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

Stroke Clinical Trial

— SHIFT  

Official title:

The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Structural Racism in Stroke Outcomes and Build Community Capacity (The SHIFT Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397937
• Other study ID #: U01NS135533
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 31, 2029

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: Olajide Williams, MD
• Phone: (212) 305-1710
• Email: ow11[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Goal:

To test the hypothesis that among AA and Hispanic 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).

Description:

Structural Racism and Discrimination (SRD) produces adverse Social Determinants of Health (SDOH), which 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 Black and Hispanic stroke patients compared with UC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: January 31, 2029
• Est. primary completion date: January 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable CAA)

2. African American/Black or Hispanic race-ethnicity.

3. Age 18-75 years old.

4. Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care).

5. Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after.

6. Pre-stroke Modified Rankin Scale score of =3

7. Residence in New York City..

8. English or Spanish speaking.

9. Can provide informed consent and engage in the initial assessment prior to stroke discharge.

10. 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.

Related Conditions & MeSH terms

• Social Determinants of Health
• Stroke

Intervention

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

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Harris J, Boehme A, Chan L, Moats H, Dugue R, Izeogu C, Pavol MA, Naqvi IA, Williams O, Marshall RS. Allostatic load predicts racial disparities in intracerebral hemorrhage cognitive outcomes. Sci Rep. 2022 Oct 3;12(1):16556. doi: 10.1038/s41598-022-20987-x. — View Citation

Mallaiah J, Williams O, Allegrante JP. Development and Validation of a Stroke Literacy Assessment Test for Community Health Workers. Health Educ Behav. 2024 Apr 22:10901981241245050. doi: 10.1177/10901981241245050. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication Adherence	medication adherence	6 months and 1 year
Other	30-day readmission rate	incidence of readmission to the hospital within 30 days of discharge	30 days post discharge
Other	Epigenetic biomarkers of stress	DNA methylation, telomere length	baseline, 6 months and 1 year
Primary	Stroke Impact Scale v3.0	a validated measure of disability and health-related quality of life after stroke	baseline, 6 months and 1 year
Secondary	Blood pressure	change in blood pressure from baseline	baseline, 6 months and 1 year
Secondary	cognition	Montreal Cognitive Assessment battery (MoCA)	baseline, 6 months and 1 year
Secondary	Stroke Specific Quality of Life (SSQOL)	validated quality of life measure	6 months and 1 year