Improving Primary Care Understanding of Resources and Screening for Urinary Incontinence to Enhance Treatment
Conditions: Urinary Incontinence
Sponsor: University of Alabama at Birmingham

Page 1 of 29 
 
 
 
 
 
 
 
 
 
Improving Primary Care Understanding of Resources 
and Screening for Urinary Incontinence to Enhance 
Treatment (PURSUIT)  
 
Funding Agency: Agency for Healthcare Research and Quality (AHRQ) 
Birmingham VA Site Principal Investigator/Study Chair: Lisa Zubkoff, PhD 
Overall Principal Investigator: Alayne Markland, DO, MSc 
 
 March 7, 2024 
 
 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 2 of 29 
 
Abstract 
The Department of Veterans Affairs Integrated Service Network (VISN-7) is our targeted region 
for this proposal, named “Improving Primary Care Understanding of Resources and Screening 
for Urinary Incontinence to Enhance Treatment (PURSUIT)” as part of the Managing Urinary 
Incontinence (MUI) initiative. Our overarching goal is to improve access to evidence-based 
nonsurgical UI treatment for women Veterans using the most effective remote delivery modality 
in the Southeast region of the U.S.  In our first Aim, we will compare two models at the practice 
level: (1) the use of a practice facilitation toolkit with our mHealth UI modality alone and (2) the 
practice facilitation toolkit with our mHealth UI model combined with education on clinical care 
consultation pathways. We will employ a Type 1 Hybrid Effectiveness-Implementation design to 
assess the effectiveness of our mHealth intervention, while using the Reach, 
Efficacy/effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to 
guide our practice level implementation approach. In our second Aim, we will compare patient 
level outcomes related to enrollment in the mHealth UI application. For our third Aim, we seek to 
explore women Veterans’ and providers’ perceptions of key factors that may influence future 
remote UI treatment scalability for national dissemination across the VHA. PURSUIT aims to 
target 62 practices to participate in the trial implementation that treat over 50,000 women 
Veterans; practices will be randomized in clusters to receive the interactive mHealth UI 
application non-surgical UI treatment modality with or without additional clinical UI education on 
clinical pathways. All primary care practices will receive practice facilitation with a PURSUIT 
toolkit that includes (1) 1-3visits with a practice facilitator engaging practices through virtual 
group sessions and one on-site visit (if allowed). (2) Mobile-health or mHealth Application 
Training (MAT) training: MAT training will be offered through in-person academic detailing, 
online resources, and ongoing support via email or office hours with project staff and experts; 3) 
Online Resource Hub: The online resource hub will be available throughout project 
implementation, and e-learning modules will serve as the structural base for virtual practice 
facilitation sessions; and (4) Health information technology (HIT) assistance: Project staff will 
offer support in screening women Veterans for UI, recruitment of women Veterans to utilize our 
mHealth UI model, and to refer women Veterans for additional clinical video visits. Our future 
goal is to disseminate the most effective modality for delivering nonsurgical UI treatment for 
women Veterans nationally within the Veterans Healthcare Administration. 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 3 of 29 
 
List of Abbreviations 
AHRQ 
Agency for Healthcare Research and Quality 
CBOC 
Community-Based Outpatient Clinic 
COIN 
Center of Innovation for Veteran-Centered and Value-Driven Care 
GRECC 
Geriatric Research, Education, and Clinical Center 
HIT 
Health Information Technology 
ICIQ-UI SF 
International Consultation on Incontinence Questionnaire – Urinary 
Incontinence Short Form 
IDEAS 
Informatics, Decision-Enhancement and Analytic Sciences 
IRB 
Institutional Review Board 
MAT 
mHealth Application Training 
MHB 
MyHealtheBladder 
MHV 
MyHealtheVet 
MPI 
Multiple Principal Investigator 
MUI 
Managing Urinary Incontinence 
PFMT 
Pelvic Floor Muscle Training 
PSQ 
Patient Satisfaction Questionnaire 
PURSUIT 
Improving Primary Care Understanding of Resources and Screening for Urinary 
Incontinence to Enhance Treatment 
RE-AIM 
Reach, Efficacy/effectiveness, Adoption, Implementation, and Maintenance 
framework 
REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SUS 
System Usability Scale 
UAB 
University of Alabama at Birmingham 
UAE 
Unanticipated Adverse Event 
UI 
Urinary Incontinence 
VHA 
Veteran’s Health Administration 
VISN 
Veterans Affairs Integrated Service Network 
VVC 
VA Video Connect 
WH-PBRN 
Women’s Health Practice-Based Research Network 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 4 of 29 
 
Contents 
 
1.0 
Study Personnel .............................................................................................................. 5 
2.0 
Introduction ..................................................................................................................... 7 
3.0 
Objectives ....................................................................................................................... 8 
4.0 
Resources and Personnel ............................................................................................... 8 
5.0 
Study Procedures ...........................................................................................................12 
5.1 Study Design – Non-Research/Quality Improvement .......................................................12 
5.2 Recruitment Methods.......................................................................................................16 
5.3 Informed Consent Procedures .........................................................................................18 
5.4 Inclusion/Exclusion Criteria ..............................................................................................19 
5.5 Study Evaluations ............................................................................................................19 
5.6 Data Management ...........................................................................................................21 
5.7 Data Analysis ..................................................................................................................22 
5.8 Withdrawal of Subjects ....................................................................................................23 
6.0 
Reporting ........................................................................................................................24 
7.0 
Privacy and Confidentiality .............................................................................................25 
7.0 
Communication Plan ......................................................................................................26 
8.0 
References .....................................................................................................................28 
Appendix 1: Power Calculation .................................................................................................29 
 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 5 of 29 
 
Protocol Title:  Improving Primary Care Understanding of Resources 
and Screening for Urinary Incontinence to Enhance Treatment 
(PURSUIT) 
 
1.0 
Study Personnel 
 
Multiple Principal Investigators: 
 
Alayne Markland, DO, MSc 
 
Birmingham Site GRECC Director 
 
Birmingham VA Medical Center GRECC – 11G 
 
700 South 19th Street 
 
Birmingham, AL 35233 
 
(205) 933-8101 ext. 336145; Alayne.Markland@va.gov  
 
 
Camille P. Vaughan, MD, MS 
Atlanta Site GRECC Director 
Atlanta VA Medical Center GRECC 
1670 Clairmont Road 
Decatur, GA  30033-4004 
(404) 321-6111 ext. 203710; elizabeth.vaughan2@va.gov  
 
Lisa Zubkoff, PhD 
 
Birmingham VA Site PI 
 
Associate Director of Research 
 
Birmingham VA Medical Center GRECC – 11G 
 
Associate Professor – UAB Department of Preventive Medicine - MT 611 
 
700 South 19th Street 
 
Birmingham, AL 35233 
 
(205) 996-2827; Lisa.Zubkoff@va.gov  
 
Co-Investigators: 
 
Beverly Williams, PhD 
 
Associate Professor 
 
UAB Division of Gerontology, Geriatrics, and Palliative Care – CH19 218K 
 
1720 2nd Avenue South 
 
Birmingham, AL 35294 
 
(205) 934-1619; brwill@uab.edu  
 
 
T. Mark Beasley, PhD 
 
GRECC Investigator  
Birmingham VA Medical Center GRECC – 11G 
700 South 19th Street 
Birmingham, Alabama 35233 
(205) 975-4957; mbeasley@uab.edu  
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 6 of 29 
 
 
Ursula Kelly, PhD, CRNP 
 
GRECC Investigator 
Atlanta VA Medical Center GRECC 
1670 Clairmont Road 
Decatur, GA  30033-4004 
(404) 321-6111 ext. 2340; ursula.kelly@va.gov  
 
 
  
 
Collaborators/Operational Partners 
Andrea Cherrington, MD, MPH 
Professor 
 
UAB Department of Preventive Medicine - MT 612 
 
1720 2nd Avenue South 
 
Birmingham, AL 35294 
 
(205) 996-2885; cherrington@uab.edu 
Kanini Rodney, MD, MPH 
Physician, Women Health Lead, VISN-7 
Birmingham VA Health Care System 
700 South 19th Street 
Birmingham, Alabama 35233 
kanini.rodney@va.gov  
 
Zachary Burningham, PhD 
Research Health Scientist, VERITAS Group 
Informatics, Decision-Enhancement and Analytic Sciences (IDEAS) 2.0 COIN 
Salt Lake City VA Medical Center 
zachary.burningham@va.gov  
 
Katharina Echt, PhD 
Associate Director for Education and Evaluation 
Birmingham/Atlanta VA Medical Center GRECC 
1670 Clairmont Road 
Decatur, GA 30033 
Katharina.echt@va.gov  
 
Christie Lo, CRNP 
Nurse Practitioner 
Atlanta VA Medical Center GRECC 
1670 Clairmont Road 
Decatur, GA 30033 
(404) 321-6111 ext. 207155; christie.lo@va.gov 
 
 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 7 of 29 
 
2.0 
Introduction 
 
Improving primary care access to evidence-based approaches to 
treatment among women Veterans is an area of increasing focus within 
VA Health Administration (VHA).1 Increasing numbers of women Veterans 
are using the VA for their general and gender-specific health care, 
representing a doubling in the past decade with 7% of all Veterans seen in 
the VHA being women. The number of women Veterans aged 50 and 
older is increasing within the VHA.2 Women across the life-span and in 
this age range suffer from increased rates of urinary incontinence (UI).3 
Many women Veterans experience UI and may be at increased risk due to 
exposures during military service, such as restricted toilet access and the 
impact of heavy protective gear and equipment on the pelvic floor. These 
factors, along with known risk factors such as pregnancy, childbirth, and 
menopausal transitions increase UI risk among women Veterans. A recent 
study showed that 20 percent of women Veterans had UI.4,5 The 
association of UI with post-traumatic stress and mood disorders in women 
Veterans returning from active service is profound and UI rates increase 
among women Veterans with post-traumatic stress disorder (PTSD), 
anxiety, and lifetime sexual assault.4,5   
 
This proposed study focuses on improving access to standard of care UI 
treatments in primary care practiced in the VHA healthcare system for 
women Veterans with UI. Several evidence-based treatments are 
available for UI including behavioral, medical, and surgical therapies. 
Specifically, behavioral self-management treatments, including pelvic floor 
muscle training (PFMT), bladder control and voiding strategies, and fluid 
management, are widely recommended by consensus groups and 
guidelines as first-line treatment options because of their demonstrated 
effectiveness and low risk of side effects.6 Persons implementing 
behavioral therapy for UI report greater confidence in self-management 
when provided with input from a clinician (physician, advanced practice 
provider, rehabilitation specialist) with specific training in UI management.7 
To identify gaps in UI treatment modalities within VHA, our group 
surveyed gynecologists, urologists, and behavioral and physical therapy 
providers for nonsurgical UI treatments at large VA medical centers 
delivering specialty care. We found that only 55% of facilities reported 
offering PFMT, while 14% referred to another VA, and 44% referred to 
non-VA care. Sixteen percent of the large facilities had no way to provide 
PFMT. Our data demonstrate that women Veterans have limited access to 
clinicians who can provide these safe and effective treatments. We 
proposed this study to increase access to safe, routine, standard of care 
behavioral treatments for urinary incontinence among women Veterans.  
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 8 of 29 
 
3.0 
Objectives 
Our overarching objective is to improve access to evidence-based 
nonsurgical, behavioral UI treatment for women Veterans using an 
effective remote delivery modality in the Southeast region of the U.S.  
The Department of Veterans Affairs Integrated Service Network (VISN-7) 
is our targeted region for this proposal, named “Improving Primary Care 
Understanding of Resources and Screening for Urinary Incontinence to 
Enhance Treatment (PURSUIT)” as part of the Managing Urinary 
Incontinence (MUI) initiative. We will employ a Type 1 Hybrid 
Effectiveness-Implementation design to assess the effectiveness of our 
mHealth intervention, while using the Reach, Efficacy/effectiveness, 
Adoption, Implementation, and Maintenance (RE-AIM) framework to guide 
our practice level implementation approach. 
In this study, we will randomize clinics to one of two models: (1) our 
practice facilitation toolkit combined with education on existing consult 
pathways or (2) our practice facilitation toolkit alone.  
Aim 1: In our first objective (practice level – non-research Aim), we 
propose an implementation strategy of practice facilitation, to improve 
awareness and adherence to evidence-based guidelines on nonsurgical 
UI treatments at the practice level. Our primary practice level outcome is 
the number of women screened for UI over a 6-month period. Diagnosis 
rates of UI and other LUTS will be a proxy measure for screening from the 
practice facilitation data dashboard at the clinic level.  
Aim 2: For our second objective (patient level – quasi-research and 
clinical care Aim),. our primary patient level outcome is women who are 
screened for UI from the clinics who enroll in the mHealth application, 
MHB. Our secondary patient level outcome is women who enroll in MHB 
and have UI symptom improvement.   
Aim 3: For our third objective (patients and providers – research Aim), we 
seek to explore women Veterans’ and providers’ perceptions of key 
factors related to the RE-AIM framework that may influence future remote 
UI treatment scalability for national dissemination across the VHA.  
As part of the AHRQ’s MUI consortium, PURSUIT aims to target 62 
practices to participate in the trial implementation that treat over 50,000 
women Veterans; practices will be randomized in clusters to receive our 
practice facilitation toolkit along with the interactive mHealth UI application 
non-surgical UI treatment modality with or without additional education on 
existing clinical UI pathways.  
4.0 
Resources and Personnel 
• The PRIMARY research sites for PURSUIT will be the Birmingham and 
Atlanta VA GRECC sites.  

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 9 of 29 
 
Site Summary Roles 
Sites Collecting and Analyzing Identifiable Data: 
Birmingham 
 
Sites with access to VINCI research folder:  
Atlanta, Birmingham 
 
Additional Sites Receiving Research Dollars: 
The Salt Lake City VA will adapt a currently available clinical dashboard for 
PURSUIT (this protocol) using CDW data.  The dashboard developed for 
operational purposes.   
 
Determination that Randomized Sties are Not Engaged in Research 
In speaking with the Central IRB, the cIRB lead indicated that the sites 
randomized as part of PURSUIT are not engaged in research (see Central IRB 
project waiver).  The implementation of PURSUIT, which was developed for 
quality improvement purposes, by these sites is part of clinical quality 
improvement.  The sites engaged in research as described above are part of the 
evaluation/studying the process of PURSUIT implementation and the resulting 
impact on increasing incontinence care for women Veterans.  
 
• Our multiple Principal Investigator (MPI) team includes Alayne Markland, 
DO, MSc, is an Associate Professor at the University of Alabama at 
Birmingham (UAB)/Birmingham VA Health Care System and E. Camille 
Vaughan, MD, MS, is an Associate Professor at Emory University/Atlanta 
VA Health Care System. As MPI, Dr. Markland and Dr. Vaughan co-direct 
the Birmingham/Atlanta Geriatric Research Education and Clinical Center 
(GRECC) and have more than 15 years of experience developing and 
evaluating nonsurgical UI treatments for women and men with UI. The 
work proposed is a natural extension of their current HSR&D-funded 
clinical trial at the Birmingham, Atlanta, and Durham VA sites. Both 
investigators also conduct in-person and remote telehealth care through 
their VA Continence Clinics, oversee mid-level providers who also provide 
care through these modalities, and oversee clinical trials related to 
improving access to care for women Veterans. Other leaders on the 
project team include: (1) Lisa Zubkoff, PhD, who is an Associate 
Professor at UAB and serves as the Birmingham/Atlanta GRECC 
Associate Director for Research. She is an expert in dissemination and 
implementation science methodology. She will lead the Birmingham VA 
site. She has NIH and VA funding conducting clinical research using 
dissemination and implementation methods, as well as mixed-
methodology approaches.  (2) Andrea L. Cherrington, MD, MPH, is a 
Professor in the Division of Preventive Medicine (DOPM) at UAB. Her 
research focuses on the prevention and management of diabetes and 
hypertension with a focus on health equity and community practice-based 
intervention; she has over a decade of expertise in intervention 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 10 of 29 
 
