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Michigan Stroke Transitions Trial (MISTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653170
Recruitment Status : Completed
First Posted : January 12, 2016
Results First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
University of Michigan
Saint Joseph Mercy Health System
Sparrow Health System
Massachusetts General Hospital
Information provided by (Responsible Party):
Mathew Reeves, Michigan State University

Tracking Information
First Submitted Date  ICMJE April 9, 2015
First Posted Date  ICMJE January 12, 2016
Results First Submitted Date  ICMJE May 4, 2018
Results First Posted Date  ICMJE August 16, 2019
Last Update Posted Date August 16, 2019
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) [ Time Frame: 7 days and 90 days post discharge ]
    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).
  • Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient) [ Time Frame: 7 days and 90 days post discharge ]
    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).
  • Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver) [ Time Frame: 7 days and 90 days post discharge ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • PROMIS-10 Global Quality of Life (Patient) [ Time Frame: 90 days post discharge ]
    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.
  • Bakas Caregiving Outcomes Scale (Caregiver) [ Time Frame: 90 days post discharge ]
    15-item instrument designed to measure life changes in response to providing care to stroke survivors.
Change History Complete list of historical versions of study NCT02653170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient) [ Time Frame: 7 days and 90 days post discharge ]
    Patient questionnaire to assess knowledge, skills, and self-efficacy for managing one's own healthcare. Patient Activation Measure is a 13-item survey using a five-point Likert scale (strongly disagree, disagree, agree, strongly agree, NA) whose response items are summed and converted to an activation score ranging from 0-100. Higher scores indicate a higher level of activation.
  • Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver) [ Time Frame: 7 days and 90 days post discharge ]
    The Patient Health Questionnaire (PHQ-9) measures severity of depression symptoms. PHQ-9 is a 9-item measure using a four-point Likert scale (not at all, several days, more than half the days, nearly every day). Response items are summed (range 0-27) with higher scores indicating the respondent is experiencing more symptoms of depression.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • Patient Activation Measure (Patient) [ Time Frame: 90 days post discharge ]
    Patient questionnaire to assess self-efficacy and activation in managing one's own healthcare.
  • Depression symptoms (PHQ-9) (Caregiver) [ Time Frame: 90 day post discharge ]
    Validated 9-item questionnaire to identify depressive symptoms.
Current Other Pre-specified Outcome Measures
 (submitted: September 22, 2016)
  • NeuroQOL Anxiety Scale (Patient) [ Time Frame: 90 day post discharge ]
    Validated QOL scale measuring patient anxiety (administered by computer adaptive testing).
  • Depression Symptoms (PHQ-9) (Patient) [ Time Frame: 90 day post discharge ]
    Validated 9-item questionnaire to identify depressive symptoms.
  • Hospital Readmission (Patient) [ Time Frame: 90 day post discharge ]
    Unscheduled hospital admissions
  • Stroke Recurrence (Patient) [ Time Frame: 90 day post discharge ]
    New onset acute stroke events requiring hospital admission
  • Home Time (Patient) [ Time Frame: 90 day post discharge ]
    Total number of days spent at home since discharge back to home.
  • Oberst Caregiver Burden Scale (OCBS) (Caregiver) [ Time Frame: 90 day post discharge ]
    Validated 15-item questionnaire measuring caregiver burden in response to providing care to stroke survivors.
  • Unhealthy Days (Caregiver) [ Time Frame: 90-days post discharge ]
    Number of days in the past 30 days that the caregiver reported that their own physical or mental health had not been good.
  • PROMIS Emotional Support Scale (Caregiver). [ Time Frame: 90-days post discharge ]
    A validated 4-item questionnaire measuring emotional support. Emotional support is defined as the perceived feeling of being cared for and valued as a person.
  • PROMIS Informational Support Scale (Caregiver). [ Time Frame: 90-days post discharge ]
    A validated 4-item questionnaire measuring informational support. Informational support is defined as the perceived availability of helpful information or advice.
Original Other Pre-specified Outcome Measures
 (submitted: January 8, 2016)
  • NeuroQOL Anxiety Scale (Patient) [ Time Frame: 90 day post discharge ]
    Validated QOL scale measuring patient anxiety (administered by computer adaptive testing).
  • Depression Symptoms (PHQ-9) (Patient) [ Time Frame: 90 day post discharge ]
    Validated 9-item questionnaire to identify depressive symptoms.
  • Hospital Readmission (Patient) [ Time Frame: 90 day post discharge ]
    Unscheduled hospital admissions
  • Stroke Recurrence (Patient) [ Time Frame: 90 day post discharge ]
    New onset acute stroke events requiring hospital admission
  • Home Time (Patient) [ Time Frame: 90 day post discharge ]
    Total number of days spent at home since discharge back to home.
  • Modified Caregiver Strain Index (MCSI) (Caregiver) [ Time Frame: 90 day post discharge ]
    Validated 13-item questionnaire measuring caregiver strain in response to providing care to stroke survivors.
  • Unhealthy Days (Caregiver) [ Time Frame: 90-days post discharge ]
    Number of days in the past 30 days that the caregiver reported that their own physical or mental health had not been good.
  • PROMIS Emotional Support Scale (Caregiver). [ Time Frame: 90-days post discharge ]
    A validated 4-item questionnaire measuring emotional support. Emotional support is defined as the perceived feeling of being cared for and valued as a person.
  • PROMIS Informational Support Scale (Caregiver). [ Time Frame: 90-days post discharge ]
    A validated 4-item questionnaire measuring informational support. Informational support is defined as the perceived availability of helpful information or advice.
 
Descriptive Information
Brief Title  ICMJE Michigan Stroke Transitions Trial
Official Title  ICMJE The Michigan Stroke Transitions Trial (MISTT): Improving Care Transitions for Acute Stroke Patients Through a Patient-centered Home Based Case Management Program
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Acute Stroke
Intervention  ICMJE
  • Other: 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.
  • 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.
Study Arms  ICMJE
  • No Intervention: Usual Care
    Patients in this group will receive the hospitals' usual transitional care approach.
  • Experimental: SCM

    One intervention is provided:

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

    Intervention: Other: SCM
  • Experimental: 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.
    Intervention: Other: SCM and VSSP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2018)
320
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2016)
480
Actual Study Completion Date  ICMJE November 30, 2017
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02653170
Other Study ID Numbers  ICMJE 135457
HIS-1310-07420-01 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mathew Reeves, Michigan State University
Study Sponsor  ICMJE Michigan State University
Collaborators  ICMJE
  • University of Michigan
  • Saint Joseph Mercy Health System
  • Sparrow Health System
  • Massachusetts General Hospital
Investigators  ICMJE
Principal Investigator: Mathew J Reeves, BVSc, PhD Professor, Department of Epidemiology and Biostatistics, College of Human Medicine
PRS Account Michigan State University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP