Medication ErrorsNCT01854151
Promoting Safe Use of Pediatric Liquid Medications
A study testing New Labeling/Dosing Strategy in people with Medication Errors, run by NYU Langone Health at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Errors
- What is being tested?
- New Labeling/Dosing Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,005 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Apr 2013to 25 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- parent visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
- parent with uncorrectable hearing impairment
- prior participation in study involving medication dosing
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
Northwestern University
Chicago, Illinois, 60611
New York University School of Medicine
New York, New York, 10016
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Promoting Safe Use of Pediatric Liquid Medications: A Health Literacy Approach
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.
Read the 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.
- Conditions
- Medication Errors
- Being tested
- New Labeling/Dosing Strategy
- Keywords
- Medication errors, Medication dosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Labeling/Dosing StrategyOther
Parents whose children are prescribed liquid medication will receive medications with health literacy informed labels and dosing instruments
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: New Labeling/Dosing Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication dosing accuracy
Measured: Target within 2 weeks after medication course completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study start22 Apr 2013
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication ErrorsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Emory University, Northwestern University, Stanford University
- Responsible party
- Sponsor
- Investigators
- H. Shonna Yin, MD, MS, Principal investigator, NYU School of Medicine / Bellevue Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854151
- Sponsor's protocol ID
- 11-01122
- Other IDs
- 1R01HD070864-01A1
- Status last verified
- May 2024
- First submitted
- 14 May 2013
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27621414
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Safe Use of Pediatric Liquid Medications: A Health Literacy Approach
- ClinicalTrials.gov ID
- NCT01854151
- Acronym / sponsor ID
- 11-01122
- Conditions
- Medication Errors
- Keywords
- Medication errors, Medication dosing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Emory University, Northwestern University, Stanford University
- Study start
- 22 Apr 2013 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: New Labeling/Dosing StrategyParents whose children are prescribed liquid medication and meet inclusion/exclusion criteria will receive medications with health literacy informed labels and dosing instruments |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- parent visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
- parent with uncorrectable hearing impairment
- prior participation in study involving medication dosing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Labeling/Dosing StrategyParents whose children are prescribed liquid medication will receive medications with health literacy informed labels and dosing instruments | Other | New Labeling/Dosing Strategy |
Primary outcome
Medication dosing accuracy
Time frame: Target within 2 weeks after medication course completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 27621414Yin 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.
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Shonna Yin, MD, MS principal investigator
NYU School of Medicine / Bellevue Hospital Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Labeling/Dosing Strategy in people with Medication Errors, run by NYU Langone Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication dosing accuracy (time frame: Target within 2 weeks after medication course completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01854151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.