MyPath: A Patient-Centered Web-Based Intervention to Improve Reproductive Planning for Women Veterans
Phase: NA
Conditions: Contraception, Contraception Behavior, Prepregnancy Health, Reproductive Health
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
 
Project Title:  
MyPath: A Patient-Centered Web-Based Intervention to Improve Reproductive 
Planning for Women Veterans   
  
(Alternative IRB Protocol Title: Improving Outcomes for Women Veterans Using a 
Patient-Centered Web-Based Decision Tool) 
Funding Agency: VA HSR&D 
Version 16, 09/24/2024 
 
National Clinical Trials (NCT) Number: NCT04584294 
 
 
 

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Abstract 
High rates of medical and mental health comorbidities result in elevated risks of poor maternal 
and neonatal outcomes among women Veterans compared to their civilian counterparts. While 
proactive planning and optimization of physical and mental health prior to pregnancy can 
mitigate these risks, nearly 40% of pregnancies among Veterans are unintended.[1] National 
guidelines recommend routine delivery of patient-centered reproductive planning services in 
primary care, including assessment of reproductive goals followed by tailored contraceptive 
and/or preconception counseling, to reduce unintended pregnancy and improve pregnancy 
outcomes. Only 38% of women Veterans at risk of pregnancy, however, report having 
contraceptive or preconception health discussions with their primary care provider in the past 
year.[2]  
We developed “MyPath,” a novel patient-facing web-based decision support tool, to address 
gaps in reproductive planning services in VA primary care. MyPath’s objectives are to help 
women Veterans consider their reproductive goals, increase their knowledge, align 
contraceptive and pregnancy timing decisions with their goals and health needs, and engage in 
shared decision making with providers. In pilot testing among 58 Veterans, use of MyPath prior 
to clinic visits was highly acceptable to Veterans and increased reproductive planning 
discussions compared to usual care without increasing providers’ perceived workload. We aim 
to study MyPath in a pragmatic randomized trial to assess efficacy and collect implementation 
data. 
Specific Aims:  
1) Aim 1 will test the effect of the MyPath tool used by women Veterans before primary care 
visits on occurrence of reproductive planning discussions with shared decision making (primary 
outcome), patient-provider communication self-efficacy, and contraceptive decision quality, 
compared to usual care;  
2) Aim 2 will test the longer-term effect of MyPath on contraceptive utilization, unintended 
pregnancy, and preconception health behaviors, compared to usual care;  
3) Aim 3 is an implementation process evaluation, including quantitative and qualitative data 
collection to identify implementation barriers and facilitators and intervention costs.  
Exploratory analyses will examine effect modification of Aim 1 and 2 outcomes by race/ethnicity, 
age, visit modality (in-person or virtual) and provider practice-type (Women’s Clinic or non-
Women’s Clinic). 
Methodology:  
This study is a randomized controlled trial that is clustered at the provider level among up to 100 
women’s health primary care providers and their reproductive-aged women Veteran patients at 
up to 16 sites. The trial will investigate the effect of our web-based decision support tool on 
occurrence of reproductive planning discussions with shared decision making, reproductive 
knowledge and decision quality, and contraceptive and preconception health behaviors. 

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Enrolled patients scheduled to see intervention providers will receive a text message containing 
the MyPath link prior to their visits; enrolled patients scheduled to see a control arm provider will 
receive usual care. We will assess outcomes among a minimum of 456 women Veterans by 
either telephone or online immediately after their scheduled visit, as well as by telephone at 3- 
and 6-month follow up timepoints. We will also collect data to describe implementation barriers 
and facilitators using quantitative methods, including cost analysis, and qualitative methods, 
including interviews with Veterans, providers, and clinic leaders. We will use best practices for 
the conduct and reporting of this type of trial as detailed in the CONSORT guidelines. 
 
 
 

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List of Abbreviations 
AMVAHCS – VA Amarillo Healthcare System 
AVAHCS – Atlanta VA Health Care System 
CDC – Centers for Disease Control and Prevention 
CDW – VA Corporate Data Warehouse (repository of electronic health record-based clinical and 
administrative data) 
Co-I – Co-Investigator 
COIN – VA Center of Innovation for Veteran-Centered and Value-Driven Care 
CTVAHCS – VA Central Texas Healthcare System 
DVAHCS – Durham VA Health Care System 
ELVAHCS – VA El Paso Healthcare System 
HSR&D – VA Health Services Research & Development 
LSI – Local Site Investigator 
MEDVAMC - Michael E. DeBakey Veterans Affairs Medical Center (Houston, Texas) 
OVAHCS- Orlando VA Health Care System 
PBRN – Practice-Based Research Network 
PHI – Personal Health Information 
PI/SC – Principal Investigator/Study Chair 
RA – Research Assistant 
RCT – Randomized Controlled Trial  
RLP – Reproductive Life Planning 
SDM – Shared Decision Making 
STVHCS – VA South Texas Healthcare System 
VA – Veterans Affairs 
VAECHCS – VA Eastern Colorado Health Care System 
VANTHCS – VA North Texas Healthcare System 
VAPSHCS – VA Puget Sound Health Care System 

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VAPHS – VA Pittsburgh Healthcare System 
VASDHCS – VA San Diego Healthcare System 
VASLCHCS – VA Salt Lake City Health Care System 
VATVCBHCS – VA Texas Valley Coastal Bend Healthcare System 
VINCI – VA Informatics and Computing Infrastructure 
VSSC – VHA Support Service Center 
WTVAHCS – VA West Texas Healthcare System 

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Contents 
 
Abstract...................................................................................................................................... 2 
List of Abbreviations ................................................................................................................... 4 
Contents .................................................................................................................................... 6 
1.0 
Study Personnel .............................................................................................................. 7 
2.0 
Introduction ..................................................................................................................... 8 
3.0 
Objectives ......................................................................................................................10 
4.0 
Resources and Personnel ..............................................................................................11 
5.0 
Study Procedures ...........................................................................................................14 
5.1 Study Design ...................................................................................................................14 
5.2 Recruitment Methods.......................................................................................................19 
5.3 Informed Consent Procedures .........................................................................................22 
5.4 Inclusion/Exclusion Criteria ..............................................................................................24 
5.5 Study Evaluations ............................................................................................................25 
5.6 Data Analysis ..................................................................................................................29 
5.7 Withdrawal of Subjects ....................................................................................................33 
6.0 
Reporting ........................................................................................................................33 
Table 3. Data Monitoring ....................................................................................................34 
7.0 
Privacy and Confidentiality .............................................................................................34 
8.0 
Communication Plan ......................................................................................................38 
9.0 
References .....................................................................................................................39 
 
 
 
 
 

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Protocol Title:  Improving Outcomes for Women Veterans Using a 
Patient-Centered Web-Based Decision Tool 
 
1.0 
Study Personnel 
 
Principal Investigator/Study Chair 
Lisa Callegari, MD, MPH 
Status: 8/8 VA 
Core Investigator and Gynecologist, HSR&D COIN, VA Puget Sound Health Care 
System 
Associate Professor, Department of Obstetrics and Gynecology, University of 
Washington 
206-277-3129 
Lisa.Callegari@va.gov 
 
Co-Investigators 
Karin Nelson, MD, MSHS 
Status: 8/8 VA 
Core Investigator and primary care physician, HSR&D COIN, VA Puget Sound Health 
Care System 
Professor, Department of Medicine, University of Washington 
206-277-4507 
Karin.Nelson@va.gov 
 
Jessica Johnson, MD  
Status: 5/8 VA 
Gastroenterology Section Co-Chief VA Salt Lake City Health System 
Clinical Assistant Professor Gastroenterology, Hepatology, & Nutrition University of Utah 
801-582-1565 ex-1236                                  
Jessica.B.Johnson@va.gov  
 
Deirdre Quinn, PhD, MSc, MLitt 
Status: 8/8 VA 
Research Health Scientist and Core Investigator, Center for Health Equity Research and 
Promotion (CHERP), VA Pittsburgh Health Care System 
Assistant Professor of Medicine, University of Pittsburgh 
412-360-2208 
Deirdre.Quinn@va.gov  
                                      
Alison Hamilton, PhD, MPH 
Status: 8/8 VA 
Associate Director for Implementation Science, VA Center for Healthcare Innovation, 
Implementation, and Policy (CSHIIP), VA Greater Los Angeles Health Care System 

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Research Anthropologist, Geffen School of Medicine, University of California-Los 
Angeles 
310-478-3711 
Alison.hamilton@va.gov 
 
Study Sites 
The study will be conducted at three engaged sites: 
• 
VA Puget Sound Health Care System (VAPSHCS); LSI: Lisa Callegari 
• 
VA Salt Lake City Health Care System (VASLCHCS); LSI: Jessica Johnson 
• 
VA Pittsburgh Health Care System (VAPHCS); LSI: Deirdre Quinn 
In addition, study staff will recruit, consent, and enroll VA staff and patients remotely 
from up to thirteen additional non-engaged sites that are part of the VA women’s health 
Practice-Based Research Network (PBRN). 
2.0 
 Introduction 
Delivery of high-quality reproductive healthcare for women Veterans is a national priority[3, 4]. 
The number of women Veterans of childbearing age using VA healthcare increased 2-fold over 
the past 15 years[5]. Women VA-users under the age of 35, those most likely to experience 
pregnancy, demonstrated an even more dramatic 3-fold rise in numbers over that timeframe[5]. 
Through system-wide efforts including training women’s health providers[6] and creation of 
comprehensive Women’s Health Clinics offering integrated gender-specific and general primary 
care[7], VA has made substantial progress in delivery of reproductive health services. Despite 
these advances, however, suboptimal contraceptive use, high rates of unintended pregnancy, 
and low rates of receiving contraceptive and/or preconception counseling underscore significant 
ongoing unmet reproductive health need among women Veterans[1, 2]. 
Although Veterans have access to the full range of prescription contraceptive options at low or 
no cost[8], data published by study investigators indicate that nearly 40% of pregnancies among 
women Veterans are unintended, similar to the age-adjusted general population[1]. Unintended 
pregnancy, defined as pregnancy that is unwanted or occurring earlier than desired, is 
independently associated with adverse health outcomes[9] as well as negative impacts on 
women’s economic and social wellbeing[10] and an estimated $4.5 billion dollars annually in 
healthcare costs in the US[11]. Additionally, unintended pregnancy often precludes 
opportunities for health optimization prior to pregnancy[12]. This is of particular importance in 
women Veterans who have a higher prevalence of potentially modifiable risk factors for poor 
maternal and neonatal outcomes compared to their civilian counterparts, including medical 
comorbidities[13, 14], mental health conditions[15] and psychosocial stressors[16].  
The Centers for Disease Control and Prevention (CDC)[17] and other national organizations[18, 
19] recommend routine delivery of reproductive planning services in primary care to improve 
reproductive decision making and outcomes. Reproductive planning services include 
assessment of women’s childbearing desires and goals followed by individualized contraceptive 
and/or preconception counseling to address women’s goals and needs[17]. Beyond advocating 
for increased delivery of reproductive planning services, national organizations also emphasize 
the importance of patient-centeredness in reproductive planning counseling and care[17, 18]. A 

