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Promoting Safe Use of Pediatric Liquid Medications

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by New York University School of Medicine
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Emory University
Northwestern University
Stanford University
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01854151
First received: May 14, 2013
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
Variable and poor-quality drug labeling has been cited as a leading cause of medication errors and adverse drug events, especially in the context of low health literacy. This is a particularly important issue in pediatrics as more than half of US children are exposed to one or more outpatient medications in a given week, and studies suggest that over half of caregivers make errors when dosing liquid medications for children. Our study objective is to identify evidence-based strategies for labeling and dosing prescription and over-the-counter pediatric liquid medications in order to promote safe, appropriate use, as well as to inform state and federal policy standards. We hypothesize that a health literacy-informed labeling and dosing strategy will result in improved parent ability to administer medications prescribed to their young children.

Condition Intervention
Medication Errors Other: New Labeling/Dosing Strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Health Services Research
Official Title: Promoting Safe Use of Pediatric Liquid Medications: A Health Literacy Approach

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Medication dosing accuracy [ Time Frame: Target within 2 weeks after medication course completion ]

Estimated Enrollment: 800
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Practice
Parents whose children are prescribed medication and meet inclusion/exclusion criteria will fill their medication at their regular pharmacy and receive medication with labeling and dosing instruments as per routine
Experimental: New Labeling/Dosing Strategy
Parents whose children are prescribed liquid medication and meet inclusion/exclusion criteria will receive medications with health literacy informed labels and dosing instruments
Other: New Labeling/Dosing Strategy
Parents whose children are prescribed liquid medication will receive medications with health literacy informed labels and dosing instruments

Detailed Description:

Administering pediatric medications is frequently a difficult task for parents, in large part due to reliance on liquid formulations requiring the use of confusing, and often complex, measurement devices. Use of different units of measurement (milliliter, teaspoon, and/or tablespoon units) with variations in associated abbreviations, and the variability of measuring devices (type, markings, capacity), are sources of parent confusion. Low health literacy is linked to caregiver misunderstanding. Despite high error and utilization rates for outpatient pediatric medications, research examining strategies to prevent medication errors have focused largely on adults and on inpatient populations.

The ability to understand pediatric medication instructions is a critical health literacy and patient safety concern. Recently, the US Food and Drug Administration recognized the importance of this issue and released new guidelines to promote improved labeling and measuring devices for pediatric liquid medications. While these recommendations are an essential first step, evidence is needed to support the development of 'best practices' for designing optimal instructions and devices, especially for parents with limited literacy and/or limited English proficiency.

Our study objective is to identify evidence-based 'best practices' for labeling and dosing prescription and over-the-counter pediatric liquid medications in order to promote safe, appropriate use. A series of experiments will first be conducted to examine the efficacy of specific dosing and measurement strategies for improving parent understanding and use of pediatric liquid medications, including examining the impact of milliliter-only label instructions and devices, as well as the potential role for pictographic dosing diagrams. Findings will be merged with existing evidence-based health literacy 'best practices' for medication labeling to develop a comprehensive, patient-centered strategy for the labeling and dosing of pediatric liquid medications. The effectiveness of the patient-centered strategy will then be evaluated as part of a randomized controlled trial among English and Spanish-speaking parents whose children have been newly prescribed oral liquid antibiotics in a pediatric emergency department setting. Secondary aims of the study include extending the body of literature on health literacy and pediatric medication use, and generating a policy road map for achieving and implementing labeling and dosing standards for pediatric liquid medications.

  Eligibility

Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Phase II of Study (Effectiveness Trial)

Inclusion Criteria:

  • parent/legal guardian of a child age 8 or less
  • parent/legal guardian age 18 or greater
  • child presenting for care in the emergency department
  • child prescribed short course liquid antibiotic
  • parent English or Spanish-speaking
  • parent responsible for administering medication to child

Exclusion Criteria:

  • parent visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
  • parent with uncorrectable hearing impairment
  • prior participation in study involving medication dosing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854151

Contacts
Contact: H. Shonna Yin, MD, MS 212-562-2821 yinh02@med.nyu.edu

Locations
United States, California
Stanford University School of Medicine Active, not recruiting
Stanford, California, United States, 94305
United States, Georgia
Emory University School of Medicine Active, not recruiting
Atlanta, Georgia, United States, 30303
United States, Illinois
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Hsiang S Yin, MD, MS    212-562-2821    yinh02@med.nyu.edu   
Principal Investigator: Hsiang Yin, MD         
Sponsors and Collaborators
New York University School of Medicine
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Emory University
Northwestern University
Stanford University
Investigators
Principal Investigator: H. Shonna Yin, MD, MS NYU School of Medicine / Bellevue Hospital Center
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01854151     History of Changes
Other Study ID Numbers: 11-01122
1R01HD070864-01A1 ( U.S. NIH Grant/Contract )
Study First Received: May 14, 2013
Last Updated: April 19, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
Medication errors
Medication dosing

ClinicalTrials.gov processed this record on July 21, 2017