Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06094478

Conditions

Stroke, Acute

Ischemic Stroke, Acute

Hemorrhagic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HI-SPEED Protocol

Study Details

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.

Conditions

Stroke, Acute

Ischemic Stroke, Acute

Hemorrhagic Stroke

Study ID

NCT06094478

Start date

Oct 17, 2024

Status verified date

May, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Control Phase

Pre-implementation of HI-SPEED Protocol

active comparator: Implementation Phase

Post-Implementation of HI-SPEED Protocol

Interventions

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.

Primary outcome measure

  • DIDO time in acute ischemic stroke patients [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Shyam Prabhakaran, MD, MS

773-702-0080shyam1@bsd.uchicago.edu

Jane L Holl, MD, MPH

773-702-8186jholl@bsd.uchicago.edu

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Joseph Schindler, MD

203-737-1057joseph.schindler@yale.edu

Principal Investigator:

Joseph Schindler, MD

Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33136

Contacts

Gillian Gordon Perue, MD

786-466-1380ggordonperue@miami.edu

Principal Investigator:

Gillian Gordon Perue, MD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Fadi Nahab, MD

fnahab@emory.edu

Principal Investigator:

Fadi Nahab, MD

UChicago Medicine Ingalls Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60426

Contacts

Lakshmi Warrior, MD

203-737-1057Lakshmi.Warrior@bsd.uchicago.edu

Principal Investigator:

Lakshmi Warrior, MD

University of Michigan Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Will Meurer, MD, MS

wmeurer@umich.edu

Principal Investigator:

Will Meurer, MD, MS

New York Presbyterian - Weill Cornell Hospital

Recruiting

New York, New York, United States, 10065

Contacts

Ava L Liberman, MD

all9188@med.cornell.edu

Principal Investigator:

Ava L Liberman, MD

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Christopher T Richards, MD, MS

513-585-8962richa2ch@ucmail.uc.edu

Principal Investigator:

Christopher T Richards, MD, MS

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Lee S Chung, MD

lee.chung@hsc.utah.edu

Principal Investigator:

Lee S Chung, MD

More Information

Sponsor

University of Chicago

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • interhospital transfer
  • quality improvement
  • implementation science
  • stroke systems of care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-05-20.