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

NCT00537433 | Completed Phase 1

• 1 other identifier: IRB06-168
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Errors

Keywords

Medication errors; Patient nonadherence; Literacy; Communication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Standard counseling

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.

Pictogram

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.

Other: Pictogram

Interventions

Pictogram OTHER

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.

Pictogram

Eligibility Criteria

• Age: 1 Month - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• child 30 days through 8 years old
• child prescribed a liquid medication (short course (\<14 days) daily dose medication or as needed (prn) medication)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU School of Medicine Department of Pediatrics

New York, New York, 10016, United States

Location

Related Publications (1)

• 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. doi: 10.1001/archpedi.162.9.814.

  PMID: 18762597 DERIVED

MeSH Terms

Conditions

Patient Compliance; Literacy; Communication

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: July 1, 2006
• Study Completion: January 1, 2007
• Last Updated: October 1, 2007

Record last verified: 2007-09

Locations

US (1)