Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans
Phase: NA
Conditions: Mental Health, Rural Health, Veterans Health
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
CRE 12-083, Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans 
Funding Agency: VA HSR&D Merit 
Principal Investigator/Study Chair: Karen Hope Seal, MD, MPH 
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Abstract 
Project Background: One in five OEF/OIF/OND veterans resides in rural areas and 
primarily receives care from VA CBOCs. Compared to their urban counterparts, rural 
veterans experience a significantly greater MH burden and poorer outcomes. 
Nevertheless, less than 10% of OEF/OIF/OND veterans with a new PTSD diagnosis 
attend a minimum number of sessions required for evidence-based treatment, with 
rurality being one of the strongest predictors of poor engagement. Our pilot study in 
urban OEF/OIF/OND veterans demonstrated that telephone Motivational Interviewing 
(MI) delivered by research staff significantly improved MH treatment initiation and 
retention in care. However, we do not know whether telephone MI will have as strong an 
effect on MH treatment engagement when implemented by VA staff in CBOCs serving 
rural veterans. 
 
Project Objectives: As a part of the CeMOHR CREATE application to improve rural 
veterans’ access to evidence-based mental healthcare (Fortney, PI), the overall goal of 
this project is to adapt, implement and test an MI-based coaching intervention to 
improve MH services engagement at CBOCs serving rural  veterans.  The specific aims 
of this project are: (1) Conduct a developmental formative evaluation of perceived 
barriers to MH treatment engagement and adapt the MI-based treatment engagement 
intervention and implementation strategy to the needs of stakeholders; (2) Conduct a 
randomized multi-site pragmatic effectiveness trial comparing MH Referral alone with 
MH Referral plus MI-based coaching; and (3) Conduct an implementation-focused 
formative evaluation and use this information to make mid-course corrections to the 
implementation strategy based on stakeholder and key informant input. 
 
Methods: We propose a 4-year Hybrid Type 2 effectiveness-implementation project 
that uses mixed qualitative and quantitative methods. In order to maximize 
generalizability, we will conduct this study in geographically distinct rural CBOCs in 
VISNs 16 and 21. The PARIHS and RE-AIM frameworks will guide the implementation 
and formative evaluation strategies, respectively.  During Phase 1 (months 0-10,) using 
Evidence-Based Quality Improvement (EBQI) meetings, semi-structured interviews, and 
quick ethnography, we will conduct a developmental formative evaluation to learn about 
barriers impacting  veterans who use VA CBOCs and we will adapt the MI-based 
engagement intervention and implementation strategy to the needs of project 
stakeholders (Aim 1). During Phase 2 (months 10-48), we will conduct the pragmatic 
effectiveness trial of the telephone motivational coaching intervention to determine 
whether, in comparison to MH Referral alone, telephone MI coaching improves MH 
treatment initiation and retention, the use of e-health MH resources, and perceived need 
and readiness for and access to MH treatment among  veterans who use CBOCs (Aim 
2). Also during Phase 2, using the same qualitative methods described for Aim 1, we 
will conduct an implementation-focused formative evaluation to obtain information which 
will allow us to further refine the implementation strategy based on stakeholder and key 
informant input (Aim 3).  
 

 
 
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Impact: This research will help close the knowledge gap about barriers to care and 
preferences for MH services among rural veterans. In addition, information from this 
project will be used to develop implementation toolkits for MH treatment engagement 
interventions for rural veterans. Finally, this project will determine the effectiveness of a 
telephone Motivational Interviewing engagement intervention using e-health adjuncts, 
thereby filling a gap in the scientific literature about whether novel interventions can be 
used by VA staff in CBOCs to overcome rural-urban disparities in MH treatment 
engagement.  
 
 

 
 
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List of Abbreviations 
Provide a list of all abbreviations used in the protocol and their associated meanings. 
ANCOVA 
- 
Analysis of covariance 
CAHCS 
- 
Central Arkansas Health Care System 
CAVHS 
- 
Central Arkansas Veterans Healthcare System 
CBOC 
- 
Community-Based Outpatient Clinic 
CBT 
- 
Cognitive Behavioral Therapy 
CI 
- 
Confidence Interval 
CPRS 
- 
Computerized Patient Record System 
DFE 
- 
Developmental Formative Evaluation 
DoD 
- 
Department of Defense 
EBP 
- 
Evidence-Based Practice 
EBQI 
- 
Evidence Based Quality Improvement 
GAD 
- 
Generalized Anxiety Disorder 
HBC 
- 
Health Behavior Coordinator 
HIPAA 
- 
Health Insurance Portability and Accountability Act 
ICD 
- 
International Classification of Diseases 
IRB 
- 
Institutional Review Board 
IRR 
- 
Incidence Rate Ratio 
ITT 
- 
Intent-To-Treat 
MH 
MI 
- 
- 
Mental Health 
Motivational Interviewing 
MINT 
- 
Motivational Interviewing Network of Trainers 
NCP 
- 
National Center for Prevention 
NCPTSD 
- 
National Center for PTSD 
NIDA 
- 
National Institute on Drug Abuse 
OEF 
- 
Operation Enduring Freedom 
OIF 
- 
Operation Iraqi Freedom 
OND 
- 
Operation New Dawn 
PACT 
- 
Patient Aligned Care Team 
PARiHS 
- 
Promoting Action on Research Implementation in Health Systems 
PCMH-I 
- 
Patient-Centered Medical Home Initiative 
PDSA 
- 
Plan-Do-Study-Act 
PTSD 
- 
Post-Traumatic Stress Disorder 
QE 
- 
Quick Ethnography 
RA 
- 
Research Assistant 
RCT 
- 
Randomized Controlled Trial 
RE-AIM 
- 
Reach, Effectiveness, Adoption, Implementation, Maintenance 
RN 
- 
Registered Nurse 
RR 
- 
Relative Risk 
RUCA 
- 
Rural-Urban Commuting Area 

 
 
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SFVAMC 
- 
San Francisco VA Medical Center 
SLVHCS 
SOTA 
- 
Southern Louisiana Veterans Health Care System 
State Of The Art 
TBI 
- 
Traumatic Brain Injury 
UAMS 
- 
University of Arkansas for Medical Sciences 
VISN 
- 
Veterans Integrated Service Network 
VistA 
- 
Veterans Health Information Systems and Technology Architecture 
 

 
 
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Contents 
Protocol Title:  Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans
 .................................................................................................................................................. 7 
1.0 
Study Personnel .............................................................................................................. 7 
2.0 
Introduction ..................................................................................................................... 8 
3.0 
Objectives ......................................................................................................................14 
4.0 
Resources and Personnel ..............................................................................................15 
5.0 
Study Procedures ...........................................................................................................21 
5.1 Study Design ...................................................................................................................21 
5.2 Recruitment Methods.......................................................................................................26 
5.3 Informed Consent Procedures .........................................................................................28 
5.4 Inclusion/Exclusion Criteria ..............................................................................................29 
5.5 Study Evaluations ............................................................................................................31 
5.6 Data Analysis ..................................................................................................................37 
Power Calculation:.................................................................................................................37 
Rationale for the RCT sample size: .......................................................................................38 
Randomization for the RCT (Aim 2) .......................................................................................38 
Plans for and specification of the purpose of any interim analysis of the data (with regard to 
stopping rules for superiority, futility, or sample size re-estimation): ......................................38 
Methods for dealing with data transformations: There are no a priori plans to transform 
outcome measures; during data analysis, if transformations of data appear necessary to 
satisfy key statistical assumptions, we will revisit at that time.  Definitions of the analytical sets 
(i.e. intent-to-treat, per protocol, and any other analytical subsets): For Intention to Treat 
Analysis, analytical sets will consist of all enrolled patients according to treatment assignment.
 ..............................................................................................................................................38 
5.7 Withdrawal of Subjects ....................................................................................................39 
6.0 
Reporting ........................................................................................................................39 
7.0 
Privacy and Confidentiality .............................................................................................40 
8.0 
Communication Plan ......................................................................................................44 
9.0 
References .....................................................................................................................45 
 
 
 
 

 
 
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Protocol Title:  Motivational Coaching to Enhance Mental Health 
Engagement in Rural Veterans 
 
1.0 
Study Personnel 
 
Principal Investigator/Study Chair:  Karen Hope Seal MD MPH 
Position/Title: Staff Physician, Director of Integrated Care Clinic 
Organization name: San Francisco Veterans Affairs Medical Center 
Street: 4150 Clement St, 111-A1 
City: San Francisco, CA 94121-1545 
Country: USA 
Phone number: (415)221-4810 x4852 
Fax number: (415)379-5573 
E-mail: Karen.Seal@va.gov 
Credential: KASEAL 
 
Co-Investigators:  
Co-Investigator:   Jennifer Manuel, PHD 
Position/Title: Health Behavior Coordinator 
Organization name: San Francisco Veterans Affairs Medical Center 
Street: 4150 Clement St, 111-A1 
City: San Francisco, CA 94121-1545 
Country: USA 
Phone number:  415-221-4810 x5206 
Fax number: (415)379-5573 
E-mail: jennifer.manuel@va.gov 
 
Co-Investigator: Christopher Koenig PHD 
Position/Title: Research Sociologist 
Organization name: San Francisco Veterans Affairs Medical Center 
Street: 4150 Clement St, 111-A1 
City: San Francisco, CA 94121-1545 
Country: USA 
Phone number: (415)221-4810 x6419 
Fax number: (415)379-5573 
E-mail: Christopher.Koenig@va.gov 
 
Collaborators: 
Central Arkansas Healthcare System 
Co-Investigator: Jeffrey Pyne PHD 

 
 
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Position/Title: Deputy Director 
Organization name: Central Arkansas Veterans Health Care System 
Street: 2200 Fort Roots Drive, Bldg 58 
City: North Little Rock, AR, 72214-1706 
Country: USA 
Phone number: (501)257-1083 
E-mail: Jeffrey.Pyne@va.gov 
 
Credential: JMPYNE 
 
Southeast Louisiana Veterans Health Care System 
 
Co-Investigator Name: Madeline Uddo, Ph.D. 
Position/Title: Staff Clinical Psychologist/Team Leader, PTSD Clinical Team 
Organization name: Southeast Louisiana Veterans Health Care System 
Building & Room Number: Mental Health Clinic #204 
Street: 3500 Canal St 
City: New Orleans 
Country: USA 
Phone number: 504-571-8296 
E-mail: Credential: madeline.uddo@va.gov 
 
Co-Investigator Name: Michelle Hamilton 
Position/Title: Clinical Psychologist 
Organization name: Southeast Louisiana Veterans Health Care System 
Building & Room Number: Mental Health Clinic, room 203 
Street: 3500 Canal Street 
City: New Orleans 
Country: USA 
Phone number: 504-571-8295 
E-mail: Michelle.Hamilton@va.gov   
Credential:  Ph.D 
2.0 
Introduction 
 
There is a substantial burden of mental health (MH) problems in rural OEF/OIF/OND 
veterans. After a decade of war, over 51% of OIF, OEF, and OND veterans in VA 
healthcare have received MH diagnoses; the majority (27%) have received 
diagnoses of posttraumatic stress disorder (PTSD).1 Studies show that veterans 
residing in rural areas experience significantly greater MH severity and poorer 
outcomes than their urban counterparts2, 3, 9  Surprisingly, there are no published 
studies on the differential MH burden among OEF/OIF/OND veterans in VA 
healthcare based on rurality. To begin to address this knowledge gap, using rural-
urban commuting area (RUCA) zip code data to define rurality 10, 11 and national VA 
administrative data to obtain ICD-9 MH diagnoses codes, our group found that 
increasing rurality was associated with a higher prevalence of MH disorders in 

 
 
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OEF/OIF/OND veterans nation-wide and in VISNs 16 and 21. (Seal, preliminary 
data) For instance, compared to the prevalence of MH diagnoses among urban 
OEF/OIF/OND veterans in VISN 21 (44.7%), the MH burden was higher in rural 
veterans(47.4%) and even greater in “isolated rural” veterans (54.6%),(Relative 
Risk=1.22, 95% CI=1.11-1.34 for MH diagnoses in isolated rural vs. urban veterans) 
(Seal, preliminary data). 
 
