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

Overview

About this study

C3FIT’s overall goal is to assess if patient outcomes are improved when the Comprehensive and Primary Stroke Center (CSC/PSC) system is supplemented with an Integrated Stroke Practice Unit (ISPU) system of care, a patient-centric model of care involving the patient and caregiver/family that coordinates care from the acute management through the rehabilitation and recovery of the patient.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 18+.
  • Clinical diagnosis of acute stroke with brain imaging compatible with intracerebral hemorrhage or ischemic stroke (including normal brain scan); see ICD 10 codes in Table 4.
  • English or Spanish speaking subjects.
  • Patient admitted within 7 days of their index stroke event.
  • Patient is discharged alive and not to hospice care.
  • Patient living at discharge within the geography of recruitment for that C3FIT site.
  • Pre-morbid mRS Rankin score of 0-1.
  • Patient and/or surrogate give consent to participate after an informed consent process.
  • Patients who go to rehabilitation inpatient therapy or other care facilities are eligible, as long as they reside in the geographic are of recruitment and do not go to hospice care.

Exclusion Criteria:

  • Clinical transient ischemic attack (TIA)38-41 is excluded even if there is a computerized tomography (CT) or magnetic resonance imaging (MRI) lesion corresponding to the clinical syndrome at presentation.
  • Already enrolled or planned enrollment in another clinical trial for which participation in C3FIT would be compromised with regard to follow-up assessment of outcomes or continuation in C3FIT.
  • Patients with a planned admission to hospice care prior to consent.
  • Patients not anticipated to survive for 1 year due to neurological or other medical status (i.e., advanced cancer, hospice care, heart disease, etc.).
  • Patients who in the opinion of the site investigator cannot be involved in follow up care.
  • Inability or unwillingness of subject or legal guardian/representative to understand and cooperate with study procedures or provide informed consent.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

William Freeman, M.D.

Open for enrollment

Contact information:

Breanna Calhoun

(904) 953-4412

Calhoun.Breanna@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available