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Comparative Effectiveness
Randomized Trial to Improve
Stroke Care Delivery: C3FIT:
Coordinated, Collaborative,
Comprehensive, Family-Based,
Integrated, and Technology-
Enabled Care
Project Summary
Stroke is the fifth-leading cause of death and the leading cause of adult
disability in the United States, as each year about 780,000 people have a
stroke or transient ischemic attack. Up to 90 percent of stroke survivors have
some functional deficit, resulting in 5 million (roughly the population of
South) living with sequelae of stroke that impact both health quality and
psychologically, particularly caregivers. Recurrent stroke occurs in 17 percent
of transient ischemic attacks and 18 percent of nondisabling strokes within 3
months; after 5 years, nearly a third have a recurrence, and mortality is
greater after a second stroke than the first (24-month survival rates: 48
percent versus 57 percent).
Stroke is complex, with multiple interacting risk factors (e.g., genetic;
hypertension; hypercholesterolemia; and lifestyle such as smoking, diet, and
exercise) that lead to the initial and recurrent strokes. Stroke patients and
their families deal with a high risk and cost acute disease state that often
results in significant functional and cognitive deficits and impacts physical
function, activities of daily living, and quality of life.
Patients face stroke impairments and complex risk of recurrence within a
current stroke care delivery system characterized by poor coordination and
inefficient care delivery. High-quality scientific evidence to identify the best
stroke care delivery system is lacking, despite years of work with guidelines,
American Stroke Association (Get With the Guidelines) certifications, and the
Joint Commission.
We completed a three year, $3.8 million Centers for Medicare-Medicaid
Innovations Award pilot that tested a novel stroke care delivery Integrated
Practice Unit (IPU) redesign that evolved with stakeholder input from
patients, caregivers, rehabilitation specialists, nurses, vascular neurologists,
patient advocacy groups, payers, and technology companies. It embraced
team-based care in-hospital and enhanced collaboration with
rehabilitation/skilled nursing facilities using telemedicine technology via a
redesign component, called Stroke Central. The IPU encompassed a one-year
continuum of stroke care from onset through 12-month follow-up in a home
or skilled nursing/rehabilitation facility–based program, called Stroke
Mobile, with a registered nurse and lay health educator team that visited the
patient and the caregiver’s/family’s home or facility to assess recovery,
medication compliance, and risk factor control with telemedicine that
facilitated access to multiple layers of care providers and was associated with
decreased hospital length of stay and readmissions, decreased recurrence
rates, and lower cost.
In this larger trial, 18 clinical sites will be randomized to either continue
comprehensive/primary stroke care or to reengineered Integrated Stroke
Practice Unit care. Results will be key for patients, caregivers, organizations,
payers, and policy makers to apply high-quality scientific evidence to the
decision, currently in equipoise, on how to best direct resources toward
implementing the most effective and efficient stroke care delivery systems
that enhance health outcomes for patients and caregivers.
Project Details
Principal Investigator
Kenneth Gaines, MD, MBA
Project Status
Awarded; Contract pending
Board Approval Date
August 2018
Organization
Vanderbilt University Medical Center
Project Type
Research Project
Funding Announcement
Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes
Project Budget *
$15,700,000
*All proposed projects, including requested budgets and project periods, are
approved subject to a programmatic and budget review by PCORI staff and
the negotiation of a formal award contract.
Page Last Updated:
August 22, 2018

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Comparative effectiveness randomized trial to improve stroke care delivery c3 fit_ coordinated coll

  • 1. Comparative Effectiveness Randomized Trial to Improve Stroke Care Delivery: C3FIT: Coordinated, Collaborative, Comprehensive, Family-Based, Integrated, and Technology- Enabled Care Project Summary Stroke is the fifth-leading cause of death and the leading cause of adult disability in the United States, as each year about 780,000 people have a stroke or transient ischemic attack. Up to 90 percent of stroke survivors have some functional deficit, resulting in 5 million (roughly the population of South) living with sequelae of stroke that impact both health quality and psychologically, particularly caregivers. Recurrent stroke occurs in 17 percent of transient ischemic attacks and 18 percent of nondisabling strokes within 3 months; after 5 years, nearly a third have a recurrence, and mortality is greater after a second stroke than the first (24-month survival rates: 48 percent versus 57 percent). Stroke is complex, with multiple interacting risk factors (e.g., genetic; hypertension; hypercholesterolemia; and lifestyle such as smoking, diet, and exercise) that lead to the initial and recurrent strokes. Stroke patients and their families deal with a high risk and cost acute disease state that often results in significant functional and cognitive deficits and impacts physical function, activities of daily living, and quality of life. Patients face stroke impairments and complex risk of recurrence within a
  • 2. current stroke care delivery system characterized by poor coordination and inefficient care delivery. High-quality scientific evidence to identify the best stroke care delivery system is lacking, despite years of work with guidelines, American Stroke Association (Get With the Guidelines) certifications, and the Joint Commission. We completed a three year, $3.8 million Centers for Medicare-Medicaid Innovations Award pilot that tested a novel stroke care delivery Integrated Practice Unit (IPU) redesign that evolved with stakeholder input from patients, caregivers, rehabilitation specialists, nurses, vascular neurologists, patient advocacy groups, payers, and technology companies. It embraced team-based care in-hospital and enhanced collaboration with rehabilitation/skilled nursing facilities using telemedicine technology via a redesign component, called Stroke Central. The IPU encompassed a one-year continuum of stroke care from onset through 12-month follow-up in a home or skilled nursing/rehabilitation facility–based program, called Stroke Mobile, with a registered nurse and lay health educator team that visited the patient and the caregiver’s/family’s home or facility to assess recovery, medication compliance, and risk factor control with telemedicine that facilitated access to multiple layers of care providers and was associated with decreased hospital length of stay and readmissions, decreased recurrence rates, and lower cost. In this larger trial, 18 clinical sites will be randomized to either continue comprehensive/primary stroke care or to reengineered Integrated Stroke Practice Unit care. Results will be key for patients, caregivers, organizations, payers, and policy makers to apply high-quality scientific evidence to the decision, currently in equipoise, on how to best direct resources toward implementing the most effective and efficient stroke care delivery systems that enhance health outcomes for patients and caregivers. Project Details
  • 3. Principal Investigator Kenneth Gaines, MD, MBA Project Status Awarded; Contract pending Board Approval Date August 2018 Organization Vanderbilt University Medical Center Project Type Research Project Funding Announcement Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes Project Budget * $15,700,000 *All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract. Page Last Updated: August 22, 2018