NCT01294501

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

February 4, 2011

Last Update Submit

April 23, 2015

Conditions

Keywords

Medication administrationMedication errorsHealth LiteracyPediatric Emergency DepartmentWeb-based education

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

EXPERIMENTAL

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

Other: Medication administration educational module

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.

Also known as: Health Literacy Intervention
Fever assessment and management

Eligibility Criteria

Age2 Months - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

Study Officials

  • Anupama Subramony, MD, MBA

    Columbia University

    PRINCIPAL INVESTIGATOR

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

Locations