NCT04000971: C3FIT

Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care

Completed NA Last updated 29 January 2025

What this trial tests

NA trial testing Integrated Stroke Practice Unit in Stroke in 1,198 participants. Completed in 30 September 2024.

Timeline

25 February 2020

Primary endpoint
30 September 2024

30 September 2024

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	1,198
Start date	25 February 2020
Primary completion	30 September 2024
Estimated completion	30 September 2024
Sites	21 locations across United States

Drugs / interventions tested

• Integrated Stroke Practice Unit
• Comprehensive or Primary Stroke Center

Conditions studied

• Stroke — all drugs for Stroke →
• Stroke, Ischemic — all drugs for Stroke, Ischemic →
• Stroke, Acute — all drugs for Stroke, Acute →
• Stroke Sequelae — all drugs for Stroke Sequelae →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Stroke or Stroke, Ischemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stroke is the 5th leading cause of death and the leading cause of adult disability in the United States (US). Stroke is a complex disease with multiple interacting risk factors (including genetic, high blood pressure and cholesterol, and lifestyle factors like smoking, diet, and exercise) that lead to initial and recurrent stroke. Up to 90% of stroke survivors have some functional deficit that impacts both physical and mental health.

Scientific evidence that identifies the best stroke care delivery design is lacking. We completed a three-year, Centers for Medicare \& Medicaid Services (CMS) Health Care Innovation Award that tested a new stroke care design called an Integrated Practice Unit (IPU). This IPU was developed through stakeholder input from patients, caregivers, nurses, stroke specialists, rehabilitation specialists, patient advocacy groups, payers, and technology companies. This IPU design was associated with decreased hospital length of stay, readmissions, and stroke recurrence, as well as lower cost.

Based on the CMS study, a larger, pragmatic trial was developed that is called C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT will randomly assign approximately 22 US hospital sites to continue Joint Commission-certified Comprehensive/Primary (CSC/PSC) design or to the novel Integrated Stroke Practice Unit (ISPU) design for stroke care. C3FIT's ISPU uses team-based, enhanced collaboration (called Stroke Central) and follows patients from presentation at the Emergency Department (ED) through 12-months post-discharge (called Stroke Mobile). Stroke Mobile includes a nurse and lay health educator team who visit patients and caregivers at home or at a rehabilitation or skilled nursing facility to assess function and quality of life using telehealth technology to facilitate access to multiple providers. Results from C3FIT will provide high quality scientific evidence to determine the best stroke care design that ensures positive health for patients and caregivers.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. mHealth impact on secondary stroke prevention: a scoping review of randomized controlled trials among stroke survivors between 2010-2020.
   Adcock AK, Haggerty T, Crawford A, Espinosa C. · · 2022 · cited 10× · PMID 35449509 · DOI 10.21037/mhealth-21-27
2. Evolution and Future of Stroke Trials.
   Broderick JP, Mistry EA. · · 2024 · cited 7× · PMID 38328974 · DOI 10.1161/strokeaha.123.044265
3. A Blueprint for the Conduct of Large, Multisite Trials in Telemedicine.
   Commiskey P, Armstrong AW, Coker TR, Dorsey ER, et al · · 2021 · cited 3× · PMID 34542417 · DOI 10.2196/29511
4. Design and methods of a cluster-randomized pragmatic trial of post-discharge stroke care.
   Commiskey P, Long DL, Howard VJ, Braunlin J, et al · · 2025 · cited 1× · PMID 40189199 · DOI 10.1016/j.cct.2025.107890