Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >=18 years
Final diagnosis: AIS, ICH, or SAH
Disqualifiers
Final diagnosis: TIA or stroke NOS
Age <18 years
Comfort care measures on day 0 or 1
Left hospital against medical advice
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: Control PhaseNo intervention 0 interventions
Group B: Implementation PhaseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
BaselineSecondary outcomes
1
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
Time frame
Baseline2
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
Time frame
3 months post-strokeSponsors and contacts
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University of Chicago
Lead sponsor
University of Miami
Collaborator
Yale University
Collaborator
University of Cincinnati
Collaborator
Weill Medical College of Cornell University
Collaborator
University of Utah
Collaborator
Emory University
Collaborator
University of Michigan
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov