Medication Dosing ErrorNCT05146388
Working With Doctors and Pharmacists to Help Parents Give Children's Liquid Medicines Safely
A study testing EHR-Based Approach in people with Medication Dosing Error, run by NYU Langone Health at 3 sites in United States.
Trial summary
The study objective is to assess the impact of an automated electronic health record (EHR)-based intervention that leverages e-prescriptions to support pharmacist adherence to recommended dispensing practices, with the goal of reducing parent dosing errors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Dosing Error
- What is being tested?
- EHR-Based Approach
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Apr 2022to 5 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregiver/Child
- English or Spanish-speaking
- Parent or legal guardian of a child prescribed a liquid medicine in the NYU Langone Health - Brooklyn or Bellevue ED, general outpatient pediatric clinic, or specialty care clinics
- 18 years of age or older
- Child ≤8y discharged home with a Rx for ≥1 daily liquid medication dose ≤10mL, for use as a chronic or short course (≤14 days) medication
- Primary person who will administer child's medications
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- Access to a smartphone that can take photos and send/receive text messages
- Willingness and ability to participate
- Pharmacy staff
- 1. Works at a pharmacy that dispensed index medicine to one of our study participants.
Who cannot join
- Caregiver/Child
- Does not have a working phone number
- Not able to return for in-person follow-up visit
- Was told to stop medication by provider after doctor/ED visit
- Parent no longer having index medication bottle
- Uncorrected hearing impairment
Show all 9Show fewer
- Self-reported poor visual acuity
- Pharmacy staff
- 1. Staff with no responsibility in determining unit of measure to include on Rx's or type/capacity of the dosing tool to dispense for pediatric oral liquid medications.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NYU Langone Health - Brooklyn
Brooklyn, New York, 11220
Sunset Park Family Health Center at NYU Langone
Brooklyn, New York, 11220
NYC Health + Hospitals / Bellevue
New York, New York, 10016
About this study
Official title: Leveraging the EHR to Promote Pharmacy Adoption of Dosing Best Practices and Reduce Parent Errors in Administering Pediatric Liquid Medications: A Health Literacy-Informed Approach
The study objective is to assess the impact of an automated electronic health record (EHR)-based intervention that leverages e-prescriptions to support pharmacist adherence to recommended dispensing practices, with the goal of reducing parent dosing errors.
Specifically, the study aims are to: 1) Examine the efficacy of the EHR-based intervention in improving pharmacy dispensing practices, including a) adherence to mL-only dosing and b) provision of optimal dosing tools; 2) Examine the efficacy of the EHR-based intervention in reducing parent dosing errors. The study will also explore whether implementation of the EHR-based intervention will reduce disparities in dosing errors by parent health literacy and LEP, and explore the efficacy of the EHR-based intervention in reducing ADEs.
Read more
A pre-/post-implementation study will be performed with English- and Spanish-speaking parents of children prescribed oral liquid medications in the pediatric emergency room, outpatient general pediatric clinic, and pediatric subspecialty clinics of 2 New York City hospital systems (NYU Langone Health - Brooklyn and NYC Health+Hospitals - Bellevue Hospital). Prior to implementation, e-Rx's will be generated by the EHR in the usual fashion; after implementation, e-Rx's will be generated by the EHR with instructions to the dispensing pharmacy to: 1) keep the dosing instructions in mL-only, and 2) dispense a specific dosing tool based on the amount prescribed.
The proposed project is consistent with a growing national focus on promoting the adoption of evidence-based strategies to improve disease management that address the needs of those with low health literacy and LEP from groups like the Joint Commission and the AHRQ.
- Conditions
- Medication Dosing Error
- Being tested
- EHR-Based Approach
- Keywords
- Electronic Prescriptions (e-Rx), Pharmacy Dispensing Practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR-Based ApproachOther
The intervention will be built directly into the EHR. E-prescriptions will be generated with pharmacy instructions for all prescription medications. The intervention will impart: 1) inclusion with e-Rx request for pharmacy to keep metric-only (mL-only) dosing on Rx label and 2) inclusion of guidance on the e-Rx requesting that the pharmacy give an optimal tool based on an algorithm. Algorithm for dosing tool recommendation: 1) for a prescribed dose of <= 1mL, optimal tool is 1 mL syringe, 2) for >1 mL to 5 mL, use a 5 mL syringe, 3) for >5mL to 10mL, use 10 mL syringe.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation - Usual Care | No intervention | In pre-implementation phase, patient e-Rxs will be generated by the EHR in the usual fashion. |
| Post-Implementation - EHR-Based Approach | Experimental | Not described Receives: Other: EHR-Based Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Dosing Error
Dosing error will be defined as >20% deviation from the prescribed dose
Measured: Within 8 weeks of index visit (Visit 2)
Caregiver Large Dosing Error
Large dosing error will be defined as >40% deviation from the prescribed dose
Measured: Within 8 weeks of index visit (Visit 2)
Pharmacy Use of mL-only on Rx Label
Measured: Within 4 weeks of index visit (Visit 1)
Pharmacy Provision of Optimal Dosing Tool
Measured: Within 4 weeks of index visit (Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start21 Apr 2022
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Dosing ErrorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- H. Shonna Yin, MD, MS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146388
- Sponsor's protocol ID
- 21-00972
- Status last verified
- Mar 2026
- First submitted
- 23 Nov 2021
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging the EHR to Promote Pharmacy Adoption of Dosing Best Practices and Reduce Parent Errors in Administering Pediatric Liquid Medications: A Health Literacy-Informed Approach
- ClinicalTrials.gov ID
- NCT05146388
- Acronym / sponsor ID
- 21-00972
- Conditions
- Medication Dosing Error
- Keywords
- Electronic Prescriptions (e-Rx), Pharmacy Dispensing Practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 6 Dec 2021 (actual)
- 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.
