AzTrials
AzTrials

Stroke, AcuteHI-SPEEDNCT06094478

Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

A study testing HI-SPEED Protocol in people with Stroke, Acute and Ischemic Stroke, Acute, run by University of Chicago at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HI-SPEED Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
8 sitesUnited States
Study dates
17 Oct 2024to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shyam Prabhakaran, MD, MS contact

773-702-0080

shyam1@bsd.uchicago.edu

Jane L Holl, MD, MPH contact

773-702-8186

jholl@bsd.uchicago.edu

8 sites in 1 country

United States8 sites, 8 recruiting

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

    Will Meurer, MD, MS, wmeurer@umich.edu

    Will Meurer, MD, MS

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Fadi Nahab, MD, fnahab@emory.edu

    Fadi Nahab, MD

    Recruiting

  • UChicago Medicine Ingalls Memorial Hospital

    Chicago, Illinois, 60426

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

    Lakshmi Warrior, MD

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

    Christopher T Richards, MD, MS, 513-585-8962, richa2ch@ucmail.uc.edu

    Christopher T Richards, MD, MS

    Recruiting

  • Jackson Memorial Hospital

    Miami, Florida, 33136

    Gillian Gordon Perue, MD, 786-466-1380, ggordonperue@miami.edu

    Gillian Gordon Perue, MD

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

    Joseph Schindler, MD, 203-737-1057, joseph.schindler@yale.edu

    Joseph Schindler, MD

    Recruiting

  • New York Presbyterian - Weill Cornell Hospital

    New York, New York, 10065

    Ava L Liberman, MD, all9188@med.cornell.edu

    Ava L Liberman, MD

    Recruiting

  • University of Utah Health

    Salt Lake City, Utah, 84132

    Lee S Chung, MD, lee.chung@hsc.utah.edu

    Lee S Chung, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
HI-SPEED Protocol
Keywords
interhospital transfer, quality improvement, implementation science, stroke systems of care
Medical subject headings
Stroke, Ischemic Stroke, Hemorrhagic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HI-SPEED ProtocolBehavioural

    Also called HI-SPEED Bundle

    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.

Study groups in NCT06094478
Study groupRoleWhat they receive
Control PhaseNo interventionPre-implementation of HI-SPEED Protocol
Implementation PhaseActive comparatorPost-Implementation of HI-SPEED Protocol
Receives: Behavioral: HI-SPEED Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

Secondary outcomes (2)

  1. 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

    Measured: Baseline

  2. 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

    Measured: 3 months post-stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start17 Oct 2024
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094478
Sponsor's protocol ID
IRB22-1932
Other IDs
1U01NS131797-01
Acronym
HI-SPEED
Status last verified
May 2026
First submitted
17 Oct 2023
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only aggregate data and analyses will be shared between sites while sites will have IPD for their own site level data only.

Publications

  • 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.

    PubMed 24066751

  • 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.

  • 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.

    PubMed 25681065

  • 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.

    PubMed 23780461

  • 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.

    PubMed 29298854

  • 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.

    PubMed 22310560

Questions about this trial

What is this clinical trial studying?

A study testing HI-SPEED Protocol in people with Stroke, Acute and Ischemic Stroke, Acute, run by University of Chicago at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shyam Prabhakaran, MD, MS (773-702-0080, shyam1@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DIDO time in acute ischemic stroke patients (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06094478, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in