Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)
Phase: NA
Conditions: Cardiovascular Diseases, Hypertension, Hyperlipidemias, Dyslipidemias, Obesity, Diabetes Mellitus, Tobacco Use Disorder, Overweight
Sponsor: VA Office of Research and Development

Correspondence:  Approval of an Amendment to an Approved PI/SC 
Project Application, VA Central IRB Study Number  16‐12
Facility Name: VA Greater Los Angeles Health Care System
Subject:
From:
VA Central Institutional Review Board
Date:
Amendment #:
01
Determination Date:
6/9/2017 12:15:33 PM
Amendment Summary:
1.
2.
6/15/2017
The amendment request involved 1) Adding Component B to the study protocol 
which involves Veteran surveys and interviews; and 2) Adding the Provider Mid‐
Implementation and Post Implementation Guides and Email Invitations for 
Component A to the study.
To:
The VA Central IRB reviewed the following request of an amendment to the project listed above
The VA Central IRB made the following determination regarding the above amendment to the PI/SC application:
3.
4.
APPROVED:  All IRB approval criteria have been met. The modifications for this amendment 
do not pose an increased risk to participants.
This approval does not change the date the project is due for continuing review. All documents associated with 
this approved amendment have been made available on the VA Central IRB SharePoint site and an approval 
notice has been forwarded to you, the local site investigators, and the local site liaison.  If local policy requires 
R&D Committee review and approval amendments, please forward a copy of their review to our office upon 
completion of review.
Any questions concerning the review of this project or for any other administrative issue pertaining to this study 
and the functions and responsibilities of the VA Central IRB can be addressed to the VA Central IRB Manager for 
this project, Kendra Clarke, at 202‐443‐5766 or e‐mail, Kendra.Clarke2@va.gov.
Protocol Title: Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans
Approval of an Amendment to the Approved PI/SC Project Application
under expedited procedures.
Bevanne Bean‐Mayberry
Bevanne.Bean‐Mayberry@va
Principal Investigator:
Melissa Farmer Coste
Melissa.FarmerCoste@va.gov
Co‐Principal Investigator:
Hemen Saifu
Hemen.Saifu@va.gov
Study Coordinator:
Page 1 of 2

VA Central Institutional Review Board
Documents posted to the VA Central IRB Share Point website:
01. Form 116_03/30/17
02. Form 112b_03/03/17
03. Form 10‐0493_05/22/17
04. Form 103_03/30/17
05. Protocol tracked version_05/18/17
06. Patient Information Sheet_05/22/17
07. Patient Baseline Survey_03/30/17
08. Patient Invite Follow‐Up_05/23/17
09. Patient Follow‐Up Survey_03/20/17
10. Patient Invitation_05/18/17
11. Patient Baseline Interview Guide_
12. Patient Follow‐Up Interview Guide_03/30/17
13. Provider Mid‐Implemation Invite_03/30/17 
14. Provider Post‐Implementation Invite_03/30/17
15. Provider Mid‐Implementation Interview Guide_03/30/17 
16. Provider Post‐Implementation Interview Guide_03/30/17 
17. Baseline Survey_05/18/17
Copy To:
Local Site(s)
Local Site Liaison(s)
Local Site Investigator(s)
San Antonio, TX
Dennis.Bryan@va.gov
Erin.Finley@va.gov
Los Angeles, CA
Elizabeth.Corey@va.gov
Giselle.Henry@va.gov
Los Angeles, CA
Elizabeth.Corey@va.gov
Giselle.Henry@va.gov
PI/SC Site Liaison(s)
Page 2 of 2

 
 
 
FACILITATING CARDIOVASCULAR RISK SCREENING AND 
RISK REDUCTION IN WOMEN VETERANS  
 
  
Project 1 of EMPOWER QUERI  
Protocol Component A combined with Component B 
Component B additions are in red in the track change version 
Funding Agency: QUE 15-272   
Principal Investigator/Study Chair: Bevanne Bean-Mayberry, MD 
March 30, 2017 
 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 2 of 36 
 
 
 
Abstract 
Project Background:  Cardiovascular disease (CVD) is the number one cause of death in 
American women.  While the American Heart Association has documented that public 
awareness of CVD increased from 1997 to 2009 (from 30% to 54%), women still demonstrate 
limited understanding of imminent CVD-associated morbidity and mortality risks.  Moreover, 
women’s control of CVD risk factors, such as lipids, blood pressure and diabetes, is worse than 
men’s, while women also have higher obesity and inactivity rates nationally.  Given persistent 
VA gender disparities in CVD risks, we conducted a partnered project with VA Women’s Health 
Services to identify barriers and facilitators to CVD screening and management in women 
Veterans.  Findings informed development of the proposed multi-component cardiovascular 
(CV) risk reduction toolkit.   
 
Project Objectives:  The objective of this project is to implement and evaluate a (CV) risk 
reduction toolkit (CV toolkit) designed to increase identification of CV risk among Women 
Veterans, enhance patient/provider communication about their risk, and increase Women 
Veterans’ engagement and retention in relevant health services including referrals to key health 
programs (e.g., MOVE!, dieticians, health coaches, and CV specialists as needed).   
 
Project Methods:  The CV toolkit will be implemented at four women’s health clinics over two 
years.  The CV toolkit includes four components: (1) Patient education/activation tools, such as 
informational posters and fliers about women’s CV risk (2) a CV risk assessment computerized 
template, which systematically captures CVD risk factor history and data from patients’ medical 
records, and provides open fields for the provider to enter any relevant information from the 
patient’s CV worksheet (worksheet captures CVD risk of patient and family history), (3) provider 
information and education programs as well as referral tools to internal services (e.g., women’s 
MOVE! Program, smoking cessation clinics, dieticians, health coaches, pharmacists and CV or 
mental health specialists as needed), and (4) the Gateway to Healthy Living program tailored to 
Women Veterans, a facilitated group meeting that occurs in a structured format with 
personalized goal setting and identification of key services available at the local site to assist 
with lifestyle changes necessary for patient-targeted CV risk reduction. We will conduct baseline 
and post-implementation surveys and/or interviews with 260 patients (65 per site) as well as 
pre-, mid-, and post-implementation non-human subjects research interviews with 60 staff 
(15/site).  
 
Results:  The project is currently in the pre-implementation phase at the first site (GLA) which 
includes the activities from Component A (non-human subjects research interviews with staff).  
We have also recruited the second site and will begin pre-implementation work once the site 
application (LSI) is approved.   
 
Anticipated Impacts on Veterans’ Healthcare:  The proposed toolkit is designed to promote 
patient-centered decision-making and effective clinical action around CV risk reduction among 
women Veterans and their VA primary care providers.  Toolkit implementation and spread 
should ultimately reduce persistent gender disparities in quality and outcomes of VA care. 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 3 of 36 
 
 
 
List of Abbreviations Used in this Protocol 
1. CV………………………Cardiovascular 
2. CVD…………………….Cardiovascular Disease 
3. AHA……………………..American Heart Association 
 
4. WH………………………Women’s Health 
5. WHS…………………….Women’s Health Services 
6. GLA……………………..Greater Los Angeles 
7. NCP……………………..National Center for Disease Prevention and Health Promotion 
8. BPE……………………...Blueprint for Excellence 
9. CPRS……………………Computerized Patient Record System 
10. EMR……………………..Electronic Medical Record 
11. REP……………………..Replicating Effective Programs 
12. TECH……………………Tool for Evaluating Research Implementation Challenges 
13. WHRN…………………..Women’s Health Research Network 
14. PBRN……………………Practice-Based Research Network 
15. PACT……………………Patient Aligned Care Team 
16. DART……………………Data Access Request Tracker 
17. MORE……………………Measuring Organizational Readiness for patient Engagement 
18. MOVE……………………A VA National Weight Management Program 
19. GLM……………………...Generalized Linear Model 
20. EMPOWER…………..…Enhancing Mental and Physical health of Women through 
Engagement and Retention 
21. PCP……………………Primary Care Physician 
22. LVN……………………Licensed Vocation Nurse 
23. MSA……………………Medical Support Assistant 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 4 of 36 
 
 
 
 
Contents 
Protocol Title: .......................................................................................................................... 5 
1.0 
Study Personnel............................................................................................................ 5 
2.0 
Introduction ................................................................................................................... 9 
3.0 
Objectives ..................................................................................................................... 9 
4.0 
Resources and Personnel ............................................................................................. 9 
5.0 
Study Procedures........................................................................................................ 10 
5.1 Study Design ............................................................................................................... 11 
5.2 Recruitment Methods ................................................................................................... 20 
5.3 Informed Consent Procedures ...................................................................................... 22 
5.4 Inclusion/Exclusion Criteria........................................................................................... 23 
5.5 Study Evaluations ........................................................................................................ 23 
5.6 Data Analysis ............................................................................................................... 24 
5.7 Withdrawal of Subjects ................................................................................................. 26 
6.0 
Reporting .................................................................................................................... 26 
7.0 
Privacy and Confidentiality .......................................................................................... 29 
8.0 
Communication Plan ................................................................................................... 32 
9.0 
References ................................................................................................................. 34 
 
 
The CV Risk protocol is divided into 2 components. Component A was approved on 08/09/2016 
and focuses on providers and key stakeholders in this study (non-patient data collection and 
only pre-condition interviews). The current submission is a combination of Component A with 
Component B (in red in track changes version) and includes our protocol for implementation and 
summative interviews with providers and key stakeholders, protocol for patients in this study 
including patient data collection, and nonrandomized stepped wedge analysis.  

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 5 of 36 
 
 
 
(Protocol Title: Cardiovascular (CV) Risk) 
1.0 
Study Personnel  
Principal Investigator/Study Chair: Bevanne Bean-Mayberry, MD, MHS 
Board Certifications: American Board of Internal Medicine  
VA Employee: 5/8ths 
VA Facility: VA Greater Los Angeles Healthcare System  
VA Facility Address: 
VA Greater Los Angeles HSR&D Center of Innovation  
VA Sepulveda Campus 
16111 Plummer St (152) 
North Hills, CA  91343 
Phone:  818-895-9449, x36009   
Fax:  818-895-3858 
VA E-mail: bevanne.bean-mayberry@va.gov 
Affiliations:   
1) VA GLA HSR&D Center for the Study of Healthcare Innovation, Implementation, and Policy 
2) Department of Medicine, David Geffen School of Medicine, UCLA, Los Angeles, CA 
 
Co-Principal Investigator: Melissa Farmer Coste, PhD 
VA Employee: 5/8ths 
VA Facility: VA Greater Los Angeles Healthcare System  
VA Facility Address: 
VA Greater Los Angeles HSR&D Center of Innovation  
VA Sepulveda Campus 
16111 Plummer St (152) 
North Hills, CA  91343 
Phone:  818-895-9449, x36046   
Fax:  818-895-3858 
VA E-mail: Melissa.Farmer@va.gov 
Affiliations:   
1) VA GLA HSR&D Center for the Study of Healthcare Innovation, Implementation, and Policy 
 
Collaborators: 
Co-Investigator: Alison Hamilton, PhD 
VA employee: 7/8 
VA Facility: VA Greater Los Angeles Healthcare System 
Phone: 818-749-6530 
VA email: Alison.Hamilton@va.gov  
Affiliations 
1) VA GLA HSR&D Center for the Study of Healthcare Innovation, Implementation, and Policy, 
VA Greater Los Angeles Healthcare System, Los Angeles, California 
2) Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, 
University of California, Los Angeles 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 6 of 36 
 
 
 
 
Co-Investigator: Jessica Zuchowski, PhD 
VA employee: 8/8 
VA Facility: VA Greater Los Angeles Healthcare System 
Phone: 818.891.7711 Ext 36055 
VA email: Jessica.zuchowski@va.gov  
Affiliations 
1) VA GLA HSR&D Center for the Study of Healthcare Innovation, Implementation, and Policy, 
VA Greater Los Angeles Healthcare System, Los Angeles, California 
 
Co-Investigator: Erin Finley, PhD 
VA employee: 8/8 
VA Facility: South Texas Veterans Health Care System 
Phone: (210) 617-5300 
VA email: Erin.Finley@va.gov   
Affiliations 
1) Veterans Evidence-based Research Dissemination and Implementation Center (VERDICT) at 
the South Texas Veterans Health Care System,  
2) Adjunct Assistant Professor with the Division of Clinical Epidemiology, Department of 
Medicine, at the University of Texas Health Science Center at San Antonio. 
 