development and evaluation and community-based participatory research. 
(3) For qualitative methodology expertise and analysis, Beverly Williams, 
PhD, is a medical sociologist and will provide support for Aim 3 to 
establish the interview guides, provide oversight in the coding analysis, 
and synthesis of the qualitative findings. (4) For biostatistical expertise, T. 
Mark Beasley, PhD, provided input into prior and current VA trials related 
to improving access to nonsurgical UI treatments for Veterans. He has 
expertise related to adaptive clinical trial designs and implementation. (5) 
In Atlanta, Ursula Kelly, RN, PhD will provide expertise related to her role 
as a clinician researcher and the co-director of Atlanta’s Women’s Health 
Practice-Based Research Network (WH-PBRN). (6) Also, in Atlanta,  
Katharina Echt, PhD, who has gerontology training will inform our 
qualitative approach and provide expertise related to the interview guides, 
interviews, and qualitative synthesis of our findings with Dr. Beverly 
Williams.  
• Along with the MPI with Drs. Markland and Vaughan, along with expertise 
in the co-investigator team, we also involve program management 
support, support with clinical research coordinators, and with Advance 
Practice Providers who have over 10 years of experience working with the 
team and providing non-surgical UI treatments. The overall governance 
structure includes a 2-site leadership structure that parallels to our current 
2-site leadership structure in the VA for the Birmingham/Atlanta GRECC. 
For this project, we will have weekly team calls with the project 
management team and bi-monthly calls with the project oversight team. 
Our participating operational partners include: (1) VISN-7 (regional) VHA 
Women’s Health Leadership, Kanini Rodney, MD, MPH, (2) National 
VHA Women’s Health Leadership through the Women’s Health Practice-
Based Research Network (WH-PBRN - Susan Frayne, MD and Diane 
Carney), and (3) the VA office of Connected Care within the Primary Care 
Service Line, and (4)  Tonic for Health© platform (Parent company: 
Scheduling.com), providing remote patient intake, patient education, and 
contactless check-in using mHealth platforms among large health 
systems. 
• For expertise in the creation and maintenance of a data dashboard, 
Zachary Burningham, PhD, joined our team and participates in 
PURSUIT team calls to provide input on the dashboard to focus the data 
provided on CBOC providers in the tri-state region (AL, GA, and SC). The 
dashboard is designed to provide primary care providers information about 
UI screening and care provided in VA settings of care to specific patients 
in their care panel. 
 
 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 11 of 29 
 
Study Personnel (role) 
PHI 
access 
Recruitment 
of CBOCs 
Practice 
Facilitation 
Toolkit 
Facilitator 
Collection of 
primary and 
secondary 
outcome 
measures 
Remote 
care 
provider 
Qualitative 
Interviews 
Data 
Analysis 
Markland, Alayne  
(Multi-PI) 
Yes 
Yes 
Yes 
No 
Yes 
No 
No 
Vaughan, Camille  
(Multi-PI) 
Yes 
Yes 
Yes 
No 
Yes 
No 
No 
Zubkoff, Lisa 
(Birmingham VA Site 
PI) 
No 
No 
No 
No 
No 
No 
Yes 
Beasley, Mark  
(Co-I) 
No 
No 
No 
No 
No 
No 
Yes 
Cherrington, Andrea 
(Collaborator) 
No 
No 
No 
No 
No 
No 
No 
Kelly, Ursula 
(Collaborator) 
No 
Yes 
Yes 
No 
No 
No 
No 
Lo, Christie 
(Operational Partner) 
Yes 
No 
Yes 
No 
Yes 
No 
No 
Woodbury, Terri 
(Operational Partner) 
Yes 
No 
Yes 
No 
Yes 
No 
No 
Rodney, Kanini 
(Operational Partner) 
No 
No 
Yes 
No 
No 
No 
No 
Echt, Katharina 
(Collaborator) 
No 
No 
No 
No 
No 
Yes 
No 
Burningham, Zachary 
(Collaborator) 
No 
No 
No 
No 
No 
No 
No 
Phillips, Janice 
(Program Director) 
Yes 
Yes 
Yes 
Yes 
No 
No 
No 
Howell, Hannah 
(Study Manager) 
Yes 
No 
No 
Yes 
No 
No 
No 
Yoo, Steven(Atlanta 
Research 
Coordinator) 
Yes 
Yes 
Yes 
Yes 
No 
No 
No 
Boers, Johanna 
(Atlanta Research 
Coordinator) 
Yes 
Yes 
Yes 
Yes 
No 
No 
No 
Sergent, Taressa 
(Atlanta Research 
Coordinator) 
Yes 
Yes 
Yes 
Yes 
No 
Yes 
No 
Davis, Kate 
(Research 
Coordinator) 
Yes 
No 
No 
Yes 
No 
No 
No 
Adams, Katelyn 
(Research 
Coordinator) 
Yes 
No 
No 
Yes 
No 
No 
No 
Reinicke, Kayla 
(Practice Facilitator) 
Yes 
No 
Yes 
No 
No 
No 
No 
Khakharia, Anjali 
(Data Analyst) 
Yes 
No 
No 
No 
No 
No 
Yes 
Klemensen, Terry 
(Data Analyst) 
Yes 
No 
No 
No 
No 
No 
Yes 
 
• VA Contractors for this Proposal: Tonic® (Parent company: 
Scheduling.com) is an independent contractor and a registered VA Vendor 
who translated our intervention onto a mobile platform. The Tonic® 
platform can be used with iPads, iPhones, and Android devices. The 
system allows us to provide secure links to the program that can be used 
with any browser on any smartphone or computer. Moreover, Tonic’s 
browser version dynamically resizes any survey or form, so that the 
patient experience is independent of screen size or type of device. This 
platform enables women Veterans to access the daily modules on a 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 12 of 29 
 
mobile device (of their choice) or on the internet. Access is granted with a 
secure link.  
• Additional VA Services for this Proposal: Annie© is a VA service 
developed by the Office of Connected Care to assist Veterans in playing 
an active role and focusing on their care through the VA. Annie allows 
Veterans to opt into their service to receive text message reminders to 
facilitate interaction with daily modules through Tonic ®.  
Qualtrics is a web-based platform available to VA researchers, through 
the Office of Research and Development, to build/send surveys or 
analyze/export survey responses. Qualtrics is approved to collect, 
process, and retain PII and PHI on 1) Veterans and dependents, 2) VA 
employees, and 3) Volunteers. 
MyHealtheVet is a VA service that is designed to allow Veterans to 
become an active partner with their health care team. MyHealtheVet will 
permit additional secure contact to inform individuals about UI treatment 
that is available to them.   
• Memoranda of Understandings (MOUs) or Data Use Agreements (DUAs) 
for this Proposal: No MOU or DUA exists with this protocol. Our current 
contract will be formalized for this protocol between the Department of 
Veterans Affairs (participating sites) and Tonic.  
5.0 
Study Procedures 
5.1 Study Design – Non-Research/Quality Improvement 
• For this proposal, our targeted region is the VA Integrated Service 
Network (VISN) - 7 and includes the states of Alabama, Georgia, and 
South Carolina. VISN 7 encompasses an area containing eight VA 
medical centers and numerous outpatient clinics, called community-
based outpatient clinics (CBOCs), throughout most of Alabama, 
Georgia and South Carolina. 
We will recruit 62 CBOCs (in clusters of 8, including 4 for Birmingham 
site and 4 for Atlanta site) with a goal to randomly assign 50 CBOCs 
over a 30-month period to receive our practice facilitation toolkit along 
with our standard of care mHealth UI (MyHealtheBladder) alone or our 
toolkit with mHealth UI program combined with clinical referral 
pathways for consultation.  
 
 
 
 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 13 of 29 
 
 
• Study Design: Standard of Care Interventions include the (1) practice 
facilitation toolkit, (2) access to the mHealth UI behavioral treatment 
program (MyHealtheBladder) with or without education on (3) 
continence care via consult pathways.  
Standard of Care Interventions: 
o Practice Facilitation Toolkit (4 components) – All CBOCs will receive 
the practice facilitation toolkit. The toolkit has 4 components: (1) 
Practice Facilitation Visits, (2) Mobile-health or mHealth Application 
Training (MAT) training, (3) Access and education on the Data 
Dashboard, and (4) Health information technology (HIT) assistance. 
Each practice will receive 1-3 practice facilitation visits conducted 
virtually or in-person. All visits will involve a practice facilitator 
engaging CBOCs through virtual group sessions and one on-site visit 
(if allowed). (2) MAT training will be offered through in-person 
academic detailing, online resources, and ongoing support via email or 
office hours with project staff and experts; remote consultation with a 
continence care specialist will be added through the non-surgical UI 
mHealth modality at pre-specified randomized practice sites; (3) Data 
Dashboard: The online resource hub/data dashboard will be available 
throughout project implementation, and e-learning modules will serve 
as the structural base for virtual practice facilitation sessions, covering 
topics such as interpreting data provided about women Veterans on 
the dashboard, developing skills for UI screening and treatment; and 
access to MyHealtheBladder; and (4) Health information technology 
(HIT) assistance from the Birmingham and Atlanta study teams, along 
with the Salt Lake City team. 
Practice/CBOC Level Enrollment and Implementation Timeline 
Practices for 
Clusters 
Year 1 
Year 2 
Year 3 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Practice 1-8 
  
  
○ 
● 
  
  
  
  
  
  
  
  
Practice 9-16 
  
  
  
○ 
● 
  
  
  
  
  
  
  
Practice 17-
24 
  
  
  
  
○ 
● 
  
  
  
