Caregiver SOS: An Intervention for Employed Caregivers
Phase: NA
Conditions: Caregiver Distress, Job Stress
Sponsor: VA Office of Research and Development

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CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 1 of 51
APPROVED by CMCVAMC IRB on 12/27/2023
Application and Submission Instructions (IRB Form 101)
DO NOT CHANGE THE FORMATTING OF THIS DOCUMENT.
DO NOT USE THIS FORM ON A MAC; IT WILL CHANGE THE FORMATTING
OF THIS DOCUMENT, WHICH WILL MAKE IRB REVIEW MORE DIFFICULT
AND LENGTHIER.
- FOR CHECKBOXES - DOUBLE CLICK THE BOX - CHOOSE 'CHECKED';
HIT OK.
Each section of the application requires a response.
Ensure all responses are consistent with the approved funded project, the 
informed consent, and the HIPAA Authorization, if applicable. Ensure all
sections of the application are completed or marked “Not Applicable.”
One single-sided hard copy of this application form must be submitted to 
the IRB Office with ALL required signatures.
The electronic version sent to the IRB Coordinator must be Word documents,
unless the form is already a PDF.
This application form was designed to be self-explanatory with embedded 
instructions and guidance to follow as the form is being completed. However, if 
any questions arise as the form is being completed, contact one of the IRB 
Coordinators, Eileen.McCarthy-Dorsey@va.gov or Joan.Havey@va.gov.
THERE MAY BE OTHER DOCUMENTS YOU WILL NEED FOR YOUR 
PROJECT, SUCH AS THE RESEARCH STAFF FORM, INFORMED CONSENT, 
HIPAA AUTHORIZATION/REVOCATION FORMS, ETC., WHICH CAN BE 
OBTAINED FROM
Eileen.McCarthy-Dorsey@va.gov or Joan.Havey@va.gov
Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center (CMCVAMC) 
Institutional Review Board (IRB)
INITIAL IRB APPLICATION
- FOR TEXT BOXES - CLICK IN SHADED BOX AND TYPE.
The Principal Investigator (PI) is required to use this form to submit new 
research projects to the IRB. This form is to be used when there is 
interaction with human subjects.

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 2 of 51 
 
APPROVED by CMCVAMC IRB on 12/27/2023 
TABLE OF CONTENTS 
Section 1:  PI Information ........................................................................................................................ 3 
Section 2:   PI Study Team Information .................................................................................................... 4 
Section 3:  Project Overview ................................................................................................................... 5 
Section 4:  Potential Risk/Benefit Analysis ............................................................................................... 7 
Section 5:  Human Participant Information ............................................................................................... 9 
Section 7:  HIPAA Authorization for Project Participants ........................................................................ 11 
Section 8:  Participant Recruitment Information ..................................................................................... 12 
Section 9:  Payment to Participants ....................................................................................................... 13 
Section 10: Biological Specimens ......................................................................................................... 14 
Section 11:  Privacy, Confidentiality, and Information Security in Research ........................................... 15 
Section 12:  FDA-Regulated and Other Products ................................................................................... 19 
Section 13:  Request for Expedited Review ........................................................................................... 20 
Section 14: Abstract ............................................................................................................................... 22 
Section 15: List of Abbreviations ............................................................................................................ 23 
Section 16: Protocol Summary .............................................................................................................. 25 
1. 
Introduction .................................................................................................................................................... 25 
2. 
Objectives ....................................................................................................................................................... 27 
3. 
Resources and Personnel ................................................................................................................................ 28 
4. 
Study Procedures ............................................................................................................................................ 29 
5. 
Recruitment Methods ..................................................................................................................................... 32 
6. 
Informed Consent Procedures ........................................................................................................................ 33 
7. 
Inclusion/Exclusion Criteria ............................................................................................................................ 34 
8. 
Study Evaluations ............................................................................................................................................ 34 
9. 
Data Analysis ................................................................................................................................................... 36 
10. 
Withdrawal of Subjects ............................................................................................................................... 37 
11. 
Reporting .................................................................................................................................................... 37 
12. 
Privacy and Confidentilaity ......................................................................................................................... 38 
13. 
Communication Plan for Multi-Site Studies or Studies being done at Non-CMCVAMC Locations ............. 39 
14. 
References (bibliography of cited literature).............................................................................................. 40 
Section 17: Keywords ............................................................................................................................ 44 
Section 18: Institutional Support ............................................................................................................. 44 
Section 19: Data Management and Access Plan (DMAP) ...................................................................... 44 
Section 21: Attestation to Follow Federal Regulations ............................................................................ 47 
Section 22: Institutional Approvals ......................................................................................................... 48 

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 3 of 51
APPROVED by CMCVAMC IRB on 12/27/2023
SECTION 1: PI'S INFORMATION
Project Title: Caregiver SOS: An Intervention 
for Employed Caregivers
Initial
Revised
CMCVAMC Version Date/Version #: 
10/27/2023; V12
1.
Name of Principal Investigator (PI) Amy Helstrom
PI's VA Email: Amy.Helstrom@va.gov
PI's VA Telephone Number:
215 823 4164
PI's VA Mailing Address:
MIRECC – B228
PI's Other Business Email:
N/A
PI's Other Business Telephone
Number:
N/A
2.
PI's Academic Degrees:
2.1. PI's Board Certifications, if applicable:
3.
PI's Employment Status: (Check all that apply)
VA Employee (#8ths)
8/8ths
Other (VA WOC, IPA)
Specify Appointment Type:
3.1. For ORD-funded studies, is the PI at least a 5/8ths VA employee? 
Yes 
- (skip to question 4)
No
- (answer question 3.2)
N/A
3.2. If the response to 3.1 is no, is a copy of the ORD funding service approval waiver 
included as part of this submission?
Yes
No
- If no, indicate when submitted for approval:
4.
Describe the PI’s qualifications to act in the capacity as PI to do the research in this 
project and attach a copy of his/her biosketch (Merit Review or NIH Format):
The proposed randomized study seeks to evaluate the impact of a novel intervention designed 
to provide evidence-based, role performance-focused telephonic self-management counseling to 
employed caregivers of Veterans who have a diagnosis of, or clinically significant symptoms of 
depression, anxiety, TBI, or PTSD.  Given my methodological, substantive, and statistical 
experience, I hope to serve as the Principal Investigator on the proposed project, devoting 35% time 
and effort. I have expertise in psychosocial and mental health interventions and services research 
as well as quantitative and qualitative data analysis methods. My research focuses on the 
association between psychosocial factors and mental and physical well-being, particularly among 
individuals with behavioral and neuropsychiatric conditions, with an emphasis on understanding 
psychosocial correlates of patient and caregiver behavioral health outcomes. I have recently worked 
on a number of clinical trials that have focused on the comparative effectiveness of different 
modalities and health service delivery models for the treatment of behavioral health conditions. 
Specific to this project, I recently served as the PI on a Department of Veterans Affairs-funded pilot 
clinical intervention trial that evaluated the feasibility and outcomes of a patient/caregiver-centered 
dementia care management program. Similar to the program proposed in this application, the pilot 
program emphasized training in caregiver coping and self-management strategies. I also currently 
serve as a Co-PI on a multi-center, randomized clinical trial comparing the effectiveness of a group 
vs. individually-delivered collaborative care management program for caregivers of Veterans with 
dementia. The intervention proposed in this project builds upon, in part, our intervention for 
caregivers of Veterans with dementia and the PACE/PACENET Supporting Seniors Receiving 
Treatment and Intervention (SUSTAIN) and Caregiver Research, Education, and Support (CREST) 
programs (of which I am the PI). As both a PI and a Co-I on other projects, I also have been 
involved in the study design and analysis of data from studies examining the role of Veterans’ 
caregivers/relationship partners in other contexts (e.g., depression, substance use, Parkinson’s
N/A
PhD

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 4 of 51
APPROVED by CMCVAMC IRB on 12/27/2023
Disease, post-deployment).  Past studies have required that I develop and refine intervention 
material (e.g., caregiver workbooks, training material), manage study teams comprised of research 
and clinical staff, provide supervision and ensure model fidelity, collaborate with stakeholders, and 
manage both small and large datasets. Moreover, I have a number of years of experience 
extracting, managing, and analyzing both VA and non-VA patient level and program data. Thus, I 
feel I have the organizational, methodological, and analytic experience to successfully lead, 
manage, and guide all aspects of the proposed project. This includes staff training, data acquisition, 
management, analysis, and evaluation efforts, program quality and fidelity monitoring, protocol 
preparation and modifications, and dissemination of study results.
5.
Complete the questions below regarding the PI’s current research activities:
5.1. What current percentage of the PI time is devoted to research activities?
5.2. What percentage of the PI’s time will be devoted to this project?
5.3. How many active studies is the PI currently overseeing?
5.4. How many of the above are multisite studies in which the PI is the overall PI?
6.
Is/Are there Co-PI (s)?
Yes
-(see additional questions below)
No 
6.1.
If yes, indicate the following for each:
Name:
Site:
SECTION 2: PI'S STUDY TEAM INFORMATION
1.
Study coordinator's contact Information.
N/A
1.1.
Name of Study Coordinator:
Marybeth Groot
Study Coordinator's VA Email:
Marybeth.Groot@va.gov
Study Coordinator's VA Telephone Number:
215 823 5800 ext. 203870 
Study Coordinator's VA Mailing Address:
Annex: Suite 202
Study Coordinator's Other Business Email:
N/A
Study Coordinator's Other BusinessTelephone
Number:
N/A
2.
Does the above-named Study Coordinator have prior experience coordinating:
2.1.
A VA research study?  Yes
      No
2.2.
Obtaining informed consent at the CMCVAMC?  Yes
   No
If yes, provide the date study coordinator took the Research Compliance Officer 
training course. Circa 2021
3.
Does this project involve a designated Coordinating Center(s)? Yes
No 
3.1.
If yes, provide the name of the Coordinating Center(s) and contact information below.
3.1.1.
Name of Coordinating Center:
3.1.2.
Contact Name (Program Manager or other POC):
3.1.3.
Phone Number:
Email address:
1
3
35%
100%

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 5 of 51
APPROVED by CMCVAMC IRB on 12/27/2023
SECTION 3: PROJECT OVERVIEW
1.
What organization is funding this study? (Check all that apply)
CSP
CSR&D
HSR&D
RR&D
BSLR&D
QUERI
VHA Central Office
Private Nonprofit: Please specify:
Department of Defense (DoD)
Commercial Sponsor: Please specify: 
None; If none is checked, provide justification why there is no funding source.
Funding Agency Project number: 1 I01 HX002824-01A2
2.
What are the research questions or hypotheses to be studied?
Aim 1 is to determine whether a novel intervention, Caregiver Self-Management of Stress 
(Caregiver SOS, providing evidence-based telephonic work/CG stress self-management counseling, 
is superior to usual care (UC) in reducing caregiver (CG) psychological distress (primary outcome; 
Aim 1a), and improving ability to function effectively in work and CG roles (secondary outcome; 
Aim 1b). We hypothesize that, compared to CGs in UC, CGs in the intervention arm will have 
significantly less distress (Hyp. 1a), and a better ability to function effectively in their work and CG 
roles (Hyp. 1b). Aim 2 (Exploratory) is to determine whether, relative to UC, the intervention 
improves CGs’ overall physical health and mental well-being (Aim 2a), and CGs’ and care 
recipients' (CRs’) access to needed healthcare and social services (Aim 2b). We hypothesize that 
relative to those in UC, CGs assigned to the intervention arm will have higher levels of physical and 
emotional well-being (Exploratory Hyp. 2a). We also hypothesize that CGs/CRs in the intervention 
arm will report higher utilization of needed services (e.g., CR MH and primary care and CG-related 
services) (Exploratory Hyp. 2b).
3.
Describe the relevance to Veterans of studying the above questions or hypotheses and 
the importance of the knowledge this project is likely to generate:
Approximately 5.5 million Veterans rely on CGs to help them with their daily care. CGs often 
cope with stress and strain from CG/work roles. This may be particularly true of CGs of Veterans 
coping with behavioral health issues related to conditions such as depression, posttraumatic stress 
disorder (PTSD), anxiety, and traumatic brain injury (TBI). Programs that specifically address 
caregiving-work role stress may be especially effective in improving CGs’ wellbeing and 
work/financial stability and the quality of Veterans’ care. Given this project’s focus, it is responsive 
to multiple ORD and HSR&D priority areas, including long-term care/aging, access to care, mental 
health/PTSD, and health equity, expanded Veteran/CG access to high quality clinical trials, and 
legislative priorities such as the MISSION Act, which emphasizes research on new models that 
support and benefit both Veterans and CGs and maximize the ability of Veterans to age in place.
4.
What research methods will be used in the project? (Check all that apply)
Surveys/Questionnaires
Interviews
Audio Taping 
Behavioral Observations
Chart Reviews
Video Taping 
Focus Groups
Randomization
Double-Blind
Control Group
Placebo
Withhold/Delay Treatment 
Specimen Collection
Deception
Other (Specify):
5.
Does the project involve usual care? Yes
     No
- If no, skip to question 6.
5.1. If yes, answer the following additional questions:
5.1.1.
Who will provide the usual care, i.e., the study team or the participant's
health care provider? With the exception of 1 phone call by a study CM, CGs’
l
(and Veterans’) health care provider (please see 5.1.2. below for details of usua
care)

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 6 of 51
APPROVED by CMCVAMC IRB on 12/27/2023
5.1.2. Clearly differentiate what is usual care and what procedures and/or 
interventions are being performed solely for research purposes. Indicate if 
usual care is limited to one arm of the study or if it is being delivered to all 
participants:
Research procedures: CGs randomized to the intervention arm will participate in the CG
SOS program. SOS care is a comprehensive approach to helping CGs gain the knowledge,
skills and confidence to achieve success in stress self-management. The intervention concept
was developed by Dr. Debra Lerner and her research group and adapted for the VA context.
Through a range of techniques, CGs develop abilities to modify psychological and social
sources of stress, including the stress associated with performing both caregiving and work
roles. SOS care is brief, telephonic care (6 one-hour sessions over 3-4 months) offered during
either work or non-work hours, and tailored to the CG’s needs, preferences, and priorities.
Supportive visual aids and CG workbook material are distributed via mail or email. SOS is
delivered by SOS-trained VA CMs; clinicians with a Master’s degree or higher in Social Work
or Psychology. SOS care is an opportunity for CGs to form an alliance with a VA healthcare
professional ready to meet their health and psychosocial needs, including concerns about CR
health and treatment.
Usual Care: CGs randomized to the usual care (UC) arm will be contacted
telephonically once by a Care Manager (CM). After a brief needs assessment, the CM will 
provide contact information for appropriate VA (e.g., local CSP clinicians) and non-VA 
community resources/services. CGs will be sent brochures for the national VA Caregiver 
Support Program (CSP). Information on both the program’s website (which includes links to 
training, education, resources, and outreach programs for CGs) and the national CG hotline 
number will be included in the mailed packet. Receipt of information regarding the VA CSP is 
consistent with the standard of care for informal CGs in the VHA since 2010.30 After this initial 
contact, CGs in this group will only be contacted again 4 and 9 months after baseline for 
administration of follow-up research assessments. CGs will be encouraged to seek medical,
addressed through seven modules (please see Appendix 2). In six sessions, the CM will cover
certain modules will become more or less important depending on a shared understanding of
implementing them. This process reflects theory and research pertaining to achieving self-
management behavior change and the psychosocial mechanisms of stress. Addressing both
Lerner, and Helstrom (Co-Is).
management plan. The process of care is supported by ongoing supervision with Drs. Adler,
Caregiver-Work Limitations Questionnaire (C-WLQ).22 The final session solidifies a self-
CMs assess CG progress every other session in a clinical interview using criteria from the
progress is monitored to identify strategies that effectively achieve self management goals.
context through problem-solving and self-monitoring, and motivational support. The CG’s
personal social supports, reducing barriers to managing stress at work and in the caregiving
behavior change strategies, approaches for strengthening and reinforcing workplace and
(including emotional and problem-focused coping), work, and CG role redesign and role
experiments to test these strategies (“homework”). Modules address cognitive-behavioral
dimensions. CMs introduce strategies for self-managing stress and collaboratively design
the work and caregiving contexts, CMs will educate CGs about stress and its biopsychosocial
formulating self-management goals and action plans and preparing CGs to succeed in
the CG’s preferences and self-management needs. SOS care involves an ongoing process of
each module at least once (more than one module can be covered per session), after which
skills. These pillars are built in a CG-centered and collaborative relationship. The pillars are
confidence and motivation to modify stress; and 5) work and CG-focused problem-solving
stress management skills and abilities; 3) supports and resources (VA and non-VA); 4)
The five pillars of behavior change in SOS care are: 1) knowledge of work and CG stress; 2)
SOS care addresses both work and caregiving stress. Each domain receives equal emphasis.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 7 of 51
APPROVED by CMCVAMC IRB on 12/27/2023
psychological, social support, and social services that are available to them through VAMCs or
any other non-VA/community source. CGs in the SOS group will be offered similar information.
6.
Does this project involve international research?  Yes
No
NOTE: International research does not include studies in which VA is only one of multiple participating 
sites where the overall study-wide PI is not a VA investigator.
7.
Does this project involve collaborative research?  Yes
- See below No 
7.1.
If yes, delineate which research activities will be conducted as the VA portion of the 
overall collaborative research study:
N/A
NOTE: Collaborative studies do not include studies conducted under a Cooperative Research and 
Development Agreement (CRADA) with pharmaceutical companies or other for-profit or non-
Federal partners.
SECTION 4: POTENTIAL RISK/BENEFIT ANALYSIS
1.
Indicate the potential risk level of the project: (Minimal Risk is defined as “the probability 
and magnitude of harm or discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily life or during the performance ofroutine 
physical or psychological examinations or tests.”)
Minimal
Greater than Minimal
NOTE: The IRB will make the final risk level determination.
2.
What are the potential risks or harms for participants in this project?
(List in bullet or number format)
NOTE: Risks or harms can be physical, psychological, financial, social, or legal. They may involve
breaches of confidentiality and privacy. Do not include the risks of usual care unless usual care
is part of the research interventions being performed.
3.
What are the anticipated benefits, if any, to participants or to society from this project?
(List in bullet or number format)
4.
Briefly describe the procedures for the orderly withdrawal or termination of subjects if this 
study involves any medical therapy. N/A 
5.
Will any of the following be administered to participants or will they be exposed?
YES
NO
Ionizing Radiation
Radioactive Materials
6.
Check one of the boxes below based on your study design and provide the references from 
the protocol for the information in the table:
Prospective Study
Retrospective Study
Both
NOTE: If retrospective is checked, some of the below categories may not apply and can be marked as
“Not applicable.”
experience.
2. Potential discomfort due to answering questions about psychological concerns or the caregiving
1. Potential breach of confidentiality;
2. Potential improvement in the quality of the Veterans’ care.
1. Potential improvement in CG well-being, stress management, and work functioning

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 8 of 51
Safety Issues
What Safety Information is 
Collected
How will Safety Information 
be collected
Frequency of Safety Data 
Collection
Safety Conditions that Trigger 
Immediate Suspension of 
Research
Procedures to notify 
participants or PCP of 
findings affecting 
participants’ health or welfare 
Procedures to minimize risk
Inclusion Criteria
Reference the protocol 
page and section.
p.8, Section 4, #7
p.8, Section 4, #7
p.8, Section 4, #7 
N/A
N/A
p. 4, Section 4, #1-4; p. 
31, Section 16,
#4.1.2
p. 34, Section 7, #7
If not referenced in the 
protocol, cite document 
type, page and section 
where it is referenced.
Exclusion Criteria
p. 34, Section 7, #7
7.
Will an independent Data Safety Monitoring Board (DSMB) or a Data Monitoring 
Committee (DMC) monitor the project?
Yes
    No
7.1.
If yes, provide a description of responsibilities to include frequency of meetings:
As part of HSR&D’s Just in Time process, we have been instructed to submit a Data 
Analysis Plan (DAP) in order to determine assignment to a DSMB (see Appendix 4 for DAP). 
Once we receive feedback and guidance from HSR&D, we will submit a protocol modification with 
greater detail regarding frequency of meetings, etc.
7.2.
If no, provide the protocol section and/or page where the data safety and monitoring 
plan is described, to include statistical tests to be used for analyzing the safety data to 
determine if harm is occurring.
8.
If the PI is not a clinician, is there an appropriately credentialed and privileged clinician 
who has been designated as a member of the study team to make required decisions to 
help protect the health of the subject, review data on adverse events, and report new 
findings?
Yes
    No
N/A
9.
How will you manage information from participating sites that might be relevant to 
participant protection and describe how that information will be conveyed to the IRB (i.e., 
reports of problems, interim results)?
Should there be any breaches of confidentiality, improper use or disclosure, or deviations to 
the protocol at either of the two study sites (i.e., CMCVAMC and the VISN 2 Center for Integrated 
Healthcare), the PI will report these incidents to the IRB, Associate Chief of Staff for Research, and 
Research Compliance Officer at the local site. All breaches of confidentiality will be immediately 
reported to the Information Security Officer and Privacy Officer. PHI extracted for the purposes of 
this project will under no circumstances leave the CMCVAMC or VINCI servers. In order to protect 
participants’ privacy and confidentiality, we will follow the Health Insurance Portability and 
Accountability Act of 1996 and its privacy regulations and all other applicable laws when handling 
participants’ data. Protocol deviations, serious adverse events, and breaches of confidentiality will 
be communicated to each site as required by their IRB guidelines. With respect to record retention, 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 8 of 51 
 
 
all research records will be retained until disposition instructions are approved by the National 

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 9 of 51
N/A
Archives and Records Administration and are published in VHA's Records Control Schedule (RCS
10-1). VHA Handbook 1200.05 §26.h. Until a schedule for local research records is published, all
records including identifiers will be retained.
SECTION 5: HUMAN PARTICIPANT INFORMATION
NOTE: A participant is considered “enrolled” at the time the consent is signed so this number should
include an allowance for screen failures prior to randomization.
1.
How many participant records will be reviewed PRIOR to enrollment/consent occurring?
4800 (this is a very conservative estimate; we anticipate that most of our sample will be referred
directly by clinicians and Caregiver Support Program coordinators; this number assumes
identification of patients by our VINCI query (which will then require us to identify their providers,
etc.))
2.
How many participants will be screened PRIOR to enrollment/consent occurring?
3.
How many participants will be enrolled (total number to include randomized and screen 
failures AFTER consent is obtained)?
3.1.
Will all research activity be the same at all sites? Yes
No
N/A
3.2.
If no, please describe the activity that is different or limited (For example; 2 sites will 
analyze data only, or, 1 site will consent and enroll all participants etc.):
4.
Are there any further screening procedures after enrollment? Yes
No 
4.1.
If yes, describe:
5.
Are non-Veterans being enrolled? NOTE: This does not include non-Veterans enrolled at
non-VA sites.
Yes
    No
5.1.
If yes, provide justification.
NOTE:
2400 (this takes into account presence/absence of a CG)
1200 (this takes into the account that roughly 50% of those approached from #2 above will
agree to screening)
N/A
The study is specifically designed to target caregivers of
Veterans with depression, anxiety, posttraumatic stress disorder, or traumatic brain injury.
Thus, non-Veterans must be enrolled.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page10 of 51
1.2. If yes, check one or both of the below boxes if they apply to this study:
1.2.1.
Information will be obtained through oral or written communication with the 
prospective subject or the subject’s LAR
1.2.2.
Identifiable information or biospecimens will be obtained by accessing records  
or stored identifiable biospecimens.
NOTE: If either or both of the above boxes is checked an informed consent waiver request does not
have to be submitted for this activity. However, a request for a HIPAA waiver will still need to be
submitted and informed consent obtained for any research interventions after eligibility is established. If
neither box was checked, this activity will need to be included in a request for an informed consent
waiver.
¾
Every non-Veteran should sign VA form 10-0483, Acknowledgement of the Notice 
of Privacy Practices (ANOP)
¾
Once the ANOP is signed, the research study staff must send the non-Veteran's 
name to the CMCVAMC Privacy Officer via encrypted e-mail. The signed ANOP 
must be kept in the research study binder.
¾
If an oral informed consent is used, the NOP should be sent to the non-Veteran 
via postal mail. In addition, the research study staff must write a Note-to-File that the 
NOP was sent to the non-Veteran.
6.
Does this project target a specific race, gender or ethnic group as participants? 
Yes
No 
6.1.
If yes, indicate which group and why this group is being targeted.
N/A
7.
What is the age range of participants? (Check all that apply.)
Neonates (See note below) 
Children Under 18 (See note 
below)
Young Adults (18-21)
Adults (22-65)
Seniors (Over 65)
NOTE: If neonates or children is checked, certification by the Medical Center Director will be 
required. Only minimal risk research may be performed with children. Only non-invasive monitoring
and/or prospective observational and retrospective record review studies that are minimal risk can
be conducted in VA involving neonates.
8.
Does the project involve the potential enrollment of any of the following populations or 
categories of participants? That is, are you targeting a specific group. NOTE: These
populations must be checked “Yes” if they are not being excluded from the research.
Yes
No
N/A
a. Employees
b. Students at the VA or Penn
c Individuals with impaired decision-making capacity
d. Pregnant women (See below)
e. Economically and/or educationally disadvantaged persons
f. Prisoners (See Below)
g. Illiterate, limited, or no English language proficiency
h. Terminally ill patients
i. Children (See Below)
Section 6: Informed Consent
No
- See below
Yes
authorized representative (LAR)?
1.1.If no, skip to question 2.
Will the study team obtain
information or
biospecimens for the purpose of 
screening, recruiting, or determining the eligibility of prospective subjects without the 
informed consent of the prospective subject or the prospective subject’s legally
1.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 11 of 51
Check all of the following that apply if Protected Health Information (PHI) will be used. If 
more than one box is checked, specify the part or phase of the study to which the 
specific checked boxes apply:
2.
Will the project involve requesting any waiver or alteration of the consent process or a 
waiver of documentation of consent for any part of the project? Yes 
- See below No 
2.1.If no, skip to question 3.
2.2. If yes, check one or more of the following boxes and submit the applicable waiver request(s).
An alteration of the informed consent process NOTE: If deception is involved this
box should be checked.
Waiver of informed consent for only a specific portion(s) of the study (not including
recruitment). Specify for what portion(s) of the study the request is being 
submitted:
This study will examine the impact of a psychoeducational and support 
intervention on caregiver outcomes; accordingly only caregivers will be consented
and enrolled. However, in order to utilize Veterans’ medical records for the 
purpose of identifying potentially eligible participants and recruitment, we are 
requesting a waiver of all elements of informed consent, including HIPAA. We 
also are requesting a waiver of informed consent/HIPAA in order to extract 
Veterans’ medical record data for research purposes. Without the waiver, we 
cannot verify the Veterans’ diagnoses or extract and analyze clinical data, as only 
their CGs are consented and enrolled. Moreover, without access to Veterans’ 
names, phone numbers, and addresses prior to their assent, we cannot contact
potentially eligible participants for the initial screening and assent process.
Waiver of documentation of informed consent. Specify for what portion(s) of the
study the request is being submitted:
Since this study/intervention takes place primarily via phone and mail, we also 
request a waiver of documentation of informed consent so we can obtain oral
consent for the convenience of the CGs and to expedite the enrollment process.
3.
Will documented informed consent be obtained from participants?
Yes
No 
3.1. If no, go to question 4.
3.1.1.
If yes, will there be the use of surrogate consent? Yes
No
3.1.2.
If yes and this is a repository study, will a broad consent be used?
Yes
No
NOTE: Reference the CMCVAMC IRB Form 104 template, Combined ICD/HIPAA Authorization, and
follow the instructions. If planning to obtain surrogate consent, check applicable state and local laws to
ensure compliance.
4.
Does the project involve photos, videos or voice recordings of a participant that are done 
for research purposes?
Yes
     No
4.1.
If yes, this must be covered in the informed consent document (ICD), information sheets, 
telephone screen scripts)
SECTION 7: HIPAA AUTHORIZATION FOR PROJECT PARTICIPANTS
1.
NOTE:   Written HIPAA Authorization signed by the individual to whom the information or record 
pertains is required when VA health care facilities need to utilize individually-identifiable health
information for a purpose other than treatment, payment, or health care operations, e.g., research. (VHA
Handbook 1605.1).

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Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 12 of 51
2.
Will the project require that participants authorize release of medical records or health
information from non-VA sites?
Yes
No
A project specific HIPAA Authorization is combined with the informed consent 
document.
A separate project specific participant HIPAA Authorization form (VA Form 10-0493) 
is attached. NOTE: This is highly recommended when enrolling individuals with
impaired decision making or with longitudinal studies requiring reconsent
A request for a HIPAA Waiver of Individual Authorization is attached to cover the 
entire study.
A request for a HIPAA Waiver of Individual Authorization for recruitment purposes 
only is attached.
A request for a HIPAA Waiver of Individual Authorization is attached to cover a 
portion of the study. Specify portion of study: In order to utilize Veterans’ 
medical records for the purpose of identifying potentially eligible participants and 
recruitment, we are requesting a waiver of all elements of informed consent, 
including HIPAA. We also are requesting a waiver of informed consent/HIPAA in 
order to extract Veterans’ medical record data for research purposes. Without the 
waiver, we cannot verify the Veterans’ diagnoses or extract and analyze clinical 
data, as only their CGs are consented and enrolled. Moreover, without access to 
Veterans’ names, phone numbers, and addresses prior to their assent, we cannot 
contact potentially eligible participants for the initial screening and assent
process.
SECTION 8: PARTICIPANT RECRUITMENT INFORMATION
1.
Describe the recruitment strategy for the just, fair, and equitable recruitment and selection of 
subjects, and reference recruitment procedures as cited in the protocol to include the 
following: Step-by-step how recruitment will take place, i.e., obtaining names from CPRS or other 
databases, use of recruitment letters, referrals, posters, phone calls etc., to
include any screening procedures prior to enrollment. Number steps or use bullets.
Guided by our prior IRB-approved intervention trials, there will be three recruitment strategies (we
will document and analyze the recruitment source of each potential participant):
1) The first strategy will involve direct referrals from clinical staff at the CMCVAMC and VA
Western New York Health System (VAWNYHS)
Prior to recruitment, study staff will meet with various CMCVAMC and VAWNYHS staff, 
including, for example, Caregiver Support Program (CSP) clinicians and clinical staff from local
Mental Health Clinics, Geriatric clinics, Home Based Primary Care, and theBehavioral Health
Laboratory (BHL). The BHL is the Primary Care- Mental Health Integration program at the
CMCVAMC and is responsible for triaging the majority of Veterans who are seeking mental
healthcare and provides clinical behavioral health assessments for referred Veterans. During 
these meetings, study staff will provide a brief overview of the project’s aims and procedures and
review study referral procedures. Study staff will document in an electronic database (stored on
the shared secure, password-protected MIRECC server) the names and phone numbers of 
individuals who have been referred by clinical staff.
2) The second strategy will involve placing IRB-approved advertisements targeted specifically at
employed CGs in patient waiting rooms in the
Mental Health Clinics. The advertisements will include a study phone number that potential
participants can call in order to learn more about the study.
3) Third, using data extracted from VINCI, we will prepare a list of Veterans who have appropriate
diagnoses and are receiving care at each of the sites (i.e., attended at least one appointment in
the past 6 months). The list will also include each Veteran’s respective provider. To facilitate 
referrals, each provider will receive a list of his or her patient names and will be asked to identify
any patients who may be eligible for the project, or for whom the provider believes that the CG
would benefit from the  SOS program. This recruitment strategy has been used successfully in our

