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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-17

Study Completion Date

2025-03-14

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Stroke Social Determinants of Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 3, randomized, blinded outcome

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

SHIFT team intervention

Intervention Type BEHAVIORAL

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).

Usual Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No