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Clinical Trials/NCT06094478
NCT06094478
Recruiting
Not Applicable

Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

University of Chicago7 sites in 1 country900 target enrollmentOctober 17, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Acute
Sponsor
University of Chicago
Enrollment
900
Locations
7
Primary Endpoint
DIDO time in acute ischemic stroke patients
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 17, 2024
End Date
July 31, 2028
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

DIDO time in acute ischemic stroke patients

Time Frame: Baseline

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

Secondary Outcomes

  • 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)

Study Sites (7)

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