NCT06094478

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Oct 2024Jul 2028

First Submitted

Initial submission to the registry

October 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

October 17, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

August 22, 2025

Status Verified

April 1, 2025

Enrollment Period

3.3 years

First QC Date

October 17, 2023

Last Update Submit

August 20, 2025

Conditions

Stroke, AcuteIschemic Stroke, AcuteHemorrhagic Stroke

Keywords

interhospital transferquality improvementimplementation sciencestroke systems of care

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (2)

  • DIDO time in acute hemorrhagic stroke patients

    Baseline

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

    3 months post-stroke

Study Arms (2)

Control Phase

NO INTERVENTION

Pre-implementation of HI-SPEED Protocol

Implementation Phase

ACTIVE COMPARATOR

Post-Implementation of HI-SPEED Protocol

Behavioral: HI-SPEED Protocol

Interventions

HI-SPEED ProtocolBEHAVIORAL

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
Implementation Phase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>=18 years
  • Final diagnosis: AIS, ICH, or SAH

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Jackson Memorial Hospital

Miami, Florida, 33136, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

UChicago Medicine Ingalls Memorial Hospital

Chicago, Illinois, 60426, United States

RECRUITING

New York Presbyterian - Weill Cornell Hospital

New York, New York, 10065, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

RECRUITING

University of Utah Health

Salt Lake City, Utah, 84132, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 24066751BACKGROUND

  • 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.

    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.

    PMID: 25681065BACKGROUND

  • 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.

    PMID: 23780461BACKGROUND

  • 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.

    PMID: 29298854BACKGROUND

  • 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.

    PMID: 22310560BACKGROUND

MeSH Terms

Conditions

StrokeIschemic StrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Shyam Prabhakaran, MD, MS

    University of Chicago

    PRINCIPAL INVESTIGATOR

  • Jane Holl, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shyam Prabhakaran, MD, MS

CONTACT

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

Jane L Holl, MD, MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study is a multicenter, prospective cluster-randomized, controlled study designed to establish the effectiveness of a multi-component DIDO intervention, the HI-SPEED Protocol, to reduce the median DIDO time for acute ischemic stroke (primary outcome) and for hemorrhagic stroke (secondary outcome) and increase the proportion of acute ischemic stroke patients with good functional outcomes after endovascular therapy (secondary outcome), defined as a 3-month modified Rankin Score of 0-2.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 23, 2023

Study Start

October 17, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

August 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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

Locations

US(7)