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

This study has been completed.
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00537433
First received: September 28, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

September 28, 2007
September 28, 2007
July 2006
Not Provided
Medication Dosing Accuracy (observed and reported); Medication Adherence (reported) [ Time Frame: 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. ]
Same as current
No Changes Posted
Medication Knowledge and Related Medication Practices (dose frequency, preparation, storage, dosing instrument use) [ Time Frame: 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. ]
Same as current
Not Provided
Not Provided
 
Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention
An RCT to Reduce Liquid Medication Dosing Errors and Improve Adherence in Caregivers of Young Children Through a Pictogram-Based Intervention

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Medication Errors
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.

  • No Intervention: Standard counseling
    Families in the control group receive standard care, including routine counseling regarding medications prescribed from their physician and post-visit counseling by the pediatric nursing staff. Dosing instruments are given at the discretion of the physician or nurse.
  • Experimental: Pictogram
    Parents randomized to the pictogram-based intervention group receive medication counseling utilizing the pictogram-based medication instruction sheets. These sheets help to facilitate medication counseling, including teaching about dosage and adherence.
    Intervention: Other: Pictogram
Yin HS, Dreyer BP, van Schaick L, Foltin GL, Dinglas C, Mendelsohn AL. Randomized controlled trial of a pictogram-based intervention to reduce liquid medication dosing errors and improve adherence among caregivers of young children. Arch Pediatr Adolesc Med. 2008 Sep;162(9):814-22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
January 2007
Not Provided

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
Both
1 Month to 8 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00537433
IRB06-168
No
Not Provided
New York University School of Medicine
Not Provided
Principal Investigator: Hsiang (Shonna) Yin, MD, MS NYU School of Medicine Department of Pediatrics
Principal Investigator: Alan L Mendelsohn, MD NYU School of Medicine Department of Pediatrics
Principal Investigator: Benard P Dreyer, MD NYU School of Medicine Department of Pediatrics
New York University School of Medicine
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP