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Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention
This study has been completed.
Study NCT00537433   Information provided by New York University School of Medicine
First Received: September 28, 2007   No Changes Posted

September 28, 2007
September 28, 2007
July 2006
 
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
 
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.

Phase I
Interventional
Prevention, Randomized, Open Label, Parallel Assignment
Medication Errors
Other: Pictogram
  • No Intervention: 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: 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.
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 National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
251
January 2007
 

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
New York University School of Medicine
 
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