Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

Study Overview
=================
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.

Official Title
-----------------
Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

Conditions
-----------------
Stroke, Acute, Ischemic Stroke, Acute, Hemorrhagic Stroke

Intervention / Treatment
-----------------
* Behavioral: HI-SPEED Protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Phase<br>Pre-implementation of HI-SPEED Protocol | |
| Active Comparator: Implementation Phase<br>Post-Implementation of HI-SPEED Protocol | Behavioral: HI-SPEED Protocol<br>* 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.<br>* Other names: HI-SPEED Bundle;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline | 
| 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 | 3 months post-stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interhospital transfer, quality improvement, implementation science, stroke systems of care