Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition (HI-SPEED)

May 18, 2026 updated by: University of Chicago

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Schindler, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Jackson Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Gillian Gordon Perue, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Fadi Nahab, MD
    • Illinois
      • Chicago, Illinois, United States, 60426
        • Recruiting
        • UChicago Medicine Ingalls Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Lakshmi Warrior, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital
        • Contact:
        • Principal Investigator:
          • Will Meurer, MD, MS
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian - Weill Cornell Hospital
        • Principal Investigator:
          • Ava L Liberman, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
        • Principal Investigator:
          • Christopher T Richards, MD, MS
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Health
        • Principal Investigator:
          • Lee S Chung, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Phase
Pre-implementation of HI-SPEED Protocol
Active Comparator: Implementation Phase
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.
Other Names:
  • HI-SPEED Bundle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
3 months post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

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

Investigators

  • Principal Investigator: Shyam Prabhakaran, MD, MS, University of Chicago
  • Principal Investigator: Jane Holl, MD, MPH, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB22-1932
  • 1U01NS131797-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only aggregate data and analyses will be shared between sites while sites will have IPD for their own site level data only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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