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 13 of 51
past (and current) IRB-approved clinical trials at the VA, and our experience indicates that providers
typically support contact the majority of Veterans on the list.
CGs referred by the Caregiver Support Program coordinators or by self-referral will be contacted 
directly (in person or by phone) to assess interest in participating and to complete necessary 
informed consent procedures prior to screening.
NOTE: VA policy prohibits “cold calls” to potential VA research participants. Initial contact must be made in 
person or by letter prior to making any telephone contact, unless there is written documentation that the 
subject is willing to be contacted by phone about the specific study or the specific kind of research. The initial 
telephone contact must also provide a telephone number or other means for the potential participant to use 
to verify the study constitutes VA research (VHA Handbook 1200.05)
2.
Will the recruitment strategies described above be allowed to vary among sites?
Yes
No
    N/A
3.
Are any model recruitment materials going to be made available?
Yes
     No
3.1.
If yes, list all type of materials that will be used and indicate whether each type of material is 
being submitted with this application or whether it will be submitted later as an amendment. If 
there will be telephone contact during the recruitment process, a script must be 
provided and listed below.
Recruitment Material Type
Included with Application
Phone Script
Yes
No
Will submit an amendment
Recruitment letter
Yes
No
Will submit an amendment
Study brochure
Yes  X
No         Will submit an amendment
Additional rows can be added as required.
NOTE: All recruitment materials must be reviewed and approved by the IRB prior to use as part of any
recruitment activities. All recruitment materials must include a statement that the study involves VA
research and a telephone number or other means for the potential participant to use to verify that the 
study is VA research.
SECTION 9: PAYMENT TO PARTICIPANTS
1.
Will participants receive compensation in this study?
Yes
       No
(If no, skip this section and go to Section 10.)
NOTE: If applicable, the method (and relative amounts) of payment should be the same at all
participating sites whenever possible. Investigator will be asked to provide justification to the IRB for
differences in method and/or relative amounts.
2.
Indicate the preferred method and mode of payment as follows:
2.1.
What form of payment will be used, i.e., check, voucher, gift card?
Electronic payment through direct bank deposit or debit card.
Veterans/CGs referred to study staff through non-Caregiver Support Program provider referrals
will either be contacted directly (where appropriate) or will receive a
letter describing the study. Patients identified via VINCI also will receive a letter describing the 
study.     The letter will include a telephone number tocall, which can be used if they want more 
information or do not want to be contacted for recruitment. Within two weeks of receiving this 
letter, the Veteran/CG will be called by study staff to assess interest in participating. We will use 
a stepped process whereby we will first ask the Veteran for verbal assent to allow research staff 
to speak with his/her care partner (i.e., CG). The designated CG will then be contacted to 
assess interest in study participation.

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HRPP Accepted: 08/21/2019
Page 14 of 51
2.2.
What is the schedule of payments, i.e., one-time or after specific visits?
2.3.
Provide the total amount for entire participation
Enrolled CGs will receive $40 for their baseline data collection session and then $25 for
each of the two subsequent follow-up sessions (4M and 9M) for a total of $90 per
participant. CGs who complete the qualitative interview (n=30) will receive $35 at the 4M
follow-up (for a total of $100)
3.
Provide justification that the proposed payments are reasonable and commensurate with 
the expected contributions of the participant to the project:
Participation in the study assessments will take approximately 1-2 hours (depending on
whether CGs also complete the qualitative interview). The amount of payment proposed is
commensurate with the time and commitment required to complete the assessments, and is
comparable to that offered in our previous and current intervention work.
4.
Does the payment include transportation costs? Yes
No 
4.1.
If no, will transportation costs be paid separately? Yes
No 
4.2.
If yes, explain
5.
Specify the source of payment:
CMCVAMC
Other (specify):
6.
Will a social security number (SSN) be requested and/or used in making 
payment/compensation?  YesX No 
NOTE: If yes, be sure to include in the 'combined ICD/HIPAA' or the separate HIPAA authorization and
informed consent the name of the organization making payment.
SECTION 10: BIOLOGICAL SPECIMENS
1.
Will biological specimens be used in this protocol? Yes
No 
(If no, skip this section and go to the next.)
2.
List the specimens that are being collected and indicate the purpose of the collection (one 
or both boxes may be checked.)
Type of specimens
Research Use
Clinical Use
Additional rows may be added as required.
3.
Respond to the following questions by checking the appropriate box:
YES
NO
a. Does the project involve genetic testing? If yes, see below:
1) Does this include whole genome sequencing?
2) Will participants be informed of the results of any DNA
testing?
b. Will specimens be kept for future use in other studies? If
yes, see question 7 below.
c. Will samples be made anonymous to maintain 
confidentiality? NOTE: Coding data is not considered
making it anonymous.
d. Will specimens be destroyed after the project-specific use is
completed?
assessment.
After the baseline assessment, after the 4 month assessment, and after the 9 month

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 15 of 51
PI, RA, RC, Care Manager. It will
e. Will specimens be used for commercial profit? If yes, see 
below:
1) If yes, will participants share in this commercial profit?
f.
Will participants be informed of the results of the specimen 
testing?
g. Are there any implications for family members based on
specimen testing results? (If yes, the family members may 
be participants.)
4.
Will specimens be de-identified? Yes
No
4.1.
If yes, describe how the data will be de-identified, who will do it, and at what point in the 
process will the specimens be de-identified.
5.
What measures will be taken to minimize the potential for physical, psychological, 
financial, social, or legal harm from breaches of confidentiality and privacy resulting from 
unauthorized access to or loss of the specimens?
6.
Describe how the destruction of samples will be substantiated:
7.
If specimens are to be banked for future use in other studies, the following questions 
must be answered:
N/A
7.1.
Indicate where the specimens will be banked.
7.2.
If above is a VA location, what IRB is responsible for overseeing the operations of the 
tissue bank (i.e., local IRB or other multi-site IRB?).
NOTE: If the bank is located at CMCVAMC, a Standard Operations Procedures (SOP) manual is 
required. Contact one of the IRB Coordinators to obtain the SOP template.
SECTION 11: PRIVACY, CONFIDENTIALITY, AND INFORMATION SECURITY IN RESEARCH
1.
What type of data will be recorded/collected by the Principal Investigator study team?
Check all that apply:
De-identified – Data does not contain any identifiers that could link the data to a specific 
participant. (See VHA Handbook 1605.01, Appendix B, para 2b, for a list of identifiers that
must be removed before data can be considered de-identified. Data must be de-identified in
accordance with HIPAA and Common Rule criteria. Scrambling of names and social security
numbers is not considered de-identified information.)
   Identified – Data contains direct identifiers sufficient to identify participants as indicated in 
VHA Handbook 1605.01, Appendix B, para 2b. ALL HIPAA IDENTIFIERS INCLUDING
DATES.
   Coded – Data linked to a specific subject by a code rather than a direct identifier. While the 
data may contain some protected health information (PHI) only someone possessing the 
code can link the data to a particular participant.
1.1.
If coded data is checked, specify how the link or code will be maintained, and list each 
person/role who will have access to the link or code:
2.
Indicate how the PHI will be obtained by checking one or more of the boxes below:
  From existing sources such as medical records, clinical databases, or research 
records.
be maintained in a password protected file on the MIRECC server.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
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If the above box is checked, specify each source and who maintains the database:
Database Name
Who Maintains the Database
VINCI
Corporate Data Warehouse
CPRS
Additional rows may be added as required.
  Directly from project participants during protocol procedures as described elsewhere 
in this application or in the protocol.
3.
Check which of the following HIPAA identifiers will be collected and recorded during the 
course of the study:
Names
Social Security (or 
scrambled SSNs)/Medical
record numbers
Device identifiers and serial 
numbers
E-mail addresses
IP Addresses (Internet 
Protocol
URLs (Universal Resource 
Locator)
All elements of dates
(except year) and any age 
over 89
Health plan beneficiary 
numbers
All geographic subdivisions’ 
smaller than a state
Specify: Participant address
Specify:
Ages (may be
over 89); dates of Veteran
VHA appointments
Telephone numbers
Account numbers
Biometric Identifiers 
including finger and voice print
Fax numbers
Certificate or license
numbers
Full face photographic
images and comparable images
Vehicle ID and serial
numbers including license 
plate numbers
Other unique identifying 
number, characteristic, or code
HIV (testing or infectious 
disease) records
Specify:
Sickle Cell Anemia
Drug Abuse Information
Alcoholism or Alcohol Use
4.
Will a non-VA entity have access to VA sensitive data?
Yes
4.1.
If yes, specify each entity and identify their roles in the study:
- See below
No 
Name of Non-VA Entity
Role in Study
Additional rows may be added as required.
4.2.
If yes, will a copy of a Data Use Agreement (DUA) or a Cooperative Research and 
Development Agreement (CRADA) with this application? Yes
No
N/A 
NOTE: If no, a DUA or CRADA must be provided to the IRB for review prior to initiation 
of any research procedures.
5.
List the study team members by title who will have access to the data. (Specify 
approximate number of personnel and their job categories, e.g., 2 Co-investigators, 4 Nurse 
Coordinators, etc.)
6.
Will specially obtained software be used?
Yes
- See below
No
Research Assistants
1 Principal investigator; 3 Co-Investigators; 1 Care Manager; 1 Research Coordinator; 2

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 17 of 51
6.1.
If yes, describe the software, the source of the software, whether a license will be 
required and who will fund the license, as well was any data that will be stored in 
temporary files on the computer’s hard drive.
7.
Will any web-based applications be used?
Yes 
- See below No
7.1.
If yes, identify the application and its security features. Indicate how it will be used, e.g., 
for recruiting subjects, completing questionnaires, or processing data.
8.
How will electronic data and/or paper records be secured? If data is being stored on a 
computer hard drive, indicate if it is encrypted per VA guidelines.
9.
Will mobile devices be used in the study, i.e., laptops, audio recorders?  Yes
    No
9.1.
If yes, indicate that mobile devices will be encrypted and that the encryption is FIPS 140-
2 validated.
10.
How will data be transmitted and/or shipped, and how will it be protected during 
transmission or shipping?
11.
How will project research data be stored?
11.1. Indicate precisely where data will be stored to include physical site, network 
location/server name, type of mobile storage device, building and room number etc. 
Paper data – CHERP suite, Annex, Room 202; VAWNY CIH, Room 128-
8electronic data – MIRECC server
NOTE: If data will reside on a non-VA server or non-VA equipment, specify that the server is certified 
and accredited as required by the Federal Information Security Management Act of 2002 (FIMSA) and
that the required permissions for use of a non-VA server have been obtained. Contact the CMCVAMC
Information System Security Officer (ISSO) for more information.
Intranet and requires a log-in for each user. It will be used for completing questionnaires. 
We also will use Qualtrics for completing questionnaires/entering research assessment 
data.  Only coded data will be used in these applications (PHI will not be entered or 
stored).
REDCap; the VA approved web-based application can only be accessed on the VA
y
g
NOTE: Electronic research records should be stored/secured on the Research and 
Development server (Z drive), MIRECC server, PADRECC server or CHERP server.
in locked cabinets in the CHERP suite in the Annex, room 202 or at the Center for Integrated 
Healthcare (CIH); VA Western New York - Buffalo Bldg. 20, Rm 128-8.
in locked cabinets in the CHERP suite in the Annex room 202 or at the Center for Integrated
Electronic research records will be stored on the MIRECC server. Paper records will be secured
The recorder we use is encrypted and it is FIPS 140-2 validated.
N/A

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 18 of 51
11.2. If any of the 18 HIPAA identifiers (VA sensitive information) is being stored outside 
the protected VA environment, the following questions must be answered:
N/A
11.2.1. How are the data being protected?
11.2.2. Indicate what VA information will be returned to the VA, how the
information will be returned, and/or the plans for its eventual destruction 
at the alternate non-VA site.
11.2.3. Is there a Memorandum of Understanding (MOU) and/or a Data Use
Agreement (DUA) in place regarding the transfer and storage of the data 
outside the VA environment?
Yes
No
a) If yes, specify and/or attach agreement.
b) If no, indicate why not.
12.
How long will the research data be stored and describe how the data will be destroyed 
once the maximum retention period as specified by the VHA Records Control schedule or 
the indicated retention period, if longer, is met?

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
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With respect to record retention, all research records, including those with identifiers, will be
retained according to the current instructions and schedule set forth in VHA's Records Control
Schedule (RCS 10-1). VHA Handbook 1200.05 §26.h.
13.
What is the plan for protecting project research data from improper use or disclosure?
NOTE: As part of the response to this question, indicate that removal of access to research 
study data will be accomplished for study personnel when they are no longer part of the 
research team. Include that the ISO and Privacy Officer will be notified within one hour of the 
improper use or disclosure.
14.
Will a Certificate of Confidentiality (CoC) be obtained?
Yes
No 
14.1. If yes, include this information in the informed consent document (ICD).
NOTE: If this is a qualifying NIH Study, the CoC will be assumed. A CoC helps investigators protect
the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms
of sensitive research. Certificates protect against compulsory legal demands, such as court orders and
subpoenas, for identifying information or identifying characteristics of a research participant. For more
information on CoCs go to: http://grants.nih.gov/grants/policy/coc/.
15.
Will data be disclosed (copy given) outside of VHA?  Yes
No 
15.1. If yes, describe to whom the data are to be disclosed, the justification for such 
disclosure, and the authority for the disclosure, e.g., HIPAA authorization or VA Form 10-
5045, Request for and Authorization to Release Medical Records or Health Information.
16.
Will data be banked for re-use in future studies?
Yes
- See Below
No 
16.1. Where will the data be banked?
16.1.1.
Name of entity:
16.1.2.
Location:
16.2. Is this an existing data repository with appropriate oversight mechanism per VHA 
Handbook 1200.12 or, if a non-VA entity, are the appropriate safeguards addressed 
in the CRADA or DUA?  Yes
No
16.1.1.
If no, indicate for VA entities that approval will be sought from the local IRB 
where the repository will be housed, whether a separate study or amendment
Participant data will be coded and identifiable. Research databases containing clinical data will
be stripped of identifiers (e.g., name, address) and coded with numerical study IDs and merged
with the research assessment data. To protect confidentiality during the course of cleaning and
analyzing data, we will use this merged research database. To facilitate data tracking and
monitoring, the PI and her designee will maintain, under a limited password, a unique ID number
for each subject in the research database. This unique number will be used as the code that
links the research database to the original databases with PHI in the event that identification of
the individual patient is necessary. The lookup database linking the unique IDs and PHI will be
kept on the MIRECC server and routinely monitored by the PI. Access to research study data
.
will be immediately removed for study personnel who are no longer part of the research team
Should there be any breaches of confidentiality, improper use or disclosure, or deviations to the
protocol during this process, the Principal Investigator will report these incidents to the IRB,
Associate Chief of Staff for Research, and Research Compliance Officer, as appropriate. All
breaches of confidentiality will be immediately (i.e., within 1 hour) reported to the Information
Security Officer and Privacy Officer. In order to protect participants’ privacy and confidentiality,
we will follow the Health Insurance Portability and Accountability Act of 1996 and its privacy
regulations and all other applicable laws when handling participants’ data. Protocol deviations,
serious adverse events, and breaches of confidentiality will be communicated to the IRB as
required by their guidelines.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 19 of 51
SECTION 12: FDA-REGULATED AND OTHER PRODUCTS
1.
Does the project require use of drugs, biologics, supplements, or devices? 
Yes
No 
- If no, skip to Section 13
2.
Indicate the type of clinical trial if applicable?
Phase I
Phase II
Phase III
Phase IV
3.
Does the project involve an Investigational New Drug Application (IND) orInvestigational 
New Device Exemption (IDE), Abbreviated IDE, or IND Exception?
Yes
No
3.1.
If yes, attach a copy of any applicable correspondence with the FDA and complete the 
following:
3.2.
If applicable, indicate the name of the person or organization holding the IND or IDE.
3.3.
Is there a plan for onsite data monitoring?
Yes
No
3.3.1.
If yes, specify who will conduct monitoring responsibilities and how often.
4.
How will FDA-regulated products used in this study be dispensed and tracked to 
participating sites?
5.
If using FDA-regulated drugs or biologics, indicate use: N/A
Approved Drug(s) or Biologics For Approved Uses
Approved Drug(s) or Biologics for Unapproved Uses (Use will be 
inconsistent with product labeling or involves a new use, labeling, 
advertising change, or a change in dose, dosage form, administration
schedule, or recipient)
6.
List all drugs, biologics, or supplements to be used below. N/A
Generic Name
Trade Name
Manufacturer
Use Consistent 
with Product 
Labeling?
Yes/No
IND
Number if 
Applicable
Add additional rows to table if necessary
6.1.
Is an Investigator’s Brochure included with the application materials? Yes
No
6.1.1.
If no, indicate why?
6.2.
For all approved drugs used for an unapproved use, describe the unapproved use:
N/A
6.3.
If an IND is not required, explain and/or provide sponsor or FDA documentation:
N/A
7.
If using FDA-regulated devices, indicate use: N/A
Approved Device(s) for an Approved Use
Approved Device(s) for an Unapproved Use
Other (e.g., humanitarian use device; 510k clearance) Specify:
8.
List the FDA-regulated devices that will be used.
N/A
will be submitted to the IRB for review for creation of the data repository, OR for 
non-VA sites, whether the CRADA or DUA is still being negotiated.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 20 of 51
Name
Manufacturer
Use Consistent 
w/ Product 
Labeling?
Yes, No, or N/A
Significant Risk (SR) 
or Non-significant 
Risk (NSR),
Unknown, or N/A
IDE
Number if 
Applicable
8.1. Is manufacturer’s device information included with the application materials?  Yes
No
8.2. If this is a non-significant risk device study, is documentation attached with the application 
materials explaining the manufacturer’s or a sponsor’s determination why the device is not a 
Significant Risk (SR) device ? (See 21 CFR 812) Yes
No
8.3. If applying for an IDE, is a copy of the dated IDE application letter to the FDA attached?
Yes
No
N/A
SECTION 13: REQUEST FOR EXPEDITED REVIEW
Check if NOT requesting expedited review
1.
Check the below boxes as applicable for this study. All three boxes must be checked in 
order for the study to qualify for expedited review:
  The project presents no more than minimal risk to participants.
  The identification of participants or their responses will not reasonably place them at risk of 
criminal or civil liability or be damaging to their financial standing, employability, insurability, 
reputation, or be stigmatizing, unless reasonable and appropriate protections will be 
implemented so that risks related to invasion of privacy and breach of confidentiality are no 
greater than minimal.
   The project is not classified.
2.
If all three boxes are checked above, indicate one or more categories below for which this 
study would qualify for expedited review:
Category 1: Clinical studies of drugs and medical devices only when one of the following 
conditions is met.
1a: Research on drugs for which an investigational device exemption application (21 CFR 
Part 812) is not required.
1b: Research on medical devices for which:
(i)
an investigational device exemption application (21 CFR Part 812) is not 
required; or
(ii)
the medical device is cleared/approved for marketing and the medical device is 
being used in accordance with its cleared/approved labeling.
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as 
follows:
2a: From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, 
the amounts drawn may not exceed 550 ml in an 8-week period and collection may not 
occur more frequently than 2 times per week.
2b: From other adults and children, considering the age, weight, and health of the subjects, 
the collection procedure, the amount of blood to be collected, and the frequency with 
which it will be collected. For these subjects, the amount drawn may not exceed the

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 21 of 51
lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more 
frequently than 2 times per week.
Category 3: Prospective collection of biological specimens for research purposes by 
noninvasive means.
Category 4: Collection of data through noninvasive procedures (not involving general 
anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving 
x- rays or microwaves. Where medical devices are employed, they must be cleared/approved 
for marketing.
Category 5: Research involving materials (data, documents, records, or specimens) that have 
been collected, or will be collected solely for non-research purposes (such as medical treatment 
or diagnosis). This category also includes research involving materials that were previously 
collected for either non-research or research purposes, provided that any materials collected for 
research were not collected for the currently proposed research.
Category 6: Collection from voice, video, digital or image recordings made for research 
purposes.
  Category 7: Research on individual or group characteristics or behavior (including, but not 
limited to, research on perception, cognition, motivation, identity, language, communication, 
cultural beliefs or practices, and social behavior) or research employing survey, interview, oral 
history, focus group, program evaluation, human factors evaluation, or quality assurance 
methodologies.
If the project does not fit into one of the above categories, it does not qualify for expedited
review.

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 22 of 51 
 
 
SECTION 14: ABSTRACT 
1. Objectives(s): 
The objectives of this study are to, 1) determine the extent to which, relative to 
 
usual care, a novel intervention providing evidence-based, telephonic CG/work stress self- 
management counseling is related to changes in CG psychological distress and ability to function 
effectively in work and CG roles, and 2) evaluate whether participation in the intervention is related to  
CGs’ overall wellbeing and CRs’ health care utilization. 
 
2. Research Design: Randomized controlled, longitudinal trial 
 
3. Methodology: We will compare pre/post changes among 300 CGs allocated to the Caregiver SOS 
(for Self-Management of Stress) program or usual care. CGs who, 1) care for Veterans diagnosed 
with depression, anxiety, PTSD, and/or TBI and, 2) screen positive for clinically significant distress 
and CG/work role difficulty will be recruited to participate from two VA Medical Centers and their 
affiliated outpatient clinics. A novel intervention, Caregiver SOS includes 6, 1-hour telephonic 
sessions with a care manager. Usual care will consist of 1 telephonic session with a care manager. 
Primary and secondary outcomes will be pre-post change in CG distress and work functioning, 
respectively. Additional CG and CR outcomes (i.e., physical mental and interpersonal functioning) 
also will be measured and analyzed. CRs’ VA health utilization data will be extracted from clinical 
patient records and non-VA health utilization data will be collected via CG self-report. Intent to treat 
analysis using mixed effects models will be used to test the study hypotheses. We anticipate that 
CGs in the intervention arm will show significantly greater improvements in outcomes compared to 
those in usual care. 
 
4. Clinical relationships: 
N/A 
 
5. Impact/Significance: Approximately 5.5 million Veterans rely on CGs to help them with their daily 
care. CGs often cope with stress and strain from CG/work roles.  This may be particularly true of 
CGs of Veterans coping with behavioral health issues related to conditions such as depression, 
posttraumatic stress disorder (PTSD), anxiety, and traumatic brain injury (TBI). Programs that 
specifically address caregiving-work role stress may be especially effective in improving CGs’ 
wellbeing and work/financial stability and the quality of Veterans’ care. Given this project’s focus, it is 
responsive to multiple AORD and HSR&D priority areas, including long term care/aging, access to 
care, mental health/PTSD, and health equity, expanded Veteran/CG access to high quality clinical 
trials, and legislative priorities such as the MISSION Act, which emphasizes research on new models 
that support and benefit both Veterans and CGs and maximize the ability of Veterans to age in place. 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 23 of 51 
 
 
SECTION 15: LIST OF ABBREVIATIONS 
Provide a list of all abbreviations used in the protocol and their associated meanings. 
ADLs=activities of daily living 
ANCOVA=analysis of covariance 
BHL=Behavioral Health Laboratory 
BHP=behavioral health practitioner 
BTC=Behavioral Telehealth Center 
BVAMC=Buffalo VA Medical Center 
CARE=Caregiver Appreciation Recognition and Education 
CG=caregiver 
CHERP=Center for Health Equity Research and Promotion 
CI=confidence interval 
CIDER=Center for Information Dissemination and Education Resources 
CIH =Center for Integrated Healthcare 
CM=Care Manager 
CMCVAMC=Corporal Michael J. Crescenz VA Medical Center 
COE=Center of Excellence 
Co-I=Co-Investigator 
CR=care recipient 
CSP=Caregiver Support Program 
C-WLQ=Caregiver Work Limitations Questionnaire 
DSMB=Data and Safety Monitoring Board 
ES=effect size 
GAD-7=Generalized Anxiety Disorder-7 
GPS=Geographic Information System 
HERC= Health Economics Resource Center 
HIPAA=Health Insurance Portability and Accountability Act 
HSR&D=Health Services Research & Development 
IADLs=instrumental activities of daily living 
IMR=Illness Management and Recovery 
IRB=Institutional Review Board 
K10=Kessler Psychological Distress Scale 
MAR=missing at random 
MDES=minimum detectable effect size 
MH=mental health 
MIRECC=Mental Illness, Research, Education, and Clinical Center 
MISSION Act=Maintaining Systems and Strengthening Integrated Outside Networks Act 
NIOSH=National Institute for Occupational Safety and Health 
ORD=Office of Research and Development 
PC-MHI=Primary Care-Mental Health Integration 
PCP=primary care provider 
PHQ-9=Patient Health Questionnaire-9 
PI=Principal Investigator 
PROMIS=Patient-Reported Outcomes Measurement Information System 
PTSD=posttraumatic stress disorder 
QUERI=Quality Enhancement Research Initiative 
RAISE=Recognize, Assist, Include, Support, and Engage 
RCT=randomized controlled trial 
REDCap=Research Electronic Data Capture 
RRP=Rapid Response Project 
SAIL=Strategic Analytics for Improvement and Learning 
SD=standard deviation 
SDP=Service Directed Project 
SOS= Self-Management of Stress 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 24 of 51 
 
 
TBI=traumatic brain injury 
TBN=To be named 
US=United States 
VA=Veterans Affairs 
VAMC=Veterans Affairs Medical Center 
VAWNYHS=VA Western New York Health System 
VAWNYHS CIH=VA Western New York Health System Center for Integrated Healthcare 
VCAB=Veterans Community Advisory Board 
VEG=Veterans Empowerment Group 
VHA=Veterans Health Administration 
VINCI=VA Informatics and Computing Infrastructure 
VISN=Veterans Integrated Service Networks 
VR12=Veterans RAND 12-item Health Survey 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 25 of 51 
 
 
SECTION 16: PROTOCOL SUMMARY 
 
1. 
Introduction 
1.1. Provide scientific background and rationale for study. 
A. Caregiving and Workplace Stress – The Challenge of Balancing Multiple Roles: 
Stress is a significant public health problem for informal CGs, with added consequences for 
the health and well-being of CRs. Among the 44 million CGs who provide mainly unpaid 
assistance to an ill, disabled and/or aging relative, almost 40% suffer from severe, often chronic 
stress.1,2 Stress is assumed to be at least partly responsible for the higher rates of physical and 
mental morbidity1,10 and mortality risk observed for CGs compared to non-CGs.25 CGs also 
exhibit greater impairment in stress-related disease mechanisms such as weaker immune 
function and metabolic syndrome.10 CG stress also has been associated with poorer CR 
outcomes, including increased behavioral symptoms, institutionalization, morbidity, and 
mortality.1,27-29 
CG stress is partly explained by the objective burden of care (e.g, care hours and intensity of 
tasks), CG coping style and resources, and the availability of social supports.12,13 Research 
suggests that interactions with social contexts such as employment also contribute.2 Though 
generally, employed CGs have certain financial advantages over working-age CGs who are not 
employed, the negative effects of work on CG MH are partly explained by the fact that at least 
45% of employed CGs perform the same complex medical/nursing tasks as unemployed CGs 
(e.g., medication management).2,83 Further, while work may provide occasional respite from 
caregiving, many CGs go to work in stressful jobs: work is a leading source of stress in 
America.6,7 
By any measure, stress is a large problem for employed CGs. Either by choice or necessity, 
most CGs (60%) work; 56% full-time. For CGs under age 65, the employment rate is 68%. 
National CG surveys estimate that approximately 60% of employed CGs experience economic 
and psycho-social shocks that, in the parlance of stress research, represent major stressors.2 
These shocks include giving up work hours, taking unwanted leaves of absence, receiving 
warnings, giving up a job, turning down promotions, and/or losing job benefits. Workday 
interruptions occur regularly. Also, employed CGs bear higher burdens than employed non- 
caregivers including poorer health, more lost work time due to sickness,79 more absences due to 
caregiving, and more difficulty performing routine job tasks.23,46 These stressors can have 
repercussions for CG earnings and job satisfaction as well as for their CRs, and translate into 
higher employer and societal costs. 
Between potentially doing harm by continued exposure to high levels of stress or exiting the 
labor market and losing the rewards of working, employed CGs have few places to turn for help. 
Intervention research has been slow to respond to the needs of employed CGs,6,7 and there are 
few studies identifying the most effective means of supporting CGs who need and/or want to 
work.2,4,31,32 CGs assisting Veterans with behavioral health conditions, many of whom are post- 
9/11 military CRs, may especially benefit from work and CG focused stress intervention. These 
CGs are more likely to report depressive symptoms12 and more likely to stop working than other 
CGs.12,13 A comprehensive evaluation of the personal impact of participating in work and CG 
roles, and addressing stress through interventions that focus on adapting roles and contexts, are 
key steps towards improving CG outcomes.33-35 
B.  The Need for Multicomponent Interventions to Address Working Caregivers’ Needs 
Designing such interventions is challenging. Despite stress and their own chronic illnesses,1 
CGs frequently do not take care of their health and report high levels of health distress.2,36 Help- 
seeking requires time, energy, motivation, and resources, which often are in short supply. CGs 
report time constraints, conflicts with other roles and responsibilities (e.g., work), financial strain, 
failure to recognize stress as a health issue and limited social supports.1,2,11-13 
Two critical barriers hinder progress in developing and disseminating interventions for 
employed CGs. First, while evidence for CG-based interventions has improved,15,16,37 it remains 
fragmented, making it difficult to apply results. Many CG studies use highly restrictive eligibility 
criteria, and small convenience samples, and/or lack a realistic comparator or control.16,37,54 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 26 of 51 
 
 
Second, the focus, content, and outcomes considered in CG interventions rarely include stress 
due to employment or managing work and CG demands. 
However, two discrete areas of theory and research pertaining to the self-management of 
health and illness and the stress process offer conceptual pillars for developing interventions. 
Self-management conceptual frameworks18,40 mostly focus on supporting positive health behavior 
change for patients with long-term chronic illness, but they could be applied to conceptualizing 
the challenge to reduce CG stress. Generally in self-management frameworks, acquiring a new 
health behavior, such as managing stress, is a complex process involving steps to activate the 
person with the health problem, establish an alliance with healthcare providers, and address 
enabling and constraining factors at the level of the individual, healthcare system, social network 
and/or community.18,41 For example, according to Individual and Self-Management Theory,18 
health outcomes (distal outcomes) are regarded as the result of using appropriate self- 
management behavior (proximal outcomes). The degree to which behavior is adopted is related 
to contextual factors (the individual’s health, physical and social environment and family factors), 
and process factors, such as developing accurate health knowledge, confidence and beliefs, 
acquiring skills and abilities, and using social supports. Acquiring skills and abilities is a 
structured process of setting behavioral goals and developing action plans, managing emotional 
reactions to health challenges, and problem-solving to reduce individual and social barriers to 
change. In this and other models, the social context is regarded as a change barrier or enabler: 
as conditioning self-management behavior. In this study, we consider both caregiving and work 
roles and contexts to be stress risk factors partly modifiable through guided self-management 
behavior at the individual level. 
While self-management theory serves as a conceptual pillar for intervening, the stress 
process model provides a more detailed specification for an intervention’s content; it describes 
the nature of the health problem and modifiable targets.8,9 According to Folkman and Lazarus’s 
Transactional Model of Stress and Coping,8,17 stress occurs when coping is ineffective for 
confronting life events and experiences perceived as threatening or harmful (“stressors”). These 
perceptions (“primary cognitive appraisals”) evoke coping behaviors and secondary appraisals 
(reassessing threat and need for further coping), resulting in either adaptation or distress. Coping 
effectiveness is related to approach (e.g., problem-focused such as searching for a solution, or 
emotion-focused such as wishful thinking), resources, and social supports. Guided by this model, 
CG stress can be explained partly by exposure to social role demands of working and caregiving 
and constraints in the social contexts that overwhelm the CG’s capacity to cope, as well as the 
efficacy of available coping resources.19 According to Pearlin, CGs experience both primary 
objective stressors (e.g., severity of CR problematic behavior), and primary subjective stressors 
(CGs’ emotional reactions to or appraisals of the primary stressors), which accumulate and 
impact other life domains such as work, causing secondary stressors to emerge (e.g., caregiving- 
work conflict).19,31 The stress-inducing influence of multiple demands of caregiving and work are 
bidirectional, impacting each other.31,42 
Stress process models have been tested with positive results in various trials of support 
programs for CGs of patients with dementia,15,16,43,44 and a supportive online stress management 
nursing intervention for CGs of chronically ill elderly.45 No intervention has specifically sought to 
reduce CG distress by: 1) addressing work and caregiving as major sources of CG stress with the 
potential for cumulative and bi-directional effects; and 2) applying the model to CGs of individuals 
with behavioral health problems 
C. Conclusions and Conceptual Framework for the Current Study 
The proposed intervention, Caregiver SOS, is a novel program employing intervention 
principles guided by Individual and Self-Management Theory and the science of stress,8,9,17 which 
utilizes knowledge and techniques from an evidence-based telephonic care program for 
employees with depression.47,48,50 Caregiver SOS will be delivered by specially-trained CMs who, 
in a collaborative relationship with the participating CGs, will tailor the intervention to CG needs, 
preferences, work situation, and health status. They will provide knowledge and skills necessary 
to help CGs manage stress at work and at home, help CGs access and use appropriate VA and 
community services and resources, provide psycho-education about CR behavioral health 
problems, and teach strategies for coping with behavioral symptoms. We hypothesize that 

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 27 of 51
providing tailored, comprehensive care that includes psycho-education, support, and skills
training, via our brief, manualized, telephone-delivered Caregiver SOS program will reduce CGs’
distress, improve CGs’ work functioning, and result in positive changes in additional domains
(e.g., CGs’ well-being, CRs’ healthcare utilization).
1.2. Include summary of gaps in current knowledge, relevant data, and how the study
will add to existing knowledge.
Recognizing that family members play an essential part in supporting Veterans’ health and 
well-being, VA clinical practice guidelines encourage involving families and CGs in ensuring 
quality care outside of the medical care setting.  However, the guidelines and current 
configuration of services are insufficient. First, the guidelines promote providing general 
education and offer generic suggestions for engaging CGs in family interventions and are not 
targeted to employment issues.13,54 Second, many caregiving services and programs require the 
CG to be a primary family member to be eligible.13 Third, programs and interventions frequently 
are not evidence-based and, of those that are, most are designed for CGs of older Veterans with 
conditions such as dementia.13,16,54 Perhaps in response to these gaps, a recent QUERI review 
was commissioned to consolidate the evidence base for interventions that support CGs or 
families of Veterans with conditions such as TBI and PTSD, many of whom are post-9/11 CGs.54
Findings from the review cite the poor quality of many studies and clinically insignificant results. 
The research was characterized by design flaws such as testing interventions that are too diffuse 
in their focus, lacking in a theoretical foundation, and unclear with regard to the intervention target 
(i.e., CG or patient), and neglecting to include patient/CG-reported outcomes.54 Also, though 
many Veterans and their families report financial strain, few interventions attempt to improve the 
economic status or financial stability of CGs and, by extension, their CRs. These gaps have 
prompted calls for interventions that address financial issues and include relevant outcome 
measures.13,54,86 While stipend programs compensate for income loss due to caregiving, there are 
no interventions that focus on helping CGs stay productive at work and employed. Such 
programs could reduce the productivity loss and costs of caregiving that affect CGs and their 
families, employers, and the nation.
The proposed study will address many of the cited gaps, and accelerate progress towards 
achieving more cost-effective, coordinated, and focused services for CGs and Veterans. We 
include the work role and context as having a direct impact on stress and health. This innovative 
perspective is woven throughout the intervention protocol. The intervention techniques and 
principles have been refined over many years in other populations, and our preliminary research 
suggests it has promise for improving CG distress and functioning.47,48,50 Moreover, the study’s 
comprehensive, well-validated approach to measurement and analysis using CG-reported 
outcomes as well as its focus on CGs of Veterans with depression, PTSD, anxiety, or TBI, will 
help service providers and policymakers in their efforts to better support CGs, and by extension 
Veterans, at home, at work, and in the community.
1.3. Include rationale for including or excluding certain populations – in 
particular vulnerable populations.
2.
Objectives
2.1.
Describe the study’s purpose, specific aims, or objectives.
possibility, however, that the CG sample may include pregnant women.
prisoners, and institutionalized individuals, will not be included in the project. There is a
behavioral health issues. Special vulnerable populations, such as fetuses, neonates, children,
examines the impact of an intervention designed specifically for employed CGs of Veterans with
Non-Veterans are necessary for recruitment purposes by virtue of the fact that this study
telephonic work/CG stress self-management counseling, is superior to usual care (UC) in
Aim 1 is to determine whether this novel intervention, providing evidence-based
outcomes.
experiencing distress and work difficulty due to caregiving and improve CR health
Our goal is to enhance the well-being and functional performance of employed CGs

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 28 of 51 
 
 
reducing CG psychological distress (primary outcome; Aim 1a), and improving ability to 
function effectively in work and CG roles (secondary outcome; Aim 1b). 
 
Aim 2 (Exploratory) is to determine whether, relative to UC, the intervention improves
CGs’ overall physical health and mental well-being (Aim 2a), and CGs’ and CRs’ access 
to needed healthcare and social services (Aim 2b). 
 
2.2. 
State the hypotheses to be tested. 
 
Aim 1 Hypotheses: We hypothesize that, compared to CGs in UC, CGs in the 
intervention arm will have significantly less distress (Hyp. 1a), and a better ability to 
function effectively in their work and CG roles (Hyp. 1b). 
 
Aim 2 Hypotheses: We hypothesize that relative to those in UC, CGs assigned to the 
intervention arm will have higher levels of physical and emotional well-being (Exploratory 
Hyp. 2a). We also hypothesize that CGs/CRs in the intervention arm will report higher 
utilization of needed services (e.g., CR MH and primary care and CG-related services) 
(Exploratory Hyp. 2b). 
 
 
3. 
Resources and Personnel 
3.1. 
Include where and by whom the research will be conducted. 
 
Study procedures will take place at the CMCVAMC’s Mental Illness, Research, Education, and 
Clinical Center (MIRECC), VA HSR&D Center for Health Equity Research and Promotion (CHERP), and 
the VAWNYHS Center for Integrated Healthcare (CIH). All telephone-delivered components of the 
study (i.e., recruitment, screening, research assessments, care management calls) and completion of 
mailed/e-mailed CG assessment packets (in cases where CGs prefer to complete the packet 
themselves at home) will take place in the participants’ homes. The sample will be recruited from the 
CMCVAMC’s Primary Care-Mental Health Integration program (i.e., the Behavioral Health Laboratory 
(BHL)), both VA sites’ Mental Health Clinics and CSPs, and via VINCI. Tufts researchers will administer 
the SOS CM training and supervision procedures telephonically. Each site and team contribute to the 
overall feasibility of implementing the study; they have experience recruiting CG intervention study 
participants, a history of successful collaboration, and, in the CMCVAMC and VAWNYHS, the ability to 
provide a representative sample of Veterans with depression, anxiety, TBI, and/or PTSD and their CGs. 
Randomization group will be assigned by the PI, Research Coordinator, or Biostatistician. 
Screening, research assessments, and chart reviews will be conducted by the Research Assistants and 
Research Coordinator (and, where appropriate, Care Manager). Care management will be provided by 
Care Managers. Supervision will be provided by Drs. Amy Helstrom, Debra Lerner, and David Adler and 
Ms. VanTreese. Data collection and quality assurance activities will be conducted by the Research 
Assistants and Research Coordinator, PI, and Biostatistician, respectively. Data analyses will be 
conducted by the Biostatistician and PI. 
 
 
3.2. 
Provide a brief description of each individual’s role in the study. Be sure to indicate 
who will have access to protected health information and who will be involved in 
recruiting subjects; obtaining informed consent; administering survey/interview 
procedures; and performing data analysis. 
 
-Amy Helstrom, PhD: Principal Investigator; supervise and participate in all the proposed 
activities including staff training; data acquisition, management, and analysis; protocol 
modifications; staff supervision; manuscript preparation; dissemination of findings; training and 
weekly supervision of care managers, review data to monitor CM performance, provide expert 
consultation to the PI on specific quality improvement issues. 
 
. 
 
 
 
-Greg Beehler, PhD: Co Principal Investigator; supervise and participate in all the proposed 
activities including staff training; data acquisition, management, and analysis; protocol 
modifications; staff supervision; manuscript preparation; dissemination of findings; training 

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 29 of 51
and weekly supervision of care managers, review data to monitor CM performance, provide 
expert consultation to the PI on specific quality improvement issues.
Marybeth Groot, MS: : Research Coordinator; Recruit, screen, randomize, and track 
participants; conduct chart reviews, research assessments, data entry; under guidance of 
PI, manage data and help ensure data integrity
-Brenda Jeffries-Silmons, BA: Research Assistant; Recruit and screen participants; 
conduct chart reviews; collect, enter, and clean baseline and follow-up data; maintain 
study records
Catherine Westerduin, LCSW: Care Manager; provide care management; recruit/
consent participants (as needed)
Suzanne DiFilippo, RN:  Care Manager; provide care management/usual care
Marybeth Groot, MA: Research Coordinator; recruit and screen participants; conduct 
chart review, collect, enter and clean baseline and follow-up data; maintain study 
records
Of note: Drs. Lerner and Adler will not discuss PHI during supervision. 
3.3 If applicable provide information on any services that will be performed by 
contractors including what is being contracted out and with whom.
3.4 If applicable provide information on any Memoranda of Understandings (MOUs) or 
Data Use Agreements (DUAs) that are being entered into including with whom and for 
what reason.
4
Study Procedures
4.3
Study Design
4.3.1
Describe experimental design of the study. Include sequential and/or
parallel phases of the study, including durations, and explain which 
interventions are standard of care.
A. Overview
We will conduct a prospective, longitudinal, randomized control trial (RCT) with (n=300) CGs 
randomly assigned in equal proportion to the experimental CG SOS Program or a usual care 
(UC) arm. CGs will include employed, informal CGs of Veterans with depression, anxiety, PTSD, 
and/or TBI, who themselves screen positive for psychological distress and work performance 
limitations due to caregiving. CGs will be involved in providing regular assistance with IADLs.
Following referral, recruitment, consent, and screening, eligible CGs will be surveyed at pre-
intervention baseline, with post-intervention follow-ups at 4 and 9 months. Research data will be 
obtained from self-report telephone interviews using validated tools (with a mail/email version 
option) and chart-review of clinical patient record data from the VA Informatics and Computing 
Infrastructure (VINCI). SOS care managers (CMs) will provide the intervention telephonically.
Neither the SOS nor the UC group will be restricted in its use of VA or non-VA care. Our 
proposed study design and methods were chosen to minimize known weaknesses in the extant, 
primarily observational CG research.54 We use a pre/post randomized design, well-validated, CG-
reported measures to capture the primary and secondary outcomes of psychological distress 
(K10 Psychological Distress Scale) 20,21 and CG work functioning (the C-WLQ),22 rigorous 
eligibility criteria, and a realistic intervention approach reflecting CG input with a clear intervention 
goal.
-David Oslin, MD: Consultant; engage in dissemination of results                            
-David Oslin, MD: Consultant; engage in dissemination of results
-David Adler, MD:; Consultant; participate in dissemination; provide clinical supervision
David Adler MD:; Consultant; participate in dissemination; provide clinical supervision
intervention procedures; contribute to dissemination activities; provide clinical supervision
res; contribute to dissemination activities; provide clinical supervision
t ib t
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Consultant; supervise implementation; provide consultation of
intervention procedures; c
Cons
Cons
-Debra Lerner, PhD:
facilitate IRB recruitment activities/ Care Manager/Supervisor; provide clinical supervision to
the care manager; provide care management
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IRB
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-Katharine Vantreese, LCSW:; assist with oversight of the study RA;
N/A
N/A

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 30 of 51 
 
 
 
B. Study Procedures 
B.1 Screening, Baseline and 4 and 9 month Follow-up Research Assessment Procedures: 
Once the CG is identified (by self-referral, VA providers, or VINCI), indicates an interest in study 
participation, and consents (in-person or by phone), the RA will complete the initial screening 
and, if the CG is eligible, the baseline research assessment. Next, to ensure blinding of the RAs, 
the Project Coordinator will use a random number table to inform each CG of their group 
assignment. Procedures for the assigned study arm will commence (see B.2 and B.3). All CGs 
will be contacted again for 4- and 9-month follow-ups, at which point the majority of baseline 
assessments will be re-administered. Before each assessment, RAs will remind CGs not to 
disclose their assigned study arm. Data on care recipients' (CRs’) health and service utilization 
will be extracted from the CRs’ clinical record via VINCI, while CG VA and non-VA CG/CR health 
 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 31 of 51 
 
 
and service utilization will be captured by CG assessment. All research assessments (including 
follow-ups) will be completed by the RA by telephone (with an email/mail-in option, if preferred) 
and include validated questionnaires regarding CR- and CG-level sociodemographic, clinical, 
work- related, and psychosocial variables (Appendix 1; Table 1). In-depth qualitative interviews 
will be conducted at 4-month follow-up with a subgroup of CGs (n=30) from the SOS arm. 
These qualitative interviews will be audio recorded.  
B.2 Caregiver SOS Intervention Procedures: SOS care is a comprehensive approach to 
helping CGs gain the knowledge, skills and confidence to achieve success in stress self- 
management. The intervention concept was developed by Dr. Lerner and her research group and 
will be adapted for the VA context. Through a range of techniques, CGs develop abilities to 
modify psychological and social sources of stress, including the stress associated with performing 
both caregiving and work roles. SOS care is brief, telephonic care (6 one-hour sessions over 3-4 
months) offered during either work or non-work hours, and tailored to the CG’s needs, 
preferences, and priorities. Supportive visual aids and CG workbook material are distributed via 
mail or email. SOS is delivered by SOS-trained VA CMs; clinicians with a Master’s degree or 
higher in Social Work or Psychology. SOS care is an opportunity for CGs to form an alliance with 
a VA healthcare professional ready to meet their health and psychosocial needs, including 
concerns about CR health and treatment. 
SOS care addresses both work and caregiving stress. Each domain receives equal  
emphasis. The five pillars of behavior change in SOS care are: 1) knowledge of work and CG 
stress; 2) stress management skills and abilities; 3) supports and resources (VA and non-VA); 4) 
confidence and motivation to modify stress; and 5) work and CG-focused problem-solving skills. 
These pillars are built in a CG-centered and collaborative relationship. The pillars are addressed 
through seven modules (please see Appendix 2). In six sessions, the CM will cover each module 
at least once (more than one module can be covered per session), after which certain modules 
will become more or less important depending on a shared understanding of the CG’s 
preferences and self-management needs. SOS care involves an ongoing process of formulating 
self-management goals and action plans and preparing CGs to succeed in implementing them. 
This process reflects theory and research pertaining to achieving self-management behavior 
change and the psychosocial mechanisms of stress. Addressing both the work and caregiving 
contexts, CMs will educate CGs about stress and its biopsychosocial dimensions. CMs introduce 
strategies for self-managing stress and collaboratively design experiments to test these strategies 
(“homework”). Modules address cognitive-behavioral (including emotional and problem-focused 
coping), work, and CG role redesign and role behavior change strategies, approaches for 
strengthening and reinforcing workplace and personal social supports, reducing barriers to 
managing stress at work and in the caregiving context through problem-solving and self- 
monitoring, and motivational support. The CG’s progress is monitored to identify strategies that 
effectively achieve self management goals. CMs assess CG progress every other session in a 
clinical interview using criteria from the C-WLQ.22 The final session solidifies a self-management 
plan. The process of care is supported by ongoing supervision with Drs. Adler, Lerner, and 
Helstrom (Co-Is). 
B.3. UC Comparator Procedures: CGs in this arm will be contacted telephonically once by a 
CM. After a brief needs assessment, the CM will provide contact information for appropriate VA 
(e.g., local CSP clinicians) and non-VA community resources/services. CGs will be sent 
brochures for the national VA CSP. Information on both the program’s website (which includes 
links to training, education, resources, and outreach programs for CGs) and the national CG 
hotline number will be included in the e/mailed packet. Receipt of information regarding the VA 
CSP is consistent with the standard of care for informal CGs in the VHA since 2010.30 After this 
initial contact, CGs in this group will only be contacted again 4 and 9 months after baseline for 
administration of follow-up research assessments. CGs will be encouraged to seek medical, 
psychological, social support, and social services that are available to them through VAMCs or 
any other non-VA/community source. CGs in the SOS group will be offered similar information. 
B.4. Training and Supervision: The SOS care CM will have 16 hours of training (telephone 
and webinar) that will cover the study protocols, modules, assessment tools, care documentation 
and performance standards. Training will continue during team supervision sessions (telephone 

