NCT01854151

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,005

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

5.9 years

First QC Date

May 14, 2013

Last Update Submit

May 16, 2024

Conditions

Medication Errors

Keywords

Medication errorsMedication dosing

Outcome Measures

Primary Outcomes (1)

  • Medication dosing accuracy

    Target within 2 weeks after medication course completion

Study Arms (2)

Standard Practice

NO INTERVENTION

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

New Labeling/Dosing Strategy

EXPERIMENTAL

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

Interventions

New Labeling/Dosing StrategyOTHER

Parents whose children are prescribed liquid medication will receive medications with health literacy informed labels and dosing instruments

New Labeling/Dosing Strategy

Eligibility Criteria

AgeUp to 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • parent visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
  • parent with uncorrectable hearing impairment
  • prior participation in study involving medication dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • Yin HS, Parker RM, Sanders LM, Dreyer BP, Mendelsohn AL, Bailey S, Patel DA, Jimenez JJ, Kim KA, Jacobson K, Hedlund L, Smith MC, Maness Harris L, McFadden T, Wolf MS. Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment. Pediatrics. 2016 Oct;138(4):e20160357. doi: 10.1542/peds.2016-0357. Epub 2016 Sep 12.

    PMID: 27621414DERIVED

Study Officials

  • H. Shonna Yin, MD, MS

    NYU School of Medicine / Bellevue Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 15, 2013

Study Start

April 22, 2013

Primary Completion

March 25, 2019

Study Completion

March 25, 2019

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

US(4)