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key component of patient-centered counseling is shared decision making (SDM), a two-way 
process of communication between patients and providers that incorporates patients’ goals, 
values and preferences into the decision making process[20, 21]. SDM in contraceptive 
counseling is preferred by women[22-24], including Veterans[25], and is associated with 
increased rates of contraceptive continuation and use of effective contraceptive methods[26-28]. 
Delivery of patient-centered reproductive planning services happens infrequently in primary care 
outside[29, 30] or within VA[2]. As the vast majority of basic reproductive healthcare in VA is 
provided in primary care rather than specialist gynecology care[31], provision of reproductive 
planning counseling and services by VA primary care providers is essential. In a large national 
survey, however, only 38% of Veterans at risk of pregnancy reported discussing contraception 
and/or preconception health with their primary care provider in the past year[2]. Of additional 
concern, studies indicate that key elements of patient-centered counseling, such as active 
listening and eliciting women’s values and preferences, are often absent in reproductive 
planning encounters in VA[25, 26, 32]. Patient-level barriers to high-quality reproductive 
planning counseling identified in qualitative work by Dr. Callegari include women Veterans’ 
perceived low self-efficacy to request this counseling and perceived lack of time in visits. 
Veterans’ low self-efficacy is linked to negative past experiences of reproductive health 
counseling in the military and VA, including gender-based discrimination and dismissal of 
reproductive health concerns, resulting in fears that reproductive planning conversations will not 
be valued by VA providers[25]. 
Existing interventions have had limited effect on increasing delivery or patient-centeredness of 
reproductive planning services. Prior efforts to increase reproductive planning counseling and 
services include use of a paper-based “Reproductive Life Planning (RLP)” tool created by the 
CDC over 10 years ago[12, 33]. The RLP tool was developed without an explicit evidence- or 
theory-based process, however, and recent studies suggest that its content does not address 
the complexity of women’s actual reproductive health decision making[34, 35]. Other efforts to 
improve reproductive planning services in primary care, such as clinical decision support 
systems in the electronic medical record, have had similarly limited effects[36, 37]. These prior 
studies suggest that additional research is needed to identify effective strategies for increasing 
the quantity and quality of reproductive planning services in primary care. 
The MyPath intervention is a theory-based, state-of-the-art web-based decision support tool. 
Patient-facing decision tools have been shown to promote SDM and to improve decision quality; 
preliminary data also suggests improvements in clinical outcomes such as medication 
continuation and adherence[20]. Our research team utilized an evidence-based and theory-
informed process to develop MyPath, a patient-facing web-based tool designed to be used prior 
to primary care visits to help women Veterans (1) consider their reproductive goals, (2) improve 
their knowledge about fertility, contraception, and preconception health risks, (3) align 
contraceptive decisions with their preferences and goals, and (4) engage in SDM with providers. 
The tool also offers users the option to email a “summary page” of their questions and choices 
to themselves to use at an upcoming medical appointment.  
From April to August 2017, we conducted a non-randomized pilot study of MyPath (n=30) with a 
historical pre-intervention control group (n=28) in VA Seattle and VA American Lake Women’s 
Health Clinics. Veterans spent an average of 11 minutes using MyPath. Acceptability of MyPath 

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was high among both women Veterans and providers. All Veterans (100%) felt that MyPath was 
useful for thinking about one or more topic areas (menstrual cycle/fertility, preconception health, 
contraception), 97% agreed they gained new information from using MyPath, and 93% would 
recommend MyPath to other women Veterans. Providers reported that MyPath did not 
significantly increase their workload and 83% would like their patients to use it in the future. Our 
pilot data demonstrate that MyPath is highly acceptable to women Veterans and has potential to 
increase reproductive planning services and decision quality using a low-intensity, scalable 
approach. Further research is needed to establish whether MyPath is efficacious at increasing 
the quantity and quality of patient-provider communication, increasing effective contraceptive 
use, and increasing pre-conception health behaviors. 
3.0 
Objectives 
 
Our overarching hypothesis is that MyPath will increase patient-centered reproductive planning 
discussions and improve contraceptive decision quality, leading to improved reproductive 
behaviors and health outcomes for women Veterans receiving primary care at VA. To test this 
hypothesis, we will conduct a randomized controlled trial (RCT) at up to 16 sites, clustered at the 
provider level among up to 100 providers and their reproductive-aged women Veteran patients, 
guided by the following aims:  
Aim 1. To test the effect of MyPath on the occurrence of reproductive planning discussions 
with SDM (primary outcome), compared to usual care. Secondary outcomes include the impact 
of MyPath on communication self-efficacy and measures of contraceptive decision quality 
(knowledge, decisional conflict, values concordance).  
Aim 2. To test the effect of MyPath on clinical outcomes at 3 and 6 months after the index visit 
including contraceptive utilization (continuous contraceptive use, use of effective methods) and 
unintended pregnancy, compared to usual care. Exploratory outcomes will include behaviors to 
modify preconception health risks.  
Aim 3. To identify potential barriers and facilitators to implementation by collecting process 
and cost data and conducting qualitative interviews with Veterans, providers, and clinic leaders, 
with the goal of facilitating future implementation in partnership with Women’s Health Services if 
MyPath is found to be effective.  
Exploratory analyses will also look for effect modification of Aim 1 and 2 outcomes by 
race/ethnicity, age, visit modality (in-person or virtual) and provider practice-type (Women’s 
Clinic or non-Women’s Clinic).  
In addition, we plan to obtain covariate and outcome data in VA Corporate Data Warehouse 
(CDW) from the electronic health record to collect some demographic and covariate variables 
and inform future implementation studies. We will compare self-reported reproductive health 
outcomes of participants (collected at 3- and 6-months) with reproductive health data from the 

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electronic health record to assess for agreement and identify possible CDW structured data that 
would be used as outcomes for larger-scale implementation studies. 
4.0 
Resources and Personnel 
Study investigators are located at four VA sites (including the three engaged study sites, plus 
VA Greater Los Angeles). Study staff will recruit, consent, and collect data remotely from 
providers and patients at up 16 VA sites (including the three engaged sites as well as up to 
thirteen non-engaged PBRN sites described below). In addition, we have a contract with a 
software company for maintenance of the web-based decision tool. The contracted software 
company will have no access to identifiable data or personal health information (PHI) and will 
not be involved in study analysis. 
The two co-investigators who are not LSIs (Karin Nelson at VAPSHCS and Alison Hamilton at 
VA Greater Los Angeles) will have access to aggregate-level, de-identified data only.  
Study Sites 
The study will be conducted at three engaged sites: 
• 
VA Puget Sound Health Care System (VAPSHCS); LSI: Lisa Callegari 
• 
VA Salt Lake City Health Care System (VASLCHCS); LSI: Jessica Johnson 
• 
VA Pittsburgh Health Care System (VAPHCS); LSI: Deirdre Quinn 
In addition, study staff will recruit, consent, and enroll VA staff and patients remotely from up to 
13 non-engaged sites that are part of the VA women’s health PBRN. Site contacts listed below 
serve as PBRN site leads. They are not engaged in the research study, but provide periodic 
guidance on recruitment methods and other site-specific questions as they arise. Additionally, 
site contacts serve as a liaison between study staff/investigators and site leadership: 
Non-Engaged Sites 
Site 
Women’s Health Site Contact 
Site Status 
VA Eastern Colorado Health 
Care System (VAECHCS) in 
Denver, CO 
Kim Chen, MD 
Obtained facility level 
approvals and currently 
enrolling 
Michael E. DeBakey VA 
Medical Center (MEDVAMC) 
in Houston, TX 
Deleene Menefee, PhD 
Obtained facility level 
approvals and currently 
enrolling 
Durham VA Health Care 
System (DVAHCS) 
Karen Goldstein, MD, MSPH 
Obtained facility level 
approvals and currently 
enrolling 
Atlanta VA Health Care 
System (AVAHCS) 
Ursula Kelly, PhD, ANP-BC, 
PMHNP-BC 
Obtained facility level 
approvals and currently 
enrolling 

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Orlando VA Health Care 
System (OVAHCS) 
Georgine Lamvu, MD, MPH 
Obtained facility level 
approvals and currently 
enrolling 
VA San Diego Healthcare 
System (VASDHCS) 
Karuna Ahuja, MD 
Obtained facility level 
approvals and currently 
enrolling 
VA Amarillo Healthcare 
System (AMVAHCS) 
Juli McNeil, MSSW, LCSW 
Pursuant to facility-level 
approvals, will begin 
enrollment 
VA Central Texas Healthcare 
System (CTVAHCS) 
Juli McNeil, MSSW, LCSW 
Pursuant to facility-level 
approvals, will begin 
enrollment 
VA El Paso Healthcare 
System (ELVAHCS) 
Seigrid Nixon, MD 
Obtained facility level 
approvals and currently 
enrolling  
VA South Texas Healthcare 
System (STVHCS) 
Araceli Revote, MD 
Obtained facility level 
approvals and currently 
enrolling  
VA North Texas Healthcare 
System (VANTHCS) 
Juli McNeil, MSSW, LCSW 
Pursuant to facility-level 
approvals, will begin 
enrollment 
VA Texas Valley Coastal 
Bend Healthcare System 
(VATVCBHCS) 
Juli McNeil, MSSW, LCSW 
Pursuant to facility-level 
approvals, will begin 
enrollment 
VA West Texas Healthcare 
System (WTVAHCS) 
Juli McNeil, MSSW, LCSW 
Pursuant to facility-level 
approvals, will begin 
enrollment 
 