The majority of OEF/OIF/OND veterans with MH problems do not receive an 
adequate course of MH treatment. The VA Uniform Mental Health Services 
Handbook mandates that all veterans, including those receiving care at CBOCs 
serving rural veterans, have access to evidence-based MH treatments. Minimally 
adequate MH treatment has been defined as ≥ 8 MH treatment sessions or receiving 
≥ 2 months of psychiatric medication plus > 4 visits within 1 year.5  Unfortunately, the 
majority of OEF/OIF/OND veterans has not received an adequate course of MH 
treatment as found in a nationally representative sample of veterans,12 and veterans 
enrolled in VA healthcare.6, 13 Indeed, at the San Francisco VA Medical Center 
(SFVAMC), our group demonstrated significantly improved MH treatment initiation in 
OEF/OIF/OND veterans who presented to our new co-located primary care-mental 
health clinic compared to usual primary care, but sustained engagement in specialty 
MH services remained poor with drop-out after 1-2 sessions.14  
 
Poor retention in MH services may be even more pronounced for rural 
OEF/OIF/OND veterans.6 13 Our own research showed that living > 25 miles from a 
VA facility was a strong predictor of failing to receive adequate MH treatment.6 In a 
more recent analysis of MH utilization in OEF/OIF/OND veterans in the first year of 
receiving MH diagnoses nationwide, we found a significant association between 
increasing rurality and drop-out after 1-2 MH visits. Specifically, in VISN 21, only 
35% of isolated rural veterans with MH diagnosis compared to 45% of urban 
veterans completed  ≥ 8 MH visits (RR for isolated rural=0.77, 95% CI=0.59, 
1.00)(Seal, preliminary data) Geographical distance is a significant logistical barrier, 
but rurality may also serve as a proxy for other access and engagement barriers 
such as cultural, financial, and digital barriers, as outlined in the State of the Art 
Conference (SOTA) Access Framework, developed by Dr. Fortney (see CREATE 
Overview).15 SOTA hypothesizes that the most salient barriers to care for rural 
veterans may be cultural barriers, including heightened levels of stigma, and lack of 
perceived need including negative beliefs about MH treatment, stoicism, and self-
reliance.16-18   
 
Motivational Interviewing is an evidence-based practice to promote MH treatment 
engagement in veterans. Telephone-based referral care management (Behavioral 
Health Lab) consisting of 1 to 2 telephone MI sessions plus pre-scheduled 
appointments for 113 older, depressed veterans resulted in significantly improved 
MH treatment initiation, but no improvements in clinical outcomes.19, 20  In another 
study of 114 older veterans (mean age 56 years), those randomized to 4 sessions of 
group MI demonstrated greater retention in PTSD therapy than veterans who 
received 4 sessions of psychoeducation.21 Neither of these MI-based trials was 

 
 
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conducted in OEF/OIF/OND or rural veterans, but results underscored that MI, 
including telephone MI, improved MH treatment initiation and/or retention in care. In 
contrast, results from a Cognitive Behavioral Therapy (CBT)-based MH treatment 
engagement intervention for a small sample of OEF/OIF/OND veterans were mixed.  
In OEF/OIF veterans, using a pre-post quasi-experimental design, Stecker et al., 
showed that among 26 National Guard and Reserve veterans, one session of 
telephone-administered CBT significantly increased veterans’ self-reported intention 
to engage in treatment, but did not result in actual increases in MH treatment 
initiation.22  
Our recent pilot RCT demonstrated the efficacy of telephone MI to increase MH 
treatment engagement in OEF/OIF/OND veterans.  This efficacy data supports our 
taking the next step in conducting a hybrid effectiveness-implementation study. 
Seventy-three OEF/OIF veterans who screened positive for one or more MH 
problem(s), but were not engaged in treatment, received an MH referral and were 
randomized to either 4 brief sessions of telephone MI or 4 brief neutral attention-
control telephone sessions at baseline, 2, 4, and 8 weeks. Of note, MI was 
conducted by non-clinician Master’s-level research staff who had been trained in MI 
for this study. Blinded assessment occurred at 8 and 16 weeks. In intent-to-treat 
analyses, 62% assigned to telephone MI initiated MH treatment compared to 26% of 
Controls [Relative Risk (RR) =2.41, 95% Confidence Interval (CI) =1.33- 4.37, p= 
0.004], which represented a large effect size (Cohen’s h=0.74). We also observed 
significant reductions in stigma about MH treatment and in marijuana use (both p-
values<0.05). In addition, while this MI trial was not focused on MH treatment 
retention, the MI group also demonstrated significantly greater retention in MH 
treatment than Controls (Incidence Rate Ratio (IRR) =4.36, 95% CI=1.96-9.68), 
signaling that telephone MI could be used to enhance MH treatment retention in 
OEF/OIF/OND veterans.7 While the evidence from this pilot study supports 
progression toward implementation, because we are now targeting a rural, and not 
urban population, and VA staff as opposed to research staff will deliver the 
intervention, we propose a pragmatic effectiveness study using a hybrid design that 
will also allow us to critically evaluate the implementation strategy at the same time 
as the interventions’ effectiveness.8 
The conceptual underpinnings of Motivational Interviewing (MI) support an MI-based 
coaching intervention to enhance MH treatment engagement in rural veterans. MI is 
a patient-centered counseling style for enhancing intrinsic motivation for change by 
exploring and resolving ambivalence.23  MI is based on the principles of 
interpersonal, patient-centered psychotherapy 24 and the Transtheoretical Model of 
Change 25 which posits that patients move in graduated stages from pre-
contemplation through contemplation to action. Rollnick places the construct of 
“readiness to change” at the center of his model and identifies two elements: 

 
 
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“importance” and “self-confidence” regarding change that contribute to readiness.23 
A specific MI strategy that we will use in this study, involves the use of the 
“Readiness Ruler” to gauge an individual’s perception on a scale from 0 to 10 of the 
importance, their confidence, and readiness to make behavioral changes such as 
engaging in MH treatment.23 In multiple randomized controlled trials, MI has been 
shown to enhance both MH treatment initiation as well as retention in care, 26,27 and 
MI has been successfully adapted for administration by telephone.28,29  
MI has been effectively used in culturally diverse populations, including rural 
populations; peer counselors who “speak the same language” may be highly 
effective in engaging rural veterans in care. 30, 31  Cultural meanings of MH problems 
may be reflected back to patients to explore ambivalence, negative beliefs and 
stigma regarding MH treatment.  In addition, culturally-based strengths and coping 
mechanisms, e.g., spirituality, family and peer supports may be leveraged to 
promote treatment engagement.32  Indeed, ancillary healthcare staff and peer 
counselors have been successfully trained to conduct MI.33, 34 VA has a long-
standing tradition of peer counseling as evidenced by 207 Vet Center Centers 
nationwide, many of which are staffed by veteran peers.35 Veteran peer counseling 
programs capitalize on shared experience and camaraderie to foster credibility and 
trust, decrease stigma and promote help-seeking in veterans.35 VA has also 
successfully used peer counseling in substance abuse and MH treatment 
programs.36, 37 In January 2011, the VA/DoD Defense Centers of Excellence 
produced a White Paper identifying best practices in peer support, drawing on the 
experience and outcomes of numerous veteran peer counseling programs, e.g., 
Vet2Vet, Vets 4 Vets, Vet Center etc….38 The White Paper serves a blueprint that 
will guide us in the hiring, training, and monitoring of experienced veteran peer 
counselors who will become part of an MI coaching team (see below). As an adjunct 
to MI coaching, this study will also refer study participants to “Considering 
Professional Help,” 
https://www.myhealth.va.gov/course/ConsiderProffHelpPresentation/index.html 
an Office of Mental Health Services program available on MyHealtheVet, which, 
consistent with MI principles, features veteran peers working through and resolving 
their ambivalence about engaging in MH treatment.  
The PARiHS framework will guide us in adapting and implementing the MI treatment 
engagement intervention for  veterans who use CBOCs serving rural veterans. To 
evaluate the impact of rural culture on prevailing MH referral and engagement 
processes at rural CBOCs and use this information to adapt and implement the MI 
coaching intervention, we will use the Promoting Action on Research Implementation 
in Health Systems (PARiHS) Framework.39 The components of PARiHS: Evidence, 
Context and Facilitation will guide the identification of the necessary conditions 
under which MI, as an evidence-based practice (EBP), may be implemented in 
clinical practice at CBOCs.  According to PARiHS, successful implementation is 
most likely to occur when scientific evidence supporting an intervention fits with 
providers’ experience and local cultural norms, the healthcare organizational context 
is supportive of implementation, and there are culturally appropriate mechanisms to 

 
 
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facilitate and maintain implementation.40  The RE-AIM framework 41 (see below) will 
provide a framework to evaluate the progress and outcomes of the implementation 
strategy. PARiHS fits well with the theoretical underpinnings of MI because both 
require an interactive partnership of behavioral change agents (researcher and VA 
leadership and staff) with the targets of behavioral change (patients and VA 
providers) who may be ambivalent about the need/desire to change. To implement 
an MH engagement intervention that is culturally appropriate, responsive to the 
needs of the recipients, and readily adopted and maintained in clinical practice, it will 
be critical to develop an ethnographic understanding of rural  veterans and VA 
CBOC staff and incorporate these cultural understandings in the MI coaching 
intervention and implementation plan.   
 
“Secretary Shinseki talks about the tyranny of distance –the distance that separates 
veterans from care at their nearest VA medical facilities…Distance can mean rural 
veterans don’t have access to the care and services they’ve earned.” 42 
Of the 758,683 OEF/OIF/OND veterans who have separated from military service 
and have enrolled in VA healthcare nationwide, a quarter receives the majority of 
their care from VA CBOCs. (Seal, preliminary data) This project focuses on testing 
the effectiveness of an MH treatment engagement intervention for veterans who use 
CBOCs serving rural veterans for the following reasons:   
First, this is a sub-group of veterans with a disproportionate burden of recent military 
service-related MH problems. Since the conflicts began in 2002, more than half of all 
OEF/OIF/OND veterans have received one or more MH diagnoses. Mental illness 
not only hinders successful reintegration, including obtaining education and gainful 
employment, but also can leave deep and enduring scars on families, potentially 
impacting generations to come. Moreover, several studies have shown that 
compared to their urban counterparts, rural veterans experience more severe MH 
symptoms and have poorer MH outcomes, the most tragic of which is suicide.3, 43  
Although not a specific aim of this project, we will capitalize on our group’s data 
analytic strengths to further investigate rural-urban disparities in MH burden and 
utilization among veterans. 6, 44-46 
 
Second, sustained engagement of  veterans in MH treatment is poor; rurality is a 
strong predictor of poor engagement.6 Quality evidence-based MH treatment is 
mandated for all veterans, including veterans receiving care in CBOCs serving rural 
veterans. The VA has gone to extraordinary lengths to fulfill this mandate by hiring 
large numbers of new MH personnel, providing training in evidence-based MH 
therapies, initiating telemental health, and by establishing PCMH-I and the Office of 
Rural Health.47, 48 Nevertheless, engagement in MH treatment remains 
disappointing, particularly among rural veterans.6 For young veterans, failing to 
engage in MH treatment early may result in chronic mental illness and associated 
social and occupational dysfunction with high costs to individuals, families, and 
society. 49, 50 Our group and others have demonstrated strong links between mental 
illness, negative health behaviors and physical health problems, such as smoking, 

 
 
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hypertension, and drug and alcohol abuse, resulting in disproportionately high 
medical (non-MH) services utilization.46, 51-53 Promoting MH treatment engagement 
and targeting negative health behaviors early may prevent costly morbidity and 
excessive services utilization as this generation ages. With our VA clinical and 
operations partners, Aim 2 will test the effectiveness of an MI-based treatment 
engagement intervention that aims to not only improve MH treatment engagement, 
but also to reduce unhealthy behaviors in rural veterans.  
 
Third, a knowledge gap exists with regard to barriers to MH care that differentially 
impact rural veterans.  It is likely that rurality exacerbates many of the same patient-
level barriers that impact urban veterans,12, 17 but there may be other barriers that 
are unique to rural veterans.  Distances to care are greater for rural veterans, 
requiring increased travel times, more time off from work or school, and childcare 
etc…Rural veterans are less likely to have the financial resources to orchestrate 
these logistics, especially for weekly MH appointments.  In addition, rural culture 
may present powerful barriers to MH treatment engagement.15 These “barriers” 
include the central importance of family, community, and religion, which may be 
perceived as better resources for addressing personal MH problems than MH 
professionals.54 Rugged individualism, self-reliance, pride, and stigma may deter 
rural veterans from asking for help.48 Finally, altruism and humility may lead rural 
veterans to believe they are not deserving of help.48 MI, used skillfully, may 
transform these cultural “barriers” into actual strengths.32 For instance, family can be 
encouraged to motivate treatment engagement, clergy may provide initial 
counseling, and veteran peer coaches may be able to communicate in a way rural 
veterans understand.37, 54, 55  Moreover, rural veterans are disproportionately 
impacted by VA system barriers such as lower MH staffing ratios at CBOCs, 
resulting in longer wait times.56 While the proposed MI coaching intervention will not 
directly change systemic barriers to care, it may encourage veterans to pursue MH 
treatment despite barriers, as well as motivate veterans to seek non-traditional MH 
treatment options, including telemental health and online resources.  During Phase 1 
formative evaluation, we will partner with our stakeholders to achieve a deeper 
understanding of the salient barriers to care so that we can tailor the MI coaching 
intervention and implementation plan (Aim 1). Aim 3 will consist of an 
implementation-focused formative evaluation that will inform mid-course adjustments 
to our implementation strategy. 
 
Fourth, innovations to enhance treatment engagement in OEF/OIF/OND veterans 
with MH problems are a national US priority. In separate testimonies to the 
Government Accountability Office (2011) and the House Committee on Veterans 
Affairs (2011)57, Dr. Seal (PI) argued that while evidence-based MH treatments are 
available within VA, there is a significant engagement gap in which OEF/OIF/OND 
veterans, particularly rural veterans, are lost between VA primary care (where they 
first present with MH symptoms) and VA specialty MH clinics, where they are 
referred for MH treatment. Until we: (1) develop an evidence-base to guide the 
effective delivery of MH treatments, and (2) successfully implement effective MH 

 
 
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treatment engagement strategies, rural-urban disparities in MH services use and 
outcomes will likely persist.58 In her Congressional testimony, Dr. Seal proposed 
innovative strategies to address this engagement gap which may be attractive to 
young, rural OEF/OIF/OND veterans: (1) employing experienced veteran peer 
counselors to promote MH treatment engagement,38 and (2) expanding the use of e-
health technologies to augment engagement interventions and MH resources. 
Recent meta-analyses and studies indicate that Internet therapy is an efficacious, 
effective and acceptable treatment for depression and anxiety disorders, including 
PTSD, and produces results comparable to face-to-face treatment. 59 60 61 Aim 1 will 
use qualitative methods to identify effective, feasible, and culturally acceptable 
engagement strategies and MH options for young rural veterans, testing the 
hypothesis that telephone-, smartphone- and internet-based options will increase 
perceived access.  Aim 2 will test the effectiveness of the MI coaching intervention, 
in part delivered by experienced veteran peer counselors. 
3.0 
Objectives 
This hybrid effectiveness-implementation project 8 will use mixed qualitative 
/quantitative observational and experimental methods to achieve the following study 
objectives and test related hypotheses in  veterans who receive care at CBOCs serving 
rural veterans:  
 
Aim 1: Prior to implementing the intervention, to conduct a developmental 
formative evaluation of perceived barriers to MH engagement among rural 
veterans, identify feasible, acceptable and effective MH treatment options, and 
adapt a proven MI-based MH treatment engagement intervention to the needs and 
preferences of CBOC staff and  veterans who receive care at CBOCs.   
 
H1a. Among rural  veterans, cultural attitudes such as stigma and lack of perceived 
need (e.g., stoicism, and self-reliance) present significant barriers to care.  
H1b.  veterans will favor online, telephone- and smartphone-based MH treatment 
options. 
H1c.   veterans will favor a treatment engagement intervention that is, in part, 
conducted by experienced veteran peer counselors.  
 
Aim 2: In a randomized multi-site pragmatic effectiveness trial, compare the 
effectiveness of MH Referral alone with MH Referral plus MI-based coaching to 
improve MH services engagement in  veterans receiving care at CBOCs. 
Compared to MH Referral alone, MI coaching will significantly: 
H2a.  Increase MH services initiation and retention (number of MH visits) (Primary 
Hypothesis). 
H2b.  Increase the use of e-health “self-help” MH treatment options, such as 
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H2c.  Increase perceived need and readiness for MH treatment, and decrease barriers to 
MH services. 
 
Secondarily, we will evaluate change in mental health symptoms, high-risk behaviors 
(e.g., driving under the influence, etc…), functioning, quality of life, perceived access to 
MH care, and satisfaction with VA healthcare. 
 
Aim 3: During the pragmatic effectiveness trial, conduct an implementation-
focused formative evaluation with stakeholders to collect information that will 
allow us to refine the implementation strategy and further tailor the MI coaching 
intervention to the needs of  veterans and CBOCs serving rural veterans. 
4.0 
Resources and Personnel 
The main aim of this research is to implement telephone or e-Motivational Coaching in order to 
enhance engagement of rural Veterans in mental health treatment at local VA Community-
Based Outpatient Clinics (CBOCs) or in their own communities. The study will be based at the 
San Francisco VA Medical Center (SFVAMC), the Central Arkansas Health Care System 
(CAHCS) and the Southeast Louisiana Veterans Health Care System (SLVHCS).  SFVAMC and 
CAVHS will serve as “Motivational Coaching Centers”, where the coaches will conduct outreach 
to Veterans.  Recruitment in VISN16 will take place in CBOCs located in the SLVHCS.  CAVHS 
staff will travel to SLVHCS to enroll participants and conduct most study procedures. Some 
assistance with semi-structured interviews (for both sets of participants) will be provided by over 
the phone by the SFVAMC Qualitative team. The first phase of the study (first 10 months) will 
be used to define exactly which affiliated 2-3 CBOCs in SFVAMC and SLVHCS are best suited 
as mental health referral sites for this research.  We already have letters of support from heads 
of primary care and mental health at each VA Medical Centers agreeing to this process. Study 
staff members at SFVAMC and CAVHS will conduct study procedures for participants in both 
VISN 16 and VISN 21. 
 
 
San Francisco VA Medical Center (SFVAMC)  
 
Karen H. Seal, MD, MPH, Principal Investigator  Dr. Seal is a VA staff physician and 
Director of the Integrated Care Clinic for Iraq and Afghanistan veterans at the San 
Francisco VA Medical Center. Dr. Seal is an Associate Professor in Residence in the 
Departments of Medicine and Psychiatry at the University of California, San 
Francisco.  For the proposed study, Dr. Seal will oversee all aspects of the study at both 
study sites.  This includes communication with affiliated VA operations partners, staff 
hires and training, qualitative and quantitative data collection activities, recruitment and 
enrollment of study subjects, fidelity to the motivational interviewing intervention, human 
subjects compliance, data management and analysis, and dissemination of study 
results, including manuscript preparation.  Practically, Dr. Seal will manage the multi-
site study by holding conference calls with study staff at both sites twice monthly with 
additional calls and e-mail correspondence with individual staff members as 
needed.  Dr. Seal will travel to Little Rock once a year for a site visit.  Access to PHI- 
YES 

 
 
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Christopher Koenig, PhD, Co-Investigator Dr. Koenig is a medical sociologist and 
qualitative researcher.  Dr. Koenig (in collaboration with Drs. Curran and Abraham, see 
below) will be responsible for all qualitative aspects of the proposed study including the 
conducting the developmental formative evaluation and process evaluations of the MI 
coaching intervention.  Dr. Koenig will assist with the development of the semi-
structured interview scripts, conduct semi-structured interviews with VA CBOC and 
community mental health staff and veteran patients, attend and take notes at all EBQI 
meetings, and conduct “quick ethnography”.  These activities will both inform the 
adaptation of the MI coaching intervention as well as evaluate the effectiveness of the 
implementation strategy.  In addition, together with the other two qualitative analysts on 
the study, Dr. Koenig will conduct qualitative data analysis and assist with manuscript 
preparation. Access to PHI- YES 
 
Jennifer Manuel, PHD, Co-Investigator At the SFVAMC, in her current role as the 
HBC, Dr. Manuel will assist Dr. Seal with the selection of VA staff and the hiring of an 
experienced veteran peer counselor for this project.  In addition, after initial MI training 
by the MI trainer, Dr. Manuel will conduct at least monthly supervision sessions with the 
MI coaches (in part, informed by MI fidelity coding), in addition to the quarterly booster 
trainings by the MI trainer.  As with Dr. Mesidor, the HBC counterpart at CAVHS, Dr. 
Manuel will be in close communication with the MI trainer to calibrate the MI coaching 
intervention across sites and to discuss the results of MI fidelity coding. Access to PHI- 
YES  
 
Brian Borsari, PHD, Co-Investigator At the SFVAMC, in his current role as the HBC, 
Dr. Borsari will assist Dr. Seal with the selection of VA staff and the hiring of an 
experienced veteran peer counselor for this project.  In addition, after initial MI training 
by the MI trainer, Dr. Borsari will conduct at least monthly supervision sessions with the 
MI coaches (in part, informed by MI fidelity coding), in addition to the quarterly booster 
trainings by the MI trainer.  As with Dr. Mesidor, the HBC counterpart at CAVHS, Dr. 
Borsari will be in close communication with the MI trainer to calibrate the MI coaching 
intervention across sites and to discuss the results of MI fidelity coding. Access to PHI- 
YES  
 
Other Study Staff- SFVAMC 
 
Project Coordinator an experienced project coordinator will oversee all field operations 
of the proposed study, including the hiring and supervision of study staff (particularly the 
RA and data manager), coordinating regular meetings of co-investigators and 
consultants, development of study materials, subject recruitment, verifying study 
eligibility, enrollment and informed consent procedures, randomization, and all data 
collection activities, including conducting baseline phone assessments.  The Project 
Coordinator will also be responsible for maintaining Central IRB approval and ensuring 
human subjects protections. In addition, the coordinators at both study sites will set up 
the EBQI meetings with research staff and stakeholders and coordinate communication 

 
 
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between the EBQI meetings.  The project coordinator based at the SFVAMC will be 
supervised by Dr. Seal. Access to PHI- YES 
 
Research Assistant An experience research assistant (RA) will be provide assistance 
to the PI and Project Coordinator. Specifically, this Research Assistant will be 
responsible for assisting with the submission of protocol changes to the VA Central IRB 
and for conducting the some of the quantitative assessments (baseline and follow-up) 
during the RCT. Access to PHI- YES 
 
Research Assistant This Research Assistant will collaborate with Dr. Koenig in the 
collection of qualitative and ethnographic data through the EBQI meetings, semi-
structured interviews, and observations with both providers and veterans. He/she will 
also conduct quantitative assessment (both baseline and follow-up) in the RCT portion 
of the study. Access to PHI- YES 
 
Veteran Peer Counselor  The Veteran Peer Counselor will implement the Motivational 
Interviewing intervention in RCT study participants. They will be trained by the MI 
Trainer and will be supervised by the HBCs at each of the participating medical centers.  
He/she will also help support other study operations such as recruitment, informed 
consent procedures, and qualitative assessments. Access to PHI- YES 
 
Motivational Interviewing Trainer This individual will be a certified MI trainer by the 
Motivational Interviewing Network of Trainers (MINT). For the proposed study, the MI 
Trainer will provide a standard initial 8-hour MI training session for VA staff and veteran 
peer counselors. Following this initial training, he/she will conduct at least quarterly in-
person or V-Tel booster training sessions. He/she will supervise the MI fidelity coder (as 
she has done in the past) and communicate the results of MI coding to the HBCs who 
will directly supervise the MI coaches at the CBOCs in each of the VISNs. He/she will 
also help to calibrate the MI coaching intervention across sites. Access to PHI- YES 
 
Statistician, MPH This individual will be responsible for conducting all planned study 
analyses in consultation with the PIs and Co-Investigators and will participate in 
manuscript preparation. Access to PHI- YES 
 
Statistician, PhD Working in tandem with the other Statistician, this individual will be 
responsible for conducting all planned study analyses in consultation with the PIs and 
Co-Investigators and will participate in manuscript preparation. Access to PHI- YES 
 
Data Programmer/Manager The data programmer and manager will be responsible for 
uploading the quantitative study questionnaire to our web-based data management 
system, for secure electronic data entry.  He/she will maintain the study database in 
compliance with VA standards for data security and conduct data quality checks 
periodically.  Subsequently, prior to data analysis, he/she will “clean,” validate, and 
prepare data for analysis by the statistician, assuring data quality.  Access to PHI- YES 
 

 
 
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Research Assistant, PhD: The research assistant is a post-doc at the SFVAMC. He will 
participate in data analysis, interpretation, publication, and dissemination. Access to PHI- YES. 
 
 
CONSULTATION SERVICE 
 
Annabel Prins, PhD Dr. Prins has served as clinical psychologist within the VA for the 
past 15 years and has cultivated expertise in the areas of PTSD assessment and web-
based trainings and interventions. She has served as PI and Co-PI on a number of VA 
grants in these areas and is thus well situated to serve as consultant for Dr. Seal’s grant 
proposal.  She is extremely familiar with VA and DoD e-health resources for mental 
health treatment, and will assist Dr. Seal and the MI coaching staff in using these, as 
appropriate.  Dr. Prins is currently stationed at the National Center for Telehealth and 
Technology (T2) where she is evaluating the effectiveness of several online self-help 
workshops, as well as the overall clinical utility of afterdepoloyment.org, a web-site with 
wellness resources for the military and veteran community.  She has also worked 
closely with Dr. Rusek at the National Center for PTSD to develop PTSD smartphone 
apps, such as “PTSD Coach”.  In this capacity, she will provide trainings to VA providers 
on bringing technology into clinical care through the use of specific e-health tools.  
Because this project is so closely aligned with her own clinical and research interests, 
Dr. Prins will donate her effort as a consultant on this project. 
 
Craig Rosen, PhD, Consultant As Deputy Director of the NCPTSD Dissemination & 
Training Division, Dr. Rosen’s main research focus is in increasing veterans’ access to 
high quality PTSD care.  For this study, he will lend his expertise to the refinement and 
execution of the motivational coaching intervention to improve engagement in mental 
health treatment for rural OEF/OIF/OND veterans.   
 
 
Central Arkansas Veterans Healthcare System (CAVHS) 
 
KEY PERSONNEL 
 
Jeffrey Pyne, MD, Co-Investigator Dr. Pyne is a Psychiatrist/Research Health 
Scientist and a full-time VA employee and Staff Physician.  Dr. Pyne has experience 
conducting studies in VISN 16 CBOCs and will assist Dr. Seal in implementing the study 
intervention in these CBOCs.  Dr. Pyne will serve as the site lead for this project and, as 
such, will directly supervise the Project Coordinator based at CAVHS. Dr. Pyne will also 
oversee the activities of the qualitative research team that is conducting the 
developmental and formative evaluations of the intervention and implementation 
strategy.  Dr. Pyne will participate in the bi-weekly study calls with Dr. Seal and will have 
additional correspondence with Dr. Seal as needed to coordinate study activities at the 
2 sites. Access to PHI- YES 
 
 

 
 
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Marie Mesidor, PHD, Co-Investigator.  Dr. Mesidor currently serves as the Behavior 
Health Coordinator (BHC) at the CAVHS.  Her role on this project will be to supervise 
the veteran peer coach.  After initial MI training by the MI trainer, Dr. Mesidor will 
conduct at least monthly supervision sessions with the MI coaches (in part, informed by 
MI fidelity coding), in addition to the quarterly booster trainings by the MI trainer.  As 
with Dr. Manuel, the HBC counterpart at SFVAMC, Dr. Mesidor will be in close 
communication with the MI trainer to calibrate the MI coaching intervention across sites 
and to discuss the results of MI fidelity coding. Access to PHI- YES  
 
Other Study Staff- CAVHS 
 
Project Coordinator Is an experienced Project Coordinator who will oversee all field 
operations of the proposed study, at CAVHS.  This includes hiring and supervising of 
study staff, coordinating regular meetings of co-investigators and consultants, 
development of study materials, subject recruitment, verifying study eligibility, 
enrollment and informed consent procedures, randomization, and all data collection 
activities, including conducting baseline and follow-up phone assessments.  The 
Coordinator will also be responsible for maintaining Central IRB approval and ensuring 
human subjects protections. In addition, the Coordinators at both study sites will set up 
the EBQI meetings with research staff and stakeholders and coordinate communication 
between the EBQI meetings.  The Coordinator based at the CAVHS will be supervised 
by Dr. Jeffrey Pyne.  Access to PHI- YES 
 
Research Assistant will assist with obtaining informed consent, scheduling qualitative 
interviews, recruiting, scheduling, and conducting baseline and follow-up telephone 
assessments.  She will make travel arrangements and assist with correspondence.  She 
will also assist with the development, publication, and dissemination of study 
products.  Access to PHI- YES 
 
Veteran Peer Counselor The Veteran Peer Counselor will implement the Motivational 
Interviewing intervention in RCT study participants. They will be trained by the MI 
Trainer and will be supervised by the HBCs at each of the participating medical centers.  
He/she will also help support other study operations such as recruitment, informed 
consent procedures, and qualitative assessments. Access to PHI- YES 
 
Qualitative Analyst will conduct the semi-structured interviews with veterans and VA 
providers and administrative staff in VISN 16 CBOCs. In addition, he/she will attend and 
take field notes during the EBQI meetings and will conduct quick ethnography in the 
participating CBOC.  He/she will collaborate closely with her SFVAMC-based 
counterpart, in coordinating data collection methods, analysis and coding of data, and in 
manuscript preparation. Access to PHI- YES 
 
Data Programmer/Manager The data programmer will support the SFVAMC Data 
Programmer, as needed. The manager will be responsible for uploading the quantitative 
study questionnaire to our web-based data management system, for secure electronic 
data entry.  He/she will maintain the study database in compliance with VA standards 

 
 
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for data security and conduct data quality checks periodically.  Subsequently, prior to 
data analysis, he/she will “clean,” validate, and prepare data for analysis by the 
statistician, assuring data quality. The Data Programmer will also assist with the 
Research Assistants on recruitment and assessments, as needed.  Access to PHI- 
YES 
 
Southeast Louisiana Veterans Health Care System (SLVHCS) 
 
KEY PERSONNEL 
 
Madeline Uddo, PhD, Co-Investigator- Dr. Uddo’s clinical, administrative, and 
research experience in PTSD has prepared her to serve as the Co-Investigator of this 
study.  As supervisor of the Outpatient PTSD Program since its inception in 1989, she 
has extensive experience in both clinical and administrative aspects of working with 
PTSD veterans. The PTSD Program is extremely active with approximately 100 
consults per month for PTSD treatment. Additionally, she has solid working 
relationships with Mental Health staff members, including Mental Health and 
administrative staff at all CBOCs. Throughout the duration of her 25 year career at the 
VA, she has been involved in PTSD research as a PI, Co-PI, or Co-I, including serving 
as site investigator for four VA Cooperative Studies in the area of PTSD.  Access to 
PHI- YES 
 
Michelle Hamilton, PhD, Co-Investigator- As a clinical psychologist, Dr. Hamilton has 
specialized in the treatment of mental disorders, more recently in the area of PTSD.  In 
her work in the PTSD program she has treated numerous veterans and is thus aware of 
the challenges in getting veterans in for treatment and compliance with treatment. The 
program she works in addresses barriers to mental health treatment for rural veterans 
quite regularly.  She is connected with the CBOC’s in her area and has relationships 
with many of the providers.  Most recently she spent time at the rural CBOCS 
implementing a yoga project for veterans.  She is well qualified to serve as co-
investigator for this project bringing her many years of experience in mental health as 
well as numerous collaborations with providers in the SLVAHCS CBOC’s.  Access to 
PHI- YES 
 
Other Study Staff- SLVHCS 
 
Project Coordinator will serve as the project coordinator and provide assistance to the 
PIs in SLVHCS. Specifically, he will be responsible for maintaining the regulatory binder 
at SLVAHCS and making sure participant’s medical records get updated with research 
progress notes and informed consent forms.  Access to PHI- YES 
 
Contractors: 
John Fortney, PhD, Co-Investigator Dr. Fortney is a Medical Geographer/Research Health 
Scientist located at the Seattle HSR&D Center of Innovation for Veteran-Centered and 

 
 
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Value-Driven Care, VA Puget Sound Health Care System, 1660 S. Columbian Way, S-
152, Seattle, WA  98108, Tel: 206-764-2430.  Dr. Fortney is a Geographer and health 
services researcher at the Seattle HSR&D Center of Innovation for Veteran-Centered 
and Value-Driven Care, VA Puget Sound Health Care System. 
He has conducted ground-breaking research as PI of a study implementing 
telemedicine strategies to identify and manage depression in VA CBOCs and has 
served as the co-chair of a state of the art (SOTA) conference on Access to Care in 
the VA. Dr. Fortney is the PI of the CEMHOR CREATE application. He has already 
assisted Dr. Seal in the development of this mental health engagement project 
proposal. Dr. Fortney will donate his effort to this study and thus no salary support is 
requested. Access to PHI- No 
 
Paul M. Garton Inc., Transcription company. As in our prior studies, we will record a 
total of approximately 220 semi-structured and unstructured interviews using audio 
digital voice recorders with providers, administrators, managers, clinic staff, and 
veterans. A private, non-VA company, Paul M. Garton, Inc., will be contracted with to 
render the digital audio files into textual transcripts for data management and analysis. 
We will devise unique transcription formatting for the project and use strict data 
management and security protocols he developed at the SFVAMC. When transferring 
the audio files, the research team will encrypt the recordings using FIPS-approved 
encryption software that will require a unique password to de-crypt the file. This 
encrypted volume will then be uploaded through secure means to the transcription 
company for transcription. Access to PHI- YES 
5.0 
Study Procedures 
5.1 Study Design 
 
We propose a 4-year Hybrid Type 2 effectiveness-implementation project.8 In this 
design, the results of the two components under study, intervention and implementation 
effectiveness, will reciprocally inform one another to facilitate the adaptation of each to 
the needs of our stakeholders and individual CBOC sites. To maximize the 
generalizability of our findings, we will conduct this mixed methods study in 
geographically distinct CBOCs in Northern California (VISN 21) and VISN 16. The 
PARiHS framework will guide the development of the implementation strategy, which 
will include Evidence Based Quality Improvement (EBQI), a multi-stakeholder facilitation 
process that we have used successfully in prior studies to adapt evidence-based 
practices (EBPs), promote uptake, and provide audit and feedback during 
implementation.62 The RE-AIM framework41 will guide the formative evaluation of the 
implementation strategy. During Phase 1 (months 0-10,) we will conduct a 
developmental formative evaluation to learn how to adapt the MI engagement 
intervention and implementation strategy to the needs of CBOCs serving rural veterans 
(Aim 1). During Phase 2 (months 10-48), we will conduct the randomized pragmatic 
effectiveness trial of the MI-based coaching intervention and determine its effectiveness 
for MH treatment engagement in CBOCs serving rural  veterans (Aim 2).  While 

 
 
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conducting the trial, we will conduct a formative evaluation of the implementation 
strategy based on stakeholder and key informant input which will allow us to further 
refine the implementation strategy and intervention to increase the likelihood that it will 
be adopted and maintained in clinical practice. (Aim 3)  
 
Study Timeline (Table 1): 
Study Phase 
Phase 1 
Phase 2 
Study Year 
Year 1 
Year 2 
Year 3 
Year 4 
 
Aim 1: Develop 
Formative Eval 
Aim 3: Implementation Formative Evaluation/Qual Data Analysis 
 
 
Aim 2: MI Coaching Pragmatic Effectiveness Trial 
Quant Data 
Analysis 
 
This study will be conducted in at least 4 medium to large VA CBOCs serving rural  
veterans: at least 2 CBOCs in VISN 16 and at least 2 CBOCs in VISN 21 (Northern 
California).  We are choosing geographically distinct locations to maximize 
generalizability and medium to large CBOCs because of the imperative to provide 
evidence-based MH treatment in CBOCs of this size. Leadership in VISNs 16 and 21 
will assist the research team in selecting medium to large VA CBOCs with the following 
characteristics: (1) sufficient volume of rural  veterans (≥ 20%), (2) CBOC leadership 
and staff that are enthusiastic about implementation of an MH engagement project, (3) 
adequate PACT, PCMH-I and MH personnel, i.e., at least 1 PACT social worker or RN 
care manager,1 on-site psychologist or psychiatrist affiliated with PCMH-I or specialty 
mental health, and/or a functioning telemental health program, and (4) access to a 
Health Behavior Coordinator.  
 
The SFVAMC will recruit and enroll participants in throughout designated CBOCs in 
VISN 21.  The identified CBOCs are as follows: 
Clearlake VA Clinic 
15145 Lakeshore Drive 
Clearlake, CA 95422 
Phone: 707-995-7200 
 
Eureka VA Clinic 
930 W. Harris 
Eureka, CA 95503 
Phone: 707-269-7500 
San Bruno VA Clinic 
1001 Sneath Lane, Suite 300, Third Floor 
San Bruno, CA 94066 
Phone: 650-615-6000 
 
San Francisco VA Downtown Clinic 
401 3rd Street 
San Francisco, CA 94107 
Phone: 415-281-5100 
 
 
Activity  
24 
36 
48 
44 
0 
Month 
10 

 
 
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Santa Rosa VA Clinic 
3841 Brickway Blvd 
Santa Rosa, CA 95403 
Phone: 707-569-2300 
 
Ukiah VA Clinic 
630 Kings Court 
Ukiah, CA 95482 
Phone: 707-468-7700 
There will be no participants enrolled from CAVHS CBOCs, instead CAVHS staff will recruit and 
enroll study participants from SLVHCS CBOCs in VISN 16.    In addition SFVAMC staff will 
assist CAVHS staff in conducting phone interviews with SLVHCs participants across all aims of 
the study. The following are the identified SLVHCS CBOCs: 
St. John 
247 Veterans Blvd. 
Reserve, LA 70084 
Phone: 504-565-4705 
 
Slidell 
60491 Doss Dr Ste B 
Slidell, LA 70461 
Phone: 985-690-2626 Or 985-690-2626 
 
Hammond 
1131 South Morrison Avenue 
Hammond, LA 70403 
Phone: 985-902-5100 
Fax: 985-902-5030 
 
New Orleans 
1601 Perdido Street 
New Orleans, LA 70112 
 
Implementation Strategy (Aims 1 & 3)  
In this study, we will use the PARiHS framework to guide our implementation strategy.39 
The PARiHS framework proposes that successful implementation of an EBP, in this 
case, Motivational Interviewing (MI), is a function of: (1) evidence, (2) context, and (3) 
facilitation.40 Below, we discuss how each element contributes to the implementation of 
a new MI coaching intervention to promote MH treatment engagement in veterans who 
use CBOCs serving rural veterans. 
Evidence from our own RCT that demonstrates MI’s efficacy in promoting MH 
treatment engagement, decreasing stigma, and increasing positive behavioral change 
will be presented to stakeholders7 (see Appendix, Manuscript). PARiHS melds local 

 
 
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clinical expertise with research evidence because ultimately clinicians and leadership 
are more likely to rely on “practice-based evidence” in their decision-making.40 
Organizational Context refers to organizational culture, climate and capacity that 
influences whether or not EBPs such as MI are adopted into clinical practice.63, 64 
Culture is generally conceptualized as the values and expectations of an organization. 
Climate is conceptualized as activities and experiences of workers (e.g., ratio of MH 
staff to caseload). 64 Capacity is conceptualized as an organization’s ability to make 
changes (e.g., resources, staff skill set, etc.).65 We expect that some CBOCs will be 
more likely to have the organizational context to support implementation of an 
innovative MH engagement intervention. Context will be ascertained by observing EBQI 
meetings (see below), through semi-structured interviews with VISN, Medical Center 
and CBOC staff, ethnographic fieldwork, including informal interviews and participant 
observation at the CBOCs.  
Facilitation involves an integrated set of implementation strategies including 
identifying and engaging key stakeholders at all organizational levels, academic 
detailing, staff training, audit and feedback, and quality improvement with the goal of 
promoting adoption of a new EBP. 66, 67  For this study we will use a well-validated 
facilitation strategy that includes most of these elements, known as Evidence-Based 
Quality Improvement (EBQI).68  We are choosing EBQI because it has been used 
successfully in other recent VA implementation projects, 62, 69it meshes well with our 
implementation frameworks (PARiHS and RE-AIM), and it is consistent with CREATE 
partnered research.  In EBQI, both researchers and local staff and administrators 
participate fully in the implementation process, with researchers facilitating rather than 
dictating the implementation strategy. EBQI thus fosters a researcher and clinician/ 
administrator partnership that activates staff participation in the implementation effort 
and promotes buy-in from leadership, which is critical to successful implementation.70 
EBQI facilitation also emphasizes continuously revising the adapted EBP (i.e., MI 
coaching intervention) based on audit and feedback with stakeholders during a series of 
Plan-Do-Study-Act (PDSA) cycles. 68, 69 This results in the implementation of EBPs that 
are robust and feasible to deploy in real-world practice settings. Specifically, we will hold 
two in-person 90-minute EBQI meetings during study phases 1 and 2 (total of 4 in-
person EBQI meetings in each VISN, 2 in Y1 and 2 in Y2-3) (see Appendix). If there are 
key stakeholders that cannot attend the meeting in person, we will offer the option of 
phoning into the EBQI meetings on a VANTS line. This will be available upon special 
request to VA employees only. The EBQI meetings will be composed of CBOC clinical 
and administrative staff, the Health Behavior Coordinator at each Medical Center, 
patient representatives, and a community MH provider, as well as members of the 
research team (PI, Project Coordinator, Qualitative Researcher). During Phase 1 of the 
study, EBQI meetings will focus on the “Planning” phase in the PDSA cycle.  

 
 
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Researchers will present evidence for the EBP (MI for MH treatment engagement), and 
elicit clinicians’ experience with acceptable and effective local MH treatment resources 
for rural veterans, details about the CBOC MH referral process, including barriers and 
facilitators of MH treatment engagement (including caseload and wait-times), 
experiences evaluating readiness for MH treatment and using EBPs such as MI to 
promote MH treatment engagement. During subsequent EBQI meetings, data derived 
from Phase 1 semi-structured interviews and ethnography (see below) will be fed-back 
to EBQI participants in order to adapt the MI coaching intervention and plan for 
implementation during Phase 2 (Plan).  During Phase 2 EBQI meetings, the focus will 
shift to Do, Study and Act after the start of the MI coaching effectiveness trial (Do).  
Guided by the RE-AIM framework, researchers will continue to audit and feed-back 
information from formative evaluations of the implementation process (Study).  In turn, 
this information will be used to make mid-course corrections to further adapt and refine 
both the intervention and the implementation strategy (Act).   
 
Implementation of Phase 2 (RCT): 
 
We will conduct a pragmatic effectiveness RCT of MH referral plus MI-based coaching 
intervention vs.MH referral only (control) in veterans who receive care in VA CBOCs 
serving rural veterans.  The RCT will be conducted over the course of 34 months with 
recruitment and enrollment in the first 26 months. All participants will be enrolled and 
followed for 8-10 months.  Enrollment will begin at study month 10 and will conclude at 
study month 44. The last wave of enrollment will begin at month 36 to allow a full 8-10 
month follow-up period until month 44. This leaves 4 months for data analysis and 
manuscript preparation. 
 
The RCT will occur at the same VA CBOC sites identified during the Phase 1 
Developmental Formative Evaluation (DFE). Veteran participants will be recruited as 
outlined in section 5.2. During the initial phone contact between the veteran and study 
staff, the study staff will use a phone script and eligibility screener to determine if the 
veteran is willing and eligible to participate in the baseline assessment. If the patient is 
interested in participating, the study team member will schedule a time to conduct the 
baseline assessment.  If the veteran is not interested in participating in the study, the 
study team will no longer contact the veteran. 
 
The participant will be contacted at week 0 for a baseline assessment.  Before the 
baseline assessment, a study team member will go through the informed consent 
process described in section 5.3.  If the veteran consents to participate, the study team 
member will conduct the baseline assessment.  The baseline assessment will include 
demographic questions and quantitative measures described in section 5.5.  If the 
participant is still considered to be eligible after the baseline assessment, the study 
team member will enroll the participant in the study and use computer software to 
randomize the participant into the intervention or control arm.  The control arm will 
receive a MH referral list in a neutral manner. The intervention arm will receive their first 
 

 
 
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dose of MI coaching for treatment initiation from the Veteran Peer Coach and their MH 
referral list.  If the participant is not considered to be eligible after the baseline 
assessment, the participant will be thanked for their time and will no longer be contacted 
by the study staff. 
 
After the initial does of MI coaching for treatment initiation, the intervention arm will be 
contacted by the Veteran Peer Coach for up to 3 additional doses of MI coaching for 
treatment initiation and for up to 2 additional doses of MI coaching for treatment 
retention.  During the MI coaching sessions, the Veteran Peer Coach will also 
administer a brief assessment to determine where the participant is in terms of mental 
health care engagement. Once it is determined by the study staff that the participant 
has initiated mental health treatment, the participant will transition from the MI coaching 
for treatment initiation track to the MI coaching for treatment retention track.  Therefore, 
the number of doses of MI coaching will vary between participants depending on if and 
when the participant initiates MH treatment. The varied MI coaching will reflect real life 
differences between veterans engagement in MH treatment as this implementation 
study. 
 
Both the intervention and control groups will be contacted for a full assessment 2 
months after the baseline assessment, for another full assessment 2 months after the 
first full assessment, and for a final, brief assessment 4 months after the second full 
assessment. We will allow a 30 day window of time at these assessments to mitigate 
any issues in scheduling or contacting the participant.  The full assessments will be 
conducted by a blinded study team member.  They will assess outcomes and include 
quantitative measures described in section 5.5.  The final, brief assessment will be 
conducted by a blinded study team member.  It will assess outcomes and include some 
of quantitative measures as described in section 5.5.   
 
Participant Payment: In the RCT portion of the study Veteran subjects are paid for 
assessments only (at baseline, 2 full assessments, and final brief assessment).  They 
are not paid for  MI Coaching sessions, since this could not also be offered to the 
control group, or for engaging into mental health treatment.  Subjects will be 
compensated $20 for each assessment, the same amount of compensation that we pay 
subjects in our other studies.  
 
A thank you letter will be sent via US Mail to the participants after each of the 4 
assessments. This will thank them for their participation and, if scheduled, will remind 
them of future appointments.  The letters except for the final letter will also include the 
mental health referrals. 
 
5.2 Recruitment Methods 
 
Recruitment of Providers- Provider participants include the providers working within 
our CBOC study sites (clinicians, nurses, social workers, advocates and administrative 
personnel), VISN level leadership, and community providers who serve veterans within 

 
 
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the communities associated with the CBOC study sites. VA potential Provider 
participants will be referred through Co-investigators and admin contacts at identified 
CBOCs and by their colleagues. Community Providers who serve veterans will be 
referred through VA Providers. Providers will be recruited via email asking them if they 
are interested in the study. We have attached an example of the type of e-mail that will 
be sent, although each e-mail will be tailored to the individual we are recruiting (VA 
provider, VISN leadership, community provider). All e-mail recruitment correspondence 
will include an attachment with the Study Information Sheet. Potential Provider 
participants will be asked in the email to respond with whether or not they are interested 
in participating in the study.  We will not contact those Providers who opt-out via email 
response.  If we do not receive a response from Providers we will wait 1 week and then 
follow-up with a phone call or email as indicated in the Provider Recruitment Phone 
Script. 
 
Study Recruitment/Enrollment Strategy for Veterans:  Information derived from the 
Phase 1 DFE will inform the research team about which CBOC providers (e.g. MH 
social workers, PCMH-I staff, or RN nurse care managers etc...) at each participating 
CBOC facility will pass information along to patients.  During Phase 2 formative 
evaluation (Aim 3), the research team and the Health Behavior Coordinator (HBC) will 
monitor the adoption. This will contribute to the evaluation of adoption and 
implementation fidelity as outlined in the RE-AIM framework. Finally, as in our pilot 
study which enrolled 36% female veterans and 55% ethnic minorities, which far 
exceeds the proportions of each among  veterans enrolled in VA nationwide, we will 
plan to over-sample women and ethnic minorities .7 
 
Recruitment streams for Veterans are as follows  
1. CBOC providers will refer veterans who they believe are moderately or highly 
ambivalent about engagement in mental health treatment. In addition, they will refer 
potential participants who have frequent NO SHOWs or who have prematurely dropped 
out of MH treatment during the past year. The CBOC Providers will refer eligible 
patients to the research staff to be assessed for study enrollment. Prior to referring 
veterans, CBOC staff will have the option to briefly explain the study, provide veterans 
an information sheet, and ask for their permission to be mailed recruitment materials. 
The research staff will then send recruitment materials outlined in (3) to the potential 
participant. 
2. In addition, CBOC Providers will also identify their patients which they believe would 
meet study inclusion criteria and refer these names and last 4 of the SSN to the 
research staff (approved for a HIPAA Waiver for Recruitment).  The research staff will 
then find the patient’s contact information in CPRS and send recruitment materials 
outlined in (3) to the potential participant.  
3. VA administrative data will be used to identify additional veterans in VISNs 16 and 21 
who have received care at participating CBOCs within 1 year of the study start date. We 
will identify veterans who screened positive on VA MH screens or received MH 
diagnoses, but have never attended a MH visit (treatment naïve), or attended ≤ 2 MH 
visits without follow-up (treatment drop-out) ≥  90 days prior to the study start date. 
Potentially eligible veterans will be mailed Patient Letters, Study Information Sheets, 

 
 
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Opt-out  Letters (including a VA return envelope addressed to the local study site) using 
previously described IRB-approved “opt-out” methods. We will wait 2 weeks for Opt-out  
Letters to be returned.  If subjects do not opt-out we will contact them via phone call. No 
cold calls will take place. 
4. Self-referral will be used to identify Veterans interested in participating in the study 
through the use of various advertisement methods and word of mouth. Advertisement 
methods will include: posting flyers at places such as the VA clinics, Veteran Service 
Organizations, and public areas, using e-bulletins (example- www.craigslist.com), direct 
outreach by the study team at events where large numbers of veterans congregate.  
Since the veteran will be contacting us directly to inquire, we will provide information 
over the phone and go into the eligibility screen if the veteran is still interested.  
5. Finally, we will use a technique called “snowball sampling” to increase recruitment. 
After completing an interview, participants will receive a “thank you” letter which thanks 
them for their time and efforts as well as provides the names, addresses, and phone 
numbers of the referrals they received during the phone session. Enclosed in the letter 
will be small contact cards that the veterans can pass onto their peers who they think 
may be interested in participating in the study. Participants are under no obligation to 
distribute these cards or disclose that they are participating in the study. Choosing not 
to distribute the contact cards will in no way jeopardize their ability to continue 
participation in the study. The contact cards include study information.  If a veteran who 
receives a contact card calls the study staff, the study staff with provide the veteran with 
information over the phone and go into the eligibility screen if the veteran is still 
interested. 
 
5.3 Informed Consent Procedures 
Requesting a waiver of written consent for participants enrolled in the RCT portion of 
the study (Aim 2) and also those participants under Aims 1 & 3 that are contacted solely 
via telephone (both veteran participants and provider participants). Subjects in Aims 1 & 
3 will have the choice to have their semi-structured interviews take place in-person or 
over the telephone.  This is necessary because many participants would have to travel 
long distances to participate in in-person interview. 
46.117(c) (2) The research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written consent is normally required outside of the 
research context.  It is not practicable to conduct the research without the waiver, nor is 
it practicable to conduct the research without access to the requested information. 
Waiving consent/authorization will not adversely affect subjects' rights and welfare.  
Verbal consent will take place for the participants whose participation is conducted over 
the phone.  Study Interviewers will read information sheets describing the purpose of 
the study, the study procedures, and the risks and benefits of the study will be read to 
potential participants over the telephone. After each major section of the script, the 
interviewer will pause and ask whether the participant understood what was read and/or 
has any questions about what was read. At the script’s conclusion, subjects will be 

 
 
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invited to give verbal consent. We enter in every participant’s consent decision to 
participate in our study in our ACCESS database. Records of such are kept 
electronically in our database. Prospective study participants will be given as much time 
as they need to consider study participation, limited only by the length of the study 
period; those wishing to consider study participation further will be invited to call study 
staff back if and when they are ready to participate. Justification for verbal consent lies 
in the fact that this group of veterans experiences substantial barriers to accessing 
mental health treatment. Requesting that potential participants mail back a signed 
informed consent sheet may constitute a further barrier to participating and potentially 
accessing mental health treatment, if necessary. 
For those subjects that come in to a VA facility for the EBQI meeting or scheduled 
interview we will obtain written consent. The research staff will explain the study, read 
an informed consent emphasizing that there is no obligation to participate in the study. 
The research staff will stop periodically to elicit questions and make sure the subject 
understands the study procedures, risks, etc. For those participants that request to take 
part in the EBQI meeting via a VANTs line, verbal consent will take place prior to the 
meeting as described in the paragraph above.  
 
 
Consenting of SLVHCS veteran participants: 
CAVHS personnel will obtain written consent from SLVHCS subjects Aims 1 & 3 using 
CAVHS consent form since CAVHS personnel is responsible for consenting. If subjects 
under Aims 1 & 3 participate in a phone interview instead of an in-person interview the 
CAVHS personnel will obtain verbal consent via the phone. For in-person consent, the 
consent form will be signed in duplicate (copy for participant and CAVHS). CAVHS 
personnel will transport consent documents to CAVHS.  CAVHS/SFVAMC personnel 
will verbally consent Aim 2 SLVHCS veteran subjects over the phone. CAVHS will 
maintain original written consent documents. CAVHS/SFVAMC personnel will maintain 
verification of verbal consent. 
  
For all participants, a member of the study staff will walk through the study procedures 
with them, pausing several times to confirm that the subject understands or check to 
see if the participant has any questions. We will use clear, declarative statements when 
describing the questions. When interviews are conducted in person, we will look for 
non-verbal signs of understanding, such as head nods, and vocal signs of 
understanding, such as "uh huh" to gauge understanding. At the conclusion of reviewing 
sections of the informed consent we will ask the subject questions to see if they are able 
to repeat back important aspects of the trial and answers certain questions regarding 
the trial.  We will re-review the informed consent when necessary.  
5.4 Inclusion/Exclusion Criteria 
Sample Size: 
Veterans: 1000 
Stakeholder/Provider: 400  

 
 
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Total:  1400 
 
Aims 1 &3 SSIV: 
VISN/ Medical Center/CBOC Leadership, VA CBOC providers, Community 
Providers: Leadership at the selected CBOCs will assist Drs. Seal (PI),Pyne (site lead, 
VISN 16) and Uddo in recruiting CBOC providers, i.e., primary care, Mental Health 
(MH), or PCMH-I providers, social workers, and nurse care managers distributed across 
each of the 4 or more CBOC sites. We will also recruit CBOC, Medical Center, and/or 
VISN administrators and Health Behavior Coordinators across each of the 2 VISNs. 
Finally, we will identify and recruit community MH providers (e.g. Vet Center providers, 
other non-VA community providers) in rural areas in each VISN. Total is approximately 
120 (60 each VISN). 
 
Veterans- For Phase 1  
 
Inclusion criteria: (1) a Veteran of military service over age 18, (2) receives care at 
VISN 16 or 21 CBOC sites (3) fall into one of 3 strata of Veterans who have differential 
MH treatment engagement within 1 year of a positive MH screen or MH diagnosis and a 
documented referral for MH treatment who: failed to attend any MH visits (n=20), have 
attended 1-2 MH visits only (n=20), or have attended ≥ 6 MH visits (n=20) 
 
Exclusion Criteria: (1) hearing impaired, (2) no working telephone 
 
For Phase 2, implementation formative evaluation, another semi-structured interview will 
be conducted with approximately 40  different Veterans who are participating in the 
pragmatic effectiveness trial and have been randomized to the MI coaching arm (see 
below). As above, we will use purposive maximum variation sampling to select 2 groups 
of veterans after 8 weeks of study enrollment. One group of Veterans who have engaged 
in MH treatment by 8 weeks and another group who have not engaged in mental health 
treatment by 8 weeks after study enrollment (See RCT inclusion/exclusion criteria 
below). The Phase 2 semi-structured interview will be scheduled with the veteran at a 
time that is convenient for the veteran participant and interviewer. All interviews will be 
conducted via telephone. This can occur in conjunction with a RCT visit or be a separate 
study visit. The interview will last an hour or less.   We plan for a sample of 40 Veterans 
(n=20 per each VISN) and to be in overlap with the RCT enrollment of Aim 2. 
 
Aim 1&3 EBQI: 
VISN/ Medical Center/CBOC Leadership, VA CBOC providers, Community 
Providers: These individuals will likely come from the SSIV or be referred by the 
leadership at the local CBOCs.  We will seek providers that have a good understanding 
of the local health care environment and resources in the community. 
 
Veterans: We will seek veterans who are local to the participating CBOC. These 
Veterans should have a good pulse on the local veteran community and feel comfortable 
representing their veteran peers. 
 

 
 
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Inclusion criteria: (1) a Veteran of military service over age 18 
 
Exclusion criteria: (1) hearing impaired 
 
Aim 2 RCT: 
As a pragmatic effectiveness trial, there are minimal exclusion criteria to maximize 
generalizability and facilitate future implementation. We approximate that up to 940 
Veterans would need to be contacted and screened at baseline in order to enroll our 
target sample size into the RCT. 
 
Inclusion criteria: from initial phone screen: (1) a Veteran of military service, over age 
18 (2) a resident of VISN 16 or 21 catchment areas receiving with no plans to re-locate 
within 8 months of enrollment, and from baseline assessment: (3) positive for ≥ 1 of the 
following disorders PTSD, depression, generalized anxiety disorder, panic disorder, high-
risk drinking, and/or illicit substance use (as ascertained at the baseline assessment). 
 
Exclusion criteria: from initial phone screen: (1) hearing- impaired, (2) no working 
telephone, (3) Veterans with self-reported (and/or CPRS-confirmed) diagnoses of 
schizophrenia, psychosis or bipolar disorder(4) received mental health treatment within 
the last 60 days and/or future appointments for mental health treatment scheduled in the 
next 30 days (these questions will be repeated during the baseline assessment so that the 
information is documented in Qualtrics for data analysis) and from the baseline 
assessment: (5) active suicidality or homicidality. Prisoners will be excluded because they 
will not be able to engage in mental health treatment. Our staff only speaks the English 
language; therefore we must also exclude those subjects that are not proficient in the 
English language. We must also exclude those with impaired cognitive function 
because our psychometric measures are designed for self-response and cannot be 
validly answered by a subject’s caretaker. 
5.5 Study Evaluations 
Summary of Quantitative Measures (AIM 2): 
Participant Characteristics (Study Co-Variates)  
Sociodemographic and Military Service Characteristics Non-standard instrument 
used in pilot RCT.7 
VA TBI Screen**-Considered positive if veteran reports head injury mechanism and 
specific consequences (e.g. loss of consciousness)81  
Psychometric Assessments (To determine RCT eligibility; binary and continuous 
scores used to stratify randomization and primary analyses (H.2a); as covariates 
in H.2. a, b, c, and as outcomes in exploratory analyses, Aim 2) 

 
 
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World Health Organization Alcohol, Smoking and Substance Involvement 
Screening Test WHO-ASSIST**-a validated screening instrument to detect 
presence/absence and severity of alcohol and illicit drug abuse and dependence, and 
smoking.82  The AUD-C will be used to screen for high-risk drinking across CREATE 
projects.83 
PTSD Checklist-Veteran Version (PCL-V)-validated 17-item PTSD inventory; yields a 
binary determination of PTSD using PTSD symptom cluster criteria or a continuous 
score for PTSD severity.84 
PHQ-9 Depression Screen- widely-used, validated measure of depression in primary 
care. Cut score of ≥ 10 yields sensitivity of .88 and specificity of .88 for Major 
Depressive Disorder.85 
GAD-7- validated, brief 7-item scale used to screen for Generalized Anxiety Disorder 
(GAD)86 
Panic Disorder Severity Form (PDSS)- validated self-report assessment for panic 
disorder; produces continuous score to determine moderate PD severity.87  
Psychosocial Measures (Covariates used in H.2.a, b, and c and in exploratory 
analyses, Aim 2) 
World Health Organization Quality of Life Inventory WHOQOL-BREF**-a 26 item 
validated brief assessment which measures physical and psychological health, social 
relationships, and environment.88 
MH Treatment (Primary Outcome-H.2.a, and secondary outcomes-H.2.b, and 
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Barriers to MH treatment-a published scale of barriers commonly reported by military 
personnel and veterans regarding mental health treatment, including a 6-item stigma 
subscale and perceived effectiveness of MH treatment.17  
MH Treatment experiences**-non-standard inventory of VA and community MH 
treatment-number of sessions attended and duration of treatment, use and duration of 
psychiatric medication, and use, frequency, and duration of telephone and e-health 
(online and smartphone) MH treatment resources.7 
Modified General-Practice Users Perceived Need Inventory (GUPI)**-assesses 
degree to which veterans perceive a need for 6 categories of VA psychosocial/ MH 
services.92 
Readiness Ruler- Measures importance, confidence and readiness for MH treatment 
engagement/behavior change on a scale from 0-10.23  
Satisfaction with VA Healthcare (CSQ-8)-8-item validated client satisfaction survey of 
VA health services.93 
Perceived Access Inventory (PAI)*- a questionnaire developed by our sister study, 
Development and Validation of a Perceived Access Measure (ACCESS), to measure 
veteran’s perceived access to mental healthcare at the VA. Including the questionnaire in 
our study will help the ACCESS study validate and standardize the measure.   
 
*Note about the Perceived Access Inventory (PAI): During survey administration, should 
we see the need for changes to correct spelling, grammatical or formatting errors and/or 
increase clarity by re-wording or reordering items, we will make those changes.  We may also 
drop an item that offends or is misunderstood by many respondents without applying for CIRB 
approval but will not add anything without CIRB approval.  Should any change(s) be needed 
that substantially affect the content of the questionnaire, we will submit the revised 
questionnaires for CIRB approval. This is because the questionnaire is still in development. 
Aim 2: CPRS Data Collection 
In addition to self-report measures, we will use participants CPRS records for outcomes 
ascertainment. This will help us to verify the self-report data. For CPRS data collection, 
our statistician will collect the data using the CDW in accordance with our DART 
approval. He will use relevant stop codes to collect data that includes: mental health 
diagnoses, mental health visit information, and pharmacotherapy for mental health. If 
there are discrepancies in the data collected from CDW, we may have a blinded 
member of the study team verify the data by accessing CPRS directly and verify only 

 
 
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those specific records. The CPRS data will be used alongside the self-report data 
during data analysis. 
Summary of Qualitative study evaluation techniques 
Aims 1 and 3:  
Evidence-Based Quality Improvement (EBQI) meetings. EBQI are a validated 
formative evaluation strategy that enables diverse clinical, administrative, and 
managerial stakeholders to discuss concerns and to formulate problems solutions with 
the research team members. Multiple EBQI meetings will be held throughout Aim 1 
(during Phase 1 and Phase 2) and Aim 3. 
Semi-structured interviews. Qualitative semi-structured interviews are a standard data 
collection technique for developmental formative and summative evaluations and for 
qualitative research projects more generally. Semi-structured interviews will be held 
throughout Aim 1 (during Phase 1 and Phase 2) and Aim 3. 
Quick Ethnography. Quick Ethnography (QE) is a modified form of ethnographic 
fieldwork adapted to applied environments, such as CBOC clinics. QE uses focused 
observational strategies and informal interviews to gather key information for 
developmental formative and summative evaluations and for rapid qualitative research 
projects more generally. QE will be conducted throughout Aim 1 (during Phase 1 and 
Phase 2) and Aim 3. 
 
