An interventional study of HI-SPEED Protocol in Stroke, Acute, Ischemic Stroke, Acute and Hemorrhagic Stroke, sponsored by University of Chicago. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by University of Chicago · Not applicable, Interventional, and Health services research
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.
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.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's planned enrollment of 900 is above the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pre-implementation of HI-SPEED Protocol
Post-Implementation of HI-SPEED Protocol
Behavioral: HI-SPEED Protocol
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.
Also known as: HI-SPEED Bundle
DIDO time in acute ischemic stroke patients
Time from ED arrival to ED departure prior to transfer to a comprehensive stroke center among ischemic stroke patients
Time frame: Baseline
DIDO time in acute hemorrhagic stroke patients
Time from ED arrival to ED departure prior to transfer to a comprehensive stroke center among hemorrhagic stroke patients
Time frame: Baseline
Modified Rankin Scale score at 3 months in acute ischemic stroke patients undergoing endovascular therapy
Proportion of acute ischemic stroke patients who undergo endovascular therapy and achieve good functional outcome (mRS 0-2) at 3 months post-stroke
Time frame: 3 months post-stroke
Plan to share: No — Only aggregate data and analyses will be shared between sites while sites will have IPD for their own site level data only.
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