Promoting Safe Use of Children's Cough/Cold Medicines
Primary Purpose
Cough
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Label
Sponsored by
About this trial
This is an interventional prevention trial for Cough
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
No age range / no explicit warning
age range / no explicit warning
age range / explicit warning in words
age range / explicit warning+pictogram
Arm Description
Label: No age range and no explicit warning on front display panel of medication box.
Label: Age range present but no explicit warning on front display panel of medication box.
Label: Age range present with explicit warning in words on front display panel of medication box.
Label: Age range present with explicit warning in words plus pictographic warning on front display panel of medication box.
Outcomes
Primary Outcome Measures
# 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
Secondary Outcome Measures
# 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03126851
Brief Title
Promoting Safe Use of Children's Cough/Cold Medicines
Official Title
Identifying "Best Practices" for the Safe Use of Pediatric Cough and Cold Medications
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
See Brief summary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No age range / no explicit warning
Arm Type
Experimental
Arm Description
Label: No age range and no explicit warning on front display panel of medication box.
Arm Title
age range / no explicit warning
Arm Type
Experimental
Arm Description
Label: Age range present but no explicit warning on front display panel of medication box.
Arm Title
age range / explicit warning in words
Arm Type
Experimental
Arm Description
Label: Age range present with explicit warning in words on front display panel of medication box.
Arm Title
age range / explicit warning+pictogram
Arm Type
Experimental
Arm Description
Label: Age range present with explicit warning in words plus pictographic warning on front display panel of medication box.
Intervention Type
Other
Intervention Name(s)
Label
Intervention Description
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.
Primary Outcome Measure Information:
Title
# of parents making correct decision about whether medication should be given based on age restriction information (survey)
Description
# of parents making correct decision about whether medication should be given to their child based on age restriction information, assessed by survey question
Time Frame
on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
Secondary Outcome Measure Information:
Title
# of parents with correct knowledge of age group that medication can be given to (survey)
Description
# of parents with correct knowledge of the age of the youngest and oldest child the medication can be given to, assessed by survey questions
Time Frame
on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shonna Yin, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Promoting Safe Use of Children's Cough/Cold Medicines
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