  
  
  
Practice 25-
32 
  
  
  
  
  
○ 
● 
  
  
  
  
  
Practice 33-
40 
  
  
  
  
  
  
○ 
● 
  
  
  
  
Practice 41-
48 
  
  
  
  
  
  
  
○ 
● 
  
  
  
Practice 49-
54 
  
  
  
  
  
  
  
  
○ 
● 
  
  
○ Recruitment      ● 6-month close out 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 14 of 29 
 
o MyHealtheBladder – All CBOCs will receive access to the 
MyHealtheBladder self-treatment mHealth program for women 
Veterans that have urinary incontinence and desire treatment via this 
modality.  The study team in Birmingham and Atlanta will help facilitate 
access for the women Veterans once the CBOCs identify women with 
incontinence who desire treatment. As part of MyHealtheBladder, our 
study proposes that we use an embedded information sheet for women 
Veterans to “opt-in” for our study team to use their data in 
MyHealtheBladder for research purposes. Our study team uses a 
waiver of informed consent documentation for the individual women 
Veterans who are identified and use MyHealtheBladder to improve 
their urinary incontinence symptoms.  
o Continence Care via Clinical Care Consultative Pathways– half of the 
CBOCs will be randomized to also include consultative services via a 
consult pathway (existing or a newly created inter-facility consult or 
IFC), located in Birmingham or Atlanta, to deliver the same content as 
MyHealtheBladder and assist with routine standard of care 
incontinence treatments for women Veterans. As part of the practice 
facilitation toolkit (above), CBOCs randomized to have this additional 
component will be provided with education on clinical pathways for 
routine clinical care consultation via VA Video Connect telehealth visits 
with a continence provider.  
Process for Providing Tools to Sites that will Be Randomized.   
 
The section below describes the assistance that will be provided to sites who are 
implementing the PURSUIT intervention (with or without the clinical referral 
pathways component) as part of their quality improvement efforts.  While the 
processes outlined below will be provided by individuals who are on the research 
team, the process is part of the quality improvement implementation of 
PURSUIT. Names are mentioned as examples. Tasks described below may be 
done by members of the study team with appropriate credentials who are listed 
on staff study lists and have completed required research training. Additionally, 
the timelines outlined for the process of implementation support provided by the 
study team may need to be adjusted depending on the needs of the CBOCs.   
 
Stage 1 - Pre-Implementation Preparation (Approximately 1 Month):    
1) Identify and Coach Site Champion. It is critical that all sites have a clinical 
champion, typically a health care provider who is designated as the site 
Women’s Health Provider, who will lead the efforts to promote ongoing 
PURSUIT education and use of MyHealtheBladder. The site champion will 
liaison with the Birmingham-based and Atlanta-based implementation teams, 
negotiate time for clinical staff to participate in PURSUIT activities, and help 
to interface with the women Veterans for screening and interest in receiving 
treatment for urinary incontinence. The site champion will also review the data 
dashboard with local staff.  

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 15 of 29 
 
2) MAT Training and Data Dashboard Training: Each site champion will 
participate in conference calls or in-person visits at baseline, 3-mo, and 6-mo, 
with the implementation team to guide the implementation of PURSUIT 
practice facilitation components. Some sites may opt to implement a select 
number of practice facilitation toolkit components.   
3) Obtain Baseline Data: Using the data dashboard, our team will identify 
women Veterans seen at the CBOC level and identify women for targeted 
recruitment efforts by the baseline diagnosis of UI/LUTS rates.  All 
practices/site champion will complete data on a form, “About Your Practice,” 
 
Stage 2 – Launch Implementation Models:  
The Birmingham team, led by Dr. Markland, will finalize a training manual for site 
champions to screen for urinary incontinence and offer treatments for urinary 
incontinence, specifically in their local CBOCs. The education materials include 
didactic information on tools to screen for urinary incontinence, how to engage 
women Veterans to use MyHealtheBladder, education on available VA treatment 
for urinary incontinence, referral for urinary incontinence treatments with 
specialists, and other tools and training materials needed to train staff at the 
CBOC. All clinical decision support tools will be accessible in CPRS and out 
dedicated Sharepoint site. Baseline data will be available through an existing 
project folder within the VA’s VINCI framework on a secure VA server. Baseline 
data from Stage 1 will be shared with all site champions to incorporate in the 
initial provider education session.  Additionally, if a site is randomized to receive 
additional information on consultation pathways, the team will coach the site 
champion (and clinical partner for 1:1 feedback, if applicable) in the use of the 
education materials to train providers in the rationale for referral for additional 
treatments. Using a short 20-minute, PowerPoint presentation appropriate for in-
service training, a teleconference training session will be conducted to provide a 
structure. A certification checklist will be used to ensure all champions 
demonstrate competency. 
 
Stage 3 – Continue Provider Feedback and Measurement of 3-month and 6-
month Outcomes:  
1) CBOC women’s health providers will receive dashboard reports at baseline, 
3-mo, and 6-mo for the number of women Veterans seen in clinic, number of 
women Veterans screened for incontinence, number of referrals for 
MyHealtheBladder, and the number of referrals for consultative visits (if 
randomized to this group). 
2) Provider Feedback:  In addition to the electronic dashboard reports available 
for the practice facilitation intervention, the champion (or clinical partner) will 
provide 1:1 academic detailing that includes audit and feedback with other 
site providers who provide care for women Veterans.   
3) Qualitative Interviews: Site champions, providers (target recruitment for site 
champions/providers: 25-50total), and patients (target recruitment: 62-75 
patients) will be recruited to participate in one 30-minute structured interview 
on perceptions of key factors that may influence future remote UI treatment 
scalability for national dissemination across the VHA. 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 16 of 29 
 
4) The survey, About Your Practice, will be repeated at 6-months to monitor for 
CBOC level changes in staffing.  
• Minimization of Anticipated Risk: Designated site champions and other 
health care providers who see women Veterans at the CBOCs will 
complete surveys for clinical descriptives for Aim 1, called “About Your 
Practice.” Women Veterans who complete MyHealtheBladder will 
complete a demographics questionnaire and outcomes data 
questionnaires for Aim 2. The individual level data will be de-identified and 
will be analyzed in aggregate when possible.  Loss of privacy related to 
incontinence treatment is a potential risk of this proposed study. All efforts 
will be maintained to protect and use de-identified data related to the care 
of women Veterans. 
• Description of the study population  
o Site Champions – Dedicated women’s health providers at the VISN-7 
Medical Centers and CBOCs. 
o Health Care Providers – clinicians who provide care for women 
Veterans at the VISN-7 Medical Centers and CBOCs. May include 
physicians, advanced practice providers, nurses, social workers, and 
pharmacists. 
o Women Veterans – female Veterans who receive primary care visits at 
the VISN-7 Medical Centers and CBOCs. 
• Added protections for vulnerable populations – VA/CBOC Employees  
o Provider-level descriptive data and outcome data (CBOC employees) 
will be captured and stored using a VA REDCap survey.  
o Randomization stratification will be according to the number of women 
Veterans assigned to individual patient-aligned care team (PACT) 
where each PACT may have more than one provider. CBOCs are 
usually smaller clinics with less providers than the PACT teams that 
focus solely on providing women’s health and wellness. To balance 
these factors across randomization groups, we will use the following 
stratification schema: 
o Large size PACTs/CBOCs – defined as serving 500 or more 
women Veterans 
o Moderate size PACTs/CBOCs – defined as serving 100-499 
women Veterans 
o Small size PACTs/CBOCs – defined as serving 50 to <100 
women Veterans 
5.2 Recruitment Methods 
• Practice level - We plan to engage Medical Centers (WH PACTs and 
primary care PACTs) and CBOCs that serve at least 50 women Veterans 
with primary care services (practice sites = 62). These CBOCs will be 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 17 of 29 
 