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Key Study Personnel 
Name 
Role 
VA Site 
PHI 
Access 
Recruit/ 
Consent / 
Data 
Collection 
Analysis 
Lisa Callegari, MD, 
MPH 
PI/SC, LSI 
Seattle 
Y 
Y 
Y 
Karin Nelson, MD, 
MSHS 
Co-I 
Seattle 
N 
N 
Y 
Deirdre Quinn, 
PhD, MSc, MLitt  
Co-I, LSI 
Pittsburgh 
Y 
N 
Y 
Jessica Johnson, 
MD 
Co-I, LSI 
SLC 
Y 
N 
Y 
Alison Hamilton, 
PhD, MPH 
Co-I 
Los 
Angeles 
N 
N 
Y 
 
Non-Key Overall Study Personnel 
Name 
Role 
Location 
PHI 
Access 
Recruit/ 
Consent/ 
Data 
Collection 
Analysis 
Samantha 
Benson, MPH 
Study 
Manager 
Seattle 
Y 
Y 
Y 
Siobhan 
Mahorter, MPH 
Research 
Coord. 
Seattle 
Y 
Y 
Y 
Leslie Taylor, PhD 
Biostatistician 
Seattle 
N 
N 
Y 
Scott Coggeshall, 
PhD 
Biostatistician 
Seattle 
N 
N 
Y 
Jeff Todd-
Stenberg, PhD 
Data 
Requisitioner 
Seattle 
Y 
N 
N 
Rachel Hunter-
Merrill, MA 
Data Analyst 
Seattle 
Y 
N 
Y 
Vyshnika 
Sriskantharajah 
Data Manager 
Seattle 
Y 
N 
Y 
George Sayre, 
PsyD 
Qualitative 
Methodologist 
Seattle 
N 
N 
Y 
Deirdre Quinn, 
PhD, MSc, MLitt 
Research 
Consultant 
Pittsburgh 
Y 
N 
Y 
Kristen Rice, MPH 
Research 
Assistant 
Pittsburgh 
Y 
Y 
Y 
Aarthi Yogendran 
Research 
Assistant 
Seattle 
Y 
Y 
Y 
Amy Alcantara 
Research 
Assistant 
Salt Lake 
City 
Y 
Y 
Y 
Shannon Mitchell 
Research 
Assistant 
Pittsburgh 
Y 
Y 
Y 

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Caroline Merkel 
Research 
Assistant 
Seattle 
Y 
Y 
Y 
Na’imah 
Muhammad 
Research 
Assistant 
Seattle 
Y 
Y 
Y 
Christine Sulc 
Research 
Assistant 
Seattle 
Y 
Y 
Y 
Theresa Neinas 
Research 
Assistant 
Seattle 
Y 
Y 
Y 
Services Performed by Outside Contractor 
The software development company Nitid Bit, LLC, will perform maintenance and updates to 
support the web-based decision tool, MyPath, and will store MyPath analytics data (which is not 
identifiable). The decision tool was built by Nitid Bit using prior VA research funding. The 
contractors will manage de-identified analytic data on use of the tool (e.g. time spent on each 
section of the tool) but will not have access to any PHI.  
5.0 
Study Procedures 
 
5.1 Study Design 
Experimental Design 
For Aims 1, and 2, we will use a cluster randomized trial design with clustering at the provider 
level to study the efficacy of MyPath delivered via text message to patients prior to primary care 
appointments at VA. The unit of randomization is the provider. This approach allows us to 
optimize efficiency while minimizing the risk of bias and contamination. Specifically, randomizing 
providers rather than patients addresses the contamination concern that providers interacting 
with patients who use MyPath may be exposed to the Summary Page from the tool highlighting 
patients’ goals and preferences, which could alter communication with patients who have not 
used the tool. 
After enrollment, providers will be randomized to intervention arm or usual care arm with a 
1:1 allocation ratio. Randomization will be stratified by the clinic practice-type (Women’s Clinic 
vs. non-Women’s Clinic) and study site (Seattle, Salt Lake City, Pittsburgh, and the additional 
non-engaged PBRN sites: Atlanta, Denver, Durham, Houston, Orlando, San Diego, Amarillo, 
Central Texas, El Paso, South Texas, North Texas, Texas Valley Coastal Blend, and West 
Texas). We will include stratification by clinic practice-type because we expect providers located 
in Women’s Clinics may communicate about reproductive planning differently than providers in 
other primary care settings. 
Women Veterans will be identified for recruitment if they have a scheduled primary care 
appointment with an enrolled study provider, are 18-44 years old, and have no CDW evidence 
of impaired decision-making or a past procedure that would result in infertility (e.g., 
hysterectomy, oophorectomy, or sterilization). Those patients will be screened, consented, and 
enrolled approximately one week before their scheduled appointment. Recruitment will take 
place over the course of 18 months. 

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Intervention:  The MyPath intervention is designed to promote guideline-recommended 
care and best practices for reproductive health care. As such, MyPath itself is a variation 
of usual practice. Providers randomized to the intervention arm will receive the link to the 
MyPath tool, a brief orientation to MyPath by telephone, a brief conversation guide 
(Attachment T), and a wearable button (Attachment U) and card (Attachment V) 
prompting patients to bring up MyPath during their appointment. Study staff may also 
identify and send publicly available clinical resources for reproductive health counseling 
or decision making when requested. Study staff will contact providers in the intervention 
arm approximately every six months (via phone, email or MS Teams message) to 
provide updates on the study and offer support and advice regarding the MyPath tool. 
Providers in the control/usual care arm will not be provided any education or information 
about the intervention, will be asked not to disseminate MyPath to their patients during 
the study recruitment phase, and will provide usual care.  
Enrolled patients scheduled to see intervention providers will be sent a text message 
prior to their appointment through the existing national VA VetText program (see letter of 
support from Dr. Callegari’s IIR grant application, Attachment B). The text message will 
include a brief invitation to use MyPath along with a link to the tool. Participants will be 
asked whether they consent to receive text messages from VA that include PHI, a 
practice that the VetText program uses to be able to send additional details about 
appointments in text messages. Participant consent will be documented in their study 
record. In the MyPath pilot study, patients spent an average of 11 minutes using the 
MyPath tool. The MyPath tool can be accessed at va.mypathtool.org using a mobile 
device or Google Chrome web browser. Screens shots from each main section of 
MyPath may be reviewed in the attached MyPath Intervention Overview (Attachment C). 
Blinding: All recruitment for providers and patients will be done via telephone and email 
by study Research Assistants (RAs). Consent and survey data collection for the trial for 
both providers and patients will be done via telephone by RAs. Survey data collection for 
the patient post-visit survey will either be done through a Qualtrics online survey that will 
be sent to patients via a VA-approved Qualtrics one-way text message, or completed via 
telephone by RAs. RAs will remain blinded to the intervention and control arm 
assignment of providers throughout the period of study data collection. RAs will remain 
blinded to the intervention and control arm assignments of patients until the end of the 
post-visit survey, after Aim 1 outcomes have been assessed. The final questions of the 
post-visit survey for patients will assess adherence to the intervention (i.e., use of the 
MyPath tool), which will unblind RAs to each patient’s study arm when the patient 
reaches that point in the study. Because RAs will never be made aware of which patient 
is scheduled to see which provider, the unblinding of patients’ study arms at the end of 
the post-visit survey will not result in RAs being unblinded to providers’ study arms.   
Use of Administrative Data: Survey data will be supplemented with medical record data 
housed in CDW to describe the study population, assess some study covariates, and 
compare outcomes assessed by survey with outcome data available in CDW as 
described in the Administrative Data Sources and Codes document (Attachment D).  

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For Aim 3, we will collect both qualitative and quantitative data to understand barriers and 
facilitators to the implementation of the MyPath intervention in VA clinical practice. This aim will 
be guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) 
framework, a widely used implementation framework incorporating both individual- and 
organizational-level elements[38]. 
Qualitative: Up to 30 intervention arm patients will be interviewed after their post-visit 
survey about their experiences using MyPath. Intervention arm providers will be 
interviewed at the close of patient recruitment about their experiences in the study and 
about potential barriers and facilitators to implementing MyPath in clinical practice. Up to 
15 clinic leaders will be interviewed at the close of patient recruitment about potential 
barriers and facilitators to implementing MyPath in clinical settings. 
Quantitative: Quantitative data collection to assess reach will include intervention 
adherence by patient participants (i.e., the proportion of patients in the intervention arm 
who used the intervention). Analytic data from the software developers hosting MyPath 
will be obtained. Analytic data will verify self-reported use of the tool, quantify time spent 
using the tool, and describe which pages of MyPath are most visited to better 
understand the reach of MyPath among women receiving the intervention. Women in the 
intervention group will be assigned a personal code consisting of two words and a 
number when they access MyPath, and MyPath analytic data will be linked to this code. 
Linkage of the code will be maintained in a crosswalk behind the VA firewall.  Lastly, 
process data will be collected to estimate costs of implementing the intervention, 
including time spent training intervention arm providers, costs of disseminating the tool, 
and costs of software  
 
