RECRUITINGINTERVENTIONAL

SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes

The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Social Determinants of Stroke Outcomes and Build Community Capacity (The SHIFT Trial)

About This Trial

Primary Goal: To test the hypothesis that among stroke patients 18-75 years with ≥3 SDOH risk factors, SHIFT will improve: (1) functional outcomes as measured by the SIS (Primary Outcome), (2) physiological outcomes as measured by changes in blood pressure and cognition, (secondary outcomes) and (3) epigenetic allostatic load biomarkers (exploratory outcome) such as DNA methylation (DNAm) and telomere length, at 6 months and 1-year post-stroke, compared with usual care (UC).

Who May Be Eligible (Plain English)

Who May Qualify: - Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable cerebral amyloid angiopathy by Boston Criteria) - African American/Black or Hispanic race-ethnicity - Age 18-75 years old - Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care) - Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after - Pre-stroke Modified Rankin Scale score of ≤3 - Residence in New York City. - English or Spanish speaking. - Can provide willing to sign a consent form and engage in the initial assessment prior to stroke discharge - Lives in a household with a telephone, and has a caregiver (family member or Home Health Aide) if not fully independent on discharge. If the patient requires a family member to assist with activities of daily living or decision-making, the family member must state a willingness to be present at home visits where their assistance is needed. Who Should NOT Join This Trial: - Discharge disposition to a long-term care facility. - Diagnosis of dementia or other neurological diagnosis that affects cognition - Diagnosis of active major depression - Aphasia severe enough to preclude initial examination - Impaired level of consciousness at initial cognitive assessment - Subarachnoid hemorrhage - Diagnosis of probable cerebral amyloid angiopathy by Boston criteria - Life expectancy less than 1 year Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable cerebral amyloid angiopathy by Boston Criteria) * African American/Black or Hispanic race-ethnicity * Age 18-75 years old * Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care) * Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after * Pre-stroke Modified Rankin Scale score of ≤3 * Residence in New York City. * English or Spanish speaking. * Can provide informed consent and engage in the initial assessment prior to stroke discharge * Lives in a household with a telephone, and has a caregiver (family member or Home Health Aide) if not fully independent on discharge. If the patient requires a family member to assist with activities of daily living or decision-making, the family member must state a willingness to be present at home visits where their assistance is needed. Exclusion Criteria: * Discharge disposition to a long-term care facility. * Diagnosis of dementia or other neurological diagnosis that affects cognition * Diagnosis of active major depression * Aphasia severe enough to preclude initial examination * Impaired level of consciousness at initial cognitive assessment * Subarachnoid hemorrhage * Diagnosis of probable cerebral amyloid angiopathy by Boston criteria * Life expectancy less than 1 year

Treatments Being Tested

BEHAVIORAL

SHIFT team intervention

The SHIFT team, comprising a community health worker (CHW), community social worker (CHW), and community nurse (CN) will visit the participant starting within 72 hours of hospital discharge and provide social service referrals related to food insecurity, housing, immigration, and employment, and assist with medical appointment preparation (CHW), deliver individualized counseling focused on coping skills, reducing caregiver strain, and the psychological distress associated with experiences of racism and SDOH (CSW), and address health literacy and review of treatment goals and medications (CN).

Locations (1)

Columbia University Medical Center

New York, New York, United States