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

Sponsor:	New York University School of Medicine
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00537433

Purpose

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.

Condition	Intervention	Phase
Medication Errors	Other: Pictogram	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	An RCT to Reduce Liquid Medication Dosing Errors and Improve Adherence in Caregivers of Young Children Through a Pictogram-Based Intervention

Resource links provided by NLM:

MedlinePlus related topics: Caregivers

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

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. ]

Secondary Outcome Measures:

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. ]

Enrollment:	251
Study Start Date:	July 2006
Study Completion Date:	January 2007

Arms	Assigned Interventions
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 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.

Arms

Assigned Interventions

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

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.

Detailed 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.

Eligibility

Ages Eligible for Study:	1 Month to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537433

Locations

United States, New York
NYU School of Medicine Department of Pediatrics
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

Investigators

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

More Information

No publications provided by New York University School of Medicine

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	IRB06-168
Study First Received:	September 28, 2007
Last Updated:	September 28, 2007
ClinicalTrials.gov Identifier:	NCT00537433 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

Medication errors
Patient nonadherence
Literacy
Communication

ClinicalTrials.gov processed this record on February 08, 2010