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IMPROVE Stroke Care- Developing and Optimizing Regional Systems of Stroke Care

Completed
Conditions
Acute Stroke
Intracranial Hemorrhages
Subarachnoid Hemorrhage
Registration Number
NCT04242784
Lead Sponsor
Duke University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
21646
Inclusion Criteria
  • Adult patients > 18 years of age who undergo the local acute code stroke process
Read More
Exclusion Criteria
  • In house patients with stroke are not included in this data set.
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in Time from door to drug as measured by medical recordFrom baseline (Q1, 2017), to Quarter 4 (2020)

The time frame starting from the earliest time that the patient is documented as arriving to the hospital to the beginning time of the administration of the drug (TPA)

Change in Time from Door to Tici 2c/3 flow measured by medical recordFrom baseline (Q1, 2017), to Quarter 4 (2020)

The time frame starting from the earliest time that the patient is documented as arriving to the hospital to the beginning time of Tici 2c/c flow noted in the vessel

Change in Time from Door to Administration of Reversal Agent as measured by medical recordFrom baseline (Q1, 2017), to Quarter 4 (2020)

The time frame starting from the earliest time that the patient is documented as arriving to the hospital to the beginning time of the administration of the drug (reversal agent)

Secondary Outcome Measures
NameTimeMethod
Change in Number of Deaths from Stroke as measure by medical recordFrom baseline (Q1, 2017) to Quarter 4 (2020)

Count of number of deaths from stroke

Change in Functional Long Term Outcomes as measured by Modified Rankin ScaleFrom baseline , 3 months

Modified Ranking Scale ranges from 0-6,

0 No symptoms at all

1. No significant disability despite symptoms; able to carry out all usual duties and activities

2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

3. Moderate disability; requiring some help, but able to walk without assistance

4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance

5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention

6. Dead

Trial Locations

Locations (9)

Novant Health Presbyterian Medical Center

🇺🇸

Charlotte, North Carolina, United States

Atrium Health's Carolinas Medical Center

🇺🇸

Charlotte, North Carolina, United States

New Hanover Regional Medical Center

🇺🇸

Wilmington, North Carolina, United States

Atrium Health Cabarrus

🇺🇸

Concord, North Carolina, United States

Mission Health

🇺🇸

Asheville, North Carolina, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

Prisma Health

🇺🇸

Columbia, South Carolina, United States

Novant Forsyth Medical Center

🇺🇸

Winston-Salem, North Carolina, United States

Wake Forest Baptist Medical Center

🇺🇸

Winston-Salem, North Carolina, United States

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