Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention
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|ClinicalTrials.gov Identifier: NCT00537433|
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : October 1, 2007
|Condition or disease||Intervention/treatment||Phase|
|Medication Errors||Other: Pictogram||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An RCT to Reduce Liquid Medication Dosing Errors and Improve Adherence in Caregivers of Young Children Through a Pictogram-Based Intervention|
|Study Start Date :||July 2006|
|Actual Study Completion Date :||January 2007|
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.
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.
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.
- 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. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537433
|United States, New York|
|NYU School of Medicine Department of Pediatrics|
|New York, New York, United States, 10016|
|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|