recruited through connections with each locally identified women’s health 
providers and other health providers who provide care to women Veterans. 
We anticipate recruiting 62-100 providers across the 62 CBOCs with a goal 
to recruit at least 50 practices.  
Practice recruitment (Table above): In VISN-7, we will recruit primary care 
practices that serve at least 50 women Veterans. Recruitment will start in 
the third quarter of year 1.  A total of 8 practices will be recruited with each 
wave – 4 by the Birmingham site and 4 by the Atlanta site.  These 8 sites 
will be followed for 6 months with rolling recruitment, adding 8 additional 
sites per quarter to reach our goal of 50 total practices. For recruitment to 
begin, we will conduct an informational meeting (onsite or remotely) to 
further explain the study objectives and procedures with the designated 
women’s health practice consultant. Per VHA guidelines, all CBOCs have a 
designated women’s health practice consultant. Then, the practice 
facilitators will meet one on one with the site champion for each practice at 
the CBOC.  
• Patient level Screening and Enrollment in MyHealtheBladder– With 
permission from the providers who evaluate and treat women Veterans, we 
can send letters directly to women Veterans at each VISN-7 primary care 
clinics (Medical Centers/PACTs and CBOCs) and inform them about the 
ability to receive nonsurgical UI treatments with our mHealth application 
(Aim 2), MyHealtheBladder. We estimate that we can target 50,000 women 
Veterans at 50 CBOCs. From this catchment area, we estimate that 30% of 
the women (n=15,000) will have UI symptoms. From this number, we 
anticipate that 35% of the women Veterans will participate (n=2500) in 
screening and increase in UI/LUTS diagnosis rates. 
o The Corporate Data Warehouse (CDW) houses the majority of 
patient-level information within the VHA. Data are collected across a 
variety of relational databases and updated on a daily basis. The 
CDW databases will be used to obtain contact information of women 
Veterans, with primary care visits in a VISN-7, for recruitment 
efforts. Our team will submit a DART request for acquisition of this 
data. 
o Approximately 60-75 women Veterans who participated in Aim 2 
and agreed at that time to be contacted for a qualitative interview, 
will be invited to participate in a phone interview. 
• Recruitment Materials: Emails and telephone calls will be used to recruit 
providers at the CBOCs who evaluate and treat women Veterans.  
Presentations about the study will also be coordinated at the VISN level 
through the women’s health provider groups.  Letters will be mailed to 
women Veterans with permission from the CBOC providers for local 
recruitment. Emails will also be sent to women Veterans through 
MyHealtheVet (VA online patient portal). Additionally, with permission of 
the CBOC providers, we will provide an informational study flyer and 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 18 of 29 
 
brochure for display and/or distribution at the respective CBOC location. 
We will also send messages through the patient portal, MyHealtheVet. 
• Participant Payments: Women Veterans who enroll and start using 
MyHealtheBladder will receive $50 in compensation via a check or direct 
deposit through the current participant payment processes at the 
Birmingham and Atlanta VA research offices. A $25 payment will be 
provided at baseline completion and a $25 payment at 8-week completion.  
o Additionally, women Veterans who participate in a qualitative 
interview (Aim 3) will receive $20 in compensation via a check or 
direct deposit. 
5.3 Informed Consent Procedures 
• Aim 1: We are requesting a waiver of informed consent for providers who 
receive the practice facilitation components for this study.  The practice 
facilitation phase (Aim 1) is non-research.  
• Aim 2: We are requesting a waiver of HIPAA Authorization for screening and 
recruitment purposes of women Veterans who receive care at VISN-7 
CBOCs.  
We are requesting a waiver of documentation of informed consent for 
patients/women Veterans for this study.  We will embed an information sheet 
in MyHealtheBladder for women Veterans to “opt-in” to having their data used 
for additional data analysis.  As needed, we will obtain HIPAA Authorization, 
via the VA-approved DocuSign platform, from patients for study 
compensation purposes. 
• Aim 3: We will obtain written informed consent for the patient (ICF) and 
provider (ICF in development and to be submitted for IRB approval prior to 
implementation of Aim 3) qualitative interviews, via the VA-approved 
DocuSign platform. The research study coordinators will obtain informed 
consent prior to the qualitative interviews. No consent will be obtained from 
authorized representatives for this study. We will also request a waiver of 
HIPAA authorization for the patient and provider qualitative interviews. No 
PHI will be collected during these interviews and patient participants in this 
Aim will have already consented and participated in Aim 2.  
• All study personnel will be trained regarding human subjects protections 
requirements and how to obtain and document informed consent. 
 
 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 19 of 29 
 
5.4 Inclusion/Exclusion Criteria 
• Study eligibility criteria are in Table 3. We will recruit 
15,000 women Veterans who provide informed 
consent, aged 20 and older.  
• A diagnosis of UI, including all types of UI (stress UI, 
urgency UI, and mixed UI) is required for inclusion. 
Women who are currently pregnant will be excluded 
until they are at least 12-weeks post-partum. We will 
also exclude women Veterans who have no access 
to a telephone (will provide access to the internet and 
a tablet device when needed), or cannot speak 
English.  
5.5 Study Evaluations 
In summary, the study evaluation will begin by identifying baseline characteristics of the 
CBOC and the providers, as well as the patients, that may impact implementation.  This 
will be measured at Baseline by 1)an “About Your Practice” survey; 2) monitoring of the 
implementation process through meetings with a clinical champion at baseline, 3-
months, and 6-months to give feedback on women being screened and diagnosed with 
UI, as well as consults placed; 3) monitoring of implementation progress for the women 
who are screened and then enroll in MHB; and 4) qualitative interviews addressing 
implementation factors suggested by the 6 months following initial implementation of 
PURSUIT.  
 
Steps in the Evaluation Process for Clinic Level Data 
1. Collection of Baseline Characteristics that may impact implementation.  The 
sites will be asked to identify all individuals directly involved in the planning and 
execution of implementing PURSUIT (e.g., clinical champions, providers, and other 
staff). These sites will be asked to complete a baseline site information document, 
About Your Practice (1 survey report per site/medical center completed via the VA 
REDCap system) that will collect information on clinical team members, processes, 
and size and composition of the CBOC and impacted clinical services, as well as 
identify additional providers and staff potentially impacted by the implementation.    
2. Quarterly Monitoring of Process/Workflow of Implementation. At the start of the 
implementation, the research team will send written site-level questions to the Site 
Clinical Champions to fill out on behalf of their respective site’s core implementation 
team. The purpose is to establish baseline information on the process of 
implementing the PURSUIT practice facilitation intervention model (depending on the 
study arm).  Additionally, we will collect baseline information on the organization of 
women’s health services at each CBOC. Components of the workflow process will 
then be stored in a Microsoft Excel or Word spreadsheet to be sent to the sites for 
updates approximately every three months. We will pull data from Corporate Data 
Warehouse on the number women empaneled at the CBOC, as well as some basic 
demographics (age, race/ethnicity, and BMI). No individual patient level data will be 
collected at the CBOCs. 
Table 3: Inclusion and Exclusion Criteria 
Inclusion criteria: 
• 
Female 
• 
Veteran 
• 
20 years old or above 
• 
Diagnosis of UI (all types) 
• 
Access to internet via mobile 
device or computer  
Exclusion criteria: 
• 
Non-Veteran 
• 
Currently pregnant or less than 
12 weeks postpartum 
• 
Non-community dwelling 
• 
Non-English speaking 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 20 of 29 
 
3. Monitoring of Implementation – Implementation Progress.  We will also measure 
the degree of implementation and barriers and facilitators of implementation process 
through approximately every 3 months after baseline and 6-months with facility-level 
reports from the data dashboard (monitoring provider engagement, diagnosis rates, 
and consults placed).   
4. Evaluation of the Implementation Process – Qualitative Interviews.  At 
approximately 6 months following the start of the implementation process at each of 
the sites, we will conduct semi-structured qualitative telephone interviews with one 
member of the core implementation team at each site to assess factors suggestive of 
implementation success. The goal will be to interview the same individuals 
interviewed at Baseline. The questions composing the qualitative interview guide will 
depend upon the formative evaluation. As such, the guide will be developed after the 
initial implementation and approved by the IRB prior to use, see attached. 
 
Evaluation Process for Patient Level Data 
1. Self-Enrollment into MyHealtheBladder – This is the number women who 
complete the baseline data and enroll in the MHB program.  
2. UI Symptom Severity - We will evaluate effectiveness of our two models using 
questionnaires embedded within MyHealtheBladder. For UI severity, we 
embedded the validated International Consultation on Incontinence 
Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) for the patient-
centered primary outcome measure based on psychometric properties and 
use in other studies using similar interventions. 
3. Adherence - We also propose to study program adherence and have 
embedded questionnaires on adherence to our behavioral treatments, 
specifically pelvic floor muscle exercise adherence.  
4. Usability and Satisfaction - We embedded several questionnaires within the 
intervention, including usability with the System Usability Scale (SUS)70 and 
satisfaction with program (Patient Satisfaction Questionnaire and General 
Impression of Improvement, PGII Questionnaire).  
5. Other patient level covariates include demographic variables, such as age, 
education, marital status, and race/ethnicity, medical and mental health 
conditions, and medication usage. 
6. Qualitative Interviews – Approximately 1-4 weeks after completion of the MHB 
program sessions, some patient participants will be invited to participate in a 
semi-structured telephone interview with one member of the core 
implementation team at each site to assess factors related to program 
satisfaction and adherence. 
 
