Clinical trial NCT02653170: Michigan Stroke Transitions Trial
Official title: The Michigan Stroke Transitions Trial (MISTT): Improving Care Transitions for Acute Stroke Patients Through a Patient-centered Home Based Case Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: acute stroke
care transitions
patient engagement
patient education
caregivers
social workers
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Saint Joseph Mercy Health System
name: Sparrow Health System
name: Massachusetts General Hospital
First posted: 2016-01-12
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient)
timeFrame: 7 days and 90 days post discharge
measure: Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient)
timeFrame: 7 days and 90 days post discharge
measure: Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver)
timeFrame: 7 days and 90 days post discharge
Secondary outcomes:
measure: Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient)
timeFrame: 7 days and 90 days post discharge
measure: Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver)
timeFrame: 7 days and 90 days post discharge
Other outcomes:
measure: NeuroQOL Anxiety Scale (Patient)
timeFrame: 90 day post discharge
measure: Depression Symptoms (PHQ-9) (Patient)
timeFrame: 90 day post discharge
measure: Hospital Readmission (Patient)
timeFrame: 90 day post discharge
measure: Stroke Recurrence (Patient)
timeFrame: 90 day post discharge
measure: Home Time (Patient)
timeFrame: 90 day post discharge
measure: Oberst Caregiver Burden Scale (OCBS) (Caregiver)
timeFrame: 90 day post discharge
measure: Unhealthy Days (Caregiver)
timeFrame: 90-days post discharge
measure: PROMIS Emotional Support Scale (Caregiver).
timeFrame: 90-days post discharge
measure: PROMIS Informational Support Scale (Caregiver).
timeFrame: 90-days post discharge
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Lansing
country: United States
facility: Sparrow Health System
state: Michigan
city: Ypsilanti
country: United States
facility: Saint Joseph Mercy Health System
state: Michigan
Study officials:
affiliation: Professor, Department of Epidemiology and Biostatistics, College of Human Medicine
name: Mathew J Reeves, BVSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reeves MJ, Hughes AK, Woodward AT, Freddolino PP, Coursaris CK, Swierenga SJ, Schwamm LH, Fritz MC. Improving transitions in acute stroke patients discharged to home: the Michigan stroke transitions trial (MISTT) protocol. BMC Neurol. 2017 Jun 17;17(1):115. doi: 10.1186/s12883-017-0895-1.
citation: Reeves MJ, Fritz MC, Woodward AT, Hughes AK, Coursaris CK, Swierenga SJ, Nasiri M, Freddolino PP. Michigan Stroke Transitions Trial. Circ Cardiovasc Qual Outcomes. 2019 Jul;12(7):e005493. doi: 10.1161/CIRCOUTCOMES.119.005493. Epub 2019 Jul 12.