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

Vanderbilt University Medical Center1,198 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

Interventions

Integrated Stroke Practice UnitOTHER

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 CenterOTHER

Primary and secondary outcomes will be assessed at 3, 6, and 12 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. * 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.

Locations (21)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Hospital

Phoenix, Arizona, United States

Hartford Hospital

Hartford, Connecticut, United States

Mayo Clinic

Jacksonville, Florida, United States

Emory University/Grady Health

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Louisville Hospital

Louisville, Kentucky, United States

Intermountain

Las Vegas, Nevada, United States

...and 11 more locations

Outcomes

Primary Outcomes

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.

Time frame: 12 months post-stroke

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).

Time frame: 12 months post-stroke

Secondary Outcomes

Stroke Impact Scale 3.0

Time frame: 3 and 6 months post-stroke

Modified Rankin Scale

Time frame: 3 and 6 months post-stroke

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.