The Michigan Stroke Transitions Trial (MISTT): Improving Care Transitions for Acute Stroke Patients Through a Patient-centered Home Based Case Management Program
Phase: NA
Conditions: Acute Stroke
Sponsor: Michigan State University

The Michigan Stroke Transitions Trial (MISTT): Improving Care 
Transitions for Acute Stroke Patients Through a Patient-centered 
Home Based Case Management Program 
NCT02653170 
August 19, 2016 

Initial IRB
Application
Approval
October 12, 2015
To:
Mathew Reeves
East Lansing, MI  48824
Re:
IRB# 15-992M Category:  EXPEDITED 5, 7
Approval Date: October 12, 2015
Expiration Date: October 11, 2016
Title:
Michigan Stroke Transitions Trial (MISTT) Study [CGA#135457]
The Institutional Review Board has completed their review of your project.  I am pleased to advise
you that your project has been approved.
This protocol falls under the Reliance agreement between MSU and Sparrow Hospital. YOU
MAY NOT BEGIN THIS PROJECT AT SPARROW UNTIL YOU RECEIVE AN
ACCEPTANCE LETTER FROM THE SPARROW IRRC.
This protocol falls under the Reliance agreement between MSU and McLaren Healthcare
System.  This study will be conducted at the following McLaren sites:  McLaren Greater
Lansing.
This study is also conducted at University of Michigan Hospital and St. Joseph Mercy Hospital,
Ann Arbor. These sites conducted separate IRB review.
The review level of this project has been changed from Full Review to Expedited categories 5
and 7.  Please submit a revision to add the social workers as additional personnel to this project
when they are hired.
The committee has found that your research project is appropriate in design, protects the rights and
welfare of human subjects, and meets the requirements of MSU's Federal Wide Assurance and the
Federal Guidelines (45 CFR 46 and 21 CFR Part 50).  The protection of human subjects in research is
a partnership between the IRB and the investigators.  We look forward to working with you as we
both fulfill our responsibilities.
Renewals:  IRB approval is valid until the expiration date listed above.  If you are continuing your
project, you must submit an Application for Renewal application at least one month before expiration.
If the project is completed, please submit an Application for Permanent Closure.
Revisions:  The IRB must review any changes in the project, prior to initiation of the change.  Please
submit an Application for Revision to have your changes reviewed.  If changes are made at the time
of renewal, please include an Application for Revision with the renewal application.
Problems:  If issues should arise during the conduct of the research, such as unanticipated problems,
adverse events, or any problem that may increase the risk to the human subjects, notify the IRB office
promptly.  Forms are available to report these issues.
Please use the IRB number listed above on any forms submitted which relate to this project, or on any
correspondence with the IRB office.
Ashir Kumar, M.D.
BIRB Chair
c: Michele Fritz, Anne Hughes, Amanda Woodward, Paul Freddolino, Constantinos Coursaris
Sincerely,
Office of Regulatory Affairs
Human Research
Protection Programs
Biomedical & Health
Institutional Review Board
(BIRB)
Community Research
Institutional Review Board
(CRIRB)
Social Science
Behavioral/Education
Institutional Review Board
(SIRB)
Olds Hall
408 West Circle Drive, #207
East Lansing, MI 48824
 (517) 355-2180
Fax: (517) 432-4503
Email: irb@msu.edu
www.hrpp.msu.edu
MSU is an affirmative-action,
equal-opportunity employer.

APPLICATION FOR INITIAL REVIEW
APPROVAL OF A PROJECT INVOLVING HUMAN SUBJECTS
Biomedical, Health Sciences Institutional Review Board (BIRB) 
Social Science, Behavioral, Education Institutional Review Board (SIRB)
207 Olds Hall, Michigan State University
East Lansing, MI 48824-1047
Phone: (517) 355-2180
Fax: (517) 432-4503
E-mail: irb@msu.edu
Office Hours: M-F (8:00 A.M.-5:00 P.M.)
IRB#: 15-992M
ID# i049657
1a. 
Responsible Project Investigator:
Name:
Mathew Reeves
ID#:
Department:
College:
EPIDEMIOLOGY 
HUMAN MED
Academic Rank: Associate Professor 
Mailing Address: 
East Lansing, MI 48824
Phone:
Fax:
Email:
ReevesM@msu.edu
1b.
Secondary Investigator:
Name:
Michele Fritz
ID#:
Department:
College:
EPIDEMIOLOGY & BIOSTATISTICS 
HUMAN MEDICINE
Academic Rank: Research Assistant 
Mailing Address: 
Phone:
Fax:
Email:
fritzmi2@msu.edu
1c.
Additional Investigators and Key Personnel:
Anne Hughes
Amanda Woodward
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Paul Freddolino
Constantinos Coursaris
Other Personnel:
1d.
Person Preparing Document:
Mathew Reeves
2.
Study Coordinator:
Name:
Michele Fritz
ID#:
Department:
College:
EPIDEMIOLOGY & BIOSTATISTICS 
HUMAN MEDICINE
Academic Rank: Research Assistant 
Mailing Address: 
Phone:
Fax:
Email:
 fritzmi2@msu.edu
3.
Title of Project: Michigan Stroke Transitions Trial (MISTT) Study
4.
Have you ever received a 45 CFR 46.118 designation for this project?
NO 
5.
Category of Review
(a) Subcategory:
1. Clinical studies of drugs and medical devices when neither
an IND or IDE is required.
2. Collection of blood samples from healthy, non-pregnant
adults or other adults.
3. Prospective collection of biological specimens for research
purposes by noninvasive means.
4. Collection of data through noninvasive procedures routinely
employed in clinical practice.
FULL REVIEW
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5. Research involving materials that have been collected, or
will be collected for nonresearch purposes.
6. Collection of data from voice, video, digital, or image
recordings made for research purposes.
7. Research on individual or group characteristics or behavior
or research employing survey, interview, oral history, focus group, 
program evaluation, or quality assurance methodologies.
(b) Please describe why your project is minimal risk.
6.
Is this project being conducted to fulfill the requirements of an
education/training program?
Project Is Not 
Primarily An 
Education/Training 
Activity
7a.
Funding: 
(1) Select appropriate funding source(s). Multiple funding 
sources may be selected. If a funding source is selected, list 
the name(s) of the funding source(s) and the CGA number.
Funding Source Type
If funding 
source is 
selected, 
list the 
name(s) 
of the 
funding 
source
OSP/CGA 
Number
YES
U.S. Federal Government 
(e.g. Department, Agency)
Patient 
Centered 
Outcomes 
Research 
Institute 
(PCORI) 
IHS-1310-
07420 
Transitions 
Trial 
(MISTT) 
Study 
U.S. State Government (e.g. 
Department, Agency)
Foreign Government
Industry Sponsored
Foundation or Non-Profit
Internal Funds (e.g. MSU 
department)
(2) Are any of the funding sources pending?
NO 
(i) Describe pending funding source(s):
(ii) If the project is not funded will you do the research?
YES
7b.
The protection of human subjects often requires resources be dedicated for things such as 
the consent process (space, personnel), the performance of the research (trained personnel 
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interacting with subjects, time, access to subjects, access to facilities) care of subject issues 
or injuries (counseling, medical care), confidentiality of data (space, equipment) and other 
monetary and non-monetary resources. Describe the resources that are available for this 
project for the protection of human subjects. 
The MISTT investigators understand that the protection of human subjects is absolutely essential to 
the successful implementation of the project. All study personnel involved in patient screening, 
consent, and enrollment, delivery of study interventions and collection of study data will be fully 
trained in all IRB relevant procedures and mechanisms. This includes trainings and certificates 
provided by the specific university or hospital IRBs, as well as study specific trainings and materials 
provided by the MISTT study investigators. All MISTT study personnel are employed either full time 
or part time by the study and thus these trainings are directly funded by the grant. Maintenance of 
human subjects protection during the course of the study is the responsibility of each study personnel 
who is directly funded by the MISTT study. Non-monetary resources used to ensure human subjects 
protection include secure computers and data servers, secure (lockable) office space and storage 
facilities which are provided by the Department of Epidemiology and Biostatistics, The School of 
Social Work and at the study sites (hospitals). 
8a.
List all sites where this research will be conducted.
Patients will be recruited from 4 study sites: Sparrow Hospital, Lansing; McLaren Greater Lansing 
Hospital, Lansing; University of Michigan Hospital, Ann Arbor; and St. Joseph Mercy Hospital, Ann 
Arbor. This current application seeks approval to begin the study at the two Lansing area hospitals 
both of whom have reliance agreements with MSU. Once IRB approval has been obtained from the 
two Ann Arbor area hospitals these will be added to this application as a revision. 
8b.
Do any of these sites have their own IRB?
YES
8c.
Will employees or agents of non-MSU organizations (e.g. schools, 
companies, hospitals) be involved in the research?
(1) Explain how the employees or agents will be involved (e.g. 
will they perform research procedures, will they obtain 
informed consent from subjects).
Employees at each of the 4 hospital will be employed by the 
MISTT study to complete all patient screening, consent and 
enrollment, and collection of baseline study data
YES
8d.
Will MSU units (e.g. Department of Radiology, Biomedical Research 
Informatics Core (BRIC), Department of Psychology) outside the control or 
supervision of the investigator be involved in the conduct of the research?
(1) Identify the units. Biomedical Research Informatics Core 
(BRIC) will be used to develop and maintain a REDCap database. 
LEARN Dat will develop and maintain a study website. 
YES
8e.
Are any of these sites international?
NO
8f.
Please indicate if you or your research team will be collaborating with any of the following 
organizations for this research project.
 Allegiance Health 
 Borgess 
 Bronson 
 Covenant HealthCare System 
 Genesys Health System 
 Hurley Medical Center 
 Marquette General Health System 
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
McLaren Health Care
Memorial Healthcare
Mercy Health Saint Mary’s
Michigan Department of Health and Human Services
Michigan Public Health Institute
Munson Medical Center
Pine Rest Christian Mental Health Services

