Promoting Safe Use of Children's Cough/Cold Medicines



Status:Enrolling by invitation
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:12/8/2018
Start Date:August 11, 2017
End Date:December 2020

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Identifying "Best Practices" for the Safe Use of Pediatric Cough and Cold Medications

This study seeks to identify ways to help parents safely use cough/cold medications with
their children. The study focuses on 3 key tasks that have been found to be difficult for
parents: 1) decision-making about whether medicines should be given based on a child's age,
2) use of active ingredient information to determine which medications are safe to give
together, and 3) medication dosing.

Specific ways that labels and dosing tools can be changed to improve parent understanding and
ability to use pediatric cough and cold medications will be tested. This includes looking at
whether including age restriction information on the front panel helps parents make better
decisions about whether a medication should be given to a child, as well as whether presence
of a specific warning or pictogram can help improve this understanding. In addition, the role
of font size, including a box around ingredients, and use of a specific warning to look at
and compare active ingredients, will be examined to see if these can help parents decide if
two medications can be given together safely. Finally, dosing charts with pictograms of
dosing tools, and provision of certain dosing tools, can lead to fewer parent dosing errors.

A label/dosing tool combination that incorporates what is learned from the first part of the
study will be developed based on findings from the first part of the study, and then tested
to see whether this improves parent understanding and use of pediatric cough and cold
medicines.

Hypotheses include: 1) changes in labels and dosing tools, such as including explicit
warnings, and pictographic warnings/instructions can improve parent understanding and ability
to act on of medication instructions, 2) parents with low health literacy and/or LEP will
especially benefit from strategies such as explicit wording, warnings, and pictogram, and 3)
parents receiving the comprehensive labeling and dosing strategy will have a better
understanding of appropriate use of cough/cold medications, including fewer dosing errors,
compared to standard labels.

A multi-part experiment will be conducted. Findings will be merged with known evidence around
health literacy best practices to develop a comprehensive, consumer-centered strategy for
English and Spanish-speaking parents. Pilot testing of the comprehensive strategy in
comparison to existing labels will then take place.

See Brief summary.

Inclusion Criteria:

- Parent/Legal guardian 18 years or older

- Parent/Legal guardian with children <6 years old

- English or Spanish speaking

Exclusion Criteria:

- Visual acuity worse than 20/50 (Rosenbaum Pocket Screener)

- Uncorrectable hearing impairment

- Parents/ children too ill to participate will also be excluded
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Hsiang Yin, MD
Phone: 212-562-2821
New York University School of Medicine NYU School of Medicine has a proud history that...
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