Hemorrhagic Stroke, Ischemic Stroke, Acute, Stroke, Acute
Conditions
Keywords
interhospital transfer, quality improvement, implementation science, stroke systems of care
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.
Interventions
BEHAVIORALHI-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.
Sponsors
University of Chicago
University of Miami
Yale University
University of Cincinnati
Weill Medical College of Cornell University
University of Utah
Emory University
University of Michigan
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DIDO time in acute ischemic stroke patients | Baseline | Time from ED arrival to ED departure prior to transfer to a comprehensive stroke center among ischemic stroke patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DIDO time in acute hemorrhagic stroke patients | Baseline | Time from ED arrival to ED departure prior to transfer to a comprehensive stroke center among hemorrhagic stroke patients |
| Modified Rankin Scale score at 3 months in acute ischemic stroke patients undergoing endovascular therapy | 3 months post-stroke | Proportion of acute ischemic stroke patients who undergo endovascular therapy and achieve good functional outcome (mRS 0-2) at 3 months post-stroke |
Countries
United States
Contacts
CONTACTShyam Prabhakaran, MD, MS
CONTACTJane L Holl, MD, MPH
PRINCIPAL_INVESTIGATORShyam Prabhakaran, MD, MS
University of Chicago
PRINCIPAL_INVESTIGATORJane Holl, MD, MPH
University of Chicago
Outcome results
None listed