Sparrow Health Systems
Spectrum Health System
Van Andel Research Institute
None
9.
Do you have any related project that were approved by an MSU IRB?
(a) IRB Numbers: 14-1112M
YES
10.
Have you or will you submit this to any non-MSU IRBs?
(a) Name of instititution(s): University of Michigan Medical 
School IRB (IRBMED), and St. Joseph Mercy Health System IRB.
(b) Category of review submitted: Full review
(c) Status of review (approved, not approved, pending): 
Pending. Once approval has been obtained from these 2 hospitals 
we will add these sites to this current application as a revision.
YES
11.
Is another institution(s) relying on MSU's IRB as the IRB of record?
(a) Name of institution(s): Sparrow Hospital, McLaren Greater 
Lansing Hospital. 
YES
12.
Are you using an FDA approved drug/device/diagnostic test?
NO
13.
Does this project involve the use of biological products, color additives,
food additives, human drugs, medical devices, foods, infant formulas,
dietary supplements, or nutritional supplements?
NO
14.
Has this protocol been submitted to the FDA or are there plans to submit it
to the FDA?
NO
15a.
Does this project involve the use of materials of human origin (e.g. human 
blood, tissue, or cell lines)?
NO
15b.
Will there be any use of radioactive materials and/or use of radiation 
producing machines?
NO
15c.
Will this project involve human embryos?
NO
15d.
Has or will this study be registered with clinicaltrials.gov?
YES
15e.
Have you or will you be contractually obligated or otherwise obligated to 
comply with the E6 International Conference on Harmonisation - Good 
Clinical Practice Guidelines?
NO
15f.
Are you going to utilize any equipment from MSU Radiology (e.g. MRI, CT, 
PET)?
NO
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15g.
Does your research study include any patient care services or items (e.g. 
clinic visits, EKGs, EEGs, blood draws, procedures, radiology, labs, etc.)? 
These events are typically associated with a CPT and/or HCPCS code.
NO
16.
Research Category
Education Research
Yes 
Gene Transfer 
Research
Yes 
Clinical Trial Type
 Surgical 
 Therapeutic 
 Prevention 
 Other 

Investigator
Initiated 
Clinical Trial Phase
 Phase I 
 Phase II 

Phase III
Phase IV
Survey/Interview

Yes 
Fetal Research
Yes 
Audio/Video Recording
Yes 
Medical Records

Yes 
Oral History
Yes 
Stem Cell Research
Yes 
Internet-based
Yes 
Medical Imaging
Yes 
Analysis of Existing 
Data
Yes 
Oncology
Yes 
International Research
Yes 
Clinical Research