 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 21 of 29 
 
Data 
Collection 
Outcome 
Instrument 
(Collected from) 
Administration Timepoint 
Length of 
time 
 
Primary 
Outcome 
Diagnosis rates of 
UI/LUTS 
Data 
dashboard 
(Clinic/Provider) 
Change in diagnosis rate 
from Baseline and 6 
months post-Baseline 
N/A 
 
Other  
Outcomes 
Adoption rates of the 
provider toolkit 
Data 
dashboard 
(Clinic/Provider) 
Change in usage from 
Baseline and 6 months 
post-Baseline 
N/A 
Enrollment rates of 
women Veterans for 
MHB 
Qualtrics 
(Patient-Primary) 
3-and 6-months post-
Baseline 
N/A 
Site information & 
Workflow 
7-item “About 
Your Practice” 
survey 
(Provider) 
Baseline and 6-months 
post-Baseline 
15-30 minutes 
Demographics & 
Health History 
11-item form 
in Tonic (MHB)  
(Patient) 
Baseline 
5-7 minutes 
Symptom 
Improvement 
4-item 
ICIQ-UI SF in 
Tonic (MHB) 
(Patient) 
Baseline, 2-months post-
Baseline, 3-months post-
Baseline 
2-3 minutes 
Adherence 
2-item 
PFME 
adherence 
(Patient) 
7-, 21-, 35-, and 42-days 
post-Baseline, 2-months 
post-Baseline, and 3-
months post-Baseline 
1-2 minutes 
Usability 
10-item 
SUS 
(Patient) 
2-months post-Baseline 
4-5 minutes 
Treatment 
7-item 
Treatment 
Follow-up in 
Tonic (MHB) 
(Patient) 
3-months post-Baseline 
1-2 minutes 
Satisfaction and 
Perception of 
Improvement 
3-item 
PSQ, PGI-I, 
and EPI 
(Patient) 
2-months post-Baseline, 3-
months post-Baseline 
2-3 minutes 
PFM and Bladder 
Diary Assessment 
8-item (total) 
(Patient) 
Day 3 (6 items), 30 (1 item), 
and 54 (1 item) post-
Baseline 
2-3 minutes 
5.6 Data Management 
• REDCap: VA REDCap is a free, secure VA application approved for 
storage of PHI and PII. Provider- and patient-level data will be stored in 
REDCap for recruitment and status tracking, as well outcomes data 
management. 
Only approved study staff will have access to data stored in REDCap and 
user permissions can limit access between different sites’ data within 
multi-site studies.  
• VA Informatics and Computing Infrastructure (VINCI): The VA 
Informatics and Computing Infrastructure (VINCI) is a Department of 
Veterans Affairs (VA) Health Services Research & Development (HSR&D) 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 22 of 29 
 
resource center that provides a secure, central analytic platform for 
performing research and supporting clinical operations activities. It is a 
partnership between the VA Office of Information Technology (OI&T) and 
the Veterans Health Administration Office of Research and Development 
(VHA ORD). VINCI includes a cluster of servers for securely hosting suites 
of databases integrated from select national VA data sources. It will be 
used by our team for acquisition and access to CDW data. 
VA-credentialed research staffs are granted access to study-specific data 
along with tools for analysis and reporting in the secure, virtual working 
environment through a certified VHA network computer within the VA. 
Data Storage Locations 
o REDCap and VINCI (e.g., CDW) data is housed on VINCI servers 
located at the Austin Information Technology Center, 1615 Woodward 
St., Austin, TX 78772-0001.  
o VA Network Shared Drive: A collaborative VA network shared drive 
has been created for this multi-site study. Only VA-credentialed 
research staff will have access to this shared drive. Study data 
downloaded from the VINCI environment, Qualtrics, and Tonic 
(MyHealtheBladder) will be stored on this drive before uploading to 
REDCap. 
5.7 Data Analysis 
• For the provider-level outcome (primary outcome), we will measure the 
diagnosis rate of UI/LUTS at baseline, 3-mo, and 6-mo to evaluate the 
changes over time. This This measure will be collected through the team 
at the Salt Lake City VA using the CDW data on the data dashboard.   
• For the patient level outcomes (secondary outcome), we will evaluate 
screening and enrollment outcomes, as well as engagement with , 
MyHealtheBladder.  
o Enrollment rates in MyHealtheBladder will be defined from the 
women screen who complete the baseline data 
o For UI severity, we embedded the validated International 
Consultation on Incontinence Questionnaire – Urinary Incontinence 
Short Form (ICIQ-UI SF) for the patient-centered primary outcome 
measure based on psychometric properties and use in other 
studies using similar interventions.8,9,10,11 Specifically, we will use 
the minimally important clinical difference (ICIQ-UI Short Form, 
Range is 0-21 and MICD is 2.52 (SD 2.56)) to measure 
improvement in UI severity. 
Participant demographics, medication usage, and health history 
will be collected using instrument currently in use for the 
PRACTICAL study and be analyzed as covariates. 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 23 of 29 
 
o We will measure the patients’ adherence to the pelvic muscle 
exercise guidance provided through the MyHealtheBladder 
program using a 2-item instrument (secondary patient level 
outcome) 
o For system usability (secondary patient level outcome), we will use 
the 10-item System Usability Scale (SUS).12 Patient responses are 
on a 5-point Likert scale from “Strongly Disagree” to “Strongly 
Agree.” The SUS has a score range of 0 to 100. The general 
guideline for interpreting the SUS score is: ≥ 68 = “Above 
Average”; <68 = “Below Average.” = “Excellent.” 
o We will use the following questionnaires to measure patient 
satisfaction and global improvement. One question will inquire 
about patient satisfaction (Patient Satisfaction Question (PSQ)), 
one will address patient impression of improvement (Patient Global 
Impression of Improvement (PGI-I)13), and one will have the 
patients estimate their improvement on a scale from 0-100% 
(Patient Estimated Percent Improvement (EPI)). 
• Data will be analyzed using de-identified data from REDCap databases for 
provider and patient-level data sources. The study biostatistician will 
analyze the data on a VA server behind the VA firewall.  
• Randomization design is based on stratification as in section 5.1 
• Clustering is done for clinics by site per the table in section 5.1  
• Sample size considerations are based on a cluster analysis14 by the 
number of clinics. Our recruitment goal is to recruit and randomize 50 
clinics to each group (n=25 per group).  Assuming an unequal number of 
women Veterans (patients) in each group according to cluster, we would 
have 80% power (alpha level = 0.05 and an ICC of 0.05 for each group) to 
detect changes in diagnosis rates of UI/LUTS between randomization 
groups in our primary provider level outcome..  
• See Appendix 1 for power calculation table. 
• AHRQ has contracted the RAND organization to evaluate each grantee 
within the MUI consortium. Aggregate data will be sent to RAND for 
evaluation quarterly. No PHI/PII or identifying information will be shared 
outside of the program team. All aggregate data will be reviewed by the 
Privacy Officer prior to being sent outside of the VA to ensure data being 
shared does not pose any privacy concerns. A copy of the evaluation 
done by RAND will be returned to VA investigators. VA investigators will 
be allowed to review and approve prior to publication.  
5.8 Withdrawal of Subjects 
• CBOCs, providers, and patients can withdraw from study participation at 
any timepoint during the study progress.   

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 24 of 29 
 
• If a site, a provider, or a patient decides to stop participation (withdraw), 
no further data will be collected, and communication will cease from the 
study team. If patient desire additional treatments after withdrawal from 
MyHealtheBladder, this information will be communicated with the treating 
provider at the CBOC.  
 
6.0 
Reporting 
 
The Multi-PIs will make determinations on unanticipated adverse events. 
 
Serious Adverse Events (SAE) are: 
• A serious adverse event is defined to include any adverse experience 
that results in the following: 
o Death 
o Life Threatening 
o Hospitalization – initial or prolonging  
o Persistent or significant disability or incapacity 
o Medical event that may jeopardize the subject and require 
medical or surgical intervention to prevent permanent outcome 
 
Documentation 
 
Multi-PIs will make determinations if SAE is related, probably related, not 
related or unable to determine. Any local research death that is 
unanticipated and related to the research must be reported orally to IRB 
immediately. Within 5 business days of becoming aware of an event, the 
study team must provide a written report utilizing the SAE Reporting Form.  
 
All local adverse events (expected, unexpected, related or not related), 
serious adverse events, protocol deviations, and safety reports, are to be 
recorded by the investigator in their study documents at the time of the 
event, and summarized in a spreadsheet/table format to be turned in at 
the time of continuing review or study closure.  
 
