Michigan Stroke Transitions Trial

NCT02653170 | Completed Results

• 2 other identifiers: 135457HIS-1310-07420-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Stroke

Keywords

acute stroke; care transitions; patient engagement; patient education; caregivers; social workers

Outcome Measures

Primary Outcomes (3)

• Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient)

  Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Physical Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).

  7 days and 90 days post discharge

• Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient)

  Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Mental Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).

  7 days and 90 days post discharge

• Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver)

  Instrument designed to measure perceived caregiver life changes in response to providing care to stroke survivors. Bakas is a 15-item measure using a rating scale with 7 points ranging from -3 (changed for the worse) to +3 (changed for the best); responses are converted to a 1-7 scale and summed (range 15-105). Higher scores indicate more positive changes resulting from caregiving experience whereas lower scores indicate negative changes.

  7 days and 90 days post discharge

Secondary Outcomes (2)

• Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient)

  7 days and 90 days post discharge

• Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver)

  7 days and 90 days post discharge

Other Outcomes (9)

• NeuroQOL Anxiety Scale (Patient)

  90 day post discharge

• Depression Symptoms (PHQ-9) (Patient)

  90 day post discharge

• Hospital Readmission (Patient)

  90 day post discharge

Study Arms (3)

Usual Care

NO INTERVENTION

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

SCM

EXPERIMENTAL

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

Other: SCM

SCM and VSSP

EXPERIMENTAL

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.

Other: SCM and VSSP

Interventions

SCM 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

SCM and VSSP 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.

SCM and VSSP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Michigan State University: lead
• University of Michigan: collaborator
• Trinity Health Michigan: collaborator
• Sparrow Health System: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Sparrow Health System

Lansing, Michigan, 48912, United States

Location

Saint Joseph Mercy Health System

Ypsilanti, Michigan, 48197, United States

Location

Related Publications (2)

• 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.

  PMID: 28623892 BACKGROUND

• 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.

  PMID: 31296043 DERIVED

MeSH Terms

Conditions

Stroke; Patient Participation

Interventions

Spectinomycin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dioxanes; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Mathew Reeves
• Organization: Michigan State University

reevesm@msu.edu

517-353-8623

Study Officials

• Mathew J Reeves, BVSc, PhD

  Professor, Department of Epidemiology and Biostatistics, College of Human Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Epidemiology

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: January 12, 2016
• Study Start: January 1, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: August 16, 2019
• Results First Posted: August 16, 2019

Record last verified: 2019-07

Locations

US (3)