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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Social Determinants of Health
• Intervention / Treatment: Behavioral: SHIFT team intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 275
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olajide Williams, MD; Phone Number: (212) 305-1710; Email: ow11@cumc.columbia.edu
• Study Contact Backup: Name: Randolph S Marshall, MD; Phone Number: (212) 305-8389; Email: rsm2@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
      • Contact: Randolph S Marshall, MD; Phone Number: 212 305 8389; Email: rsm2@columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	change in blood pressure from baseline	baseline, 6 months and 1 year
cognition	Montreal Cognitive Assessment battery (MoCA)	baseline, 6 months and 1 year
Stroke Specific Quality of Life (SSQOL)	validated quality of life measure	6 months and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	medication adherence	6 months and 1 year
30-day readmission rate	incidence of readmission to the hospital within 30 days of discharge	30 days post discharge
Epigenetic biomarkers of stress	DNA methylation, telomere length	baseline, 6 months and 1 year

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Olajide Williams, MD, Columbia University

Publications and helpful links

General Publications

• 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.
• Mallaiah J, Williams O, Allegrante JP. Development and Validation of a Stroke Literacy Assessment Test for Community Health Workers. Health Educ Behav. 2024 Oct;51(5):764-774. doi: 10.1177/10901981241245050. Epub 2024 Apr 22.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2024
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: stroke; health disparities; social determinants of health; community health workers; home visits
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: ACYY0520; U01NS135533 (U.S. NIH Grant/Contract); AAAV1743 (Other Identifier: Columbia University Irving Medical Center Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To share individual participant data (IPD) of baseline characteristics, follow up, outcomes, etc. based on NIH/NINDS requirements.
• IPD Sharing Time Frame: As per NIH/NINDS requirements
• IPD Sharing Access Criteria: All items required by NIH/NINDS will be publicly shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No