The study objective is to assess the impact of an automated electronic health record (EHR)-based intervention that leverages e-prescriptions to support pharmacist adherence to recommended dispensing practices, with the goal of reducing parent dosing errors.
Specifically, the study aims are to: 1) Examine the efficacy of the EHR-based intervention in improving pharmacy dispensing practices, including a) adherence to mL-only dosing and b) provision of optimal dosing tools; 2) Examine the efficacy of the EHR-based intervention in reducing parent dosing errors. The study will also explore whether implementation of the EHR-based intervention will reduce disparities in dosing errors by parent health literacy and LEP, and explore the efficacy of the EHR-based intervention in reducing ADEs.
A pre-/post-implementation study will be performed with English- and Spanish-speaking parents of children prescribed oral liquid medications in the pediatric emergency room, outpatient general pediatric clinic, and pediatric subspecialty clinics of 2 New York City hospital systems (NYU Langone Health - Brooklyn and NYC Health+Hospitals - Bellevue Hospital). Prior to implementation, e-Rx's will be generated by the EHR in the usual fashion; after implementation, e-Rx's will be generated by the EHR with instructions to the dispensing pharmacy to: 1) keep the dosing instructions in mL-only, and 2) dispense a specific dosing tool based on the amount prescribed.
The proposed project is consistent with a growing national focus on promoting the adoption of evidence-based strategies to improve disease management that address the needs of those with low health literacy and LEP from groups like the Joint Commission and the AHRQ.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation - Usual Care | No intervention | –In pre-implementation phase, patient e-Rxs will be generated by the EHR in the usual fashion. |
| Post-Implementation - EHR-Based Approach | Experimental | Other: EHR-Based Approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Caregiver/Child
- English or Spanish-speaking
- Parent or legal guardian of a child prescribed a liquid medicine in the NYU Langone Health - Brooklyn or Bellevue ED, general outpatient pediatric clinic, or specialty care clinics
- 18 years of age or older
- Child ≤8y discharged home with a Rx for ≥1 daily liquid medication dose ≤10mL, for use as a chronic or short course (≤14 days) medication
Key exclusion criteria (9 listed)
- Caregiver/Child
- Does not have a working phone number
- Not able to return for in-person follow-up visit
- Was told to stop medication by provider after doctor/ED visit
- Parent no longer having index medication bottle
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 |
|---|---|---|
| EHR-Based ApproachThe intervention will be built directly into the EHR. E-prescriptions will be generated with pharmacy instructions for all prescription medications. The intervention will impart: 1) inclusion with e-Rx request for pharmacy to keep metric-only (mL-only) dosing on Rx label and 2) inclusion of guidance on the e-Rx requesting that the pharmacy give an optimal tool based on an algorithm. Algorithm for dosing tool recommendation: 1) for a prescribed dose of <= 1mL, optimal tool is 1 mL syringe, 2) for >1 mL to 5 mL, use a 5 mL syringe, 3) for >5mL to 10mL, use 10 mL syringe. | Other | Post-Implementation - EHR-Based Approach |
Primary outcome
Caregiver Dosing Error
Time frame: Within 8 weeks of index visit (Visit 2)
Dosing error will be defined as >20% deviation from the prescribed dose
Caregiver Large Dosing Error
Time frame: Within 8 weeks of index visit (Visit 2)
Large dosing error will be defined as >40% deviation from the prescribed dose
Pharmacy Use of mL-only on Rx Label
Time frame: Within 4 weeks of index visit (Visit 1)
Pharmacy Provision of Optimal Dosing Tool
Time frame: Within 4 weeks of index visit (Visit 1)
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 6 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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 Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR-Based Approach in people with Medication Dosing Error, run by NYU Langone Health at 3 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 10 inclusion and 9 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Caregiver Dosing Error (time frame: Within 8 weeks of index visit (Visit 2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.