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临床试验/NCT06094478
NCT06094478招募中不适用

Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

University of Chicago15 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2024年10月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
15
主要终点
DIDO time in acute ischemic stroke patients

研究概览

简要总结

Most stroke patients are initially evaluated at the closest hospital but some need to be transferred to a hospital that can provide more advanced care. The "Door-In-Door-Out" (DIDO) process at the first hospital can take time making transferred patients no longer able to get the advanced treatments. This study will help hospitals across the US "stand up" new ways to evaluate stroke patients, decide who needs to be transferred, and transfer them quickly for advanced treatment.

详细描述

Nearly 800,000 people in the United States (US) each year experience acute stroke, which remains the leading cause of adult disability and 5th leading cause of death. Despite the proliferation of stroke centers nationwide, almost half of the US population lives beyond a 60-minute drive of a comprehensive stroke center (CSC) and many patients require inter-hospital transfer (IHT) from a non-CSC to a CSC. Building upon prior work to reduce door-in-door-out (DIDO) time at referring hospitals, this proposal entitled "Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition (HI-SPEED)" study seeks to (1) implement a novel, evidence-based, multi-component DIDO intervention in eight diverse stroke systems of care across multiple regions of the US and (2) conduct a dual evaluation of its effectiveness in reducing median DIDO time (primary outcome) and disability (secondary outcome) and of the fidelity and quality of implementation. The HI-SPEED study will definitively establish the effectiveness and generalizability of a multi-component evidence-based DIDO intervention and provide information about contextual adaptations for high-quality implementation and widespread dissemination. This study benefits from our well-established interdisciplinary expertise in stroke, emergency and prehospital medicine, systems and quality engineering, health services research, and strong multicenter research collaborations. Findings from HI-SPEED will have substantial implications for a wide range of hospitals and stroke systems of care worldwide.

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

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

入选标准

  • Age >=18 years
  • Final diagnosis: AIS, ICH, or SAH

排除标准

  • Final diagnosis: TIA or stroke NOS
  • Age <18 years
  • Comfort care measures on day 0 or 1
  • Left hospital against medical advice
  • Enrolled in clinical trial related to stroke that is competing with this study

研究组 & 干预措施

Control Phase

No Intervention

Pre-implementation of HI-SPEED Protocol

Implementation Phase

Active Comparator

Post-Implementation of HI-SPEED Protocol

干预措施: HI-SPEED Protocol (Behavioral)

结局指标

主要结局

DIDO time in acute ischemic stroke patients

时间窗: Baseline

Time from ED arrival to ED departure prior to transfer to a comprehensive stroke center among ischemic stroke patients

次要结局

  • Modified Rankin Scale score at 3 months in acute ischemic stroke patients undergoing endovascular therapy(3 months post-stroke)
  • DIDO time in acute hemorrhagic stroke patients(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (15)

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