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 32 of 51
and webinar) and on an individual ad hoc basis (with Drs. Helstrom, Lerner, and Adler). 
Supervision sessions, held weekly, will involve review of specific cases.
Fidelity to the SOS protocols will be measured at the CG and CM level. At the CG-level, we 
will assess the extent to which the CG is adequately exposed to the intervention (i.e., intervention 
dose, which is the number of sessions completed).60 After each session, the CM will complete a 
session checklist, rating six coaching process items and seven content items, using a three-point 
rating scale (0=none, 1=some, 2=a great deal). The process items are: 1) identifying caregiving 
stressors; 2) identifying workplace stressors; 3) assigning homework; 4) reviewing homework; 5) 
reinforcing motivation; and 6) addressing problem-solving. The content items are: 1) building the 
knowledge base; 2) collaborative goal setting and action planning; 3) skill building in cognitive 
behavioral strategies; 4) skill building in CG/work role modification; 5) preparing for individual and 
social barriers to change; 6) linking to resources and social supports; and 7) problem-solving and 
self-monitoring. A total dose score on each content item will be calculated as the sum across all 
coaching sessions for each participant. In order to monitor and ensure the quality of the care 
management sessions and CMs’ fidelity to the model, 15% of the sessions will be randomly 
selected for audiotaping using a random number generator and reviewed. A fidelity checklist, 
which we have developed and used in our other intervention work, will be completed by raters 
(Drs. Helstrom and Mavandadi), analyzed, and used to provide feedback to the CM.
C. Assessment and Data Collection Procedures
C.1. Measures and Data Collection Timeline: Table 1 (Appendix 1) describes the proposed 
assessment tools and timing. These data will be collected by the RAs. As part of SOS care, the 
CM will administer and document results from a brief C-WLQ every other session. For purposes 
of tracking the care process, the CM will document each contact with CGs, referrals to 
VA/community service agencies, and each contact with Veterans’ PCPs/providers (when 
indicated) and results. Finally, in cases where CGs report needing assistance with the Veterans’ 
care, CMs will track whether concerns were discussed with the Veterans’ PCPs and whether 
recommendations were made or help was coordinated for scheduling in primary and specialty 
care. To complement the quantitative data analyses, we will use rapid qualitative content 
analysis to evaluate the intervention’s acceptability, appropriateness, and value of the content 
from the CGs’ perspective.
We propose to collect screening, baseline, intervention, and 4 and 9-month follow-up data in 
42 months. Study enrollment will be on a rolling basis, and participation in the SOS intervention 
will occur over the span of 3-4 months. Research assessments will take up to 60 minutes by 
phone. Qualitative interviews with the subset of CGs will take up to 30 minutes. CGs will be paid
$40 for the baseline and $25 for each follow-up research assessment ($90); this is similar to the 
amount of compensation provided to participants in our other studies.44 CGs completing 
qualitative interviews will get an additional $10 at the 4-month follow-up.
4.3.2
Include a description of how anticipated risk will be minimized and include 
an analysis of risk vs. potential benefit.
similar methods and assessments and has experienced very few issues. Our VISN 4 MIRECC
We would like to note that the study team has conducted a number of studies employing
or intervention sessions at any time.
uncomfortable with and that may choose to cease their participation in the research assessment
small, participants will be reminded that they do not need to answer any questions that they feel
caring for the CR may lead to some uncomfortable feelings. To minimize any risk, no matter how
that being asked questions about some psychological concerns and discussing feelings related to
and/or anxiety due to the time required to complete questionnaires. Finally, there is a small risk
procedures, we do not foresee any serious risks. There is a small risk of some inconvenience
psychosocial functioning. Thus, in light of the relatively non-invasive nature of the assessment
validated measures of sociodemographic variables, CR- and CG-characteristics, and
With respect to CGs’ participation, all assessment batteries include standardized, well-
purposes.
to the Veterans whose medical records are accessed and extracted for recruitment and research
There is minimal risk to CGs due to their participation in this study. There is also minimal risk

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 33 of 51
4.3.3
Provide description of the study population (delineate all categories 
of subjects – patients, providers, family members, employees, etc.).
Include anticipated enrollment numbers.
l 
s
4.3.4
As applicable, provide information on any added protections for 
vulnerable populations.
4.3.5 If applicable include information on data and specimen banking.
5
Recruitment Methods
5.3
State how many subjects will be needed.
5.4
Describe when, where, how and by whom potential subjects will be identified and 
recruited.
health coaching that the CM provides. Coaching employed CGs on various strategies to reduce
participation is judged to be acceptable.
In sum, the risks of study participation are minimal. Thus, the risk/benefit ratio of study
outcomes.
caregiving) may shed light on effective methods of improving work performance and psychosocial
stress and more effectively cope with demands from work and other social roles (including
from the self-management strategies, psychoeducation, community resource connection, and
assigned to the Caregiver SOS intervention arm, CGs (and, by extension, CRs) might benefit
There are no guaranteed benefits to participating in the proposed study. However, if
services they are entitled to.
CGs need not participate in this project in order for their Veteran CRs to continue receiving any
There are no alternative treatments and procedures to participating in the proposed research.
data and PHI. Thus, we do not anticipate this to pose a significant risk either.
Our team also has extensive experience with research studies that have used medical record
risk, every effort will be taken by study staff to ensure participants’ privacy and confidentiality.
associated with participating in this study is potential breach of confidentiality. To minimize this
Given the use of CGs’ self-report data and Veterans’ clinical patient records, the mainrisk
short, we do not anticipate the procedures will pose a significant risk.
intervention is rarely needed, but it is very important for staff to be prepared for the possibility. In
and can provide direct access to the VA suicide hotline. In our experience this level of
clinically significant symptoms while on the phone. We have the capacity to work with local police
interventions. As such, we have written guidelines for managing distress or expression of
and VAWNYHS CIH teams have extensive experience in conducting telephone-based
N/A
N/A
300 caregivers
We will enroll 300 employed, informal CGs of community-dwelling Veterans with a confirmed
diagnosis (per provider/self-report and verified upon medical chart review) or clinically significant 
symptoms of depression, PTSD,
anxiety, or TBI receiving care at the CMCVAMC, VAWNYHS, or affiliated CBOCs. Using a
definition adapted from the National Alliance for Caregiving,2,12 a current informal CG is a person
who regularly provides (or arranges for) help to a relative or significant other who is a Veteran
with one of the included conditions. To be eligible, CGs must endorse assisting the Veteran with
at least 2 IADLs (e.g., help with household chores, finances or personal, medical, or psychosocia
needs). The caregiving assistance must be provided on an unpaid basis (not as paid job). We wil
not exclude CGs who receive payments under VA programs or other health insurance plans.
Eligibility also requires CGs to work for pay outside of the home ≥10 hours per week, be 18 year
of age or older, score ≥6 on the Kessler-6 or 4 with a score of 2+ on the Perceived Stress 
Scale20,21 (indicating mild/moderate distress) and ˃3% on the C-WLQ.

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 34 of 51 
 
 
 
 
Recruitment will take place over the course of 2.75 years. Participants will be identified and 
recruited via direct referrals from providers at each site (e.g., providers from the Caregiver 
Support Program (CSP), Home Based Primary Care, and Geriatric and Mental Health Clinics), 
through direct mailings to potential participants identified via VINCI, or via self-referral. 
CGs referred by the Caregiver Support Program coordinators or by self-referral will be 
contacted directly (in person or by phone) to assess interest in participating and to complete 
necessary informed consent procedures prior to screening. The Behavioral Health Laboratory 
(BHL) health technicians may also refer to study staff after contacting Veterans for a behavioral 
health assessment if Veterans score 15 or more on the PHQ-9 or GAD-7, or score 31 or more 
on the PTSD Checklist (PTSD-C). Care managers/clinicians from the BHL/Primary Care-MH 
Integration program may also refer potentially eligible Veterans/CGs to study staff over the 
course of MH care management.Veterans/CGs referred to study staff by provider referrals or 
identified through VINCI will either be contacted directly (where appropriate) or will receive a 
letter describing the study . The letter will include a telephone number to call, which can be used 
if they want more information or do not want to be contacted for recruitment. Within two weeks 
of receiving this letter, the Veteran/CG will be called by study staff to assess interest in 
participating. We will use a stepped process whereby we will first ask the Veteran for verbal 
consent to allow research staff to speak with his/her care partner (i.e., CG) and access his/her 
medical record to collect research data. We will inform the Veteran that their CG will be told their 
diagnosis.  We will then document the Veteran’s assent  or dissent in the recruitment log. If the 
Veteran provides assent, the designated CG will then be contacted to assess interest in study 
participation.  If the CG is interested in enrolling him/herself in the study, informed consent 
procedures will commence.  
The research team also will participate in the Veterans Research Town Hall Philadelphia 
CHERP Veterans Community Advisory Board (VCAB) Platform. Members of the research team 
will participate in information sessions with veterans who are interested in learning about 
research being carried out at the CMCVAMC.  At the virtual breakout session, the research 
team will provide information about the research study and why it is being done.  They will 
answer questions about the study.  Because of confidentiality concerns, the research team will 
only provide a contact number that Veterans can use to contact the research team.  Veterans 
cannot directly provide their contact information. Approved posters and handouts will be 
distributed.  
 
5.5 
Describe materials that will be used to recruit subjects, e.g., advertisements. 
Include materials as an appendix or separate attachment 
Providers will be given an IRB-approved study brochure/flyer (either in person 
or via e-mail), and IRB-approved advertisements will also be placed in clinic 
waiting areas. Flyers will also be distributed to caregivers via e-mail.  Study 
introduction letters will be mailed. 
 
5.6 
Describe any payments to subjects, including the amount, timing (at the end of the 
study or pro-rated for partial study participation), method (e.g., cash, check, gift 
card), and whether subjects will experience a delay in receiving the payment. 
 
Enrolled CGs will receive $40 (by electronic deposit) for their baseline data collection 
session and 
then $25 for each of the two subsequent follow-up sessions (4M and 9M) for a total of $90 
per participant. CGs who complete the qualitative interview (n=30) will receive $35 at the 
4M follow-up (for a total of $100). 
 
6 
Informed Consent Procedures 
6.1 Indicate if informed consent will be obtained and/or if you are requesting a 
waiver of informed consent or waiver of documentation of informed consent. If 
the research involves multiple phases, specify for which phases of the research 
the waiver(s) is being requested and/or the informed consent will be sought. 
 

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 35 of 51
t
as a checklist to ensure each element of consent is covered. Interested CGs will be mailed a
enrolled in the study. The Research Coordinator/RA will be using an IRB approved script aswell
encouraging the asking of questions/concerns, the CG will be asked if s/he gives consent to 
and VAWNYHS. After telephone discussion of the information in the consent form, and
procedures comply with current standards of the Institutional Review Boards at the CMCVAMC
participation in this study will be obtained either in person or over the phone. Informed consent
for the convenience of the CGs and to expedite the enrollment process. CG consent for
study/intervention takes place primarily via phone and mail, we would like to obtain oral consen
We are also requesting a waiver of documentation of informed consent and HIPAA for 
screening and assent process.
addresses prior to their assent, we cannot contact potentially eligible participants for the initial
consented and enrolled. Moreover, without access to Veterans’ names, phone numbers, and
verify the Veterans’ diagnoses or extract and analyze clinical data, as only their CGs are
to extract Veterans’ medical record data for research purposes. Without the waiver, we cannot
Veterans, including HIPAA. We also are requesting a waiver of informed consent/HIPAA in order
participants and recruitment, we are requesting a waiver of all elements of informed consent for
In order to utilize Veterans’ medical records for the purpose of identifying potentially eligible

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 36 of 51
copy of the verbal informed consent script. CGs also will receive a Copy of Notice of Privacy
Practices, and acknowledgement of its receipt will be noted. In all cases, the investigators view
the process of informed consent as an ongoing process that continues throughout participation in
the study. 
The electronic ICF data will be kept separate fromany
coded, de-identified data. Following the consent and baseline process, CGs will be randomized 
to either usual care or Caregiver SOS using a random number table.
 
6.2
Describe who will be obtaining informed consent, if applicable, and any 
circumstances that may need to be addressed (e.g. subjects with impaired decision 
making ability and the use of a legally authorized representative, etc.)
6.3
If applicable, indicate how local site study personnel will be trained regarding 
human subjects' protections requirements and how to obtain and document 
informed consent.
7
Inclusion/Exclusion Criteria
7.1 Describe the criteria that determine who will be included in or excluded from 
the study.
Inclusion Criteria:
1. Veteran receives care at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC), 
VA Western New York Healthcare System (VAWNYHS), or affiliated community-based 
outpatient clinics
2. Veteran and CG are 18 years of age or older
3. Veteran and CG are community dwelling
4. Veteran has a confirmed diagnosis OR clinically significant symptoms of depressive 
disorder, generalized anxiety disorder, PTSD, and/or TBI (per medical chart).
5. CG is a relative or significant other who endorses that s/he assists the Veteran care recipient 
(CR) with two or more instrumental activities of daily living (IADLs). IADLS include: 
housework, managing finances, arranging/providing transportation (e.g., to medical 
appointments and community services), grocery shopping, preparing meals, health 
management and maintenance (e.g., giving medications, minimizing exposure and response 
to stress triggers), and arranging for and/or supervising the delivery of services for assistance 
with everyday activities.
6. CG is employed (i.e., works for pay ≥10 hours per week)
7. CG screens positive for at least mild-moderate distress (i.e., score >6 on the Kessler 
Psychological Distress 6-item Scale or a score >4 on the Kessler 6-item Scale and a 
score >2 on the Perceived Stress scale)
8. CG screens positive for at least moderate work role difficulty due to caregiving (i.e., ˃3% on 
the Caregiver Work Limitations Questionnaire)
9. CG is willing and able to provide informed consent.
Exclusion Criteria:
1. CG cognitive, hearing, visual, or other physical impairments leading to difficulty with informed 
consent process, assessment, or participation in intervention visits
2. CG unable to speak or read English
8.
Study Evaluations
8.1.
Describe all evaluations to be conducted (including screening; tests/questionnaires 
that will be administered; any procedures that subjects will be required to complete) 
and data collection methods. Include materials as an appendix or separate 
attachment.
The Research Coordinator and Research Assistants (and, if needed, Care Manager) will 
be obtaining informed consent.
Training; PI and Research Coordinator will train staff on consent procedures.
All study personnel will complete and remain current on CITI and VA Human Subjects

