Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03126851
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2017-04-13
Brief Title:
Promoting Safe Use of Childrens CoughCold Medicines
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Identifying Best Practices for the Safe Use of Pediatric Cough and Cold Medications
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to identify ways to help parents safely use coughcold 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 childs 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 labeldosing 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 warningsinstructions can improve parent understanding and ability to act on of medication instructions 2 parents with low health literacy andor 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 coughcold 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
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 labeldosing 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 warningsinstructions can improve parent understanding and ability to act on of medication instructions 2 parents with low health literacy andor 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 coughcold 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None