Yes 
Other
Yes 
17.
Project Description (Abstract)
Patients and caregivers often struggle to adjust to life after they leave the hospital following a stroke. 
Poor transitions in stroke patients can result in hospital readmissions, slow recovery, poor quality of 
life, dissatisfaction with care, and caregiver stress. Social workers play a vital role in healthcare by 
advocating for clients, providing counseling, and coordinating services. The Michigan Stroke 
Transitions Trial (MISTT) will implement a Social Work Case Management (SWCM) program, which 
through a combination of home visits and follow-up phone calls, will result in a personalized case 
management program designed to address unmet needs, increase patient engagement, decrease 
stress and improve quality of life. Access to accurate medical information during the transition period 
is also critical to patients and caregivers. The ideal information resource needs to be reliable, 
accessible, and responsive to the patient’s changing needs. Therefore a second component to the 
MISTT study is the development of a study website that will serve as an information and support 
resource for patients and caregivers. The MISTT study will test the efficacy of these two 
complementary interventions in 480 acute stroke patients discharged from 4 Michigan hospitals. 
Patients will be randomly assigned to one of 3 groups: 1) usual care, 2) the SWCM program, or 3) the 
SWCM program plus the MISTT Study website. The intervention period will last 2 months and 
outcomes data (including quality of life) will be measured after 90-days. 
18. 
Procedures
Baseline Clinical Data: For all subjects enrolled in the MISTT study, clinical data will be abstracted 
from the medical charts by the study coordinators at each hospital. Specific data elements are listed 
in Appendix 2a (Hospital baseline data) and will include demographic variables (age, race, sex, 
insurance status, pre-stroke residence), past medical history, comorbidities, pre-stroke function 
(mRS), and clinical stroke data (stroke type, stroke severity, tPA treatment, in-hospital complications, 
discharge mRS). All of these variables are collected as part of usual hospital care.
Baseline Patient-Reported data: Additional background data will be collected from all trial subjects at 
the first follow-up phone interview conducted at 7 days following discharge back to home. These 
variables include education level, marital status, family structure, in-home versus outside caregiver, 
patient function (dependence in activities of daily living [ADL] and instrumental activities of daily living 
[IADL]), CTM-15 (Care transition measures), Morisky scale (medication adherence), and technology 
related measures (Computer Self-efficacy, Attitudes to Technology, and Technology Utilization). 
These data elements are listed in Appendix 2b (Baseline Patient-reported data).
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Intervention-related Process data: Data relevant to the SW case management intervention will be 
collected by the SWs during the home visits and telephone follow-up calls. These data include the 
patient’s bio-psycho-social assessment, details of the personalized case management treatment 
plan, progress toward goals, and details of any referrals made. These data elements are listed in 
Appendix 2c (Intervention-related process data). For those subjects who are given access to the 
MISTT Study website, data will be collected through Google Analytics concerning patient and 
caregiver use of the website. Data will include how often users log in, what pages they go to, how 
long they spend on those pages, the type of technology they use including type of browser, operating 
system, and use of mobile technology. 
Outcome data: Outcomes data will be collected on all enrolled trial subjects (patients and caregivers) 
by telephone interviews conducted at 7-days and 90-days after the patient returns home. Patient 
related data elements are listed in Appendix 2d (Patient Outcomes), caregiver specific outcomes are 
listed in Appendix 2e (Caregiver Outcomes). The final choice of outcome measures will be decided 
upon by the research team after pilot testing of the candidate measures is completed. The following 
list includes the universe of candidate measures we are considering:
1) END Outcomes (Collected at 90-days): NIH PROMIS quality of life instruments including PROMIS
Global QOL (Q10), and PROMIS self-efficacy (social interaction, medications, emotions and daily 
activities). NeuroQOL quality of life instruments including depression, anxiety, and satisfaction with 
social roles and activities, patient activation measure (PAM), hospital and ED visits since discharge, 
stroke recurrence, and 90-day home time (number of days at home during 90-day period). 
2) Mediating Outcomes (Collected at 90-days): NIH PROMIS support measures including
informational, instrumental, and emotional support. Dyad relationship scale, stroke knowledge test, 
stroke action test.
3) Effect modifier variables (collected at baseline, 7-days and/or 90-days): Demographics, stroke
severity/stroke type, disability measures (mRS, Barthel Index (BI), ADL, IADL, cognitive function, 
social and living arrangements. CTM-15, technology use (Computer Self-efficacy, Attitudes to 
Technology, and Technology Utilization), medication adherence measures (Morisky scale), 
NeuroQOL quality of life instruments including communication, positive affect and well-being, 
emotional and behavioral dyscontrol.
4) Caregiver Specific Outcomes (collected at 7days and 90-days): Caregiver Strain index,
Preparedness for Caregiving, mood, stroke knowledge, satisfaction, and function/disability (ADLs and 
IADLs). For enrolled patient-caregiver dyads we will also collect information from both parties on the 
Dyadic Relationship Scale, patient ADLs/IADLs, patient quality of life, patient depressive symptoms, 
and patient social support. 
All baseline, process, and outcomes data will be entered into the Study’s REDCap database. The 
management and protection of REDCap data is described in sections 22B and 22D. 
19.
Does your investigation involve incomplete disclosure of the research
purpose or deception of the subjects?
NO 
20a.
Subject Population
Adult stroke patients who are discharged from the hospital to their home or patients discharged to a 
rehabilitation facility with the expectation that they will return home within 4 weeks. The subject 
population will also include the primary caregiver of enrolled patients if available. 
20b.
Age range of subjects
18 to no limit
20c1. The following study populations will be purposely included in the research:
 Minors 
 Pregnant Women 
 Women of Childbearing Age 
 Institutionalized Persons 
 Students 
 Low Income Persons 
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 Minorities 
 Prisoners 
 HIV/AIDS Individuals 
 Psychiatric Patients 
 Individuals with Diminished Capacity 
 Wards 

None of These
20c2. Will some or all of the subjects likely be vulnerable to coercion or undue 
influence?
NO 
20c3. Will some or all of the subjects be prisoners (i.e. involuntarily confined or 
detained in a penal institution)?
NO 
20c4. Will the research be conducted in the Federal Bureau of Prisons (i.e. 
Federal Prison System)?
NO
20d.
Total expected number of subjects (including controls) for the entire 
project period
500 (20 for the 
pilot test, 480 for 
the final study) 
20e.
Provide the rationale for your sample size.
Sample size estimates were based on 2 outcome measures: Stroke-specific QOL (SS-QOL), and the 
Patient Activation Measure (PAM). Anticipated differences in the summary SS-QOL measure were 
obtained from a previous registry study of the PI (Reeves) (Ref: Gargano et al, 2007) which found 
significant differences of 0.5 with a standard deviation of 1.9. Validation work on the PAM measure 
has shown that an average PAM score is 56 with a standard deviation of 13 (Ref: Hibbard et al, 
2005), and that increases of 4.6 are clinically meaningful (Ref: Fowles et al, 2009). In all simulations, 
power was set to 80% with alpha= 0.05. All estimates were generated in SAS using the overall F test 
for a one-way ANOVA model based on the 3 group RCT design. To detect a 0.5 unit difference in 
mean SS-QOL scores with an assumed standard deviation of 1.9, a total sample size of 213 is 
required. To detect a 5 unit difference in mean PAM score with an assumed standard deviation of 13, 
a total sample size of 102 is required. When these baseline estimates were subjected to plausible 
changes in the effect size (through changes in detectable difference or the standard deviation) we 
obtained estimates between 63 or as high as 366. Our goal total sample size of 480 is therefore more 
than sufficient to detect clinically meaningful differences in these two outcomes. 
20f.
Describe the criteria for the inclusion of subjects.
Patient Inclusion Criteria:
All of the following inclusion criteria need to be met for a patient to be included in the trial.
i) A final confirmed hospital diagnosis of acute stroke (ischemic or hemorrhagic).
ii) Patient living at home pre-stroke.
iii) Presence of stroke-related deficits at admission (defined as a National Institute of Health Stroke
Severity score of >=1). 
iv) Presence of functional limitations at discharge (defined as a modified Rankin score [mRS] score of
>=1). 
v) Discharged directly home (includes patient’s residence or that of a family member), or discharged
to a rehabilitation facility with the expectation of return to home within 4 weeks 
Caregiver Inclusion Criteria:
All of the following inclusion criteria need to be met for a caregiver to be included in the trial.
i) Any person identified by the stroke patient as the primary caregiver (individual who has primary
responsibility for assisting with the patient’s care).
ii) Age 18 or over.
20g.
Describe the criteria for the exclusion of subjects.
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Patient Exclusion Criteria:
Patients will be excluded from the trial if they meet any of these criteria:
i) Patients who live more than 50 miles from the hospital (for reasons related to the home visits).
ii) Patients discharged to hospice care, nursing home for long term care, or long term care hospital
(LTCH). 
iii) Patients who fail the Abbreviated Mental Test Score (AMTS) screening for cognitive function and
for whom a proxy respondent is not available.
iv) 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).
v) Limited life expectancy (< 6 months) or significant medical comorbidity likely to impact completion
of the study (e.g., severe mental illness, drug or alcohol abuse, metastatic cancer). 
vi) Does not speak English.
Caregiver Exclusion Criteria:
The following caregivers would be excluded from the trial.
i) Does not speak English.
20h
(1). 
How will the subjects be identified, recruited and enrolled? Include who will make initial 
contact with the subjects, who will recruit the subjects, and who will enroll the subjects.
Potential study subjects are patients hospitalized due to acute stroke at one of the 4 participating 
institutions. Hospital personnel (clinical stroke nurses or site coordinators) who are employed by the 
MISTT study will screen stroke patients during their hospital stay and will be responsible for 
contacting, consenting and enrolling all eligible patients. Procedures for approaching and consenting 
stroke subjects into clinical studies are well established at the participating hospitals, having been 
built on the experience of prior clinical research studies including the MASCOTS stroke registry that 
was conducted by PI (Reeves). In brief, study personnel will introduce the study to the patient, assess 
the patient’s eligibility (including AMTS screening for cognitive function), seek their consent, and ask 
them to identify the primary caregiver who will also be invited to participate. Stroke patients will be 
identified by reviewing the hospital’s daily census logs. At a suitable time during the hospital stay, 
preferably when family members are present, the study coordinator will approach the patient to 
introduce the study. If the patient and family express interest and eligibility is confirmed, the 
coordinator will complete the consent process. When the patient agrees to participate, he/she will 
read and sign the written consent and HIPPA approval forms. The informed consent process will 
explain the potential risks and include appropriate HIPAA language that will not prohibit data from 
being shared with the research team. A copy of the informed consent instrument and HIPPA form will 
be provided to each participant. Study personnel will query the patient for the name of the person 
most likely to provide the majority of care for them when they return home (i.e., the primary 
caregiver). Study personnel will then approach this identified caregiver to assess eligibility, attempt 
recruitment, and obtain informed consent from the caregiver. If the primary caregiver declines to 
participate in the study, this will not affect the inclusion of the patient. If a patient is unable to give 
consent because they fail the AMTS screening then a proxy respondent will be sought (e.g., see 
section 24B1 for further details). We believe that the use of proxy respondents is critically important 
for stroke studies to avoid study bias from exclusion of the most severely affected patients. 
Enrollment of caregivers will most likely occur in the hospital setting (when they visit the patient) but 
may occur by phone (if study personnel are unable to meet with them in person). 
20h
(2).
Will an advertisement be used?
NO
20i. 
Are you associated with the subjects?
NO
20j. 
Will someone receive payment for recruiting the subjects?
NO
20k. 
Will the research subjects be compensated?
(1) Details concerning payment, including the amount and 
schedule of payments including any conditions:
Subjects will received a one time $25 payment after completing 
the 90-day data collection follow-up call.
YES
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20l.
Will the subjects incur additional financial costs as a result of their 
participation in this study?
NO
20m.
Will this research be conducted with subjects in another country?
NO 
20n.
Will this research be conducted with subjects in the U.S. from an ethnic 
group of sub-group or other non-mainstream minorities (including non-
English speakers)?
NO 
20o.
Will student education records that directly relate to a student be 
accessed?
NO 
20p.
Will any subjects be recruited from MSU Health Team clinics?
NO 
20q.
Will any subjects’ insurance be billed as part of this project?
NO 
21a. 
Risks and Benefits for subjects: Describe and assess any potential risks (physical, 
psychological, social, legal, economic) and assess the likelihood and seriousness of such 
risks.
This RCT study is designed to ameliorate stress and burden associated with the transition back to the 
home that occurs under current usual care environments. The two interventions used in this study 
include: 1) home based case management services provided by the social worker (SW), and 2) 
training and use of the MISTT study website (a purpose-built, patient-centered, online information and 
support resource). Both interventions have limited risk for participants. The most substantial of these 
is loss of confidentiality. There is also a possibility that identifying and addressing unmet needs with 
the social worker may raise difficult and emotional issues for both the patient and the caregiver that 
would have otherwise gone unaddressed. It is also possible that medical emergencies or other 
adverse situations might arise when study personnel are interacting with the subjects. Social workers 
are trained to identify such problems and provide crisis intervention; the social workers will be able to 
refer patients for additional services if needed. They will have regular meetings with and receive 
ongoing supervision from Co-Investigator Dr. Hughes to address potential problems and a protocol 
will be in place for emergencies (see section 21B for further details).
21b. 
Describe procedures for protecting against or minimizing potential risks and provide an 
assessment of their likely effectiveness.
There are two study related potential risks to participants in this study: 1) loss of confidentiality, and 
2) increased stress as a result of the social work intervention addressing unmet needs and other bio-
psycho-social stressors. It is also possible that a medical emergency or other adverse situation might 
arise when study personnel are interacting with the subjects. Section 22A and 22D provide a 
description of the extensive protections put in place to mitigate the risk of loss of confidentiality. Here 
we address the protections put in place to protect subjects against increased stress or unexpected 
medical emergencies: 
If, during the trial, a serious non-medical situation arises that suggests the patient is in crisis, the SW 
will refer the patient to local crisis support services and ensure that the patient is connected to the 
appropriate services. In these situations the SW will contact Co-Investigator Dr. Hughes to develop 
an emergency care and follow-up plan to ensure patient safety. Dr. Hughes has considerable prior 
experience in practical community-based social work including home visits. The SW will also inform 
the hospital study coordinator about any serious issues. The SWs will have bi-weekly meetings with 
Dr. Hughes where they will discuss strategies to manage high-needs cases. Also, these situations will 
be discussed at the bi-weekly research team meetings (including the PI, Project Manager, Co-I 
Hughes and other team members) where strategies can be discussed and refined to ensure that 
patients receive necessary services. 
It is also possible that medical emergencies or adverse conditions may be identified by either the SW 
(during their home visits or the follow-up calls) or by the research assistants who are conducting the 
telephone follow-up data collection calls. All personnel will be instructed on the appropriate use of 
9-1-1 services should any situation arise that could represent a medical emergency (examples could 
include recurrence of stroke symptoms, a serious fall, acute cognitive change). If other serious but 
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non-emergent medical problems arise (for example, ran out of medications, symptoms suggestive of 
a new medical problem or condition) the SW or research assistants will contact the patient’s primary 
care provider to set up an appointment and will follow-up to insure that treatment is received. 
21c. 
Assess the potential benefits (if any) to be gained by the subjects in this study, as well as 
benefits which may accrue to society in general as a result of the planned work.
Patients enrolled in the two intervention groups (the SW case management program, or the SW case 
management program plus access to the study website) may directly benefit from the case 
management services delivered by the SWs, and/or may benefit from the information and support 
services provided by the study website. The risks associated with this study are reasonable 
considering that the study interventions may improve the transition experience (by decreasing 
stress/anxiety and improving overall quality of life). Other benefits include the fact that the knowledge 
gained from this study may benefit future stroke patients and caregivers. All study subjects will be 
given access to the study website after completing their final 90-day telephone interview.
22a.
How will the subject's privacy be protected? Include a description of who will be interacting 
with the subjects or accessing and abstracting data from the subject's records (academic, 
medical, etc.) and where the study will take place. For example, will individuals not associated 
with the research study be present during the consent process and the conduct of the study? 
All interviewers and study staff will follow study specific procedures for maintaining respondent 
confidentiality. All of our study staff will receive training in the proper method of conducting interviews 
that contain personal information, including mandatory HIPAA training. Consent processes will occur 
within the hospital inpatient setting and will be conducted by the hospital study coordinators. In the 
hospital setting, study related bedside interactions and conversation with patients will be conducted 
by the hospital personnel using their usual protections against loss of patient confidentiality. 
Procedures for approaching and consenting stroke subjects into clinical studies are well established 
at the participating hospitals, having been built on the experience of prior clinical research studies. 
Study identification numbers, rather than written names or other personal identifying information, will 
be used to identify and track hard copy data forms containing patient information. The Social Work 
Case Management intervention will occur in the privacy of the patient’s home, and so threats to 
patient privacy are minimal. The MISTT web site will be structured to require strong passwords for all 
subjects, and no identifiable data will be retained on the site.
22b.
Where will the data be stored and for how long?
All electronic data collected in REDCAP will be stored on the secure BRIC server (hosted at the 
MSU-Health Information Technology computer data center). All hard copy files that pertain to patient 
or caregiver data (e.g., signed consent forms, patient contact information) will be kept in lockable file 
drawers within secure offices located in either the Department of Epidemiology or the MSU School of 
Social Work. Study forms maintained by the hospitals will be stored using equivalent security 
procedures. 
All study related data will be maintained for at least 3 years after the completion of the research. 
22c.
Who will have access to the research data?
Only members of the research team will have access to the data. No identifiable data will be shared 
outside the research team. 
22d.
How will you ensure the confidentiality and/or anonymity of the research data? Include a 
description of the procedures and safeguards you will use, including if identifying information 
will be stored with the data.
Patient specific clinical data will be entered remotely by hospital study coordinators into a REDCap 
database using secure web-based data entry screens. Similarly, remote data entry in REDCap will 
also be used by the social workers (SW) to record data collected during home visits and telephone 
follow-up calls. Contact information required to find the patient’s home be stored on secure password 
protected study laptop computers and cell phones – no hard copy forms that contain patient 
information will be maintain by the SWs. The outcomes data for this trial will be collected by phone by 
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trained research assistants working under the supervision of the PI (Reeves) and Project Manager 
(Fritz). Data will be collected at two time points: 7 days and 90-days after returning home. Separate 
interviews will be conducted for patients and caregivers. The Project Manager, social workers, and 
research assistants conducting the telephone follow-up calls will all use secure (password protected) 
study-specific laptop and desktop computers. Laptop computer bags will be locked during transport 
and will be stored in locked offices. Desktop machines will be kept in a locked designated interview 
room in the Department of Epidemiology at MSU. 
During this research project, MSU-BRIC personnel will have no contact with human subjects and will 
play no role in the collection of patient data. Only the PI and Project Manager (both located at MSU) 
will have global privileges that permit viewing and editing of the total database. The PI will be 
responsible for authorizing users and permissions for access to the database via read and write 
privileges. Study field personnel (i.e., hospital study coordinators and the SW) will be allowed to view 
only the patient data from their study site. Audit logs, created automatically within REDCap, will 
capture the complete user history of database activity. REDCap variables designated as ‘personally 
identifying’ will be excluded from export by using REDCap user-defined permissions. In addition, 
BRIC tracks the certification of IRB training for all REDCap users and will suspend access to 
REDCap in the unlikely event that current IRB training certification lapses for any of the study 
personnel. 
Study data will be stored and managed using the REDCap application hosted on servers at the MSU-
Health Information Technology computer data center in a HIPPA-class compliant server room with 
climate-control and swipe-card entry. Daily and monthly backups of the database will be made and 
retained on the server and backups will be moved to a separate site on a monthly basis. 
All subjects using the MISTT study website will be required to use strong passwords, and no 
identifiable data will be retained on the site. MISTT website utilization data collected through Google 
Analytics (e.g., how often users log in, what pages they go to, how long they spend on those pages) 
will be stored on Google servers. Google will not have access to any data that identifies an individual 
user (such as name, Email or address). The utilization data will be linked to the project-specific 
subject ID numbers and not subject names or other identifiers. The key to link the utilization data to a 
specific individual will be stored in a Drupal database on secure MSU servers, and are not publicly 
available 
We believe that the combination of high level training of all study personnel with respect to 
confidentiality and data security, in combination with state-of-the art security features implemented by 
MSU-BRIC on its REDCAP databased minimize any risk of a breach in subject confidentiality. 
22e.
Is it appropriate for your research to have a monitoring plan to periodically 
assess the data to ensure the safety of subjects or to ensure negative 
outcomes do not occur (e.g., ongoing study of domestic abuse, clinical 
trial, full board projects)?
Describe the steps that you will be taking to assure that 
subjects are protected. If appropriate, attach a copy of the 
plan.
The safety of the subjects participating in this study is of 
paramount concern to the investigators. The PI (Reeves) is 
ultimately responsible for the overall safety monitoring of the study. 
Because there is no drug or investigational device being tested in 
this trial, participation has no more than minimal risk to the 
subjects. Commensurate with the very low risk associated with 
study participation and the lack of any tangible Adverse Events to 
monitor, the study team (PI, Co-I’s, Project Manager, SWs) plans 
to directly oversee all safety monitoring. Thus no formal data 
safety monitoring board is planned. All patient safety concerns 
identified by the SWs will be discussed at their weekly meetings, 
and at the bi-weekly research team meetings. Summaries of these 
issues and the approaches used by the project team to address 
them will be shared with a Patient-Professional Advisory Panel 
who will meet every 6 months during Years 2 and 3 to provide 
oversight on the trial’s implementation. These data will also be 
YES
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shared with the funding agency (PCORI) as part of the regular 
biannual reports submitted to them.
With respect to monitoring the integrity of the REDCap database, 
Dr. Nicole Jones will work closely with the BRIC Unit Information 
Systems Manager to oversee and ensure implementation and 
monitoring of the data management plan. She will ensure that the 
informatics configuration, testing, and production processes are 
conducted appropriately to ensure security and confidentiality of 
data in the Study’s REDCap database.
Is there a data safety monitoring committee or data safety 
monitoring board?
NO
23.
Does this project involve protected health information as defined by
HIPAA?
YES
24.
(a) Select appropriate consent option.
Approval of a 
consent form and 
process
(b) Consent Procedures:
Hospital personnel (clinical stroke nurses or study site coordinators) who are 
employed by the MISTT study will be responsible for consenting eligible 
patients. Procedures for approaching and consenting stroke subjects into clinical 
studies are well established at the participating hospitals; all study personnel 
have experience in enrolling patients into clinical research studies. Hospital 
study personnel will first assess the patient’s eligibility and will screen each 
patient using the Abbreviated Mental Test Score (AMTS) to determine if a proxy 
consent is required (see below for further details). If a patient is deemed 
potentially eligible at a suitable time study personnel will approach the patient to 
introduce the study (preferably when other family members are present). If the 
patient and family express interest and eligibility is confirmed, the coordinator 
will provide further details of the study. This discussion will follow the information 
on the consent form including a description of the study’s purpose, the use of 
randomization, the study procedures involved (including the use of home visits), 
the expectations of participating subjects with respect to providing information 
via follow-up telephone calls. Risks and potential benefits as well as 
compensation will also be discussed. If the patient agrees to participate, he/she 
will read and sign the written consent and HIPPA forms. A copy of these forms 
will be provided to each participant.
Study personnel will query enrolled patients for the name of the person most 
likely to provide the majority of care for them when they return home (i.e., the 
primary caregiver). Study personnel will then approach this identified caregiver 
to assess eligibility, attempt recruitment, and obtain informed consent from the 
caregiver. Enrollment of caregivers will most often occur either in the hospital 
setting (if they visit the patient) or may occur by phone (if study personnel are 
unable to meet with them in person). Whether the caregiver chooses to 
participate in the study or not, will not affect the inclusion of the patient.
We will seek to enroll any patient who fails the Abbreviated Mental Test Score 
(AMTS) screening – a 10-item screening tool that identified subjects with 
confusion or disorientation. If a patient scores &#8804;7 or has aphasia and is 
not able to complete the test then a proxy respondent will be sought. We will 
follow the rules as outlined in the MSU HRPP manual (Section 6-8-D) for 
determining the most appropriate person to act as a surrogate decision maker. 
In the absence of an advanced care directive that addresses consent for 
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research studies, or power of attorney, or health care guardian, we will be next 
defer to the patient’s spouse or family member as available. 
(b)(2)Will the subject or legally authorized representative sign a consent 
document(s)? YES
25a.
Does any person responsible for the design, conduct, or reporting of 
findings of this protocol have a Significant Financial Interest (as defined 
for the MSU Faculty Conflict of Interest Policy) or other opportunity for 
tangible personal benefit related to the conduct of the research that might 
compromise, or reasonably appear to compromise, the independence of 
judgment with which their responsibilities would be completed under this 
research protocol? A reportable financial interest includes, but is not 
limited to, a financial interest in the sponsor, product, or service being 
tested, or in a competitor of the sponsor or product or service being 
tested. 
NO
25b.
Has any financial arrangement, including compensation, ownership 
interest, stock options, or other ownership interest, (e.g., compensation 
that is: explicitly greater for a favorable result; in the form of an equity 
interest in the sponsor of a covered study; or in the form of compensation 
tied to sales of the product, such as a royalty interest) been established 
whereby the value of compensation or ownership interest to investigators 
conducting the study could be influenced by the outcome of the study?
NO
25c.
Is this a clinical study where the results may be used to support marketing 
applications for new human drugs and biological products and marketing 
applications and reclassification petitions for medical devices to the FDA, 
as required by law?
NO
25d.
Are you aware of any individual who has a financial interest which may 
create an organizational conflict of interest?
NO
26a.
When would you prefer to begin this project?
11/1/2015 
26b.
Estimated duration of project (including identifiable data analysis):
2 years
ADDITIONAL DOCUMENTS/ATTACHMENTS
01. 9/18/2015 Grant Application Materials (i049657_9-18-2015_PCORI Grant References-FINAL.docx)
02. 9/18/2015 Abstract (i049657_9-18-2015_PCORI Public Abstract FINAL.docx)
03. 9/22/2015 Specific Aims (i049657_9-18-2015_PCORI Specific Aims FINAL.docx)
04. 9/18/2015 Appendix contents (i049657_9-18-2015_PCORI_Appendix FINAL.docx)
05. 9/18/2015 Research Strategy (i049657_9-18-2015_PCORI_Stroke Research Strategy FINAL.docx)
06. 9/18/2015 Caregiver consent Form (i049657_9-18-2015_MISTT Caregiver consent form_V2.docx)
07. 9/18/2015 Patient Consent Form (i049657_9-18-2015_MISTT Patient consent form_V2.docx)
08. 9/18/2015 Hospital baseline data (i049657_9-18-2015_MISTT MSU IRB appendix
2a_V2_FINAL.DOCX)
09. 9/18/2015 patient baseline data (i049657_9-18-2015_MISTT MSU IRB appendix 2b_V3_FINAL.DOCX)
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10. 9/18/2015 Data collection form (i049657_9-18-2015_MISTT MSU IRB appendix 2c_V2_FINAL.DOCX)
11. 9/18/2015 Patient Outcome Measures (i049657_9-18-2015_MISTT MSU IRB appendix
2d_V4_FINAL.DOCX)
12. 9/18/2015 Caregiver Outcome Measures (i049657_9-18-2015_MISTT MSU IRB appendix
2e_V1_FINAL.DOCX)
13. 9/18/2015 use of PHI appendix p. 2 (i049657_9-18-2015_MISTT Use of Protected Health Information
Application_Sept 2015_REEVES S....pdf)
14. 9/18/2015 use of PHI appendix p.1 (i049657_9-18-2015_MISTT Use of Protected Health Information
Application_Sept 2015_V1_FINAL....docx)
15. 9/21/2015 Signature Page (i049657_9-18-15_Signature Page.pdf)
16. 9/24/2015 Revised Consent (i049657_9-24-15_MISTT Caregiver consent form_V2_FINAL2.docx)
17. 9/24/2015 Revised Consent (i049657_9-24-15_MISTT Patient consent form_V2_FINAL2.docx)
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Revision
Application
Approval
March 16, 2016
To:
Mathew Reeves
B614 W Fee Hall
East Lansing, MI  48824
Re:
IRB# 15-992M Category:  EXPEDITED 5, 7
Revision Approval Date: March 16, 2016
Project Expiration Date: October 11, 2016
Title:
Michigan Stroke Transitions Trial (MISTT) Study [CGA#135457][IRRC# 1500-13M]
The Institutional Review Board has completed their review of your project.  I am pleased to advise
you that the revision has been approved.
This revision includes changes to the consent form, research instruments, receipt of DUA from
the U of M IRB, registration of the project with ClinicalTrails.gov and the addition of Dr.
 the project. In addition to other personnel being added
to the project.
The review by the committee has found that your revision is consistent with the continued protection
of the rights and welfare of human subjects, and meets the requirements of MSU's Federal Wide
Assurance and the Federal Guidelines (45 CFR 46 and 21 CFR Part 50).  The protection of human
subjects in research is a partnership between the IRB and the investigators. We look forward to
working with you as we both fulfill our responsibilities.
Renewals:  IRB approval is valid until the expiration date listed above.  If you are continuing your
project, you must submit an Application for Renewal application at least one month before expiration.
If the project is completed, please submit an Application for Permanent Closure.
Revisions:  The IRB must review any changes in the project, prior to initiation of the change.  Please
submit an Application for Revision to have your changes reviewed.  If changes are made at the time
of renewal, please include an Application for Revision with the renewal application.
Problems:  If issues should arise during the conduct of the research, such as unanticipated problems,
adverse events, or any problem that may increase the risk to the human subjects, notify the IRB office
promptly.  Forms are available to report these issues.
Please use the IRB number listed above on any forms submitted which relate to this project, or on any
correspondence with the IRB office.
Good luck in your research.  If we can be of further assistance, please contact us at 517-355-2180 or
via email at IRB@msu.edu.  Thank you for your cooperation.
Ashir Kumar, M.D.
BIRB Chair
c: Michele Fritz, Anne Hughes, Amanda Woodward, Paul Freddolino, Constantinos Coursaris, Kristen
Boeskool, Debra Montgomery, Danielle Steplowski, Taylor Seaton, Shyamali Mukerjee, Anmar
Razak, Ann Ripberger
Sincerely,
Office of Regulatory Affairs
Human Research
Protection Programs
Biomedical & Health
Institutional Review Board
(BIRB)
Community Research
Institutional Review Board
(CRIRB)
Social Science
Behavioral/Education
Institutional Review Board
(SIRB)
Olds Hall
408 West Circle Drive, #207
East Lansing, MI 48824
 (517) 355-2180
Fax: (517) 432-4503
Email: irb@msu.edu
www.hrpp.msu.edu
MSU is an affirmative-action,
equal-opportunity employer.

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1/4
APPLICATION FOR RENEWAL or REVISION
APPROVAL OF A PROJECT INVOLVING HUMAN SUBJECTS
Biomedical, Health Sciences Institutional Review Board (BIRB) 
 
Community Research Institutional Review Board (CRIRB) 
Social Science, Behavioral, Education Institutional Review Board (SIRB)
207 Olds Hall, Michigan State University
East Lansing, MI 48824-1047
 
Phone: (517) 355-2180
 
Fax: (517) 432-4503
 
E-mail: irb@msu.edu
Office Hours: M-F (8:00 A.M.-5:00 P.M.)
IRB#: 15-992M 
ID# r049818
Title: Michigan Stroke Transitions Trial (MISTT) Study [CGA#135457][IRRC# 1500-13M]
Review Category: EXPEDITED 5, 7
Expiration Date: 9/14/2018
Responsible Project Investigator:
Name:
Mathew Reeves
ID#:
Department:
College:
EPIDEMIOLOGY & BIOSTATISTICS 
HUMAN MEDICINE
Academic Rank: Professor 
Mailing Address: 
 
East Lansing, MI 48824
Phone:
Fax:
Email:
ReevesM@msu.edu
REVISION
1.
Categories: Mark all categories of proposed changes below.
Administrative Changes
Funding
NO
Project Title
NO
Study Investigator(s)
NO
Data Analysis Only
NO
Study Changes / Amendments
Advertisement/Recruitment
NO

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Consent
YES
Eligibility Criteria
NO
Instrument(s)
YES
Protocol/Design/Analysis
NO
Subject Incentive
NO
Target Population
NO
Protected Health Information NO
Other
YES
2.
Briefly describe the proposed revision(s) and rationale:
We request the following revisions:
1) OTHER - Add Dr.
 as study personnel. 
 is the study Investigator at
Sparrow and 
 is a social worker who will be providing our Stroke Case Management intervention.
 
The following approved personnel only need to be listed as "additional personnel" and not identified as "investigators
and key personnel"
2) CONSENT - Approval for a waiver of documentation to obtain Caregiver Consent verbally over the phone. This will
occur if the Caregiver is unavailable at the time of patient consent. A script is included in the supporting documentation.
 
Hospital site coordinators, Social Work Stroke Case Managers (SWSCMs), and student research assistants will all be
trained to conduct informed consent for both in-person and over-the-phone processes. 
3) INSTRUMENTS - The finalized Patient and Caregiver 7 day Phone Interview instruments have been submitted for
approval. The Caregiver Instrument contains two scales that were not previously approved: the Oberst Caregiving
Burden Scale and the Bakas Caregiving Outcomes Scale.
4) OTHER - Approval for University of Michigan as a study site. The U-M IRB approval letter has been included with our
supporting documentation which includes the executed Data Use Agreement (DUA) and their approved consent forms.
5) OTHER - The ClinicalTrials.gov ID is: NCT02653170
6) OTHER - We have included letters and educational materials for the first and second mailings. For the first mailing,
enrolled patients will receive a letter and, depending on their randomized group assignment, two National Stroke
Association (NSA) brochures and an interview response option sheet (attached). The second mailing is sent only to the
usual care group and includes two American Stroke Association (ASA) brochures (previously approved). The second
letter has been attached. The "Mailing Supply List" document summarizes the timeline and specifics for each mailing.
3.
Does the proposed revision(s) add or increase the level of risk for subjects (including any additional
adverse effects)?
NO
4.
Does the proposed revision(s) require changes in the consent process and/or forms (e.g., parental
permission, child assent, diminished cognitive capacity)?
(a) The new consent, parental permission, or child assent document(s) is in addition to the
current one(s). YES 
 
(b) The revised consent, parental permission, or child assent document(s) is to replace the
current one(s). NO
 
(c) Please describe changes to the consent process (e.g. who will obtain consent and
inform/educate the subjects).
YES
5.
Have any new funding sources been added to the project?
NO

1/29/2019
MSU IRB - Application - Renewal/Revision
6.
If needed, provide any special name/number/language that should appear in this revision's approval letter.
please provide a list of the things that have been approved
7.
Is the approval period for this project two years (i.e. project was granted a two year approval as part of
the demonstration project)?
NO
ADDITIONAL DOCUMENTS/ATTACHMENTS
01. 3/7/2016 Consent Form (r049818_03-04-2016_MISTT verbal phone consent for caregiver_3.docx)
02. 3/7/2016 Survey/Instrument (r049818_03-04-2016_CAREGIVER 7d data collection v10.docx)
03. 3/7/2016 Survey/Instrument (r049818_03-04-2016_PATIENT 7d data collection_V9.docx)
04. 3/7/2016 Data Use Agreement (r049818_03-04-2016_AGR2016-00606 UM-MSU DUA_FINAL SIGNED.PDF)
05. 3/7/2016 University of Michigan Approval (r049818_03-04-2016_HUM00107251_initial approval letter_2-2016.docx)
06. 3/7/2016 Consent Form (r049818_03-04-2016_MISTT Informed consent patient final_U-M.PDF)
07. 3/7/2016 Consent Form (r049818_03-04-2016_MISTT Informed consent caregiver final_U-M.PDF)
08. 3/7/2016 Protocol (r049818_03-04-2016_mailing supply list_2.docx)
09. 3/7/2016 Other (r049818_03-04-2016_NSA_CaregiversAndStroke.pdf)
10. 3/7/2016 Other (r049818_03-04-2016_NSA_STARSBrochure.pdf)
11. 3/7/2016 Survey/Instrument (r049818_03-04-2016_PATIENT 7d interview response options SHEET_v2.docx)
12. 3/7/2016 Other (r049818_03-04-2016_UC mail 1_Adjusted WITH heading and logo_V3.docx)
13. 3/7/2016 Other (r049818_03-04-2016_UC mail 2_Adjusted WITH heading and logo_v2.docx)
14. 3/7/2016 Survey/Instrument (r049818_03-04-2016_CAREGIVER 7d interview response options SHEET_v2.docx)
15. 3/7/2016 Other (r049818_03-04-2016_Intervention mail 1_Adjusted WITH margin and logo_v3.docx)
16. 3/8/2016 Oral Consent (r049818_3-8-16_MISTT verbal phone consent for caregiver_4.docx)
17. 3/16/2016 University of Michigan Approval (r049818_03-16-2016_HUM00107251_Ame00059544_approval letter_3-
2016.docx)