Evaluation technique: Evidence-Based Quality Improvement (EBQI) meetings.  
As part of the study, we will hold two in-person 90-minute EBQI meetings during study 
Phase 1 (FY1) and Phase 2 (FY2-3) for a total of 4 in-person EBQI meetings in each 
VISN 21 and VISN 16. The EBQI meetings will be composed of CBOC clinical and 
administrative staff, patient representatives, and a community MH provider, if available, 
as well as members of the research team (PI, Project Coordinator, Qualitative Research 
staff).  During Phase 1 of the study, EBQI meetings will focus on the “Planning” phase in 
the PDSA cycle.  Researchers will present evidence for the EBP (MI for MH treatment 
engagement), and elicit clinicians’ experience with acceptable and effective local MH 
treatment resources for rural veterans, details about the CBOC MH referral process, 
including barriers and facilitators of MH treatment engagement (including caseload and 
wait-times), experiences evaluating readiness for MH treatment and using EBPs such 
as MI to promote MH treatment engagement. During subsequent EBQI meetings, data 
derived from Phase 1 semi-structured interviews and quick ethnography (see below) will 
be fed-back to EBQI participants in order to adapt the MI coaching intervention and plan 

 
 
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for implementation during Phase 2 (Plan).  During Phase 2 EBQI meetings, the focus 
will shift to Do, Study and Act after the start of the MI coaching effectiveness trial (Do).  
Guided by the RE-AIM framework, researchers will continue to audit and feed-back 
information from formative evaluations of the implementation process (Study).  In turn, 
this information will be used to make mid-course corrections to further adapt and refine 
both the intervention and the implementation strategy (Act).  The qualitative team will 
observe EBQI meetings and record condensed field notes which will be subsequently 
expanded. Additionally, a summary chart with key issues discussed and the resulting 
decisions made will be generated after each meeting to facilitate progress reporting and 
an audit trail of each EBQI meeting. 
Evaluation technique: Qualitative Semi-Structured Interviews with stakeholders:  
During Phase 1 (Aim 1), separate interview guides will be used for providers, 
administrators, and clinic staff in VISN 16 and VISN 21 as well as patients in both VISN 
16 & 21 about MH problems and MH treatment, preferences regarding in-person, 
telephone and online VA and non-VA MH treatment resources, current CBOC MH 
assessment and referral processes, current assessment (if any) of readiness for MH 
treatment including use of the CPRS “Readiness Ruler”, barriers to and facilitators of 
MH treatment engagement, tracking of No Shows, and current MH treatment 
engagement strategies (if any).  Semi-structured interviews will also solicit preferences 
for an MH treatment engagement intervention, including the specific use of MI as an 
engagement technique, delivery of the intervention and by whom (e.g. VA primary care 
or MH providers, nurses and/or social workers and/or by experienced veteran peer 
counselors). Interviews with providers, administrators, and staff will last approximately 
30 minutes. Interviews with patients will last approximately 45-60 minutes. 
 
During Phase 2 (Aim 3), after the start of the pragmatic effectiveness trial, we will 
conduct a process evaluation of the implementation of the MI-based intervention. With 
VA staff, we will conduct semi-structured interviews with VA providers, administrators, 
managers, clinic staff, and if necessary and relevant, non-VA providers in both VISN 16 
and VISN 21. Providers could participate in up to two semi-structured interviews, one 
during Phase 1 and one during Phase 2 of the study. Providers will not be paid for their 
participation. Veteran participants in Phase 1 will be conducted only one-time (n=40 
total). In Phase 2, we will seek to enroll and interview a total of 40 Veterans who have 
participated in the RCT and who, after study enrollment after 8 weeks’ participation 1) 
have already engaged in MH treatment (n=10 for VISN 16, n=10 for VISN 21); and 2) 
who have not yet engaged in MH treatment (n=10 for VISN 16, n=10 for VISN 21). We will 
compensate Veteran subjects $20 for each hour long (or less) interview.  This is the 
same hourly amount of compensation that we pay subjects in our other studies.   
Interviews will be conducted either in-person or over the telephone according to the 
convenience and preference of both participants and interviewers. Interviews will last an 
hour or less and will cover topics related to the barriers and facilitators to the 
implementation according to organizational capacity, staffing, and patient-centeredness, 
including perceived cultural appropriateness, feasibility, and acceptability. The interview 

 
 
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guides will include open-ended “grand tour” questions followed up by probes to elicit 
more nuanced detail 77(Appendix -Draft Interview Guides). We will obtain a letter of 
support from the appropriate leadership official allowing their staff to be interviewed for 
this study prior to conducting the interviews.   Feedback from the interviews will be 
presented to stakeholders in EBQI meetings and used to make adjustments to the 
intervention and implementation strategy during Phase 2. 
 
Evaluation technique: Quick Ethnography 
The qualitative team (VISN 16 & 21) will conduct quick ethnography 75 (QE) in each of 
the participating CBOC sites.  QE uses ethnographic principles in a time-efficient 
manner by narrowing the focus to identify specific attitudes, beliefs and behaviors 
(organizational context) as they relate to implementation of the MI coaching 
intervention. Information gleaned from the QE will thus guide subsequent qualitative 
evaluation methods. The qualitative team will initiate QE by attending EBQI meetings 
where they will take notes on who attends and who occupies which organizational roles, 
as well as other contextual factors that might impact implementation. They will also 
conduct informal interviews with staff who attend EBQI meetings. Second, they will 
conduct targeted participant observations within the CBOCs to observe what people 
actually do, not just what they say they do, and to obtain context-rich understandings of 
clinic processes that will impact implementation. Specifically, they will observe 
organizational structure including staff dynamics, & clinic culture/norms. Throughout 
their fieldwork, the qualitative team will jot down observations that will form the basis for 
fully expanded field notes that will be transcribed and used for analysis.76  Data from the 
QE will then be used to refine our draft semi-structured interview guides and to better 
interpret data obtained from patients and providers by situating their narratives within 
the context of the CBOCs. The qualitative team will conduct direct observations of and 
informal (unstructured) interviews with clinic interactions among clinical, administrative, 
and managerial staff that result in written condensed field notes, which will be 
subsequently expanded and used as research and evaluation data and will be reported 
back to stakeholders during EBQI meetings as noted above. 
Evaluation of the Implementation Strategy (Aim 3)  
During Phase 2, the RE-AIM (Reach, Effectiveness, Adoption, Implementation, 
Maintenance) Framework41 71 will be used to conduct a formative evaluation of the 
progress of the implementation strategy. Reach represents the proportion of eligible 
participants that is referred and enrolls in the study.72 Adoption represents the 
proportion of CBOC staff that assesses readiness for MH treatment and refers to the 
study, as well as adoption of the intervention by the MI coaching teams based at each 
of the Medical Centers in each VISN.72 Both Reach and Adoption are readily 
ascertained through administrative data audit. Implementation represents the fidelity 
with which the intervention is implemented in routine care. 72 Effectiveness will be 
evaluated at the conclusion of the pragmatic effectiveness trial as part of Aim 2. 

 
 
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Maintenance represents the degree to which the EBP (MI coaching) is likely to be 
sustained.72 This dimension will be assessed during Phase 2 through semi-structured 
interviews with stakeholders.  
 
5.6 Data Analysis 
Statistical Analysis for H.2a. and H.2b  In Intent-To-Treat (ITT) analyses, generalized 
linear models using a poisson distribution and robust error variance  (binary outcomes) 
and traditional poison and truncated-poisson regression (count variables) will be used to 
determine the effect (relative risk or standardized coefficient) of Motivational Coaching 
(vs. Control) on MH treatment initiation and retention, respectively, adjusting for 
clustering by CBOC and region as well as potential confounding by other covariates 
(see above). The threshold for significant p-values will be set at p ≤ 0.05. Effect sizes 
will be calculated using Cohen’s d for binary outcomes (MH treatment engagement) and 
Cohen’s h for continuous outcomes (# MH visits).98 Stratified analyses of MH treatment 
engagement will be conducted for treatment-experienced vs. treatment naïve 
participants, MH severity (high vs. low), rurality (urban vs. rural), and if there is sufficient 
power, gender (men vs. women).  Finally, as an alternate analysis for MH engagement 
based on group assignment, we will compare the binary outcome of attending ≥ 8 visits 
or receiving ≥ 2 months of psychiatric medication plus > 4 visits during the 8-month 
follow-up period, a metric which has been used in prior studies to denote “minimally 
adequate MH treatment”.5, 12 This is not a primary outcome in this study because this 
metric is based on a 1-year and not an 8-month follow-up period.5 
Statistical Analysis for H.2c and exploratory analyses Analysis of covariance 
(ANCOVA) methods will compare groups on change over time for secondary and 
exploratory outcomes (detailed above) after adjusting for baseline values.  
Power Calculation: Our power calculation is based on the primary hypothesis that 
telephone MI Coaching (vs. Control) will significantly improve MH treatment initiation 
and retention (H.2a). In our prior pilot trial, for MH treatment initiation (binary outcome), 
we achieved a Cohen’s h effect size of 0.74 (62% engaged in MI arm vs. 26% engaged 
in Control arm), and for MH treatment retention (# of visits), we achieved a Cohen’s d 
effect size of 0.67 among all subjects (ITT) and Cohen’s d of 0.48 for retention in the 
subset of subjects that engaged in MH treatment. Therefore for this study, to achieve 
adequate power to detect improvement in both MH treatment initiation and retention, we 
will require approximately 140 participants per study arm across the 2 VISNs (N=280).  
This sample size accounts for 20% drop-out and achieves > 90% power to detect a 
Cohen’s h effect size=0.60 for binary MH treatment initiation at α=0.05 and a Cohen’s d 
effect size =0.55 for MH treatment retention (# of visits) among all subjects (ITT) at 
α=0.05. This sample size also achieves 80% power to detect a Cohen’s d effect 

 
 
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size=0.55 for MH treatment retention (# of visits) at α=0.05 in the subset that engages in 
MH treatment.  
Rationale for the RCT sample size: 
Sample Size for the RCT (Aim 2):  Based on power calculations which already 
account for a 20% drop-out rate, we will need to enroll 140 participants per study arm 
(total N=280) into the RCT over 26 months.  Different from our efficacy study in which 
we recruited exclusively from administrative databases and had no prior knowledge of 
potential study participants, because this is an effectiveness trial, CBOC staff will refer a 
portionof the total sample of 280 (N=224) directly from CBOC sites, referring veterans to 
the study who they believe to be eligible and interested in study participation. We 
project that we will need to recruit and conduct baseline assessments in roughly 940 
veterans across both VISNs in 26 months or 36 per month (18 per month per VISN).  
 
Randomization for the RCT (Aim 2): Otherwise eligible participants who screen 
positive for ≥ 1 MH problem(s) will be randomized to MH Referral + MI Coaching 
(Intervention) versus MH Referral alone (Control). Block randomization will be stratified 
by: (1) MH treatment history (treatment naïve or treatment experienced) within the last 5 
years, (2) binary MH disorder severity defined as ≥ 2 MH problems and at least one MH 
problem with a score indicating severe symptomatology, and (3) the VISN where the 
participant is located. Strata will optimize random distribution of veterans with differential 
likelihood of MH treatment engagement between the two study arms.7 
Plans for and specification of the purpose of any interim analysis of the data (with 
regard to stopping rules for superiority, futility, or sample size re-estimation): 
As a pragmatic effectiveness trial, formal Peto-style stopping rules are not applicable.  
In the spirit of ongoing data monitoring, at six-month intervals, differences between 
treatment and control groups will be evaluated and discussed by investigators, and the 
intervention will be revised in light of lessons learned in the field and insights from the 
qualitative analyses.   
 
Methods for handling missing data points and subject dropouts: Per Intention to 
Treat Analysis, participants will be analyzed based on group assignment.  The primary 
outcome, MH treatment engagement, can be ascertained for VA facilities using 
VisTA/CPRS chart review and will not require continuing patient participation.  Self-
reported MH treatment outside of VA facilities is also a study outcome, but this cannot 
be ascertained for subject dropouts.  As a sensitivity analysis to assess non-VA 
utilization, we will repeat the analyses of the primary outcomes based solely on VA 
utilization and compare those results with the primary results based on all outcomes.  
We do not anticipate that multiple imputation techniques will be useful for addressing 
unknown non-VA utilization for study dropouts, based on the limited quantitative 
information that we will have available for those participants.  
 
Methods for dealing with data transformations: There are no a priori plans to 

 
 
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transform outcome measures; during data analysis, if transformations of data 
appear necessary to satisfy key statistical assumptions, we will revisit at that 
time. 
 
Definitions of the analytical sets (i.e. intent-to-treat, per protocol, and any other 
analytical subsets): For Intention to Treat Analysis, analytical sets will consist of all 
enrolled patients according to treatment assignment. 
 