Study Population  
Providers: We will enroll up to 100 primary care providers who have seen at least 30 unique 
reproductive-aged women in the past year. Providers will be recruited across the 9-16 study 
sites. Trainees who must staff with attending providers (e.g. residents and medical students) will 
be excluded from participation.  After patient recruitment is complete, we will invite intervention 
arm providers to complete qualitative interviews for Aim 3 about their experiences seeing 
patients who used the tool. 
Patients: We anticipate enrolling approximately 456 women Veteran patients (not to exceed 570 
patients) scheduled to see enrolled providers over the course of 18 months of recruitment. We 
aim to recruit approximately 15 patients scheduled to see each study provider, for a cluster size 
of 15 and a total sample size of 456, though depending on enrollment rates and in efforts to 
balance the number of patients in study arms, additional patients may be enrolled up to a 
maximum of 570. Up to 30 intervention arm Veteran participants will be interviewed for Aim 3. 
They will be purposively sampled for variety in characteristics such as intervention adherence, 
race/ethnicity, age, parity, provider in a women’s clinic vs non-women’s clinic, and 
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Clinic Leaders: We will enroll and interview up to 20 clinic leaders who work with enrolled 
providers for Aim 3. 
Potentially vulnerable groups that may be included in our patient population because we are not 
specifically excluding them include employees or students; economically and/or educationally 
disadvantaged persons; and patients that identify as racial or ethnic minorities. It is unlikely that 
study eligible patients will be illiterate or have limited English language proficiency as these are 
requirements of military service enrollment. Pregnant women will be excluded from the study 
because the MyPath intervention is designed for non-pregnant women. Additional groups that 
will be excluded include women who are not capable of pregnancy (e.g., with known infertility for 
reasons such as hysterectomy or tubal sterilization), who are not interested in receiving 
information about birth control or planning for pregnancy, and women who are older than 44, as 
fertility and risk of pregnancy drops significantly over this age. 
Minimizing Anticipated Risks 
Risks to VA employees (providers and clinic leaders): The primary risk of the study to VA 
employees is the potential of disclosure of confidential or sensitive data. Although unlikely, 
employees may experience discomfort while completing self-report surveys or qualitative 
interviews. In addition, providers may perceive additional burden due to seeing patients who 
have used the MyPath tool. We anticipate this burden to be minimal, however, as no providers 
in our pilot study felt that that MyPath added significant burden and some providers felt that 
MyPath made counseling more efficient because patients were informed about their options. 
The following strategies will help minimize risks to employees: 
• 
The Seattle Health Services Research & Development (HSR&D) Center of Innovation 
(COIN) has developed extensive security measures (discussed below in section 7.0) to 
minimize the risk of disclosure of confidential or sensitive data. 
• 
Steps will be taken to minimize the risk of invasion of privacy. Employees will be sent a 
recruitment email, which will include the study information sheet. This email will invite 
employees who do not wish to be contacted further about the study to opt-out of further 
contact/recruitment efforts by responding to the email. 
• 
When reached by telephone for recruitment, consent, and enrollment, study staff will 
discuss the voluntary nature of study participation with employees, emphasizing that 
their choice of whether to participate will not affect their employment or work 
environment. 
• 
All participants will be informed by study staff that they may choose not to answer any 
questions for any reason. 
• 
All participants will be informed that they may choose to withdraw from the study at any 
time. 
Risks to patients: The MyPath tool is a variation of normal care and designed to promote 
guideline-recommended reproductive healthcare, including assessment of reproductive goals, 

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contraceptive care, and preconception care. The expected benefit is an increase in the 
likelihood that women Veteran patients receive national guideline-recommended care. The 
primary risk of the study to VA patients is the potential of disclosure of confidential or sensitive 
data. Although unlikely, patients may experience discomfort while completing the MyPath tool, 
self-report surveys, or qualitative interviews. The following strategies will help minimize risks to 
patients: 
• 
The Seattle HSR&D COIN has developed extensive security measures (discussed 
below in the “Data Security Measures” section 7.0) to minimize the risk of disclosure of 
confidential or sensitive data. 
• 
Steps will be taken to minimize the risk of invasion of privacy. Initial contact with 
prospective participants will be via an introductory study mailing, which will include the 
study information statement and a postage-paid post card that patients may return to 
opt-out of further contact by the study team.  
• 
Recruitment emails will emphasize the voluntary nature of the study. When prospective 
participants are reached by telephone for recruitment, consent, and enrollment, study 
staff will discuss the voluntary nature of study participation with patients, emphasizing 
that their choice of whether to participate will not affect the care they receive at VA or the 
benefits for which they are eligible. 
• 
All participants will be informed by study staff that they may choose not to answer any 
questions for any reason. 
• 
All participants will be informed that they may choose to withdraw from the study at any 
time. 
• 
Although unlikely, some respondents may find some questions intrusive or offensive or 
may become distressed. To minimize this risk, study personnel will be trained in how to 
communicate with patients regarding reproductive and sexual health and remind 
participants about their rights as listed above (to withdraw from the study or skip any 
question). Any participant who experiences distress or any adverse reaction as a result 
of any study questions will be given information about who to call to talk in more detail. 
They will be provided with resources as listed in the attached Crisis Protocol 
(Attachment E).  
Analysis of Risk vs. Benefit 
VA Employees: Employee participants may benefit from this research in several ways. First, 
employee participants may gain satisfaction from participating in a research project designed to 
improve the quality of care for reproductive-aged women Veterans. In Dr. Callegari’s previous 
work, providers felt that preconception and contraception care are essential to the health and 
well-being of their Veteran patients and were enthusiastic about offering feedback regarding 
barriers and facilitators to providing reproductive planning services in the primary care setting. 
Participation could provide VA providers and staff a sense that they are contributing to important 
quality improvement work. Further, a number of providers in the MyPath pilot study felt that the 

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tool made their counseling more efficient because patients were more informed about their 
options. Providers in the intervention group during the study, and providers in the control group 
after the study if the intervention is continued, could thus benefit from more efficient counseling 
experiences.  
Patients: Veteran participants may benefit in several ways from the study. From Dr. Callegari’s 
previous work, women Veterans of childbearing age generally perceive significant gaps in care 
related to pregnancy planning and contraception counseling in VA primary care. In prior 
qualitative work, Veterans were enthusiastic about efforts on the part of VA to improve these 
services. Women Veteran participants may benefit from knowing that they are contributing to 
research efforts to improve delivery and quality of VA care. Women Veteran participants in the 
study intervention arm may benefit by knowledge gained, improved quality of their reproductive 
decisions, improved communication with their providers, and improved health behaviors after 
using the MyPath tool. Women Veterans in the control arm will not benefit from the MyPath 
intervention during the study but could benefit from implementation after the study, if the 
intervention is found to be effective. Veteran participants will also receive monetary incentives to 
compensate their time.  
Balance of Potential Risks and Benefits: These potential benefits outweigh the minimal risks 
related to loss of privacy and confidentiality and of discomfort when discussing health or 
operational matters, which are no greater that those encountered by employees and VA patients 
in daily life.  
Protection for Vulnerable Populations 
All VA employees will be informed that their participation is voluntary and that opting out will not 
affect their employment, work environment, or benefits in any way.  
It is likely that patients from vulnerable populations will be included in our datasets, such as 
employees or students; economically and/or educationally disadvantaged persons; and patients 
who identify as racial/ethnic minorities. We do not anticipate the intervention or participation in 
the study evaluations will pose any additional risks to these populations. Should members of 
these groups be included, we anticipate that they will be adequately protected by the above 
strategies of risk minimization. 
Data Repository/Data Banking 
Due to a CIRB determination in January 2024, data collected under a Waiver of HIPAA 
Authorization cannot be deposited into a data repository or registry; thus, these activities have 
been discontinued. No study data (past or future) collected under this protocol will be deposited 
into a data repository or registry and participants will no longer be asked if they would like to 
store their data for future use in a data repository and registry.  
5.2 Recruitment Methods 
Sample Size 

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Providers: Up to 100 providers will be enrolled for Aims 1 and 2, and all intervention arm 
providers (up to approximately 38) will be invited to complete the qualitative interview at the end 
of the patient recruitment/enrollment phase. 
Patients: no more than 570 patients will be enrolled for the RCT, and up to 30 intervention-arm 
patients will complete the qualitative interview after the post-visit survey. 
Clinic Leaders: Up to 35 clinic leaders will complete qualitative interviews at the end of the 
patient recruitment/enrollment phase. 
Identifying and Recruiting Study Participants 
Providers: Providers from each study site will be identified as potentially eligible for study 
recruitment using data available through CDW. These data will be accessed by our data 
requisitioner using the VA Informatics and Computing Infrastructure (VINCI). Recruitment emails 
will be sent to potentially eligible providers by study staff (see attached email, Attachment F). 
Recruitment emails will include a study information statement for providers (Attachment G) and 
will instruct providers to respond if they do not wish to be contacted about participation in the 
study. Opt-out responses from providers will be collated by the study manager. Recruitment lists 
will be made available to study RAs at least one week later. RAs will contact providers by 
telephone, email, and MS Teams messenger. Screening, consent, and study enrollment will 
occur over the telephone (see attached script, Attachment H). No more than 3 voice messages, 
3 emails, and 3 MS Teams direct/instant messages will be sent by study staff to potentially 
eligible providers that have not opted-out of study contact.  
Patients: After study providers have been enrolled, the data requisitioner will pull lists of all 
potentially eligible VA patients (women ages 18-44 without medical record evidence of infertility) 
empaneled to enrolled providers. Recruitment letters will be mailed to these patients 
(Attachment I) by the study manager or research coordinator at the start of the study. 
Recruitment letters will include a study information statement for patients (Attachment J) and a 
postage-paid opt-out postcard (Attachment K) which patients may return by mail if they do not 
wish to be contacted further about study participation. The data requisitioner will pull lists of 
potentially eligible patients assigned to enrolled provider primary care panels again at 6 and 12 
months into the patient recruitment phase and recruitment letters will be mailed to any new 
patients (those not previously mailed a recruitment letter). The study manager and research 
coordinator will track any opt-out postcards in the patient crosswalk database so that no further 
contact will be made with those patients. 
During the active patient recruitment phase of the study, the data requisitioner will pull weekly 
lists of potentially eligible VA patients (same criteria as above) that are scheduled to see 
enrolled study providers during the following week. In-person, telephone, and video-
conferencing appointments will be eligible study visits. The study manager, research 
coordinator, or database manager will match these lists against the patient crosswalk database 
to remove any patients to whom a recruitment letter was never sent, who returned the opt-out 
postcard, who already enrolled in the study, or who have declined participation or withdrawn 
from the study previously.  

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Those vetted recruitment lists will be distributed to the study RAs, who will make contact with 
patients prior to their appointments by email (for screening, when email addresses are 
available) and subsequently by telephone (for screening, consent and enrollment; see attached 
script, Attachment L). 
• 
Email recruitment: To provide Veterans a second opportunity to opt-out of the study, 
RAs will send an unencrypted email from a designated study email account (to which 
only study staff have access). The recruitment email will introduce Veterans to the study 
and invite them to complete a confidential online questionnaire (using the Qualtrics 
online survey program) as a means of opting-in or opting-out of being contacted about 
the study and screening for eligibility. The study information statement (which was 
previously mailed to all potentially eligible participants; Attachment J) will also be made 
available as a downloadable document within the online Qualtrics recruitment survey.  
The recruitment email does not contain the Veteran’s name or other PII, and contains 
no statements that could be used to infer anything about the Veteran’s health status. 
This strategy of recruiting Veterans by email is Veteran-centered because it allows 
Veterans who may have received the mailing many months ago, and who may have 
forgotten details or changed their mind about the study in the intervening time, to 
reconsider whether they are interested in the study and let us know before receiving 
recruitment calls.   
• 
Telephone recruitment: If we fail to receive an opt-out (by mail, Qualtrics survey, or 
telephone) from a Veteran at 7 days from the Veteran’s appointment date, we will 
contact the Veteran by telephone to invite them to learn more about the study and 
consider participating.  
Study RAs will be responsible for recruiting, consenting and collecting data from patients at all  
study sites. To avoid overlap, RAs will be assigned specific shifts when they will be responsible 
for conducting recruitment calls/emails, and survey phone calls. RAs will document contact 
attempts and call outcomes in a shared recruitment list (stored on a secure VA server) to avoid 
overlap and ensure recruitment is synchronized. Additionally, the Study Manager and/or Study 
Coordinator will provide daily oversight and coordination to ensure accuracy. 
Clinic Leaders: Potentially eligible clinic leaders will be identified by study co-investigators at 
engaged study sites and site contacts at non-engaged study sites. Recruitment emails will be 
sent to potentially eligible clinic leaders by the study team (see attached email, Attachment M). 
Recruitment emails will include a study information statement for clinic leaders (Attachment N) 
and will instruct clinic leaders to respond if they do not wish to be contacted about participation 
in the study. Opt-out responses will be collated by the study manager. Study staff conducting 
qualitative interviews will contact clinic leaders up to 3 times by telephone, 3 times by email, and 
3 times by MS Teams instant/direct message for recruitment purposes. Screening, consent, and 
enrollment will happen over the telephone (see attached script, Attachment O). 
Payment 
Providers and Clinic Leaders: VA employees will not receive payment for participation in the 
study. 

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Patients: Enrolled patients will receive $25 by electronic funds transfer from VA or receive a $25 
Amazon gift card after completing three of the study surveys (baseline, at 3 months, and at 6 
months), and, when applicable, after completing a qualitative interview. Enrolled patients who 
complete the post-visit survey after their scheduled primary care appointment will receive $50 
by electronic funds transfer from VA or a $50 Amazon gift card. This means that patients can 
receive up to $125 for completing all study surveys for Aims 1 and 2, and an additional $25 if 
invited to do a qualitative interview for Aim 3. Payments will be initiated after each completed 
study survey or interview; thus, patients will be paid for partial study participation. We will give 
Veterans the option of receiving a gift card or an electronic fund transfer from VA as payment for 
their study participation. VA electronic fund transfer payments are distributed through the VA 
Austin payment center. If a Veteran would like to receive their payment by electronic funds 
transfer and they have not previously filled out VA Form 10-091, Veterans have the option to 
complete a paper VA Form 10-091 (returned by mail) or complete VA Form 10-091 online 
through the VA’s online Customer Engagement Portal. If a Veteran chooses to receive their 
payment as an Amazon gift card, these will be mailed by the study team or sent as a gift card 
claim code in an unencrypted email from the study email account. No Veteran identifiers would 
be included in the email (Attachment Z). Veterans may experience a delay in receiving 
electronic funds transfer payments for up to 6 months due to processing time. 
5.3 Informed Consent Procedures 
Study Staff Involved in Screening, Consent, and Enrollment: 
Screening, verbal consent, and enrollment of providers and patients will be conducted by study 
RAs following the attached scripts (Attachments H and L). Study staff who will conduct 
qualitative interviews (investigators, study manager, or research coordinator) will conduct 
screening, verbal consent, and enrollment with clinic leaders before the qualitative interview 
following the attached script (Attachment O). The PI/SC will be responsible for ensuring that all 
study staff are up-to-date on VA-required human subjects protection trainings. The PI/SC and 
study manager will provide further specific training on obtaining verbal consent during a study 
orientation that will be provided to RAs, which will include role playing verbal consent scenarios. 
Waiver of Documentation of Consent for Entire Study: 
Because the study poses minimal risk to participants, and because recruitment and enrollment 
would not be feasible in-person for all participants, we are requesting a waiver of documentation 
of consent for the entire study. Verbal consent procedures will be conducted over the telephone 
by study staff after recruitment emails or physical letters with opt-out option are sent to 
potentially eligible participants. 
Study staff obtaining verbal consent will be trained in consent processes, including to 
understand the importance of consent processes being interactive and non-coercive. Study staff 
obtaining verbal consent will be trained not to continue with the consent and enrollment if they 
have any reason to believe that a potentially eligible participant is not able to provide informed 
consent at the time of the telephone call. 
Alteration of Consent During Patient Enrollment: 

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We are asking for an alteration of consent processes during patient enrollment, to include 
withholding the specific topics addressed by the intervention from eligible patients until after 
they have enrolled and attended their scheduled appointment. We will obtain prospective 
agreement from patients for this alteration during the consent process. We also propose using a 
small number of unnecessary screening questions to obfuscate the specific purpose of the 
study at the time of screening. Once patients have completed their scheduled appointment, and 
before any outcomes are assessed in the post-visit survey, patients will learn about the 
information that was withheld from patients using the Deception Debrief Script (Attachment P). 
Patients will learn about the information that was withheld from them either from the RAs if they 
complete the post-visit survey by telephone, or at the beginning of the post-visit survey if they 
complete the survey online via Qualtrics. We are proposing this minimal alteration in consent 
procedures because discussing the specific topics addressed by the tool and intervention with 
eligible patients could prime patients in the control arm to discuss reproductive planning with 
their medical provider during their scheduled appointment. Since the occurrence and the quality 
of reproductive planning discussions between patients and providers is our primary outcome, 
we hope to minimize the extent to which we prime control arm patients to discuss these topics. 
Withheld Information and Prospective Agreement: As detailed in the patient information 
statement (Attachment J) and during verbal consent processes (Attachment L), we will 
inform potentially eligible patients that this study is trying to improve the primary care 
that women Veterans receive and is evaluating a web-based decision tool designed for 
women Veterans. The purpose of the intervention will be described as helping women 
Veterans get the most out of their primary care visits and make informed health care 
decisions. We will inform patients that we are interested in studying whether the 
intervention affects the type and quality of discussions patients have with their providers 
and their decisions. We will state that we are choosing not to reveal the specific topics 
addressed by web-based tool until after enrolled patients have seen their medical 
provider so that we do not influence what they decide to discuss with their providers. 
Patients will be informed before they decide whether or not to enroll in the study that the 
specific purpose of the study and the specific topics addressed by the intervention will be 
revealed after they have seen their provider and before we ask them any questions 
about their medical appointment.  
Added Screening Questions: We will screen patients on the inclusion and exclusion 
criteria detailed below in section 5.4. Screening questions may also be found in the 
patient survey instruments (Attachment Q) and in the patient screening and consent 
script (Attachment L). In addition to asking potentially eligible patients whether they 
would like information about pregnancy and birth control, we will also ask if they are 
interested in receiving information about other health-related topics, including sleep, 
healthy weight, pain, smoking cessation, and stress management. Including those 
additional, unnecessary screening questions will reduce the extent to which eligible 
participants are primed to discuss pregnancy and birth control with their providers and 
will help to maintain the obfuscation of the specific topics covered by the intervention 
until after they have received the intervention or seen their provider.  

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Analysis of Potential Risks to Patients: An alteration to consent procedures such as what 
we propose may pose additional risks to patients. Patients may feel discomfort once the 
full details of the study purpose are revealed to them and may decide they no longer 
wish to participate after the study purpose is revealed to them. We are taking the 
following measures to reduce the risks that our proposed alteration poses: 
• 
The withholding of information about the study purpose will be made clear in the 
study information statement and by RAs doing screening, consent, and 
enrollment. Patients can choose whether or not to enroll in the study knowing 
that this information will not be revealed to them until after their scheduled 
appointment. 
• 
We will provide as much information about the study as possible without 
revealing that our outcomes are related to reproductive planning. All information 
provided in the study information sheet and by RAs about the study will be 
accurate. No inaccurate or misleading information about the study will be 
provided to patients. 
• 
The withheld information will be revealed to participants using the Deception 
Debrief Script (Attachment P) as soon as withholding the information is no longer 
necessary to the conduct of the study. This will be after they have attended their 
medical appointment and before the post-visit survey. Participants will be offered 
the opportunity to ask any questions they have and will be asked if they are 
comfortable continuing to participate in the study. 
• 
Patients will be screened and included in the study only if they say they are 
interested in receiving information about pregnancy planning and/or birth control 
(see inclusion and exclusion criteria in section 5.4), which means the intervention 
is concordant with the patients’ desires for information. This reduces the 
likelihood that enrolled patients will find the MyPath intervention or the purpose of 
the study to be intrusive or offensive. 
• 
The additional, unnecessary screening questions are not of a sensitive nature, 
and patient answers to the additional screening questions will not be recorded or 
stored as part of study datasets. 
5.4 Inclusion/Exclusion Criteria 
Providers: 
Inclusion Criteria: 
• 
Primary Care Provider (MD, Nurse Practitioner, Physician Assistant) at a study site 
• 
Designated as a Women’s Health Provider [defined in VA directive 1330.01 as primary 
care providers who have demonstrated proficiency (e.g. pelvic exams and pap smears) 
in women’s health and who have at least 10% of their panel comprised of women] 
• 
Completed appointments with at least 30 unique female patients ages 18-44 in the past 
year at a study site. If a study site does not have enough providers who meet this 

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criterion and are willing to enroll in the study, the study team may reduce the minimum to 
15 unique female patients ages 18-44 in the past year at a study site. (pulled from CDW) 
Exclusion Criteria: 
• 
Previous involvement as provider in MyPath pilot work (identified by PI/SC) 
• 
Medical trainee (e.g., resident physician or medical student) 
• 
Self-report that they have plans to leave VA, go on extended leave, retire, stop primary 
care practice, or change VA site in the 18 months following their enrollment 
Patients:  
Inclusion Criteria:  
• 
Female (obtained via CDW) 
• 
18 – 44 years old (obtained via CDW) 
• 
Has a scheduled VA medical appointment with an enrolled study provider and plans to 
attend the appointment at the time of enrollment (obtained via VSSC and/or CDW) 
• 
Interested in receiving information or talking with their provider about pregnancy 
planning and/or birth control 
• 
At least one valid telephone number available in medical record (obtained via CDW) 
 
Exclusion Criteria:  
• 
Medical record history of hysterectomy, bilateral oophorectomy, female sterilization, or 
diagnosed infertility for another reason 
• 
Self-reported history of hysterectomy or bilateral oophorectomy 
• 
Self-report of not having a uterus or ovaries (e.g. transgender women), which precludes 
the capacity to become pregnant 
• 
[For VAPSHCS patients] Self-report of completing MyPath decision tool previously (e.g. 
during pilot study or Quality Improvement work). 
• 
Unable to communicate in English  
• 
Impaired decision making (by ICD code, from CDW) 
• 
Currently pregnant 
• 
Self-report that they have opted out of VA text messages, or that they are unable to 
receive text messages 
 
Clinic Leaders: 
Inclusion Criteria: 
• 
Managerial role in a VA clinical setting where at least one enrolled provider practiced 
during study data collection 
Exclusion Criteria: 
• 
none 
 
5.5 Study Evaluations 
Providers: 

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Screening: During screening, we will determine whether potentially eligible providers meet the 
eligibility criteria for participation in the study by reviewing inclusion and exclusion criteria. The 
list of provider screening variables is included as part of the attached Provider Survey 
Instrument (Attachment R). 
Demographic and Practice Characteristics Survey: Providers complete a brief demographic and 
practice characteristics survey prior to randomization. The list of demographic and practice 
characteristics variables is attached as part of the Provider Survey Instrument (Attachment R). 
Aim 3 Qualitative Interview: After completion of patient enrollment, intervention arm providers 
who participate in the qualitative interview will be invited to do a 15-20 minute qualitative 
interview. During the interview, providers will be asked questions about their experience 
providing care to women receiving the MyPath intervention and facilitators and barriers to 
implementing MyPath in clinical practice (see attached interview guide, Attachment S). 
Patients: 
Screening: During screening, we will determine whether potentially eligible patients meet the 
eligibility criteria for participation in the study by reviewing inclusion and exclusion criteria. We 
will ask additional screening questions in service of obfuscating the specific purpose of the 
study until after patients have attended their medical appointment (as discussed above in 
section 5.3). All screening questions are detailed in the Patient Survey Instruments (Attachment 
Q). 
Intervention: Intervention arm participants will be asked questions after their scheduled visit 
about whether they accessed and used the MyPath website prior to their visit. They will also be 
assigned a personal code at the start of the MyPath tool. We will then ask participants to 
provide the personal code at the post-visit survey so that we can obtain analytic information on 
their use of the tool after the fact. Analytics collected using this method will include the length of 
time the patient stayed on the MyPath webpage, which modules they used, and whether or not 
they navigated to the MyPath summary page. MyPath can be viewed at va.mypathool.org and 
the MyPath Intervention Overview (Attachment C) includes example screen shots from each 
main section of the web-based intervention. 
Study Surveys (baseline, post-visit, 3 months, 6 months): Veterans in both the control and 
intervention arms will complete a demographic and health survey at baseline (at the time of 
enrollment), a post-visit survey, a 3-month survey, and a 6-month survey. The baseline, 3-
month and 6-month surveys will be completed via telephone with a study RA utilizing VA 
REDCap for data collection.  
The post-visit survey will primarily be completed online. Veterans will be sent a VA-approved 
Qualtrics one-way text message with a link to complete the post-visit survey online after their 
appointment. Veterans will receive no more than 5 additional brief Qualtrics one-way text 
messages within the three weeks following their primary care appointment to remind them to 
complete the post-visit survey. If the Veteran does not complete the post-visit survey online, 
RAs will reach out to the Veteran via telephone and utilize VA REDCap for the post-visit survey 
data collection.  

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• 
One-way text message that will be sent to Veterans to complete the post-visit survey 
online via Qualtrics:  
It’s time to complete your VA study survey:  
[Link to Qualtrics Survey] 
Thanks for contributing! Questions? Call 206-716-5901 
• 
Example reminder one-way text messages that will be sent to Veterans to complete the 
post-visit survey online via Qualtrics:  
Reminder: It’s time to do the next survey for the women Veterans study: 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Don’t forget to complete the next VA study survey to receive $50: 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Please complete this survey for “Improving Outcomes for Women Veterans”:  
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Reminder: It’s time to do the next survey for the women Veterans study: 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Don’t forget to complete the next VA study survey to receive $50: 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Don’t forget to complete your VA survey by MM/DD to receive $50! 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Survey reminder! Your responses will help VA improve care for women Vets. 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Reminder from VA! Please complete this study survey ($50 compensation) 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 

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Please complete this survey for “Improving Outcomes for Women Veterans”:  
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Reminder: Submit your next survey to help improve women Vets’ healthcare: 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Reminder: Submit survey to support women’s health at VA and receive $50: 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Please complete VA women’s health study survey by MM/DD to receive $50: 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
Reminder: Help the VA improve care for women Vets and receive $50: 
[Link to Qualtrics Survey] 
Questions? Call 206-XXX-XXXX 
 
All survey questions assessed at each timepoint are provided in the attached Patient Survey 
Instruments (Attachment Q) and summarized below. 
• 
Baseline survey: Demographics, pregnancy intentions, and whether the patient is at risk 
of unintended pregnancy (UIP) will be assessed. Baseline preconception health risks will 
be assessed. 
• 
Post-visit survey: The primary outcome of the occurrence of a reproductive planning 
discussion with SDM and the secondary outcomes of communication self-efficacy and 
family planning knowledge will be assessed among all participants. Secondary outcomes 
relating to contraceptive choices and decisions will also be assessed post-visit among 
the subgroup at risk of UIP. Whether participants discussed preconception health risks 
or received any services related to preconception health risks identified at baseline will 
be assessed among participants considering pregnancy. At the end of the post-visit 
survey we will ask questions related to use of the intervention for Aim 3, including 
collecting the users’ assigned personal codes as described above. 
• 
3- and 6-month surveys: Changes in pregnancy goals and whether the patient continues 
to be at risk of UIP will be assessed. Secondary outcomes relating to contraceptive use 
and unintended pregnancy will be assessed among the group remaining at risk of UIP. 
Preconception health behaviors, an exploratory outcome, will be assessed. 

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Aim 3 Qualitative Interview: Intervention arm patients who participate in the qualitative interview 
will be asked questions about their experience receiving the MyPath text message, using or not 
using the MyPath intervention, and using any other similar health-related tools previously (see 
interview guide, Attachment S). 
Clinic Leaders: 
Brief Demographic Survey and Qualitative Interview: Clinic leaders who complete the qualitative 
interview will be asked questions about their experience having the MyPath intervention 
provided to patients in their clinic and facilitators and barriers to implementing MyPath in clinical 
practice. See attached interview guide (Attachment S).  
5.6 Data Analysis 
Aims 1 and 2 - Sample Size: 
Sample size and power calculations are based on our primary outcome, occurrence of 
reproductive planning discussion between patient and provider with shared decision making 
(SDM), and rely on formulas specified for use in cluster randomized trials accounting for non-
use of the tool in the intervention group and attrition.[39] We estimate that the baseline 
prevalence of discussions of contraception and/or preconception health among women who 
could potentially become pregnant will be 50%, based on estimates from the nationally-
representative VA ECUUN study and our pilot study.[2] Based on field testing, we estimate that 
30% of women participants enrolled in the intervention arm who receive the text with the 
MyPath link will not actually view the tool and the sample size calculation will thus account for 
this estimated non-use. Assuming a kappa coefficient of 0.01 and attrition of 5%, a sample of 
456 patients (approximately 15 patients for each of 30 providers) will yield 80% power in 2-sided 
tests with a type-1 error rate of 5% to detect a 20-percentage point increase in reproductive 
planning with SDM to 70%. This difference is clinically meaningful and consistent with what we 
observed in our pilot (22% increase). 
Aims 1 and 2 - Missing data and subject dropouts: 
For the 3- and 6-month follow-up periods, we assume 20% attrition (15% lost to follow up and 
5% who either become pregnant or change to desiring pregnancy). This is a conservative 
estimate based on 7% attrition at 3-months in our pilot. All appropriate efforts will be made to 
avoid missing data, including monitoring of missingness and subject dropout rates by the PI and 
study manager or research coordinator biweekly during the study data collection phase. The 
research coordinator will investigate causes and remedies. For key analysis variables that have 
15% or more missing values, we will analyze factors that are associated with having a missing 
value and perform a sensitivity analysis using multiple imputation to allow an unbiased analysis 
for all subjects. 
Because informative missingness would violate the covariate-dependent missing at random 
(CDMAR) assumption of the standard multiple imputation procedure, we will conduct sensitivity 
analyses in which we multiply impute missing data under plausible informative missing data 
mechanisms – in particular, lower contraceptive continuation rates among participants with 
missing values of this outcome, in one or both arms.  In all analyses, we will check for 
departures from model assumptions. 

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Aims 1 and 2 - Outcome Analyses: 
Intention to Treat:  Primary analyses of treatment effects will be intent-to-treat, with participants 
analyzed in the groups to which they were originally assigned irrespective of whether or not they 
received the intervention. Therefore, participants who “cross-over” from their assigned study 
arm will be analyzed in their originally assigned group.  Participants will be withdrawn/removed 
from the study and excluded from analysis after enrollment in either of these circumstances:  
• 
Participants who do not attend their scheduled visit with the study provider after 
enrollment (and thus have an undefined outcome for patient-provider reproductive 
planning discussion). 
• 
Participants who find out they are pregnant during their enrollment visit (and thus would 
have been ineligible had this been known prior to enrollment).  
Secondary analysis will utilize causal inference methods (e.g., using instrumental variables) to 
estimate the treatment effect between participants who actually used the MyPath tool vs. those 
who did not (i.e., accounting for adherence).  
 
Analytic Subgroups:  Certain secondary outcomes will be analyzed only among a pre-defined 
cohort/subgroup of participants. Assignment to these groups is made at patient 
screening/enrollment (pre-intervention).  Definitions of the full sample and analytic subgroups 
are as follows: 
• 
The full sample: includes all individuals who are eligible for and enrolled in the study 
based on inclusion/exclusion criteria (capable of pregnancy with no prior history of 
hysterectomy, oophorectomy, sterilization, not currently pregnant, interested in receiving 
information about either pregnancy planning or birth control, and able to receive VA text 
messages).    
• 
At risk of unintended pregnancy (UIP):  a subgroup of the full sample defined as 
having had sex with a man in the past 12 months who has not had a vasectomy and not 
currently seeking pregnancy. Outcomes related to contraception will be assessed in the 
subgroup at risk for UIP. 
• 
Considering pregnancy: a subgroup of the full sample who are considering or 
ambivalent about pregnancy in the next few years. The exploratory preconception health 
behaviors outcomes will be assessed in this subgroup. 
 
Description of the study populations: Provider, patient, and clinic leader participants will be 
described through summary statistics of demographic characteristics, and for providers, practice 
characteristics. 
Aim 1 Primary Outcome: The analysis for our primary outcome of patient-provider discussion of 
reproductive planning with share decision making (SDM) will be assessed post-visit in the full 
sample. For our Aim 1 primary outcome analysis, we will use a mixed effects logistic regression 
model to test whether the odds of occurrence of reproductive planning with SDM is significantly 
different in the intervention versus control arm post-visit. In addition to estimating the odds ratio, 
we will also estimate the difference in predicted probabilities between the intervention and 
control group. 
Covariates to be included in adjustment models are as follows: 

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• 
Study site (categorical) 
• 
Clinic practice-type (binary) – Women’s Clinic Y/N 
• 
Visit Type (virtual/telephone vs. in-person) 
• 
Patient Age (categorical) 
• 
Patient Race/ethnicity (categorical) 
• 
Patient Household Income (categorical) 
• 
Patient Marital Status (categorical) 
• 
Patient Parity (categorical)  
• 
Mental Health Diagnosis (one or more, binary) 
• 
Medical Comorbidity (one or more, binary) 
 
Aim 1 Secondary Outcomes:  Secondary outcomes for Aim 1 will be assessed post-visit.  
Secondary outcomes assessed in the full sample include provider-patient communication self-
efficacy and reproductive planning knowledge. Secondary outcomes assessed in the subgroup 
at risk of UIP include contraceptive decisional conflict, values concordance, and contraceptive 
method decision. We will use a mixed effects logistic regression model to test whether these 
outcomes are different in the intervention versus control arm post-visit. 
Aim 2 Secondary Outcomes:  Secondary outcomes for Aim 2, including continuous 
contraceptive use, consistent contraceptive use, and unintended pregnancy, will be assessed at 
3- and 6-month follow up in the subgroup at risk of UIP.  We will use a mixed effects logistic 
regression model to test whether outcomes differ between groups. For continuous and 
consistent contraceptive use outcomes, we will adjust for self-reported pre-study contraceptive 
use (measured at the post-visit survey).  
Exploratory Preconception Health Behaviors: These outcomes will be assessed among a 
subgroup of study participants considering pregnancy in the next few years or who are 
ambivalent about pregnancy (unsure). Preconception risk factors will be measured at baseline 
and using medical record data, and behaviors to modify those risk factors will be assessed at 
post-visit, 3-months, and 6-months. 
Exploratory Analyses of Interaction Effects: For Aim 1 and 2 outcomes, we will assess 
modification of the effect of assignment to the intervention by the following 4 pre-specified 
factors: age, race/ethnicity, visit modality (in-person or virtual) and clinic type (Women’s Health 
Clinic yes/no).  We will assess evidence for effect modification by adding the effect modifier and 
its interaction with the treatment assignment indicator to the primary analysis models specified 
above.   
Exploratory Analyses of Patient-Centered Contraceptive Outcomes: Recognizing that 
pregnancy intentions may fluctuate and participants in the subgroup at risk of UIP may decide 
that they wish to pursue pregnancy during the study timeframe, we will create “goals-
concordant” measures for both continuous contraceptive use over 6 months and consistent 
contraceptive use at 6 months. Goals-concordant continuous contraceptive use will be defined 
as non-continuous use among women who desire pregnancy now; any continuous use outcome 
among women who are not trying but would be okay with pregnancy; and continuous use 
among women who desire pregnancy later, never, or who are not sure. Goals-concordant 

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consistent contraceptive use will be defined as no method or inconsistent use among women 
who desire pregnancy now; no method, inconsistent use or consistent use among women who 
are not trying but would be okay with pregnancy; and consistent contraceptive use among 
women who desire pregnancy later, never, or who are not sure. 
In addition, we will create a “goals-concordant” reproductive behaviors outcome at 6 months, 
combining consistent contraceptive use and folic acid supplementation. Goals-concordant 
reproductive behavior will be defined as taking folic acid among women who desire pregnancy 
now; taking folic acid or consistent contraceptive use among women who are not trying but 
would be okay with pregnancy or who are unsure; and consistent contraceptive use among 
women who desire pregnancy later or never. 
Aim 3 – Analysis Plan 
Quantitative analyses will involve both MyPath analytics data and estimated cost data and will 
provide summary statistics such as total cost estimates, means or medians (e.g., of time spent 
using the tool), and proportions (e.g., of participants who used the tool, or who used specific 
components of the tool), etc. These analyses will be descriptive. 
 
The qualitative interviews will be recorded, transcribed, and analyzed. Transcripts will be 
analyzed using inductive and deductive content analysis, which will allow us to obtain specific 
information about implementation barriers and facilitators as well as capture unanticipated 
themes and previously unidentified factors[41]. We will (1) deductively develop a priori codes 
based on the specified RE-AIM domains in Table 8, and (2) inductively create emergent codes 
to capture data that do not fit a priori codes. Two trained coders will independently code all 
transcripts. For each group separately (Veterans, providers, clinic leaders), we will begin with an 
initial codebook using our a priori codes and then add codes as they emerge[42, 43].To 
maintain the iterative process even as the final codebooks are applied, open codes will continue 
to be developed and added to the codebooks. Transcripts coded before addition of the new 
codes will be reexamined with the updated codebooks to ensure consistency. All analyses will 
be facilitated by use of ATLAS.ti software. Code output will be reviewed and discussed amongst 
the investigator team to identify common themes within and across groups. 
Staff Analysis Responsibilities and Involvement: 
The PI/SC and study biostatisticians are responsible for overseeing the analysis of all Aim 1 and 
2 outcomes. The VA-employed study data analyst will be responsible for carrying out Aim 1 and 
2 analyses in VA computing space, using STATA, SAS or R software packages. The PI/SC and 
Qualitative Methodologist are responsible for overseeing the analysis of all Aim 3 qualitative 
interviews. The PI/SC, study manager, research coordinator, and qualitative methodologist will 
be involved in the Aim 3 qualitative data analysis, including coding and synthesis of qualitative 
findings. Qualitative analysis will be facilitated by Atlas.ti software housed in VA computing 
space. 
Co-I and Collaborator involvement: Study co-investigators will collaborate with the Puget Sound 
team to do analysis for the study. Co-Is will be involved to inform high-level analysis planning 
and preparation of findings for publication or presentation. Non-LSI Co-Is, including Karin 

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Nelson and Alison Hamilton will have access to de-identified data only, and will not have access 
to any participant PHI. 
5.7 Withdrawal of Subjects 
As discussed above in the Intention to Treat approach of section 5.6, we plan to withdraw 
participants from the study after enrollment under two circumstances. Both of these criteria will 
be assessed at the start of the post-visit survey and withdrawal would happen before 
assessment of any study outcome measures. The patient information statement (Attachment J) 
details the circumstances in which a patient could be withdrawn from the study. Participants will 
be removed from the study and excluded from analysis after enrollment in either of these 
circumstances:  
• 
Participants who do not attend their scheduled visit with the study provider after 
enrollment (and thus have an undefined outcome for patient-provider reproductive 
planning discussion). 
• 
Participants who find out they are pregnant during their enrollment visit (and thus would 
have been ineligible had this been known prior to enrollment).  
 
Research participants may withdraw from the research at any time by notifying an RA or LSI. 
Participants may withdraw permission for the research team to access their medical record data 
by notifying an RA or LSI in writing. RAs and LSIs will notify the PI/SC, study manager, and 
research coordinator of any withdrawals. The PI/SC, study manager, research coordinator, or 
database manager will set the status of the participant to “Withdrawn/Do not contact” in the 
patient crosswalk, preventing further contact for study follow-up. There will be no consequences 
to the participant if they choose to withdraw from the research. 
6.0 
Reporting 
No Serious Adverse Events (SAEs) are expected as a result of this study. The intervention 
will deliver guideline-concordant information and care. Other study procedures, including 
telephone surveys and qualitative interviews are minimal risk. Participants in this study will not 
receive any information or be asked questions outside of what they are recommended to 
receive in guideline-concordant primary care. 
We will adhere to CIRB requirements for reporting of unanticipated problems, such as breach of 
confidentiality or loss of study documents containing PHI. CIRB requires reporting of these 
problems in writing within 5 business days. 
We will adhere to CIRB requirements for reporting of adverse events (AEs) at continuing review 
and at study closure. As detailed in the crisis protocol (Attachment E), RAs will report any 
adverse patient reactions to survey questions to the PI/SC, their LSI, and the study manager as 
soon as possible.  
Quarterly meetings with study investigators and study personnel will occur to discuss issues 
such as study progress, modifications, documentation, recruitment, retention, data analysis and 
confidentiality and to address any issues or concerns as they arise. These meetings will be 
overseen by the PI/SC. 

