Clinical trial NCT06094478: Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition
Official title: Implementation of a Stroke Protocol for Emergency Evaluation and Disposition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Ischemic Stroke, Acute
Hemorrhagic Stroke
Keywords: interhospital transfer
quality improvement
implementation science
stroke systems of care
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Yale University
name: University of Cincinnati
name: Weill Medical College of Cornell University
name: University of Utah
name: Emory University
name: University of Michigan
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-10-23
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: DIDO time in acute ischemic stroke patients
timeFrame: Baseline
Secondary outcomes:
measure: DIDO time in acute hemorrhagic stroke patients
timeFrame: Baseline
measure: Modified Rankin Scale score at 3 months in acute ischemic stroke patients undergoing endovascular therapy
timeFrame: 3 months post-stroke
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: New York
country: United States
facility: New York Presbyterian - Weill Cornell Hospital
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: University of Chicago
name: Shyam Prabhakaran, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Jane Holl, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: 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.
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.
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.