Clinical trial NCT01294501: Decreasing Medication Errors by Caregivers Using a Health Literacy Intervention
Official title: Decreasing Medication Errors by Caregivers Using a Health Literacy Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Medication Administration
Medication Errors
Keywords: Medication administration
Medication errors
Health Literacy
Pediatric Emergency Department
Web-based education
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 132
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Score on the telephone interview post-test
timeFrame: 48-72 hours post Emergency Department visit
Secondary outcomes:
measure: Prevalence of perfect performance on each element of the questionnaire
timeFrame: 48-72 hours post Emergency Department visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Anupama Subramony, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: