Social Determinants of Health, Stroke
Conditions
Keywords
stroke, social determinants of health, health disparities, community health workers, home visits
Brief summary
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).
Detailed description
Adverse Social Determinants of Health (SDOH) have been shown increase stroke risk in a dose dependent manner. The SDOH-Homecare Intervention Focus Team (SHIFT) trial is a Phase 3, randomized, blinded outcome trial that tests the hypothesis that a homecare intervention shortly after discharge from an acute stroke unit by a team comprising a community health worker (CHW), a community social worker (CSW) and a community nurse (CN) can improve health outcomes among stroke patients with three or more SDOH compared with UC.
Interventions
BEHAVIORALSHIFT 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).
Sponsors
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Phase 3, randomized, blinded outcome
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Impact Scale v3.0 | baseline, 6 months and 1 year | a validated measure of disability and health-related quality of life after stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | baseline, 6 months and 1 year | change in blood pressure from baseline |
| cognition | baseline, 6 months and 1 year | Montreal Cognitive Assessment battery (MoCA) |
| Stroke Specific Quality of Life (SSQOL) | 6 months and 1 year | validated quality of life measure |
Countries
United States
Contacts
CONTACTOlajide Williams, MD
CONTACTRandolph S Marshall, MD
PRINCIPAL_INVESTIGATOROlajide Williams, MD
Columbia University
Outcome results
None listed