Michigan Stroke Transitions Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-11-30

Brief Summary

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The Michigan Stroke Transitions Trial (MISTT) is a patient-centered randomized control trial that aims to improve the experience of stroke patients after they return home. The MISTT study will test the effect of two complementary interventions against usual care. The two interventions include: a) Stroke Case Managers (SCMs) who are trained social workers, and b) an online informational website or portal. The 12 week intervention period begins when the stroke patient returns home from the hospital or rehab facility. The SCMs will conduct at least 2 home visits with the patient (one within 3-4 days and one around 30 days) along with weekly follow-up telephone calls. Supplemental home visits will be used as necessary over the 12 week period. At the first home visit the social workers will conduct a comprehensive in-home assessment and link patients and caregivers to local resources as necessary. Patients also assigned to the website will have access to a patient-centered online information and support resource called the Virtual Stroke Support Portal (VSSP). The investigators hypothesize that this personalized case management program will reduce patient and caregiver needs, improve quality of life, and decrease caregiver stress. The MISTT study will enroll 315 acute stroke patients discharged from 3 Michigan hospitals and will be completed by the end of 2017.

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Detailed Description

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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.

Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual Care

Patients in this group will receive the hospitals' usual transitional care approach.

Group Type NO_INTERVENTION

No interventions assigned to this group

SCM

One intervention is provided:

1\. SCM (Stroke Case manager): a trained social worker who provides in-home case management services.

Group Type EXPERIMENTAL

SCM

Intervention Type OTHER

One intervention (SCM) is provided. Stroke Case Managers (SCMs) will conduct 2 home visits; the first within 72-96 hours and the other after 30-days of returning home. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted if needed. Home visit activities include:

1. Biopsychosocial assessment of patient and caregiver needs.
2. Set up appointments.
3. Assist scheduling appointments with primary care physician and other medical providers.
4. Promote medication adherence through medication tool kits, pill organizers and other aids.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.

SCM and VSSP

Two interventions are provided:

1. SCM (Stroke Case manager): a trained social worker who provides in-home case management services. Plus:
2. VSSP (Virtual Stroke Support Portal): Access and training in the use of the VSSP: a purpose-built, online, patient-centered information and support resource.

Group Type EXPERIMENTAL

SCM and VSSP

Intervention Type OTHER

SCM: Stroke Case Managers (SCMs) will conduct home visits at 72-96 hours and after 30-days. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted as needed. Activities include:

1. Biopsychosocial assessment of patient and caregiver needs.
2. Set up appointments.
3. Assist scheduling appointments with primary care physician and other medical providers.
4. Promote medication adherence through medication tool kits, pill organizers and other aids.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.

VSSP: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes:

1. Contact list of care team members.
2. Access to hospital patient portal.
3. Stroke education materials, resources, and guidelines.
4. Access to Michigan 2-1-1 services.
5. Medication information and adherence tools.
6. Patient and Caregiver support networks.

Interventions

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SCM

One intervention (SCM) is provided. Stroke Case Managers (SCMs) will conduct 2 home visits; the first within 72-96 hours and the other after 30-days of returning home. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted if needed. Home visit activities include:

1. Biopsychosocial assessment of patient and caregiver needs.
2. Set up appointments.
3. Assist scheduling appointments with primary care physician and other medical providers.
4. Promote medication adherence through medication tool kits, pill organizers and other aids.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.

Intervention Type OTHER

SCM and VSSP

SCM: Stroke Case Managers (SCMs) will conduct home visits at 72-96 hours and after 30-days. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted as needed. Activities include:

1. Biopsychosocial assessment of patient and caregiver needs.
2. Set up appointments.
3. Assist scheduling appointments with primary care physician and other medical providers.
4. Promote medication adherence through medication tool kits, pill organizers and other aids.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.

VSSP: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes:

1. Contact list of care team members.
2. Access to hospital patient portal.
3. Stroke education materials, resources, and guidelines.
4. Access to Michigan 2-1-1 services.
5. Medication information and adherence tools.
6. Patient and Caregiver support networks.

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No