Clinical trial NCT05146388: Working With Doctors and Pharmacists to Help Parents Give Children's Liquid Medicines Safely
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medication Dosing Error
Keywords: Electronic Prescriptions (e-Rx)
Pharmacy Dispensing Practices
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2021-12-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

Caregiver/Child

1. English or Spanish-speaking
2. 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
3. 18 years of age or older
4. 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
5. Primary person who will administer child's medications
6. Access to a smartphone that can take photos and send/receive text messages
7. Willingness and ability to participate

Pharmacy staff

1. Works at a pharmacy that dispensed index medicine to one of our study participants.

Exclusion Criteria:

Caregiver/Child

1. Does not have a working phone number
2. Not able to return for in-person follow-up visit
3. Was told to stop medication by provider after doctor/ED visit
4. Parent no longer having index medication bottle
5. Uncorrected hearing impairment
6. 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.

Primary outcomes:
measure: Caregiver Dosing Error
timeFrame: Within 8 weeks of index visit (Visit 2)
measure: Caregiver Large Dosing Error
timeFrame: Within 8 weeks of index visit (Visit 2)
measure: Pharmacy Use of mL-only on Rx Label
timeFrame: Within 4 weeks of index visit (Visit 1)
measure: Pharmacy Provision of Optimal Dosing Tool
timeFrame: Within 4 weeks of index visit (Visit 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYU Langone Health - Brooklyn
state: New York
city: Brooklyn
country: United States
facility: Sunset Park Family Health Center at NYU Langone
state: New York
city: New York
country: United States
facility: NYC Health + Hospitals / Bellevue
state: New York
Study officials:
affiliation: NYU Langone Health
name: H. Shonna Yin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: