Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health Care
Phase: NA
Conditions: PTSD, Depression, Substance Use Disorder, Traumatic Brain Injury
Sponsor: VA Office of Research and Development

Online and Shared Decision-Making 
Interventions to Engage Service Men and 
Women in Post-Deployment Mental 
Health Care
NCT03539068
December 16, 2022

GRANT NARRATIVE 
 
2.0 BACKGROUND 
Mental health conditions are prevalent in OEF/OIF/OND war Veterans but many do not 
seek care. OEF/OIF/OND Veterans experience complex mental health (MH) consequences 
of deployment(s). Almost a third (32%) of OEF/OIF Veterans in the VA have received a MH 
diagnosis; PTSD is the most prevalent condition, followed by substance abuse and then 
depression.1 OEF/OIF servicewomen have high levels of combat exposures, only slightly 
lower than men, yet gender differences of the impact of these stressors appear to be 
minimal.2-3 A RAND study of a community sample of OEF/OIF war Veterans found rates of 
MH disorders similar to VA populations, however, only half of OEF/OIF war Veterans 
meeting criteria for current PTSD or major depression had sought help from a provider for a 
MH problem in the past year.4 In a study of almost 50,000 Iraq/Afghanistan Veterans with 
newly diagnosed PTSD, only a minority (9.5%) received the recommended number and 
intensity of VA MH treatment sessions within the first year.5  
Barriers to seeking MH care are well-documented. Stigma and not being able to admit to 
having a problem or ask for help impede Veterans’ willingness to seek needed care.6 
Veterans who have not used VA services report not knowing what benefits are available to 
them or how to access them.7 Veterans who have used VA health care identify long waiting 
periods as one of the greatest barriers to accessing MH services.8 Care disparities may be 
further compounded for those who reside in rural locations.9 Recent era Veterans who wait 
longer to get outpatient MH treatment have been found to live geographically further from a 
VA and to be less likely to have improvement in their symptoms of PTSD compared to peers 
who live closer and seek care sooner.10 This is of particular concern given approximately 
41% of the Veteran population are rural residents and research indicates rural Veterans 
have lower MH-related quality of life.9 Our research on Veterans eligible for Choice 
(Veterans Access, Choice, and Accountability Act of 2014) because of distance barriers to 
VA care have found that few Veterans had closer access to Community MH Centers. The 
percent of Veterans living more than 40 miles from their nearest VA health facility who had 
access to a Community MH Center ranged from 3% to 34% across MyVA Regions.11 
Online health screening, education, and interventions are effective. There is a recent 
and growing precedent of using web-based interventions in high risk populations, including 
interventions that identify MH conditions (e.g., substance abuse, PTSD) and focus on 
behavior change to promote patient engagement in care.12 Research investigating online 
treatment of PTSD13 suggests that there may be greater follow through with internet-based 
approaches, which further supports the need for finding creative ways of safely extending 
education and services beyond traditional methods. The Department of Defense (DoD) 
provides online feedback to service members on topics ranging from assessments (e.g., 
post-deployment health) to educational resources (e.g., health promotion).  
Online health education and interventions are preferred. VA-enrolled OEF/OIF combat 
Veterans report a preference to seek readjustment services or information over the internet 
(53%) and virtually all (97%) have internet use.14 The majority of OEF/OIF Veterans are 
computer-literate, and many use the internet as a daily part of their lives.15 A recent study 

found that most Veterans with a MH diagnosis who are engaged in VA care had access to an 
internet capable device (cell phones and computer) and are interested in using technology for 
healthcare-related communications.16  
Informed patients have improved engagement, satisfaction, and outcomes. 
Information plays a critical role in helping patients become aware of their treatment needs, 
options, and effective self-care strategies.17 A lack of knowledge about PTSD, its causes, 
and available treatments have been identified as important barriers to help-seeking among 
Veterans.18 Conversely, considerable evidence suggests that patients who are better 
informed about their medical/MH conditions and treatment tend to have more favorable 
outcomes. For example, having adequate information about one’s medical condition is 
associated with better adherence to treatment recommendations.19 Patients who are 
better informed tend to be more satisfied with their care19 and experience reduced 
uncertainty and anxiety regarding treatment.19-20 Patient-provider communication patterns 
involving more information-sharing on the part of the provider have also been associated 
with greater patient satisfaction, knowledge, and adherence21 as well as better health 
outcomes.22 
Engaging patients in shared decision-making (SDM) improves MH care satisfaction 
and outcomes. SDM, considered the “pinnacle of patient-centered care,”23 involves 
clinicians and patients participating together in the decision-making process, discussing 
treatment preferences, and reaching agreement about treatment choice.24 Such a 
participatory care model of decision-making is a central theme of many evidence-based 
psychosocial MH treatments and a core component of the chronic care model.25 Improved 
health outcomes and patient satisfaction of MH consumers have been associated with 
SDM.26 Both men and women report improved patient satisfaction with SDM and MH care 
receipt.27 Furthermore, improved self-management of MH conditions has been found, e.g., 
greater follow-through with treatment plans, and improved therapeutic alliances with 
clinicians.28  
Implementation of SDM into routine clinical practice is needed. Currently personal 
health records (PHR) have little data about patients’ health preferences, with the exception 
of end of life decisions. Integration of SDM, as a part of Meaningful Use regulations, is 
gaining recognition as feasible and necessary.29 However, more work needs to be done to 
overcome difficulties implementing SDM into routine practice because of the time 
required, lack of explanation on using decision aids, and need for electronic medical 
record (EMR) inclusion.29 
Technology efficiently supports access to MH care and population health. There is 
growing evidence that eHealth tools have the capability to promote health and overcome 
stigma. MH care stigma frequently results in delays and suboptimal use of care.30 The 
Institute of Medicine (IOM) 2001 report, “Crossing the Quality Chasm,”31 notes that 
technology can reshape healthcare delivery and recommends that “access to care should 
be provided over the internet, by telephone, and by other means in addition to in person 
visits.” A web-interface for Veterans to screen for common post-deployment readjustment 
and MH conditions, at any time and any place, offers a substantial advantage to Veterans 
who are returning from war and who are unsure if their symptoms are treatable conditions 

or lack knowledge about VA services available to them. Enabling this priority population’s 
ability to confidentially screen, then enroll in VA and My HealtheVet (MHV), in order to 
communicate screening results to VA OEF/OIF/OND Transition Patient Advocates (TPA) or 
providers has great potential to address unmet need and recognized barriers to VA MH 
care.  
Existing VA technology can be leveraged to promote Veteran access to VA MH care. 
Within VHA, MHV (My HealtheVet Program Office) is an online PHR available to all 
Veterans. This PHR can 1) facilitate Veterans’ ability to maintain a comprehensive medical 
history in one place; 2) monitor and promote positive health behaviors; and 3) for those 
who enroll in VA and become MHV premium members, confidentially message VA 
providers or care managers to engage more actively in their own care. This PHR has the 
capability of improving engagement, safety, satisfaction, and health outcomes.32 PHRs 
also can provide patients with ownership of their health information so they can share it 
with multiple providers.33 Within VHA, only about 20% of Veterans receiving services are 
registered on MHV. While a majority of Veterans use the internet, only about a quarter of 
VA MH service users and a fifth of VA general service users access the MHV website for 
their personal health care.34 This slow adoption is similar to that in non-VA health care 
systems.32 It is encouraging that a qualitative study found that Veterans seeing their 
records positively affects communication with providers and the health system, enhances 
knowledge of their health and improved self-care, and allows for greater participation in 
their care and decision-making regarding when to seek care.35 Non-VA patients given 
access to a website allowing a shared medical record report high adoption and 
satisfaction.36  
VA is promoting VA provider adoption of MHV secure messaging. The 2014 MHV 
advance allowing secure messaging with providers offered a great opportunity to improve 
Veteran-provider communication.  In April 2016, VA began allowing staff to obtain 
workload credit, or increments of time, for MHV secure messages they complete and save 
into CPRS as progress notes. One study with VA providers found that those who attain 
workload benefits from secure messaging are more likely to adopt use.37 Secure 
messaging has been found to increase patient-provider communication and patient 
activation while at the same time reducing in-person visits and telephone contacts.16,38-39  
Technology can address the needs of vulnerable Veteran sub-populations. A recent 
literature review found that women who have experienced military sexual trauma (MST) 
experience high levels of organizational distrust, social isolation, and self-perceived 
stigma which create a significant barrier for participation in treatment and community 
reintegration. Authors concluded that the use of internet technologies show promise 
among MST survivors not only as therapeutic tools but also as effective outreach to identify 
and connect with those difficult to reach.40 The VHA Handbook (1330.01) indicates that VA 
women’s health care should be delivered in environments that attend to their dignity, 
safety, and privacy. For some, this environment might be their home as they begin their VA 
care journey. This work also has implications for males experiencing MST and other forms 
of trauma.  

The PI and her team have studied post-deployment readjustment and MH care access 
for the past seven years. Findings across five studies show participant age, VA enrollment, 
military characteristics, and MH screening results are similar for men and women, 
demonstrating generalizability and eligibility (Appendix 1).  
Study I: Most participants did not know their post-deployment symptoms were 
treatable psychiatric conditions. Phase 1 involving 18 focus groups with OEF/OIF service 
members (65 women/33 men) found most participants: 1) had received no information 
about VA eligibility or how to access VA services, and 2) frequently noted concerns with 
post-deployment adjustment, e.g., family re-adjustment. In the Phase 2 cross-sectional 
study, we found that among Reserve and National Guard (RNG) servicewomen (n=665), 
most chose not to seek care. Almost 80% did not use MH care in the past year despite 
psychiatric problems at rates consistent with other studies of post-deployment Veterans. 
This gap in receipt of care occurred despite women’s belief that MH counseling can help 
(82%) and that VA MH providers could better understand their problems (91%). 
Study II: Online interventions can be successfully implemented within VA and can 
decrease RNG servicewomen’s discomfort with seeking MH care.41 Dr. Sadler 
demonstrated feasibility of conducting online interventions behind the VA firewall. One-third 
(31%) of participants reported that the web-based screening and education (WEB-ED) 
reduced their reluctance to seek MH care. 
Study III: Servicewomen (82%) would like their WEB-ED screening results linked to a VA 
secure network (such as MHV) to facilitate VA provider access to the results, and 
would be more likely to ask questions or secure message a VA provider about their 
screens if available in MHV (77%). We found that of 214 RNG women returning from 
deployment to Iraq or Afghanistan, 83% screened positive on at least one screen, averaging 
three positive screens for MH conditions. Thus, WEB-ED is effectively reaching a high-risk 
population with substantial MH consequences from service. Only 16% of the total sample 
had received VA MH care following their most recent deployment, of which 16% was from a 
community facility.  
Study IV: Servicemen’s screening results were not significantly different from 
servicewomen’s with regard to MH complexity, post-deployment concerns, and care 
seeking. Co-Investigator Dr. Mengeling implemented WEB-ED with a Midwestern cohort of 
RNG OEF/OIF/OND servicemen (N= 200), finding that over half (57%) expressed concern 
about their post-deployment adjustment but < 20% sought MH care.  
Study V: Half of servicewomen participants indicated that as a direct result of WEB-ED, 
they will follow up with a provider. Women reported higher satisfaction and intent to 
seek needed PTSD treatment when they talked by telephone about WEB-ED results 
and engaged in SDM about treatment options with a MH nurse. Dr. Sadler’s current 
HSR&D CREATE study with active component and RNG post-deployed servicewomen 
(n=1,104) found WEB-ED outcomes remain consistent with prior findings of high-risk 
populations, but in a sample of increased diversity (38% non-white). Veterans continue to 
want a direct interface (e.g., MHV) to communicate their WEB-ED/SDM results to a VA 
provider to facilitate discussion. Using the Patient Activation Measure, we found that 
compared to PCL-5 PTSD+ women, PTSD- women were more likely to have high activation 

(“taking action”/“pushing further” (71% vs 40%). PTSD+ women were more likely to feel 
“disengaged & overwhelmed”/“aware but struggling” (60% vs 28%). This emphasizes 
the need for Veteran empowerment through information about their MH conditions, 
treatment options, and SDM.  
In summary, available literature combined with our extensive prior studies have set the 
stage for our proposed study, focused on using technology to increase Veterans’ access to 
and engagement in VA MH care and to promote a SDM interface between Veterans and VA 
practitioners. 
The Consolidated Framework for Implementation Research (CFIR) will be used to 
guide our study implementation, educational materials, training strategies, and 
outcomes analyses (Figure 1).42 CFIR serves as an excellent framework for our purposes 
as: (a) we propose to develop and test augmentations to enhance the perceived utility, 
adoption, and impact of our Enhanced WEB-ED (WEB-ED+) intervention; and (b) our 
approach is consistent with the recommended use of mixed methods focusing on both 
clinical effectiveness and implementation outcomes to speed the pace from intervention 
development/refinement to adoption and routine use in clinical or community settings.43 
For implementation of WEB-ED+, all five CFIR domains are included to guide our proposal, 
but we have tailored the constructs applicable to our work by domain to include: 1) 
Intervention focuses on refining and augmenting our current version of WEB-ED to build 
upon existing VA infrastructure (e.g., MHV) and including an electronic SDM component to 
support VA’s priorities of delivering patient-centered care. Key informant input will be 
solicited to guide refinement and enhancements for adaptability in VA care systems, and 
to elicit stakeholder perspectives of the relative advantage of WEB-ED+ over the current 
version; 2) Outer Setting allows us to determine patients’ perceptions of their need for VA 
care and preferences for engagement through VA eHealth and SDM interface to facilitate 
VA and MH engagement; 3) Inner Setting considers VA processes of care for engaging 
Veterans (whether enrolled or not enrolled in VA) in needed MH care as well as by 
supporting existing eHealth access and communication routes (i.e., enrollment, 
MyHealtheVet); 4) Individual Characteristics comprises determining characteristics of the 
key informants, i.e., provider knowledge and beliefs about MH needs and care (including 
SDM), and their sense of self-efficacy with using eHealth/SDM and patient activation to 
partner with their patients; and 5) the Implementation Process includes executing a 
randomized controlled trial (RCT) to engage key informants in planning, executing, and 
evaluating the impact of WEB-ED+ relative to existing WEB-ED measured by increased 
Veteran care engagement and satisfaction of key stakeholders. 
 
3.0 SIGNIFICANCE  
The Institute for Health Care Improvement notes that patients with complex needs 
encounter a “one size fits all” healthcare system that fails to take into account individuals’ 
goals for care. They propose new care rules that customize services to meet the needs and 
preferences of the patients and change the balance of power between providers and 
patients through the interface of SDM. Our prior research has confirmed that recent war 
Veterans want a health system that respects and values them, is convenient, provides 

information to help them understand and manage their post-deployment MH conditions, 
and connects them to caregivers and others in a way that is patient-centered, effective, 
and efficient, all of which has led to this proposal. This work supports VA efforts to move 
beyond traditional avenues to these new care rules in order to fulfill the organizational 
aims of Veteran engagement in their health care and other needed services (Appendix 2). 
Our proposed patient-centered intervention builds on our preceding studies by addressing 
Veterans’ preference for their unique MH screening results to be imported into MHV, 
thereby decreasing stigma, facilitating Veteran communication with VA providers, and 
seeking key informants’ input to promote system adoption. Prior research on transfer of 
important medical information from PHR using MHV found that Veterans required 
additional education and awareness to increase their ability to transfer medical 
information.33 MHV has the potential to enhance the capability of providers/TPAs to use 
screening and SDM results to comprehensively and efficiently engage and triage Veterans 
in needed MH care. MHV linkage broadens the implementation of WEB-ED to reduce 
barriers to both VA and non-VA enrolled war Veterans’ enrollment in MHV and VA. 
Furthermore, MHV has the potential to activate Veterans currently seen in VA primary care 
who screen positive for MH conditions and are symptomatic but not accessing VA MH care 
to help them and their families. Our proposed qualitative component will provide valuable 
insights about war Veterans’ perceptions of eHealth and SDM interfaces, as well as VHA 
MH services and barriers to engagement in needed care. It will improve our understanding 
of the most effective recruitment and educational approaches to engage and to empower 
Veterans to obtain the care they are entitled to and be active partners in their care. It is also 
critical to promote VA provider adoption of WEB-ED+ with an eHealth interface and SDM to 
facilitate patient engagement and have more efficient workflow processes. Our proposed 
WEB-ED+ interface is an innovative way to promote provider engagement in the patient-
centered care they wish to provide and in empowering Veterans to be care partners. This is 
vitally important for Veterans who have experienced a lack of power or control in traumatic 
exposures associated with their military service. Our proposed work is responsive to the 
Under Secretary’s Health Priorities for Strategic Action in striving to ensure Veterans 
have safe, high-quality, personalized, and timely care wherever they receive care. it is 
also consistent with and cross-cuts multiple current HSR&D priorities, including: A) 
healthcare access/rural health; B) healthcare equity/ health disparities; C) healthcare 
informatics (e.g., secure messaging) impact on patient care and on patient and clinician 
experiences); D) mental & behavioral health; E) women’s health; F) implementation 
science; G) patient-centered care; and H) health promotion. It also addresses HSR&D 
methods-oriented domains to engage Veterans, providers, and other stakeholders in 
research methods, outcomes, implementation, and scalability. Our proposed work is also 
responsive to Veteran and VA system needs in developing innovative tools and strategies 
for enhancing engagement of Veterans (Strategy 6 of the VA Blueprint for Excellence) and 
improving their access to care, which addresses MH conditions that afflict our Nation’s 
newest Veterans. It is also consistent with the goals of the VA’s MH recovery orientation 
to engage both male and female Veterans in more actively using VA MH care.  
4.0 RESEARCH DESIGN AND METHODS 

The goal of this proposed mixed-methods research is to facilitate male and female 
OEF/OIF/OND war Veterans’ engagement in needed VA MH care. To achieve this, we 
will increase the reach, adoption, and clinical impact of our online-intervention WEB-
ED by enhancing it with electronic MHV and VA enrollment as well as SDM interfaces, 
supported by our prior findings from studies with Veterans.  
 
Methods: To achieve our study 
aims, we will partner with the 
HSR&D Women’s Health 
Practice-Based Research 
Network (PBRN), leveraging their research infrastructure and research/clinical 
relationships already in place (see Frayne letter). This study will include three phases that 
correspond with each study aim (see figure above). In Phase 1 we will obtain CFIR-guided 
key informant feedback in order to a) refine our current WEB-ED online screening and SDM 
protocols, and b) conduct process mapping that documents current site-specific 
processes of engaging OEF/OIF/OND Veterans in VA and VA MH care as they currently exist.  
In Phase 2 we will conduct a randomized controlled trial (RCT) to test the effectiveness of 
“Enhanced” vs. “Current” WEB-ED in increasing Veteran engagement in VA MH care and a 
SDM interface with their providers. In Phase 3 we will use qualitative methods in a process 
evaluation to determine the acceptability of our WEB-ED+ intervention to RCT participants, 
their providers, and other key informants, identify facilitators and barriers to incorporating 
WEB-ED+ into the electronic medical record (EMR), and determine perceived differences in 
Veteran VA and MH care engagement based on feedback from WEB-ED+ participants and 
their providers.  
Specific Aim #1: To obtain key stakeholder perspectives regarding refinement of WEB-
ED, including enhancement with shared decision making (SDM) interventions, linkage 
with MyHealtheVet (MHV), and VA enrollment materials. 
Phase 1 (Aim 1): Key Informant Engagement: To address Aim 1, semi-structured 
interviews guided by CFIR will be conducted by Dr. Sadler to obtain key informant 
feedback on the WEB-ED+ content which will include: 1) MHV authentication and secure 
messaging directions; 2) online VA enrollment directions; and two educational SDM 
educational videos, one for Veterans and one for providers, regarding the benefits and 
process involved in SDM, respectively; and 3) patient activation scores and their 
relationship to SDM and care engagement. To complement the qualitative data, Dr. Sadler 
will engage with local stakeholders and champions at each facility in order to map clinical 
workflow processes (process 
mapping) at each of the five 
study sites and determine how to 
best integrate WEB-ED+ into 
existing workflows. Process 
mapping is a method used to 
create a diagram of clinical 
workflow to show sequential 
Phase/Aim 1
WEB-ED 
Enhancement
Phase/Aim 2
Randomized Controlled 
Trial (RCT)
Phase/Aim 3
Process 
Evaluation 

steps of a process.44-45 It also identifies the personnel who are directly involved in the 
process, as well as critical steps and potential bottlenecks, allowing the team to eliminate 
unnecessary steps in the process, and suggest potential solutions to barriers that are 
identified. Specifically, process mapping will document current site-specific processes of 
engaging OEF/OIF/OND Veterans in VA and VA MH care. Dr. Sadler and team will also 
identify key decision points along the way that determine how efficiently and effectively 
these Veterans access patient-centered MH care. Existing clinical workflow and time 
delays may result in an unintended consequence of attrition prior to MH care 
engagement for Veterans both entering and already within the VA. Thus, mapping a 
clinical workflow process allows all participants to visualize and come to agreement on the 
process, shows unexpected complexity where simplification may be possible, and serves 
as an aid to understand the complete process.44 Engagement in process mapping will also 
assist Dr. Sadler to obtain buy-in from key informants and to determine how to best 
integrate WEB-ED+ into existing workflows and real-world clinical demands. This 
information will further inform ways that WEB-ED+ could be optimally implemented to help 
facilitate patient-centered care both for those new to VA and those already enrolled. Quality 
implementation requires collaboration among multiple stakeholders46 (Appendix 3). On-site 
visit interviews allow our research team important insights about the localized nature of 
health care delivery and how this might impact refinement of WEB-ED+ and its potential 
adoption and reach.47 Individual interviews ensure greater likelihood of the participation of 
key informants at times that accommodate their schedules and equalizes the importance 
of information from each of them.48 Informants can view and evolve potential SDM and 
EMR templates and training materials in printed versions and via laptop computer to view 
You Tube video clip comparisons (described in Aim 2). 
Settings: Interviews with key informants (see figure) will take place at five sites (one site per 
each MyVA region): Region 1: Canandaigua VA Medical Center (NY); Region 2: Miami VA 
Healthcare System (FL); Region 3: Minneapolis VA Health Care System (HCS; MN); Region 
4: Central Texas Veterans HCS (Temple) (TX); and Region 5: VA Puget Sound (Seattle) (WA). 
Interviews will take place in private settings. Should key informants at each site identify 
other individuals whom they believe can provide valuable feedback related to 
accomplishing our objectives at their site, e.g., women’s MH champions, we will attempt 
to interview them as well (snowball sampling). The PBRN network as well as the number of 
providers at each site make their engagement feasible for this and subsequent study 
phases (Appendix 4). 
Participants: A total of 60 interviews (12 individuals at each of 5 sites) will be conducted. 
Key informant roles include: Primary Care-Mental Health Integration (PCMHI) providers 
(n=1-2), PC and/or MH providers (n=2), PCMHI or PC and MH case managers (n=1-2), MHV 
champion (n=1), Enrollment Specialists (n=1), OEF/OIF/OND Transition Patient Advocates 
(TPA) (n=1-2), and OEF/OIF/OND Veterans (n=4-5). An effort will be made to have a gender 
mix of key informants. VA personnel can be identified through VA national websites and 
our PBRN site leads. We will use site Veteran Panels to engage OEF/OIF/OND male and 
female war Veterans, when possible, as well as using our Veteran registry obtained VADIR 
to identify Veterans who are and are not currently VA engaged, respectively. VADIR is the 

VA group that interfaces with Defense Manpower Data Center to obtain sample 
characteristics of service members/Veterans, including postal and military e-mail 
addresses, and work/home telephone numbers. 
Data Collection: Prior to implementation of each study phase, Dr. Sadler and Dr. Cook 
(Medical Director, VISN 23 Mental Health Service Line) will brief VISN/MyVA as well as local 
VA leadership at each study site about this research and its potential local impact in order 
to engage their support and to facilitate success. They have done this previously for their 
current CREATE grant, resulting in highly positive VISN and local support. Notably, the 
recent MyVA Access- Mental Health Breakthrough Initiative (May 2016) has required that 
each VA has a memorandum of understanding with MH Operations to identify a standard 
point of entry to Veterans new to VA, with PCMHI being the preferred entry route if possible. 
Consequently, Dr. Cook will facilitate obtaining this information prior to engagement at 
each site in order to assist our selection of key informants. It is anticipated that most sites 
will have PCMHI as the initial point of access to triage, assess, and treat depending on the 
MH needs and wishes of the Veteran. Dr. Sadler will work closely with PBRN site leads to 
engage providers through established processes at each site, e.g., via champions, e-mail, 
meetings. Following IRB and local union approval, key informants will be recruited at each 
of the sites with the goal of obtaining their expert opinions. A semi-structured interview 
guide based on CFIR domains/constructs will be used to allow staff to talk freely about their 
knowledge and perceptions (Appendix 5). A separate, but consistent, interview script, also 
guided by CFIR, will be developed for Veterans. Veteran participants will be reimbursed 
$40 for their time. The interviews will be completed by experienced interviewers in Dr. 
Sadler’s CATI lab and digitally recorded when verbal consent is provided; manual notes will 
be taken for interviews where consent to record is not provided (which is rare in our 
experience). The CADRE Qualitative Team will complete verbatim transcription. 
Qualitative Analysis (Aims 1 and 3): CFIR will guide the key domains/constructs queried 
in Phases 1 and 3 with key informants and in Phase 3 with RCT participants and providers 
(see below). The initial analytic approach to the interview data will use the constant 
comparison method, whereby we use open coding to identify salient issues and concerns 
raised by the participants across all of the groups. These open codes will be examined by 
the investigators in order to develop themes that pertain to the majority of participants, 
with a focus on addressing the specific aims of the study (rather than all emergent 
themes). These themes will also be analyzed for their potential “fit” with the CFIR model, 
i.e., their relevance to the concepts of intervention, outer and inner setting, individual 
characteristics, and implementation process. Assuming that there will be some degree of 
fit between emergent themes and conceptual domains, each conceptual domain will be 
summarized with reference to its applicability to refinements to the intervention as well as 
overall implementation processes. MAXQDA v12, a qualitative data analysis software 
program, will be used to assist this process. The codebook will be developed initially by Dr. 
Sadler and Dr. Hamilton with subsequent co-investigator and qualitative team 
independent coding of transcripts. In Phase 3 this will be specific to RCT participation 
(WEB-ED+ versus WEB-ED). 

Specific Aim #2: To conduct a randomized controlled trial (RCT) to test differences in 
VA mental health (MH) care engagement in screen-positive male and female Veterans, 
comparing: 1) WEB-ED+ integrating secure messaging of screening results, SDM 
educational video clip, educational materials, and electronic medical record (EMR) 
SDM template vs. 2) Current WEB-ED. 
 
Phase 2 (Aim 2): Improving Access: RCT Comparing WEB-ED+ vs. Current WEB-ED 
Setting: WEB-ED+ will be implemented virtually from Iowa City to the catchment areas 
of 10 sites (two per MyVA regions); the 5 sites included in Phase 1 and 5 additional sites 
(1 per MyVA Region):  Region 1: Coatesville VA Medical Center (PA); Region 2: Ralph H. 
Johnson VA Medical Center (SC); Region 3: Edward Hines, Jr. VA Hospital (IL); Region 4: 
VA Salt Lake City Health Care System (UT); Region 5: VA Sierra Nevada Health Care 
System (NV). All listed sites are members of the WH PBRN. Note, these sites were 
selected because a national sample will allow for greater understanding of process 
differences across VA sites and promote generalizability of findings. In addition, these 
sites represent: 1) rural/highly rural and urban mix; 2) high density of Veterans deployed 
to Iraq and Afghanistan (VA-DoD Data Identification Repository VADIR communication); 
and 3) racial/ethnic diversity. This community sample includes both VA enrolled/users 
and non-VA Veterans who are eligible for and entitled to post-deployment VA care.  
Population: Our target population is OEF/OIF/OND male and female Veterans eligible for 
VA care, which we will randomly sample from two overlapping populations. The first group 
includes those who returned from deployment to Iraq or Afghanistan within the preceding 
four years and who reside within the catchment areas of one of our 10 study sites (identified 
by zip code). We want to ensure that those who participate and screen positive on one or 
more of the screens have access to VA care. Consequently, we have selected the time 
frame of four years post-deployment because these Veterans have priority access to VA 
care for five years after their most recent deployment. The second group is OEF/OIF/OND 
Veterans who are already enrolled in VA care and will not be excluded if they have been 
home from deployment more than four years. The VA Informatics and Computing 
Infrastructure (VINCI) provided exact numbers of OEF/OIF/OND Veterans seen at each of 
our 10 sites: ~238K (202K male/37K female). Overlap will potentially occur among those 
enrolled in VA care and home from deployment less than four years, therefore we will not 
stratify sample on this variable, but will take care that the same Veterans [name, sex, age, 
address] are not sampled twice. Our prior studies have found that approximately half of 
WEB-ED participants are already VA enrolled, although few have sought MH care. Among 
those who screened positive on WEB-ED, only 14% had received VA MH care prior to study 
participation. We do not anticipate any problems recruiting sufficient numbers for our 
sample as less than 1% of VA users would need to participate to reach our recruitment 
goals. However, if we need to enhance our recruitment efforts, we will do so by adding 
additional PBRN-affiliated sites 
Sample Identification and Recruitment: We will work with VADIR to obtain contact 
information and military characteristics for OEF/OIF/OND service members. VADIR is 
able to provide mailing, phone, and military addresses as well as sociodemographic (e.g., 

age) and service information (e.g., rank, number of deployments). We have used VADIR 
military and sociodemographic data to augment our primary data collections, reduce 
participant burden, and analyze differences between responders and non-responders. 
VADIR and Dr. Sadler have a successful working relationship for her current CREATE and 
three prior grants. We will also work with VA enrollment data and the VA OEF/OIF/OND 
roster to obtain similar data identifying post-deployed Veterans who have VA care access. 
We have learned from our prior grants that study participation is maximized when 
potential participants are postal mailed a study packet (study materials, informed 
consent document, the web-based study link, and notification that we will also be 
sending an email in the next few days) and then contacted by email. Non-responders will 
be re-contacted in 10 days following initial mailing. Our previous work has found that 
response rates, screening outcomes, and care activation are similar between male and 
female participants in studies focused specifically to either gender. We will institute 
adaptive randomized sampling to insure that neither male or female participants are less 
than 25% of the total sample. 
Current WEB-ED screening (Appendices 6-12): All study participants will be asked to 
complete the online survey and screenings and be provided with their results, tailored 
educational information, and key points of contact at the VA geographically closest to 
them (i.e., Current WEB-ED). Pharos Innovations has provided this online interface for all 
of Dr. Sadler’s prior online studies and will for this proposed research if funded. 
Documentation of informed consent for Phase 2 participation (WEB-ED) is integrated into 
the web-based interface (“click approval”). Participants receive a hardcopy version of the 
consent form in the study packet and can read a copy online. This process has been 
approved in five prior projects using WEB-ED. The consent document will also inform 
participants that they may be invited to participate in the subsequent study phase that 
addresses VA and post-deployment care access. WEB-ED includes a brief pre-
intervention survey that will query stigma associated with MH care, prior and current 
utilization (VA and non-VA; primary care, MH, emergency) and their reasons for accessing 
VA or not, knowledge about post-deployment VA eligibility, services and satisfaction with 
VA care, potential barriers to MH service use, and their use of or barriers to MHV and 
secure messaging. Those who meet screening criteria for MH conditions and readjustment 
concerns receive online notification and a recommendation for a face-to-face evaluation, 
education about each MH domain for which there is a positive screen, and information 
about access to care. Patients who may have immediate needs will also be provided with 
specific VA resources, contact names and numbers, as well as information for providers or 
resources unique to their needs and geographic locations. The 24 hour Veterans Crisis Line 
(1-800-273-TALK (8255)) will be provided. Patients with negative screens will be informed 
to seek care if they believe that it is needed. We note that neither our research team’s 
studies using focus groups and telephone interviews with more intensive questions about 
sexual assault or combat experiences in deployed populations, nor our prior web-based 
intervention studies, have resulted in any subsequent clinical emergencies. Veterans who 
have no positive screens will be able to access the same educational information, web 
links, and video-clips if they choose. Data security: Study data and linkage study ID 
number will be maintained in a locked and limited access research network electronic file 

behind the VA firewall. Screens will include the following (those that are mandatory VA 
screens currently used in face-to face contact with patients are bolded): 
MH and Trauma Exposure Screens:  
1. PTSD - VA Post-Traumatic Stress Disorder (PTSD) Screen.   
2. Domestic Violence (DV) - American College of Obstetrician and Gynecologist screen 
for DV. This was modified to include parallel questions that query participant DV 
perpetration.  
3. Family Readjustment- developed from PI’s focus groups from another HSR&D funded 
study.  
4. Substance Abuse - AUDIT-C Substance Abuse Screen.  
5. Prescription Drug Abuse- DoD Survey of Health Related Behaviors modified for the web.  
6. TBI - VA Traumatic Brain Injury (TBI) Screen, modified to include more descriptive 
questions.  
7. Depression - Physician’s Health Questionnaire (PHQ-8) depression questions (suicide 
question omitted).  
8. Anger- Dimensions of Anger Reactions (DAR5) Scale.49 
Trauma Exposure Screens 
9. Combat Exposure - Exposures to Combat Screen.50 
10. Sexual Trauma - VA Military Sexual Trauma Screen. 
Other: 
11. Patient Activation Measure-13 - 13-item measure of patients’ self-report of their health 
management skills, knowledge, confidence, and motivation.51 The PAM score will not 
be considered as a MH indicator but instead a measure associated with access and 
SDM interface associated with Aim 2 and 3 outcomes. 
12. CollaboRATE - 3-item measure of the SDM process52 tailored to the provider or TPA.  
13. Social Determinants of Health Questions - 6 items53 that address social needs 
including: food, housing, finances, and ability to get to medical appointments. 
A web-based satisfaction survey immediately follows screening and tailored education. 
In addition to questions about barriers and facilitators to access to care, satisfaction with 
an online process, and ways that we can make Veterans more satisfied with this screening 
and educational interface, we will also ask questions from the SHEP ambulatory care 
2015 survey pertinent to study domains (provider and VA interface satisfaction for 
outpatients), e.g., did your provider: 1) tell you there was more than one choice for your 
treatment or care; 2) talk with you about the pros and cons of each choice for your 
treatment, 3) ask which choice was best for you, 4) listen carefully to you. Our prior studies 
found most participants completed the screening and education on the same day (92%; 
mean 26 minutes/median 17 minutes). Participants will be reimbursed $30.00 for WEB-ED 
completion and an additional $20 for returning their HIPAA and consent forms allowing for 
subsequent VA chart review and interface with the Veteran’s VA provider (Phase 3), 
inclusive of VA-purchased care from non-VA providers (e.g., Choice, fee-basis). These 
forms will be made available electronically if Veterans choose to print them and return 
them to the provided address, and we will automatically send a pre-stamped envelope 
with the consent document using our established recruitment protocols. A toll-free 
number will be provided to participants to facilitate contact for any questions or to decline 

participation. Note, subjects who engage in WEB-ED+ interfaces will not receive additional 
reimbursement. 
RCT Recruitment and Assignment: Veterans who screen positive on one or more MH 
screens will be eligible for the RCT and asked online at WEB-ED completion for permission 
to re-contact them about continuing their participation in the RCT. Those who indicate yes 
will be sent IRB-approved study information. Those who decline will be thanked again for 
their participation and contact will be discontinued. We will use adaptive randomization to 
assign those who consent to WEB-ED+ or Current WEB-ED. Those who are assigned to 
Current WEB-ED will not be contacted again until Phase 3.   
WEB-ED+ augments Current WEB-ED in a next step online interface via Pharos. If 
successful, this enhancement could be integrated into the next iteration of WEB-ED. 
Enhanced WEB-ED information and process will be guided and refined by Phase 1 findings 
as will the preferred means of providing SDM educational YouTube videos and training 
materials. Enhancements include: 1. An eHealth interface tailored to Veterans’ VA and 
MHV enrollment needs, links for an electronic interface with VA enrollment, MHV and MHV 
premium status enrollment, and secure messaging guidance (Appendix 13). 2. A shared 
decision-making (SDM) interface Veteran SDM-related educational (e.g., existing 
YouTube videos) and structured questions about treatment concerns, preferences, and 
questions and can be accessed through postal and email distribution or Pharos portal. 
Provider/TPA SDM is accessible in the same avenues identified for Veterans. If a TMS 
training format is preferred, this can be created and accessed the Pharos interface. As 
presented to key informants in Phase 1, the SDM training models to consider are: 1) The 
Dartmouth Center for Health Care Delivery Science model that consists of Choice talk, 
Option talk, and Decision talk about each treatment option and guided by treatment 
decision aids,55 and the AHRQ SHARE approach that encourages SDM processes that 
include: exploring and comparing the benefits, harms and risks of each treatment option 
through dialog about what matters most to the patient (Appendices 14-18). These models 
represent an informed choice model of care as opposed to a paternalistic model focused 
on the patient in a “sick role.”56 The University of Iowa (UI) consultants (see Syrop and 
Hansen letters), experienced in SDM engagement and training of providers and patients 
and EMR documentation, will assist us. The WEB-ED+ Veteran and Provider/TPA SDM 
interface (Appendix 19): To return with the informed consent, Veterans will be asked to 
identify their primary provider. Or, if they are not VA enrolled or have no current provider, 
the study team will link participants with a TPA at the geographically closest VA. As a 
minority of Veterans participating in our prior WEB-ED studies have engaged VA MH care, 
we anticipate this will be a PC provider. If a MH care provider is identified, we will follow the 
same study process. The Veteran along with their partner provider or TPA will receive 
information by postal and e-mail outreach by the study team followed by a telephone 
contact from the Health coach within 10 days of initial outreach. The e-mail will also 
include a link to a training video that they can access with a unique identification # that will 
allow them to access a YouTube video about SDM (or TMS type interface). This link is 
contained in our research network behind the VA firewall which will allow us to determine if 
the Veteran and Provider/TPA team opened the link and for how long. All Veterans will 

complete SDM questions online via the Pharos interface where they will also be clearly 
instructed through the eHealth interface tailored to their unique needs, with resulting 
secure messaging of screening and SDM results to their provider/TPA. In the provider/TPA 
email we will inform them about the study, what to expect, and encourage engagement but 
remind them that participation is voluntary. We will also include our toll-free number so 
the health coach can address any questions or provide additional information. Study 
communications will encourage the provider to watch the SDM video (vs TMS-like 
interface), to review SDM materials (e-mailed or accessible online with a link), to 
perform SDM with their patients, and to document this SDM interface in CPRS, 
preferably guided by the SDM template provided in the secure messaged materials 
from the Veteran and/or provided by the research team. We will be clear to both Veteran 
participants and their providers that it is up to each provider’s discretion to decide if and 
how they wish to participate. Providers will receive no financial compensation for their 
participation. However, we will identify in Phase 1 if there is any form of recognition locally 
or nationally that they would consider of value, e.g. certificate of completion, Hospital 
Director’s letter of appreciation. 3) Access to a health coach (our research coordinators) 
will be available through a toll-free number to assist both Veterans and providers/TPAs. 
They will initiate contact to consenting Veterans and their partnered provider/TPA who are 
placed in the WEB-ED+ treatment arm both at the initiation of the RCT and prior to Phase 3. 
Study protocols and checklists will be employed in order to characterize participant and 
process needs. For study convenience and to minimize burden on staff at study sites, the 
health coaches (research coordinators) will essentially be carrying out functions that 
already fall under the purview of existing VA staff (e.g., VA care managers, providers, MHV 
champions, TPAs). In the event of a possible national dissemination, these functions will 
be resumed by existing staff in their respective roles but with the benefit of our study 
findings to assist them. Our results will be especially useful given changes in care access 
with My VA MH Access transitions. Consequently, the health coach is an FTEE neutral role 
should a national dissemination result from this work. As Dr. Turvey has done with her prior 
studies, our health coach will also have the authority to authenticate Veterans to 
expedite the MHV process. This will also allow us to overcome site-to-site variability in 
MHV enrollment and authentication timelines (that can take up to 20 days). Online VA 
enrollment takes approximately two days for verification. Unlikely difficulty with secure 
messaging can be addressed by the health coaches who are able to upload results directly 
into the CPRS.  
4) Chart review: VA health services utilization will be obtained from VA chart review for all 
consenting participants. Utilization measures will include: enrollment in VA, MHV 
enrollment, secure messaging of results, initiation of telephone or face-to-face contact 
with a provider or TPA interface about screens or secure messaged results, and MH 
consult sent or services receipt and location (in PC, PCMHI, or MH). We developed an 
efficient electronic and chart reviewer interface in our CREATE study, which will be 
leveraged for this study. The VA EMR will be electronically checked monthly for up to 6 
months following WEB-ED completion. Chart reviews will encompass VA purchased care 
records (inclusive of non-VA provider care received via Choice). 

Aim 2 Sample Size and Power: We will aim for 2000 Veterans completing WEB-ED, with 
approximately 1100 completing the RCT. Not all 2000 will be eligible for the RCT. Based on 
our five prior studies, ~77-85% of WEB-ED participants screened positive on at least one of 
the MH screens (~70% screened positive on depression, PTSD, or substance use). We will 
assume that 70% will eligible for the RCT (~1400) and use adaptive randomization to assign 
positive-screeners to each RCT arm; two-thirds to WEB-ED+ (~950) and one-third to 
Current WEB-ED (~450). There are no additional RCT participation activities for those in the 
Current WEB-ED arm, therefore attrition would be minimal. However, we anticipate there 
may be attrition among those assigned to WEB-ED+. Our CREATE multi-phase study 
resulted in attrition of ~30%. Therefore, we expect 650 completers for WEB-ED+. We have 
increased this sample size to have sufficient power to detect differences per RCT arm. This 
study is powered to detect whether WEB-ED+ increases VA MH care engagement 
compared to Current WEB-ED. In our prior work, half indicate that as a direct result of 
WEB-ED, they will follow up with a provider and 38% with a VA provider, although actual 
follow-up may be lower (our CREATE study is currently validating participant self-report 
with chart review data). This proposed study will document VA utilization (including VA 
purchased care) by VA chart review. We estimated the minimum sample size needed to 
ensure adequate power (80%) for a variety of assumptions (percentage of Current WEB-ED 
participants engaging in VA MH care, effect (odds ratios), and variance inflation factors 
(VIF)57, using nQuery 4.0. We anticipate random assignment will result in no statistical 
differences between RCT arms based on WEB-ED data (e.g., prior enrollment in VA, 
positive screens). However, covariates will be included (e.g., gender, rurality, patient-
activation scores, VA site) in multivariate analyses to control for variation due to these 
other variables. Any significant covariates may point to sources of variability to explore in 
future research efforts, but we do not anticipate having sufficient power to conduct 
subsample analyses by gender or VA site. 
Estimates of Total Sample Size for 80% Power based on Varying Assumptions 
 
% assigned to Current WEB-ED who engage in VA MH Care* 
 
25% 
30% 
35% 
OR 
No VIF 
VIF=0.2 
VIF=0.3 
No 
VIF 
No VIF 
VIF=0.3 
No 
VIF 
VIF=0.2 
VIF=0.3 
1.5 
834 
1043 
1191 
759 
949 
1084 
714 
893 
1020 
1.8 
387 
484 
553 
354 
443 
506 
336 
420 
480 
2.0 
237 
296 
339 
252 
315 
360 
240 
300 
343 
 
Aim 2 Analyses: We will begin with bivariate analyses (i.e., chi-square test for proportions) 
to test significance of differences in care engagement between RCT arms. Care 
engagement is the primary outcome and will be operationalized by VA MH services receipt 
(yes/no). Our primary analyses will use logistic regression models to estimate the adjusted 
ORs for treatment engagement controlling for participant characteristics. The logistics 
regression models will provide an estimate of the association between health care 
engagement by RCT arm, controlling for covariates such as Veteran gender, prior VA 
enrollment, severity [screening scores] and complexity [multiple positive screens], patient-

activation scores, and rurality. Potential confounding variables that will be assessed in all 
hypotheses include socio-economic variables (e.g., age, income, marital status), and 
military characteristics (e.g., months home from deployment, rank). In addition, depending 
on the resulting proportions of Veterans who get care in various VA clinics (i.e., PC, PCMHI, 
MH), we plan to conduct a multinomial logistic regression, treating RCT-arm as a 
covariate. We have used multinomial logistic regression previously to examine 
associations with three levels of VA health care use (all, some, none).58 
 
Specific Aim # 3: To elicit feedback from key stakeholders in both arms of the RCT 
(Enhanced vs. Current WEB-ED) regarding 1) the usefulness of an eHealth process of 
interface, and 2) perceptions of how WEB-ED+, including SDM, influenced patient 
access to and efficiency of VA patient-centered care delivery, and 3) Veteran and 
provider satisfaction; and to document the VA processes Veterans used to enroll and 
engage in VA care. 
Phase 3 (Aim 3). Process Evaluation: This phase will consist of a process evaluation to 
include RCT participants and providers. This is necessary to determine effectiveness of the 
combined process of an eHealth interface supporting secure messaging of MH information 
and consequent communication with providers by determining the enhanced: 
acceptability, “buy in” among Veterans and VA providers, utility in facilitating SDM to 
support patient-centered care, improvement of efficiency of MH care access and 
engagement that is patient-centered, and potential barriers and facilitators to 
sustainability of Enhanced WEB-ED. 
Participants: Post-intervention process evaluation will rely on data collected via 
Computer-Assisted Telephone Interview (CATI), with which our team has extensive 
experience. We will recruit 76 Veteran participants, and all Veteran-identified VA providers 
who agree to participate. We will use 3:1 sampling as shown above. It is anticipated that in 
each of the four groups (“Engaged in VA Care” column) we will have appropriate 
representation of gender and racial/ethnic groups, but we will monitor this and use 
purposeful sampling if needed. Fewer numbers of those who did not engage in VA care 
reflects our expectation of less variation in subgroup data. As we do monthly EMR checks 
of participants, we will be able to identify provider/TPA interface initiated following WEB-
ED and attempt to initiate contact within the month following RCT interface or at 6 months 
post-RCT vs post-WEB-ED if they have not. We will use a convenience sample of those in 
each identified comparison group (see above figure) who are first able to be contacted by 
the study research coordinator or trained research interviewers by telephone.  
Recruitment: To contact Veterans, the study coordinator will use an IRB-approved call 
contact protocol, varying times of day and days of week (used successfully by this team) 
and conduct an approximately 25-minute semi-structured qualitative interview with 
consenting participants using CATI data collection. In addition, up to two postal mail 
recruitments will be sent with information, a return postal card indicating preferred 
contact times or preference to discontinue participation. All participants recruited will be 
asked for confirmation of their VA care engagement or not, and their current level of 
distress with current post-deployment readjustment. Veterans will be reimbursed an 
additional $50.00 for their time and effort to participate with this study phase. Providers 

will be recruited for participation by e-mail invitation and a response template that allows 
them to identify a time they would like to be interviewed, a toll-free number so that they 
can initiate contact themselves, and an option that identifies they would not like to be 
contacted. VA employees will receive no financial remuneration for their time and effort. 
However, in Phase 1 we will determine if there are any other non-financial rewards that 
would be meaningful to them.  
Data collection: Semi-structured interviews with qualitative and survey questions will be 
implemented from Dr. Sadler’s CATI laboratory, with established data security and 
interviewer training/monitoring protocols in place for a decade. Guided by CFIR, we hope 
to understand participants’ perceptions of the intervention to which they were assigned 
with regard to ease and usefulness, need for improvements, and perceptions of 
barriers/facilitators to VA and MH services receipt or provision. We will interview both 
those who did/did not subsequently engage in the eHealth process/secure messaging and 
among these groups those who did/did not engage in VA MH care consequently. WEB-ED+ 
Veteran Participants will be asked about their use of secure messaging, VA provider 
engagement, satisfaction with use of WEB-ED results, if their VA provider participated in 
SDM with them, and satisfaction with the type of care they received. Those not activated to 
participate in VA care or who did not secure message results will be asked about 
barriers/facilitators to this process and how we might improve this interface or MH 
engagement. Current WEB-ED Veterans will be asked the same questions except for 
those specific to WEB-ED+ (Appendix 20). Participants from both RCT arms will be asked 
about satisfaction with process and care (if sought). Process Mapping: A brief Veteran 
process map will be developed from the Veteran’s perspective to show whether each step 
of the WEB-ED RCT process helped create a clear value for them as a care customer or 
not. Provider/TPAs will be asked parallel questions to the Veterans, respective to each 
treatment arm. A Provider process map will be developed to help us understand the 
specific roles of individuals in the overall system of care, i.e. the # of teams involved, if 
there are bottlenecks and delays, rework that occurs in facilitating war Veterans’ access to 
patient-centered MH care, and the potential system impact of WEB-ED+ and perceived 
value to the provider/TPA. Satisfaction: Questions included in the CATI interviews for 
Veterans will include questions from the SHEP Ambulatory Care 2015 Survey (as detailed 
previously). The SDM interface will be further evaluated by CollaboRATE, 3-item measure 
of the SDM process.52 These include: “How much effort was made to: 1) help you 
understand your MH issues, 2) listen to the things that matter most to you in your MH 
issues. and 3) include what matters most to you in choosing what to do next”. 
OMB Considerations: Our prior QUERI and VA HSR&D CREATE studies that serve as the 
foundation for this proposal were exempt from OMB review since the survey and collection 
of information being conducted was research to prevent a clinical disorder (identified as a 
basis for exemption under 5 CFR 1320.3). We anticipate that this will be the case with this 
study as it addresses prevention of chronic post-deployment MH and social issues 
entrenchment (e.g., SUD, social determinants). We readily obtained OMB exemption for 
our HSR&D and DoD funded studies with similar domains in OEF/OIF/OND service 
members. 
Study Feasibility: 1) We are confident of this study’s feasibility given the relatively small 

sample size needed from the national sampling frame and density of Iraq and 
Afghanistan war Veterans in these areas, following our current correspondence with 
VADIR. Given national security concerns, VADIR data is not available until study funding. 
Therefore, once proposed funding is approved, we will work with VADIR to have a sample 
consistent with current OEF/OIF/OND post-deployment populations. 2) VADIR oversees 
the registry of actively serving and Veteran military members and Dr. Sadler has had a 
fruitful working relationship with them for four studies, successfully obtaining and 
updating contact information for deployed study populations. 3) Our CREATE study 
findings demonstrates the feasibility of engaging Veterans who participated in WEB-ED 
into multi-phase SDM, telephone interface, and chart reviews. 4) This study is also 
feasible because of our successful relationship with Pharos, the corporation that 
assists with the web-based implementation and has a dedicated research server behind 
the VA Firewall. Pharos follows standards for Section 508 compliancy, therefore 
allowing future accommodation of Veterans with disabilities should there ultimately be 
a MHV interface. 5) The VA EMR allows for accessible chart review confirmation and this 
team is well experienced in interfacing with the national chart review system through 
CAPRI and VISTA WEB with special research user permission obtained via DART. 6) The 
WEB-ED+ technology linkage is feasible. Through MyVA transformation efforts, improved 
online enrollment was initiated June 30, 2016 resulting in a rapid and user-friendly 
enrollment process. Furthermore, our health coach will have the authority to expedite 
Veteran authentication. 7) The Women’s PBRN infrastructure assures successful 
interface with key informants, in particularly providers, as does the sufficient number of 
providers at study sites.8) Lastly, this research team is uniquely poised to conduct this 
research, building on a strong track record of success with deployment-related health, 
application of mixed quantitative and qualitative methods, SDM, and implementation 
research, along with our expertise in developing cutting edge web-based interfaces to 
facilitate access to VA care.  
5.0 DISSEMINATION PLAN 
Dr. Sadler will work closely with Drs. Cook and Kudler (MH), Ms. Capra, MPH (Rural 
Health), Ms. Kennedy (National VA Care Management), Dr. Turvey (MHV), Dr. Frayne 
(PBRN), Dr. Fortney (Virtual QUERI); and HSR&D research leadership to facilitate 
dissemination of findings to respective groups and integration of products into relevant VA 
initiatives to improve Veterans access to care and address unmet need for MH care (see 
following table). Dr. Nazi will be highly instrumental in determining next steps with MHV. 
Dr. Sadler will also communicate findings in her roles as a committee member of the 
VA/DoD Health Executive Committee Women’s Health Work Group that deals with VA-DoD 
transitions in care, and the VA Office of Care Management and Social Work Integrated 
Case Management Mode of Care Task Force. Dr. Sadler and her team will present 
preliminary data at national level research meetings, such as Academy Health and VA 
HSR&D. They will submit articles to germane peer reviewed journals, such as Journal of 
Traumatic Stress, American Journal of Preventive Medicine, and Health Services Research.  
 

eSDM
PI:
Anne Sadler
IRB ID #: 201708746
Other Mod and/or Comments
Per VA Research project modification approval received November 2022 (attachment: ORD-ProjectModification_Sadler_IIR_16-096_September2022_
rwob for LC sig-lmc.pdf), we are now able to provide subjects with an additional $30 for already returned signed HIPAA form and consent to participate
with this study phase. We will notify previous subjects using attachments (Phase 2 New Reimbursement postal mail and Phase 2 New Reimbursement
email), and submit this request, anticipating that they should receive this direct deposit within 4 to 8 weeks. For new RCT recruitments we have edited the
Phase 2 RCT recruitment to indicate that if they return their signed HIPAA form and consent to participate in this study phase they will received $50.00 (the
same amount as those who have already returned these forms will receive). In the attachments 'RCT Intervention Assignment Letter.rtf' and 'Recruitment
Scripts.docx,' we have added text describing the additional compensation we are now able to provide, as well as to let subjects know when activities for the
study need to be completed. We updated the text for the Follow up Script Phase 2 RCT – No appointment follow-up call at 6 and 10 weeks, as well as the
VA Provider Invitation Script for Teams (information summarized from above telephone script and approved email the provider will have already received)
to include responses to frequently asked questions from providers. The reimbursement follow up script has been edited to reflect the increased compensation
amount we are now able to provide to subjects.
Because of new VA research policy changes, we are now also able to provide subjects with an additional $75.00 upon completion of the RCT “intervention
group” steps of this research phase that involves seeing their VA provider (as described in the consent and the encrypted study group assignment email).
The chart review (as described in section VII.E.6) template has been attached. We have made changes to existing RCT attachments to reflect these changes,
and added the chart review template, added Dan Corry to the research team, as well as removed Michala Cox from the research team since she no longer
works with VA. We also removed Samantha Solimeo from the research team as she no longer works on the project.
Modifications

VII.E
.6
Provide a detailed description in sequential order of the study procedures following the consent process - DO NOT cut and paste from the
Consent Document.
Describe study populations separately if they will be participating in different procedures - include CONTROL population if applicable.
DESCRIBE:
What subjects will be asked to do/what happens in the study (in sequential order)
The time period over which procedures will occur
The time commitment for the subject for individual visits/procedures
Long-term followup and how it occurs
Old Value
Phase 1: A total of 60 interviews (12 individuals at each of 5 sites) will be conducted. Key informant roles include: Primary Care-Mental Health Integration
(PCMHI) providers (n=1-2), PC and/or MH providers(n=2), PCMHI or PC and MH case managers (n=1-2), MHV champion (n=1), Enrollment Specialists
(n=1), OEF/OIF/OND Transition Patient Advocates (TPA) (n=1-2) and OEF/OIF/OND Veterans (n=4-5). An effort will be made to have a gender mix of
key informants. VA personnel can be identified through VA national websites and our PBRN site leads. We will use site Veteran Panels to engage
OEF/OIF/OND male and female war Veterans when possible, as well as using our Veteran registry obtained VINCI/VADIR to identify Veterans who are
and are not currently VA engaged, respectively. Due to delays related to COVID-19, the research team has decided to move forward with the data collected
for phase one, and not to collect any one-to-one Veteran interviews for that phase. VINCI is a partner with the Corporate Data Warehouse (CDW) and hosts
all data available through CDW as well as some unique data. VADIR is the VA group that interfaces with Defense Manpower Data Center to obtain sample
characteristics of service members/Veterans, including postal and military e-mail addresses, and work/home telephone numbers. In phase 1, we will also
develop a template for use in the VA electronic medical record to document the shared decision-making interface that is a component of our intervention
for those in the RCT treatment arm (WEB-ED+). This will be an important material reviewed by our key informants in Phase one interviews. Prior to these
interviews, this template will be developed with the assistance of study consultants who have developed templates for shared decision making
documentation in a university health care setting and with assistance and with the guidance and initial consultation and prior approval from key VA offices,
e.g. National VA Privacy office.
Following IRB approval, Consolidated Framework for Implementation Research (CFIR) guided qualitative interviews will be conducted by Dr. Sadler and
other research team members (Cook, Steffensmeier) to determine key informant critiques of the WEB-ED+ content that will include: 1) MHV
authentication and secure messaging directions; 2) online VA enrollment directions; and educational shared decision-making (SDM) educational videos,
one for Veterans and one for providers, regarding the benefits and process involved in SDM respectively (video links (unlisted, only accessible via links:
Shared Decision-Making SDM-Non-SDM https://youtu.be/9Exh5qm2D4s; Shared Decision-Making ‘Veterans’ https://youtu.be/FaevM-mTJtU; Shared
Decision-Making ‘Providers’ https://youtu.be/xETkUedZ2N4); 3) decision aids for PTSD, depression and substance use disorder for use by patient and
provider, and 4) patient activation scores and their relationship to SDM and care engagement. Dr. Cook and Dr. Sadler will engage top leadership at each
study site as well as work with the Women’s Practice Based Research Network leadership site leads at each facility to promote communication and
engagement at each VA. To complement the qualitative data, Dr. Sadler will engage with local stakeholders and champions at each facility in order to map
clinical workflow processes (process mapping) at each of the five study sites and determine how to best integrate WEB-ED+ into existing workflows. On-
site visit interviews allow our research team important insights about the localized nature of health care delivery and how this might impact refinement of
WEB-ED+ and its potential adoption and reach. Individual interviews ensure greater likelihood of the participation of key informants at times that
accommodate their schedules and equalizes the importance of information from each of them. These interviews will be recorded, and this will be explained
during the consent process prior to the start of the interviews. The following attachments will be sent in the following order: Phase 1 Confirmation Email;
2. Interview Direction Email; and 3. Link Email. Phase 1 Confirmation Email is sent immediately after interview is scheduled to confirm date and time of
interview. Interview Direction Email is sent after to explain the interview protocol and to allow adequate time for questions. The Link Email is sent 24-
hours before the scheduled interview, this email has the link to follow to watch the study video and the access number to the VANTS line. This is to
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increase the fidelity to the interviewee’s first time watching the Shared Decision-Making video while on the VANTS conference call with the interviewer.
Phase 2: Participants will include two overlapping populations of OEF/OIF/OND male and female Veterans eligible for VA care, which we will randomly
sample from two overlapping populations. The first group includes those who returned from deployment to Iraq or Afghanistan within the preceding four
years and who reside within the catchment areas of the current PBRN study sites (identified by zip code). We want to ensure that those who participate and
screen positive on one or more of the screens have access to VA care. Consequently, we have selected the time frame of 4 years post-deployment because
these Veterans have priority access to VA care for five years after their most recent deployment. The second group is OEF/OIF/OND Veterans who are
already enrolled in VA care and will not be excluded if they have been home from deployment more than four years. We are doing purposeful sampling to
achieve sufficient numbers of men vs women and we will work with VINCI/VADIR to have a sample representative by gender and race consistent with the
current OEF/OIF/OND post-deployment populations.
All study participants will be asked to complete the online survey and screenings and be provided with their results and tailored educational information.
Documentation of informed consent for Phase 2 participation (WEB-ED) is integrated into the web-based interface (“click approval”). Participants receive
a hardcopy version of this form containing the elements of consent in the study packet and can read a copy online. This process has been approved in five
prior projects using WEB-ED. The consent document will also inform participants that they may be invited to participate in the subsequent study phase that
addresses VA and post-deployment care access. WEB-ED includes a brief pre-intervention survey that will query stigma associated with MH care, prior
and current utilization (VA and non-VA; primary care, MH, emergency) and their reasons for accessing VA or not, knowledge about post-deployment VA
eligibility, services and satisfaction with VA care, potential barriers to MH service use, and their use of or barriers to MHV and secure messaging. Those
who meet screening criteria for MH conditions and readjustment concerns receive online notification and a recommendation for a face-to-face evaluation,
education about each MH domain for which there is a positive screen, and information about access to care. Patients who may have immediate needs will
also be provided with specific VA resources, contact names and numbers, as well as information for providers or resources unique to their needs and
geographic locations. The 24-hour Veterans Crisis Line (1-800-273-TALK (8255)) will be provided. Patients with negative screens will be informed to seek
care if they believe that it is needed. We note that neither our research team’s studies using focus groups and telephone interviews with more intensive
questions about sexual assault or combat experiences in deployed populations, nor our prior web-based intervention studies, have resulted in any
subsequent clinical emergencies. Veterans who have no positive screens will be able to access the same educational information, web links, and video-clips
if they choose.
A web-based satisfaction survey immediately follows screening and tailored education. In addition to questions about barriers and facilitators to access to
care, satisfaction with an online process, and ways that we can make Veterans more satisfied with this screening and educational interface, we will also ask
questions from the SHEP ambulatory care 2015 survey pertinent to study domains (provider and VA interface satisfaction for outpatients), e.g.: 1) did their
provider tell you there was more than one choice for your treatment or care; 2) talk with you about the pros and cons of each choice for your treatment, 3)
ask which choice was best for you, 4) listen carefully to you.
Phase 2 RCT Intervention (WEB-ED+) Veteran Procedures: Veterans who screen positive on one or more MH screens will be eligible for the RCT and
asked online at WEB-ED completion for permission to re-contact them about continuing their participation in the RCT. Those who indicate yes will be sent
IRB approved study information, including the RCT consent letter (2B), consent and HIPAA forms attached to this application. A summary of the
screening results will be sent by encrypted email (attachment Phase 2 encrypted email - treatment arm RCT.rtf) to Veterans in the RCT treatment arm
(WEB-ED+). An email will be sent in advance of this to alert Veterans that they will be receiving secure information by encrypted email. Additionally,
Veterans will be asked to indicate which screening results bother them the most that they would like to talk with their provider about (To share with
Provider). Veterans are asked to return that form along with their signed consent forms. Phase 2 Thank you letter-returned forms will be used to thank
participants for returning their signed consent and HIPAA authorization forms.
To receive care in the VA health care system, Veterans must enroll in the VA system. Online VA enrollment links and information (available to every
Veteran) will be provided to help RCT participating Veterans with this process. If they are unable to enroll electronically, key points of contact at the VA
geographically closest to them will be provided so they can receive assistance with this process. Additionally, enrollment in My HealtheVet (MHV), a
secure online ehealth portal, allows Veterans to access their medical records and send secure messages to their VA providers. As part of the RCT,
participants will be asked to secure message their screening results summary to the VA provider of their preference. If they are new to the VA, enrolling as
a result of the RCT participation, their newly assigned provider will be the individual that they will be asked to secure message their screening results
summary. Note, that the study team will be monitoring enrollment and provider assignment of Veterans new to the VA and will invite the provider as soon
as the assignment is made. If needed, the study team will be available to secure message the screening results, rather than the Veteran.
Phase 2 RCT Intervention (WEB-ED+) Provider Procedures: once the provider has agreed to participate, they will be sent an email that contains links to 2
short videos about shared decision-making and three brief decision aids (PTSD, depression, substance use disorder).
Using the knowledge both the provider and patient learned from the WEB-ED+ materials, they will discuss treatment options at the patient's appointment.
If subjects do not complete steps in the process, the appropriate attachment (Phase 2 RCT missing VA enrollment, Phase 2 RCT missing MHV premium
enrollment, or Phase 2 RCT missing secure messaging) will be sent via email or postal mail if email is not available to support completion of these steps,
with a toll free number provided. Further, up to 3 contact calls will be made until the subject is reached, to determine if the participant has discontinued
study participation, if the study team can be of further assistance, or to determine the completion barrier(s), and if the Veteran is enrolled- to assist them
with MHV barriers by sending the study screening results summary by encrypted email to the participant’s preferred or new provider in their stead (eSDM
Chart Review-Secure Message) so they are able to progress to their appointment in order to use shared decision-making with their provider about their
positive MH screens. Requested Resources Email Scripts will be sent per request of subject as needed. The missing email notice attachment will be used
for those in the treatment arm of RCT to encourage them to contact us and update their email address so we can continue their participation with the study.
The provider consent notification document will be sent via mail or email letting the participant know that their provider has consented to participate in the
RCT.
Those who decline will be thanked again for their participation and contact will be discontinued. We will use adaptive randomization to achieve balance in
the assignment of those who consent to WEB-ED+ or Current WEB-ED. Those who are assigned to Current WEB-ED will not be contacted again until
Phase 3.
If subjects do not complete the screening, attachments Phase 2G Incomplete Survey Email and Phase 2H Incomplete Survey Letter will be sent to
encourage completion.
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A medical chart review will be conducted for the subjects who return the signed HIPAA and consent forms for the RCT and prior to the interview for phase
3. Chart reviews will focus on VA outpatient care the subject received (or not) including medication, therapy, & substance use treatment. We will review
the time from post-deployment through 6 months after the subject's initial study participation. We will assess/confirm enrollment status and upcoming
appointments of participating Veterans using a combination of national visual chart review using CAPRI/JLV, along with accessing enrollment and
appointment data from the CDW.
Phase 3: Post-intervention process evaluation will rely on data collected via Computer-Assisted Telephone Interview (CATI), with which our team has
extensive experience. We will recruit 76 Veteran participants, and all Veteran-identified VA providers who agree to participate. We will use 3:1 sampling. It
is anticipated that in each of the four groups, we will have appropriate representation of gender and racial/ethnic groups, but we will monitor this and use
purposeful sampling if needed. Fewer numbers of those who did not engage in VA care reflects our expectation of less variation in subgroup data. As we do
monthly EMR checks of participants, we will be able to identify provider/TPA interface initiated following WEB-ED and attempt to initiate contact within
the month following RCT interface or at 6 months post-RCT vs post-WEB-ED if they have not. We will use a convenience sample of those in each
identified comparison group, who are first able to be contacted by the study research coordinator or trained research interviewers by telephone.
Semi-structured interviews with qualitative and survey questions will be implemented from Dr. Sadler’s CATI laboratory, with established data security
and interviewer training/monitoring protocols in place for a decade. These interviews will not be recorded. Guided by CFIR, we hope to understand
participants’ perceptions of the intervention to which they were assigned with regard to ease and usefulness, need for improvements, and perceptions of
barriers/facilitators to VA and MH services receipt or provision. We will interview both those who did/did not subsequently engage in the eHealth
process/secure messaging and among these groups those who did/did not engage in VA MH care consequently. WEB-ED+ Veteran Participants will be
asked about their use of secure messaging, VA provider engagement, satisfaction with use of WEB-ED results, if their VA provider participated in SDM
with them, and satisfaction with the type of care they received. Those not activated to participate in VA care or who did not secure message results will be
asked about barriers/facilitators to this process and how we might improve this interface or MH engagement. Current WEB-ED Veterans will be asked the
same questions except for those specific to WEB-ED+. Participants from both RCT arms will be asked about satisfaction with process and care (if sought).
A Veteran process map will be developed from the Veteran’s perspective to show whether each step of the WEB-ED RCT process helped create a clear
value for them as a care customer or not. Provider/TPAs will be asked parallel questions to the Veterans- respective to each treatment arm. A Provider
process map will be developed to help us understand the specific roles of individuals in the overall system of care, i.e. the # of teams involved, if there are
bottlenecks and delays, rework that occurs in facilitating war Veterans’ access to patient-centered MH care, and the potential system impact of WEB-ED+
and perceived value to the provider/TPA.
VII.E
.6
Provide a detailed description in sequential order of the study procedures following the consent process - DO NOT cut and paste from the
Consent Document.
Describe study populations separately if they will be participating in different procedures - include CONTROL population if applicable.
DESCRIBE:
What subjects will be asked to do/what happens in the study (in sequential order)
The time period over which procedures will occur
The time commitment for the subject for individual visits/procedures
Long-term followup and how it occurs
New Value
Phase 1: A total of 60 interviews (12 individuals at each of 5 sites) will be conducted. Key informant roles include: Primary Care-Mental Health Integration
(PCMHI) providers (n=1-2), PC and/or MH providers(n=2), PCMHI or PC and MH case managers (n=1-2), MHV champion (n=1), Enrollment Specialists
(n=1), OEF/OIF/OND Transition Patient Advocates (TPA) (n=1-2) and OEF/OIF/OND Veterans (n=4-5). An effort will be made to have a gender mix of
key informants. VA personnel can be identified through VA national websites and our PBRN site leads. We will use site Veteran Panels to engage
OEF/OIF/OND male and female war Veterans when possible, as well as using our Veteran registry obtained VINCI/VADIR to identify Veterans who are
and are not currently VA engaged, respectively. Due to delays related to COVID-19, the research team has decided to move forward with the data collected
for phase one, and not to collect any one-to-one Veteran interviews for that phase. VINCI is a partner with the Corporate Data Warehouse (CDW) and hosts
all data available through CDW as well as some unique data. VADIR is the VA group that interfaces with Defense Manpower Data Center to obtain sample
characteristics of service members/Veterans, including postal and military e-mail addresses, and work/home telephone numbers. In phase 1, we will also
develop a template for use in the VA electronic medical record to document the shared decision-making interface that is a component of our intervention
for those in the RCT treatment arm (WEB-ED+). This will be an important material reviewed by our key informants in Phase one interviews. Prior to these
interviews, this template will be developed with the assistance of study consultants who have developed templates for shared decision making
documentation in a university health care setting and with assistance and with the guidance and initial consultation and prior approval from key VA offices,
e.g. National VA Privacy office.
Following IRB approval, Consolidated Framework for Implementation Research (CFIR) guided qualitative interviews will be conducted by Dr. Sadler and
other research team members (Cook, Steffensmeier) to determine key informant critiques of the WEB-ED+ content that will include: 1) MHV
authentication and secure messaging directions; 2) online VA enrollment directions; and educational shared decision-making (SDM) educational videos,
one for Veterans and one for providers, regarding the benefits and process involved in SDM respectively (video links (unlisted, only accessible via links:
Shared Decision-Making SDM-Non-SDM https://youtu.be/9Exh5qm2D4s; Shared Decision-Making ‘Veterans’ https://youtu.be/FaevM-mTJtU; Shared
Decision-Making ‘Providers’ https://youtu.be/xETkUedZ2N4); 3) decision aids for PTSD, depression and substance use disorder for use by patient and
provider, and 4) patient activation scores and their relationship to SDM and care engagement. Dr. Cook and Dr. Sadler will engage top leadership at each
study site as well as work with the Women’s Practice Based Research Network leadership site leads at each facility to promote communication and
engagement at each VA. To complement the qualitative data, Dr. Sadler will engage with local stakeholders and champions at each facility in order to map
clinical workflow processes (process mapping) at each of the five study sites and determine how to best integrate WEB-ED+ into existing workflows. On-
site visit interviews allow our research team important insights about the localized nature of health care delivery and how this might impact refinement of
WEB-ED+ and its potential adoption and reach. Individual interviews ensure greater likelihood of the participation of key informants at times that
accommodate their schedules and equalizes the importance of information from each of them. These interviews will be recorded, and this will be explained
during the consent process prior to the start of the interviews. The following attachments will be sent in the following order: Phase 1 Confirmation Email;
2. Interview Direction Email; and 3. Link Email. Phase 1 Confirmation Email is sent immediately after interview is scheduled to confirm date and time of
interview. Interview Direction Email is sent after to explain the interview protocol and to allow adequate time for questions. The Link Email is sent 24-
hours before the scheduled interview, this email has the link to follow to watch the study video and the access number to the VANTS line. This is to
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increase the fidelity to the interviewee’s first time watching the Shared Decision-Making video while on the VANTS conference call with the interviewer.
Phase 2: Participants will include two overlapping populations of OEF/OIF/OND male and female Veterans eligible for VA care, which we will randomly
sample from two overlapping populations. The first group includes those who returned from deployment to Iraq or Afghanistan within the preceding four
years and who reside within the catchment areas of the current PBRN study sites (identified by zip code). We want to ensure that those who participate and
screen positive on one or more of the screens have access to VA care. Consequently, we have selected the time frame of 4 years post-deployment because
these Veterans have priority access to VA care for five years after their most recent deployment. The second group is OEF/OIF/OND Veterans who are
already enrolled in VA care and will not be excluded if they have been home from deployment more than four years. We are doing purposeful sampling to
achieve sufficient numbers of men vs women and we will work with VINCI/VADIR to have a sample representative by gender and race consistent with the
current OEF/OIF/OND post-deployment populations.
All study participants will be asked to complete the online survey and screenings and be provided with their results and tailored educational information.
Documentation of informed consent for Phase 2 participation (WEB-ED) is integrated into the web-based interface (“click approval”). Participants receive
a hardcopy version of this form containing the elements of consent in the study packet and can read a copy online. This process has been approved in five
prior projects using WEB-ED. The consent document will also inform participants that they may be invited to participate in the subsequent study phase that
addresses VA and post-deployment care access. WEB-ED includes a brief pre-intervention survey that will query stigma associated with MH care, prior
and current utilization (VA and non-VA; primary care, MH, emergency) and their reasons for accessing VA or not, knowledge about post-deployment VA
eligibility, services and satisfaction with VA care, potential barriers to MH service use, and their use of or barriers to MHV and secure messaging. Those
who meet screening criteria for MH conditions and readjustment concerns receive online notification and a recommendation for a face-to-face evaluation,
education about each MH domain for which there is a positive screen, and information about access to care. Patients who may have immediate needs will
also be provided with specific VA resources, contact names and numbers, as well as information for providers or resources unique to their needs and
geographic locations. The 24-hour Veterans Crisis Line (1-800-273-TALK (8255)) will be provided. Patients with negative screens will be informed to seek
care if they believe that it is needed. We note that neither our research team’s studies using focus groups and telephone interviews with more intensive
questions about sexual assault or combat experiences in deployed populations, nor our prior web-based intervention studies, have resulted in any
subsequent clinical emergencies. Veterans who have no positive screens will be able to access the same educational information, web links, and video-clips
if they choose.
A web-based satisfaction survey immediately follows screening and tailored education. In addition to questions about barriers and facilitators to access to
care, satisfaction with an online process, and ways that we can make Veterans more satisfied with this screening and educational interface, we will also ask
questions from the SHEP ambulatory care 2015 survey pertinent to study domains (provider and VA interface satisfaction for outpatients), e.g.: 1) did their
provider tell you there was more than one choice for your treatment or care; 2) talk with you about the pros and cons of each choice for your treatment, 3)
ask which choice was best for you, 4) listen carefully to you.
Phase 2 RCT Intervention (WEB-ED+) Veteran Procedures: Veterans who screen positive on one or more MH screens will be eligible for the RCT and
asked online at WEB-ED completion for permission to re-contact them about continuing their participation in the RCT. Those who indicate yes will be sent
IRB approved study information, including the RCT consent letter (2B), consent and HIPAA forms attached to this application. A summary of the
screening results will be sent by encrypted email (attachment Phase 2 encrypted email - treatment arm RCT.rtf) to Veterans in the RCT treatment arm
(WEB-ED+). An email will be sent in advance of this to alert Veterans that they will be receiving secure information by encrypted email. Additionally,
Veterans will be asked to indicate which screening results bother them the most that they would like to talk with their provider about (To share with
Provider). Veterans are asked to return that form along with their signed consent forms. Phase 2 Thank you letter-returned forms will be used to thank
participants for returning their signed consent and HIPAA authorization forms.
To receive care in the VA health care system, Veterans must enroll in the VA system. Online VA enrollment links and information (available to every
Veteran) will be provided to help RCT participating Veterans with this process. If they are unable to enroll electronically, key points of contact at the VA
geographically closest to them will be provided so they can receive assistance with this process. Additionally, enrollment in My HealtheVet (MHV), a
secure online ehealth portal, allows Veterans to access their medical records and send secure messages to their VA providers. As part of the RCT,
participants will be asked to secure message their screening results summary to the VA provider of their preference. If they are new to the VA, enrolling as
a result of the RCT participation, their newly assigned provider will be the individual that they will be asked to secure message their screening results
summary. Note, that the study team will be monitoring enrollment and provider assignment of Veterans new to the VA and will invite the provider as soon
as the assignment is made. If needed, the study team will be available to secure message the screening results, rather than the Veteran.
Phase 2 RCT Intervention (WEB-ED+) Provider Procedures: once the provider has agreed to participate, they will be sent an email that contains links to 2
short videos about shared decision-making and three brief decision aids (PTSD, depression, substance use disorder).
Using the knowledge both the provider and patient learned from the WEB-ED+ materials, they will discuss treatment options at the patient's appointment.
If subjects do not complete steps in the process, the appropriate attachment (Phase 2 RCT missing VA enrollment, Phase 2 RCT missing MHV premium
enrollment, or Phase 2 RCT missing secure messaging) will be sent via email or postal mail if email is not available to support completion of these steps,
with a toll free number provided. Further, up to 3 contact calls will be made until the subject is reached, to determine if the participant has discontinued
study participation, if the study team can be of further assistance, or to determine the completion barrier(s), and if the Veteran is enrolled- to assist them
with MHV barriers by sending the study screening results summary by encrypted email to the participant’s preferred or new provider in their stead (eSDM
Chart Review-Secure Message) so they are able to progress to their appointment in order to use shared decision-making with their provider about their
positive MH screens. Requested Resources Email Scripts will be sent per request of subject as needed. The missing email notice attachment will be used
for those in the treatment arm of RCT to encourage them to contact us and update their email address so we can continue their participation with the study.
The provider consent notification document will be sent via mail or email letting the participant know that their provider has consented to participate in the
RCT.
Those who decline will be thanked again for their participation and contact will be discontinued. We will use adaptive randomization to achieve balance in
the assignment of those who consent to WEB-ED+ or Current WEB-ED. Those who are assigned to Current WEB-ED will not be contacted again until
Phase 3.
Per VA Research project modification approval received November 2022, we are now able to provide subjects with an additional $30 for already
returned signed HIPAA form and consent to participate with this study phase. We will notify previous subjects using attachments (Phase 2 New
Reimbursement postal mail and Phase 2 New Reimbursement email), and submit this request, anticipating that they should receive this direct
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deposit within 4 to 8 weeks. For new RCT recruitments we have edited the Phase 2 RCT recruitment to indicate that if they return their signed
HIPAA form and consent to participate in this study phase they will received $50.00 (the same amount as those who have already returned these
forms will receive).
Because of new VA research policy changes, we are now also able to provide subjects with an additional $75.00 upon completion of the RCT
“intervention group” steps of this research phase that involves seeing their VA provider (as described in the consent and the encrypted study
group assignment email).
We will send the new funding notice to all RCT consenters first by email, followed by postal mail with follow up a week later via telephone using a
3-call protocol.
If subjects do not complete the screening, attachments Phase 2G Incomplete Survey Email and Phase 2H Incomplete Survey Letter will be sent to
encourage completion.
A medical chart review will be conducted for the subjects who return the signed HIPAA and consent forms for the RCT and prior to the interview for phase
3. Chart reviews will focus on VA outpatient care the subject received (or not) including medication, therapy, & substance use treatment. We will review
the time from post-deployment through 6 months after the subject's initial study participation. We will assess/confirm enrollment status and upcoming
appointments of participating Veterans using a combination of national visual chart review using CAPRI/JLV, along with accessing enrollment and
appointment data from the CDW.
Phase 3: Post-intervention process evaluation will rely on data collected via Computer-Assisted Telephone Interview (CATI), with which our team has
extensive experience. We will recruit 76 Veteran participants, and all Veteran-identified VA providers who agree to participate. We will use 3:1 sampling. It
is anticipated that in each of the four groups, we will have appropriate representation of gender and racial/ethnic groups, but we will monitor this and use
purposeful sampling if needed. Fewer numbers of those who did not engage in VA care reflects our expectation of less variation in subgroup data. As we do
monthly EMR checks of participants, we will be able to identify provider/TPA interface initiated following WEB-ED and attempt to initiate contact within
the month following RCT interface or at 6 months post-RCT vs post-WEB-ED if they have not. We will use a convenience sample of those in each
identified comparison group, who are first able to be contacted by the study research coordinator or trained research interviewers by telephone.
Semi-structured interviews with qualitative and survey questions will be implemented from Dr. Sadler’s CATI laboratory, with established data security
and interviewer training/monitoring protocols in place for a decade. These interviews will not be recorded. Guided by CFIR, we hope to understand
participants’ perceptions of the intervention to which they were assigned with regard to ease and usefulness, need for improvements, and perceptions of
barriers/facilitators to VA and MH services receipt or provision. We will interview both those who did/did not subsequently engage in the eHealth
process/secure messaging and among these groups those who did/did not engage in VA MH care consequently. WEB-ED+ Veteran Participants will be
asked about their use of secure messaging, VA provider engagement, satisfaction with use of WEB-ED results, if their VA provider participated in SDM
with them, and satisfaction with the type of care they received. Those not activated to participate in VA care or who did not secure message results will be
asked about barriers/facilitators to this process and how we might improve this interface or MH engagement. Current WEB-ED Veterans will be asked the
same questions except for those specific to WEB-ED+. Participants from both RCT arms will be asked about satisfaction with process and care (if sought).
A Veteran process map will be developed from the Veteran’s perspective to show whether each step of the WEB-ED RCT process helped create a clear
value for them as a care customer or not. Provider/TPAs will be asked parallel questions to the Veterans- respective to each treatment arm. A Provider
process map will be developed to help us understand the specific roles of individuals in the overall system of care, i.e. the # of teams involved, if there are
bottlenecks and delays, rework that occurs in facilitating war Veterans’ access to patient-centered MH care, and the potential system impact of WEB-ED+
and perceived value to the provider/TPA.
 
VII.E
.19
Describe the compensation plan including
Compensation amount and type per visit
Total compensation
Pro-rating for early withdrawal from study
Old Value
Phase 1: Providers will receive no financial compensation for their participation.
Phase 2: $30.00 will be compensated for WEB-ED completion, and an additional $20 will be compensated for return of participant HIPAA and consent
forms allowing for consequent VA chart review and with the Veteran’s VA provider for all assigned to the RCT portion of Phase 2. Participants need to sign
and return a bank form to initiate the electronic deposit. The Bad Address Contact Call script will allow the research team to confirm the correct mailing
address to send forms to the participant. If the research team is unable to reach the Veteran by phone, the Bad Address Contact Email will be sent. The
reimbursement follow up script and email will be used to see if the participant would like reimbursement materials resent so they can be compensated.
Phase 3: $40 will be compensated for each participant (76) who completes the Phase 3 semi-structured Veteran interviews.
VII.E
.19
Describe the compensation plan including
Compensation amount and type per visit
Total compensation
Pro-rating for early withdrawal from study
New Value
Phase 1: Providers will receive no financial compensation for their participation.
Phase 2: $30.00 will be compensated for WEB-ED completion, and an additional $20 will be compensated for return of participant HIPAA and consent
forms allowing for consequent VA chart review and with the Veteran’s VA provider for all assigned to the RCT portion of Phase 2. Given a recent VA
research modification that allows us to reimburse an additional $30 to those who have already returned signed HIPAA and consent forms
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necessary to be reimbursed will be contacted about this increase in reimbursement as well as the new policy change that allows us to reimburse
$75.00 for completion of the "intervention group" requirements. Those in the RCT will be notified about this change and those newly recruited
will have this change included in their initial recruitment and consent documents. Participants need to sign and return a bank form to initiate the
electronic deposit(s). Those who have already done and are eligible for the additional reimbursement will not need to do so again. The Bad Address
Contact Call script will allow the research team to confirm the correct mailing address to send forms to the participant. If the research team is unable to
reach the Veteran by phone, the Bad Address Contact Email will be sent. The reimbursement follow up script and email will be used to see if the participant
would like reimbursement materials resent so they can be compensated.
In summary: Per project modification approval received November 2022 (attached), we are now able to provide subjects with an additional $30
for already returned signed HIPAA form and consent to participate with this study phase. We will notify previous subjects using attachment
(Phase 2 New Reimbursement postal mail and Phase 2 New Reimbursement email), and submit this request, anticipating that they should receive
this direct deposit within 4 to 8 weeks.
Because of new policy changes, we are now also able to provide subjects with an additional $75.00 upon completion of the RCT “intervention
group” steps of this research phase that involves seeing their VA provider by March 1, 2023 (as described in the consent and the encrypted study
group assignment email). Those who have returned consents and HIPAA forms for the RCT will be notified of this change and encouraged to
complete their RCT intervention steps if they have not already. Those newly recruited to the RCT will have this included in their updated Phase 2
RCT consent document.
Phase 3: $40 will be compensated for each participant (76) who completes the Phase 3 semi-structured Veteran interviews.
 
Attachments
Old Value
Attachment Name
Category
Ver
Size Type
Attached
Phase 2 RCT Informed Consent.rtf
Informed
Consent
13
304 k
E
09/13/21
Phase 2A Consent letter - Current Web-Ed.rtf
Consent Letter
9
729 k
E
07/12/21
Phase 2B Consent letter - RCT.rtf
Consent Letter
11
183 k
E
11/08/21
Sadler 2016 IIR Fall Resubmission2.pdf
Funding Source
Grant
1
11 M
E
06/22/17
Phase 3 Invitation Letter - Veterans.rtf
Recruitment
Script: Mail
8
179 k
E
09/13/21
Phase 1B Email to Leadership.rtf
Recruitment
Script: Email
7
271 k
E
03/08/19
Phase 1C Email to Key Experts.rtf
Recruitment
Script: Email
13
203 k
E
09/19/19
Phase 2 RCT Provider Recruitment Email.rtf
Recruitment
Script: Email
8
217 k
E
08/10/22
no changes made to content. Just a title change.
Phase 2 encrypted email - treatment arm RCT.rtf
Recruitment
Script: Email
1
117 k
E
09/28/21
Phase 2C Email - Current Web-Ed.rtf
Recruitment
Script: Email
13
92 k
E
11/08/21
Phase 2D RCT Recruitment Email.rtf
Recruitment
Script: Email
11
159 k
E
11/08/21
Phase 1 VA Key Informant Interview.docx
Subject Data
Collection
Instruments
4
30 k
E
03/08/19
Phase 1 Veteran Consumer Interview Revised 03-06-20.docx
Subject Data
Collection
Instruments
6
19 k
E
03/16/20
Phase1_Questions_CFIR_Constructs.pdf
Subject Data
Collection
Instruments
1
171 k
E
08/10/17
Phase3_Process_Eval_Samp_Ques.pdf
Subject Data
Collection
Instruments
1
34 k
E
08/10/17
Sadler_eSDM 2021_01_08 Programmed.docx
Subject Data
Collection
Instruments
2
78 k
E
01/14/21
Sadler_eSDM 2021_01_08 Questions.pdf
Subject Data
Collection
Instruments
1
7 M
E
01/14/21
Non-participant sociodemographic and military characteristics.docx
Screening:
Screening Log
1
13 k
E
08/24/17
7/24/24, 9:08 AM
HawkIRB
https://hawkirb.research.uiowa.edu/hawkirb/summary/forms.page?mode=pf&OID=90358380
8/38

Anger Educational Module.pdf
Miscellaneous
3
207 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Bad Contact Info Call Script and Email.docx
Miscellaneous
2
19 k
E
02/07/22
CONTACT INFORMATION FORM - Veterans.docx
Miscellaneous
2
14 k
E
01/14/21
CONTACT INFORMATION FORM.docx
Miscellaneous
4
16 k
E
07/16/19
Crisis Call Procedures-Steps for Managing Crisis Calls + Warm Transfers to VCL
2015.03.docx
Miscellaneous
1
36 k
E
08/10/17
Depression Educational Module updated links 4.20.21.pdf
Miscellaneous
4
155 k
E
05/27/21
This change is to remove broken web links and add current web links.
Encrypted email notice to Veteran.rtf
Miscellaneous
2
1 M
E
07/12/21
FAQ_eSDM Qualtrics.docx
Miscellaneous
4
17 k
E
07/12/21
FINAL Decision Aid-AUD.pdf
Miscellaneous
1
362 k
E
07/02/20
We are modifying to add the final decision aid documents that will be used in the study.
FINAL Decision Aid-Depression.pdf
Miscellaneous
1
358 k
E
07/02/20
We are modifying to add the final decision aid documents that will be used in the study.
FINAL Decision Aid-PTSD.pdf
Miscellaneous
1
319 k
E
07/02/20
We are modifying to add the final decision aid documents that will be used in the study.
Insomnia Educational Module.pdf
Miscellaneous
1
121 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Interview Sign In Sheet (1).doc
Miscellaneous
5
27 k
E
04/03/19
Intimate Partner Violence Educational Module.pdf
Miscellaneous
3
132 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
LMR SIGNED CONCURRENCE -- BY ROY FERGUSON 00240542 19-C-85212 LMR
Concurrence signed Online and Shared Decision Making Interventions for Post-Dep.pdf
Miscellaneous
1
213 k
E
06/26/19
Link Email AGS Final 03_16_2020.docx
Miscellaneous
3
37 k
E
03/16/20
Loneliness & Social Isolation Educational Module.pdf
Miscellaneous
1
243 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
MHV_Linkage_Enrollment_Flowchart.pdf
Miscellaneous
1
729 k
E
08/10/17
Military Sexual Trauma Educational Module.pdf
Miscellaneous
3
185 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Missing email notice to treatment arm RCT participants.docx
Miscellaneous
1
24 k
E
04/05/22
NON SDM 121919.docx
Miscellaneous
1
19 k
E
01/21/20
Phase 1 Confirmation Email.docx
Miscellaneous
1
35 k
E
03/06/19
Phase 1 Leadership Thank You Letter.docx
Miscellaneous
1
72 k
E
03/06/19
Phase 1 Web Link_Mailed Scheduling Template.docx
Miscellaneous
1
12 k
E
03/06/19
Phase 1G Key Expert Thank You Letter.docx
Miscellaneous
1
72 k
E
03/06/19
Phase 2 RCT missing VA enrollment reminder.rtf
Miscellaneous
4
1 M
E
09/13/21
Phase 2 RCT missing MHV premium enrollment reminder.rtf
Miscellaneous
3
1 M
E
09/09/21
Information was added to assist Veterans with enrolling in My HealtheVet secure electronic health record system.
Phase 2 RCT Provider Instructions Email.rtf
Miscellaneous
4
112 k
E
08/11/22
Phase 2 RCT missing secure messaging reminder.rtf
Miscellaneous
4
1 M
E
09/13/21
Phase 2 Thank you letter-returned forms.rtf
Miscellaneous
2
246 k
E
02/07/22
Phase 2G Incomplete Survey Email.docx
Miscellaneous
2
54 k
E
07/12/21
Phase 2H Incomplete Survey Letter.docx
Miscellaneous
2
53 k
E
07/12/21
Phase 2I Thank you letter.rtf
Miscellaneous
5
1 M
E
07/12/21
Phase 3C Thank you letter.rtf
Miscellaneous
2
1 M
E
05/28/21
Editing changes were made to provide consistent information as given in other documents used in this study and improve readability for the study
participants.
Phase2_RCT_Trmt_Arm_WEBED+_&_SDM.pdf
Miscellaneous
1
494 k
E
08/10/17
Post Traumatic Stress Disorder.pdf
Miscellaneous
3
113 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Postdeployment Family Adjustment Educational Module updated links 5.11.21.pdf
Miscellaneous
4
175 k
E
05/27/21
This change was to remove broken web links. Current web links were added.
Prescription Drug Misuse Educational Module.pdf
Miscellaneous
3
89 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Protocol_to_address_potential_risks.rtf
Miscellaneous
1
39 k
E
08/10/17
Provider Consent Notification.docx
Miscellaneous
1
16 k
E
04/05/22
Provider Info Sheet to be completed by Veteran.docx
Miscellaneous
3
15 k
E
10/05/21
RCT Control Arm letter.rtf
Miscellaneous
1
109 k
E
09/09/21
This letter informs the Veteran which arm of the study group they have been randomly assigned to and what to expect
RCT Intervention Assignment Letter.rtf
Miscellaneous
1
161 k
E
09/09/21
This letter informs the Veteran what arm of the study they have been randomly assigned to and what to expect.
REF 10-22 eSDM Summary Report Error Email Notification.docx
Miscellaneous
1
18 k
E
11/01/22
7/24/24, 9:08 AM
HawkIRB
https://hawkirb.research.uiowa.edu/hawkirb/summary/forms.page?mode=pf&OID=90358380
9/38

This is the email to be sent notifying subjects of the incorrect blank template that they received in error. This document was also included as an
attachment in the reportable event form.
Recruitment Scripts.docx
Miscellaneous
21
52 k
E
08/10/22
separated out the Teams script from the telephone call script.
Reimbursement Follow-up Email_Revised - Final.docx
Miscellaneous
3
36 k
E
05/13/22
Requested Resources Email Scripts.docx
Miscellaneous
1
20 k
E
02/07/22
SDM Provider Animation 121919.docx
Miscellaneous
1
14 k
E
01/21/20
SDM Veteran animation 121919.docx
Miscellaneous
1
13 k
E
01/21/20
Sadler HSRD HX002185-01A2- Union Information with interview questions.pdf
Miscellaneous
1
120 k
E
06/26/19
Sample_WEB_ED_Neg_Screen.pdf
Miscellaneous
1
90 k
E
08/10/17
Sample_WEB_ED_Pos_Screen.pdf
Miscellaneous
1
169 k
E
08/10/17
Screening Summary - Secure Message.rtf
Miscellaneous
4
103 k
E
10/25/21
Skype Script.docx
Miscellaneous
1
14 k
E
06/26/19
Social Determinants of Health Educational Module.pdf
Miscellaneous
1
250 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Study_Q&A - Current Web-Ed.rtf
Miscellaneous
5
86 k
E
09/13/21
Substance & Alcohol Misuse Educational Module.pdf
Miscellaneous
3
151 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Suicide Prevention Educational Module.pdf
Miscellaneous
1
158 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
To share with Provider.rtf
Miscellaneous
1
65 k
E
07/22/21
This form will enable the Veteran to indicate which screening results they are most concerned about and would like to discuss with their health care
provider.
Traumatic Brain Injury Educational Module updated links 4.20.21.pdf
Miscellaneous
5
160 k
E
05/27/21
This change was to remove broken web links and add active links to online information.
VA10091 05.22.17.pdf
Miscellaneous
1
811 k
E
08/10/17
assurance-document.pdf
Assurance
Document
1
39 k
E
08/09/17
 
New Value
New Attachment Version Attachment Name
Category
Ver
Size Type
Attached
*
Phase 2 RCT Informed Consent 12-14-22.rtf
Informed
Consent
16 307 k
E
12/19/22
Phase 2A Consent letter - Current Web-Ed.rtf
Consent Letter
9 729 k
E
07/12/21
*
Phase 2B Consent letter - RCT.rtf
Consent Letter
13 184 k
E
12/19/22
*
ORD-ProjectModification_Sadler_IIR_16-096_September2022_ rwob
for LC sig-lmc.pdf
Funding
Source Grant
1
1 M
E
12/14/22
Sadler 2016 IIR Fall Resubmission2.pdf
Funding
Source Grant
1 11 M
E
06/22/17
Phase 3 Invitation Letter - Veterans.rtf
Recruitment
Script: Mail
8 179 k
E
09/13/21
Phase 1B Email to Leadership.rtf
Recruitment
Script: Email
7 271 k
E
03/08/19
Phase 1C Email to Key Experts.rtf
Recruitment
Script: Email
13 203 k
E
09/19/19
Phase 2 RCT Provider Recruitment Email.rtf
Recruitment
Script: Email
8 217 k
E
08/10/22
no changes made to content. Just a title change.
Phase 2 encrypted email - treatment arm RCT.rtf
Recruitment
Script: Email
1 117 k
E
09/28/21
Phase 2C Email - Current Web-Ed.rtf
Recruitment
Script: Email
13
92 k
E
11/08/21
*
Phase 2D RCT Recruitment Email.rtf
Recruitment
Script: Email
13 186 k
E
12/19/22
Phase 1 VA Key Informant Interview.docx
Subject Data
Collection
Instruments
4
30 k
E
03/08/19
Phase 1 Veteran Consumer Interview Revised 03-06-20.docx
Subject Data
Collection
Instruments
6
19 k
E
03/16/20
Phase1_Questions_CFIR_Constructs.pdf
Subject Data
Collection
Instruments
1 171 k
E
08/10/17
Phase3_Process_Eval_Samp_Ques.pdf
Subject Data
Collection
1
34 k
E
08/10/17
7/24/24, 9:08 AM
HawkIRB
https://hawkirb.research.uiowa.edu/hawkirb/summary/forms.page?mode=pf&OID=90358380
10/38

Instruments
Sadler_eSDM 2021_01_08 Programmed.docx
Subject Data
Collection
Instruments
2
78 k
E
01/14/21
Sadler_eSDM 2021_01_08 Questions.pdf
Subject Data
Collection
Instruments
1
7 M
E
01/14/21
Non-participant sociodemographic and military characteristics.docx
Screening:
Screening Log
1
13 k
E
08/24/17
Anger Educational Module.pdf
Miscellaneous
3 207 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Bad Contact Info Call Script and Email.docx
Miscellaneous
2
19 k
E
02/07/22
*
CHART REVIEW 12-14-22.docx
Miscellaneous
1
25 k
E
12/16/22
CONTACT INFORMATION FORM - Veterans.docx
Miscellaneous
2
14 k
E
01/14/21
CONTACT INFORMATION FORM.docx
Miscellaneous
4
16 k
E
07/16/19
Crisis Call Procedures-Steps for Managing Crisis Calls + Warm
Transfers to VCL 2015.03.docx
Miscellaneous
1
36 k
E
08/10/17
Depression Educational Module updated links 4.20.21.pdf
Miscellaneous
4 155 k
E
05/27/21
This change is to remove broken web links and add current web links.
Encrypted email notice to Veteran.rtf
Miscellaneous
2
1 M
E
07/12/21
FAQ_eSDM Qualtrics.docx
Miscellaneous
4
17 k
E
07/12/21
FINAL Decision Aid-AUD.pdf
Miscellaneous
1 362 k
E
07/02/20
We are modifying to add the final decision aid documents that will be used in the study.
FINAL Decision Aid-Depression.pdf
Miscellaneous
1 358 k
E
07/02/20
We are modifying to add the final decision aid documents that will be used in the study.
FINAL Decision Aid-PTSD.pdf
Miscellaneous
1 319 k
E
07/02/20
We are modifying to add the final decision aid documents that will be used in the study.
*
Follow up script with RCT new reimbursement.docx
Miscellaneous
1
17 k
E
12/14/22
Insomnia Educational Module.pdf
Miscellaneous
1 121 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Interview Sign In Sheet (1).doc
Miscellaneous
5
27 k
E
04/03/19
Intimate Partner Violence Educational Module.pdf
Miscellaneous
3 132 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
LMR SIGNED CONCURRENCE -- BY ROY FERGUSON 00240542
19-C-85212 LMR Concurrence signed Online and Shared Decision
Making Interventions for Post-Dep.pdf
Miscellaneous
1 213 k
E
06/26/19
Link Email AGS Final 03_16_2020.docx
Miscellaneous
3
37 k
E
03/16/20
Loneliness & Social Isolation Educational Module.pdf
Miscellaneous
1 243 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
MHV_Linkage_Enrollment_Flowchart.pdf
Miscellaneous
1 729 k
E
08/10/17
Military Sexual Trauma Educational Module.pdf
Miscellaneous
3 185 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Missing email notice to treatment arm RCT participants.docx
Miscellaneous
1
24 k
E
04/05/22
NON SDM 121919.docx
Miscellaneous
1
19 k
E
01/21/20
Phase 1 Confirmation Email.docx
Miscellaneous
1
35 k
E
03/06/19
Phase 1 Leadership Thank You Letter.docx
Miscellaneous
1
72 k
E
03/06/19
Phase 1 Web Link_Mailed Scheduling Template.docx
Miscellaneous
1
12 k
E
03/06/19
Phase 1G Key Expert Thank You Letter.docx
Miscellaneous
1
72 k
E
03/06/19
Phase 2 RCT missing VA enrollment reminder.rtf
Miscellaneous
4
1 M
E
09/13/21
*
Phase 2 New RCT Reimbursement email notification.docx
Miscellaneous
2
24 k
E
12/19/22
*
Phase 2 New Reimbursment postal mail.docx
Miscellaneous
1
21 k
E
12/14/22
Phase 2 RCT missing MHV premium enrollment reminder.rtf
Miscellaneous
3
1 M
E
09/09/21
Information was added to assist Veterans with enrolling in My HealtheVet secure electronic health record system.
Phase 2 RCT Provider Instructions Email.rtf
Miscellaneous
4 112 k
E
08/11/22
Phase 2 RCT missing secure messaging reminder.rtf
Miscellaneous
4
1 M
E
09/13/21
*
Phase 2 Thank you letter-returned forms.rtf
Miscellaneous
4 247 k
E
12/19/22
Phase 2G Incomplete Survey Email.docx
Miscellaneous
2
54 k
E
07/12/21
Phase 2H Incomplete Survey Letter.docx
Miscellaneous
2
53 k
E
07/12/21
Phase 2I Thank you letter.rtf
Miscellaneous
5
1 M
E
07/12/21
Phase 3C Thank you letter.rtf
Miscellaneous
2
1 M
E
05/28/21
Editing changes were made to provide consistent information as given in other documents used in this study and improve readability for the study
participants.
Phase2_RCT_Trmt_Arm_WEBED+_&_SDM.pdf
Miscellaneous
1 494 k
E
08/10/17
Post Traumatic Stress Disorder.pdf
Miscellaneous
3 113 k
E
07/02/20
7/24/24, 9:08 AM
HawkIRB
https://hawkirb.research.uiowa.edu/hawkirb/summary/forms.page?mode=pf&OID=90358380
11/38

We are modifying to add the final educational documents that will be used in the study.
Postdeployment Family Adjustment Educational Module updated links
5.11.21.pdf
Miscellaneous
4 175 k
E
05/27/21
This change was to remove broken web links. Current web links were added.
Prescription Drug Misuse Educational Module.pdf
Miscellaneous
3
89 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Protocol_to_address_potential_risks.rtf
Miscellaneous
1
39 k
E
08/10/17
Provider Consent Notification.docx
Miscellaneous
1
16 k
E
04/05/22
Provider Info Sheet to be completed by Veteran.docx
Miscellaneous
3
15 k
E
10/05/21
RCT Control Arm letter.rtf
Miscellaneous
1 109 k
E
09/09/21
This letter informs the Veteran which arm of the study group they have been randomly assigned to and what to expect
*
RCT Intervention Assignment Letter.rtf
Miscellaneous
3 187 k
E
12/19/22
REF 10-22 eSDM Summary Report Error Email Notification.docx
Miscellaneous
1
18 k
E
11/01/22
This is the email to be sent notifying subjects of the incorrect blank template that they received in error. This document was also included as an
attachment in the reportable event form.
*
Recruitment Scripts.docx
Miscellaneous
23
66 k
E
12/19/22
Reimbursement Follow-up Email_Revised - Final.docx
Miscellaneous
3
36 k
E
05/13/22
Requested Resources Email Scripts.docx
Miscellaneous
1
20 k
E
02/07/22
SDM Provider Animation 121919.docx
Miscellaneous
1
14 k
E
01/21/20
SDM Veteran animation 121919.docx
Miscellaneous
1
13 k
E
01/21/20
Sadler HSRD HX002185-01A2- Union Information with interview
questions.pdf
Miscellaneous
1 120 k
E
06/26/19
Sample_WEB_ED_Neg_Screen.pdf
Miscellaneous
1
90 k
E
08/10/17
Sample_WEB_ED_Pos_Screen.pdf
Miscellaneous
1 169 k
E
08/10/17
Screening Summary - Secure Message.rtf
Miscellaneous
4 103 k
E
10/25/21
Skype Script.docx
Miscellaneous
1
14 k
E
06/26/19
Social Determinants of Health Educational Module.pdf
Miscellaneous
1 250 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
*
Study_Q&A - Current Web-Ed.rtf
Miscellaneous
7
87 k
E
12/19/22
Substance & Alcohol Misuse Educational Module.pdf
Miscellaneous
3 151 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Suicide Prevention Educational Module.pdf
Miscellaneous
1 158 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
To share with Provider.rtf
Miscellaneous
1
65 k
E
07/22/21
This form will enable the Veteran to indicate which screening results they are most concerned about and would like to discuss with their health care
provider.
Traumatic Brain Injury Educational Module updated links 4.20.21.pdf
Miscellaneous
5 160 k
E
05/27/21
This change was to remove broken web links and add active links to online information.
VA10091 05.22.17.pdf
Miscellaneous
1 811 k
E
08/10/17
assurance-document.pdf
Assurance
Document
1
39 k
E
08/09/17
Asterisk indicates modified attachment.
Enrollment as Reported on Previous Forms
Type
Approval Date Total Subjects Approved by IRB Total Subjects Reported Enrollment Stopped
Mod
06/07/24
2060
Mod/CR 02/29/24
2060
1601
Yes
Mod
12/07/23
2060
Mod
11/15/23
2060
Mod
11/02/23
2060
Mod
08/02/23
2060
Mod
06/28/23
2060
Mod
05/12/23
2060
Mod
03/24/23
2060
Mod/CR 03/21/23
2060
1575
No
Mod
01/12/23
2060
Mod
12/22/22
2060
Mod
12/16/22
2060
Mod
11/21/22
2060
Mod
11/02/22
2060
Mod
10/06/22
2060
7/24/24, 9:08 AM
HawkIRB
https://hawkirb.research.uiowa.edu/hawkirb/summary/forms.page?mode=pf&OID=90358380
12/38

Type
Approval Date Total Subjects Approved by IRB Total Subjects Reported Enrollment Stopped
Mod
09/08/22
2060
Mod
08/11/22
2060
Mod
07/20/22
2060
Mod
07/13/22
2060
Mod
07/13/22
2060
Mod
06/14/22
2060
Mod
05/13/22
2060
Mod/CR 04/05/22
2060
631
No
Mod
03/29/22
2060
Mod
03/15/22
2060
Mod
03/14/22
2060
Mod
02/24/22
2060
Mod
02/07/22
2060
Mod
11/30/21
2060
Mod
11/19/21
2060
Mod
11/08/21
2060
Mod
10/25/21
2060
Mod
10/08/21
2060
Mod
10/04/21
2060
Mod
09/20/21
2060
Mod
09/13/21
2060
Mod
08/06/21
2060
Mod
07/29/21
2060
Mod
07/12/21
2060
CR
05/02/21
36
No
Mod
04/08/21
2060
Mod
01/29/21
2060
Mod
09/11/20
2060
Mod
08/31/20
2060
Mod
07/07/20
2060
Mod
06/18/20
2060
Mod
06/16/20
2060
Mod
06/03/20
2060
CR
06/01/20
36
No
Mod
05/21/20
2060
Mod
05/05/20
2060
Mod
03/16/20
2060
Mod
02/21/20
2060
Mod
02/16/20
2060
Mod
02/03/20
2060
Mod
01/23/20
2060
Mod
01/02/20
2060
Mod
09/19/19
2060
Mod
09/05/19
2060
Mod
08/19/19
2060
Mod
07/24/19
2060
Mod
07/16/19
2060
CR
07/02/19
0
No
Mod
07/01/19
2060
Mod
04/03/19
2060
Mod
03/08/19
2060
Mod
09/17/18
2060
Mod/CR 08/13/18
2060
0
No
Mod
06/08/18
2060
Mod
05/10/18
2060
New
09/06/17
2060
Form Content
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I. Project Introduction
I.1
Project to be reviewed by:
IRB-03 VA Only
I.2
Project Title:
Online and Shared Decision-Making Interventions to Engage Service Men and Women in Post-Deployment Mental Health
Care
I.3
Short Title (optional):
eSDM
I.4
Provide a short summary of the purpose and procedures of the study proposed in this IRB application.
DO NOT include information on studies not proposed in this application.
Use LAY terminology only. This must be easily understandable by IRB community members and nonscientists.
DO NOT cut and paste technical abstracts from funding applications that may not be understood by a general
audience.
This study is a randomized controlled trial using mixed quantitative and qualitative methods. In Aim 1 we will obtain key
informant feedback in order to a) refine our current WEB-ED online screening and Shared Decision-Making protocols, and b)
conduct process mapping that documents site-specific processes of engaging OEF/OIF/OND Veterans in VA and VA MH care
as they currently exist. In Aim 2 we will conduct a randomized controlled trial (RCT) to test the effectiveness of “Enhanced”
vs. “Current” WEB-ED in increasing Veteran engagement in VA MH care and a SDM interface with their providers. For Aim 3
we will use qualitative methods in a process evaluation to determine the acceptability of our WEB-ED+ intervention to RCT
participants, their providers, and other key informants, identify facilitators and barriers to incorporating WEB-ED+ into the
EMR, and determine perceived differences in Veteran VA and MH care engagement based on feedback from WEB-ED+
participants and their providers. To optimize the successful completion of this study, we will build upon our work with the
HSR&D Women’s Health Practice Based Research Network (PBRN) to leverage the research infrastructure and clinical
relationships already in place at study sites. This established PBRN and the network from our current HSR&D CREATE study
will also facilitate access to key local informants. It will also facilitate our knowledge of site-specific VA services to enhance
our understanding of processes of VA access to mental health (MH) care for war Veterans across sites. This grant is
administered completely virtually from the Iowa City VA Health Care System. The sites outside of the Iowa City VA are not
engaged in this research. There are three consecutive phases to this study that correspond with each aim.
In summary, phase 1 involves qualitative interviews with key stakeholders/informants; phase 2 involves online intervention
(Web-Ed) and RCT; phase 3 involves process evaluation post-intervention, which will involve data collected via Computer-
Assisted Telephone Interview (CATI) to determine intervention effectiveness via semi-structured telephone interviews. Chart
review will be performed 6 months post phase 2 web intervention. For the WEB-ED in phase 2, if the subject is eligible per the
pre-consent screening questions, the informed consent for this online process is integrated into the web-based subject education
and participants acknowledge (“click approval”) that they have reviewed this prior to participation (attachment 2A Consent
Letter - Current Web-Ed). This online document containing the elements of consent will contain the same information as the
mailed document and will also inform participants that they may be invited to participate in a subsequent study phase that will
address VA and post-deployment care access.
Veteran participants will provide consent for RCT portion of phase 2 (as assigned), the phase 3 telephone interview, and chart
review by signing and returning via mail the consent and HIPAA forms prior to participating in the RCT portion of phase 2.
For those who participate in the first part of phase 2 and are eligible for the RCT portion of the study, they will be asked online
at WEB-ED completion for permission to re-contact them about continuing their participation in the RCT (Web-Ed+). Those
who indicate yes will be sent IRB approved study information, including the RCT consent letter (2B), consent and HIPAA
forms attached to this application. Those who decline will be thanked again for their participation and contact will be
discontinued.
I.5
Specify your research question(s), study aims or hypotheses (do not indicate "see protocol")
Specific Aim #1: To obtain key stakeholder perspectives regarding refinement of WEB-ED, including enhancement with
shared-decision making (SDM) interventions, linkage with MyHealtheVet (MHV), and VA enrollment materials.
Specific Aim #2: To conduct a randomized controlled trial (RCT) to test differences in VA MH care engagement among screen-
positive male and female Veterans randomly assigned to 1) Enhanced WEB-ED (WEB-ED+) integrating online VA and MHV
enrollment, secure messaging of screening results, SDM educational video clips for Veteran and providers and decision aids for
depression, PTSD and substance use disorder or 2) Current WEB-ED.
Hypothesis 2a: Veterans assigned to WEB-ED+ will be more likely to engage in VA MH care and indicate greater satisfaction
with their care engagement.
Exploratory Hypothesis 2b: Veterans who have multiple positive MH screens and who score low on the Patient Activation
Measure will be more likely to engage in VA care if they are assigned to WEB-ED+.
Exploratory Hypothesis 2c: Measures of improved access and MH care engagement will be similar for male and female
Veterans within RCT arms.
Exploratory Hypothesis 2d: Rural Veterans will be more likely to demonstrate improved access and MH care engagement
relative to urban Veterans regardless of RCT arm assignment.
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Specific Aim # 3: To elicit feedback from key stakeholders in both arms of the RCT (WEB-ED+ vs. Current WEB-ED)
regarding 1) the usefulness of an eHealth interface, 2) perceptions of how the interventions influenced patient access to and
efficiency of VA patient-centered care delivery, and 3) Veteran and provider satisfaction; and to document the VA processes
Veterans used to enroll and engage in VA care.
Online screening, tailored education, and links to geographically accessible VA resources has been shown to be preferred by
Veterans, providing recognition of treatable post-deployment MH concerns, and education that reduces stigma. This study
builds upon and augments this prior work with research to understand and evaluate the processes needed to integrate WEB-
ED+ into current VHA systems to support efficient care delivery, facilitate patient-centered care, and address unmet need for
MH care while also resolving disparities in VA MH care access and engagement for war Veterans. We postulate that WEB-
ED+’s enhancement with shared decision-making will be a key component for promoting and sustaining these benefits. WEB-
ED+ represents a readily implementable and cost-effective intervention that, with partner collaboration, can be integrated into
VA systems through MyHealtheVet (MHV). VA Central Office offices awaiting results of this RCT to inform potential broader
adoption of WEB-ED+ to help address high priority system needs include the Offices of: MH Services, MyHealtheVet, Rural
Health, Primary Care Services, Transition and Care Management, Military Sexual Trauma, Web Services, Women Veteran’s
Strategic Healthcare Group, Women’s Health Innovation, Family Services.
I.6
Background and significance and/or Preliminary studies related to this project.
(do not indicate "see protocol")
Mental health conditions are prevalent in OEF/OIF/OND war Veterans, but many do not seek care. OEF/OIF/OND Veterans
experience complex mental health (MH) consequences of deployment(s). Almost a third (32%) of OEF/OIF Veterans in the VA
have received a MH diagnosis; PTSD is the most prevalent condition, followed by substance abuse and then depression.
OEF/OIF servicewomen have high levels of combat exposures, only slightly lower than men, yet gender differences of the
impact of these stressors appear to be minimal. A RAND study of a community sample of OEF/OIF war Veterans found rates
of MH disorders similar to VA populations, however, only half of OEF/OIF war Veterans meeting criteria for current PTSD or
major depression had sought help from a provider for a MH problem in the past year. In a study of almost 50,000
Iraq/Afghanistan Veterans with newly diagnosed PTSD, only a minority (9.5%) received the recommended number and
intensity of VA MH treatment sessions within the first year.
Barriers to seeking MH care are well-documented. Stigma and not being able to admit to having a problem or ask for help
impede Veterans’ willingness to seek needed care. Veterans who have not used VA services report not knowing what benefits
are available to them or how to access them. Veterans who have used VA health care identify long waiting periods as one of the
greatest barriers to accessing MH services. Care disparities may be further compounded for those who reside in rural locations.
Recent era Veterans who wait longer to get outpatient MH treatment have been found to live geographically further from a VA
and to be less likely to have improvement in their symptoms of PTSD compared to peers who live closer and seek care sooner.
This is of particular concern given approximately 41% of the Veteran population are rural residents and research indicates rural
Veterans have lower MH-related quality of life. Our research on Veterans eligible for Choice (Veterans Access, Choice, and
Accountability Act of 2014) because of distance barriers to VA care have found that few Veterans had closer access to
Community MH Centers. The percent of Veterans living more than 40 miles from their nearest VA health facility who had
access to a Community MH Center ranged from 3% to 34% across MyVA Regions.
Online health screening, education, and interventions are effective. There is a recent and growing precedent of using web-based
interventions in high risk populations, including interventions that identify MH conditions (e.g., substance abuse, PTSD) and
focus on behavior change to promote patient engagement in care. Research investigating online treatment of PTSD suggests
that there may be greater follow through with internet-based approaches, which further supports the need for finding creative
ways of safely extending education and services beyond traditional methods. The Department of Defense (DoD) provides
online feedback to service members on topics ranging from assessments (e.g., post-deployment health) to educational resources
(e.g., health promotion).
Online health education and interventions are preferred. VA-enrolled OEF/OIF combat Veterans report a preference to seek
readjustment services or information over the internet (53%) and virtually all (97%) have internet use. The majority of
OEF/OIF Veterans are computer-literate, and many use the internet as a daily part of their lives. A recent study found that most
Veterans with a MH diagnosis who are engaged in VA care had access to an internet capable device (cell phones and computer)
and are interested in using technology for healthcare-related communications.
Informed patients have improved engagement, satisfaction, and outcomes. Information plays a critical role in helping patients
become aware of their treatment needs, options, and effective self-care strategies. A lack of knowledge about PTSD, its causes,
and available treatments have been identified as important barriers to help-seeking among Veterans. Conversely, considerable
evidence suggests that patients who are better informed about their medical/MH conditions and treatment tend to have more
favorable outcomes. For example, having adequate information about one’s medical condition is associated with better
adherence to treatment recommendations. Patients who are better informed tend to be more satisfied with their care and
experience reduced uncertainty and anxiety regarding treatment. Patient-provider communication patterns involving more
information-sharing on the part of the provider have also been associated with greater patient satisfaction, knowledge, and
adherence as well as better health outcomes.
Engaging patients in shared decision-making (SDM) improves MH care satisfaction and outcomes. SDM, considered the
“pinnacle of patient-centered care,” involves clinicians and patients participating together in the decision-making process,
discussing treatment preferences, and reaching agreement about treatment choice. Such a participatory care model of decision-
making is a central theme of many evidence-based psychosocial MH treatments and a core component of the chronic care
model. Improved health outcomes and patient satisfaction of MH consumers have been associated with SDM. Both men and
women report improved patient satisfaction with SDM and MH care receipt. Furthermore, improved self-management of MH
conditions has been found, e.g., greater follow-through with treatment plans, and improved therapeutic alliances with
clinicians.
Implementation of SDM into routine clinical practice is needed. Currently personal health records (PHR) have little data about
patients’ health preferences, with the exception of end of life decisions. Integration of SDM, as a part of Meaningful Use
regulations, is gaining recognition as feasible and necessary. However, more work needs to be done to overcome difficulties
implementing SDM into routine practice because of the time required, lack of explanation on using decision aids, and need for
electronic medical record (EMR) inclusion.
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Technology efficiently supports access to MH care and population health. There is growing evidence that eHealth tools have
the capability to promote health and overcome stigma. MH care stigma frequently results in delays and suboptimal use of care.
The Institute of Medicine (IOM) 2001 report, “Crossing the Quality Chasm,” notes that technology can reshape healthcare
delivery and recommends that “access to care should be provided over the internet, by telephone, and by other means in
addition to in person visits.” A web-interface for Veterans to screen for common post-deployment readjustment and MH
conditions, at any time and any place, offers a substantial advantage to Veterans who are returning from war and who are
unsure if their symptoms are treatable conditions or lack knowledge about VA services available to them. Enabling this priority
population’s ability to confidentially screen, then enroll in VA and My HealtheVet (MHV), in order to communicate screening
results to VA OEF/OIF/OND Transition Patient Advocates (TPA) or providers has great potential to address unmet need and
recognized barriers to VA MH care.
Existing VA technology can be leveraged to promote Veteran access to VA MH care. Within VHA, MHV (My HealtheVet
Program Office) is an online PHR available to all Veterans. This PHR can 1) facilitate Veterans’ ability to maintain a
comprehensive medical history in one place; 2) monitor and promote positive health behaviors; and 3) for those who enroll in
VA and become MHV premium members, confidentially message VA providers or care managers to engage more actively in
their own care. This PHR has the capability of improving engagement, safety, satisfaction, and health outcomes. PHRs also can
provide patients with ownership of their health information so they can share it with multiple providers. Within VHA, only
about 20% of Veterans receiving services are registered on MHV. While a majority of Veterans use the internet, only about a
quarter of VA MH service users and a fifth of VA general service users access the MHV website for their personal health care.
This slow adoption is similar to that in non-VA health care systems. It is encouraging that a qualitative study found that
Veterans seeing their records positively affects communication with providers and the health system, enhances knowledge of
their health and improved self-care, and allows for greater participation in their care and decision-making regarding when to
seek care. Non-VA patients given access to a website allowing a shared medical record report high adoption and satisfaction.
VA is promoting VA provider adoption of MHV secure messaging. The 2014 MHV advance allowing secure messaging with
providers offered a great opportunity to improve Veteran-provider communication. In April 2016, VA began allowing staff to
obtain workload credit, or increments of time, for MHV secure messages they complete and save into CPRS as progress notes.
One study with VA providers found that those who attain workload benefits from secure messaging are more likely to adopt
use. Secure messaging has been found to increase patient-provider communication and patient activation while at the same
time reducing in-person visits and telephone contacts.
Technology can address the needs of vulnerable Veteran sub-populations. A recent literature review found that women who
have experienced military sexual trauma (MST) experience high levels of organizational distrust, social isolation, and self-
perceived stigma which create a significant barrier for participation in treatment and community reintegration. Authors
concluded that the use of internet technologies show promise among MST survivors not only as therapeutic tools but also as
effective outreach to identify and connect with those difficult to reach. The VHA Handbook (1330.01) indicates that VA
women’s health care should be delivered in environments that attend to their dignity, safety, and privacy. For some, this
environment might be their home as they begin their VA care journey. This work also has implications for males experiencing
MST and other forms of trauma.
The PI and her team have studied post-deployment readjustment and MH care access for the past seven years. Findings across
five studies show participant age, VA enrollment, military characteristics, and MH screening results are similar for men and
women, demonstrating generalizability and eligibility.
Study I: Most participants did not know their post-deployment symptoms were treatable psychiatric conditions. Phase 1
involving 18 focus groups with OEF/OIF service members (65 women/33 men) found most participants: 1) had received no
information about VA eligibility or how to access VA services, and 2) frequently noted concerns with post-deployment
adjustment, e.g., family re-adjustment. In the Phase 2 cross-sectional study, we found that among Reserve and National Guard
(RNG) servicewomen (n=665), most chose not to seek care. Almost 80% did not use MH care in the past year despite
psychiatric problems at rates consistent with other studies of post-deployment Veterans. This gap in receipt of care occurred
despite women’s belief that MH counseling can help (82%) and that VA MH providers could better understand their problems
(91%).
Study II: Online interventions can be successfully implemented within VA and can decrease RNG servicewomen’s discomfort
with seeking MH care. Dr. Sadler demonstrated feasibility of conducting online interventions behind the VA firewall. One-third
(31%) of participants reported that the web-based screening and education (WEB-ED) reduced their reluctance to seek MH
care.
Study III: Servicewomen (82%) would like their WEB-ED screening results linked to a VA secure network (such as MHV) to
facilitate VA provider access to the results, and would be more likely to ask questions or secure message a VA provider about
their screens if available in MHV (77%). We found that of 214 RNG women returning from deployment to Iraq or Afghanistan,
83% screened positive on at least one screen, averaging three positive screens for MH conditions. Thus, WEB-ED is
effectively reaching a high-risk population with substantial MH consequences from service. Only 16% of the total sample had
received VA MH care following their most recent deployment, of which 16% was from a community facility.
Study IV: Servicemen’s screening results were not significantly different from servicewomen’s with regard to MH complexity,
post-deployment concerns, and care seeking. Co-Investigator Dr. Mengeling implemented WEB-ED with a Midwestern cohort
of RNG OEF/OIF/OND servicemen (N= 200), finding that over half (57%) expressed concern about their post-deployment
adjustment but < 20% sought MH care.
Study V: Half of servicewomen participants indicated that as a direct result of WEB-ED, they will follow up with a provider.
Women reported higher satisfaction and intent to seek needed PTSD treatment when they talked by telephone about WEB-ED
results and engaged in SDM about treatment options with a MH nurse. Dr. Sadler’s current HSR&D CREATE study with
active component and RNG post-deployed servicewomen (n=1,104) found WEB-ED outcomes remain consistent with prior
findings of high-risk populations, but in a sample of increased diversity (38% non-white). Veterans continue to want a direct
interface (e.g., MHV) to communicate their WEB-ED/SDM results to a VA provider to facilitate discussion. Using the Patient
Activation Measure, we found that compared to PCL-5 PTSD+ women, PTSD- women were more likely to have high
activation (“taking action”/“pushing further” (71% vs 40%). PTSD+ women were more likely to feel “disengaged &
overwhelmed”/“aware but struggling” (60% vs 28%). This emphasizes the need for Veteran empowerment through information
about their MH conditions, treatment options, and SDM.
In summary, available literature combined with our extensive prior studies have set the stage for our proposed study, focused
on using technology to increase Veterans’ access to and engagement in VA MH care and to promote a SDM interface between
Veterans and VA practitioners.
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II.3
The Principal Investigator of this study is:
Staff
II.5
Select research team member who is the primary contact for study participants.
Anne Sadler
III. Funding/Other Support
III.1
Funding Sources
Source Entered as Text DSP Link
Type
Source
Project Title Name of PI on Grant Status
Source is entered as text no
Federal Agency US Department of Veterans Affairs
Online and
Shared
Decision-
Making
Interventions
to Engage
Service Men
and Women
in Post-
Deployment
Mental
Health Care
Anne G. Sadler,
Ph.D., R.N.
* new source name
III.2
What type of funding agreement would be completed?
Iowa City VAMC

III.5
What is the current status of this funding source?
Source
Status Other Status Description
US Department of Veterans Affairs Awarded
IV. Project Type
IV.1
Do you want the IRB to give this project
Regular (expedited or full board) review
IV.2
Enter the date you will be ready to begin screening subjects/collecting data for this project. (If you do not have a specified
date, add "upon IRB approval")
October 2017
IV.3
Are you requesting a waiver of informed consent/authorization (subjects will not be given any oral or written information
about the study)?
No
V. Other Committee Review
V.1
Does this project involve any substance ingested, injected, or applied to the body?
Do not answer yes, if the involvement includes a device, wire, or instrument
No
V.2
Are any contrast agents used for any purpose in this study?
No
V.9
Will any subject be asked to undergo a diagnostic radiation procedure (including radiographic, nuclear medicine, DEXA)?
No
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V.14
Will any subject be asked to undergo a radiation therapy procedure (including external beam therapy, brachytherapy, or nuclear
medicine therapy)?
No
V.20
Does this project involve the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from
recombinant or synthetic nucleic acid molecules, into one or more human research participant?
No
VI. Subjects
VI.1
How many adult subjects do you expect to consent or enroll for this project?
2060
VI.2
What is the age of the youngest adult subject?
18.0
VI.3
What is the age of the oldest adult subject?
60.0
VI.4
What is the percentage of adult male subjects?
60
VI.5
What is the percentage of adult female subjects?
40
VI.6
How many minor subjects do you expect to consent or enroll for this project?
0
VI.13
Describe EACH of your subject populations
Include description of any control group(s)
Specify the Inclusion/Exclusion criteria for EACH group
Phase 1: Key Informant Interviews: A total of 60 interviews (12 individuals selected at each of 5 PBRN sites) will be conducted. Key
informant roles include: Primary Care-Mental Health Integration (PCMHI) providers (n=1-2), PC and/or MH providers(n=2),
PCMHI or PC and MH case managers (n=1-2), MHV champion (n=1), Enrollment Specialists (n=1), OEF/OIF/OND Transition
Patient Advocates (TPA) (n=1-2) and OEF/OIF/OND Veterans (n=4-5). An effort will be made to have a gender mix of key
informants. VA personnel can be identified through VA national websites and our PBRN site leads. We will use site Veteran Panels to
engage OEF/OIF/OND male and female war Veterans when possible, as well as using our Veteran registry obtained VADIR to
identify Veterans who are and are not currently VA engaged, respectively. Due to delays related to COVID-19, the team has decided
to move forward with the data collected for phase one, and not to collect any one-to-one Veteran interviews for that phase. VINCI is a
partner with the Corporate Data Warehouse (CDW) and hosts all data available through CDW as well as some unique data. VADIR is
the VA group that interfaces with Defense Manpower Data Center to obtain sample characteristics of service members/Veterans,
including postal and military e-mail addresses, and work/home telephone numbers.
Phase 2: Randomized Controlled Trial: Participants will include two overlapping populations of OEF/OIF/OND male and female
Veterans eligible for VA care, which we will randomly sample from two overlapping populations. The first group includes those who
returned from deployment to Iraq or Afghanistan within the preceding four years and who reside within the catchment areas of one of
our 10 study sites (identified by zip code). We want to ensure that those who participate and screen positive on one or more of the
screens have access to VA care. Consequently, we have selected the time frame of 4 years post-deployment because these Veterans
have priority access to VA care for five years after their most recent deployment. The second group is OEF/OIF/OND Veterans who
are already enrolled in VA care and will not be excluded if they have been home from deployment more than four years. We are doing
purposeful sampling to achieve sufficient numbers of men vs women and we will work with VINCI/VADIR to have a sample
representative by gender and race consistent with the current OEF/OIF/OND post-deployment populations. Veteran contact
information will be provided by the VA Informatics and Computing Infrastructure (VINCI)/VA-DoD Data Identification Repository
(VADIR). VINCI/VADIR and Dr. Sadler have a successful working relationship for prior grants. Given lessons learned from our
preceding grants we have revised our VINCI/VADIR registry requirements to sample potential participants with both e-mail and
postal mail. VINCI/VADIR is able to provide sociodemographic and military information (e.g. age, marital status, race, rank, number
of deployments) that will subsequently allow us to compare study participants with refusers and non-responders. This will facilitate
follow up and better analysis of the generalizability of findings.
Phase 3: Process evaluation: Post-intervention process evaluation will rely on data collected via Computer-Assisted Telephone
Interview (CATI), with which our team has extensive experience. We will recruit 76 Veteran participants, and all Veteran-identified
VA providers who agree to participate. We will use 3:1 sampling. It is anticipated that in each of the four groups, we will have
appropriate representation of gender and racial/ethnic groups, but we will monitor this and use purposeful sampling if needed. Fewer
numbers of those who did not engage in VA care reflects our expectation of less variation in subgroup data. As we do monthly EMR
checks of participants, we will be able to identify provider/TPA interface initiated following WEB-ED and attempt to initiate contact
within the month following RCT interface or at 6 months post-RCT vs post-WEB-ED if they have not. We will use a convenience
sample of those in each identified comparison group, who are first able to be contacted by the study research coordinator or trained
research interviewers by telephone.
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VI.13.a
Does this study propose to enroll any subjects who are not Veterans?
Yes
VI.13.b
Non-Veterans may be entered into a VA-approved research study that involves VA outpatient or VA hospital treatment (38
CFR 17.45, 17.92), but only when there are insufficient Veteran patients suitable for the study. Provide an explanation for
why there are insufficient Veteran patients suitable for the study.
To address Aim 1, semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR)
will be conducted by Dr. Sadler to obtain key informant feedback on the WEB-ED+ content which will include: 1) MHV
authentication and secure messaging directions; 2) online VA enrollment directions; and two educational SDM educational
videos, one for Veterans and one for providers, regarding the benefits and process involved in SDM, respectively; and 3)
patient activation scores and their relationship to SDM and care engagement. To complement the qualitative data, Dr. Sadler
will engage with local stakeholders and champions at each facility in order to map clinical workflow processes (process
mapping) at each of the five study sites and determine how to best integrate WEB-ED+ into existing workflows. A total of 60
interviews (12 individuals at each of 5 sites) will be conducted. Key informant roles include: Primary Care-Mental Health
Integration (PCMHI) providers (n=1-2), PC and/or MH providers (n=2), PCMHI or PC and MH case managers (n=1-2), MHV
champion (n=1), Enrollment Specialists (n=1), OEF/OIF/OND Transition Patient Advocates (TPA) (n=1-2), and
OEF/OIF/OND Veterans (n=4-5). An effort will be made to have a gender mix of key informants. VA personnel can be
identified through VA national websites and our PBRN site leads. Due to delays related to COVID-19, the team has decided to
move forward with the data collected for phase one, and not to collect any one-to-one Veteran interviews for that phase.
VI.14
Provide an estimate of the total number of subjects that would be eligible for inclusion in each of your study populations (include
your control population if applicable)
Over 2.5 million service members have been deployed to Iraq, Afghanistan in the past decade. Given national security and safety
concerns, DMDC does not provide comprehensive registry numbers of military/Veteran populations for sample request such as ours.
VADIR has reviewed our study specifications and sample requirements in order to provide us with a cost estimate and expressed no
concerns regarding feasibility. We are aware that given the overall population numbers noted above we have more than sufficient
population numbers to draw from for potential study participants.
VI.15
Describe how you will have access to each of your study populations in sufficient number to meet your recruitment goals.
Phase 1 key informant roles include: Primary Care-Mental Health Integration (PCMHI) providers (n=1-2), PC and/or MH
providers(n=2), PCMHI or PC and MH case managers (n=1-2), MHV champion (n=1), Enrollment Specialists (n=1), OEF/OIF/OND
Transition Patient Advocates (TPA) (n=1-2) and OEF/OIF/OND Veterans (n=4-5). Key informants will be selected at each PBRN
site. An effort will be made to have a gender mix of key informants. VA personnel can be identified through VA national websites and
our PBRN site leads. We will use site Veteran Panels to engage OEF/OIF/OND male and female war Veterans when possible, as well
as using our Veteran registry obtained VADIR to identify Veterans who are and are not currently VA engaged, respectively. VADIR is
the VA group that interfaces with Defense Manpower Data Center to obtain sample characteristics of service members/Veterans,
including postal and military e-mail addresses, and work/home telephone numbers. Due to delays related to COVID-19, the team has
decided to move forward with the data collected for phase one, and not to collect any one-to-one Veteran interviews for that phase.
Phase 2 participants will include two overlapping populations of OEF/OIF/OND male and female Veterans eligible for VA care,
which we will randomly sample from two overlapping populations. The first group includes those who returned from deployment to
Iraq or Afghanistan within the preceding four years and who reside within the catchment areas of one of our 10 study sites (identified
by zip code). We want to ensure that those who participate and screen positive on one or more of the screens have access to VA care.
Consequently, we have selected the time frame of 4 years post-deployment because these Veterans have priority access to VA care for
five years after their most recent deployment. The second group is OEF/OIF/OND Veterans who are already enrolled in VA care and
will not be excluded if they have been home from deployment more than four years. We are doing purposeful sampling to achieve
sufficient numbers of men vs women and we will work with VADIR to have a sample representative by gender and race consistent
with the current OEF/OIF/OND post-deployment populations. Veteran contact information will be provided by the VA-DoD Data
Identification Repository (VADIR).
For phase 3 we will recruit 76 Veteran participants, and all Veteran-identified VA providers who agree to participate. We will use 3:1
sampling. It is anticipated that in each of the four groups, we will have appropriate representation of gender and racial/ethnic groups,
but we will monitor this and use purposeful sampling if needed. Fewer numbers of those who did not engage in VA care reflects our
expectation of less variation in subgroup data. As we do monthly EMR checks of participants, we will be able to identify
provider/TPA interface initiated following WEB-ED and attempt to initiate contact within the month following RCT interface or at 6
months post-RCT vs. post-WEB-ED if they have not. We will use a convenience sample of those in each identified comparison
group, who are first able to be contacted by the study research coordinator or trained research interviewers by telephone.
VI.16
Do you plan to recruit/enroll non-English speaking people?
No
VI.18
Do you propose to enroll any of the following in this study as subjects?
Employee of the PI or employee of a research team member
Individual supervised by PI or supervised by member of research team
Individual subordinate to the PI or subordinate to any member of the research team
Student or trainee under the direction of the PI or under the direction of a member of the research team
No
VI.20
Will subjects provide any information about their relatives?
No
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VI.23
Will anyone (other than the subject) provide you with information about the subject (e.g. proxy interviews)?
No
VI.26
Is this project about pregnant women?
No
VI.27
Will this project involve fetuses?
No
VI.28
Does this project involve adult subjects who may be incompetent or have limited decision-making capacity on initial enrollment
into the study?
No
VI.32
Does this project involve subjects whose capacity to consent may change over the course of the study?
No
VI.37
Does this project involve prisoners as subjects?
No
VI.46
Do you propose to enroll any subjects diagnosed with Posttraumatic stress disorder (PTSD)?
Yes
VI.47
Describe how this protocol will take into consideration the perspectives of individuals with PTSD.
One of the MH (mental health) and Trauma screens within the RCT is the VA Post-Traumatic Stress Disorder (PTSD) Screen.
VI.48
Does this study involve a study drug(s)?
No
VII.A. Project Description (A)
VII.A.1
Where will project procedures take place (check all that apply)?
U.S. off-campus - Web-based survey Web-based survey For phase 1, members of the Iowa City research team will travel to
conduct interviews with key informants will take place at five sites (one site per each MyVA region): Region 1: Albany VA
Medical Center (NY); Region 2: Miami VA Healthcare System (FL); Region 3: Minneapolis VA Health Care System (HCS;
MN); Region 4: Central Texas Veterans HCS (Temple) (TX); and Region 5: VA Puget Sound (Seattle) (WA). If participants are
unable to participate face-to-face on these dates, we can arrange to talk with them by telephone using approved methods of
communication, such as Doximity or Cisco SoftPhone. Due to delays related to COVID-19, the team has decided to move
forward with the data collected for phase one, and not to collect any one-to-one Veteran interviews for that phase.
VAMC - CADRE research unit & CATI lab
VII.A.2
Is this project also being conducted by other researchers at their own sites (e.g. a multi-site collaborative project)?
No
VII.B. Project Description (B)
VII.B.1.
Does this project involve any of the following (Check all that apply):
Interventional – Includes Clinical (or Treatment) trial, Physiology intervention/study, Behavioral intervention/study,
Diagnostic Trial.
Clinical (or Treatment) trial – A prospective biomedical or behavioral research study of new treatments, new drug or
combinations of drugs, new devices, or new approaches to surgery or radiation therapy. (NIH and ClinicalTrials.gov &
FDA)
Physiology intervention/study – A pharmacologic or measurement study aimed at understanding basic mechanisms of
disease and/or of normal human physiology, often without any therapeutic intent (though a clinical trial could include
such components, often labeled as “translational” or “basic science” aims.) Measurements in such studies could include,
but are not limited to, a blood draw, EKG, EEG, MRI, auditory or sensory testing, checking vital signs, DEXA scans, eye
tracking, specimen collection, exercise, fasting, special diets, etc.
Behavioral intervention/study – May be used to refer to studies of individual or group behavior. This option does not
include drugs, biologics, or devices but could include psychotherapy, lifestyle counseling, behavior modification, etc.
Diagnostic trial – Protocol designed to evaluate one or more interventions aimed at identifying a disease or health
condition (ClinicalTrials.gov & FDA)
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VII.B.1.a
Does this project involve any of the following (Check all that apply):
VII.B.2
Does this project involve a drug washout (asking subject to stop taking any drugs s/he is currently taking)?
No
VII.B.6
Will any subjects receive a placebo in this study when, if they were not participating, they could be receiving an FDA-
approved treatment for their condition?
No
VII.B.11
Is there a separate, written protocol that will be submitted in addition to this IRB New Project form? (Note: a grant application is
not considered to be a protocol)
No
VII.B.18
Does this project involve testing the safety and/or efficacy of a medical device?
No
VII.C. Project Description (C)
VII.C.1
Does this project involve any research on genes or genetic testing/research?
No
VII.D. Project Description (D)
VII.D.1
Check all materials/methods that will be used in recruiting subjects (you will need to attach copies of all materials at the end of
the application):
Other - Provider key informants will be recruited via email and phone. Veterans will be recruited via postal mail, phone, as
well as email, when possible.
Use of any information available to the researchers or their colleagues because this person is a patient OR use of any
information considered to be Protected Health Information (PHI) OR review of patient/clinic records - VINCI/VADIR will be
reviewed to select eligible veterans for recruitment.
Existing Registry/database - DMDC, VINCI and VADIR databases as previously described.
Letter -
E-mail -
Observational
Expanded Access – A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide
investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. Examples
of expanded access include non-protocol access to experimental treatments, including protocol exception, single-patient
IND, treatment IND, compassionate use, emergency use, continued access to investigational drug, and parallel track
(ClinicalTrials.gov & FDA).
Registry – The collection and maintenance of data (not including biologic samples) in which: (1) the individuals in the
registry have a common or related condition(s), and/or (2) the individuals in the registry are interested in being contacted
for future studies by investigators other than those listed in Section II of this project.(UI Guide)
Repository – The collection, storage, and distribution of human biologic samples and/or data materials for research
purposes. Repository activities involve three components: (i) the collection of data and/or specimens such as blood, tissue,
saliva, etc.; (ii) the storage of data or specimens, and data management function; and (iii) the sharing of data/specimens with
recipient investigators other than the original investigators. (paraphrased from OHRP)
Other – Describe:
interview study
Phase I trials – include initial studies to determine the metabolism and pharmacologic actions of drugs in humans,
the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy
participants and/or patients (ClinicalTrials.gov & FDA)
Phase II trials – include controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular
indication or indications in patients with the disease or condition under study and to determine the common short-
term side effects and risks(ClinicalTrials.gov & FDA)
Phase III trials – include expanded controlled and uncontrolled trials after preliminary evidence suggesting
effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall
benefit-risk relationship of the drug and provide an adequate basis for physician labeling(ClinicalTrials.gov & FDA)
Phase IV trials – studies of FDA-approved drugs to delineate additional information including the drug’s risks,
benefits, and optimal use(ClinicalTrials.gov & FDA)
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VII.D.2
List the individual data elements you will need to access/use from the patient or clinic records to identify potential subjects
for recruitment
Individual elements: Name and contact information (address, phone, email), DOD military service and health records, VA
health records, individual medical record identifiers, and SSN.
Data will be linked across the various CDW domains using unique patient-level identifiers internally assigned by CDW and
VINCI, including SIDs (surrogate ids) and ICNs (integration control numbers), and Real Social Security Number (for
CAPRI/JLV nationwide chart reviews).
VII.D.3
Describe why you could not practicably recruit subjects without access to and use of the information described above
Without this access we would not be able to recruit veterans to participate in the study. Due to the large number of possible
participants, it is not practical to obtain authorization from potential subjects to review records for recruitment purposes. As
this study is not conducted in-person, we are unable to approach patients in clinic to obtain this information.
VII.D.4
Describe why you could not practicably obtain authorization from potential subjects to review their patient or clinic records
for recruitment purposes.
By reviewing records prior to recruitment, we can minimize contacting Veterans who may be ineligible for the study. Due to
the large number of possible participants, it is not practical to obtain authorization from potential subjects to review records for
recruitment purposes. As this study is not conducted in-person, it is impractical to approach every patient in the clinic to get
authorization to review their medical record.
VII.D.5
Describe plans to protect the identifiers from improper use or disclosure
Potential study subjects will be assigned a random coded number to which all data will be associated. Information linking
study numbers with personal information and answers will be kept in locked files and databases accessible only to study
researchers within the VA. All paper documents containing confidential information will be kept in the secured office space in
locked filing cabinets. All study personnel will complete CITI Human Subjects Training and VA confidentiality certifications.
Data are stored on the HSR&D and/or the VINCI server, behind the VA firewall. Data are secured with directory permissions
as directed by the PI. Files with identifiable human subject data are password protected. All analysis will occur on VA owned
servers and computers. No data will be stored on removable media. Individuals will not be identified in results; aggregate data
will be presented. Anyone accessing data must take annual VA Human Subjects, Privacy, and Research Data Security Training.
VII.D.6
Describe your plan to retain research records until disposition instructions are approved by the National Archives and
Records Administration and are published in VHA’s Records Control Schedule (RCS 10-1)
Records will be retained as instructed by NARA and published in the VHA Records Control Schedule. Data will remain on the
CADRE server in accordance with NARA requirements, at which time the data will be destroyed per Information Resources
Management (IRM) and the latest VA Data Security Protocols for secure file deletion.
VII.D.7
Does the research team agree that the requested information will not be reused or disclosed to any other person or entity,
except as required by law, for authorized oversight of the study, or for other research for which the use or disclosure of the
requested information would be permitted by the HIPAA Privacy Rule
Yes
VII.D.8
Will a member of the research team discuss the study with the subject in person prior to the subject agreeing to participate?
Yes
VII.D.9
Describe the physical location where the consent process will take place:
Phase 1 subjects/key informants will consent in person prior to the guided qualitative interviews, or via telephone if
participants are unable to participate face-to-face on-site visit dates. When possible, the interviews will be 1:1, so the location
will give the participant privacy in which to consent. Some interviews may be completed in a group setting. For participants
completing interviews via telephone, they may set up a time that is convenient for them at a location of their choosing.
Phase 2 subjects will indicate consent as part of the online screening. For subjects who are invited to participate in the RCT, a
consent form and HIPAA authorization form will be mailed to them after completion of the initial online screening.
Phase 3 subjects will consent via telephone prior to the semi-structured CATI interview.
VII.D.10
Will a member of the research team discuss the study with the subject by phone prior to the subject agreeing to participate?
Yes
VII.D.11
Describe:
A toll-free number is provided with in the information summary letter should potential subjects have further questions. Phone
calls to return calls for subjects who have left a message on the study toll-free secure voicemail, returned a contact form or
email. Phone calls to recruit potential subjects using a call protocol. None of the phases will have the initial contact with a
potential subject be a phone call. For phase 1 subjects, if there is no response from prior mail or email recruitment, we will
initiate telephone contact consisting of 3 calls during different times of the day in attempts to schedule for the in-person or
telephone interview. Providers will complete the interview by phone only if they are unable to complete the interview in
person.

Name
Consent Process Involvement
VII.D.14
The PI has formally delegated the responsibility of conducting the consent process and obtaining consent to the individuals
listed above. The individuals delegated this responsibility have received appropriate training to perform these activities.
Yes
VII.D.15
Check all materials that will be used to obtain/document informed consent:
Consent Document
Letter or Information sheet containing elements of consent
VII.D.16
Are you requesting a waiver of documentation of consent (either no subject signature or no written document)?
Yes
VII.D.17
Choose one of the following to indicate why you are requesting that the IRB waive the requirement to obtain a subject
signature as documentation of consent:
A.  The research presents no more than minimal risk (minimal risk means 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 of routine physical or psychological examinations or tests)
     AND
The study involves no procedures for which consent is normally required ouside of a research context. (This type of waiver is
often permitted for a minimal risk mail-out survey that includes a cover letter with all elements of consent, and returning the
survey indicates consent. You cannot request this waiver if the study also involves the use of any protected health information
(PHI).)
VII.D.18
Explain why this meets the chosen criteria in A. or B. above:
This research presents no more than minimal risk and that the study involves no procedures for which consent is normally
required outside of a research context. Web-based participation will involve use of a randomly assigned study identification
number so no personally identifying information will be used on-line. This study replicated protocols we have used in our other
research projects with no untoward/adverse outcomes, further confirming our belief this is no more than minimal risk. All
phases present no more than minimal risk. The waiver of documentation is for phase 1 and the initial portion of phase 2. Prior
to participation in the RCT portion of phase 2, veteran subjects will sign and return via mail the consent and HIPAA
authorization forms for this phase attached to this application.
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VII.D.18.a
Does the information you are collecting from subjects involve health information (either oral or written)? NOTE: The VHA
considers all identifiable information collected from researcher’s individually identifiable information based upon the 18
HIPAA identifiers. (See VHA Handbook 1605.1, Appendix B for explanation of Individually-identifiable Health
Information and De-identification).
Yes
VII.D.19
Before the subject gives consent to participate are there any screening questions that you need to directly ask the potential subject
to determine eligibility for the study?
Yes
VII.D.20
List any screening questions you will directly ask the potential subject to determine eligibility.
Phase 2 Web-Ed Eligibility Questions
1. Have you served in the US Military after October 2001?
o Yes (1)
o No (0)
If participant answers ‘No’ then they are not eligible. Must have served as a US Military service member since beginning of
OEF/OIF/OND to be eligible for participation.
1a. (If yes) What year(s) did you serve in the US Military since 2001?
&#9633; 2001 &#9633; 2009
&#9633; 2002 &#9633; 2010
&#9633; 2003 &#9633; 2011
&#9633; 2004 &#9633; 2012
&#9633; 2005 &#9633; 2013
&#9633; 2006 &#9633; 2014
&#9633; 2007 &#9633; 2015
&#9633; 2008 &#9633; 2016
&#9633;2017-2021
2. Were you ever deployed to Iraq or Afghanistan as a US Military service member or in support of Operation Iraqi Freedom,
Operation Enduring Freedom, or Operation New Dawn (OEF/OIF/OND)? (select all that apply)
o Yes (1)
o No (0)
Must have answered ‘Yes’ to above question to be eligible for participation.
3. When did you return from your most recent deployment to either 1.) Iraq and/or Afghanistan or 2.) a deployment in support
of Iraq/Afghanistan? (Month, Year)
VII.D.21
Will you keep a screening log or other record that would include information on people who do not enroll in the study?
Yes
VII.D.22
Describe the information being collected and the purpose for keeping this information.
It is necessary to determine differences between participants vs. non-participants to understand if there are differences that
might reflect response bias and consequently influence generalizability of our findings. Consequently, we will collect and keep
information on military branch, age, era of service, deployment status, rank, race, and geographic location (including zip
codes). Note that this identifiable information is already in VADIR provided data. These data are stored on the HSRD server,
which is maintained, backed-up, and secured in a locked server room by the Iowa City VA’s Information Resources
Management (IRM) department. The server can only be accessed by individuals with an IRM-created network account. Data
are further secured using network directory permissions assigned by IRM at the direction of the Principal Investigator (PI).
This ensures that only study personnel with the approval of the PI (in accordance with IRB requirements) have access to
identifiable human subject/patient data. Additionally, files on the network that contain identifiable human subject data are
password protected, and individuals accessing the server on a client machine are instructed to password protect their screen
saver in order to maintain data security.
Study subjects including those who decline to participate, will be assigned a coded number to which all data will be associated.
Linking information will be kept in locked files and databases accessible only to study researchers. All paper documents
containing confidential information will be kept in the secured office space in locked filing cabinets. All records will be
retained as instructed by the National Archives and Records Administration and are published in VHA’s Records Control
Schedule (RCS 10-1).
VII.D.23
Will this information be shared with anyone outside the VA research team members?
No
VII.D.25
After the subject agrees to participate (signs consent), are there any screening procedures, tests, or studies that need to be done to
determine if the subject is eligible to continue participating?
No
VII.D.27
Discuss how much time a potential subject will have to agree to consider participation and whether or not they will be able to
discuss the study with family/friends before deciding on participation.
The potential participant will receive mailed recruitment letters, emails, as well as have advance notice of upcoming in-person or
telephone interviews so they will have time to discuss the study with family and friends before deciding on participation. For phase 2,
the potential subject can participate with the study at any time that the study is open and therefore has the capability of discussion of
the study with family or friends at the time of their choosing.
VII.D.28
How long after the subject agrees to participate do study procedures begin?
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We anticipate that the recruitment will occur within 6 weeks prior to the first phase of the study.
VII.D.29
Provide a description of the enrollment and consent process for adult subjects
Describe each study population separately including control population
Include when recruitment and consent materials are used
Use 3rd person active voice “The Principal Investigator will identify subjects. For example, the principal investigator will
identify potential subjects, the study coordinator will discuss the study with subjects over the telephone and schedule the
first study visit, etc...”
Describe the steps that will be taken by the research team to minimize the possibility of coercion or undue influence during
the consent process
Phase 1: The providers selected for phase 1 will be recruited via email and phone contact. Telephone contact will only be initiated
after the email is sent. Providers will receive an initial email. 5 days after the initial email is sent, a follow up email will be sent. If
still no contact has been made within 3 days, a call protocol consisting of 3 calls will be implemented. Provider emails will also
include a web link via Qualtrics, where providers can indicate best times to schedule interviews with them during site visit dates.
Once a date and time has been selected, participants will be emailed a confirmation email with time and date, as well as a second
email or phone call with this same information if email is not provided. Some subjects may be recruited on-site. If the subject has not
received a letter, copies of the letter will be available to them on-site to review prior to participation. VA Skype (internal, secure
messaging) recruitment will be used with key informants who do not respond to email invitation. This messaging system will be used
as an additional means to contact key informants who do not respond to the email invitation by using the script to answer any
questions the potential participant may have, schedule a time to call them to discuss the study or their concerns in more detail, as well
as to schedule an interview, if applicable. Potential subjects can indicate if they do not wish to participate via Skype as well.
Phase 2 WEB-ED Recruitment: participants selected from the VA Informatics and Computing Infrastructure (VINCI)/VA/DoD
Identity Repository (VADIR) and per Defense Manpower Data Center (DMDC) will be recruited with a mailed recruitment letter
(attachment 2A) containing the elements of consent, e-mail, and telephone follow up using call protocols. If we have not heard from
the subject within 10 days of the initial mailing, a follow-up email (2C for Web-Ed and 2D for RCT) will be sent with “Do Not
Reply” added to the subject line. If we have not had participant contact by 10 days after sending the email, we will resend an
additional email. If there is still no response, we will initiate telephone contact consisting of 3 total calls during different times of the
day (morning, afternoon, evening) in attempts to address any questions and to encourage online screening completion. A toll-free
number will be provided to participants to facilitate contact for any questions. Bad Contact Info Call Script and Email will be used to
contact subjects in effort to update their contact information For the WEB-ED, if the subject is eligible per the pre-consent screening
questions, the informed consent for this online process is integrated into the web-based subject education and participants
acknowledge (“click approval”) that they have reviewed this prior to participation (attachment 2A Consent Letter - Current Web-Ed).
This online document containing the elements of consent will contain the same information as the mailed document and will also
inform participants that they may be invited to participate in a subsequent study phase that will address VA and post-deployment care
access.
Veteran RCT Recruitment (WEB-ED+) and Assignment: Veterans who screen positive on one or more MH (mental health) screens
will be eligible for the RCT and asked online at WEB-ED completion for permission to re-contact them about continuing their
participation in the RCT. Those who indicate yes to study re-contact will be sent IRB approved study information, including the RCT
consent letter (2B), consent and HIPAA forms attached to this application. Those who decline will be thanked again for their
participation and contact will be discontinued. We will use adaptive randomization to achieve balance in the assignment to the
treatment intervention arm of WEB-ED+ relative to the control arm of Current WEB-ED. Participants will be sent a letter to inform
them about which arm of the RCT they have been assigned to and the expected participation steps for each arm (RCT Intervention
Assignment letter or RCT Control Arm Letter). Those who are assigned to the Current WEB-ED arm of the RCT (those who had
positive screens for the current WEB-ED, but randomly assigned to no intervention) will not complete Web-Ed+ and will not be
contacted until Phase 3. The phase 2D email - RCT will be used to follow up with subjects who have been selected for participation
but have not yet completed the additional online screening per randomization.
A medical chart review will be conducted for all subjects who return the signed HIPAA and consent forms for the RCT. Chart
reviews will focus on VA care the subject received (or not) including medication, therapy, & any mental health and substance use
treatment. We will review the time from post-deployment through 6 months after the subject's initial study participation.
We will assess/confirm enrollment status and upcoming appointments of participating Veterans using a combination of national visual
chart review using CAPRI/JLV, along with accessing enrollment and appointment data from the CDW.
Provider RCT Recruitment (Web-Ed+): Phase 2 Provider Recruitment Email is sent after we receive the information back from the
Veteran participant identifying their provider. If a VA provider does not respond to the email invitation, we will contact them via
telephone or Teams and follow the Recruitment Script - VA Provider Invitation Script for telephone and Teams. If the Veteran is new
to the VA, we will identify the VA provider they are assigned to and then immediately approach that provider. If they do not respond
within 1-2 weeks, they may be sent the Teams message again. Once they agree to participate, we send them the Phase 2 Provider
Instructions Email.
Phase 3 Veteran Recruitment: To contact participants who have participated in the RCT and agreed to be contacted for phase 3 by
returning the signed consent and HIPAA forms, the study research team will use an IRB approved 3 call contact protocol varying
times of day and days of week, using the study Q&A document to answer questions, in attempts to schedule an approximately 25
minute semi-structured qualitative interview to willing participants using computer-assisted telephone interview data collection. In
addition, up to two postal mail recruitments will be sent with information, a return contact form indicating preferred contact times or
preference to discontinue participation. All Veteran participants recruited for phase 3 will be asked for verbal confirmation of their
VA care engagement or not, and their current level of distress with current post-deployment readjustment. Providers will also be
asked to participate in the interviews for phase 3 and will be contacted via email (phase 3 participation email to providers) and a 3
call contact protocol.
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In summary, for the initial portion of phase 2, if the subject is eligible per the pre-consent screening questions, the informed consent
for this online process is integrated into the web-based subject education and participants acknowledge (“click approval”) that they
have reviewed this prior to participation (attachment 2A Consent Letter - Current Web-Ed). This online document containing the
elements of consent will contain the same information as the mailed document and will also inform participants that they may be
invited to participate in a subsequent study phase that will address VA and post-deployment care access.
Veteran participants will provide consent for RCT portion of phase 2 (as assigned), the phase 3 telephone interview, and chart review
by signing and returning via mail the consent and HIPAA forms prior to participating in the RCT portion of phase 2. For those who
participate in the first part of phase 2 and are eligible for the RCT portion of the study, they will be asked online at WEB-ED
completion for permission to re-contact them about continuing their participation in the RCT (Web-Ed+). Those who indicate yes
will be sent IRB approved study information, including the RCT consent letter (2B), consent and HIPAA forms attached to this
application. Those who decline will be thanked again for their participation and contact will be discontinued.
VII.D.37
Does the study include any form of deception (e.g., providing participants with false information, misleading information, or
withholding information about certain study procedures)?
Examples:
Procedure includes a cover story that provides a plausible but inaccurate account of the purposes of the research.
Participants will be provided with false information regarding the particular behaviors of interest in the research.
Procedures include a confederate pretending to be another participant in the study.
Participants will be told that the research includes completion of a particular task, when in fact, that task will not be
administered.
Study is designed to introduce a new procedure (or task) that participants are not initially told about.
If yes, a waiver of informed consent must be requested under question IV.3.
No
VII.E. Project Description (E)
VII.E.1
Will subjects be randomized?
Yes
VII.E.1.a
Will any subjects be blinded to which study arm they have been assigned?
No
VII.E.2
Describe randomization scheme/assignment including ratio such as 1:1, 2:1 etc.
For phase 2, we will use adaptive randomization to assign positive-screeners to each RCT arm; two-thirds to WEB-ED+ (~950)
and one-third to Current WEB-ED (~450).
VII.E.3
Will any questionnaires, surveys, or written assessments be used to obtain data directly from subjects in this study?
Yes
VII.E.4
List all questionnaires, surveys, written assessments and ATTACH each one to the application. (NOTE: You are NOT
prohibited from attaching copyrighted materials to this application)
Phase 1 interview guide will include content from attachment: Phase 1 CFIR Constructs, and information included in the
attachments Phase 1 VA Key Informant interview and Phase 1 Veteran Consumer Interview
Questions for the phase 2 Web-Ed Current are provided in the attachment Sadler_eSDM 2021_01_08 Programmed, which
includes programming instructions/skip patterns as well.
Screens in phase 2 Web-Ed + will include the following:
MH and Trauma Exposure Screens:
1. PTSD - VA Post-Traumatic Stress Disorder (PTSD) Screen.
2. Domestic Violence (DV) - American College of Obstetrician and Gynecologist screen for DV. This was modified to include
parallel questions that query participant DV perpetration.
3. Family Readjustment- developed from PI’s focus groups from another HSR&D funded study.
4. Substance Abuse - AUDIT-C Substance Abuse Screen.
5. Prescription Drug Abuse- DoD Survey of Health Related Behaviors modified for the web.
6. TBI - VA Traumatic Brain Injury (TBI) Screen, modified to include more descriptive questions.
7. Depression - Physician’s Health Questionnaire (PHQ-8) depression questions (suicide question omitted).
8. Anger- Dimensions of Anger Reactions (DAR5) Scale.
Trauma Exposure Screens
9. Combat Exposure - Exposures to Combat Screen.
10.Sexual Trauma - VA Military Sexual Trauma Screen.
Other:
11. Patient Activation Measure-13 - 13-item measure of patients’ self-report of their health management skills, knowledge,
confidence, and motivation. The PAM score will not be considered as a MH indicator but instead a measure associated with
access and SDM interface associated with Aim 2 and 3 outcomes.
12. CollaboRATE - 3-item measure of the SDM process tailored to the provider or TPA.
13. Social Determinants of Health Questions - 6 items that address social needs including: food, housing, finances, and ability
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to get to medical appointments.
Phase 3 interview (not yet developed) will include content from attachment: Phase 3 Process Evaluation Sample Questions. All
materials not yet developed will be submitted in a modification prior to subject recruitment for that phase.
VII.E.5
Does this project involve creating any audiotapes, videotapes, or photographs?
Yes
VII.E.6
Provide a detailed description in sequential order of the study procedures following the consent process - DO NOT cut and paste
from the Consent Document.
Describe study populations separately if they will be participating in different procedures - include CONTROL population if
applicable.
DESCRIBE:
What subjects will be asked to do/what happens in the study (in sequential order)
The time period over which procedures will occur
The time commitment for the subject for individual visits/procedures
Long-term followup and how it occurs
Phase 1: A total of 60 interviews (12 individuals at each of 5 sites) will be conducted. Key informant roles include: Primary Care-
Mental Health Integration (PCMHI) providers (n=1-2), PC and/or MH providers(n=2), PCMHI or PC and MH case managers (n=1-
2), MHV champion (n=1), Enrollment Specialists (n=1), OEF/OIF/OND Transition Patient Advocates (TPA) (n=1-2) and
OEF/OIF/OND Veterans (n=4-5). An effort will be made to have a gender mix of key informants. VA personnel can be identified
through VA national websites and our PBRN site leads. We will use site Veteran Panels to engage OEF/OIF/OND male and female
war Veterans when possible, as well as using our Veteran registry obtained VINCI/VADIR to identify Veterans who are and are not
currently VA engaged, respectively. Due to delays related to COVID-19, the research team has decided to move forward with the data
collected for phase one, and not to collect any one-to-one Veteran interviews for that phase. VINCI is a partner with the Corporate
Data Warehouse (CDW) and hosts all data available through CDW as well as some unique data. VADIR is the VA group that
interfaces with Defense Manpower Data Center to obtain sample characteristics of service members/Veterans, including postal and
military e-mail addresses, and work/home telephone numbers. In phase 1, we will also develop a template for use in the VA electronic
medical record to document the shared decision-making interface that is a component of our intervention for those in the RCT
treatment arm (WEB-ED+). This will be an important material reviewed by our key informants in Phase one interviews. Prior to
these interviews, this template will be developed with the assistance of study consultants who have developed templates for shared
decision making documentation in a university health care setting and with assistance and with the guidance and initial consultation
and prior approval from key VA offices, e.g. National VA Privacy office.
Following IRB approval, Consolidated Framework for Implementation Research (CFIR) guided qualitative interviews will be
conducted by Dr. Sadler and other research team members (Cook, Steffensmeier) to determine key informant critiques of the WEB-
ED+ content that will include: 1) MHV authentication and secure messaging directions; 2) online VA enrollment directions; and
educational shared decision-making (SDM) educational videos, one for Veterans and one for providers, regarding the benefits and
process involved in SDM respectively (video links (unlisted, only accessible via links: Shared Decision-Making SDM-Non-SDM
https://youtu.be/9Exh5qm2D4s; Shared Decision-Making ‘Veterans’ https://youtu.be/FaevM-mTJtU; Shared Decision-Making
‘Providers’ https://youtu.be/xETkUedZ2N4); 3) decision aids for PTSD, depression and substance use disorder for use by patient and
provider, and 4) patient activation scores and their relationship to SDM and care engagement. Dr. Cook and Dr. Sadler will engage
top leadership at each study site as well as work with the Women’s Practice Based Research Network leadership site leads at each
facility to promote communication and engagement at each VA. To complement the qualitative data, Dr. Sadler will engage with local
stakeholders and champions at each facility in order to map clinical workflow processes (process mapping) at each of the five study
sites and determine how to best integrate WEB-ED+ into existing workflows. On-site visit interviews allow our research team
important insights about the localized nature of health care delivery and how this might impact refinement of WEB-ED+ and its
potential adoption and reach. Individual interviews ensure greater likelihood of the participation of key informants at times that
accommodate their schedules and equalizes the importance of information from each of them. These interviews will be recorded, and
this will be explained during the consent process prior to the start of the interviews. The following attachments will be sent in the
following order: Phase 1 Confirmation Email; 2. Interview Direction Email; and 3. Link Email. Phase 1 Confirmation Email is sent
immediately after interview is scheduled to confirm date and time of interview. Interview Direction Email is sent after to explain the
interview protocol and to allow adequate time for questions. The Link Email is sent 24-hours before the scheduled interview, this
email has the link to follow to watch the study video and the access number to the VANTS line. This is to increase the fidelity to the
interviewee’s first time watching the Shared Decision-Making video while on the VANTS conference call with the interviewer.
Phase 2: Participants will include two overlapping populations of OEF/OIF/OND male and female Veterans eligible for VA care,
which we will randomly sample from two overlapping populations. The first group includes those who returned from deployment to
Iraq or Afghanistan within the preceding four years and who reside within the catchment areas of the current PBRN study sites
(identified by zip code). We want to ensure that those who participate and screen positive on one or more of the screens have access
to VA care. Consequently, we have selected the time frame of 4 years post-deployment because these Veterans have priority access to
VA care for five years after their most recent deployment. The second group is OEF/OIF/OND Veterans who are already enrolled in
VA care and will not be excluded if they have been home from deployment more than four years. We are doing purposeful sampling
to achieve sufficient numbers of men vs women and we will work with VINCI/VADIR to have a sample representative by gender and
race consistent with the current OEF/OIF/OND post-deployment populations.
All study participants will be asked to complete the online survey and screenings and be provided with their results and tailored
educational information. Documentation of informed consent for Phase 2 participation (WEB-ED) is integrated into the web-based
interface (“click approval”). Participants receive a hardcopy version of this form containing the elements of consent in the study
packet and can read a copy online. This process has been approved in five prior projects using WEB-ED. The consent document will
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also inform participants that they may be invited to participate in the subsequent study phase that addresses VA and post-deployment
care access. WEB-ED includes a brief pre-intervention survey that will query stigma associated with MH care, prior and current
utilization (VA and non-VA; primary care, MH, emergency) and their reasons for accessing VA or not, knowledge about post-
deployment VA eligibility, services and satisfaction with VA care, potential barriers to MH service use, and their use of or barriers to
MHV and secure messaging. Those who meet screening criteria for MH conditions and readjustment concerns receive online
notification and a recommendation for a face-to-face evaluation, education about each MH domain for which there is a positive
screen, and information about access to care. Patients who may have immediate needs will also be provided with specific VA
resources, contact names and numbers, as well as information for providers or resources unique to their needs and geographic
locations. The 24-hour Veterans Crisis Line (1-800-273-TALK (8255)) will be provided. Patients with negative screens will be
informed to seek care if they believe that it is needed. We note that neither our research team’s studies using focus groups and
telephone interviews with more intensive questions about sexual assault or combat experiences in deployed populations, nor our prior
web-based intervention studies, have resulted in any subsequent clinical emergencies. Veterans who have no positive screens will be
able to access the same educational information, web links, and video-clips if they choose.
A web-based satisfaction survey immediately follows screening and tailored education. In addition to questions about barriers and
facilitators to access to care, satisfaction with an online process, and ways that we can make Veterans more satisfied with this
screening and educational interface, we will also ask questions from the SHEP ambulatory care 2015 survey pertinent to study
domains (provider and VA interface satisfaction for outpatients), e.g.: 1) did their provider tell you there was more than one choice
for your treatment or care; 2) talk with you about the pros and cons of each choice for your treatment, 3) ask which choice was best
for you, 4) listen carefully to you.
Phase 2 RCT Intervention (WEB-ED+) Veteran Procedures: Veterans who screen positive on one or more MH screens will be eligible
for the RCT and asked online at WEB-ED completion for permission to re-contact them about continuing their participation in the
RCT. Those who indicate yes will be sent IRB approved study information, including the RCT consent letter (2B), consent and
HIPAA forms attached to this application. A summary of the screening results will be sent by encrypted email (attachment Phase 2
encrypted email - treatment arm RCT.rtf) to Veterans in the RCT treatment arm (WEB-ED+). An email will be sent in advance of this
to alert Veterans that they will be receiving secure information by encrypted email. Additionally, Veterans will be asked to indicate
which screening results bother them the most that they would like to talk with their provider about (To share with Provider). Veterans
are asked to return that form along with their signed consent forms. Phase 2 Thank you letter-returned forms will be used to thank
participants for returning their signed consent and HIPAA authorization forms.
To receive care in the VA health care system, Veterans must enroll in the VA system. Online VA enrollment links and information
(available to every Veteran) will be provided to help RCT participating Veterans with this process. If they are unable to enroll
electronically, key points of contact at the VA geographically closest to them will be provided so they can receive assistance with this
process. Additionally, enrollment in My HealtheVet (MHV), a secure online ehealth portal, allows Veterans to access their medical
records and send secure messages to their VA providers. As part of the RCT, participants will be asked to secure message their
screening results summary to the VA provider of their preference. If they are new to the VA, enrolling as a result of the RCT
participation, their newly assigned provider will be the individual that they will be asked to secure message their screening results
summary. Note, that the study team will be monitoring enrollment and provider assignment of Veterans new to the VA and will invite
the provider as soon as the assignment is made. If needed, the study team will be available to secure message the screening results,
rather than the Veteran.
Phase 2 RCT Intervention (WEB-ED+) Provider Procedures: once the provider has agreed to participate, they will be sent an email
that contains links to 2 short videos about shared decision-making and three brief decision aids (PTSD, depression, substance use
disorder).
Using the knowledge both the provider and patient learned from the WEB-ED+ materials, they will discuss treatment options at the
patient's appointment.
If subjects do not complete steps in the process, the appropriate attachment (Phase 2 RCT missing VA enrollment, Phase 2 RCT
missing MHV premium enrollment, or Phase 2 RCT missing secure messaging) will be sent via email or postal mail if email is not
available to support completion of these steps, with a toll free number provided. Further, up to 3 contact calls will be made until the
subject is reached, to determine if the participant has discontinued study participation, if the study team can be of further assistance,
or to determine the completion barrier(s), and if the Veteran is enrolled- to assist them with MHV barriers by sending the study
screening results summary by encrypted email to the participant’s preferred or new provider in their stead (eSDM Chart Review-
Secure Message) so they are able to progress to their appointment in order to use shared decision-making with their provider about
their positive MH screens. Requested Resources Email Scripts will be sent per request of subject as needed. The missing email notice
attachment will be used for those in the treatment arm of RCT to encourage them to contact us and update their email address so we
can continue their participation with the study. The provider consent notification document will be sent via mail or email letting the
participant know that their provider has consented to participate in the RCT.
Those who decline will be thanked again for their participation and contact will be discontinued. We will use adaptive randomization
to achieve balance in the assignment of those who consent to WEB-ED+ or Current WEB-ED. Those who are assigned to Current
WEB-ED will not be contacted again until Phase 3.
Per VA Research project modification approval received November 2022, we are now able to provide subjects with an additional $30
for already returned signed HIPAA form and consent to participate with this study phase. We will notify previous subjects using
attachments (Phase 2 New Reimbursement postal mail and Phase 2 New Reimbursement email), and submit this request, anticipating
that they should receive this direct deposit within 4 to 8 weeks. For new RCT recruitments we have edited the Phase 2 RCT
recruitment to indicate that if they return their signed HIPAA form and consent to participate in this study phase they will received
$50.00 (the same amount as those who have already returned these forms will receive).
Because of new VA research policy changes, we are now also able to provide subjects with an additional $75.00 upon completion of
the RCT “intervention group” steps of this research phase that involves seeing their VA provider (as described in the consent and the
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encrypted study group assignment email).
We will send the new funding notice to all RCT consenters first by email, followed by postal mail with follow up a week later via
telephone using a 3-call protocol.
If subjects do not complete the screening, attachments Phase 2G Incomplete Survey Email and Phase 2H Incomplete Survey Letter
will be sent to encourage completion.
A medical chart review will be conducted for the subjects who return the signed HIPAA and consent forms for the RCT and prior to
the interview for phase 3. Chart reviews will focus on VA outpatient care the subject received (or not) including medication, therapy,
& substance use treatment. We will review the time from post-deployment through 6 months after the subject's initial study
participation. We will assess/confirm enrollment status and upcoming appointments of participating Veterans using a combination of
national visual chart review using CAPRI/JLV, along with accessing enrollment and appointment data from the CDW.
Phase 3: Post-intervention process evaluation will rely on data collected via Computer-Assisted Telephone Interview (CATI), with
which our team has extensive experience. We will recruit 76 Veteran participants, and all Veteran-identified VA providers who agree
to participate. We will use 3:1 sampling. It is anticipated that in each of the four groups, we will have appropriate representation of
gender and racial/ethnic groups, but we will monitor this and use purposeful sampling if needed. Fewer numbers of those who did not
engage in VA care reflects our expectation of less variation in subgroup data. As we do monthly EMR checks of participants, we will
be able to identify provider/TPA interface initiated following WEB-ED and attempt to initiate contact within the month following
RCT interface or at 6 months post-RCT vs post-WEB-ED if they have not. We will use a convenience sample of those in each
identified comparison group, who are first able to be contacted by the study research coordinator or trained research interviewers by
telephone.
Semi-structured interviews with qualitative and survey questions will be implemented from Dr. Sadler’s CATI laboratory, with
established data security and interviewer training/monitoring protocols in place for a decade. These interviews will not be recorded.
Guided by CFIR, we hope to understand participants’ perceptions of the intervention to which they were assigned with regard to ease
and usefulness, need for improvements, and perceptions of barriers/facilitators to VA and MH services receipt or provision. We will
interview both those who did/did not subsequently engage in the eHealth process/secure messaging and among these groups those
who did/did not engage in VA MH care consequently. WEB-ED+ Veteran Participants will be asked about their use of secure
messaging, VA provider engagement, satisfaction with use of WEB-ED results, if their VA provider participated in SDM with them,
and satisfaction with the type of care they received. Those not activated to participate in VA care or who did not secure message
results will be asked about barriers/facilitators to this process and how we might improve this interface or MH engagement. Current
WEB-ED Veterans will be asked the same questions except for those specific to WEB-ED+. Participants from both RCT arms will be
asked about satisfaction with process and care (if sought).
A Veteran process map will be developed from the Veteran’s perspective to show whether each step of the WEB-ED RCT process
helped create a clear value for them as a care customer or not. Provider/TPAs will be asked parallel questions to the Veterans-
respective to each treatment arm. A Provider process map will be developed to help us understand the specific roles of individuals in
the overall system of care, i.e. the # of teams involved, if there are bottlenecks and delays, rework that occurs in facilitating war
Veterans’ access to patient-centered MH care, and the potential system impact of WEB-ED+ and perceived value to the
provider/TPA.
VII.E.7
Will you attempt to recontact subjects who are lost to follow-up?
No - those lost to followup will not be recontacted
VII.E.9
Will subjects be provided any compensation for participating in this study?
Yes
VII.E.10
Cash
No
VII.E.11
Gift Card
No
VII.E.12
Check
No
VII.E.16
Other
Yes
VII.E.17
Describe:
Subjects will be paid via electronic deposit.
VII.E.19
Describe the compensation plan including
Compensation amount and type per visit
Total compensation
Pro-rating for early withdrawal from study
Phase 1: Providers will receive no financial compensation for their participation.
Phase 2: $30.00 will be compensated for WEB-ED completion, and an additional $20 will be compensated for return of
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participant HIPAA and consent forms allowing for consequent VA chart review and with the Veteran’s VA provider for all
assigned to the RCT portion of Phase 2. Given a recent VA research modification that allows us to reimburse an additional $30
to those who have already returned signed HIPAA and consent forms necessary to be reimbursed will be contacted about this
increase in reimbursement as well as the new policy change that allows us to reimburse $75.00 for completion of the
"intervention group" requirements. Those in the RCT will be notified about this change and those newly recruited will have
this change included in their initial recruitment and consent documents. Participants need to sign and return a bank form to
initiate the electronic deposit(s). Those who have already done and are eligible for the additional reimbursement will not need
to do so again. The Bad Address Contact Call script will allow the research team to confirm the correct mailing address to send
forms to the participant. If the research team is unable to reach the Veteran by phone, the Bad Address Contact Email will be
sent. The reimbursement follow up script and email will be used to see if the participant would like reimbursement materials
resent so they can be compensated.
In summary: Per project modification approval received November 2022 (attached), we are now able to provide subjects with
an additional $30 for already returned signed HIPAA form and consent to participate with this study phase. We will notify
previous subjects using attachment (Phase 2 New Reimbursement postal mail and Phase 2 New Reimbursement email), and
submit this request, anticipating that they should receive this direct deposit within 4 to 8 weeks.
Because of new policy changes, we are now also able to provide subjects with an additional $75.00 upon completion of the
RCT “intervention group” steps of this research phase that involves seeing their VA provider by March 1, 2023 (as described in
the consent and the encrypted study group assignment email). Those who have returned consents and HIPAA forms for the
RCT will be notified of this change and encouraged to complete their RCT intervention steps if they have not already. Those
newly recruited to the RCT will have this included in their updated Phase 2 RCT consent document.
Phase 3: $40 will be compensated for each participant (76) who completes the Phase 3 semi-structured Veteran interviews.
VIII. Risks
VIII.1
What are the risks to subjects including
- emotional or psychological
- financial
- legal or social
- physical?
We do not anticipate any health risks as a result of participating in this study. We will not ask subjects to share the results of the
screening questionnaire during the telephone interviews, but rather provide us with feedback on the currently developed web-based
screening and educational materials. Some of the questions we will discuss are of a sensitive nature and participants do not have to
answer any questions they do not wish to. Some of the questions posed in the online assessment instruments are of a sensitive nature
and participants do not have to answer any questions they do not wish to. It is possible that loss of confidentiality is a potential risk.
However, we have used random study numbers to decrease this risk. Follow up phone interviews will query the usefulness of
information women received online, their knowledge and current use of VHA care, barriers to use of VHA mental health services,
and their perceptions of and willingness to use VHA mental health services. The interview will be tailored so that participants who
already access VA primary or mental health services will be queried about their perceptions regarding utilization. This information
will be used to expand a subsequent iteration of the online questionnaire with sections designed to reduce barriers (e.g., stigma,
disinformation regarding eligibility, confidentiality concerns) and encourage engagement with VA mental health services. For the
randomization to the two study interventions, it is possible that during participation, subjects may experience an exacerbation of pre-
existing post-deployment mental health or readjustment conditions.
VIII.2
What have you done to minimize the risks?
If applicable to this study ALSO include:
How you (members of your research team at Iowa) will monitor the safety of individual subjects.
Include a description of the availability of medical or psychological resources that subjects might require as a
consequence of participating in this research and how referral will occur if necessary (e.g. availability of emergency
medical care, psychological counseling, etc.)
Dr. Sadler is an experienced clinician trained to assess and address immediate participant reactions. In the unlikely event that a
participant expresses significant acute distress and is clinically determined to be at potential risk of harming self or others, Dr. Sadler
will facilitate emergent mental health care and transportation to the appropriate resource. At the end of all telephone interviews,
veterans will be given the information about care resources for veterans and Dr. Sadler will facilitate their enrollment in care if this is
desired or needed. A protocol will be in place to address any mental health emergency or safety issues and Dr. Sadler or her designee
will be on call during study implementation. We do not anticipate that this will happen given our experience with studies that require
significantly greater sensitive information than this study covers. However, we will make sure that the protocol will provide safety
and resources in the unlikely event this does occur. Confidentiality could be considered a concern, but the participant will designate
the time of the telephone interview and choose the site they will make it from. All information obtained will be kept behind locked
doors, within a locked office within the locked CADRE research area or on VA Servers maintained by Information Resources
Management and CADRE data managers. For phase 2 randomization, the same protocol to address mental health emergencies and
safety plans will be in place. In addition, Dr. Sadler or her designee will be on call during study implementation to facilitate any
access to emergency services as needed. Notably, in our prior research using telephone interviews and web-based screening, we have
experienced no adverse subject reactions to participation.
The identifiable information will be stored on servers located behind the VA firewall located in the OI&T server room at the Iowa
City VA. Data on the server will be operating within the VA network, which is protected by a firewall maintained by OI&T. There
will be no electronic transfer of data through the Internet, e-mail, or file transfer protocols (FTP). All data transfers will occur via VA
shared network drives behind a VA firewall. Data containing Protected Health Information (PHI) will not be removed from VA
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property; however, letters will be mailed to veterans inviting them to participate in the study. There will be no remote access to the
data except through the VA network to access the data on the server. Only identified study personnel will have access to the data.
Identifiable information will not be reused or disclosed to any person or entity outside VHA, except as required by law, for
authorized oversight of the research study or as specifically approved for use in another study by an IRB.
For the interviews, audio-recordings, transcripts, and any interviewer notes will use first names only and will not include other
identifiable information. These will all be uploaded to the secure drive from the site where the interviews will be held. The consent
documents will be scanned and saved to the secure drive. Original copies will also be securely stored at the Iowa City VAHCS.
Study subjects will be assigned a coded number to which all data will be associated. Subjects can then go to web site to complete
surveys. Linking information will be behind a fire wall in locked drives. All paper documents containing confidential information
will be kept in the secured office space in locked filing cabinets. All study personnel will complete CITI Human Subjects Training
and VA confidentiality certifications before starting work. Database security will be maintained by following a confidential system of
user identifiers, passwords, and numerous other VA established standard security measures. In order to ensure subjects' privacy,
personal information collected will be limited to the minimum necessary to accomplish the goals of this research.
Data are stored on the HSR&D and/or the VINCI server, behind the VA firewall. Data are secured with directory permissions as
directed by the PI. Files with identifiable human subject data are password protected. All analysis will occur on VA owned servers
and computers. No data will be stored on removable media. Individuals will not be identified in results; aggregate data will be
presented. Anyone accessing data must take annual VA Human Subjects, Privacy, and Research Data Security Training.
VIII.3
Does this study have a plan to have an individual or committee review combined data from all subjects on a periodic basis (such
as summary or aggregate safety and/or efficacy data)?
No
IX. Benefits
IX.1
What are the direct benefits to the subject (do not include compensation or hypothesized results)?
Participants may have no direct benefit but may benefit from knowing that their study participation may help VA care access and/or
care engagement of other war Veterans. Some participants might benefit from research staff assistance in enrolling in MHV and
attaining the capability (premium status) to secure message information, such as their study results, to an OEF/OIF/OND coordinator
or their VA provider to facilitate their communication and potentially access to care. Providers will potentially benefit from
awareness that their contributions assist with improving recent war Veterans access to and needed engagement in VA care.
IX.2
What are the potential benefits to society in terms of knowledge to be gained as a result of this project?
This study seeks to develop and test WEB-ED enhancements (WEB-ED+) that integrate a shared decision-making (SDM) process
and eHealth interface to assist secure messaging of MH/SDM interfaces with VA providers. Findings are important in helping us to
understand WEB-ED+ usability and adaptability for routine use by Veterans and VA practitioners, with the goal to improve VA MH
care access and patient-centered care for Veterans.
X. Privacy & Confidentiality
X.1
What are you doing to protect the privacy interests of the subjects?
Study subjects will be assigned a random coded number to which all data will be associated. Subjects can then go to a web site and
enter this random coded number to complete the online web-based screening and access the tailored educational materials. UI
Qualtrics will provide and oversee the online screening for Phase 2/RCT according to an agreement with the VA Health Care System.
It will also be used to assist with scheduling for phase 1 interviews. A web link will be created to serve as an electronic form for
phase 1 non-veteran participants to indicate best available times for the interview. UI Qualtrics is not a subsidiary or affiliate of the
Veteran’s Administration. UI Qualtrics collects and stores the answers submitted on-line on their secure server. UI Qualtrics will not
have access to any HIPAA identifiable information. Information linking study numbers with personal information and answers will
be kept in locked files and databases accessible only to study researchers within the VA. Dr. Sadler will obtain authorization to
transport prior to conducting the phase 1 interviews. Notes from the semi-structured interview will be done only with a subject
identification number. All paper documents containing confidential information will be kept in the secured office space in locked
filing cabinets. Records will be retained as instructed by NARA and published in the VHA Records Control Schedule. Data will
remain on the CADRE server in accordance with NARA requirements, at which time the data will be destroyed per Information
Resources Management (IRM) and the latest VA Data Security Protocols for secure file deletion. All study personnel will complete
CITI Human Subjects Training and VA confidentiality certifications before starting work. The identifiable information will be stored
on servers located behind the VA firewall located in the OI&T server room at the Iowa City VA. Data on the server will be operating
within the VA network, which is protected by a firewall maintained by OI&T. There will be no electronic transfer of data through the
Internet, e-mail, or file transfer protocols (FTP). All data transfers will occur via VA shared network drives behind a VA firewall. Data
containing Protected Health Information (PHI) will not be removed from VA property; however, letters will be mailed to veterans
inviting them to participate in the study. There will be no remote access to the data except through the VA network to access the data
on the server.
Only identified study personnel will have access to the data. Identifiable information will not be reused or disclosed to any person or
entity outside VHA, except as required by law, for authorized oversight of the research study or as specifically approved for use in
another study by an IRB.
For the interviews, audio-recordings, transcripts, and any interviewer notes will use first names only and will not include other
identifiable information. These will all be uploaded to the secure drive from the site where the interviews will be held. The consent
documents will be scanned and saved to the secure drive. Original copies will also be securely stored at the Iowa City VAHCS.
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X.2
Are you collecting the Social Security Number of any subjects for any purpose?
Yes
X.3
Provide the intended usage of SSN:
To provide compensation to subjects
Other - We will use the subject's SSN to complete the chart review. We will use CAPRI/JLV/Vista Web for the national
chart review and SSN is the unique identifier nationwide.
X.4
How will information/data be collected and stored for this study (check all that apply):
Paper/hard copy records (hard copy surveys, questionnaires, case report forms, pictures, etc.) - These notes will have no direct
personally identifiable information and the notes will be maintained following the confidentiality system above within locked
offices, locked filing cabinets, on a locked research (CADRE) center. Study team members with an approved authorization to
transport will temporarily remove hard copies of transcripts off-site for review.
Electronic records (computer files, electronic databases, etc.) - CADRE project data will be stored on the CADRE server,
which is maintained, backed-up, and secured in a locked server room by the Iowa City VA's Information Resources
Management (IRM) department, and on VINCI. The server can only be accessed by individual with an IRM-created network
account. Data are further secured using network directory permissions assigned by IRM at the direction of the Principal
Investigator (PI). This ensures that only study personnel with the approval of the PI (in accordance with IRB requirements)
have access to identifiable human subject/patient data. Additionally, files on the network that contain identifiable human
subject data are password protected, and individual accessing the server on a client machine are instructed to password protect
their screen saver in order to maintain data security. A random, unique identifier will be used to identify patients in electronic
study datasets used for analyses. All direct identifiers will be removed from the study datasets before conducting analyses. The
linkage between the unique identifier and identifying information resides on a secure VA server and is only available to IRB
approved study personnel. Bank information will be collected only for the purpose of compensating subjects. It can be
collected in one of 2 ways, whichever the subject prefers. The subject can be mailed a form to fill out and return via pre-paid
postal envelope, or via secure fax. This information will be entered into our database which has all of the security measures
described above. Any incidents involving loss of data, etc., will be reported immediately to the PI and data manager. Access to
data will be terminated when a staff member is no longer on the research team. A HIPAA de-identified dataset will be shared
with outside collaborators, all of whom are either covered to carry out the research by their local institutions, or whose local
institutions have deemed the work with de-identified data does not constitute human subjects research. All HIPAA 18
identifiers will be removed, and a Data Manager, Statistician and Privacy Officer will review the data to ensure that all
identifiable elements have been removed.
X.5
Do the confidentiality protections indicated above allow only members of the research team to access the data/specimens?
No
X.6
Describe
A HIPAA de-identified dataset will be shared with outside collaborators, all of whom are either covered to carry out the
research by their local institutions, or whose local institutions have deemed the work with de-identified data does not constitute
human subjects research. All HIPAA 18 identifiers will be removed, and a Data Manager, Statistician and Privacy Officer will
review the data to ensure that all identifiable elements have been removed.
X.7
Does your study meet the NIH criteria for a Certificate of Confidentiality or will you be applying for Certificate of
Confidentiality?
No
XI. Data Analysis
XI.1
Describe the analysis methods you will use, including, if applicable, the variables you will analyze
Qualitative Analysis (Aims 1 and 3): CFIR will guide the key domains/constructs queried in Phases 1 and 3 with key informants and
in Phase 3 with RCT participants and providers (see below). The initial analytic approach to the interview data will use the constant
comparison method, whereby we use open coding to identify salient issues and concerns raised by the participants across all of the
groups. These open codes will be examined by the investigators in order to develop themes that pertain to the majority of
participants, with a focus on addressing the specific aims of the study (rather than all emergent themes). These themes will also be
analyzed for their potential “fit” with the CFIR model, i.e., their relevance to the concepts of intervention, outer and inner setting,
individual characteristics, and implementation process. Assuming that there will be some degree of fit between emergent themes and
conceptual domains, each conceptual domain will be summarized with reference to its applicability to refinements to the intervention
as well as overall implementation processes. MAXQDA v12, a qualitative data analysis software program, will be used to assist this
process. The codebook will be developed initially by Dr. Sadler and Dr. Hamilton with subsequent co-investigator and qualitative
team independent coding of transcripts. In Phase 3 this will be specific to RCT participation (WEB-ED+ versus WEB-ED).
Aim 2 Analyses: We will begin with bivariate analyses (i.e., chi-square test for proportions) to test significance of differences in care
engagement between RCT arms. Care engagement is the primary outcome and will be operationalized by VA MH services receipt
(yes/no). Our primary analyses will use logistic regression models to estimate the adjusted ORs for treatment engagement controlling
for participant characteristics. The logistics regression models will provide an estimate of the association between health care
engagement by RCT arm, controlling for covariates such as Veteran gender, prior VA enrollment, severity [screening scores] and
complexity [multiple positive screens], patient-activation scores, and rurality. Potential confounding variables that will be assessed in
all hypotheses include socio-economic variables (e.g., age, income, marital status), and military characteristics (e.g., months home
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from deployment, rank). In addition, depending on the resulting proportions of Veterans who get care in various VA clinics (i.e., PC,
PCMHI, MH), we plan to conduct a multinomial logistic regression, treating RCT-arm as a covariate. We have used multinomial
logistic regression previously to examine associations with three levels of VA health care use (all, some, none).
XI.2
Provide the rationale or power analysis to support the number of subjects proposed to complete this study.
We will aim for 2000 Veterans completing WEB-ED, with approximately 1100 completing the RCT. Not all 2000 will be eligible for
the RCT. Based on our five prior studies, ~77-85% of WEB-ED participants screened positive on at least one of the MH screens
(~70% screened positive on depression, PTSD, or substance use). We will assume that 70% will eligible for the RCT (~1400) and use
adaptive randomization to assign positive-screeners to each RCT arm; two-thirds to WEB-ED+ (~950) and one-third to Current
WEB-ED (~450). There are no additional RCT participation activities for those in the Current WEB-ED arm, therefore attrition
would be minimal. However, we anticipate there may be attrition among those assigned to WEB-ED+. Our CREATE multi-phase
study resulted in attrition of ~30%. Therefore, we expect 650 completers for WEB-ED+. We have increased this sample size to have
sufficient power to detect differences per RCT arm. This study is powered to detect whether WEB-ED+ increases VA MH care
engagement compared to Current WEB-ED. In our prior work, half indicate that as a direct result of WEB-ED, they will follow up
with a provider and 38% with a VA provider, although actual follow-up may be lower (our CREATE study is currently validating
participant self-report with chart review data). This proposed study will document VA utilization (including VA purchased care) by
VA chart review. We estimated the minimum sample size needed to ensure adequate power (80%) for a variety of assumptions
(percentage of Current WEB-ED participants engaging in VA MH care, effect (odds ratios), and variance inflation factors (VIF)57,
using nQuery 4.0. We anticipate random assignment will result in no statistical differences between RCT arms based on WEB-ED
data (e.g., prior enrollment in VA, positive screens). However, covariates will be included (e.g., gender, rurality, patient-activation
scores, VA site) in multivariate analyses to control for variation due to these other variables. Any significant covariates may point to
sources of variability to explore in future research efforts, but we do not anticipate having sufficient power to conduct subsample
analyses by gender or VA site.
XII. Future Research
XII.1
Do you wish to keep any information about subjects involved with this research project so that members of the current research
team may contact them in the future for your own research projects?
Yes
XII.2
Do you wish to keep any information about subjects involved with this research project so that other researchers may contact
them for future research?
No
XII.3
List the data or information you will keep:
Contact information and data from all study phases.
XII.4
Does this project involve storing any data, tissues or specimens for future research?
No
XIII. Other Mod and/or Comments
XIII.1
Most modifications should be made in the appropriate section (see Index) of the project itself. If you need to describe other
changes, or wish to add comments about something you changed, please do so here.
Per VA Research project modification approval received November 2022 (attachment: ORD-ProjectModification_Sadler_IIR_16-
096_September2022_ rwob for LC sig-lmc.pdf), we are now able to provide subjects with an additional $30 for already returned
signed HIPAA form and consent to participate with this study phase. We will notify previous subjects using attachments (Phase 2
New Reimbursement postal mail and Phase 2 New Reimbursement email), and submit this request, anticipating that they should
receive this direct deposit within 4 to 8 weeks. For new RCT recruitments we have edited the Phase 2 RCT recruitment to indicate
that if they return their signed HIPAA form and consent to participate in this study phase they will received $50.00 (the same amount
as those who have already returned these forms will receive). In the attachments 'RCT Intervention Assignment Letter.rtf' and
'Recruitment Scripts.docx,' we have added text describing the additional compensation we are now able to provide, as well as to let
subjects know when activities for the study need to be completed. We updated the text for the Follow up Script Phase 2 RCT – No
appointment follow-up call at 6 and 10 weeks, as well as the VA Provider Invitation Script for Teams (information summarized from
above telephone script and approved email the provider will have already received) to include responses to frequently asked
questions from providers. The reimbursement follow up script has been edited to reflect the increased compensation amount we are
now able to provide to subjects.
Because of new VA research policy changes, we are now also able to provide subjects with an additional $75.00 upon completion of
the RCT “intervention group” steps of this research phase that involves seeing their VA provider (as described in the consent and the
encrypted study group assignment email).
The chart review (as described in section VII.E.6) template has been attached. We have made changes to existing RCT attachments to
reflect these changes, and added the chart review template, added Dan Corry to the research team, as well as removed Michala Cox
from the research team since she no longer works with VA. We also removed Samantha Solimeo from the research team as she no
longer works on the project.
XIII.2.
Have you permanently stopped enrolling new subjects into this study?
No
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Project Modification Attachments
Attachment Name
Category
Ver
Size Type
Attached
Phase 2 RCT Informed Consent 12-14-22.rtf
Informed
Consent
16
307 k
E
12/19/22
Phase 2A Consent letter - Current Web-Ed.rtf
Consent Letter
9
729 k
E
07/12/21
Phase 2B Consent letter - RCT.rtf
Consent Letter
13
184 k
E
12/19/22
ORD-ProjectModification_Sadler_IIR_16-096_September2022_ rwob for LC sig-lmc.pdf
Funding Source
Grant
1
1 M
E
12/14/22
Sadler 2016 IIR Fall Resubmission2.pdf
Funding Source
Grant
1
11 M
E
06/22/17
Phase 3 Invitation Letter - Veterans.rtf
Recruitment
Script: Mail
8
179 k
E
09/13/21
Phase 1B Email to Leadership.rtf
Recruitment
Script: Email
7
271 k
E
03/08/19
Phase 1C Email to Key Experts.rtf
Recruitment
Script: Email
13
203 k
E
09/19/19
Phase 2 RCT Provider Recruitment Email.rtf
Recruitment
Script: Email
8
217 k
E
08/10/22
no changes made to content. Just a title change.
Phase 2 encrypted email - treatment arm RCT.rtf
Recruitment
Script: Email
1
117 k
E
09/28/21
Phase 2C Email - Current Web-Ed.rtf
Recruitment
Script: Email
13
92 k
E
11/08/21
Phase 2D RCT Recruitment Email.rtf
Recruitment
Script: Email
13
186 k
E
12/19/22
Phase 1 VA Key Informant Interview.docx
Subject Data
Collection
Instruments
4
30 k
E
03/08/19
Phase 1 Veteran Consumer Interview Revised 03-06-20.docx
Subject Data
Collection
Instruments
6
19 k
E
03/16/20
Phase1_Questions_CFIR_Constructs.pdf
Subject Data
Collection
Instruments
1
171 k
E
08/10/17
Phase3_Process_Eval_Samp_Ques.pdf
Subject Data
Collection
Instruments
1
34 k
E
08/10/17
Sadler_eSDM 2021_01_08 Programmed.docx
Subject Data
Collection
Instruments
2
78 k
E
01/14/21
Sadler_eSDM 2021_01_08 Questions.pdf
Subject Data
Collection
Instruments
1
7 M
E
01/14/21
Non-participant sociodemographic and military characteristics.docx
Screening:
Screening Log
1
13 k
E
08/24/17
Anger Educational Module.pdf
Miscellaneous
3
207 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Bad Contact Info Call Script and Email.docx
Miscellaneous
2
19 k
E
02/07/22
CHART REVIEW 12-14-22.docx
Miscellaneous
1
25 k
E
12/16/22
CONTACT INFORMATION FORM - Veterans.docx
Miscellaneous
2
14 k
E
01/14/21
CONTACT INFORMATION FORM.docx
Miscellaneous
4
16 k
E
07/16/19
Crisis Call Procedures-Steps for Managing Crisis Calls + Warm Transfers to VCL
2015.03.docx
Miscellaneous
1
36 k
E
08/10/17
Depression Educational Module updated links 4.20.21.pdf
Miscellaneous
4
155 k
E
05/27/21
This change is to remove broken web links and add current web links.
Encrypted email notice to Veteran.rtf
Miscellaneous
2
1 M
E
07/12/21
FAQ_eSDM Qualtrics.docx
Miscellaneous
4
17 k
E
07/12/21
FINAL Decision Aid-AUD.pdf
Miscellaneous
1
362 k
E
07/02/20
We are modifying to add the final decision aid documents that will be used in the study.
FINAL Decision Aid-Depression.pdf
Miscellaneous
1
358 k
E
07/02/20
We are modifying to add the final decision aid documents that will be used in the study.
FINAL Decision Aid-PTSD.pdf
Miscellaneous
1
319 k
E
07/02/20
We are modifying to add the final decision aid documents that will be used in the study.
Follow up script with RCT new reimbursement.docx
Miscellaneous
1
17 k
E
12/14/22
Insomnia Educational Module.pdf
Miscellaneous
1
121 k
E
07/02/20
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We are modifying to add the final educational documents that will be used in the study.
Interview Sign In Sheet (1).doc
Miscellaneous
5
27 k
E
04/03/19
Intimate Partner Violence Educational Module.pdf
Miscellaneous
3
132 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
LMR SIGNED CONCURRENCE -- BY ROY FERGUSON 00240542 19-C-85212 LMR
Concurrence signed Online and Shared Decision Making Interventions for Post-Dep.pdf
Miscellaneous
1
213 k
E
06/26/19
Link Email AGS Final 03_16_2020.docx
Miscellaneous
3
37 k
E
03/16/20
Loneliness & Social Isolation Educational Module.pdf
Miscellaneous
1
243 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
MHV_Linkage_Enrollment_Flowchart.pdf
Miscellaneous
1
729 k
E
08/10/17
Military Sexual Trauma Educational Module.pdf
Miscellaneous
3
185 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Missing email notice to treatment arm RCT participants.docx
Miscellaneous
1
24 k
E
04/05/22
NON SDM 121919.docx
Miscellaneous
1
19 k
E
01/21/20
Phase 1 Confirmation Email.docx
Miscellaneous
1
35 k
E
03/06/19
Phase 1 Leadership Thank You Letter.docx
Miscellaneous
1
72 k
E
03/06/19
Phase 1 Web Link_Mailed Scheduling Template.docx
Miscellaneous
1
12 k
E
03/06/19
Phase 1G Key Expert Thank You Letter.docx
Miscellaneous
1
72 k
E
03/06/19
Phase 2 RCT missing VA enrollment reminder.rtf
Miscellaneous
4
1 M
E
09/13/21
Phase 2 New RCT Reimbursement email notification.docx
Miscellaneous
2
24 k
E
12/19/22
Phase 2 New Reimbursment postal mail.docx
Miscellaneous
1
21 k
E
12/14/22
Phase 2 RCT missing MHV premium enrollment reminder.rtf
Miscellaneous
3
1 M
E
09/09/21
Information was added to assist Veterans with enrolling in My HealtheVet secure electronic health record system.
Phase 2 RCT Provider Instructions Email.rtf
Miscellaneous
4
112 k
E
08/11/22
Phase 2 RCT missing secure messaging reminder.rtf
Miscellaneous
4
1 M
E
09/13/21
Phase 2 Thank you letter-returned forms.rtf
Miscellaneous
4
247 k
E
12/19/22
Phase 2G Incomplete Survey Email.docx
Miscellaneous
2
54 k
E
07/12/21
Phase 2H Incomplete Survey Letter.docx
Miscellaneous
2
53 k
E
07/12/21
Phase 2I Thank you letter.rtf
Miscellaneous
5
1 M
E
07/12/21
Phase 3C Thank you letter.rtf
Miscellaneous
2
1 M
E
05/28/21
Editing changes were made to provide consistent information as given in other documents used in this study and improve readability for the study
participants.
Phase2_RCT_Trmt_Arm_WEBED+_&_SDM.pdf
Miscellaneous
1
494 k
E
08/10/17
Post Traumatic Stress Disorder.pdf
Miscellaneous
3
113 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Postdeployment Family Adjustment Educational Module updated links 5.11.21.pdf
Miscellaneous
4
175 k
E
05/27/21
This change was to remove broken web links. Current web links were added.
Prescription Drug Misuse Educational Module.pdf
Miscellaneous
3
89 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Protocol_to_address_potential_risks.rtf
Miscellaneous
1
39 k
E
08/10/17
Provider Consent Notification.docx
Miscellaneous
1
16 k
E
04/05/22
Provider Info Sheet to be completed by Veteran.docx
Miscellaneous
3
15 k
E
10/05/21
RCT Control Arm letter.rtf
Miscellaneous
1
109 k
E
09/09/21
This letter informs the Veteran which arm of the study group they have been randomly assigned to and what to expect
RCT Intervention Assignment Letter.rtf
Miscellaneous
3
187 k
E
12/19/22
REF 10-22 eSDM Summary Report Error Email Notification.docx
Miscellaneous
1
18 k
E
11/01/22
This is the email to be sent notifying subjects of the incorrect blank template that they received in error. This document was also included as an
attachment in the reportable event form.
Recruitment Scripts.docx
Miscellaneous
23
66 k
E
12/19/22
Reimbursement Follow-up Email_Revised - Final.docx
Miscellaneous
3
36 k
E
05/13/22
Requested Resources Email Scripts.docx
Miscellaneous
1
20 k
E
02/07/22
SDM Provider Animation 121919.docx
Miscellaneous
1
14 k
E
01/21/20
SDM Veteran animation 121919.docx
Miscellaneous
1
13 k
E
01/21/20
Sadler HSRD HX002185-01A2- Union Information with interview questions.pdf
Miscellaneous
1
120 k
E
06/26/19
Sample_WEB_ED_Neg_Screen.pdf
Miscellaneous
1
90 k
E
08/10/17
Sample_WEB_ED_Pos_Screen.pdf
Miscellaneous
1
169 k
E
08/10/17
Screening Summary - Secure Message.rtf
Miscellaneous
4
103 k
E
10/25/21
Skype Script.docx
Miscellaneous
1
14 k
E
06/26/19
Social Determinants of Health Educational Module.pdf
Miscellaneous
1
250 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
Study_Q&A - Current Web-Ed.rtf
Miscellaneous
7
87 k
E
12/19/22
Substance & Alcohol Misuse Educational Module.pdf
Miscellaneous
3
151 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
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Suicide Prevention Educational Module.pdf
Miscellaneous
1
158 k
E
07/02/20
We are modifying to add the final educational documents that will be used in the study.
To share with Provider.rtf
Miscellaneous
1
65 k
E
07/22/21
This form will enable the Veteran to indicate which screening results they are most concerned about and would like to discuss with their health care
provider.
Traumatic Brain Injury Educational Module updated links 4.20.21.pdf
Miscellaneous
5
160 k
E
05/27/21
This change was to remove broken web links and add active links to online information.
VA10091 05.22.17.pdf
Miscellaneous
1
811 k
E
08/10/17
assurance-document.pdf
Assurance
Document
1
39 k
E
08/09/17
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