跳至主要内容
临床试验/NCT05373771
NCT05373771招募中不适用

Sickle Cell Improvement: Enhancing Care in the Emergency Department

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 5,328 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,328
试验地点
2
主要终点
Timeliness of receipt of opioids

研究概览

简要总结

Sickle cell disease (SCD) is an inherited blood disorder affecting approximately 36,000 children in the United States, approximately 90% of whom are Black. The disease is characterized by recurrent, severe pain crises which result in high rates of emergency department visits and hospitalizations, and decreased quality of life. The National Heart, Lung and Blood Institute, as well as the American Society of Hematology, have endorsed pain management guidelines regarding the timeliness of care for children presenting with these acute pain crises. These evidence-based guidelines are infrequently followed, resulting in increased pain and hospitalizations. In additional to other barriers to following the guideline, structural racism has been proposed as a significant contributor and the New England Journal of Medicine recently called for the institution of SCD-specific pain management protocols to combat structural racism and reduce time to opioid administration. The investigators' long-term goal is to improve the care and health outcomes of children with acute painful vaso-occlusive crisis treated in the emergency department. The overall aim of the investigators is to test a care pathway using multifaceted implementation strategies to increase guideline adherent care for children in the emergency department with acute painful vaso-occlusive crisis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • ED visit for uncomplicated pain crisis
  • Sickle cell disease
  • Receipt of at least one opioid

排除标准

  • Acute chest syndrome
  • Fever > 38.5 in the ED
  • sickle cell trait

结局指标

主要结局

Timeliness of receipt of opioids

时间窗: A maximum of about 6 hours as all opioids received during the ED stay will be captured

The percent of patients who receive first dose of opioids within 60 minutes of arrival and subsequent doses within 30 minutes of previous dose

次要结局

  • Median time to opioids(A maximum of about 6 hours as all opioids received during the ED stay will be captured)
  • Percent of children hospitalized(A maximum of about 6 hours as that is the typical maximum time to disposition for patients)

研究者

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

David Brousseau

Professor, Chair

Nemours Children's Health System

研究点 (2)

Loading locations...

相似试验