What side effects are associated with this type of intervention?

Common treatments for stroke include thrombolytic therapy, antiplatelet therapy, anticoagulants, and rehabilitation therapies. Thrombolytic therapy, such as tissue plasminogen activator (tPA), can cause bleeding complications, including intracerebral hemorrhage. Antiplatelet drugs like aspirin may lead to gastrointestinal bleeding and ulcers. Anticoagulants, such as warfarin, carry risks of bleeding and require regular monitoring. Rehabilitation therapies, while generally safe, can sometimes result in muscle soreness or fatigue. The ISPU approach aims to mitigate these side effects through coordinated and comprehensive care, enhancing patient outcomes and minimizing risks.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke that align with the principles of coordinated and comprehensive care. Thrombolytic agents like alteplase (tPA) are approved for acute ischemic stroke to dissolve clots and restore blood flow. Anticoagulants such as warfarin and newer agents like dabigatran, rivaroxaban, and apixaban are used to prevent stroke in patients with atrial fibrillation. Additionally, antiplatelet drugs like aspirin and clopidogrel are approved for secondary stroke prevention. These treatments, combined with integrated care models like the Integrated Stroke Practice Unit, aim to improve outcomes through timely intervention and continuous, collaborative care.

What other types of research exist?

Promising alternatives to the Integrated Stroke Practice Unit for stroke patients in 2024 include: 1) Telemedicine-based stroke care, which enhances access to specialists and continuous monitoring; 2) Advanced rehabilitation technologies such as robotic-assisted therapy and virtual reality; 3) Comprehensive stroke centers that integrate multidisciplinary teams for personalized care; and 4) Mobile stroke units equipped with imaging and thrombolysis capabilities to provide immediate treatment at the patient's location.

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Integrated Stroke Care for Stroke (C3FIT Trial)

N/A

Waitlist Available

Led By Kenneth Gaines, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-morbid mRS Rankin score of 0-1

Pre-morbid mRS Rankin score of 0-1.

Must not have

Clinical transient ischemic attack (TIA) is excluded even if there is a computerized tomography (CT) or magnetic resonance imaging (MRI) lesion corresponding to the clinical syndrome at presentation

Patients not anticipated to survive for 1 year due to neurological or other medical status (i.e., advanced cancer, hospice care, heart disease, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, and 12 months post-stroke

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new stroke care method called the Integrated Stroke Practice Unit (ISPU). It focuses on stroke survivors, who often face ongoing health issues. The ISPU uses a team approach and technology to support patients from the emergency room through their recovery period. The goal is to improve recovery and reduce hospital visits.

Who is the study for?

This trial is for adults who've had a stroke within the last 7 days, can speak English or Spanish, and are not going to hospice care. They must live in the study area and be able to give consent. Those with minor disabilities before their stroke (mRS Rankin score of 0-1) are eligible.

What is being tested?

The C3FIT trial compares traditional stroke centers with an Integrated Stroke Practice Unit (ISPU). ISPU offers team-based care from emergency through a year post-discharge, including home visits and telehealth support by nurses and health educators.

What are the potential side effects?

Since this trial focuses on service delivery rather than medication, typical drug side effects aren't expected. However, participants may experience varying levels of stress or discomfort due to different care approaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had no or minimal disability before my current illness.

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I had no or minimal disability before my current illness.

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I have been diagnosed with a stroke, confirmed by brain scans.

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I have been diagnosed with a stroke and my brain scan shows it.

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I was admitted to the hospital within a week of my stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a temporary stroke, even if scans show a related brain lesion.

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I am expected to live more than a year despite my current health conditions.

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I am unable or unwilling to follow study procedures or give informed consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, and 12 months post-stroke

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, and 12 months post-stroke

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months post-stroke for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stroke Impact Scale (SIS 3.0)

Secondary study objectives

Depression: Patient Health Questionnaire (PHQ-9)

Modified Caregiver Strain Index (mCSI)

Modified Rankin Scale

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Integrated Stroke Practice Unit (ISPU)Active Control1 Intervention

ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.

Group II: Comprehensive or Primary Stroke Center (CSC/PSC)Active Control1 Intervention

CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Integrated Stroke Practice Unit (ISPU) design focuses on coordinated, collaborative, comprehensive, family-based, and technology-enabled care. Common treatments for stroke within this framework include thrombolytic therapy, which dissolves blood clots to restore blood flow to the brain, and antiplatelet or anticoagulant medications to prevent further clot formation. Rehabilitation therapies, such as physical, occupational, and speech therapy, are crucial for regaining lost functions and improving quality of life. The use of telehealth technology facilitates continuous monitoring and access to multidisciplinary care teams, ensuring timely interventions and support. These mechanisms are vital for stroke patients as they enhance recovery, reduce the risk of recurrence, and improve overall outcomes by providing holistic and patient-centered care.