Michigan Stroke Transitions Trial

To improve care transitions for acute stroke patients this pragmatic, community-based,
randomized, open clinical trial will test the efficacy of two separate but complementary
interventions against usual care. The parallel group design will compare the following 3
groups:

1. Usual care

2. Stroke Case Manager (SCM): trained social workers who provide home based case management
services

3. SCM services plus access to the Virtual Stroke Support Portal (VSSP) an online
information and support resource.

This patient-level randomized trial will be conducted at 3 Michigan hospitals and will enroll
a total of 315 acute stroke patients (105 per intervention group). Each hospital will enroll
cases over an 18 month period. Randomization will be balanced within each hospital to ensure
that an equal number of patients are assigned to the 3 groups. If the patient identifies a
primary caregivers they will be contacted and enrollment accordingly.

The trial interventions begin once the patient returns home (= Day 1) and end 3 months later
(= Day 90). Outcomes data will be collected by telephone at baseline (= Day 7) and at Day 90.
Subjects who are enrolled but do not go home within 1 month (because they remain in a
rehabilitation or Skilled Nursing Facility) will be dropped and replaced by new patients. Two
primary patient-level outcome measures include the Patient Activation Measure (PAM), a
measure of self-efficacy, and the PROMIS-10, a global quality of life scale. Two primary
caregiver-level outcome measures include the Bakas Caregiving Outcomes Scale (BCOS) and
depression (PHQ-9).

By adhering to the principles of pragmatic trials, this trial is designed to inform typical
U.S. clinical practice, with outcomes that are directly relevant to patients and caregivers.
Specifically, this trial is designed to answer the practical question of whether the
transitional care experience of stroke patients and caregivers can be improved by social
workers who visit the home, and whether their effectiveness can be enhanced by a
comprehensive patient-centered online resource.

Patient Inclusion Criteria:

- A final confirmed hospital diagnosis of acute stroke (ischemic or hemorrhagic).

- Patient living at home pre-stroke.

- Presence of stroke-related deficits at admission (defined as a National Institute of
Health Stroke Severity score of >=1).

- Presence of at least mild functional limitations at discharge (defined as a modified
Rankin score [mRS] score of >=1), or therapy ordered.

- Discharged directly home (includes patient's residence or that of a family member).

- Discharged to a rehabilitation facility (IRF or SNF) with the expectation of return to
home within 4 weeks.

Patient Exclusion Criteria:

- Patients who live more than 50 miles from the hospital (for reasons related to the
home visits).

- Patients discharged to nursing home, hospice care or LTCH (Long term care hospital).

- Patients who have clinically documented cognitive deficits or stroke-related
impairments including aphasia sufficient to impact the consent process and for whom a
proxy respondent is not available.

- Patients who fail the 6-item cognitive screening (SIS-6) for cognitive impairment
(score <=4) and for whom a proxy respondent is not available

- Patients enrolled in another acute stroke intervention trial that has a significant
impact on the post-acute period (i.e., intensive data collection required of patient
during follow-up).

- Limited life expectancy (< 6 months) or significant medical comorbidity likely to
impact completion of the study (e.g., severe mental illness, drug or alcohol use or
dependence, metastatic cancer).

- Neither the patient nor caregiver speaks English.

Caregiver Inclusion Criteria:

- Age 18 or over.

- Are identified by the stroke patient as the primary caregiver (individual who has
primary responsibility for assisting with the patient's care).

- Speaks English.