructions. We are developing and testing a web-based educational module to teach caregivers how to give medications. We are focusing on the pediatric emergency department because we know that this population has low literacy levels, and that many antibiotics are prescribed in this setting. We anticipate that those caregivers that view the interactive module will have increased knowledge on how to give medications once they get home.

Condition or disease Intervention/treatment Phase
Medication Administration Medication Errors Other: Medication administration educational module Not Applicable

Detailed Description:
Dosing error rates of home administration of medications to children have been reported to be as high as 50%. Contributing to this error rate are the complexity of pediatric weight-based dosing, confusing formulations of liquid medications, and a reliance on non-standardized dosing tools such as kitchen teaspoons and tablespoons to administer medications. Families with low health literacy are at particular risk for medication administration errors. Health literacy promoting interventions to improve medication administration such as dissemination of a pictogram-based medication list have been shown to work for common over-the-counter medications such as acetaminophen, but their effect on administration practices for common medications prescribed in the pediatric emergency department (PED) has not been evaluated. Of the 50,000 patients seen in the PED each year, approximately 85% of patients are discharged with a prescription for medication. This makes the PED an ideal setting to implement a health literacy intervention to reduce medication administration errors at home. The investigators are proposing to conduct a randomized controlled trial of an educational module focused on how to administer antibiotics at home and test whether there is an improvement in care practices.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Decreasing Medication Errors by Caregivers Using a Health Literacy Intervention
Study Start Date : February 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Fever assessment and management
Medication administration educational module for low literacy subjects on how to administer common medications appropriately and safely.
Other: Medication administration educational module
The Research Assistant (RA) will enter the subject's language (English or Spanish), the type of medicine (tablet/capsule, liquid, or ointment) from the antibiotic prescription, and the frequency (once a day, twice a day, three times a day, four times a day) from the antibiotic prescription into the web-based educational module on medication administration so that a tailored module will be setup for the subject. The subject will then view the educational interactive module. After the subject is done with the module, the RA will administer a verbal post-test. The post-test will include questions on medication administration as well as questions on fever assessment and management.
Other Name: Health Literacy Intervention

Primary Outcome Measures :
  1. Score on the telephone interview post-test [ Time Frame: 48-72 hours post Emergency Department visit ]
    Subject scores will be dichotomized in the follow way: anything less than 100% will be considered incorrect, a score of 100% will be considered correct.

Secondary Outcome Measures :
  1. Prevalence of perfect performance on each element of the questionnaire [ Time Frame: 48-72 hours post Emergency Department visit ]
    Each answer on the telephone interview post-test will be dichotomized into a correct/incorrect answer.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Caregivers of:

  • Patients aged 2 months to 8 years
  • Patients triaged to Emergency Severity Index (ESI) level 4 or 5 in the pediatric emergency department.
  • Patients with at least one prescription for a liquid, tablet or ointment antibiotic.

Exclusion Criteria:

Caregivers of:

  • Patients in need of immediate care.
  • Patients hospitalized.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01294501

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Anupama Subramony, MD, MBA Columbia University

Responsible Party: Columbia University Identifier: NCT01294501     History of Changes
Other Study ID Numbers: AAAI0786
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by Columbia University:
Medication administration
Medication errors
Health Literacy
Pediatric Emergency Department
Web-based education