Clinical trial NCT03126851: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cough
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: # of parents making correct decision about whether medication should be given based on age restriction information (survey)
timeFrame: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
Secondary outcomes:
measure: # of parents with correct knowledge of age group that medication can be given to (survey)
timeFrame: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Shonna Yin, MD
role: PRINCIPAL_INVESTIGATOR
References: