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临床试验/NCT05146388
NCT05146388已完成不适用

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

NYU Langone Health5 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年4月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
5
主要终点
Pharmacy Provision of Optimal Dosing Tool

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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.

排除标准

  • 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
  • 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.

研究组 & 干预措施

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

干预措施: EHR-Based Approach (Other)

结局指标

主要结局

Pharmacy Provision of Optimal Dosing Tool

时间窗: Within 4 weeks of index visit (Visit 1)

Pharmacy Use of mL-only on Rx Label

时间窗: Within 4 weeks of index visit (Visit 1)

Caregiver Large Dosing Error

时间窗: Within 8 weeks of index visit (Visit 2)

Large dosing error will be defined as \>40% deviation from the prescribed dose

Caregiver Dosing Error

时间窗: Within 8 weeks of index visit (Visit 2)

Dosing error will be defined as \>20% deviation from the prescribed dose

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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