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

• Sponsor: University of Chicago (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06094478
• Collaborator: University of Miami (Other), Yale University (Other), University of California, Los Angeles (Other), University of Cincinnati (Other), Weill Medical College of Cornell University (Other), University of Utah (Other), Emory University (Other), University of Michigan (Other), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
• Enrollment: 900
• Arms: 2
• Anticipated Duration (Months): 47.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute; Ischemic Stroke, Acute; Hemorrhagic Stroke	Behavioral: HI-SPEED Protocol	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 900 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Health Services Research
• Official Title: Implementation of a Stroke Protocol for Emergency Evaluation and Disposition
• Anticipated Study Start Date: Aug 2, 2024
• Anticipated Primary Completion Date: Jan 31, 2028
• Anticipated Study Completion Date: Jul 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Phase Pre-implementation of HI-SPEED Protocol
Active Comparator: Implementation Phase Post-Implementation of HI-SPEED Protocol	Behavioral: HI-SPEED Protocol; 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.; Other Names: HI-SPEED Bundle

Outcome Measures

Primary Outcome Measures

1. DIDO time in acute ischemic stroke patients [Baseline]

   Time from ED arrival to ED departure prior to transfer to a comprehensive stroke center among ischemic stroke patients

Secondary Outcome Measures

1. DIDO time in acute hemorrhagic stroke patients [Baseline]

   Time from ED arrival to ED departure prior to transfer to a comprehensive stroke center among hemorrhagic stroke patients

2. Modified Rankin Scale score at 3 months in acute ischemic stroke patients undergoing endovascular therapy [3 months post-stroke]

   Proportion of acute ischemic stroke patients who undergo endovascular therapy and achieve good functional outcome (mRS 0-2) at 3 months post-stroke

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Chicago
• University of Miami
• Yale University
• University of California, Los Angeles
• University of Cincinnati
• Weill Medical College of Cornell University
• University of Utah
• Emory University
• University of Michigan
• National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Shyam Prabhakaran, MD, MS, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

• Anderson CS, Chalmers J, Stapf C. Blood-pressure lowering in acute intracerebral hemorrhage. N Engl J Med. 2013 Sep 26;369(13):1274-5. doi: 10.1056/NEJMc1309586. No abstract available.
• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
• Mendelson SJ, Aggarwal NT, Richards C, O'Neill K, Holl JL, Prabhakaran S. Racial disparities in refusal of stroke thrombolysis in Chicago. Neurology. 2018 Jan 30;90(5):e359-e364. doi: 10.1212/WNL.0000000000004905. Epub 2018 Jan 3.
• Menon BK, Saver JL, Goyal M, Nogueira R, Prabhakaran S, Liang L, Xian Y, Hernandez AF, Fonarow GC, Schwamm L, Smith EE. Trends in endovascular therapy and clinical outcomes within the nationwide Get With The Guidelines-Stroke registry. Stroke. 2015 Apr;46(4):989-95. doi: 10.1161/STROKEAHA.114.007542. Epub 2015 Feb 13.
• Richards CT, Holl JL, Khorzad R, Prabhakaran S. Abstract TMP70: Simulation Modeling Predicts Actual Patient Transport Rates Following the Implementation of a Prehospital Comprehensive Stroke Center DirectTransport Protocol. Stroke. 2020;51(Suppl_1):ATMP70-ATMP70.
• Saver JL, Fonarow GC, Smith EE, Reeves MJ, Grau-Sepulveda MV, Pan W, Olson DM, Hernandez AF, Peterson ED, Schwamm LH. Time to treatment with intravenous tissue plasminogen activator and outcome from acute ischemic stroke. JAMA. 2013 Jun 19;309(23):2480-8. doi: 10.1001/jama.2013.6959.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT06094478
• Other Study ID Numbers: IRB22-1932; 1U01NS131797-01
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Chicago: interhospital transfer; quality improvement; implementation science; stroke systems of care
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Hemorrhagic Stroke; Emergencies; Methamphetamine

Study Results

No Results Posted as of Oct 23, 2023