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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EHR-Based Approach | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Dosing Error | Dosing error will be defined as >20% deviation from the prescribed dose | 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 | Within 8 weeks of index visit (Visit 2) |
| Pharmacy Use of mL-only on Rx Label | Within 4 weeks of index visit (Visit 1) | |
| Pharmacy Provision of Optimal Dosing Tool | Within 4 weeks of index visit (Visit 1) |
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Inclusion Criteria:
Caregiver/Child
Pharmacy staff
1. Works at a pharmacy that dispensed index medicine to one of our study participants.
Exclusion Criteria:
Caregiver/Child
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.
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| Name | Affiliation | Role |
|---|---|---|
| H. Shonna Yin, MD, MS | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health - Brooklyn | Brooklyn | New York | 11220 | United States | ||
| Sunset Park Family Health Center at NYU Langone |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Hsiang.Yin@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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Single (Outcomes Assessor) Two raters will independently assess dosing errors. Raters will be kept blinded to each other's estimated dose volumes and dosing error assessment in order to minimize bias.
|
| Brooklyn |
| New York |
| 11220 |
| United States |
| NYC Health + Hospitals / Bellevue | New York | New York | 10016 | United States |