Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

Stroke, Acute Clinical Trial

— HI-SPEED  

Official title:

Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06094478
• Other study ID #: IRB22-1932
• Secondary ID: 1U01NS131797-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: October 2023
• Source: University of Chicago
• Contact: Shyam Prabhakaran, MD, MS
• Phone: 773-702-0080
• Email: shyam1[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: July 31, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
University of Chicago	Emory University, National Institute of Neurological Disorders and Stroke (NINDS), University of California, Los Angeles, University of Cincinnati, University of Miami, University of Michigan, University of Utah, Weill Medical College of Cornell University, Yale University

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline
Secondary	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	3 months post-stroke