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 37 of 51 
 
 
 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 38 of 51 
 
 
We propose to use validated measures that capture multiple aspects of CR/CG psychosocial 
physical functioning. The survey tools have excellent psychometric properties and minimal response 
burden. Assessments were chosen to specifically capture CG-related factors that the intervention is 
designed to target or modify. Several measures were included to meet the Common Data Elements 
requirement (these measures are italicized in Table 1 (Appendix 1)) and from the Caregiving in the 
US 2015 Survey61 to facilitate comparison across studies. All data will be gathered and analyzed 
adhering to IRB and HIPAA requirements. 
Table 1 (Appendix 1) describes the proposed assessment tools and timing. We will use the 
validated, widely-used K10 as our global measure of psychological distress.20,21,35,70 
Psychological distress embodies negative emotions and feelings that one might experience when 
they cannot effectively cope with a stressor, and often occurs when perceived stress is 
prolonged, severe, or both.8,19 We determined that it is better suited as a primary outcome than 
CG burden, which is conceptually different from stress and distress (i.e., burden generally is a 
measure of tasks and subjective evaluations and specific to the caregiving role). Our secondary 
outcome measure, the C-WLQ, has been extensively validated and is sensitive to the intensity of 
caregiving demands and responsive to change.22,23 The measure includes 25 items capturing the 
extent to which caregiving has impacted work performance and productivity. Its four scale scores 
reflect the percentage of time (0% to 100%) in the past 4 weeks the CG was limited in performing 
time management, physical tasks, mental and interpersonal tasks, and output tasks. Item 
responses range from all of the time (5) to none of the time (1) with a “does not apply to my job” 
option. Scale scores are computed as the average of item scores within each scale and then 
converted to a score ranging from 0 to 100. These data will be collected by the RA. 
As part of SOS care, the CM will administer and document results from a brief C-WLQ every 
other session. For purposes of tracking the care process, the CM will document each contact 
with CGs, referrals to VA/community service agencies, and each contact with Veterans’ 
PCPs/providers (when indicated) and results. Finally, in cases where CGs report needing 
assistance with the Veterans’ care, CMs will track whether concerns were discussed with the 
Veterans’ PCPs and whether recommendations were made or help was coordinated for 
scheduling in primary and specialty care. 
To complement the quantitative data analyses, we will use rapid qualitative content analysis 
to evaluate the intervention’s acceptability, appropriateness, and value of the content from the 
CGs’ perspective. Rapid qualitative content analysis is a “telescoped”, action-oriented approach 
to consolidating and summarizing qualitative data.77 At the end of the first follow-up research visit 
(i.e., 4 months), 30 CGs will be purposively sampled on characteristics that can inform 
interpretation of results and future implementation efforts (i.e., CR condition, age) and asked 
semi-structured questions (e.g., which outcomes do they value most/least, positive/negative 
program experiences, what components they found most helpful, what they would change about 
the program, etc.) (see Appendix 3). After each interview (which will be conducted by the 
Research Coordinator), we will create a structured, summative memo (organized into summary 
matrices) that documents responses to a predetermined set of domains (e.g. positive/negative 
experiences, helpful components, recommendations, perceived value). Based on prior 
experience, each interview will take approximately 1 hour to review and summarize. Summaries 
will be compared across groups by Drs. Mavandadi andLerner, each of whom has experience 
with the use of qualitative methods and analyses in clinical trials. 
-Data Collection Technology and Tools: Most data will be collected by RA-administered 
telephone interview and entered electronically via a free, password-protected, web-based data 
collection system, VA REDCap. VA REDCap is supported by the VA Information Resource 
Center and is maintained within the VA firewall so that it is only accessible on the VA intranet. A 
blank copy of the assessment will be sent in advance of the scheduled assessment calls to help 
facilitate the interview. Alternatively, CGs will have the option of completing the measures on 
paper and returning via postal mail or email. CGs also will have the option of completing self-
report surveys via Qualtrics. During the baseline assessment, participants will be invited to 
provide an email address where surveys can be sent.  Qualtrics will generate no-reply reminder 
emails containing a link to complete the assessments.   Participants will be assigned a unique ID 
number; this ID number will be used to complete the Qualtrics survey and will link the 

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 39 of 51
participants’ Qualtrics responses to the lookup file (which will only be accessible to study staff 
and will have the code that matches this ID number to identifiable information (please see details 
in Section 12.2)).  The code will be kept secure in a password-protected electronic file in the 
study folder on the MIRECC server.  Data will be routinely downloaded from Qualtrics and saved 
in the secure study folder.  
CMs also will enter clinical data into VA REDCap and the Behavioral Health Laboratory (BHL) 
software. The BHL software is a VA approved and network-wide installed software package that 
allows providers to track participants and to graphically display assessment reports. The 
software has been in use for more than 10 years in the VA. All REDCap and BHL data collection, 
transfer, and storage of data will be performed on the VA Intranet and thus access to the system 
is user based and requires maintenance of all relevant employee trainings. CR and CG- related 
VA and non-VA healthcare and service utilization will be obtained using VINCI or by self- report. 
When estimating non-VA utilization of care, we plan to follow HERC’s guidebook which provides 
detailed documentation and suggestions for analyzing non-VA data on procedures.68 The 
utilization database will include a “time window” variable spanning one year prior to and one year 
following the final CM call. Extracting clinical patient record data electronically to the greatest
extent possible will improve validity and reduce respondent burden.  Detailed procedures will be 
followed to protect against potential risks to privacy and breaches of confidentiality.  
9.
Data Analysis
9.1.
Provide sample size determination and analysis (include anticipated rate of screen 
failures, study discontinuations, lost to follow-up etc.).
9.2.
Describe how, where and by whom the data will be analyzed.
All analyses will be run by the PI or Biostatistician.
Power, Sample Size, and Missing Data: As described above, the MDES is 0.235 SD for 5% 
significance tests and 80% power with a starting sample of 300. Questionnaires will be 
administered by RAs using software that encourages response and does not permit multiple or 
out-of-range responses, for which missing data rates of 1-3% are typical and are easily resolved 
with multiple imputation techniques. While non-VA care will be assessed by self-report, VA claims 
databases are complete by design. We will conduct attrition analyses to assess differences in CG 
characteristics between those with complete vs. incomplete data. If differences are found, 
covariates will be included in final adjusted models. We acknowledge that we may be 
underpowered to address sample heterogeneity and moderators of treatment effect. Thus, to 
maximize the interpretability and utility of our findings, in addition to the models described below, 
the central tendency, variation and potential trends over time will be evaluated using means, 
standard deviations, and 75%, 85%, and 95% confidence intervals (CIs) plotted across time for 
each condition.76 CIs will be interpreted with respect to clinically meaningful treatment group 
differences. Results from qualitative analyses also will be used to provide a context for treatment 
effects across potential moderators.
Preliminary Analyses: We will continually assess data quality and randomization success, 
testing for baseline group differences in key variables (e.g., gender, age, race/ethnicity, job 
flexibility, K10 and C-WLQ scores, and CR condition). If early analyses indicate group 
n
a
Exploratory analyses will be underpowered.
improvement of lost productivity due to caregiving burden (SD=4.4%), will yield a MDES of 1.0%.
differences. Similarly, for the secondary outcome measure (Aim 1b), a C-WLQ summary score
clinically meaningful treatment-control difference of 3 points is well within the range of detectable
difference of 2.35 points between treatment and control based on mixed effects models. A
a
1a) we expect a standard deviation for the K10 of about 10,58 suggesting that we could detect
the range of effect sizes found in other CG intervention studies.37 For the primary outcome (Aim
n
find a minimum detectable effect size (MDES) of 0.235 standard deviations (SD). This is withi
baseline and each of two follow-ups, 5% significance tests, and 80% power, we will be able to
maximum of 20% attrition from follow-up (final n=120/group), typical correlation of .70 between
Power calculations were computed for Aim 1 based on 300 consenting CGs. Estimating a

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 40 of 51 
 
 
differences, we will include the variables as covariates in the final adjusted models. We will 
review summary statistics (e.g., percentages, means and medians) to evaluate whether 
responses on the major variables (e.g., K10 distress score) are consistent with distributions 
obtained in other studies and psychometric performance is maintained (e.g., Cronbach’s alpha 
statistics). We will apply appropriate transformations to highly skewed continuous variables. All 
preliminary analyses will be conducted using SAS version 9.3 (SAS Institute, Cary, NC). 
Specific Aims 1 and 2-Assessing Randomization Group Differences in Outcomes: In order to 
analyze the degree to which randomization group is associated with changes in our primary (CG 
distress) and secondary (CG work functioning) outcomes over time (Hyp 1a and 1b), we will run 
separate intent-to-treat, mixed effects linear regression models (using SAS PROC MIXED). 
Mixed models account for multiple observations (baseline and follow-up) and make use of all 
available data for each CG (regardless of drop-out or missing assessment periods). Specifically, 
we will specify a mixed effects model Yt= β1T+ β2Z+ β3TF+ β4t + ε, where T is the indicator for 
treatment group (1 for SOS and 0 for UC), t=0, 1, 2 for baseline and the two follow-ups (F=1 for 
both), and Z is the vector for all other covariates and Yt is the outcome score measured at time t. 
We will specify CG distress (K10 score) and CG work functioning (C-WLQ score), respectively, 
as dependent variables to test Hyp 1a and 1b. The overall treatment effect (improvement from 
the baseline) will be measured by b3. For exploratory purposes, we will test for the treatment 
trajectory difference by expanding the mixed model to estimate TF interactions separately for each 
time point. 
To yield findings that will be used to inform future research and implementation endeavors, 
we will run exploratory analyses (using the analytic strategy outlined above) that address Aim 2. 
Overall CG physical and mental well-being and CR utilization of VA and non-VA services 
(including CG-related services), will be modeled as dependent variables. Given that we are 
underpowered for a full-scale quality of care analysis, we will compare summary statistics and 
estimates (with confidence intervals) across groups for descriptive purposes as opposed to 
formal statistical hypothesis testing. We will model group differences in CR service use (using 
negative binomial models and chi-squares) using count data of utilization/appointments from 
VINCI and CG self-report surveys (which will ask about CR non-VA healthcare use and CG use 
of VA/non-VA support services). Service utilization will be operationalized as the number (simple 
count) and occurrence of any (yes/no) outpatient visits and inpatient admissions/hospitalizations, 
and the total number of days hospitalized/bed days. Outpatient visits will be further classified 
based on the visit stop code into medical or surgical, psychiatric/substance use, social work, 
occupational therapy, other specialty care, and ER encounters. Inpatient hospitalizations will be 
further classified based on the primary diagnosis for admission into medical or 
psychiatric/substance use hospitalizations. For each participant, all utilization data will be 
summed and compared over two intervals (1 year pre-baseline and 1 year post-4 month 
assessment). Inpatient and outpatient utilization will be analyzed separately. We will also 
carefully examine specific domains of utilization where we expect to see an effect, such as MH, 
social work, and occupational health visits. While the differences may not be statistically 
significant, even clinically meaningful increases in service use by the Veteran and CG would be 
consistent with the VA mission of improving access to care. 
If the treatment is statistically significant in the appropriate direction, we will conduct 
exploratory treatment modification analyses (i.e., treatment heterogeneity), of the interaction term 
of β5 (fixed portion) and β6t (random portion). Again, we will base our interpretations on clinical 
meaningfulness of the effect size estimates and CI’s. We will also test if the treatment effect 
varies by the CR’s diagnosis, CG sociodemographics (e.g., CG gender, age, ethnicity), CG job 
type (flexible vs. inflexible) and CG occupational factors. We will conduct an exploratory dose- 
response analysis within the SOS care group. Finally, to further guide the interpretation of study 
results across subgroups of intervention participants and support future implementation efforts, 
we will also compare summaries derived from the rapid qualitative content analyses. 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 41 of 51 
 
 
 
10. 
Withdrawal of Subjects 
10.1. Describe any anticipated circumstances under which subjects will be withdrawn 
from the research without their consent. 
 
 
10.2. Describe the consequences of a subject's decision to withdraw from the research 
and the procedures for orderly termination of participation by the subject (e.g., the 
subject contacting the investigator for an end-of-study visit). 
Participants will be made aware that they may withdraw from this study at any time 
during the course of the research/care management assessments/visits without penalty or 
loss of VA or other benefits to which they are entitled. If a patient chooses to withdraw 
from the study, a note will be made in their study file. Since the caregivers are the 
participants, they are the ones who can request to withdraw from the study.   
 
 
11. 
Reporting 
11.1. Include procedures for reporting unanticipated problems, serious adverse events, 
and protocol deviations. 
All protocol deviations, breaches of confidentiality, adverse events or other problems will be 
 
identified and reported to the local site’s IRB, Privacy Officer, and/or Information Security Officer 
after discovery, as stipulated by regulations. All breaches of confidentiality will be immediately  
(within 1 hour) reported to the ISO and Privacy Officer. Non-serious adverse events and anticipated 
adverse events and problems will be logged and discussed in the routine supervision of research 
staff. The PI will initiate review of concerns arising from the ongoing review of non-serious and 
anticipated adverse events that appear to impact the study/risk ratio on an ad hoc basis. All serious 
adverse events and non-serious unexpected events will be reported to the PI and IRB in accordance 
with Good Clinical Practice Guidelines and IRB Regulations. Severe adverse events (SAEs) (e.g., 
hospitalization, death), will be reported to the PI within 24 hours and to the IRB within 48 hours. 
Unexpected adverse events will be reported to the IRB within 72 hours. Minor and anticipated 
adverse events and problems will be logged and reported in the annual/continuing review to the IRB. 
 
The Principal Investigator will be responsible for reviewing any adverse events or issues with the 
protection of subjects. Should there be a need for a clinical intervention, one of the clinicians on the 
study (Dr. Helstrom, Ms. VanTreese, Ms. DiFilippo, or Ms. Westerduin) will provide said intervention.   
 
12. 
Privacy and Confidentiality 
12.1. Describe whether the study will use or disclose subjects’ Protected Health 
Information (PHI). 
 
 
 
 
l 
 
 
12.2. Describe the steps that will be taken to secure the data (e.g., training, authorization 
of access, password protection, encryption, physical controls, Certificates of 
Confidentiality, and separation of identifiers and data) 
Procedures for protecting against or minimizing potential risks to participants’ privacy or 
confidentiality over the course of data collection, storage, management, and analysis will be 
guided by our past work with similar research methods and participants as those proposed here. 
Procedures include: 1. formal training sessions for all research staff emphasizing the importance 
of confidentiality; 2. specific procedures developed to protect CRs’/CGs’ confidentiality, and 3. 
formal mechanisms limiting access to information that can link data to individual respondents. 
During collection of research assessment data and care management calls we will ask CGs 
whether they are in a private, comfortable setting and if they are assured that their responses are 
N/A 
 
Veteran/CG PHI and identifiers (e.g., first, middle, last names; SSN’s; addresses and phone 
numbers; date of birth; age over 90 years; ID numbers/medical record numbers; and 
dates/procedural codes associated with health service utilization and pharmacy records) 
extracted from CPRS or VINCI will remain in the designated study folder on the MIRECC or 
VINCI secure servers. PHI will primarily be used for recruitment and tracking purposes. PHI will 
not be disclosed. 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 42 of 51 
 
 
not being monitored by another person. The data collection records and any collected PHI will 
remain confidential. Upon providing informed consent CGs will be assigned a random Study ID 
number/code, absent of any personal or identifying information. Hence, all research and clinical 
data used in analyses will be coded. In order to ensure participant privacy and confidentiality, 
this Study ID number will be used on all electronic research datasets, and in cases where CGs 
prefer to complete the research assessments at home, on data collection forms. All coded 
electronic dataset(s) will be located on a shared VA folder created on the MIRECC’s secure, 
password-protected server. Any hard copies of records that contain direct subject identifiers 
(e.g., name, assessment dates) will be stored in a separate locked filing cabinet in the CM’s 
office. Moreover, forms with identifiable information will be kept separate from de-identified data 
forms, which will only be labeled with the participants’ Study IDs. Only the PI and research staff 
will have access to these files, except in the case where the VA IRB and other federal regulatory 
agencies request access for auditing purposes. 
To further ensure Veterans’ and CGs’ privacy, the clinical databases that include Veteran/CG 
PHI and identifiers (e.g., first, middle, last names; SSN’s; addresses and phone numbers; date of 
birth; age over 90 years; ID numbers/medical record numbers; and dates/procedural codes 
associated with health service utilization and pharmacy records) extracted from CPRS or VINCI 
will remain in the designated study folder on the VINCI or MIRECC secure servers. However, at 
the point of conducting analyses, a separate research database will be created, de-identified of 
any personal or identifying information (i.e., all fields with PHI or identifiers will be removed), and 
kept in a separate password protected file on the shared VA folder created on the MIRECC  
server. We will merge this file with the self-report research and CM assessment data. To protect 
confidentiality during the course of coding, cleaning, and analyzing data, we will use these de- 
identified, merged research databases. The PI and Biostatistician will be responsible 
for analyzing the data, and all data entry and analysis will take place on the MIRECC server using 
the coded databases. To facilitate data tracking and monitoring, the PI and her designee will  
maintain, under a limited password, a lookup database that links the research database to the 
original clinical databases with PHI in the event that identification of the individual Veteran is  
necessary. The lookup database linking the study IDs and PHI will be kept on the designated  
study folder on the VINCI or MIRECC server and routinely monitored by the PI . 
 
