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临床试验/NCT03645590
NCT03645590已完成不适用

Stroke Ready - Optimizing Acute Stroke Care

University of Michigan2 个研究点 分布在 1 个国家目标入组 5,970 人开始时间: 2018年6月20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
5,970
试验地点
2
主要终点
Acute stroke treatment rate (tPA)

研究概览

简要总结

The study aims to increase acute stroke treatment rates in Flint, Michigan through a two-pronged approach of hospital and community level interventions. It also aims to inform future stroke preparedness interventions by exploring the relative importance of hospital optimization and community interventions.

详细描述

In this study, the participants who received the intervention are a separate group from those analyzed in the outcome measures. Stroke Ready was a multilevel intervention that included a hospital based emergency department optimization component conducted from October 2017 through May 2018 and a community based stroke preparedness intervention conducted from June 2018 through March 2020. The emergency department component focused on improving hospital level acute stroke care processes and did not involve participant enrollment, individual level data collection, or participant level outcomes. Stroke education sessions were offered to community members in quadrant based groups between 2017 and 2020, but this was simply for administrative purposes, not for analytical distinctions among the groups. Demographic information was collected based on workshop educators' perceptions of those in attendance and not taken at the individual level.

Outcome measures about acute stroke treatment rates were collected Flint wide for two different time periods: a preintervention period from July 2010 to September 2017 and a postintervention period from October 2017 to March 2020. The postintervention period was defined based on the initiation of the Stroke Ready intervention in October 2017, corresponding to the start of the emergency department optimization component.

Outcome measure data was not directly related to the intervention, as the intervention was performed among community members and outcomes obtained in people who had a stroke or TIA within time periods before and after the intervention. The workshop data was collected without identifiers at the group level based on perceptions of stroke educators. Baseline data for stroke patients was acquired from the medical record.

Consequently, the information in the Participant Flow and Adverse Events modules only reflects those who attended the community workshops in person or remotely and has no relation to the population addressed in the outcome measures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Adult stroke patients who presented to one of three hospitals in the Flint community.

排除标准

  • 未提供

研究组 & 干预措施

Stroke Ready Community intervention

Experimental

We divided the Flint community into four quadrants. We will focus our workshops and posters on one quadrant, but not exclusively, moving quadrants every 6 months over the course of two years.

干预措施: Stroke Ready (Behavioral)

结局指标

主要结局

Acute stroke treatment rate (tPA)

时间窗: Time frame: 11 years of data will be reviewed

Acute stroke treatment rate - community wide. Retrospective data captured through medical record review

Utilization of Thrombolysis Among Ischemic Stroke and Transient Ischemic Attack (TIA) Patients

时间窗: Data for this outcome was from county-wide medical records from July 2010 through September 2017 (pre-intervention) and from October 2017 through March 2020 (post-intervention, defined by initiation of the emergency department optimization component).

Proportion of Tissue Plasminogen Activator (tPA) treatment utilization among ischemic stroke and TIA patients in pre vs. post intervention periods in all Genesee county hospitals. This is a distinct group of county-wide patients who may or may not include any individuals who received the workshop intervention.

次要结局

  • Number of emergency department arrivals by ambulance(Time frame: 11 years of data will be reviewed)
  • Percent of Stroke and TIA Patients Who Arrive to the Emergency Department by Ambulance(Data was gathered retrospectively from the medical record for Flint stroke or TIA patients from October 2017 through March 2020, following initiation of the Stroke Ready intervention.)

研究者

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

Lesli Skolarus

Associate Professor of Neurology

University of Michigan

研究点 (2)

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