Promoting Safe Use of Children's Cough/Cold Medicines

NCT03126851 | Completed

• 1 other identifier: 15-01510
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• # 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 Outcomes (1)

• # of parents with correct knowledge of age group that medication can be given to (survey)

  on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)

Study Arms (4)

No age range / no explicit warning

EXPERIMENTAL

Label: No age range and no explicit warning on front display panel of medication box.

Other: Label

age range / no explicit warning

EXPERIMENTAL

Label: Age range present but no explicit warning on front display panel of medication box.

Other: Label

age range / explicit warning in words

EXPERIMENTAL

Label: Age range present with explicit warning in words on front display panel of medication box.

Other: Label

age range / explicit warning+pictogram

EXPERIMENTAL

Label: Age range present with explicit warning in words plus pictographic warning on front display panel of medication box.

Other: Label

Interventions

Label OTHER

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.

No age range / no explicit warning; age range / explicit warning in words; age range / explicit warning+pictogram; age range / no explicit warning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent/Legal guardian 18 years or older
• Parent/Legal guardian with children \<6 years old
• English or Spanish speaking

You may not qualify if:

• Visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
• Uncorrectable hearing impairment
• Parents/ children too ill to participate will also be excluded

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cough

Interventions

Drug Labeling

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Drug Packaging; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging

Study Officials

• Shonna Yin, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 24, 2017
• Study Start: May 1, 2017
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

US (1)