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Completed

NCT Number: NCT04242784

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

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mission Health, Asheville, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Time from door to drug as measured by medical record

    Time frame: From 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)

  2. Change in Time from Door to Tici 2c/3 flow measured by medical record

    Time frame: From 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

  3. Change in Time from Door to Administration of Reversal Agent as measured by medical record

    Time frame: From 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 outcomes

  1. Change in Number of Deaths from Stroke as measure by medical record

    Time frame: From baseline (Q1, 2017) to Quarter 4 (2020)

    Count of number of deaths from stroke

  2. Change in Functional Long Term Outcomes as measured by Modified Rankin Scale

    Time frame: From baseline , 3 months

    Modified Ranking Scale ranges from 0-6,

    0 No symptoms at all

    • No significant disability despite symptoms; able to carry out all usual duties and activities
    • Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • Moderate disability; requiring some help, but able to walk without assistance
    • Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • Dead

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Chiesi Farmaceutici S.p.A.
  • Daiichi Sankyo
  • Medtronic

Registry information

Official study title

IMPlementation of Best PRactices fOr Acute Stroke Care - Developing and Optimizing Regional Systems of Stroke Care

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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