Should there be any breaches of confidentiality, improper use or disclosure, or deviations to 
the protocol during this process, the PI will report these incidents to the IRB, Associate Chief of  
Staff for Research, and Research Compliance Officer at the local site. All breaches of  
confidentiality will be immediately reported to the Information Security Officer and Privacy Officer. 
PHI extracted for the purposes of this project will under no circumstances leave the CMCVAMC 
or VINCI servers. In order to protect participants’ privacy and confidentiality, we will follow the  
Health Insurance Portability and Accountability Act of 1996 and its privacy regulations and al l 
other applicable laws when handling participants’ data. 
 
 
13. 
Communication Plan for Multi-Site Studies or Studies being done at Non-CMCVAMC 
Locations 
N/A; skip to question 14 
13.1. Include plan for ensuring all required local site approvals are obtained and notifying 
the Director of any facility where the research in being conducted but the facility is 
not engaged. 
 
 
, 
 
 
13.2. Include plan for keeping all engaged sites informed of changes to the protocol, 
informed consent, and HIPAA authorization. 
We will discuss any changes to the protocol, IC, and HIPAA procedures during weekly 
meetings, and have all IRB documents shared on a shared VA server. This has been 
effective in managing and tracking procedures and changes across our two sites in past 
trials. 
This is a two-site study. We have conducted intervention trials in collaboration with the 
VAWNYHS CIH before (including a current two-site caregiver study). During weekly 
meetings, staff will discuss any IRB-related activities (approvals, modifications, reporting 
etc.) and discuss recruitment and enrollment numbers. 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 43 of 51 
 
 
 
13.3. Include plan for informing local sites of any Serious Adverse Events, Unanticipated 
Problems, or interim results that may impact conduct of the study. 
All serious adverse events and non-serious unexpected events will be reported to the PI 
and IRB in accordance with Good Clinical Practice Guidelines and IRB Regulations.  
Severe adverse events (SAEs) (e.g., hospitalization, death), will be reported to the PI  
within 24 hours and to the IRB within 48 hours. Unexpected adverse events will be 
reported to the IRB within 72 hours. Minor and anticipated adverse events and problems 
will be logged and reported in the annual/continuing review to the IRB. 
 
13.4. Include plan for ensuring the study is conducted according to the IRB-approved 
protocol. 
The PI and Research Coordinator will routinely evaluate and assess data quality and 
adherence to the IRB-approved protocol. Updates and issues will be discussed during 
weekly team meetings. 
 
 
13.5. Include plan for notifying all local facility directors and LSIs when a multi-site study 
reaches the point that it no longer requires engagement of the local facility (e.g., all 
subsequent follow-up of subjects will be performed by the PI from another facility). 
 
We will discuss updates and enrollment numbers during weekly calls. 

CMCVAMC IRB Form 101 
Philadelphia (642) 
HRPP Accepted: 08/21/2019 
Page 44 of 51 
 
 
14. 
References (bibliography of cited literature) 
 
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Page 45 of 51 
 
 
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HRPP Accepted: 08/21/2019 
Page 46 of 51 
 
 
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Page 47 of 51 
 
 
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CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 48 of 51
l
SECTION 17: KEYWORDS
(NOTE: Provide three (3) keywords. Use MeSH Headings only (Central Office Requirement).
Enter one item per line. http://www.nlm.nih.gov/mesh/MBrowser.html)
1.
2.
3.
SECTION 18: INSTITUTIONAL SUPPORT
(NOTE: If yes is marked next to any Service/Section listed below, you MUST obtain the signature of the
Service Chief or Designee of any Service/Section involved in research. OR, a letter/e-mail should be
provided to the investigator from the Service Chief or Designee of any Service/Section involved in this
research.)
Laboratory
Yes
No
Signature OR Letter/E-mail
Pharmacy
Yes
No
Signature OR Letter/E-mail
Nuclear Medicine
Yes
No
Signature OR Letter/E-mail
Psychiatry
Yes
No
Signature OR Letter/E-mail
Medicine
Yes
No
Signature OR Letter/E-mail
Radiology
Yes
No
Signature OR Letter/E-mail
Nursing
Yes
No
Signature OR Letter/E-mail
Outpatient
Yes
No
Signature OR Letter/E-mail
Union
Yes
No
Signature OR Letter/E-mail
Lab Space
Yes
No
Signature OR Letter/E-mail
Other, specify
Yes
No
Signature OR Letter/E-mail
SECTION 19: DATA MANAGEMENT AND ACCESS PLAN (DMAP)
NOTE: This Data Management and Access Plan (DMAP) should be used for Unfunded VA Research
or VA Research Funded by Entities Without a Specific DMAP.
84. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs:
combining elements of clinical effectiveness and implementation research to enhance public health
impact. Medical Care. 2012;50:217-26.
85. Schulze B, Rössler W. Caregiver burden in mental illness: Review of measurement, findingsand
interventions in 2004–2005. Curr Opinion in Psych. 2005;18:684-91.
86. Miller KE, Lindquist JH, Olsen MK, Smith V, Voils CI, Oddone EZ, Sperber NR, Shepherd-Banigan
M, Wieland GD, Henius J, Kabat M. Invisible partners in care: Snapshot of well-being among caregivers
receiving comprehensive support from Veterans Affairs. Health Sci Reports. 2019;2:e112.
87. Young AE, Roessler RT, Wasiak R, McPherson KM, van Poppel MN, Anema JR. A developmenta
conceptualization of return to work. J Occup Rehabil. 2005;15:557-68.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 49 of 51
IF THE FUNDING AGENCY HAS A DMAP, SUBMIT IT, INSTEAD OF THE BELOW.
Section 1 - Funding – (Check applicable box and indicate funding source if present.)
VHA Program Office without Specified DMAP Format
Name of Program Office:
External Funder without Specified DMAP Format
Name of Funder:
Unfunded
Not applicable; see separate DMAP from funding source
Section 2 - Public Access to Publications Resulting from the Research - (Check all applicable boxes.)
The proposed research is to be funded by VA. Publications resulting from the research will be 
made available to the public through the National Library of Medicine (NLM) PubMed Central 
website within one year after the date of publication. [Submission procedures are provided on the
Office of Research and Development (ORD) website at 
http://www.research.va.gov/resources/policies/public_access.cfm.
]
The proposed research will not be funded by VA.
Publications will be made available to the public through PubMed Central within one year after the 
date of publication. [See ORD website noted above.]
Publications will be made available to the public in another way. [Briefly describe plans below.]
Publications will not be made available to the public. [Provide a brief rationale below.]
Additional details related to plans for public access to publications results from the research, as 
indicated in section 2 above.
Section 3 - Public Access to Final Data Sets Underlying Publications Resulting from the Research -
(Check all applicable boxes.)
Final data sets underlying publications resulting from the proposed research will be shared 
outside VA in electronic format through the mechanism(s) indicated in Items #6 through #10 
below.
Final data sets underlying publications resulting from the proposed research will be shared outside 
VA ONLY in hard copy through the mechanism(s) indicated in Items #6 through #10 below. [Provide 
a brief rationale below].
Final data sets underlying publications resulting from the proposed research will not be shared
outside VA, except as required under the Freedom of Information Act (FOIA) [Provide the rationale 
below.]
Additional rationale(s) for plans to access data sets underlying publications, as indicated in 
Section 3 above.
Section 4 - Mechanisms for Public Access to Final Data Sets Underlying Publications Resulting from 
the Research – (Check all applicable boxes.)
As indicated in Item #5 above, final data sets underlying publications resulting from the 
proposed research will not be shared outside VA.
The project involves basic science research. Final data sets underlying publications resulting from
such research will be shared as described in the space below. [Describe mechanisms for sharing, 
e.g., upon request, through a databank or repository, via a website]
The research involves 
human subjects. Data 
sets based on information 
obtained from human 
subjects will be shared as 
Individually Identifiable Data will be shared pursuant to valid HIPAA 
Authorization, Informed Consent, and an appropriate written 
agreement
limiting use of the data to the conditions described in the authorization 
and consent.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 50 of 51
follows. Check 
appropriate box.
A Limited Dataset (LDS) will be created and shared pursuant to a 
Data Use Agreement (DUA) that indicates adherence to any applicable 
Informed Consent provisions, appropriately limits use of the dataset 
and prohibits the recipient from identifying or re-identifying (or taking 
steps to identify or re-identify) any individual whose data are included in 
the dataset. NOTE: An LDS does not necessarily imply de-identified
data per HIPAA.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 51 of 51
A De-identified, Anonymized Dataset will be created and shared. 
NOTE: ORO recommends that such sharing take place under a written 
agreement that adheres to any applicable Informed Consent provisions 
and prohibits the recipient from identifying or re-identifying (or taking 
steps to identify or re-identify) any individual whose data are included in 
the dataset. However, it is permissible for final datasets in machine-
readable format to be submitted to and accessed from PubMed Central 
(and similar sites) provided that care is taken to ensure that the
individuals cannot be re-identified using other publicly available 
information.
It is likely that requests for 
data from outside 
researchers (or other 
entities) may correspond 
to one or both of the 
following special 
conditions:
Individually Identifiable Data, excluding Veterans’ names and 
38 USC §7332-protected information, will be shared, pursuant to a
written request and IRB approved waiver of HIPAA authorization, with
the approval of the Under Secretary for Health, in accordance with VHA 
Handbook 1605.1 §13.b(1)(b) or §13.b(1)(c) or superseding versions of 
that Handbook. Note: Subject to all other listed requirements, Veterans’ 
names may be shared with other Federal agencies (38 USC §5701), 
and with non-Federal investigators who provide the names and
addresses of the individual subjects.
Individually Identifiable Data, including 38 USC 7332-protected 
information, will be shared, pursuant to the above requirements and a 
written assurance from the recipient that the information will be 
maintained in accordance with the security requirements of 38 CFR 
Part 1.466, or more stringent requirements, the information will not be 
re-disclosed except back to VA, and the information will not identify any 
individual patient in any report of the research or otherwise disclose
patient identities.
Additional details on mechanisms for sharing final data sets as indicated in Section 4 above.
Section 5 - Briefly summarize how, where, when, to whom, and the extent to which data resulting
from the research will be made available outside VA.
Section 5 answer:
Section 6 - Describe how and where data resulting from the research will be stored and maintained 
(e.g., data will be stored and maintained in a secure ORD data repository or resource; data will be 
stored on VA servers behind the VA firewall and backed up to a hard drive maintained and secured in
the investigator’s lab; etc.).
Section 6 answer:
Section 7 - Describe the mechanisms for ensuring the protection of personal privacy, the
confidentiality of individually identifiable information, and the security of proprietary data and 
information.
Section 7 answer:
Section 8 - Describe the scientific and/or public purposes for making the data available (i.e., howwill
scientists and/or the public benefit from making the data available) and explain how the data available 
for sharing will permit validation of results by the recipients (e.g., sufficient data and descriptors will be 
made available to confirm conclusions in the publication, duplicate statistical analysis, performadditional
analyses, etc.).
Section 8 answer:
Section 9 - Describe the mechanisms for ensuring the protection of personal privacy, the
confidentiality of individually identifiable information, and the security of proprietary data and 
information.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 52 of 51
Section 9 answer:
Section 10 - Describe the scientific and/or public purposes for making the data available (i.e., how 
will scientists and/or the public benefit from making the data available) and explain how the data 
available for sharing will permit validation of results by the recipients (e.g., sufficient data and
descriptors will be made available to confirm conclusions in the publication, duplicate statistical analysis, 
perform additional analyses, etc.).
Section 10 answer:
Section 11 - As Principal Investigator for the proposed research, I attest to the accuracy of the 
information provided above, and I understand that –
x Final data sets must be maintained locally in accordance with VA Records Control Schedule 10-1 
or until enterprise-level resources become available for long-term storage and access (unless 
otherwise required or permitted by the relevant VHA Program Office)
x Failure to implement this DMAP may result in restrictions to subsequent research activities
SECTION 21: ATTESTATION TO FOLLOW FEDERAL REGULATIONS
As the Principal Investigator for this project, I certify that I have read, understand, and accept 
the investigator responsibilities as outlined in VHA Handbook 1200.05, paragraph 5g and that 
these include but are not limited to the following:
x
Giving first priority to the protection of human subjects; upholding professional and ethical 
standards and practices; and adhering to all applicable VA and other Federal requirements, 
include IRB and the local VA Facility’s policies and procedures regarding the conduct of 
research and the protection of human subjects.
x
Ensuring all investigators and other staffs participating in this human subjects research are 
qualified; have the appropriate training, education, and experience to perform procedures 
assigned to them; and that they have been appropriately credentialed and privileged as 
applicable per current local facility and VA requirements.
x
Submitting all amendments to the project or changes in the informed consent to the IRB for 
review and approval prior to initiation, except when necessary to eliminate immediate hazard to 
the participants. Any changes implemented as a result of an immediate hazard will bepromptly 
reported to the IRB as a project deviation and an amendment submitted if determined 
necessary.
x
Obtaining and documenting legally effective informed consent of the subject or the subject’s 
legally authorized representative (LAR), as well as a HIPAA authorization, unless the IRB 
approves an applicable waiver.
x
Reporting problems, adverse events, and apparent serious or continuing noncompliance, 
including local research deaths, in accordance with VHA Handbook 1058.01, local VA Facility 
requirements, and IRB SOPs (to include the IRB Table of Reporting Requirements.)
x
Ensuring appropriate research records are maintained that includes all information made or 
received by a VA Investigator over the entire lifecycle of the research activity and that these 
records are maintained in accordance with the VA Records Control Schedule and local policies 
and procedures.

CMCVAMC IRB Form 101
Philadelphia (642)
HRPP Accepted: 08/21/2019
Page 53 of 51
x
Providing continuing review and/or requested updates for the study as applicable in a timely 
manner and in accordance with the VA and IRB policies and procedures. This includes 
submission of a closure reports for both local sites and the overall study upon completion. 
noncompliance.
x
Ensuring research does not start until final approval has been received from the IRB, and writte 
notification from the local Facility ACOS/R&D in accordance with local R&D Committee approval 
policies and procedures.
Signature or E-Signature of Principal Investigator, ONLY
Date Signed
12.13.19
SECTION 22: INSTITUTIONAL APPROVALS
Signature or E-Signature of Section Chief:
Date:
Signature or E-Signature of Service Chief:
DAVE W OSLIN
Digitally signed by DAVE W OSLIN
1416420
1416420
Date: 2019.12.11 18:31:27 -05'00'
Date:
Signature or E-Signature of Chief of Staff:
Date:
(Chief of Staff’s signature needed for ACOS investigators only.)
(I have read this proposal and find it in compliance with federal, state and local policies and 
regulations. I have read and deemed the scientific quality of this proposal to be adequate and the 
proposal has scientific relevance to both the VA’s mission and the facility’s researchprogram.
Resources necessary for the performance of this proposed study are available and adequate.)