Revision
Application
Approval
August 19, 2016
To:
Mathew Reeves
East Lansing, MI  48824
Re:
IRB# 15-992M Category:  EXPEDITED 5, 7
Revision Approval Date: August 19, 2016
Project Expiration Date: October 11, 2016
Title:
Michigan Stroke Transitions Trial (MISTT) Study [CGA#135457][IRRC# 1500-13M]
The Institutional Review Board has completed their review of your project.  I am pleased to advise
you that the revision has been approved.
This letter notes approval for the revised consent & recruitment, parent/caregiver phone
interview & letters for the third and fourth mailings along with the post-intervention MISTT
website registration e-mail.
The review by the committee has found that your revision is consistent with the continued protection
of the rights and welfare of human subjects, and meets the requirements of MSU's Federal Wide
Assurance and the Federal Guidelines (45 CFR 46 and 21 CFR Part 50).  The protection of human
subjects in research is a partnership between the IRB and the investigators. We look forward to
working with you as we both fulfill our responsibilities.
Renewals:  IRB approval is valid until the expiration date listed above.  If you are continuing your
project, you must submit an Application for Renewal application at least one month before expiration.
If the project is completed, please submit an Application for Permanent Closure.
Revisions:  The IRB must review any changes in the project, prior to initiation of the change.  Please
submit an Application for Revision to have your changes reviewed.  If changes are made at the time
of renewal, please include an Application for Revision with the renewal application.
Problems:  If issues should arise during the conduct of the research, such as unanticipated problems,
adverse events, or any problem that may increase the risk to the human subjects, notify the IRB office
promptly.  Forms are available to report these issues.
Please use the IRB number listed above on any forms submitted which relate to this project, or on any
correspondence with the IRB office.
Good luck in your research.  If we can be of further assistance, please contact us at 517-355-2180 or
via email at IRB@msu.edu.  Thank you for your cooperation.
Ashir Kumar, M.D.
BIRB Chair
c: Michele Fritz, Anne Hughes, Amanda Woodward, Paul Freddolino, Constantinos Coursaris, Kristen
Boeskool, Debra Montgomery, Danielle Steplowski, Taylor Seaton, Shyamali Mukerjee, Anmar
Razak, Alina Farah, Amy Nagaj, Lindsay Ross, Garrett Reichle
Sincerely,
Office of Regulatory Affairs
Human Research
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Biomedical & Health
Institutional Review Board
(BIRB)
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Institutional Review Board
(CRIRB)
Social Science
Behavioral/Education
Institutional Review Board
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1/29/2019
MSU IRB - Application - Renewal/Revision
http://35.9.220.5:591/ucrihs/ucrihs_main/FMPro?-db=RENEWAL_REVISION_V2&-lay=AllFields&-format=record_detail_renrev.htm&-op=eq&Serial_N…
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APPLICATION FOR RENEWAL or REVISION
APPROVAL OF A PROJECT INVOLVING HUMAN SUBJECTS
Biomedical, Health Sciences Institutional Review Board (BIRB) 
 
Community Research Institutional Review Board (CRIRB) 
Social Science, Behavioral, Education Institutional Review Board (SIRB)
207 Olds Hall, Michigan State University
East Lansing, MI 48824-1047
 
Phone: (517) 355-2180
 
Fax: (517) 432-4503
 
E-mail: irb@msu.edu
Office Hours: M-F (8:00 A.M.-5:00 P.M.)
IRB#: 15-992M 
ID# r050607
Title: Michigan Stroke Transitions Trial (MISTT) Study [CGA#135457][IRRC# 1500-13M]
Review Category: EXPEDITED 5, 7
Expiration Date: 9/14/2018
Responsible Project Investigator:
Name:
Mathew Reeves
ID#:
Department:
College:
EPIDEMIOLOGY & BIOSTATISTICS 
HUMAN MEDICINE
Academic Rank: Professor 
Mailing Address: 
 
East Lansing, MI 48824
Phone:
Fax:
Email:
ReevesM@msu.edu
REVISION
1.
Categories: Mark all categories of proposed changes below.
Administrative Changes
Funding
NO
Project Title
NO
Study Investigator(s)
NO
Data Analysis Only
NO
Study Changes / Amendments
Advertisement/Recruitment
YES

1/29/2019
MSU IRB - Application - Renewal/Revision
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Consent
YES
Eligibility Criteria
NO
Instrument(s)
YES
Protocol/Design/Analysis
NO
Subject Incentive
NO
Target Population
NO
Protected Health Information NO
Other
YES
2.
Briefly describe the proposed revision(s) and rationale:
PROPOSED REVISIONS:
 
We request the following revisions and have submitted supporting documentation via e-mail:
1) Advertisement/Recruitment: The MISTT study timeline will be used during recruitment to help explain the study.
2) CONSENT: Patient and Caregiver consent forms (both in-person and verbal) have been revised to include language
explaining that participant usage of the MISTT website will be tracked. Tracking will occur for participants randomized to
the Social Work Case Management + MISTT website group as well as for any participant that requests access to the
website after completing their 90 day intervention period. Following the completion of the 3-month intervention phase of
the study we are making the website available to all participants who request access via e-mail. This access will be
maintained for a minimum of six months, and we will continue to track website usage during this post-intervention
period, which is addressed in the consent forms.
3) INSTRUMENTS: The finalized Patient and Caregiver 90 day Phone Interview instruments have been submitted for
approval.
4) OTHER: Letters for the third and fourth mailings along with the post-intervention MISTT website registration e-mail
have been submitted. 
-The third letter is sent to patients in all intervention groups and serves as a reminder for the 90d Phone Interview. It
includes a copy of the interview response options.
 
-The fourth letter, along with a $25 gift card, is sent to both patients and caregivers who have completed the study. It
also contains an invitation to e-mail us if interested in registering for MISTT website access.
 
-The post-intervention MISTT website registration e-mail contains information for interested participants to register and
access the MISTT website after their 90d intervention period is complete.
3.
Does the proposed revision(s) add or increase the level of risk for subjects (including any additional
adverse effects)?
NO
4.
Does the proposed revision(s) require changes in the consent process and/or forms (e.g., parental
permission, child assent, diminished cognitive capacity)?
(a) The new consent, parental permission, or child assent document(s) is in addition to the
current one(s). NO 
 
(b) The revised consent, parental permission, or child assent document(s) is to replace the
current one(s). YES
 
(c) Please describe changes to the consent process (e.g. who will obtain consent and
inform/educate the subjects).
YES
5.
Have any new funding sources been added to the project?
NO
6.
If needed, provide any special name/number/language that should appear in this revision's approval letter.
please list the approved content

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MSU IRB - Application - Renewal/Revision
http://35.9.220.5:591/ucrihs/ucrihs_main/FMPro?-db=RENEWAL_REVISION_V2&-lay=AllFields&-format=record_detail_renrev.htm&-op=eq&Serial_N…
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7.
Is the approval period for this project two years (i.e. project was granted a two year approval as part of
the demonstration project)?
NO
ADDITIONAL DOCUMENTS/ATTACHMENTS
01. 8/8/2016 Data collection form (r050607_8-8-16_CAREGIVER 90d data collection_V8.docx)
02. 8/8/2016 Other (r050607_8-8-16_CAREGIVER 90d interview response options SHEET_v2.docx)
03. 8/8/2016 Email (r050607_8-8-16_e-mail for post-study VSSP access_v3.docx)
04. 8/8/2016 Other (r050607_8-8-16_Gift Card Mailing_All groups_adjusted WITH margin and logo_v4.docx)
05. 8/8/2016 Other (r050607_8-8-16_mail 3_All groups_adjusted WITH margin and logo_v1.docx)
06. 8/8/2016 Consent Form (r050607_8-8-16_MISTT Caregiver consent form_FINAL_level 9_v2.docx)
07. 8/8/2016 Consent Form (r050607_8-8-16_MISTT Patient consent form_FINAL_level 9_v2.docx)
08. 8/8/2016 Consent Form (r050607_8-8-16_MISTT verbal consent form for patient_v4 FINAL_v2.docx)
09. 8/8/2016 Consent Form (r050607_8-8-16_MISTT verbal phone consent for caregiver_4 FINAL_v2.docx)
10. 8/8/2016 Data collection form (r050607_8-8-16_PATIENT 90d data collection_V12.docx)
11. 8/8/2016 Other (r050607_8-8-16_PATIENT 90d interview response options SHEET_v1.docx)
12. 8/8/2016 Other (r050607_8-8-16_timelineINFOGRAPHIC DRAFT1.7 FINAL3 with 0.125 bleed.pdf)
13. 8/19/2016 Consent Form (r050607_08-19-2016_MISTT Patient consent form_FINAL_level 9_v3.docx)
14. 8/19/2016 Consent Form (r050607_08-19-2016_MISTT Caregiver consent form_FINAL_level 9_v3.docx)