Promoting Safe Use of Children's Cough/Cold Medicines

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.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Other: Label

Detailed Description

See Brief summary.

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No age range / no explicit warning; Label: No age range and no explicit warning on front display panel of medication box.	Other: Label; Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.
Experimental: age range / no explicit warning; Label: Age range present but no explicit warning on front display panel of medication box.	Other: Label; Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.
Experimental: age range / explicit warning in words; Label: Age range present with explicit warning in words on front display panel of medication box.	Other: Label; Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.
Experimental: age range / explicit warning+pictogram; Label: Age range present with explicit warning in words plus pictographic warning on front display panel of medication box.	Other: Label; Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
# of parents making correct decision about whether medication should be given based on age restriction information (survey)	# of parents making correct decision about whether medication should be given to their child based on age restriction information, assessed by survey question	on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
# of parents with correct knowledge of age group that medication can be given to (survey)	# of parents with correct knowledge of the age of the youngest and oldest child the medication can be given to, assessed by survey questions	on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Shonna Yin, MD, NYU School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 15-01510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No