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NCT Number: NCT06094478

Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HI-SPEED Protocol

Behavioral

The HI-SPEED Protocol or Bundle consists of 7 components including 1) stroke screening scales, 2) imaging pathways, 3) telestroke operations, 4) a best practice alert, 5) stroke team communication tool, 6) door-to-needle (thrombolysis) treatment pathway, and 7) a standardized hand-off tool. This protocol will be implemented at each participating health system in clusters of 2 health systems.

Other names: HI-SPEED Bundle

Primary outcomes

  1. 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

  1. DIDO time in acute hemorrhagic stroke patients

    Time frame: Baseline

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

  2. Modified Rankin Scale score at 3 months in acute ischemic stroke patients undergoing endovascular therapy

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jane L Holl, MD, MPH

CONTACT

[email protected]

773-702-8186

Shyam Prabhakaran, MD, MS

CONTACT

[email protected]

773-702-0080

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Emory University
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of Cincinnati
  • University of Miami
  • University of Michigan
  • University of Utah
  • Weill Medical College of Cornell University
  • Yale University

Registry information

Official study title

Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

Acronym: HI-SPEED

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 23, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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