Research coordinators will follow local VA site policies regarding 
documenting and submitted adverse event forms. Birmingham Lead Site 
should made aware and given IRB documentation for ALL UAE’s and 
SAE’s. 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 25 of 29 
 
7.0 
Privacy and Confidentiality 
 
Item 1.1: In this protocol, we outline the privacy requirements for the protection of 
the research subjects (women Veterans who agree to receive standard of care 
treatment for their urinary incontinence and providers who agree to have qualitative 
interviews). We also describe clinical care data and research data that we use in this 
protocol. Clinical care detail will be used for the practice facilitation approach (non-
research).  We are using research data collected through MyHealtheBladder for 
women Veterans and for the research data we collect with detailed qualitative 
interviews.  
Item 1.2: Our data usage with the mobile health application called MyHealtheBladder 
is described in our contract with the approved VA vendor, 
Tonic/Scheduling.com/R1RCM (non-VA entity). All data collected on this platform 
will be de-identified and used clinical care purposes within the VA and is VA data. 
The non-VA entity will not have access to this clinical data. The VA data will be 
saved in a protected database, REDCap, on the VA-approved server at all times. 
The qualitative interviews will be audio-recorded on a VA-approved device and 
transcribed by the VA-approved transcription services.  
Items 1.3, 1.4, and 1.5: For this protocol, we are waiving the HIPAA authorization for 
recruitment purposes and for the providers who will be educated on the ability to 
treat women Veterans with urinary incontinence as proposed in this protocol. We 
also requested a waiver of consent documentation and HIPAA authorization 
documentation to pay the women Veterans who elect to receive treatment with 
MyHealtheBladder. We will also obtain a written consent and waiver of HIPAA 
authorization for the women Veterans and the providers who agree to have a phone 
interview for the qualitative analysis.   No PHI/PII will be disclosed to a non-VA entity 
and a detailed contract will be approved for this protocol.  
Item 1.6: Women using the bladder mobile health app, MyHealtheBladder, will sign a 
HIPAA authorization for their data to be used for payment purposes (if required per 
IRB determination). We are requesting a waiver of written HIPAA authorization for 
Aim 3 (qualitative interviews) this protocol.  All other data obtained through 
MyHealtheBladder will be de-identified and analyzed in aggregate for clinical 
purposes and not for research purposes. This is consistent with VHA Directive 
1605.1, Appendix A.  
Item 1.7:  No biospecimens will be collected for this protocol. 
Item 2:  We requested a waiver of written consent for the providers that are receiving 
the practice facilitation model in this protocol (non-research).  For women Veterans 
who chose to complete treatment via MyHealtheBladder, we are requesting a waiver 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 26 of 29 
 
of documented consent and will obtain a signed, written research HIPAA 
authorization.  For the providers and women Veterans who agree to have recorded 
interviews, we will obtain a written research informed consent form but will request a 
waiver of HIPAA Authorization for this study activity; the interview guide does not 
include questions related to PHI/PII.   
Item 3:  We are submitting a request for waiver of HIPAA authorization to access 
PHI for recruitment purposes.  The request to obtain names and addresses of 
women Veterans seen at the participating CBOCs will be obtained for recruitment 
purpose.  Providers will agree to sign recruitment letters (see attached recruitment 
letter).  We are waiving HIPAA authorization for names/addresses since this PHI 
poses no more than minimal risk to the privacy of the research participants (all 
women Veterans will receive a letter). We would not be able to target women 
Veterans without this recruitment plan given that many women do not discuss 
urinary incontinence with providers but may want to seek available treatments. 
Likewise, many providers may not be familiar with available treatments for urinary 
incontinence and care may not be provided directly through routine clinical care. 
This research would not be able to be conducted without this waiver and access to 
PHI to send letters. We are only using names and addresses as PHI in this waiver of 
HIPAA request. With assistance from data analysts at the Atlanta VA, we will be able 
to access data for this request through the CDW.  
7.0 
Communication Plan 
The MPIs and Birmingham and Atlanta VAMC study staff will obtain local site 
approval from their respective site IRB. The CBOC facilities will not require IRB 
approval as their involvement is considered quality improvement and only the 
Birmingham and Atlanta study teams will be involved in research data collection 
and management. 
 
Birmingham and Atlanta Study Team Meetings: 
 
The Multi-PIs will conduct weekly meetings with the VA research team members. These 
team meetings will take place via Zoom. 
The conference call will include:    
• Announcements that affect all sites. 
 
• Each site will report on their recruitment activity from the last conference call and 
any issues that affect their site. 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 27 of 29 
 
• The Birmingham Project Manager will run a recruitment report of each site’s 
recruitment numbers prior to each team meeting.  
 
• Any changes to IRB documentation, informed consent, study intervention, data 
collection & management, and safety reporting will be discussed on the 
conference call. 
 
• All changes will be documented in a decision log on the study’s secure VA 
shared drive by the Birmingham Project Manager. The Birmingham and Atlanta 
study personnel have access to this folder. The Birmingham Project Manager will 
also share updated documents with other study collaborators and operational 
managers via email. 
CBOC Site Leadership and VA Research Team Meeting: 
• The Multi-PIs and Birmingham and Atlanta VA research team members will 
meet, in-person or via Microsoft Teams/Zoom, with the CBOC site leader (ex: 
Women’s health consultant) every 3 months and as requested during the initial 
6-month practice facilitation phase of the study at each respective CBOC site. 
 
Records Management 
 
The VA Federal records associated with this study will be maintained and dispositioned 
in accordance with Records Control Schedule 10-1 (RCS 10-1). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version: 3/7/2024  
IRB Protocol Template – version 8/11/2020 
Page 28 of 29 
 
8.0 
References 
 
1. 
Bean-Mayberry B, Yano EM, Washington DL, et al. Systematic review of women 
veterans' health: update on successes and gaps. Womens Health Issues 2011;21:S84-
97. 
2. 
Danan ER, Krebs EE, Ensrud K, et al. An Evidence Map of the Women Veterans' Health 
Research Literature (2008-2015). J Gen Intern Med 2017;32:1359-76. 
3. 
Wu JM, Vaughan CP, Goode PS, et al. Prevalence and trends of symptomatic pelvic 
floor disorders in U.S. women. Obstet Gynecol 2014;123:141-8. 
4. 
Bradley CS, Nygaard IE, Hillis SL, Torner JC, Sadler AG. Longitudinal associations 
between mental health conditions and overactive bladder in women veterans. Am J 
Obstet Gynecol 2017;217:430 e1- e8. 
5. 
Bradley CS, Nygaard IE, Mengeling MA, et al. Urinary incontinence, depression and 
posttraumatic stress disorder in women veterans. Am J Obstet Gynecol 2012;206:502 
e1-8. 
6. 
Gormley EA, Lightner DJ, Faraday M, Vasavada SP, American Urological A, Society of 
Urodynamics FPM. Diagnosis and treatment of overactive bladder (non-neurogenic) in 
adults: AUA/SUFU guideline amendment. J Urol 2015;193:1572-80. 
7. 
Burgio KL, Goode PS, Locher JL, et al. Behavioral training with and without biofeedback 
in the treatment of urge incontinence in older women: a randomized controlled trial. 
JAMA 2002;288:2293-9. 
8. 
Nystrom E, Sjostrom M, Stenlund H, Samuelsson E. ICIQ symptom and quality of life 
instruments measure clinically relevant improvements in women with stress urinary 
incontinence. Neurourol Urodyn 2015;34:747-51. 
9. 
Klovning A, Avery K, Sandvik H, Hunskaar S. Comparison of two questionnaires for 
assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence 
severity index. Neurourol Urodyn 2009;28:411-5. 
10. 
Sirls LT, Tennstedt S, Brubaker L, et al. The minimum important difference for the 
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short 
Form in women with stress urinary incontinence. Neurourol Urodyn 2015;34:183-7. 
11. 
Timmermans L, Falez F, Melot C, Wespes E. Validation of use of the International 
Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-
SF) for impairment rating: a transversal retrospective study of 120 patients. Neurourol 
Urodyn 2013;32:974-9. 
12.  
Brooke J. SUS: A quick and dirty usability scale. In: Jordan PW, Thomas B, 
Weerdmeester BA, McClelland AL, editors. Usability Evaluation in Industry. London: 
Taylor and Francis; 1996. pp. 189–194. [Google Scholar] 
13.       Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. 
Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379. PMID: 
12861145. 
14.       Batistatou, Roberts, & Roberts, (2014). Sample size and power calculations for trials and 
quasi-experimental studies with clustering. The Stata Journal, 14(1), 159-175. 
 