5.7 Withdrawal of Subjects 
Subjects (veterans) in the RCT portion of the study (Aim 2) will be withdrawn if it 
is determined that they are actively suicidal.  We will follow the procedure 
outlined in the “Reporting” section of this protocol (appropriate mental health 
referrals will be made).  If a subject moves outside the catchment area of the 
study they will also be withdrawn from the study.  We will not have access to 
mental health referrals outside the two VA catchment areas and therefore cannot 
evaluate the outcome for a subject that moves. 
Providers will be withdrawn if they leave their positions at the VA.  Non-VA 
community providers will be withdrawn if they too leave their positions and move 
outside our catchment area (we are specifically looking for non-VA providers who 
provide services to veterans in our catchment areas). 
6.0 
Reporting 
The PIs will be notified by the Project Coordinator(s) immediately of any possible event 
that affects the risk to a subject.   
The PIs will promptly respond to the problem and mitigate any negative consequences 
for the participant(s) involved.  The PI and/or Study Coordinator will report the event to 
the IRB of Record within the timeline as follows: 
a. Unanticipated Problems Involving Risks to Subjects or Others. Members of the 
VA research community are required to ensure that unanticipated problems involving 
risks to subjects or others in research are reported promptly to the IRB within 5 
business days. 
 
b. Serious Unanticipated Problems Involving Risks to Subjects or Others. Within 5 
business days of becoming aware of any serious unanticipated problem involving risks 
to subjects or others in VA research, members of the VA research community are 
required to ensure that the problem has been reported in writing to the IRB. 
c. Local Unanticipated SAEs. Within 5 business days of becoming aware of any local 
(i.e., occurring in the reporting individual’s own facility) unanticipated SAE in VA 

 
 
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research, members of the VA research community are required to ensure that the SAE 
has been reported in writing to the IRB.  
Adverse Events (AEs that do not meet criteria for reporting within five days in 
accordance with VHA Handbook 1058.01) will be reported to the IRB of Record at 
Continuing Review. 
The PIs have developed a suicide and homicide safety plan for other studies with 
Veterans that will also be used for this study in the event of active suicidal or homicidal 
ideation.  
If we are unsure whether a document requires submission or reporting, we will contact 
the VA Central IRB the PRIDE toll free number 877-354-3130 or va.central.irb@va.gov.  
7.0 
Privacy and Confidentiality 
 
The largest source of material for this study in both study phases will be self-reported 
information derived from structured or semi-structured interviews. In addition, we will 
use VA administrative data for the following purposes: recruitment of a small proportion 
of veteran subjects, safety checks to exclude vulnerable patients with high-risk 
conditions (e.g. suicidality), and validity checks of self-reported VA MH treatment.  
 
There are some risks to participating in this study.  First, for  veterans, some of the 
questions asked (such as questions about mental health symptoms, including drug use) 
concern sensitive issues and possibly illegal activities involved in drug use.  Similarly, 
some of the questions asked of  veterans may evoke memories of combat experiences.  
Being asked some of these questions may make participants feel uncomfortable 
however the questions asked do not fall outside what would normally be asked during a 
clinical mental health appointment.  VA staff and non-VA community providers may be 
concerned that disclosing information about CBOC procedures or programs in the 
community may negatively impact their jobs or relationships with colleagues. While the 
researchers will keep information as confidential as possible, complete confidentiality 
cannot be guaranteed.  
 
Participant data will be identified by study ID numbers only and will be kept separate 
from research data.  Participants’ personally identifying information, such as names, 
addresses, and phone numbers will be secured on an approved SFVAMC or CeMOHR 
server behind the VA firewall that is accessed through use of a password-protected 
computer terminal in a locked room.  Data will be reported only in group form in any 
reports or publications; no names of study participants will be used in any reports or 
publications resulting from this study. In addition, as with our other research studies, this 
new study will apply for a Certificate of Confidentiality from the National Institutes of 

 
 
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Health. This certificate will provide additional protection for research participants. The 
Certificate of Confidentiality will allow Dr. Seal and the research team to refuse to 
release identifying information about participants in any civil, criminal, administrative, 
legislative or other proceeding at the Federal, State or local level.  A Certificate of 
Confidentiality does not prevent researchers from disclosing information about 
participants that involves child abuse, elder abuse, and participants’ intent to hurt 
themselves or others. If the research staff learns that a participant intends to hurt 
him/herself or others, study staff will be obligated to report this information to the 
authorities and activate the study’s safety protocols. Potential participants will be 
apprised of this possibility during the informed consent procedure. 
The linking list will be maintained by the Study Coordinator. Access to the linking list 
will be limited to the Coordinator and Data Manager. PHI will be obtained from existing 
sources such as medical records, clinical databases, or research records. We will use 
national and regional databases, such as CDW and Vista to identify potential 
participants in the RCT portion of the study (Aim 2, requesting HIPAA Waiver of 
Authorization for Recruitment). Electronic medical records at the VA (SFVAMC and 
SLVHCS) will be accessed to attain outcome data (engagement in mental health 
treatment). Medical Records and Clinical databases are maintained by both the 
SFVAMC and SLVHCS. Research records are maintained at SFVAMC, SLVHCS and 
CAVHS. 
 
The following software will be used: 
The project will use two software packages for managing qualitative data analysis, 
ATLAS.ti and MAXQDA. ATLAS.ti is a product of Scientific Software Development 
GmbH (Berlin, Germany). The software is already licensed through a previous HSR&D 
grant in 2010 and recently updated in 2013. Once loaded into ATLAS.ti, qualitative data 
is saved onto a secure folder in a VA research-designated folder (e.g., R: drive) behind 
the VA firewall that is accessible only through actively granting of permission. 
ATLAS.ti temporary files are saved into the firewall-protected folder and thus are not 
saved onto the computer’s hard drive (e.g., C: drive). 
 
MAXQDA is a product of VERBI GmbH (Berlin, Germany). The software will be 
purchased through IT funds once the CREATE projects has been approved for Just In 
Time funding. Similar to the above, once qualitative data is loaded into MAXQDA, it will 
be saved into a secure VA research-designated folder (e.g., R: drive) behind the VA 
firewall that is accessible only through active granting of permission. MAXQDA 
temporary files are also saved into the firewall-protected folder and are thus not saved 
onto the computer’s hard drive (e.g., C: drive). 
 
The following web application will be used: 
Qualtrics will be used for completing questionnaires. Security features include data 
redundancies, intrusion detection, access control, application software, testing 
environment, authorizations, demographics / server load, load / stress / penetration 
testing, and anti-malware. It is FIMSA compliant, please see attached white sheet 
specifications. 
 

 
 
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Data will be stored as follows: 
Data will be stored on a VA-approved server or locked file cabinet. 
Audio recordings will be removed immediately from audio recorders and uploaded to a 
VA issued encrypted laptop.  The laptop will be securely transported back to the VA where 
the audio recording will then be transferred to the VA sever and removed from the 
laptops. 
Data collected via Qualtrics will be stored on their server which is FIMSA& FIPS 
compliant. Please see the attached Qualtrics white paper and SFVAMC ISO approval 
for specifications. Data being stored on Qualtrics server is non-sensitive 
 
Data will be transmitted and/or shipped as follows: 
Data will be transmitted via encrypted email and/or password-protected documents. 
Data will be transported between the local CBOCs and the medical centers. We will 
obtain all needed signatures for the Authorization to Transport Information. Information 
to be transported between CBOCs and medical centers are as follows: Informed consent 
forms, HIPAA authorization, voice consent, voice recordings of interviews, and hard 
copy field notes. 
Audio recordings will be removed immediately from audio recorders and uploaded to a 
VA issued encrypted laptop.  The laptop will be securely transported back to the VA where 
the audio recording will then be transferred to the VA sever and removed from the 
laptops. 
 
Transmission of Audio files for transcription is as follows: 
We will upload audio data files on to VA computers and encrypt them using FIPS-
approved encryption software. We will then upload these encrypted files via secure 
connection to the transcription company’s server. The file transfer service offers military 
grade 128-bit Secure Socket Layer (SSL) encryption security in transit and 256-bit AES 
encryption at rest. Once uploaded, the transcription company will decrypt the file using 
the unique password and will transcribe the audio files. When the transcription is 
complete, they will re-encrypt the resulting textual transcript files and send them back to 
us via secure connection. All servers are behind firewalls and can be accessed only 
through password-protected computers housed at either the VA or at Paul M. Garton, 
Inc. 
 
Our local sites in Arkansas and Louisiana will have access to a folder on our secure VA 
research drive and this is how will we communicate and share our database. 
 
Research data will be stored as follows: 
SFVAMC 
Data will be stored in SFVAMC secure server room (Bldg. 207) on server 
R01SFCHSM02.R01.MED.VA.GOV and/or VHASFCTMSSEAL 
 
 
CAVHS 
Paper copies will be stored in a locked file cabinet at the following location: 
Central Arkansas Veterans Healthcare System 

 
 
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2200 Fort Roots Drive, (152/NLR), Bldg. 58, Room 134 
North Little Rock, AR  72114   
SLVHCS     
Study-related materials will be stored in a locked filing cabinet within a locked SLVHCS office: 
3500 Canal St., Room 215, New Orleans, LA, 70119.           
At the conclusion of the study, we will maintain all research data, including subject 
identifiers and the key which links the unique study identification code to subjects’ 
personal information, in accordance with the VA Records Control Schedule 10-1.The 
ISO will be contacted for guidance/assistance in destroying the data once the maximum 
retention period is reached. 
 
All Study related data is either stored in a locked filing cabinet in a locked office or on a 
VA secure server. Once a team member resigns they no longer have access to the 
server and are required to turn in their keys to the building and office suit, including all 
filing cabinets. They are also asked to turn in the VA ID badge. 
 
CAVHS and SFVAMC staff will be responsible for consent and recruitment of SLVHCS 
subjects.  SLVHCS staff will not consent subjects.  SLVHCS research staff will keep 
study records as deemed necessary by the SLVHCS local R& D office. 
 
Transmission of COACH data to CREATE Team 
 
This study was funded as part of a larger suite of projects under the CREATE 
mechanism. As part of the CREATE suite, each project will send their data to the 
CREATE main site, CAVHS, to be used in the overall CREATE data analysis.  
 
The COACH study will send identified and de-identified data directly from the SFVAMC 
server to the CAVHS server via a data transfer. The CREATE data manager at CAVHS 
will create a local folder on the CAVHS server that the COACH data manager can 
access. The COACH data manager will place copies of the COACH data into the local 
folder. The CREATE data manager can then move the COACH data into a folder with 
the CREATE data. This method allows all data to be kept behind the VA firewall during 
the entire transfer process.  
 
SFVAMC 
Data will be stored in SFVAMC secure server room (Bldg. 207) on server 
R01SFCHSM02.R01.MED.VA.GOV and/or VHASFCTMSSEAL 
 
CAVHS 
Data will be stored in Central Arkansas Veterans Healthcare System 
2200 Fort Roots Drive. North Little Rock Ar, 72214 
Bldg 102, Room 104 
Server R02lithsmdc101.v16.med.va.gov 

 
 
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8.0 
Communication Plan 
The SFVAMC will keep on file all IRB documentation for both itself and Central 
Arkansas Veterans Healthcare System and Southern Louisiana Veterans Health Care 
System, including consent forms, HIPAA forms and supporting documents.  The local 
project coordinators will have weekly telephone check-in appointments.  At these 
meetings the following will be addressed: 
o Ensuring all required local site approvals are obtained. 
o Keeping  both engaged sites informed of changes to the protocol, 
informed consent, and HIPAA authorization 
o Informing each site of any Serious Adverse Events, Unanticipated 
Problems, or interim results that may impact conduct of the study. 
o Ensuring the study is conducted according to the IRB-approved 
protocol. 
o Notifying local facility investigators when the study reaches the 
point that it no longer requires engagement of the local facility. 
All points above are considered time sensitive and will be communicated between and 
sites immediately.  All sensitive materials will be shared between sites via our VA 
server.   The information above will be shared with each site at their own weekly team 
meeting.  Other study related issues will also be addressed (recruitment, challenges, 
issues and needed any changes). There will also be monthly telephone meeting 
between the entire project staff at both SFVAMC and CAVHS and SLVHCS.  This will 
allow staff at each site to communicate openly with each other.  The SFVAMC PI will 
travel to Central Arkansas Veterans Healthcare System and Southeast Louisiana 
Veterans Health Care System once a year to do a site visit and attend a live meeting. At 
this time the PI will review the CAVHS and SLVHCS IRB files.   The CAVHS and 
SLVHCS PIs will travel to SFVAMC once a year to attend a live meeting. The PI’s and 
Co-investigators will also have quarterly telephone check-ins to discuss the progress of 
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9.0 
References 
 
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Group, Office of Public Health Analysis of VA Health Care Utilization among Operation 
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Wallace AE, Weeks WB, Wang S, Lee AF, Kazis LE. Rural and urban disparities in 
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Zivin K, Kim HM, McCarthy JF, et al. Suicide mortality among individuals receiving 
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Dept. of Veterans Affairs. VHA HANDBOOK 1160.01: Uniform Mental Health Services 
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Seal KH, Maguen S, Cohen B, et al. VA mental health services utilization in Iraq and 
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Seal KH, Abadjian L, McCamish N, Shi Y, Tarasovsky G, Weingardt K. A randomized 
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Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation 
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Weeks WB, Wallace AE, Wang S, Lee A, Kazis LE. Rural-urban disparities in health-
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Wallace AE, Lee R, Mackenzie TA, et al. A longitudinal analysis of rural and urban 
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Seal KH, Shi Y, Cohen G, et al. Association of mental health disorders with prescription 
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47. 
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Cohen BE, Marmar C, Ren L, Bertenthal D, Seal KH. Association of cardiovascular risk 
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54. 
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to address the mental health needs of rural veterans. J Rural Health. Winter 
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Watkins KE, Pincus HA, Smith B, et al. Veterans Health Administration Mental Health 
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Seal KH, “Mental Health: Bridging the Gap between Care and Compensation for 
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58. 
Hoge CW. Interventions for war-related posttraumatic stress disorder: meeting veterans 
where they are. JAMA. Aug 3 2011;306(5):549-551. 

 
 
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