Project Summary

PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Stroke is the fifth leading cause of death and the leading cause of adult disability in the United States. Nearly a third of stroke survivors have another stroke within five years of the first one. Death is more likely after the second stroke than the first.

The stroke care patients receive in the hospital and after discharge can reduce disability and help prevent a second stroke. Clinicians such as doctors or nurses can monitor risk factors for a second stroke, such as high blood pressure and cholesterol. Health educators can help patients make lifestyle changes, such as eating healthy and getting exercise, that can help reduce the risk of stroke.

In this study, the research team is comparing two ways to deliver stroke care in the hospital and after discharge.

Who can this research help?

Results may help hospitals considering ways to deliver care to patients in the hospital and after discharge for a stroke.

What is the research team doing?

The research team is assigning 18 hospitals by chance to one of two groups. Hospitals in both groups have certified programs for primary or comprehensive stroke care. In the first group, stroke care includes a clinic visit one month after hospital discharge and other follow-up visits at the patient’s request.

Patients in the second group receive Integrated Stroke Practice Unit, or ISPU, care. The ISPU includes an in-hospital unit called Stroke Central and a postdischarge unit called Stroke Mobile. These units use technology and a team approach to coordinate patient care. With ISPU care, a nurse and health educator care team make 12 monthly visits to patients in their home, rehabilitation facility, or skilled nursing facility. At these visits, the care team

  • Checks to see how the patient is recovering
  • Checks to see if the patient is taking their medicine properly
  • Teaches and empowers patients to make lifestyle changes to prevent another stroke
  • Connects ISPU staff to each other and other clinicians using a video conferencing app to manage care

Patients fill out surveys 3, 6, 12, and 24 months after discharge to assess their quality of life and function. At 3, 6, and 12 months after a stroke, the research team checks patients’ blood pressure, cholesterol and blood sugar, body mass index, smoking status, diet, and exercise. At these same timepoints, the team is asking patients about depression and caregivers about strain related to caring for the patient. Finally, the team is looking to see how much time patients spend at home, and how often patients have another stroke, go back to the hospital, or die.

Patients, caregivers, nurses, stroke specialists, rehabilitation specialists, patient advocacy groups, payers, and technology companies helped design the ISPU care program. Patients and caregivers are helping plan and conduct the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population Approximately 1,800 adults with a clinical diagnosis of acute stroke admitted within 7 days of the stroke and not discharged to hospice care
Interventions/
Comparators
  • ISPU
  • Comprehensive and primary stroke care 
Outcomes

Primary: quality of life, function

Secondary: blood pressure, cholesterol, blood sugar, body mass index, smoking status and cessation, diet, exercise, mortality, stroke recurrence, rehospitalization, time at home, depression, caregiver strain

Timeframe 1-year follow-up for primary outcomes

Project Information

Kenneth Gaines, MD, MBA
Vanderbilt University Medical Center
$15,944,009
Comparative Effectiveness Randomized Trial to Improve Stroke Care Delivery: C3FIT: Coordinated, Collaborative, Comprehensive, Family-Based, Integrated, and Technology-Enabled Care

Key Dates

February 2025
2018

Study Registration Information

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These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them.

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PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders.

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PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

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Last updated: January 12, 2022