 

Page 29 of 29 
Appendix 1: Power Calculation 
 
 
 
 
 
alpha (α)
d
SDG
NG
N Units
MG
ρG
DG
SDC
NC
N Units
MC
ρC
DC
Dem1 Dem2 Dx
Z(α/2)
Power (1-β)
0.05
0.1889
1
3500
25
140
0.05
7.95
1
3500
25
140
0.05
7.95
0.002 0.002 2.80 -1.959964
0.800295
Equal
0.05
0.1889
1
3500
25
0.05
9.05164
1
3500
25
0.05
8.63901 0.003 0.002 2.7
-1.959964
0.757115
Unequal
0.05
0.1992
1
3500
25
0.05
9.05164
1
3500
25
0.05
8.63901 0.003 0.002 2.80 -1.959964
0.800086
Unequal
Group One
Group Two
alpha (α)
Significance Level
d
Mean Differerence
SDG
Standard Deviation for Group 1
NG
Sample Size for Group 1
N Units
Number of Clusters for Group 1
Mg
Average Cluster Size for Group 1
ρG
Intra-Class Correlation for Group 1
Dc
Design Effect for Group 1
SDC
Standard Deviation for Group 2
NC
Sample Size for Group 2
N Units
Number of Clusters for Group 2
Mc
Average Cluster Size for Group 2
ρC
Intra-Class Correlation for Group 2
Dc
Design Effect for Group 2
Legend

Approval date:
Version: 2/6/2024
RESEARCH INFORMATION SHEET
Version Date: 2/6/2024
Title of Study: Improving Primary Care Understanding of Resources and Screening for Urinary
Incontinence to Enhance Treatment (PURSUIT)
Principal Investigators: Lisa Zubkoff, PhD, and Alayne Markland, DO, MSc
VA Facilities: Birmingham and Atlanta
Sponsor: Agency for Healthcare Research and Quality (AHRQ)
KEY SUMMARY INFORMATION ABOUT THIS STUDY
You are being invited to take part in a research study that is being funded by the Agency for
Healthcare Research and Quality (AHRQ). Before you decide to take part, it is important for
you to know why the research is being done and what it will involve. This includes any potential
risks to you, as well as any potential benefits you might receive. Taking part in this study is
completely voluntary.
WHAT IS THE STUDY ABOUT AND WHY ARE WE DOING IT?
This study about improving access to non-surgical bladder leakage, or urinary incontinence
(UI), treatment for women Veterans.  It is being funded by Agency for Healthcare Research
and Quality (AHRQ).  By doing this study, we hope to learn the best way to deliver remote
non-surgical treatment to women Veterans with bladder symptoms.
WHAT DOES THE STUDY INVOLVE AND HOW LONG WILL IT LAST? 
Your participation in this research will last about 3 months. During this time, you will receive
standard of care from an online educational program called MyHealtheBladder. You will
review educational sessions on a weekly basis for 8 weeks and will be asked to complete a
follow-up survey 12-weeks after enrollment. Throughout the study, you will be asked to
answer questions online related to your health, bladder leakage, and track your behavioral
training. When you complete the intervention, you may be asked if you would like to
participate in an interview about your experience. You do not have to participate in the
interview, if you do not want to.
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
The most important reason to join this study is that your bladder leakage may improve.
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS
STUDY?
The most important reason not to join this study is if you are not willing to receive treatment for
bladder leakage via remote delivery.
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You
will not lose any services, benefits or rights you would normally have if you choose not to
volunteer.
WHAT POSSIBLE RISKS OR DISCOMFORTS MIGHT I HAVE IF I TAKE PART IN THIS
STUDY?
There are no known health risks associated with this study. Possible risks of participation are
loss of confidentiality or discomfort or fatigue from completing study questionnaires. If, for any
reason, you wish not to answer specific questions, you will be able to do so.
Page 1 of 3
 
Birmingham VAHCS Institutional Review Board (IRB)
Effective Date:
February 7, 2024
Expiration Date:
 

Approval date:
Version: 2/6/2024
RESEARCH INFORMATION SHEET
Version Date: 2/6/2024
Title of Study: Improving Primary Care Understanding of Resources and Screening for Urinary
Incontinence to Enhance Treatment (PURSUIT)
Principal Investigators: Lisa Zubkoff, PhD, and Alayne Markland, DO, MSc
VA Facilities: Birmingham and Atlanta
Sponsor: Agency for Healthcare Research and Quality (AHRQ)
WHAT ARE THE POSSIBLE BENEFITS OF THIS STUDY?
We do not know if you will get any benefits from taking part in this research study. However,
possible benefits may include improved bladder leakage symptoms and being enrolled in a
remote treatment option not normally offered by the VA.
WHAT OTHER CHOICES DO I HAVE IF I DO NOT WANT TO JOIN THIS STUDY?
You may choose not to participate in this study. If this is your decision, there are other
choices such as behavioral treatment, medication, and surgical treatment. You may discuss
these options with your doctor.
HOW WILL MY PRIVATE INFORMATION BE PROTECTED?
Study data will be stripped of all patient identifiers and each participant will be given a unique
code for the study. Paper and electronic patient records will be stored in a secure folder or
locked cabinet in a locked office. These records will only be accessible by approved study
team personnel. Electronic records will be maintained through the Veterans Administration
Computerized Patient Record System (CPRS), a secure, password-protected network.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required
by U.S. Law. This website will not include information that can identify you. At most, the
website will include a summary of the results. You can search this website at any time.
VOLUNTARY PARTICIPATION AND WITHDRAWAL
Participation in this study is voluntary and you may refuse to participate without penalty or loss
of benefits to which you are otherwise entitled. Stopping the study will in no way affect or
threaten the quality of care you receive now or in the future or your opportunity to participate
in future studies. If you would like to withdraw, please let your personal doctor or the
Birmingham VA research team (205-558-7067) know. You may also be withdrawn without
your consent for medical or other reasons if your personal doctor, or the study doctors, believe
it is in your best interest for medical or other reasons or if you do not follow study instructions.
WHAT ARE THE COSTS TO ME IF I TAKE PART IN THIS STUDY?
There will be no cost to you for taking part in this study.
Compensation/Payments
You will receive a total payment of $50 for completing the MyHealtheBladder program ($25
for completing the baseline assessment and $25 for completing the 8-week assessment). If
you participate in an optional telephone interview, you will receive an additional $20.
RE-CONTACT
The final stage of this study involves 30-minute telephone interviews with participants. These
interviews are optional. If you are interested in participating in a one-time interview, please
indicate on the “opt in” form if you are willing to be contacted about this future stage of the
study. If you agree to be re-contacted, you will receive a research study consent form for
review and signature prior to participating in a telephone interview.
Page 2 of 3
 
Birmingham VAHCS Institutional Review Board (IRB)
Effective Date:
February 7, 2024
Expiration Date:
 

Approval date:
Version: 2/6/2024
RESEARCH INFORMATION SHEET
Version Date: 2/6/2024
Title of Study: Improving Primary Care Understanding of Resources and Screening for Urinary
Incontinence to Enhance Treatment (PURSUIT)
Principal Investigators: Lisa Zubkoff, PhD, and Alayne Markland, DO, MSc
VA Facilities: Birmingham and Atlanta
Sponsor: Agency for Healthcare Research and Quality (AHRQ)
I agree to be contacted about the one-time, optional telephone interview.
o
Yes
o
No
TEXT MESSAGE REMINDERS
(Optional) If you are interested in receiving weekly text message reminders about the
program's educational modules, your contact information will be entered into Annie, a service
developed by the VA. This is an optional service and is not a requirement to participate in the
program.

Annie messages are automated and not monitored by the health care team.

Annie is not the right place to ask for help, rather patients should contact their health
care teams directly with health concerns.

SMS text messages are not secure and there may be costs associated with sending and
receiving texts.

Collection of patient’s info by Annie is subject to federal law.

Sending Start and Stop begins and ends program participation.
By selecting "Yes" below, I voluntarily agree to receive secure text message reminders to my
personal phone using Annie, a VA-created service. Standard text message rates apply.
o
Yes
o
No
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of the study is Alayne Markland of the Birmingham VA Medical Center.
If you have questions, suggestions, or concerns regarding this study or you want to withdraw
from the study his/her contact information is: (205) 558-7067.
AGREEMENT TO PARTICIPATE IN THE RESEARCH STUDY
By selecting ”Yes” below on this web-based platform (Qualtrics), I voluntarily consent to
participate in this study.
o
Yes
o
No
Page 3 of 3
 
Birmingham VAHCS Institutional Review Board (IRB)
Effective Date:
February 7, 2024
Expiration Date: