Decreasing Medication Errors by Caregivers Using a Health Literacy Intervention

NCT ID: NCT01294501

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-01-31

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.

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.

Conditions

Medication Administration; Medication Errors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Fever assessment and management

Medication administration educational module for low literacy subjects on how to administer common medications appropriately and safely.

Group Type: EXPERIMENTAL

Medication administration educational module

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Health Literacy Intervention

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anupama Subramony, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAI0786

Identifier Type: -

Identifier Source: org_study_id