Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition (HI-SPEED)

The University of Chicago

Status: Enrolling

Conditions: Hemorrhagic Stroke; Ischemic Stroke, Acute; Stroke, Acute

Treatments: Behavioral: HI-SPEED Protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06094478

IRB22-1932

1U01NS131797-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Control Phase

No Intervention group

Description:

Pre-implementation of HI-SPEED Protocol

Implementation Phase

Active Comparator group

Description:

Post-Implementation of HI-SPEED Protocol

Treatment:

Behavioral: HI-SPEED Protocol