Study Stopped
PI left the institution
Decreasing Medication Errors by Caregivers Using a Health Literacy Intervention
1 other identifier
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 4, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedApril 24, 2015
April 1, 2015
1.9 years
February 4, 2011
April 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Prevalence of perfect performance on each element of the questionnaire
48-72 hours post Emergency Department visit
Study Arms (1)
Fever assessment and management
EXPERIMENTALMedication administration educational module for low literacy subjects on how to administer common medications appropriately and safely.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Caregivers of:
- Patients in need of immediate care.
- Patients hospitalized.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Anupama Subramony, MD, MBA
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2011
First Posted
February 11, 2011
Study Start
February 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
April 24, 2015
Record last verified: 2015-04