Clinical trial NCT04242784: IMPROVE Stroke Care- Developing and Optimizing Regional Systems of Stroke Care
Official title: IMPlementation of Best PRactices fOr Acute Stroke Care - Developing and Optimizing Regional Systems of Stroke Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stroke
Intracranial Hemorrhages
Subarachnoid Hemorrhage
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Daiichi Sankyo
name: Chiesi Farmaceutici S.p.A.
First posted: 2020-01-27
Enrollment: 21646
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who undergo the Acute Code Stroke Process, who demonstrate symptoms of a possible acute stroke, and are presenting to a Spoke or Hub within the Southeastern US at the 9 Hub Hospitals and Spokes associated with those Hubs participating in the project.

Brief summary: The purpose of this program is to develop a regional integrated stroke system that identifies, classifies, and treats patients with acute ischemic stroke more rapidly and effectively with reperfusion therapy.

Detailed description: The design is based upon the implementation of best practice, that is, based on a comprehensive review of AHA guidelines regarding treatment of acute stroke, ICH (intracranial hemorrhage) and SAH(sub arachnoid hemorrhage). In the second phase, the project will be doing national and international surveys of best practices among comprehensive stroke centers and then combine evidence based guidelines and recommendation as well as expert consensus and guidelines when high level evidence is not available from the published literature. The aim to improve public stroke awareness, stroke symptom recognition within the time benefit window for treatment and calling 9-1-1, EMS transportation, and the proportion and speed of reperfusion therapy (fibrinolytic and in appropriate patients- endovascular treatment) in eligible patients. These improvements in acute stroke care delivery are expected to result in lower mortality, fewer recurrent strokes, and improved long term functional outcomes that we will measure.

Eligibility criteria: Inclusion Criteria:

* Adult patients \> 18 years of age who undergo the local acute code stroke process

Exclusion Criteria:

* In house patients with stroke are not included in this data set.

Primary outcomes:
measure: Change in Time from door to drug as measured by medical record
timeFrame: From baseline (Q1, 2017), to Quarter 4 (2020)
measure: Change in Time from Door to Tici 2c/3 flow measured by medical record
timeFrame: From baseline (Q1, 2017), to Quarter 4 (2020)
measure: Change in Time from Door to Administration of Reversal Agent as measured by medical record
timeFrame: From baseline (Q1, 2017), to Quarter 4 (2020)
Secondary outcomes:
measure: Change in Number of Deaths from Stroke as measure by medical record
timeFrame: From baseline (Q1, 2017) to Quarter 4 (2020)
measure: Change in Functional Long Term Outcomes as measured by Modified Rankin Scale
timeFrame: From baseline , 3 months
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Mission Health
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health's Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center
state: North Carolina
city: Concord
country: United States
facility: Atrium Health Cabarrus
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Columbia
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Duke University
name: Carmelo Graffagnino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Bradley Kolls, MD
role: PRINCIPAL_INVESTIGATOR
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