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

Columbia University

Status: Terminated

Conditions: Stroke; Social Determinants of Health

Treatments: Behavioral: SHIFT team intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06397937

AAAV1743

U01NS135533

Details and patient eligibility

About

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).

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable CAA)
2. Age 18-75 years old.
3. Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care).
4. Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after.
5. Pre-stroke Modified Rankin Scale score of ≤3
6. Residence in New York City..
7. English or Spanish speaking.
8. Can provide informed consent and engage in the initial assessment prior to stroke discharge.
9. 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

1. Discharge disposition to a long term care facility.
2. Diagnosis of dementia or other neurological neurological diagnosis that affects cognition.
3. Diagnosis of active major depression.
4. Aphasia severe enough to preclude initial examination.
5. Impaired level of consciousness at initial cognitive assessment.
6. Subarachnoid hemorrhage.
7. Diagnosis of probable cerebral amyloid angiopathy by Boston criteria.
8. Life expectancy less than 1 year.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Intervention

Experimental group

Description:

The SHIFT intervention team, comprising a community health worker (CHW), community social worker (CSW), and community nurse (CN),will make a first home visit within 72 hours of hospital discharge, and make regular visits to address SDOH barriers identified for each patient, provide individualized counseling, and assist with medication management, risk factor control, and health literacy.

Treatment:

Behavioral: SHIFT team intervention

Usual Care

No Intervention group

Description:

All patients will be given standard discharge information, including culturally/racially sensitive stroke education materials for post-stroke care, signs and symptoms of acute stroke, and management of stroke risk factors. Homecare referrals and other rehabilitation services will continue to be provided to discharged patients according to standard-of-care and treating physician referrals. Follow up clinic appointments at 4-6 weeks post discharge will be made with a stroke neurologist per clinical protocol. Thus the only difference between intervention and usual care will be the SHIFT intervention.