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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Integrated Stroke Practice Unit — OTHER
  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 — OTHER
  Primary and secondary outcomes will be assessed at 3, 6, and 12 months.

Study Details

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.

Key Dates

Start date

Feb 25, 2020

Status verified

Apr 2026

Primary completion

Sep 30, 2024

Completion

Sep 30, 2024

Study Design

Enrollment

1,196 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Integrated Stroke Practice Unit (ISPU)
  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.
• Active Comparator: Comprehensive or Primary Stroke Center (CSC/PSC)
  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.

Primary Outcome Measure

Stroke Impact Scale (SIS) at 12-months Post-discharge [ Time Frame: 12 months post-stroke ]

Locations (21)

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