Decreasing Medication Errors by Caregivers Using a Health Literacy Intervention

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.

Study Overview

• Status: Terminated
• Conditions: Medication Errors; Medication Administration
• Intervention / Treatment: Other: Medication administration educational module

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
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Health Literacy Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on the telephone interview post-test	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.	48-72 hours post Emergency Department visit

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Anupama Subramony, MD, MBA, Columbia University

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Estimate): April 24, 2015
• Last Update Submitted That Met QC Criteria: April 23, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Health Literacy; Medication errors; Pediatric Emergency Department; Medication administration; Web-based education
• Other Study ID Numbers: AAAI0786