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

NYU Langone Health

Status and phase: Completed; Phase 1

Conditions: Medication Errors

Treatments: Other: Pictogram

Study type: Interventional

Funder types: Other

Identifiers

NCT00537433

IRB06-168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 251 patients

Sex: All

Ages: 1 month to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

251 participants in 2 patient groups

Standard counseling

No Intervention group

Description:

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.

Pictogram

Experimental group

Description:

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.

Treatment:

Other: Pictogram