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临床试验/NCT04676490
NCT04676490已完成不适用

Recordable Cards for Optimizing Outcomes and Reducing Disparities After ED Discharge

Seattle Children's Hospital2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年12月15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
160
试验地点
2
主要终点
Protocol feasibility

研究概览

简要总结

In this pilot randomized trial, the investigators will evaluate the feasibility, acceptability, and potential family-centered outcomes associated with providing asthma discharge instructions in audio-recorded format in addition to written format, compared to written instructions alone. The study will enroll 100 families of children being discharged home from an emergency department visit, who prefer either English or Spanish for medical care, and assess outcomes at 3 time-points.

详细描述

This pilot randomized controlled trial seeks to test the feasibility and acceptability of providing and evaluating outcomes associated with audio-recorded, language concordant ED discharge instructions (the RECORD-ED intervention) among low-income parents of children treated for an asthma exacerbation. The study will enroll 100 children and their parent/caregiver with low income and/or limited English proficiency (LEP) who are being discharged home from the emergency department (ED) with a diagnosis of asthma; 20 will be randomized to receive usual discharge care, 40 will receive a physical card with audio-recorded discharge instructions, in addition to usual care, and another 40 will receive access to audio-recorded instructions through the patient portal in addition to usual care. The study team will also send a brief survey to providers and nurses in the ED about the intervention, and conduct qualitative interviews with parents and nurses about their experiences using the recordable cards for discharge instructions. Primary outcomes will focus on feasibility and acceptability of the intervention and outcome ascertainment protocols, as recommended for pilot studies. Parents will complete surveys at 3 time points. Parent outcomes (instruction recall, adherence, comfort with home care, caregiver quality of life), child outcomes (asthma control, including rescue medication use and school absence if age-appropriate), and follow-up utilization (primary care follow-up, 3-month ED and hospital re-visits) will be collected to inform planning for the subsequent R01 proposal.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Protocol feasibility

时间窗: 3 months after ED visit

\[The protocol will be determined to be feasible if the following criteria are met: * successful enrollment of 100 families over 15 months * participant retention \>70% through 3 follow-up surveys * successful ascertainment of parent, child, and utilization outcomes, with \<10% of data missing for each outcome (from among those who completed the relevant survey).\]

次要结局

  • Provider-rated intervention acceptability(Within 3 days of ED visit)
  • Instruction recall(2 days after)
  • Child asthma control(3 months after ED visit)
  • Asthma Caregiver Quality of Life(1 week after ED visit)
  • Comfort with home care(2 days after ED visit)
  • PCP follow-up(1 week after ED visit)
  • ED and hospital re-visits(3 months after ED visit)
  • Medication adherence(2 days after ED visit)

研究者

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

K. Casey Lion

Principal Investigator

Seattle Children's Hospital

研究点 (2)

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