Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- University of Chicago
- Study ID
- NCT06094478
- Status
- Recruiting
Conditions
- Hemorrhagic Stroke
- Ischemic Stroke, Acute
- Stroke, Acute
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- HI-SPEED Protocol — BEHAVIORALThe 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 Details
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.
Key Dates
- Start date
- Oct 17, 2024
- Status verified
- May 2026
- Primary completion
- Jan 31, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 900 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- No Intervention: Control PhasePre-implementation of HI-SPEED Protocol
- Active Comparator: Implementation PhasePost-Implementation of HI-SPEED Protocol
Primary Outcome Measure
DIDO time in acute ischemic stroke patients [ Time Frame: Baseline ]
Central Contacts
- Shyam Prabhakaran, MD, MS773-702-0080
- Jane L Holl, MD, MPH773-702-8186
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | Joseph Schindler, MD (PRINCIPAL_INVESTIGATOR) |
| Jackson Memorial Hospital | Miami | Florida | 33136 | Gillian Gordon Perue, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University Hospital | Atlanta | Georgia | 30322 | Fadi Nahab, MD Fadi Nahab, MD (PRINCIPAL_INVESTIGATOR) |
| UChicago Medicine Ingalls Memorial Hospital | Chicago | Illinois | 60426 | Lakshmi Warrior, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | Will Meurer, MD, MS Will Meurer, MD, MS (PRINCIPAL_INVESTIGATOR) |
| New York Presbyterian - Weill Cornell Hospital | New York | New York | 10065 | Ava L Liberman, MD Ava L Liberman, MD (PRINCIPAL_INVESTIGATOR) |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | Christopher T Richards, MD, MS (PRINCIPAL_INVESTIGATOR) |
| University of Utah Health | Salt Lake City | Utah | 84132 | Lee S Chung, MD Lee S Chung, MD (PRINCIPAL_INVESTIGATOR) |
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