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临床试验/NCT05143047
NCT05143047已完成不适用

Development and Evaluation of a Health Literacy-Informed Communication Intervention for Discharge Medication Counseling in Hospitalized Children

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2021年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
198
试验地点
2
主要终点
Observed Dosing Accuracy

研究概览

简要总结

Our objective is to design and test the efficacy of a health-literacy-informed discharge medication counseling intervention in the inpatient setting to reduce medication dosing errors and improve adherence in hospitalized children discharged on a new liquid medication.

详细描述

The goal of this research is to improve discharge medication adherence and reduce medication dosing errors following pediatric hospitalization. Medication errors are one of the most common healthcare-associated adverse events in pediatrics, with approximately one out-of-hospital medication error occurring every 8 minutes among children < 6 years of age. Liquid medications account for the majority of pediatric dosing errors which is likely due to liquid medications' inherent dosing complexities, including the need for weight-based dosing, different concentrations of medications, and parental use of unstandardized dosing instruments. The increased stress and exhaustion that many caregivers experience during a hospitalization, coupled with the need to assimilate large amounts of information pertaining to post-discharge care, makes transitioning to home from an inpatient stay a particularly high risk period for medication errors. Communication challenges, particularly failure to consider caregiver health literacy, further compounds the risk for medication errors due to poor caregiver comprehension and adherence to discharge instructions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Caregivers of children up to 6 years old who are hospitalized on a general inpatient hospital medicine teams
  • Caregivers must speak English or Spanish
  • Participants' children must be discharged home on new scheduled liquid medication for minimum 3 days.

排除标准

  • Medication will be administered by home health nurse
  • Child is in state/protected custody
  • Medication prescription is prescribed to pharmacy other than hospital outpatient pharmacy

结局指标

主要结局

Observed Dosing Accuracy

时间窗: During follow-up survey assessment 48-72 hours following hospital discharge

Participants (caregivers) will be asked to draw up a dose of their child's liquid medication using the provided oral dosing syringe and send a secure picture of the syringe via myCap (secure phone application designed to collect patient-centered outcomes for research studies) to research study staff. The primary outcome will be assessed as a continuous percent difference from the prescribed dose (in milliliters) documented in the electronic health record. Study staff assessing amount in picture are blinded to group assignment.

次要结局

  • Correct Medication Dose(During follow-up survey assessment 48-72 hours following hospital discharge)
  • Correct Medication Frequency(During follow-up survey assessment 48-72 hours following hospital discharge)
  • Correct Medication Name(During follow-up survey assessment 48-72 hours following hospital discharge)
  • Reported Dosing Accuracy(During follow-up survey assessment 48-72 hours following hospital discharge)
  • Correct Medication Indication(During follow-up survey assessment 48-72 hours following hospital discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alison Carroll

Clinical Instructor in Pediatrics

Vanderbilt University Medical Center

研究点 (2)

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