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

Stroke Clinical Trial

— C3FIT  

Official title:

C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): A Randomized Trial for Stroke

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04000971
• Other study ID #: C3FIT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 18 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1800
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Engagement, Patient
• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke Sequelae
• Stroke, Acute
• Stroke, Ischemic

Intervention

Other:
• Integrated Stroke Practice Unit
Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, and increase understanding and build positive behavior change for patients and caregivers. Primary and secondary outcomes will be assessed at 3, 6, and 12 months.
• Comprehensive or Primary Stroke Center
Primary and secondary outcomes will be assessed at 3, 6, and 12 months.

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Emory University/Grady Health	Atlanta	Georgia
United States	Augusta University Medical Center	Augusta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ohio Health Riverside Methodist Hospital	Columbus	Ohio
United States	Doctors Hospital Renaissance	Edinburg	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	Mayo Clinic	Jacksonville	Florida
United States	Johnson City Medical Center at Ballad Health	Johnson City	Tennessee
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Covenant Health Fort Sanders Regional Medical Center	Knoxville	Tennessee
United States	Intermountain	Las Vegas	Nevada
United States	University of Louisville Hospital	Louisville	Kentucky
United States	University of Wisconsin Madison	Madison	Wisconsin
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Penn State	State College	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke Impact Scale (SIS 3.0)	59-item questionnaire to assess aspects of patient quality of life following stroke; includes 8 dimensions assessed on a 5-point Likert scale that are summed by domain. Scores range from 0-100, with higher scores indicating less difficulty.	12 months post-stroke
Primary	Modified Rankin Scale	7-item scale to assess the degree of disability/dependence in the daily activities of stroke patients; scores range from 0-5, with higher score indicating higher disability (a score of 6 indicates that the patient expired).	12 months post-stroke
Secondary	Stroke Impact Scale 3.0	59-item questionnaire to assess aspects of patient quality of life following stroke; includes 8 dimensions assessed on a 5-point Likert scale that are summed by domain. Scores range from 0-100, with higher scores indicating less difficulty.	3 and 6 months post-stroke
Secondary	Modified Rankin Scale	7-item scale to assess the degree of disability/dependence in the daily activities of stroke patients; scores range from 0-5, with higher score indicating higher disability (a score of 6 indicates that the patient expired).	3 and 6 months post-stroke
Secondary	Stroke Risk Factors - Blood Pressure Control (BP)	To assess BP control through measurement of a seated patient using a blood pressure cuff; controlled BP is 120-130/80 or below for ischemic stroke patients and 140/80 or below for hemorrhagic stroke patients.	3, 6, and 12 months post-stroke
Secondary	Stroke Risk Factors - Cholesterol (LDL)	To assess LDL/lipids control through a LDL or lipids blood draw (standard of care) for patients with elevated cholesterol at baseline (prior to hospital discharge); controlled LDL is less than/equal to 70 for stroke patients.	3, 6, and 12 months post-stroke
Secondary	Stroke Risk Factors - Blood Sugar (HgBA1c)	To assess blood sugar control through a HgBA1c blood draw (standard of care) for patients with elevated blood sugar at baseline (prior to hospital discharge); controlled HgBA1c is less than/equal to 7% for stroke patients.	3, 6, and 12 months post-stroke
Secondary	Stroke Risk Factors - Body Mass Index (BMI)	To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI=18.5-24.9 (BMI less than 18.5 is underweight, and BMI 25.0 or above is overweight (BMI=25.0-29.9) or obese (BMI=30.0 or above).	3, 6, and 12 months post-stroke
Secondary	Stroke Risk Factors - Smoking Status/Cessation	To assess smoking status and cessation efforts through self-reported, yes or no questions.	3, 6, and 12 months post-stroke
Secondary	Stroke Risk Factors - Diet	To assess awareness of the DASH or Mediterranean diet through self-reported, yes or no questions.	3, 6, and 12 months post-stroke
Secondary	Stroke Risk Factors - Exercise	To assess adherence to exercise guidelines that physician or physical therapist advised through self-reported, yes or no questions.	3, 6, and 12 months post-stroke
Secondary	Mortality	Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources.	3, 6, and 12 months post-stroke
Secondary	Recurrence	Recurrence of stroke will be assessed/confirmed with study personnel.	3, 6, and 12 months post-stroke
Secondary	Rehospitalization	Rehospitalization following stroke will be assessed/confirmed with study personnel.	3, 6, and 12 months post-stroke
Secondary	Time at Home	Time spent at home compared to institution will be assessed/confirmed with study personnel.	3, 6, and 12 months post-stroke
Secondary	Depression: Patient Health Questionnaire (PHQ-9)	9-item questionnaire to assess presence and/or severity of patient depression (includes an additional question to assess difficulty that doesn't impact scoring); scores range from 0-27, with 0=No depression, 1-4=Minimal depression, 5-9=Mild depression, 10-14=Moderate depression, 15-19=Moderately severe depression; and 20-27=Severe depression.	3, 6, and 12 months post-stroke
Secondary	Modified Caregiver Strain Index (mCSI)	13-item questionnaire to assess the level of strain in caregivers; scores range from 0-100, with higher score indicating increased caregiver strain.	3, 6, and 12 months post-stroke