Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

Not Applicable

Recruiting

• Conditions: Hemorrhagic Stroke; Stroke, Acute; Ischemic Stroke, Acute
• Interventions: Behavioral: HI-SPEED Protocol

• Registration Number: NCT06094478
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Status Verified: 2024-10
• Study Start: 2024-10-17
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-23
• Primary Completion: 2028-01-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implementation Phase	HI-SPEED Protocol	Post-Implementation of HI-SPEED Protocol

Primary Outcome Measures

Name	Time	Method
DIDO time in acute ischemic stroke patients	Baseline	Time from ED arrival to ED departure prior to transfer to a comprehensive stroke center among ischemic stroke patients

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale score at 3 months in acute ischemic stroke patients undergoing endovascular therapy	3 months post-stroke	Proportion of acute ischemic stroke patients who undergo endovascular therapy and achieve good functional outcome (mRS 0-2) at 3 months post-stroke
DIDO time in acute hemorrhagic stroke patients	Baseline	Time from ED arrival to ED departure prior to transfer to a comprehensive stroke center among hemorrhagic stroke patients

Trial Locations

Locations (2)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States