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

July 27, 2021 updated by: Duke University

IMPlementation of Best PRactices fOr Acute 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

21646

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Health
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health's Carolinas Medical Center
      • Concord, North Carolina, United States, 28025
        • Atrium Health Cabarrus
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Wilmington, North Carolina, United States, 28401
        • New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Forsyth Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Prisma Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Spoke Hospital
Patients that undergo the Code Stroke process at Spoke Hospitals
Hub Hospital
Patients that undergo the Code Stroke process at Hub Hospitals
Transfer
Patients that undergo the Code Stroke process at a Spoke Hospital and transfer to the Hub Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From baseline (Q1, 2017), to Quarter 4 (2020)
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
From baseline (Q1, 2017), to Quarter 4 (2020)
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)
From baseline (Q1, 2017), to Quarter 4 (2020)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline (Q1, 2017) to Quarter 4 (2020)
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

  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
From baseline , 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Daiichi Sankyo, Inc.
Medtronic
Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Bradley Kolls, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00076593

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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