Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

NCT ID: NCT06094478

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2028-07-31

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.

Conditions

Stroke, Acute; Ischemic Stroke, Acute; Hemorrhagic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control Phase

Pre-implementation of HI-SPEED Protocol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Implementation Phase

Post-Implementation of HI-SPEED Protocol

Group Type: ACTIVE_COMPARATOR

HI-SPEED Protocol

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

HI-SPEED Bundle

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shyam Prabhakaran, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Jane Holl, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status: RECRUITING

Jackson Memorial Hospital

Miami, Florida, United States

Site Status: RECRUITING

Emory University Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

UChicago Medicine Ingalls Memorial Hospital

Chicago, Illinois, United States

Site Status: RECRUITING

New York Presbyterian - Weill Cornell Hospital

New York, New York, United States

Site Status: RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

University of Utah Health

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shyam Prabhakaran, MD, MS

Role: CONTACT

shyam1@bsd.uchicago.edu

773-702-0080

Jane L Holl, MD, MPH

Role: CONTACT

jholl@bsd.uchicago.edu

773-702-8186

Facility Contacts

Joseph Schindler, MD

Role: primary

joseph.schindler@yale.edu

203-737-1057

Gillian Gordon Perue, MD

Role: primary

ggordonperue@miami.edu

786-466-1380

Fadi Nahab, MD

Role: primary

fnahab@emory.edu

Lakshmi Warrior, MD

Role: primary

Lakshmi.Warrior@bsd.uchicago.edu

203-737-1057

Ava L Liberman, MD

Role: primary

all9188@med.cornell.edu

Christopher T Richards, MD, MS

Role: primary

richa2ch@ucmail.uc.edu

513-585-8962

Lee S Chung, MD

Role: primary

lee.chung@hsc.utah.edu

References

Anderson CS, Chalmers J, Stapf C. Blood-pressure lowering in acute intracerebral hemorrhage. N Engl J Med. 2013 Sep 26;369(13):1274-5. doi: 10.1056/NEJMc1309586. No abstract available.

Reference Type: BACKGROUND

PMID: 24066751 (View on PubMed)

Richards CT, Holl JL, Khorzad R, Prabhakaran S. Abstract TMP70: Simulation Modeling Predicts Actual Patient Transport Rates Following the Implementation of a Prehospital Comprehensive Stroke Center DirectTransport Protocol. Stroke. 2020;51(Suppl_1):ATMP70-ATMP70.

Reference Type: BACKGROUND

Menon BK, Saver JL, Goyal M, Nogueira R, Prabhakaran S, Liang L, Xian Y, Hernandez AF, Fonarow GC, Schwamm L, Smith EE. Trends in endovascular therapy and clinical outcomes within the nationwide Get With The Guidelines-Stroke registry. Stroke. 2015 Apr;46(4):989-95. doi: 10.1161/STROKEAHA.114.007542. Epub 2015 Feb 13.

Reference Type: BACKGROUND

PMID: 25681065 (View on PubMed)

Saver JL, Fonarow GC, Smith EE, Reeves MJ, Grau-Sepulveda MV, Pan W, Olson DM, Hernandez AF, Peterson ED, Schwamm LH. Time to treatment with intravenous tissue plasminogen activator and outcome from acute ischemic stroke. JAMA. 2013 Jun 19;309(23):2480-8. doi: 10.1001/jama.2013.6959.

Reference Type: BACKGROUND

PMID: 23780461 (View on PubMed)

Mendelson SJ, Aggarwal NT, Richards C, O'Neill K, Holl JL, Prabhakaran S. Racial disparities in refusal of stroke thrombolysis in Chicago. Neurology. 2018 Jan 30;90(5):e359-e364. doi: 10.1212/WNL.0000000000004905. Epub 2018 Jan 3.

Reference Type: BACKGROUND

PMID: 29298854 (View on PubMed)

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

Reference Type: BACKGROUND

PMID: 22310560 (View on PubMed)

Other Identifiers

1U01NS131797-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB22-1932

Identifier Type: -

Identifier Source: org_study_id