Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention

Medication Errors Clinical Trial

Official title:

An RCT to Reduce Liquid Medication Dosing Errors and Improve Adherence in Caregivers of Young Children Through a Pictogram-Based Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537433
• Other study ID #: IRB06-168
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2007
• Last updated: September 28, 2007
• Start date: July 2006
• Est. completion date: January 2007

Study information

• Verified date: September 2007
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Liquid medication administration errors are common, and place children at risk for adverse events. Caregivers with low socioeconomic status (SES), low education and poor health literacy skills are at increased risk for errors. In this study, we seek to assess whether at-risk parents who received a plain language, pictogram-based intervention would have reduced medication dosing errors and improved medication adherence.

Description:

Evidence suggests that errors by parents and caregivers in administering medications to their children are frequent. These errors, which include inaccurate dosing as well as nonadherence to medication regimens, place children at risk for morbidity and mortality. Misdosing is prevalent, with 50% or more of pediatric caregivers either measuring an incorrect dose or reporting a dose of liquid medication given outside the recommended range. Of further concern are reports of an overall poor adherence rate of 50% for pediatric medications, with implications for treatment failure and drug resistance.

Few studies have examined strategies for decreasing medication administration errors in pediatric patients. Pictograms represent a promising approach in which simple diagrams are used to improve understanding of concepts. Pictorial-enhanced written materials have been shown to improve comprehension and adherence with medical directions, particularly for patients with low literacy.

We developed a pictogram-based intervention to decrease dosing errors and improve adherence. In this study, we sought to assess whether this intervention would reduce medication dosing errors and improve adherence in a pediatric emergency room serving at-risk families.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 8 Years

Eligibility

Inclusion Criteria:

• child 30 days through 8 years old

• child prescribed a liquid medication (short course (<14 days) daily dose medication or as needed (prn) medication)

Exclusion Criteria:

• caregiver accompanying child to visit not primarily responsible for administering medication to the child

• caregiver not fluent in English or Spanish

• child requiring immediate medical attention

• child who typically takes medications in tablet form

• child having a visit involving a psychiatric problem or child protection issue

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Medication Errors

Intervention

Other:
• Pictogram
The plain language, pictogram-based medication instruction sheets (available in English and Spanish) utilize pictograms to convey information about the medication name, indication, dose, dose frequency, and length of treatment, along with information about preparation and storage. The sheets also include a medication log for parents to keep track of when they administer the medication. Research staff reference the sheets as they demonstrate dosing with a standardized dosing instrument; teachback is performed to reinforce concepts. For medications in which a standardized dosing instrument was not included at dispensing, a standardized oral dosing syringe is provided for the caregiver to use at home. After counseling, the caregiver is given the instruction sheet to take home.

Locations

Country	Name	City	State
United States	NYU School of Medicine Department of Pediatrics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Dosing Accuracy (observed and reported); Medication Adherence (reported)		Assessments by phone or in-person, planned at 3-5 days for prn medications, and within 1 day of last dose of prescribed treatment time for daily dose medications.
Secondary	Medication Knowledge and Related Medication Practices (dose frequency, preparation, storage, dosing instrument use)		Assessments by phone or in-person, planned at 3-5 days for prn medications, and within 1 day of last dose of prescribed treatment time for daily dose medications.