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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HI-SPEED Protocol — BEHAVIORAL
    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 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 Phase
    Pre-implementation of HI-SPEED Protocol
  • Active Comparator: Implementation Phase
    Post-Implementation of HI-SPEED Protocol

Primary Outcome Measure

DIDO time in acute ischemic stroke patients [ Time Frame: Baseline ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510
Joseph Schindler, MD
203-737-1057
Joseph Schindler, MD (PRINCIPAL_INVESTIGATOR)
Jackson Memorial HospitalMiamiFlorida33136
Gillian Gordon Perue, MD
786-466-1380
Gillian Gordon Perue, MD (PRINCIPAL_INVESTIGATOR)
Emory University HospitalAtlantaGeorgia30322
Fadi Nahab, MD
Fadi Nahab, MD (PRINCIPAL_INVESTIGATOR)
UChicago Medicine Ingalls Memorial HospitalChicagoIllinois60426
Lakshmi Warrior, MD
203-737-1057
Lakshmi Warrior, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan HospitalAnn ArborMichigan48109
Will Meurer, MD, MS
Will Meurer, MD, MS (PRINCIPAL_INVESTIGATOR)
New York Presbyterian - Weill Cornell HospitalNew YorkNew York10065
Ava L Liberman, MD
Ava L Liberman, MD (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Medical CenterCincinnatiOhio45267
Christopher T Richards, MD, MS
513-585-8962
Christopher T Richards, MD, MS (PRINCIPAL_INVESTIGATOR)
University of Utah HealthSalt Lake CityUtah84132
Lee S Chung, MD
Lee S Chung, MD (PRINCIPAL_INVESTIGATOR)

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