Co-Investigator: Alexis Huynh, PhD, MPH 
VA employee: 8/8 
VA Facility: VA Greater Los Angeles Healthcare System 
Phone: 310-478-3711 x 49862 
VA email: alexis.huynh@va.gov  
Affiliations 
1) GLA HSR&D Center for the Study of Healthcare Innovation, Implementation, and Policy 
 
 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 7 of 36 
 
 
 
2.0 
Introduction 
 
BACKGROUND 
Cardiovascular disease (CVD) is the number one cause of death in American women, and all 
adult women are potentially at risk for CVD.1,2 While the American Heart Association (AHA) has 
documented that awareness of CVD increased from 30% in 1997 to 54% in 2009, women still 
demonstrate limited understanding of the imminent risks of CVD-associated morbidity and 
mortality. Recent updates summarizing the public health impact of CVD in women identify the 
following topics as important issues: (a) greater need for prevention of incident cases of CVD, 
(b) need for increased awareness of CV risk among women, and (c) need for larger 
representation of women in prevention trials.3,4 The recently released CV guidelines for 
Cholesterol, CV Risk Assessment, Obesity and Lifestyle support directed lipid treatment and 
more personalized evaluations by providers, in addition to a strong push for educating patients 
about their risks and strongly recommending lifestyle changes (i.e., physical activity, diet, and 
behavioral counseling).2,5-7 There are clear gender differences in the control of CV risk factors 
such as lipids, blood pressure, and intermediate diabetes outcomes nationally and within the 
VA,8,9 with women Veterans often at higher CV risk than their male counterparts. 3,10-15 The 
combination of disparities and gender-specific CV risk factors suggest an urgent need for CV 
risk factor management in women Veterans.  
 
The goals of this project are to implement and evaluate a CV risk reduction toolkit (CV toolkit) 
designed to increase identification of CV risk among Women Veterans, enhance 
patient/provider communication about their risk, and increase Women Veterans’ engagement 
and retention in relevant health services including referrals to key health programs (e.g., 
MOVE!, dieticians, health coaches, and CV specialists as needed). This multi-component toolkit 
is based on findings from our recently completed work for VA Women’s Health Services (WHS), 
in partnership with VA GLA WH leadership, where we identified organizational barriers and 
facilitators to CV risk assessment and management in women Veterans. The CV toolkit 
incorporates the Gateway to Healthy Living program, a national program currently being 
implemented by the National Center for Disease Prevention and Health Promotion (NCP) that 
focuses on motivating and supporting VA patients with CV risks to engage in existing VA 
services in order to reduce their risk.  
 
This CV toolkit aligns directly with both VA WHS’s mission to provide comprehensive health care 
for women based on provider competencies and patient preferences (Hayes LoS), and NCP’s 
disease prevention goals for all Veterans (Kinsinger LoS). Moreover, per the EMPOWER 
QUERI conceptual framework, the toolkit—a personalized, proactive-patient driven care model 
(BPE 6.2.a)—represents an innovation in women Veterans’ health care (7.2.g) that will enrich 
organizational capacity to engage and retain women Veterans in appropriate care, thereby 
reducing their risk. This particular project is also responsive to the Blueprint for Excellence 
(BPE) Transformational Strategy 3.2.b in that we leverage information technology (CPRS 
templates, myHealtheVet tools) and models of healthcare delivery to optimize individual and 
population-based health outcomes. 
 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 8 of 36 
 
 
 
 
RATIONALE 
 
CV risk reduction is hampered by provider- and patient-level barriers that are addressable with 
evidence- based implementation strategies. Provider barriers to working with patients on 
appropriate CV risk reduction include lack of time, lack of awareness of the latest CVD 
prevention guidelines, difficulty interpreting the guidelines, difficulty accessing relevant electronic 
medical record (EMR) data at the point of care, low self- efficacy to counsel patients in 
behavioral change, habit or inertia, fragmentation of care, and perceptions of low patient interest 
or capacity to follow-through on recommendations.16-19 These barriers may be decreased by 
provider education, training in the discussion and management of CV risk factors, centralization 
of relevant EMR information, patient activation support, and feedback to providers.16,18 A meta-
analysis of quality improvement (QI) efforts found that patient and provider education materials 
are effective at improving blood pressure control.20 There is also evidence that clinical reminders 
are associated with better CV risk reduction practices in primary care populations.21-24 In the VA, 
non-CVD clinical reminders have similarly been effective at increasing screening (e.g., fall risk 
screening, HIV testing).25,26 While VA has multiple clinical reminders built into the VA electronic 
medical record (CPRS), this proposal merges existing data into a CV template and adds unique 
information for a more comprehensive screening and documentation process to facilitate the 
provider-patient discussion about each patient’s CV risks. Moreover, the information will be 
easily accessible in one CPRS location. 
 
 
Our team’s formative “pre-conditions” local work on CV risk reduction among women Veterans 
guides our proposed CV toolkit implementation research. In our FY2013 WHS-funded 
operations project, we 1) performed a targeted literature search on CV educational and risk 
assessment tools; 2) identified barriers and facilitators to CV risk assessment and risk reduction 
in women Veterans; and 3) identified key areas to target educational programs or tools to 
address needs in CV risk management. We conducted three focus groups with 21 Patient-
Aligned Care Team (PACT) team members and semi-structured interviews with 19 patients at 
the two VA GLA primary care women’s clinics. Provider-identified barriers ranged from system 
difficulties in promoting prevention activities to communication challenges, limited time to dialog 
with patients, and limited patient knowledge. Provider-identified facilitators included strategies 
for effective patient engagement and motivation, tools and educational resources to aid CV risk 
discussions (especially in relation to co-morbidities), organized resources on CV health and 
available referrals, stronger integration of health coaches, and technology-based resources. 
Patient-identified barriers included poor motivation and competing demands, while facilitators 
included education about CV risks and complications in women, motivational and accountability 
support from others (including providers), and exercise programs that fit their lives and 
competing demands. Patients reported that various tools would be acceptable if their providers 
suggested using them, including paper tools, electronic tools, and in-person sources of support. 
Findings from this formative work indicate that evidence-based strategies need to be combined, 
tailored, and implemented at the local system level to facilitate provider-patient discussions, 
patient activation, and accountability to promote CVD risk reduction for women Veterans. 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 9 of 36 
 
 
 
3.0 
Objectives 
SPECIFIC AIMS 
 
The goals of this project are to implement and evaluate a CV toolkit designed to increase 
identification of CV risk among Women Veterans and enhance provider communication about 
their risk as well as increase Women Veterans’ engagement and retention in relevant health 
services including referrals to key health programs (e.g., MOVE!, dieticians, health coaches, 
and CV specialists as needed). The CV toolkit incorporates the Gateway to Healthy Living 
program, a national program currently being implemented by NCP that focuses on motivating 
and supporting VA patients with CV risks to engage in existing VA services in order to reduce 
their risk by setting health behavior goals. 
 
This project aims to 1) Refine the elements of the CV toolkit, including patient 
education/activation tools, a CV risk assessment computerized template in CPRS, provider 
information/education and referral tools, and NCP’s Gateway to Health Living program 
specifically for Women Veterans; 2) Implement the CV toolkit in four VA facilities; 3) Evaluate 
CV toolkit implementation using a nonrandomized stepped wedge design and conduct an 
implementation-focused evaluation to further refine the CV toolkit to facilitate future spread. 
 
4.0 Personnel 
STAFF 
PROJECT ROLE 
STUDY ACTIVITIES 
Staff 
De
gre
e 
Sit
e 
Role 
(Level) 
Description 
Acc
ess 
to 
PHI 
Obtai
n 
Infor
med 
Cons
ent 
Rec
ruit-
men
t 
Cond
uct 
Intervi
ews 
Perf
orm 
Data 
Anal
ysis 
SITE 
Bevanne 
Bean-
Mayberr
y 
MD 
G
LA 
Site PI, 
Lead  
PI responsible for implementation of the actual CV 
Toolkit Project. 
x 
x 
X 
x 
x 
Melissa 
Farmer 
Coste 
Ph
D 
G
LA 
Co-PI 
Co-PI responsible for the evaluation of the 
implementation. 
x 
x 
X 
x 
x 
Alison 
Hamilto
n 
Ph
D 
G
LA 
Co-
Investig
ator 
Overall EMPOWER QUERI Director and Qualitative 
Expert. 
x 
x 
X 
x 
x 
Jessica 
Zuchow
ski 
Ph
D 
G
LA 
Co-
Investig
ator 
Will lead qualitative interviews and analysis. 
x 
x 
X 
x 
x 
Erin 
Finley 
Ph
D 
Sa
n 
An
to
ni
o 
Co-
Investig
ator 
She is the Implementation Coordinator for the 
overall EMPOWER QUERI and will be the local site 
investigator for San Antonio. 
x 
x 
X 
x 
x 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 10 of 36 
 
 
 
Martin 
Lee 
Ph
D 
G
LA 
Biostatis
tician 
He is our senior statistician. He will provide 
consultation on all quantitative data analysis. 
x 
 
 
 
X 
Karen 
Chu 
MS 
G
LA 
Statistic
al 
Analyst 
She’s the statistical analysist working on this 
project. She’ll be obtaining data from CDW and 
PBM. 
x 
 
 
 
X 
Alissa 
Simon 
MA 
G
LA 
IRB 
Speciali
st 
She will be the consultant on all IRB issues. 
 
 
 
 
 
Catherin
e 
Schweiz
er 
Ph
D 
G
LA 
Fellow 
She is a Psychologist/WH Fellow and will be 
working on all aspects of this project including 
measure development, interviews and analysis. 
x 
x 
X 
x 
X 
Catherin
e 
Chanfre
au 
Ph
D 
G
LA 
Fellow 
She is a Post-Doctoral Fellow and will be working 
on all aspects of this project including measure 
development, interviews and analysis. 
x 
x 
X 
X 
X 
Julian 
Brunner 
MP
H 
G
LA 
Statistic
al 
Analyst 
He is the statistical analyst working on this project. 
He’ll be obtaining data from CDW and PBM.  He will 
also assist with interviews and analysis. 
x 
 
 
 
X 
Alexis 
Huynh 
Ph
D 
G
LA 
Co-
Investig
ator 
She is a statistical analyst with qualitative 
experience and will be working on both the 
qualitative and quantitative analysis. 
x 
x 
X 
X 
X 
Cynthia 
Gamma
ge 
BA 
G
LA 
Adminis
trative 
Support 
She will be assisting with administrative support. 
X 
 
 
 
 
Hemen 
Saifu 
MP
H 
G
LA 
Project 
Manager 
She will be managing the overall CV Toolkit Project. 
x 
x 
X 
X 
X 
5.0 Study Procedures 
The CV toolkit study is part of a large EMPOWER QUERI program focusing on innovation in 
care for women Veterans at the VA. Project stakeholders include patients as subjects as well as 
staff and leadership personnel as key informants. Products include development of an 
innovative approach for addressing implementation of care models that reduce CV risk for 
women Veterans.  

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 11 of 36 
 
 
 
5.1 Study Design 
EMPOWER QUERI Conceptual Framework. EMPOWER QUERI focuses on strengthening WH 
organizational capacity for innovation in patient-centered care, using an Implementation Core 
and three projects as a collective platform for examining how particular characteristics of care 
models contribute to providers’ ability to utilize the models and to patients’ engagement and 
retention in the models.  As depicted in our conceptual framework (Fig. 1), the Implementation 
Core forms the backbone of our program, and relies on an evidence-based implementation 
strategy, 
Replicating 
Effective 
Programs (REP) 
and emphasizes 
multilevel 
stakeholder 
engagement 
and complexity 
theory. The Core 
will examine 
organizational 
capacity for 
innovation in the 
context of local 
WH care 
arrangements, 
which we know 
to be quite diverse, as well as implementation constructs such as climate and leadership, and 
novel constructs. Knowledge of organizational capacity will inform implementation of innovative 
care models that address CV risk.27 Together, these activities will contribute to our ultimate goal 
of enriching VHA’s organizational capacity to engage and retain women Veterans in patient-
centered, proactive, personalized evidence-based care. 
EMPOWER QUERI Conceptual Framework Figure 1 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 12 of 36 
 
 
 
EMPOWER QUERI 
Implementation 
Strategy: 
Replicating 
Effective Programs 
(REP). We will use 
REP28 across all 
projects to 
maximize the 
implementation 
science knowledge 
that will be 
generated by a 
common approach. 
Grounded in 
theories of 
Diffusion of 
Innovation and 
Social Learning, REP was selected because of its strong evidence base and application in VHA 
health services research.29 It also provides a phased framework for implementation, with 
different discrete implementation strategies being employed in different phases. REP’s 
demonstrated effectiveness in promoting uptake of evidence-based practices allows us to focus 
on its application in varied settings and care models. Use across all projects will allow for further 
testing and expansion of the framework, particularly through our emphasis on multilevel 
stakeholder engagement and incorporation of complexity theory. The REP framework consists 
of four phases (Fig. 2): pre-conditions, pre-implementation, implementation, and 
maintenance/evolution. Careful attention is paid to intervention packaging during pre- conditions 
and pre- implementation; training, technical assistance, and fidelity assessment during 
implementation; and recustomizing during maintenance/evolution. 
During each phase, local context is paramount, with varying deployment of the intervention 
depending on local priorities, needs, and resources. One of EMPOWER’s implementation 
science goals will be to track the relative importance of each discrete strategy in each phase at 
each site and across sites, as well as in each project and across projects 
Enhancing REP with Multilevel Stakeholder Engagement and Complexity Theory. REP was 
originally designed to guide dissemination of evidence-based practices in community-based 
organizations. Kilbourne and colleagues29 note that “it was not designed to address multilevel 
barriers to implementation,” so they enhanced REP with facilitation, using implementation 
experts as external facilitators to provide guidance for overcoming implementation barriers. 
Interestingly, outcomes were favorable for enhanced REP for their primary implementation 
outcome of uptake (i.e., completed contacts with Veterans with serious mental illness who 
had been lost to care), but not for increased utilization of services by patients who had 
dropped out of care.30 This prompted us to consider alternate REP enhancements that are 1) 
more focused on participatory action31 within complex adaptive systems32 in VHA WH clinical 
settings,33 and 2) potentially more effective in increasing patient engagement. Accordingly, we 
draw on complexity theory and multilevel stakeholder engagement. Complexity theory 
Replicating Effective Programs (REP) framework Figure 2 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 13 of 36 
 
 
 
postulates that outcomes in complex adaptive systems are nonlinear and unpredictable; it is a 
highly relational theory, examining how multiple agents involved in implementation interact in 
complex ways and “make sense” of implementation in different ways.34 This emphasis on 
incorporating multiple perspectives and differing priorities is consistent with our VHA WH 
roadmap to delivering gender-sensitive comprehensive care for women Veterans,35 which 
suggests that multilevel stakeholder engagement is key to improving women Veterans’ health 
care. 
We will operationalize complexity theory through use of the Tool for Evaluating Research 
Implementation Challenges (TECH),36 which was designed to systematically assess impacts of 
implementation challenges and guide potential solutions. TECH, which has been used 
successfully in VHA and community studies, is codified into a series of interactive steps: 
identifying challenges (e.g., through observing day-to-day dynamics, listening to complaints, 
asking questions, etc.), interpreting the challenges in weekly meetings, generating and testing 
solution strategies, and, if necessary, addressing regulatory issues. Solution strategies are 
developed through open dialogue among the team members as well as others who might have 
perspectives on potential solutions. TECH will be our research team’s internal way of tracking 
and documenting what’s going on in the clinics. It’s our way of understanding challenges and 
how to address it with people in clinic. We will ask the RAs at the sites to be involved in this 
process so they can give us a description of what’s going on at their sites. 
Multilevel Stakeholder Engagement in the EMPOWER QUERI. Our QUERI capitalizes on our 
seasoned team of implementation scientists, health services researchers, and clinicians, 
supported by a Strategic Advisory Group. Furthermore, we have the distinct advantage of 
being buttressed by the VHA HSR&D Women’s Health Research Network (WHRN), which is 
comprised of the Women’s Health Research Consortium and the Women’s Health Practice-
Based Research Network (PBRN), and a research aim on multilevel stakeholder engagement. 
Our entire team is associated with the WHRN (with EMPOWER QUERI PI Hamilton also being 
one of the WHRN PIs). In fact, this QUERI was developed with consistent input from the 
PBRN Site Leads (some of whom are on our team: Bean-Mayberry (PI), Mattocks, Sadler), 
and the projects will all be conducted at PBRN sites (Frayne LoS). Moreover, our QUERI 
proposal has been strengthened from its inception by invaluable input of women Veterans 
themselves. Specifically, a newly forming Women Veteran Patient Advisory Council has 
agreed to serve as an implementation partner for this QUERI Program (Gottke LoS); Dr. 
Hamilton will serve as an advisor to the Council and will use principles of patient engagement 
in research37 to guide collaboration and involvement of the Council. 
EMPOWER QUERI Methods 
Setting: Women’s Health Practice-Based Research Network (PBRN). The PBRN provides a 
research infrastructure for investigators seeking to increase inclusion of women in VHA research 
or conduct multi-site women’s focused research in VHA. Comprised of 60 VAMCs that see one-
third of women Veteran VHA users, the PBRN helps investigators overcome the challenges of 
multi-site studies through engagement of Site Leads with established working relationships with 
local clinicians and facility leadership. Site Leads have received implementation training, and 
have developed across-site relationships through regular national calls and technical support 
organized by the PBRN Coordinating Center in Palo Alto (Frayne LoS). 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 14 of 36 
 
 
 
Site Selection, CV Toolkit, and REP Implementation Phases  
The CV toolkit will be implemented at four VA facilities with moderately large panels of 
women Veterans.  WH clinics are eligible if they have PC panels of women patients that total 
at least 2000+ women and they have at least 4-8 PCPs per site whose panels include at 
least 100 women Veterans and women comprise at least 10% of the provider’s patient 
panel. Currently, two sites have been selected for implementation and two other sites will be 
added to our protocol at a future date. Our first site where we will launch the CV toolkit is 
GLA, where the PI (Bean-Mayberry) is the PBRN Site Lead. Our second site has now been 
recruited (West Haven) and their site application will be submitted to CIRB shortly. All site 
selection will be done in collaboration with Dr. Susan Frayne, Director of the VA WH-PBRN, 
and member of our Strategic Advisory Group (Frayne LoS). 
The CV Toolkit includes four elements:  (1) Patient education/activation tools, such as 
informational posters and fliers about women’s CV risk, including information about 
MyHealtheVet website resources. To activate patients to discuss CV risk with their providers, 
we developed a CV worksheet (Appendix 6) for patients to fill out at check-in to collect 
information about family history of CVD, pregnancy/gestational history, and smoking status, and 
to help patients formulate/document any questions regarding their CV risks that they would like 
to discuss during their visits. The goal is to help make CV risk discussion a priority for women 
before they enter the exam room. (2) A CV risk assessment computerized template 
systematically captures CVD risk factor history and data from the medical record, and provides 
open fields for the provider to enter any relevant information from the patient worksheet and the 
clinic visit (e.g., goals and decisions). The template also includes embedded links to locate CV 
guideline documents. Based on feedback from clinical teams at two GLA sites, the template 
includes data from the current visit as well as the last three entries in the medical record 
(automatically generated by the template) such as weight, blood pressure, and cholesterol lab 
results. This enables the provider to look at trends in risk factors without having to search the 
chart. The information is stored as a standard outpatient note in the patient’s medical record (in 
CPRS) and is readily accessible (and searchable) at future visits so that CV risk status will be 
an ongoing discussion. Referral options are also included on the template, including referral to 
the Gateway to Healthy Living program, so the template will be a shared template available for 
other providers to access (e.g. health coach, dietician, specialist, etc.) to review when the 
patient comes for the referral.40 (3) Provider information and education programs as well as 
referral tools to internal services (e.g., women’s MOVE! program, smoking cessation clinics, 
dieticians, health coaches, pharmacists and CV or mental health specialists as needed). (4) 
The Gateway to Healthy Living program tailored to Women Veterans is a facilitated group 
meeting that occurs in a structured format with personalized goal setting and identification of 
key services available at the local site to assist with lifestyle changes necessary for patient-
targeted CV risk reduction. In addition to the structured group, it includes at least two follow up 
phone calls from the facilitator (typically a health coach or health promotion disease prevention 
specialist) for support, reinforcement of lifestyle changes, brainstorming of barriers, and steps 
toward goal realization. 
REP implementation phases:  CV toolkit implementation will be guided by the REP framework 
consistent with all EMPOWER QUERI projects, and will feature multilevel stakeholder 
engagement to ensure that each phase is informed by women Veterans, providers, 
administrators, and operations partners. REP consists of four phases: 1) pre-conditions, 2) 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 15 of 36 
 
 
 
pre-implementation, 3) implementation and 4) maintenance and evolution.  The TECH will be 
used to guide assessment and documentation of implementation challenges during each REP 
phase. 
Pre-conditions (Aim 1): In our prior work (funded by WHS), the need for the intervention was 
established and review of effective interventions completed. Building on work completed from 
partial restoration of our QUERI RRP funding for a smaller scale version of this project, we have 
completed the refinement, programming, functionality testing and loading of the CPRS-based 
template in the CV toolkit package. We are also culling VA and AHA information on CVD in 
women and testing online VA media for patient assessments in myHealtheVet. We have also 
been working with our partners at NCP and identified the Gateway to Healthy Living program for 
in-person, patient-directed goal setting. We will work closely with NCP to evaluate the results 
from the Gateway to Healthy Living pilot project (concluded FY15) to make program 
adjustments and further tailor the program for women Veterans.  Specifically, some of these 
sessions will be offered as women only groups with women facilitators in addition to routine 
mixed gender group availability.  Additionally, sex-specific handouts on cardiovascular risk 
factors in women will be available using approved information sheets from VA central office and 
the American Heart Association.   
Furthermore, the pre-conditions phase has been completed locally at GLA, which will serve as 
an initial implementation site. For each additional PBRN site, we will revisit aspects of the pre- 
conditions phase to ensure that the toolkit, developed locally at GLA, is appropriate at the 
other sites. During site visits at the additional sites, the toolkit will be discussed with relevant 
key stakeholders (WH leaders, providers, women Veteran patient representatives), core 
elements will be explained, and, using the TECH the local team will discuss options for 
adapting delivery and anticipated barriers to implementation. For example, we will need to 
explore care options available at each site (e.g. health coaches, smoking cessation, MOVE!, 
etc.) and educational needs of the various WH teams at each site. Also during this phase, 
interviews and surveys will be conducted with all consenting key stakeholders with the 
exception of patients who will be interviewed and surveyed in the implementation phase (see 
below). 
Pre-implementation (Aim 1 cont.): At each site, a local CV toolkit champion will be identified by 
the Site Lead when s/he signs onto the project. The toolkit package will be further developed 
and locally tailored, with attention to training and technical assistance needed for each site. 
Once prepared, the toolkit will be piloted locally to ensure that it works as intended with local 
systems and processes. Using the TECH, any challenges with pilot implementation will be 
discussed and addressed by the team. When the team determines that challenges have been 
sufficiently addressed, orientation meetings will be held with the broader clinic, where the 
toolkit will be distributed and discussed. 
Implementation (Aim 2): The implementation phase will begin at the first PBRN site in the latter 
half of Year 2 and will last a total of 15 months to ensure adequate time for implementation 
evaluation and reach. The second site will begin the implementation phase at the start of year 3, 
and the toolkit will spread to two additional PBRN sites later in Year 3 through Year 4.  For CV 
toolkit training, Dr. Bean-Mayberry (PI and primary care provider in the Sepulveda WH clinic) 
and Dr. Autumn Watson (Co-Investigator, VA Clinical Psychologist and GLA Health Behavior 
Coordinator, Supervisor of GLA Health Coach Program, with guidance from Dr. Ebrihimi, 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 16 of 36 
 
 
 
cardiologist and consultant on project) will lead a series of provider education activities 
including facilitated discussions to educate the providers and office staff members on the 
importance of CV risk discussions for women within primary care as well as on how to use the 
toolkit in practice. At GLA, this training will be done in person, but the training programs will be 
tailored for virtual delivery (e.g. Lync meeting/cyberseminars) to the other sites.  In addition, our 
partners at NCP will travel to sites to train the Gateway to Healthy Living facilitators or conduct 
virtual training with travel is not feasible. During implementation, we will assess any additional 
need for provider training and monitor the use of the template in the clinic by generating reports 
on template use. This information will be collected by the research staff, the data will be 
summarized (frequencies graphed over time), and then quarterly CV template reports will be 
presented to the WH clinical team. We will also take field notes during the trainings to 
document any issues that arise with the users (clinical team) and the CV toolkit within the 
context of each distinct clinic setting. These notes will be analyzed using ATLAS.ti, and will be 
examined in conjunction with other evaluation data as described below. During regular 
implementation meetings, TECH will be used to assess and address implementation 
challenges. 
The CV toolkit is an innovative care model that is proactive, patient-centered and personalized 
to each woman that comes to an appointment. A patient begins using the CV toolkit at check-in 
for her appointment when she is given the CV worksheet to fill out while waiting to see her 
provider. Patient education materials specifically on women and CV risk will be in the waiting 
room and exam rooms. The CV worksheet will be used to initiate the provider-patient 
discussion of CV risk, and her provider or another staff member will use the information to fill 
out the CV template in CPRS during or after the appointment.  Depending on the site needs 
and preferences, a research assistant and/or the Gateway facilitator may help populate the CV 
template with the screener information.  The patient and provider will collaboratively determine 
the next steps (i.e. Gateway to Healthy Living, other referral, or waiting) and the provider will 
document the action plan in the template. All participants will be offered the Gateway to 
Healthy Living program by providers or other staff member as engagement and support for the 
patient action plan.  
After the appointment, each woman will be asked if she is willing to participate in the project for 
monitoring CV risks and choices and if she consents, she will complete a patient survey and a 
possible interview with the RA (every 3rd consented patient will be asked to participate in both 
a survey and interview).  At the sites where it is not feasible to consent a woman immediately 
after her appointment, the research staff will generate a patient list of all women seen in the 
clinic who had a CPRS template activated during her visit.  Based on that list, a sample of the 
women will be mailed a consent and survey (and every 3rd consented patient will be asked to 
participate in the interview).  Follow-up surveys and interviews will be administered to all 
women who completed the baseline survey six months after the baseline survey. 
Those women who are referred to the Gateway to Healthy Living program will be contacted by 
the program facilitator immediately to arrange the group meeting. The women will be 
considered engaged in the Gateway to Healthy Living program when she attends the first 
group meeting. Information on goal setting, behavior change intentions and participation in 
other services will be collected by the facilitator at the group meeting and at the follow-up 
phone calls.  

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 17 of 36 
 
 
 
Maintenance and Evolution: The last phase in this framework allows us to take the feedback 
and make modifications to our implementation process to enhance adoption of the toolkit, 
fidelity to the implementation process, and dissemination at future sites. Sharing these details 
with stakeholders using TECH informs the current implementation process and sustainability for 
the future. The four REP phases allow us to account for each step of the guided implementation 
strategy. Finally, the interchange between these phases and the implementation process 
components provide a granular synergy for understanding whether the implementation of this 
CV toolkit requires further adaptation and customization prior to broader VA dissemination. 
During this phase, the research team will collaborate with the local implementation teams to 
develop points for future dissemination. 
Study Design 
We will use mixed methods to evaluate implementation.  To assess our primary implementation 
outcomes, we will conduct pre-implementation, mid-implementation and post-implementation key 
stakeholder interviews (Component A) with providers and staff.  For patients, we will conduct 
baseline and follow-up surveys as well as interviews with a subsample of those patients who 
completed surveys (interview approximately every 3rd consented patient with completed survey).   
We will use administrative data from the medical record (CPRS and CDW) to capture use of 
the CV toolkit (CPRS template) and referrals to preventive services.  We will use a non-
randomized stepped wedge design to evaluate the roll out of the intervention and the change in 
referrals over time across the sites. 
Nonrandomized Stepped Wedge Study Design for Implementation Trials.  
The CV Toolkit project will use a nonrandomized stepped wedge design, which rely on 
sequential roll-out to participating sites over time, while using other sites as controls until they 
begin implementation.38 Consistent with our substantial prior experience using these designs in 
VHA and armed with complexity theory’s recognition of nonlinearity of implementation,39 we will 
use nonrandomized stepped wedges (rather than randomized) given their suitability for studying 
implementation. This design acknowledges that sites are heterogeneous, face multiple 
constraints, and, as a result, are ready to adopt interventions at different rates. The modified 
design explicitly considers the timing of implementation spread and addresses the statistical 
issues introduced by lack of randomization in implementation starts and processes. We will 
analytically compensate for the design by collecting patient-, provider-, and site-level data that 
may be associated with timing of the adoption of each intervention.  We will include three levels 
in our hierarchical nonrandomized stepped wedge models: (1) patient, (2) time of intervention 
(i.e., when a provider starts using the intervention), and (3) site. Outcomes of interest (e.g. 
referrals to Gateway, other health promotion program and/or specialist) are measured for all 
patients at each site within the given intervention time period. 
Nonrandomized stepped wedge designs make efficient use of all data available for within-site 
and between-site comparisons.  For the within-site comparison, sites act as their own controls in 
an evaluation that compares sites pre- versus post-implementation. The comparison examines 
sites as they cross-over from control to intervention states. The between-site comparison 
evaluates the intervention period for a site vs. all other intervention and control periods for all 
sites. By having these two types of comparison, the design improves on the validity of the 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 18 of 36 
 
 
 
evaluation of the intervention, by accounting for historical time trends that may occur outside of 
the intervention and for site contextual characteristics that may affect site performance. 
 
Risk to Subjects 
This study involves both Veteran (260 total across four sites) and VA Staff participants (60 total 
across four sites). 
Veteran involvement and Characteristics  
This 4-site research project aims to implement and evaluate the CV toolkit designed to increase 
identification of CV risk among women Veterans, enhance patient/provider communication 
about CV risk, and increase women Veterans engagement and retention in relevant health 
services including referrals to key health programs.  We will recruit adult women Veterans who 
visit their women’s health provider at one of the four study sites if a CPRS CV risk template was 
activated from their primary care visit or they attended the Gateway to Healthy Living program.  
As long as the woman Veteran patient is also able to give informed consent to complete our 
protocol, she is eligible to participate. We expect to approach up to 200 women Veterans per 
site over the study period in order to achieve a minimum of 65 women participants in the 
survey/interviews for CV toolkit at each site. Our goal is to have 260 women total (minimum 65 
per site across 4 sites) engaged in the project over the course of the study. Participation 
includes a brief survey at baseline and six-month post-baseline, and for a subset of women, a 
brief qualitative interview (approximately every third consented woman with a completed survey 
will be approached for an interview for a minimum of 20 patient interviews at a site).  Women 
will be consented at the time of the survey and interviews. The women will also be consented to 
link their responses to their medical records at the time of the survey.   
We will also use medical record data (CPRS template data and CDW data) to evaluate the roll-
out of the intervention and the referral rates at all sites.  This data will be evaluated for all 
women patients seen by the providers in the study over the study period.  The data will only be 
evaluated in the aggregate and will not be linked to the patient survey or interview data (unless 
medical record access consent is received at the time of the survey).   
Provider / VA Staff Involvement and Characteristics  
To obtain feedback from key participants and implementers of the CV toolkit, we intend to 
recruit approximately 15 staff per site. Staff members from each site will comprise of primary 
care providers, RN care managers, LVN provider or health technician, clinic clerk/MSA and 
other clinical staff members (e.g., dietitian, pharmacist, or mental health provider, etc.) and 
administrators (e.g., Women’s Health Medical Director, Women Veteran Program Manager, 
Primary Care Chief ). Given the diversity of VA staff, this sample will include women, men, and 
members of minority and ethnic groups.  This scope of providers and administrative staff will 
provide broader perspective of the implementation process in the clinics. 
Potential Risks 
Risks are minimal and primarily related to loss of confidentiality.  

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 19 of 36 
 
 
 
For patients, study assessments will include potentially sensitive questions and information 
about mental and/or physical health symptoms.  Thus, there is risk for embarrassment and 
negative effects on patient subjects if sensitive information was improperly disclosed and used 
in a discriminatory fashion against the individual.  Additionally, individuals’ social security 
numbers will be accessed in order to obtain data from VA databases and to collect information 
to contact them and link to medical records.  If disclosed, this information could cause negative 
financial or legal consequences.  Recruitment may also involve the risk of perceived coercion if 
the Veteran believes/assumes that refusal might threaten care or benefits.   
For staff subjects, because this study asks questions about organizational issues at the clinic 
where they are employed, there is risk for embarrassment and negative effects on subjects if 
sensitive information was improperly disclosed and used in a discriminatory f ashion against the 
individual. Risks could include psychological stress due to discussing uncomfortable topics or 
challenging situations at work involving patients or coworkers. 
However, given the safeguards against improper disclosure and steps we are taking to ensure 
protection of sensitive information as detailed below, the likelihood of any disclosure is minimal.  
Adequacy of Protection from Risk 
Procedures to safeguard against adverse events.  All data collection protocols will include 
procedures whereby research staff members report problems with the data collection, concerns 
about risk to subjects or others, or unusual occurrences during the collection. These allow 
project leaders an opportunity to quickly review and respond to any possible concerns or 
adverse effects.   
Informed consent. Research subjects are advised of the voluntary nature of participation and 
research subjects are informed of their right to withdraw from the project at any time. 
Information obtained up to the time of participant withdrawal or termination may be used in the 
data analysis.  Each participant receives a verbal and/or written description of the study. The 
Principal Investigator and delegated research team members are available at all points of the 
study to answer questions and to explain assessment procedures, uses to which the data will be 
put, and confidentiality of data. We will request a waiver for documentation of informed consent 
for interviews with staff members from each site. 
Mandatory reporting safeguards. Procedures to prevent violation of confidentiality are limited by 
the mandatory nature of legal reporting requirements. Subjects are informed in the consent 
document that their responses to the surveys and interviews are confidential, except: 
“1) If we need to protect you or others from harm. An example of this is if you want to hurt 
yourself or others. In that case, we will give information about you to others that is needed to 
protect you or others from harm.  
2) If you tell us about the abuse of a child or of an elderly person, or if you tell us about being 
abused yourself. In that case, we must report this to a supervisor, who may report it to the 
authorities.”  
Staff training safeguards. As required, all research staff will be credentialed by their VA 
Healthcare System’s research service, and will successfully complete all required trainings. 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 20 of 36 
 
 
 
Research staff will meet with their local study supervisor (the Site Lead or the Project Director) 
on a weekly basis for supervision, ongoing monitoring of interactions with subjects, and problem 
solving. Research and clinical staff are trained to identify events that would fall under mandatory 
reporting guidelines, such as harm to self or others. The PI will be available at all times by cell 
phone. When the PI is not available, the PI will delegate this responsibility to another qualified, 
credentialed staff member.  
Data safeguards. Before analysis of the data, all identifying information will be removed from the 
data. No information that could identify study subjects will be published or presented. Data will 
be reported only in the aggregate. Identifiable data will be stored separately from coded data 
sets. Access to identifiable study data will be restricted to research team on a need-to-know 
basis.  
Discomfort with assessment, intervention procedures or disclosure safeguards. During the 
course of participation in the study, a subject could feel uncomfortable answering the survey or 
interview questions.  All interviewers will be trained in the assessments and with sensitivity to 
the issues to be discussed.  All subjects are informed that they may choose to skip any 
questions that they find uncomfortable or withdraw from the study at any time.  
For patients who consent to be surveyed, the 30-minute surveys delivered in person by the RA 
will occur in a private room in the VA clinic setting at each site. Since some patients may not 
attend the group immediately or at all, patient baseline survey packets with an information sheet 
will be sent to the patient’s mailing address in CPRS/VISTA.  Patients who agree to the survey, 
by completing the survey, will have a VA addressed stamped envelope to return the survey 
document.  For the subset of women selected for the patient interviews, the interviews will be 
conducted by telephone, but could be done in person (at the medical center) if the patient 
prefers in-person.  Staff interviews will be conducted in person in a private room in the VA clinic 
setting or by telephone at each site.  
Response procedures for adverse events are described in Section 6 Reporting (below). 
Potential Benefits of the Research to Subjects and Others  
Although individual subjects do not benefit directly, there are potential benefits to human 
subjects from participation. Participants may be able to impact the development or ongoing 
modifications of the CV risk toolkit and future dissemination for women at their own or other VA 
sites. They may also be able to provide feedback on care in the clinic where they receive 
services or are employed, which may affect their treatment or working environment in the future 
if this model is widely adopted.  
5.2 Recruitment Methods 
This study involves both Veteran patients (260 total across 4 sites) and VA Staff participants (60 
total across 4 sites). 
Patients: Patient subjects will be recruited once they have made contact with the 
provider in clinic and asked to participate after a clinic visit by the local RA. The RA will 
check in with the WH PACT members (i.e., providers and RN care manager) to know 
when the template was used in clinic and if the women Veterans have been referred to 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 21 of 36 
 
 
 
Gateway.  Using a visit-based sampling method, patients are eligible during their first 
visit with the provider during the 15-month implementation period. The patient will be 
asked if they would like to participate in the research project and if so, the women will be 
given a packet with the survey and information sheet.  A return envelope will be included 
in the packet for the patient to return the completed survey (either by mail or hand it to 
the RA).  For sites where in-person recruitment is not feasible, the research team will 
generate a list of all patients seen in the clinic and had a CPRS template activated.  
Those patients will be contacted by mail about the study.  They will receive the same 
packet described above with the return envelope.   
Staff.  15 VA Staff participants will be recruited from 4 sites (total of 60 participants). Staff 
subjects will be recruited from women’s health clinics that are using a WH PACT model of care.  
To obtain the staff sample, we will work with each site’s PBRN Site Lead to develop a list of 
eligible individuals (and their contact information), who meet the staff categories we would like 
to include. If needed, the PBRN site leads can work with the Women Veterans Program 
Manager or Women’s Health Medical Director to confirm eligible individuals. The study PI and 
the Site Lead will present the study to local staff and administrators via email and or phone call.  
Staff members will be emailed an invitation to participate in an initial interview along with a 
survey, which will be collected at the time of the baseline interview. This email will also inform 
the participant that their participation includes three semi-structured interviews, either in person 
or over the phone, that will take 45 to 60 minutes each, the initial interview in the next few 
weeks, the second interview 10-12 months later and the final interview about a year later (the 
expected duration of their participation will be a total of 3 years). The recruitment process will 
include informing potential staff subjects about the study, who is conducting it, why the 
individual was selected for recruitment, and how the information gathered will be used. Potential 
staff subjects will be informed that their participation is entirely voluntary and their decision 
about participation will not affect their employment, merit, or promotion.  After explaining the 
study, if the staff member is interested, the local research staff will schedule an appointment. 
We will also inform the participant that in 10-12 months, unless they ask us not to, we will 
contact them again regarding participating in a similar follow-up interview to document events 
across time.  

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 22 of 36 
 
 
 
 
5.3 Informed Consent Procedures 
Patients.  We are requesting a waiver of documented informed consent.  For the survey, the 
informed consent process will include informing potential subjects about the study, who is 
conducting it, why the individual was selected for recruitment, that their participation in the 
research will be entered in their medical record, how the information gathered will be used, and 
about the patient subject payments.  This will be included on the information sheet included with 
the survey.  Completion and return of the survey will indicate consent. For surveys that are 
mailed to participants, we are requesting a waiver of HIPAA authorization. The HIPAA form is 
not intended for mailing to the respondent and then having the respondent mail it back. The 
subject does not have an opportunity to ask any questions or voice any concerns if it is done 
through the mail.  Additionally, only when the HIPAA form is completed in person does the 
sensitive data of name, date of birth, and last four SSN required by the form stay within the VA 
environment once the form is handed over to the researcher.  The risks of mailing this highly 
sensitive information outweigh the benefits to the respondents. For surveys that are given in 
person, we will have these participants complete a HIPAA authorization form, which will be 
securely locked in the RA’s filing cabinet. Payments include $20 VA Canteen vouchers for each 
of two surveys and, for a subset of patients, an additional $10 VA Canteen voucher for the 
interviews at baseline and six-months post-baseline.  Potential subjects will be informed that 
their participation in the research is entirely voluntary, and that if they choose not to participate, 
there will be no effect on the care they receive.  Methods for how subjects’ identity and collected 
data will be protected will be discussed.  For the interviews, verbal consent will be obtained 
before each interview. For the use of the medical record data, we are requesting a waiver of 
HIPAA Authorization.  
Staff.  We are requesting a waiver for documentation of informed consent.  Affirmative response 
to email invitation will constitute informed consent and verbal consent will be recorded at the 
time of interview.  After a response has been received, enrolled staff members will be scheduled 
for an interview with a member of the research team.   
5.4 Inclusion/Exclusion Criteria 
Staff 
Inclusion Criteria: VA staff affiliated with women’s health care and located at PBRN sites. Given 
the diversity of VA staff, we expect this will include women, men, and members of minority and 
ethnic groups. 
Exclusion criteria: Non-VA staff and not located at a PBRN site. 
 
5.5 Study Evaluations 
 
Qualitative Data Collection:  

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 23 of 36 
 
 
 
 
Non-Human Subjects Research Staff Interviews- To evaluate knowledge, attitudes, beliefs, and 
perceived acceptability and feasibility of the CV toolkit from key participants (VA staff, including 
WH primary care providers, nurses, clinical staff and health coaches); we intend to recruit 
approximately 15 staff per site who will be asked to complete a brief interview and survey. The 
brief survey, titled the MORE scale, version 1, measures the extent to which the organization 
our participants work in is willing and able to effective f oster patient engagement in their 
healthcare facility. This survey will be emailed out to staff before their pre-implementation 
interviews and the data will be collected at the time of their pre-implementation interview. For 
interviews, participation will consist of three 45-60 minute qualitative interviews (pre-, mid-, and 
post-implementation) conducted in-person or over the phone by a research staff member. We 
will focus on knowledge, attitudes, beliefs, and perceived acceptability and feasibility of the 
toolkit for the pre-implementation interviews (approximately five months into the pre-conditions 
phase); perceptions of interim implementation processes and outcomes (approximately six 
months into the implementation phase) and summative perceptions of toolkit implementation 
and potential for spread (last two months of the maintenance/evolution phase). The mid-
implementation assessment will evaluate the progress and implementation barriers and 
facilitators to CV toolkit implementation and be used to continue to tailor the implementation.  
Final interviews will re-evaluate baseline domains, and will follow-up on CV toolkit 
implementation and sustainability. 
 
Ethnographic field notes will be taken by research team members throughout project to capture 
aspects of the context of implementation and otherwise unmeasured aspects of usual care. The 
two anthropologists on the QUERI Program (Hamilton and Zuchowski) will provide training on 
writing field notes. Also, minutes will be recorded for all project meetings (including trainings) 
and conference calls. In addition, substantive emails and other communications regarding 
implementation will be archived and analyzed. 
Information from and about Veterans:  
Sources of patient data for this project includes (1) Utilization data on CV services used six 
months prior to the start of the intervention and over the course of the study program obtained 
from enrollees’ medical records, (2) information provided by patient participants via surveys and 
interviews, and (3) The implementation facilitator will track participant utilization of the program. 
Information on goal setting, behavior change intentions and participation in other services will be 
collected by the facilitator at the group meeting and during follow-up phone calls and entered on 
a coded tracking sheet.   Follow-up surveys will be administered to all women who completed 
the baseline survey six months after the baseline survey. 
After consent, all enrolled participants in each project will complete a 30-minute survey, 
delivered in-person by a research assistant (RA) at baseline and six-months post-baseline.  For 
sites where it is not feasible to reach all the eligible women in person, the surveys and 
information sheets will be mailed to the patients address listed in VISTA/CPRS.  Patients who 
do not return surveys within a 2- week window will be sent a reminder post card and then mailed 
a second informed consent and survey packet by 4 weeks if no survey is received.  The surveys 
focus on patient activation, health-related quality of life, satisfaction with treatment, and project 
specific measures.  In addition, a subset of approximately 45 women Veterans in each study 
(every third consenting patient) will also be asked to complete an additional 20-minute 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 24 of 36 
 
 
 
qualitative interview with a research staff member at baseline and six-months post-baseline 
(either in-person or by telephone). The RA will record survey answers directly into a VA 
computer storing data on a server behind the VA firewall. Patient semi-structured interviews will 
be coded only with a study ID, digitally audio-recorded, and uploaded to a secure VA server 
behind the VA firewall.  If recording consent is denied, the researchers will take hand written 
notes, which will be securely transported and stored as described below until they are 
transcribed into an electronic format.  When desired by the patient or the interviewer, or to 
accommodate the cognitive needs of the subject, the survey or interview can be performed at 
two or more sessions.  At the end of the implementation period we will obtain utilization history 
through the Data Access Request Tracker (DART) system, conducting chart review in the VA 
Informatics and Computing Infrastructure (VINCI) environment.  
5.6 Data Analysis 
Qualitative Analysis:  All semi-structured interviews will either be conducted in-person in a 
private room or be conducted via telephone with the interviewer in a private, closed office 
(either alone or occupied by other members of the research study team). Interview participants 
will be instructed not to use their real names or to provide any identifying information during 
the interviews. 
 
The interview will be recorded via digital recorder and speakerphone. Audio research data will 
be temporarily stored on a Phillips 9600 digital audio recorder as it is recorded.  Data will 
subsequently be transferred via cable connection (which only works with a security enabled 
dongle) to a secure server. The Phillips 9600 is a VA approved device and is the most secure 
recorder on the market. Voice files can be encrypted and password-protected to prevent 
unauthorized access, making the 9600 the first HIPAA compliant recorder on the market. It 
allows the user to upload a digital file only once and only via cable with a dongle. Upon 
completion of uploading the file is erased from the digital recorder; therefore, only one copy of 
the recording remains, having been saved to a VA server.  
 
The interview content will be transcribed in order to assure that interviewer notes have 
accurately and fully captured interview content. To do this, the audio-recordings and 
transcripts will be transmitted via SFTP, PKI, or hand-carry (as set out in the executed DUA 
with our transcription service contractor, Alpha Transcription) files and recordings may be 
transferred between the VA and the vendor via:  (1) encrypted PKI email,  (2) secure File 
Transfer Protocol (SFTP), or (3) files can be encrypted, copied onto a CD, and hand-carried by 
Vendor or study team staff, in a VA locked travel bag. The transcriptionist will delete any words 
that inadvertently identified the research participant, other research participants, or VA 
providers or leaders.  Given that data will be collected by teams remote to Los Angeles, the 
most likely mechanism for file transfer will be SFTP.  
 
The transcription company will generate an MS Word file transcription of the audio content. 
Data temporarily stored on Alpha Transcription secure server during the transcription process 
will be destroyed within 30 days after transcription files have been downloaded and verified by 
the study or vendor teams. The MS Word transcripts of the interviews will be stored on the VA 
GLA HSR&D Center of Innovation server, available only to authorized project staff. 
 
Transcripts will be reviewed, edited for accuracy, and summarized by members of the research 
team. Consistent with our team’s approach across multiple projects, matrix analysis methods41 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 25 of 36 
 
 
 
will be used for rapid turn-around of the results42 to share with our Strategic Advisory Group. 
In-depth analysis of the qualitative data will be conducted using ATLAS.ti, a qualitative data 
analysis software program that allows for fluid interaction of data across types and sources. 
Initially, a top-level codebook will be developed for the baseline interviews based on the semi-
structured interview guide.43   Using a constant comparison analytic approach, this codebook 
will be elaborated upon based on emergent themes, and it will be adjusted as each round of 
interviews is reviewed. Interviews will be compared within each clinic, across clinics, and over 
time. Additional sources of qualitative data (i.e. meeting minutes, field notes, and archival 
information) will also be included in the data set and will be coded separately and in relation to 
the interview data. These multiple approaches and groupings are easily facilitated within the 
software program, which has the capacity to group data in multiple ways and which allows the 
qualitative researchers maximum flexibility in negotiating a complex narrative dataset. Of note, 
the EMPOWER QUERI qualitative team has been working together for over five years; all 
described analytic procedures are well established and all members of the team have 
expertise with qualitative data analysis and dissemination of results. 
 
In the pre-conditions transcripts, we will identify commonly shared knowledge, attitudes, and 
beliefs related to care model structures, processes, and effectiveness and the potential for 
effectiveness. In mid-implementation interview data, we will identify factors facilitating and 
impeding implementation of the care model, and strengths and weaknesses of the model as 
implemented. We will assess the extent to which components of the model are being 
implemented, and which components are efficient and easy to incorporate into routine care. 
We will explore whether particular components appear to be of limited value in improving care 
and examine clinic and provider characteristics associated with varying levels of care model 
implementation and effectiveness. In post-implementation interview data, we will take a 
summative approach to characterizing overall experiences of and perspectives on 
implementation, with a particular focus on recommendations for scale up and spread.44 
 
For providers, we will compare and contrast data from frequent users of the template with 
infrequent users, and track changes in perceptions about the utility and impact of the toolkit on 
clinical practice from pre-conditions to maintenance. We will also assess provider attitudes 
toward ease of referral to the Gateway to Healthy Living program, and provider perceptions of 
changes in patient awareness and activation. For patients, we will compare and contrast data 
from those who used Gateway to Healthy Living with those who did not, and those who used 
other services. In order to evaluate the patient impact of Gateway to Healthy Living, we will 
assess changes in patient perceptions of CV risk, self-efficacy, and activation. 
 
 
Quantitative Analysis:  We will use descriptive and inferential statistics to understand variations 
in the measures described above. For patients, we will conduct bivariate analysis to examine 
variations in outcomes (CV risk factor control, cardiac event or procedure, etc.) by those who 
participated in the Gateway to Healthy Living program, versus those who received a referral to 
a different program/service, and those who received no referral. For providers, we will examine 
differences in their patient panel (e.g. those with CV risk factors under control at follow-up) by 
their engagement in the CV toolkit program. To evaluate the CV toolkit, we will use the 
nonrandomized stepped wedge design, a generalized mixed model coupled with an allowance 
for nonrandom effects, to evaluate the implementation across the providers at four sites. The 
intervention will be defined as “turning on” when a provider first engages in the CV toolkit (first 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 26 of 36 
 
 
 
uses the CV template). We will model the effect of the implementation of the CV toolkit 
intervention on referral rates, while controlling for organizational level, provider level and patient 
level covariates. 
 
Impact-focused evaluation: Secondary aims focus on factors that empower Women Veterans to 
engage in and benefit from care. We will use generalized linear mixed models (GLM) to 
evaluate a) cross-sectional relationships of patient activation, health-related quality of life, and 
care experiences at enrollment, with provider and site characteristics, adjusting for patient 
social and demographic characteristics; and b) prospective changes in patient activation, 
health-related quality of life, and care experiences from enrollment to 6-month follow-up, 
adjusting for patient, provider, and site characteristics. We will also construct multi-level 
mediation and moderation models to explore whether engagement-related factors such as 
patient activation, strength of treatment preferences, or the communication subscale of the 
CAHPS are associated with greater benefit from or satisfaction with care. 
 
Power Analysis: Our goal with the power analysis was to ascertain the number of providers who 
would need to “turn on” the intervention (i.e., the number of PCPs who use the CV template, as 
well as the minimum number of patients that would need to be exposed to the care model. 
Consistent with our nonrandomized stepped wedge design, the power analysis presented here 
is for a 3-level hierarchical linear model where patients are clustered within PCPs within sites. 
In the final analysis structure, patients are the Level 1 units, the timing of PCP template 
use/referrals represents Level 2 units, and sites are the Level 3 units. The outcome of interest 
for CV Toolkit is the number of referrals to services (e.g. Gateway to Healthy Living and other 
services), The outcome is binary (referred/retained vs. not), and measured at the patient level 
(Level 1). Treatment effect is measured at Level 2, i.e., timing of when the PCPs turn on. 
Parameters required for calculating power are: alpha (α) = 0.05, sample size of patients 
clustered within referring PCPs (n) = at least 260 (based on prior work), the number of sites (K) 
= 4, the Plausible for Retention among those with low utilization (PI) = 5% to 85%, and Effect 
Size Variability (ESV) = medium or 0.05. Based on the resulting power curve, we need at least 
8.78 (rounded to 9) referring PCPs per site to achieve power at 0.80. Our power analyses 
assume that the treatment effect is linear over time, i.e. patients that are retained longer have 
proportionally better outcomes. While selected details of the resulting dose response curve may 
vary, sensitivity analyses demonstrate a reasonable approximation enabling detection of 
treatment effects. 
 
 
In addition to project key personnel, the overall EMPOWER QUERI Implementation Core will 
be involved in data analysis.  The Implementation Core is directed by Dr. Hamilton 
(EMPOWER QUERI PI), an experienced and highly trained implementation scientist. She will 
be supported by a seasoned team of Co- Investigators, many of whom also have 
implementation research experience. Drs. Hamilton and Zuchowski will lead the qualitative 
analysis and Drs. Farmer (Co-PI), Lee and Huynh will lead the team with quantitative 
analyses including the nonrandomized stepped wedge. The implementation core personnel 
are supported by several internationally recognized implementation scientists on the Scientific 
Advisory Group, including Drs. Curran, Mittman, and Yano, who will help with their expertise in 
guiding the success of this project. The Scientific Advisory Group will not have access to 
identifiable data. 
 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 27 of 36 
 
 
 
5.7 Withdrawal of Subjects 
The PI may terminate a participant in the study at any time if the study participant does not meet 
enrollment criteria or does not comply with study requirements, e.g., keeping scheduled 
appointments with the interview team.   
Participants may withdraw at any time with no consequences.   
Information obtained up to the time of participant withdrawal or termination may be used in the 
data analysis.   
6.0 Reporting 
We do not expect our project to elicit distress among participants, as the subject matter is not of 
a sensitive nature. However, it is possible that some participants will experience distress at the 
recall of certain experiences. Interviewers will be trained to respond to indications of distress by 
redirecting the participant to another area of the interview guide. Should the participant continue 
to indicate distress, the interviewer will ask the participant if she/he needs to speak to a mental 
health professional; local contact information of such professionals will be available to all 
interviewers and will be utilized if necessary.  
 
Under any adverse circumstance, interviewers will notify Dr. Farmer or Dr. Bean-Mayberry of 
any actions taken in response to the indication of distress (specifically, Dr. Farmer for VA 
employees and Dr. Bean-Mayberry for VA patients), and regarding any unanticipated serious 
adverse events. In addition, the IRB will be notified according to guidelines if there is an adverse 
event. 
Response procedures for adverse events 
Discomfort with disclosure. Staff who collect survey and interview data will be trained on how to 
respond to embarrassment or discomfort in an appropriate and compassionate manner. 
Subjects will be encouraged to contact the study PI Co-PI, or other research staff in the event of 
a potential adverse reaction that occurs as a consequence of their participation in the interview. 
They will receive specific written (in the form of a study description and PI/Co-PI's contact 
information) and verbal instructions during the study consent procedures about how to do so, if 
needed.  
Mandatory reporting. One adversity a subject may encounter is the possibility that staff must 
report to authorities instances of physical abuse or neglect, or threat of physical harm among 
subjects to themselves or others. To anticipate these concerns, the study has established 
procedures and guidelines to respond to risk disclosures and crisis situations. Staff will be 
trained to recognize risks or crises that require immediate reporting response. We do not expect 
these events to be common in the CV toolkit study, but will inform all research staff on 
procedures to follow if any of these events arise. More commonly, we expect that discussion of 
some of the health issues (cardiovascular related) may possibly result in some emotional or 
psychological stress for a patient.  If that does occur, the RA or interviewer will stop the 
research process, check on the patient, and inform the patient that she will call the PI or 
designated local clinical staff contact for assistance. 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 28 of 36 
 
 
 
Each of the possible adverse events is described below, including background, criteria for 
emergency action, and non-emergency action.  
 1) Suicidal ideation or intention to harm self  
Research staff will not be probing for this information and it is not part of any of the research 
tasks.  However, if a subject spontaneously reports thoughts of self -harm, research staff will 
follow the procedures below:  
a. Emergency: in the rare instance that an individual is in imminent danger and needs 
emergency medical or mental health services, research staff will adhere to their medical 
center’s policies and procedures for managing and reporting such events including, if 
appropriate dialing 911 or the local police.   
b. Non-emergency: If a subject spontaneously reports that they are thinking of killing themselves 
or taking their life, for example:  
1. “I’m thinking about suicide/killing myself”  
2. “I feel like I want to kill myself”  
3. “I wish I were dead”  
4. “I wish my life were over”  
5. “I can’t go on” or “I feel I can’t go on”  
The research staff person will say, “You seem to be having a difficult time. If you think this is an 
emergency, we can call 911. If you think you need help with this problem, you can talk to your 
VA clinician or go to the VA emergency room.” The research staff person will call either the PI or 
their delegate within one hour of this incident. They will determine what further action is needed.  
2) Intent to harm others  
Research staff will not be probing for this information and it is not part of any of the research 
tasks. Sometimes threats may be voiced spontaneously. If this is a vague statement about 
intent to harm others and it is not an easily identifiable person, and does not communicate clear 
intent, capable means or immediate intent to do so, the research staff person will redirect the 
subject to the task at hand. However, if the subject makes a specific threat to a reasonably 
identifiable person, then the research staff person will remind the subject about the limits of 
confidentiality, and follow these procedures:  
a. Emergency: In the rare instance that an individual is in imminent danger and needs 
emergency medical or mental health services, the research staff will adhere to their medical 
center’s policies and procedures for managing and reporting such events including, if 
appropriate dialing 911 or the local police.  
b. Non-emergency: If a subject reports intent to commit harm to others that is a non-emergency 
in nature but that still communicates a reasonably identifiable person, clear intent, capable 
means or an immediate intent to do so, the research staff person will contact the PI within one 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 29 of 36 
 
 
 
hour and will complete an incident report the same day. In addition, the research staff person 
will talk to the subject to express concern and encourage him/her to tell someone. They will 
determine what further action is needed.  
3) Child or dependent abuse/neglect  
Research staff will not be probing for this information and it is not part of any of the research 
tasks. However, if a subject discusses that a child, dependent or elder is being sexually, 
physically, or verbally abused or there is evidence of neglect (e.g., young child left alone for 
hours), then we will follow these procedures:  
a. Emergency: In the rare instance that a child or dependent is in imminent danger, the research 
staff will adhere to their medical center’s policies and procedures for managing and reporting 
such events including, if appropriate dialing 911 or the local police.  
b. Non-emergency: If there is a report or incident of child or elder abuse that is non-emergency 
in nature, the research staff person will consult with the PI or delegate by phone within one hour 
of the incident and will complete a written incident report the same day.  
Consulting with the VA Research Service, and VA legal representatives as needed, we will 
review what is known about each situation and will assess the legal and ethical characteristics 
of each situation. If it is determined that the study has a legal or ethical obligation to report the 
incident, we will do so.  Reporting procedures of the VA Research Service will be followed for 
each incident.  
7.0 Privacy and Confidentiality 
Assurance of Patient Safety 
The local site research staff will be in regular communication with the research team at the main 
site and are responsible for monitoring patient safety at the participating sites.  The Project 
Director will monitor research operations of the project and oversee patient safety.  All research 
staff will be experienced in working with women Veteran patients and will be closely supervised 
by the study local site PI.  Since a Data Safety Monitoring Board (DSMB) is required for multi-
site studies, we plan to utilize the central HSR&D DSMB for further oversight.  The DSMB 
provides an ongoing evaluation of the study’s progress including patient accrual and retention, 
monitoring of adverse events, and the adequacy and efficiency of the analysis plan to discern 
outcomes that might require study modifications, or result in early cessation of the study due its 
benefits or harms.  In terms of patient safety, the DSMB will evaluate all adverse and serious 
adverse events, by control and intervention site, including all hospitalizations and deaths.   
Data Security 
VA Research staff use VA computers to collect and analyze study data; either desktop or laptop 
computers with the VA image installed and managed by the local Information Resource 
Management department.  All laptops are encrypted with VA-approved FIPS 140-2 certified 
encryption software to ensure that if laptops are ever lost or stolen, no data could be 
removed.  Laptop computers are never removed from VA grounds without supervisory approval 
and a VA Property Pass approved by the VA research service.  Thumb drives are never used as 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 30 of 36 
 
 
 
long-term storage of data with identifiers.  If a thumb drive is needed to transfer data from one 
computer to another, only a VA-approved thumb drive with the proper encryption software would 
be used after obtaining authorization from the local ISO. 
VA staff practice regular and secure data backup procedures.  Computer users “lock” their 
workstations when not actively in use, and office doors are closed and locked when staff 
members are not present.  Hard copies of sensitive data are stored separately from identifiers in 
locked filing cabinet in a locked office.  All research and QI project staff have access to a secure 
VA server managed by the HSR&D CSHIIP.  This server is behind the VA firewall and provides 
individual storage space for each project, and for each member of the study teams.  This server 
is backed up incrementally on a daily basis with full backup occurring monthly.  Backups go to a 
tape library and the tapes are rotated on a quarterly basis and stored in the safe located in the 
ISO’s office at the Sepulveda campus.  
This server also provides a means to transfer data between local and non-local research 
staff.  Project folders can be created where any approved individual on the VA intranet can gain 
access through their approved VA login to a project server folder.  This allows secure data 
transfers over short and long distances with the smallest risk of accidental data disclosure.  Only 
staff that are listed on delegated authorities for the project through the CIRB, are credentialed 
by Research, have completed all required data security training, and are approved by the 
CSHIIP will be given access to the research project folders on the research server.  Staff may 
only access this folder by using their VA login on a VA computer behind the VA firewall. Access 
to these files is immediately revoked for staff members who leave the project.  
All data will be stored on at VA sites behind a VA firewall, and will be shared only among the 
Principal Investigators, study staff, and transcriptions.  
Data Collection Procedures 
A series of identification (ID) numbers will be generated for all patient and staff subjects and 
participants.  Data from all subjects will be collected in a private office at each site by a trained 
member of the project team. A 4 digit study ID code will be generated for each participant and 
project staff will maintain a link file that contains the following for each participant: : (a) for 
patients: ID number, subject name, last four of the social security number, gender and date of 
birth (b) for staff: ID code, gender, name, site, and wave number. This is how the 4 digit study ID 
codes will be generated for each staff participant: 1st digit=wave #, 2nd digit=site #, Last 2 
digits= random # for unique respondent code.  This link file will be stored on a secure VA server 
behind the VA firewall. Patient survey responses will be coded with the study ID and recorded 
directly into a survey program running on a VA computer and stored in a project-specific folder 
on the CSHIIP secure server.  All information linking subject identifiers to their data will be 
destroyed in accordance with the VA Records Control Schedule and guidance from the Central 
IRB.   
All staff subjects and a subset of patient subjects will complete a semi-structured interview with 
a research staff member. With the participants’ permission, the interviews will be recorded on 
VA-approved devices and uploaded to the project-specific folders. Data on patient subjects 
extracted from VA data systems, will also be stored in project folders. Paper data collected in 
this project will be limited.  Staff subjects will be emailed a survey prior to their baseline 
interview and this data will be collected at the time of the pre-implementation interview. This 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 31 of 36 
 
 
 
data will be coded with a study ID. These surveys will be keypunched and verified, and securely 
stored in a locked cabinet in a locked office at the local HSR&D site.   
The paper surveys will be stored in a locked file cabinet within a secured room at the local site.  
A limited number of authorized project staff will have access to these forms.  The study master 
list has the subject ID number, SSN, full name and contact information. This master list is only 
accessible to the PI, Co-PI, and limited project staff.  The master list is stored on a VA computer 
on a VA server behind the VA firewall. 
The HIPAA forms collected from the participants who complete their surveys in person will be 
stored in a locked file cabinet within a secured room at the local site. A limited number of 
authorized project staff will have access to these forms. 
-Paper surveys collected from participants will have only the subject’s ID number and no 
identifying information.  No data will be collected outside the VA.  Paper data containing PHI is 
never left out on unattended desks. 
Data Transportation Procedures  
If paper data and audio recording devices need to be transported between sites they will be 
securely carried in VA locked bags. Once on site, they will be secured in a locked file cabinet in 
a secure room.  
Data Transmission Procedures 
The qualitative interviews will generate digital voice files, which are considered identifiable. To 
minimize risk, during recorded interviews subjects will only be identif ied using their project ID 
number, and subjects are instructed not to state any names or other identifying information in 
their interviews.  These audio files will be uploaded from recorders to the secure server  (See 
section 5.6 Data Analysis for more details) and then transmitted to Alpha Transcription or some 
other reputable transcription service using secure FTP where it will be temporarily securely 
stored according to conditions set out an approved Data Use Agreement.  We have used Alpha 
Transcription in several previous studies, with great success.  The transcription company will be 
informed not to transcribe any identifying information accidentally disclosed in interviews. Any 
identifying information found in voice files from the qualitative interviews is accidental and rare; 
no identifying information will be found in transcripts. The study team downloads the 
transcription files to the project-specific folders on the VA server behind the VA firewall. Once 
they have been downloaded and verified, the transcription company destroys the copies on their 
own server.  
Access, Storage and Handling of Secondary Data  
In addition to surveys and interviews, other outcome data will be extracted from national VA 
data systems, and patient medical record charts.  There are two specific types of data pulls: (1) 
data abstraction containing information on the women in VA primary care teams by their 
designated women’s health providers at each site (aggregate) and (2) data to link with 
respondents who consent to have their responses on the survey/ interview linked to their 
medical files.  Data from VA electronic data systems will initially include patients’ social security 
numbers (SSN) along with any other identifiers, since these are used to assure that the data 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 32 of 36 
 
 
 
matches the project participants.  We will merge the extracted data with our existing research 
data. Once the data have been checked to ensure the merge has been successful, within the 
shortest possible time period, the SSNs will be removed from the analytic data file and stored in 
a link file kept in a separate, high security folder on secure VA server.   For the data pull 
involving patients who consented to surveys and/or interviews, each subject will already have 
been assigned a project ID number that does not contain any identifiers. The subject’s ID 
number will replace the SSN in the files. 
All information linking subject identifiers to their data will be destroyed in accordance with the 
VA Records Control Schedule and guidance from the CIRB. 
VA records data will be obtained from CPRS, DSS or CDW.  In order to obtain data, the project 
team will work with a list of SSNs of patients consented and enrolled in the study. Project or VA-
certified database analysts will be given this list of SSNs and will then run a query to extract the 
needed data, either working in the VINCI platform or downloading the data to a temporary folder 
on the CSHIIP secure server.  Extracted data will be placed into our secure folder on the local 
CSHIIP server and coded for analysis. This data will always remain behind the VA firewall.  
Research staff will be thoroughly trained on the online survey system before enrollment begins 
to ensure they can accurately gather information from charts.  Each subject will already have 
been assigned a project ID number that does not contain any identifiers. The subject’s ID 
number will replace the SSN in the files. 
All the above data are stored and backed up on a secure VA server.  Computer users “lock” 
their workstations when not actively in use and office doors are locked when staff members are 
not present.  Hard copies of sensitive data are stored in a separate locked filing cabinet in a 
locked office.   
Special consideration and precautions will be taken with regard to sharing information provided 
by individual employees with supervisors and co-workers.  While general information derived 
from employee interviews related to relevant clinical practices, resources, quality improvement 
activities, and barriers/facilitators will be shared with other site participants in aggregate or 
synthesized form, detailed information that would allow identification of individual employee 
responses will not be shared with supervisors of the employees or their co-workers.   
8.0 Communication Plan 
 
This study will be led by Dr. Bean-Mayberry (PI), who will be responsible for the 
implementation of the CV Toolkit and Dr. Farmer (Co-PI), who will be responsible for the 
evaluation of this project’s implementation. Key operation partners include, from WHS, Drs. 
Patricia Hayes (Co-Chair, Strategic Advisory Group [SAG]) and Sally Haskell (Co-PI on QUERI 
QI Project); and from NCP, Ms. Hurley and Drs. Dundon, Kinsinger, and Kim (LoS, SAG). 
Local support stems from GLA WH Medical Director, Dr. Batuman, and WVPM, Ms. 
Andreassen (LoS, SAG), as well as our ACOS Clinical Redesign and Transformation expert, 
Dr. Lisa Altman.  Drs. Hayes, Haskell, Dundon, Kim, Batuman and Ms. Hurley and Andreassen 
will provide their expertise to help with success of this project and will not have access to 
identifiable data. Key input will be culled from our Biostatistician, Dr. Lee and Co-Investigators, 
Drs. Alison Hamilton (EMPOWER QUERI Director), Lisa Altman, Erin Finley, and Dr. Ramin 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 33 of 36 
 
 
 
Ebrahimi (LoS, SAG member, Cardiologist), Director of the GLA Cardiac Cath Lab, who will 
help guide the educational training for providers and tailoring the CPRS template locally. Dr. 
Farmer (Project Co-PI), a nonrandomized stepped wedge expert, will supervise Drs. Jessica 
Zuchowski, Alexis Huynh and key team members for the implementation evaluation. Mrs. Saifu 
will serve as Project Director.  
The project headquarters will be at the VISN 22 HSR&D CSHIIP offices in Los Angeles. The 
core team for the CV Toolkit (Drs. Bean-Mayberry, Farmer, Hamilton, Chanfreau, Schweizer, 
and Mrs. Saifu) will meet weekly to ensure progress and discuss updates for the project. 
Dr. Bean-Mayberry will be responsible for informing local sites of protocol changes, reporting 
compliance issues related to CIRB and VA research service requirements, for reporting 
progress of research at least annually, and for reporting any injuries or other unanticipated 
problems involving participants or others.   
Local Site leads are responsible for obtaining local approvals, complying with local policies, 
including notifying local facility directors of research engagement.   
Each local site lead will ensure that the study is being conducted according to the IRB-approved 
protocol.  Issues will be discussed with the Corresponding PI. Site leads will be responsible for 
tracking local events, complying with local reporting requirements, and reporting all events to 
the Coordinating PI.   
On a weekly to biweekly basis, Dr. Bean-Mayberry will meet with Local Site leads.  On a 
monthly basis, calls will be held with all leads to ensure cross-level synergies and consistency in 
qualitative approaches to data collection and analysis.  Enrollment, data collection, and 
administrative issues will also be discussed.  Issues may include IRB, protocol changes, 
informed consent, and HIPAA.   
Any events that may impact the conduct of the study or the safety of participants will be reported 
by local staff to the Coordinating PI within 1 business day.  This includes any SAEs, 
Unanticipated Problems, concerns about protocol deviations, and any interim results that may 
impact the conduct of the study. 
Although we do not anticipate any SAEs/UAPs if any safety issues (SAEs or UAPs) arise, they 
will be reported to the Coordinating PI within 1 business day.  The PI will follow CIRB reporting 
guidelines and collect relevant information.  Data collection occurs at one point in time; 
therefore, it is unlikely we will become aware of any SAEs.  If we become aware of any SAEs, 
we will collect the information by phone. Issues or interim results that may impact the conduct of 
the study will be reported by the Coordinating PI to Local Site PIs on weekly calls. 
Sites will be informed when the study is over and they are no longer engaged in research. The 
coordinating PI will report to CIRB.  Local Site PIs are responsible for reporting to local 
authorities.   
We will convene strategic planning calls with the Executive Committee (composed of the PIs, 
the Program Manager, the Leads, and the Engagement Project Leads) to internally review 
progress and coordinate efforts at least quarterly. 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 34 of 36 
 
 
 
9.0 References 
 
1) Mosca L, Benjamin EJ, Berra K, et al. Effectiveness-based guidelines for the prevention of 
cardiovascular disease in women--2011 update: a guideline from the American Heart 
Association. J Am Coll Cardiol. 2011;57(12):1404-1423. 
2) Goff DC, Jr., Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of 
cardiovascular risk: a report of the American College of Cardiology/American Heart Association 
Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2935-2959. 
3) Jarvie JL, Foody JM. Recognizing and improving health care disparities in the prevention of 
cardiovascular disease in women. Curr Cardiol Rep. 2010;12(6):488-496. 
4) Melloni C, Berger JS, Wang TY, et al. Representation of women in randomized clinical trials of 
cardiovascular disease prevention. Circ Cardiovasc Qual Outcomes. 2010;3(2):135-142. 
5) Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of 
blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the 
American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J 
Am Coll Cardiol. 2014;63(25 Pt B):2889-2934. 
6) Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of 
overweight and obesity in adults: a report of the American College of Cardiology/American 
Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 
2014;129(25 Suppl 2):S102-138. 
7) Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle management to reduce 
cardiovascular risk: a report of the American College of Cardiology/American Heart Association 
Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2960-2984. 
8) Lardizabal JA, Deedwania PC. Benefits of statin therapy and compliance in high risk 
cardiovascular patients. Vasc Health Risk Manag. 2010;6:843-853. 
9) Chou AF, Wong L, Weisman CS, et al. Gender disparities in cardiovascular disease care among 
commercial and medicare managed care plans. Womens Health Issues. 2007;17(3):139-149. 
10) Bean-Mayberry B, Yano EM, Mor MK, Bayliss NK, Xu X, Fine MJ. Does sex influence immunization 
status for influenza and pneumonia in older veterans? J Am Geriatr Soc. 2009;57(8):1427-1432. 
11) Vimalananda VG, Miller DR, Hofer TP, Holleman RG, Klamerus ML, Kerr EA. Accounting for 
clinical action reduces estimates of gender disparities in lipid management for diabetic veterans. 
J Gen Intern Med. 2013;28 Suppl 2:S529-535. 
12) Tseng CL, Sambamoorthi U, Rajan M, et al. Are there gender differences in diabetes care among 
elderly Medicare enrolled veterans? J Gen Intern Med. 2006;21 Suppl 3:S47-53. 
13) Jha AK, Perlin JB, Steinman MA, Peabody JW, Ayanian JZ. Quality of ambulatory care for women 
and men in the Veterans Affairs Health Care System. J Gen Intern Med. 2005;20(8):762-765. 
14) LaMarca BD, Gilbert J, Granger JP. Recent progress toward the understanding of the 
pathophysiology of hypertension during preeclampsia. Hypertension. 2008;51(4):982-988. 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 35 of 36 
 
 
 
15) Farmer MM, Rose DE, Riopelle D, Lanto AB, Yano EM. Gender differences in smoking and 
smoking cessation treatment: an examination of the organizational features related to care. 
Womens Health Issues. 2011;21(4 Suppl):S182-189. 
16) Cabana MD, Kim C. Physician adherence to preventive cardiology guidelines for women. 
Womens Health Issues. 2003;13(4):142-149. 
17) Crosson JC, Heisler M, Subramanian U, et al. Physicians' perceptions of barriers to cardiovascular 
disease risk factor control among patients with diabetes: results from the translating research 
into action for diabetes (TRIAD) study. J Am Board Fam Med. 2010;23(2):171-178. 
18) Kedward J, Dakin L. A qualitative study of barriers to the use of statins and the implementation 
of coronary heart disease prevention in primary care. Br J Gen Pract. 2003;53(494):684-689. 
19) Tsui JI, Dodson K, Jacobson TA. Cardiovascular disease prevention counseling in residency: 
resident and attending physician attitudes and practices. J Natl Med Assoc. 2004;96(8):1080-
1083, 1088-1091. 
20) Walsh JM, Sundaram V, McDonald K, Owens DK, Goldstein MK. Implementing effective 
hypertension quality improvement strategies: barriers and potential solutions. J Clin Hypertens 
(Greenwich). 2008;10(4):311-316. 
21) Kenealy T, Arroll B, Petrie KJ. Patients and computers as reminders to screen for diabetes in 
family practice. Randomized-controlled trial. J Gen Intern Med. 2005;20(10):916-921. 
22) McMenamin SB, Bellows NM, Halpin HA, Rittenhouse DR, Casalino LP, Shortell SM. Adoption of 
policies to treat tobacco dependence in U.S. medical groups. Am J Prev Med. 2010;39(5):449-
456. 
23) Shea S, DuMouchel W, Bahamonde L. A meta-analysis of 16 randomized controlled trials to 
evaluate computer-based clinical reminder systems for preventive care in the ambulatory 
setting. J Am Med Inform Assoc. 1996;3(6):399-409. 
24) Shojania KG, Jennings A, Mayhew A, Ramsay C, Eccles M, Grimshaw J. Effect of point-of-care 
computer reminders on physician behaviour: a systematic review. CMAJ. 2010;182(5):E216-225. 
25) Spears GV, Roth CP, Miake-Lye IM, Saliba D, Shekelle PG, Ganz DA. Redesign of an electronic 
clinical reminder to prevent falls in older adults. Med Care. 2013;51(3 Suppl 1):S37-43. 
26) Czarnogorski M, Halloran Cns J, Pedati C, et al. Expanded HIV testing in the US Department of 
Veterans Affairs, 2009-2011. Am J Public Health. 2013;103(12):e40-45. 
27) Sharp A, Nguyen H, Hahn E, et al. The Just Do It Playbook for Implementation Science. HMO 
Research Network Conference; April 1-3, 2014, 2014; Phoenix, Arizona. 
28) Kilbourne AM, Neumann MS, Pincus HA, Bauer MS, Stall R. Implementing evidence-based 
interventions in health care: application of the replicating effective programs framework. 
Implement Sci. 2007;2:42. 
29) Kilbourne AM, Abraham KM, Goodrich DE, et al. Cluster randomized adaptive implementation 
trial comparing a standard versus enhanced implementation intervention to improve uptake of 
an effective re-engagement program for patients with serious mental illness. Implement Sci. 
2013;8:136. 

 
 
 
 
CV Protocol Component A and B combined –Tracked version - 05/18/2017 
Page 36 of 36 
 
 
 
30) Kilbourne AM, Almirall D, Goodrich DE, et al. Enhancing outreach for persons with serious 
mental illness: 12-month results from a cluster randomized trial of an adaptive implementation 
strategy. Implement Sci. 2014;9:163. 
31) Leykum LK, Pugh JA, Lanham HJ, Harmon J, McDaniel RR, Jr. Implementation research design: 
integrating participatory action research into randomized controlled trials. Implement Sci. 
2009;4:69. 
32) Jordon M, Lanham HJ, Anderson RA, McDaniel RR, Jr. Implications of complex adaptive systems 
theory for interpreting research about health care organizations. J Eval Clin Pract. 
2010;16(1):228-231. 
33) Yano EM, Haskell S, Hayes P. Delivery of gender-sensitive comprehensive primary care to 
women veterans: implications for VA Patient Aligned Care Teams. J Gen Intern Med. 2014;29 
Suppl 2:S703-707. 
34) McDaniel RR, Jr., Lanham HJ, Anderson RA. Implications of complex adaptive systems theory for 
the design of research on health care organizations. Health Care Manage Rev. 2009;34(2):191-
199. 
35) deKleijn M, Lagro-Janssen AL, Canelo I, Yano EM. Creating a roadmap for delivering gender-
sensitive comprehensive care for women Veterans: results of a national expert panel. Med Care. 
2015;53(4 Suppl 1):S156-164. 
36) Simpson KM, Porter K, McConnell ES, et al. Tool for evaluating research implementation 
challenges: a sense-making protocol for addressing implementation challenges in complex 
research settings. Implement Sci. 2013;8:2. 
37) Patient-Centered Outcomes Research Institute. PCORI Engagement Rubric. Accessed May 9, 
2015. 
38) Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res 
Methodol. 2006;6:54. 
39) Rowe A, Hogarth A. Use of complex adaptive systems metaphor to achieve professional and 
organizational change. J Adv Nurs. 2005;51(4):396-405. 
40) Daumit GL, Dickerson FB, Wang NY, et al. A behavioral weight-loss intervention in persons with 
serious mental illness. New England Journal of Medicine. 2013;368(17):1594-1602. 
41) Averill JB. Matrix analysis as a complementary analytic strategy in qualitative inquiry. Qual 
Health Res. 2002;12(6):855-866. 
42) Hamilton A. Qualitative methods in rapid turn-around health services research. Spotlight on 
Women’s Health. VA HSR&D National Cyberseminar Series December 11, 2013 2013. 
43) Glaser BG, Strauss AL. The Discovery of Grounded Theory: Strategies for Qualitative Research. 
Chicago: Aldine Publishing Company; 1967. 
44) Norton WE, McCannon CJ, Schall MW, Mittman BS. A stakeholder-driven agenda for advancing 
the science and practice of scale-up and spread in health. Implement Sci. 2012;7:118.