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Given the minimal risk to study participants from this intervention that delivers guideline-
concordant health information, we propose a Data Safety Monitoring Plan, with the frequency of 
data monitoring as outlined in Table 3 below. 
Table 3. Data Monitoring 
 
7.0 
Privacy and Confidentiality 
Description of PHI used in study 
PHI of study participants will be collected from three main data sources. The sources and 
identifiable data fields that will be collected are described below. 
• 
CDW or other Electronic Health Record repository for patient data (Aims 1&2):  
Identifiable information about patients will be obtained from CDW or its replacement 
database following the Cerner electronic medical record transition (Scheduled for October, 
2020 in Seattle, WA). A list of CDW data fields and electronic health record codes used for 
the study is provided in the Administrative Data Sources and Codes document (Attachment 
D). The study data requisitioner will pull data as described below, using the VA Informatics 
and Computing Infrastructure (VINCI). Data will then be saved in the study data folder on 
the secure VA network. 
Recruitment:  
Providers: Names and VA facilities of potentially eligible providers will be pulled from 
CDW. These PHI fields are necessary for confirming eligibility for recruitment, to look up 
the provider contact information in the VA Outlook Global Address Book for recruitment 
purposes, and to identify the provider site and practice type (women’s health clinic vs. 
non-women’s health clinic) of providers for randomization purposes.  
Patients: Before study recruitment begins, and at 6 and 12 months into study 
recruitment, we will pull lists of potentially eligible patients assigned to enrolled providers’ 
panels. These are the patients to whom we will mail recruitment letters. The lists will 
include patient names and mailing addresses. Real SSNs will be accessed as they are 
necessary to look up patient medical records in CDW in order to determine potential 
subject eligibility and later to pull and match data from CDW to the patient-reported data 
as described below. SSNs are also required by the VA R&D Purchasing and Fiscal office 
to process subject payments. We will send unencrypted recruitment emails with no 
sensitive information to Veterans up to two weeks prior to the patient’s appointment and 
will notify recipients not to reply to the email. We instead provide two ways for Veterans 
Data type 
Frequency of review 
Reviewer 
Subject accrual (adherence to 
protocol inclusion/exclusion) 
Bi-Weekly 
PI/SC and Study Manager or 
Research Coordinator 
Adverse event rates  
Bi-weekly 
PI/SC and Study Manager or 
Research Coordinator 
Protocol adherence (use of tool in 
the intervention group)  
Bi-weekly 
PI/SC and Study Manager or 
Research Coordinator 
Data quality, including missingness 
Bi-Weekly 
PI/SC and Study Manager or 
Research Coordinator 

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to contact us with questions or to tell us they are not interested in the study: first, they 
may complete the Qualtrics survey (unique link embedded in the email) which asks them 
if they would like to be contacted by the study team by phone (or not); second, they may 
call the study manager at the number listed in the email. 
Covariate and Outcome Variables:  
We will pull data to describe the enrolled patient population, include in our analysis 
models (covariates) and compare reproductive health outcomes (preconception health 
and contraceptive use) between survey and medical record data. These CDW variables 
will be pulled for all enrolled patients (see Administrative Data Sources and Codes, 
Attachment D). The relevant reproductive health fields will not be identifiable or contain 
PHI; however, patient SSNs will be used to pull the CDW data for enrolled participants 
and link it to patient-reported data collected during the study. Once that matching is 
complete, SSNs will only be stored in the study crosswalk and not in the analytic 
datasets. 
• 
Joint Legacy Viewer (JLV) for viewing medical record and confirming appointment status: 
For enrolled Veteran participants who are not reachable for the Post-Visit survey, study staff 
will review their medical record using the JLV application to confirm whether the Veteran 
attended or did not attend their appointment and if so, whether pregnancy was diagnosed at 
that visit. Veterans who did attend their appointment and have no pregnancy diagnosis 
documented at the visit will be included in analyses (with missing outcome values) per our 
intent-to-treat approach. Veterans who did not attend their appointment or who had a 
pregnancy diagnosed at their appointment will be withdrawn from the study and excluded 
from analyses (i.e., they are handled in the same way as Veterans reached for the post-visit 
survey). 
In addition, for Veterans not-reachable for the Post-Visit survey, but who are included in 
analyses (because they did attend their visit and were not pregnant), study staff may use 
JLV to abstract details about the study-associated visit for analysis. These details include 
whether a discussion about reproductive health or any referrals or new prescriptions relating 
to reproductive health were documented as part of the visit. These data will be recorded 
using an abstraction form (Attachment 
• 
VSSC for patient recruitment: Identifiable information about patients will be obtained from 
VSSC for the purposes of patient recruitment. During the active patient recruitment phase, 
weekly recruitment lists of potentially eligible patients scheduled to see an enrolled provider 
will include patient names, dates of birth, real SSNs, telephone numbers, email addresses, 
VA facility, and upcoming appointment dates. These are the lists that will be used by RAs to 
contact and screen patients by telephone and email, as well as to consent and enroll 
patients by telephone. 
• 
VA Outlook Global Address Book (Aims 1-3): The contact information of potentially eligible 
providers and clinic leaders will be obtained via the VA Outlook Global Address Book for 
recruitment purposes. 
• 
Audio recorded qualitative interviews (Aim 3): Interviews with employees and patients will 
take place over the phone or via MS Teams. No names or other identifiers will be included 
on audio recordings or in transcripts; however, voiceprints themselves are considered 
identifiable.  
Data Security Measures 

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A number of steps will be taken to ensure confidentiality and data protection throughout the 
study to minimize risk breach of privacy or confidentiality to VA employees (providers and clinic 
leaders) and Veteran participants. 
Data Storage 
Physical Documents/Data: Physical study documents containing any PHI or de-identified data 
will be stored in offices at HSR&D centers at each of the three engaged study sites within 
locked filing cabinets. Physical documents will not be removed from VA badge-access protected 
or locked office areas and will be stored in a locked filing cabinet. At each site, the LSI will be 
responsible for ensuring that only approved study staff have access to any physical study 
records stored this location. 
Electronic Documents/Data: Electronic study data aside from MyPath analytics data (addressed 
below) – including all protected health information (PHI) and de-identified analytic datasets – will 
be stored in secure, password protected study folders and/or SQL databases on the Seattle 
HSR&D network or within the secure VA VINCI workspace. Access will be restricted to the study 
team. Study staff at VASLCHCS and VAPHS will be provided access to these Seattle HSR&D 
study folders, which will be accessible through the VA network. Protected health information will 
not be disclosed, copied, transmitted by email, or transmitted in total or in part to anyone not 
connected with the approved protocol and not approved by the VA (via a Data Use Agreement, 
if necessary) to access the identifiers. All data will be secured in accordance with Puget Sound 
Center of Innovation for Veteran-Centered and Value-Driven Care (COIN) policy, according to 
VA regulation requirements set forth by the Veterans Health Administration (VHA) Handbook 
1200.12. To ensure confidentiality and protection of subject data, data will only be analyzed and 
stored electronically on secure servers at the COIN or within secure VA VINCI workspace. Anti-
virus protection is maintained on all servers and workstations at the COIN office. All 
workstations and servers are physically secured in locked offices, reside behind the VA firewall, 
and fully participate in Windows NT security. The study data folder will be further safe-guarded 
against unauthorized access by network user login authentication controls, including strong 
password requirements that will only be given to IRB-approved study staff. In no case will 
patient identifiers or data be provided to any person or entity outside the IRB-approved study 
team, and we will ensure that all study results are presented in a way that no individual can be 
identified. 
MyPath Analytics Data: Analytic data for the MyPath tool, including participants’ use of 
the tool and time spent on each section of the tool, will be stored on a server maintained 
by Nitid Bit, LLC, the developers of the MyPath tool. Enrolled patients in the intervention 
group who use MyPath will be assigned a personal code consisting of two words and a 
number at the time of MyPath use that is not identifiable. Participants will have the option 
to save this code to their personal device, if they wish. Analytic data will be stored on the 
non-VA MyPath server by this personal code without any identifying information. The 
analytic data, which will not have any identifiers, will be encrypted and transferred to a 
secure VA server by the software developer team prior to any analysis. At the end of the 
post-visit survey, study staff will request that women share their personal codes. The 
personal codes will be linked to participants’ Study ID and identifying information only 
behind the VA firewall in a secure crosswalk separate from the data. Users who choose 

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to email their MyPath “summary page” to themselves may enter their email address into 
the tool but that information is immediately deleted and is not saved in any database. 
Storage and Security of Audio Recordings: Interviews will be audio recorded using a VA 
approved audio recording method. VA-approved physical audio recorders, insofar as they are 
used, will be kept physically secure and stored in a locked filing cabinet. If and when such a 
device is taken to another location, the device will be secure on the study staff who uses it. 
Regardless of the audio recording method used, study staff will download digital recordings to 
the study data folder on the secure VA network, after which the interviewer will delete the data 
from its original storage location, as soon as is feasible following an interview. For transcription 
services, we intend to use the VA Central Transcription Services Program (CTSP) and thus plan 
to transfer the audio files via the secure VA network. Interview transcripts will be stored in the 
study data folder on the secure VA network. All recordings and transcriptions will be labeled 
using study IDs only.  
Crosswalk separating identifiers from analytic data (Aims 1-3):  
We will maintain crosswalk files linking study identifiers to study IDs and MyPath personal codes 
in Excel or similar format (e.g., Access database). We will create three separate crosswalks: 
one for providers (Aims 1 and 2), one for patients (Aims 1 and 2), and a third for qualitative 
interviewees (Aim 3). Lists of four-digit Study ID numbers will be generated randomly using 
STATA software and assigned to participants as they are enrolled. After study data collection is 
complete, identifiers will be scrubbed from files used during data collection (e.g., REDCap 
database and recruitment lists) and the crosswalk files will become the only files linking PHI to 
participant study IDs (e.g., study analytic datasets will not contain identifiers).  
During study recruitment, the patient crosswalk will include information on all potentially eligible 
patients to whom recruitment mailings were sent so that any opt-out postcards can be tracked 
and weekly patient recruitment lists can be checked (by the study manager, database manager, 
or research coordinator) against the crosswalk to ensure that no patients are contacted by 
telephone for recruitment inappropriately. Entries in the patient crosswalk for non-enrolled 
potentially eligible patients will be removed at the end of study recruitment, and all remaining 
patient and provider recruitment lists will be destroyed at that time. Thus, only PHI on enrolled 
study participants will be retained after the conclusion of the active patient recruitment phase. 
The crosswalks will be password protected and kept in a separate folder from the analytic 
datasets within the study data folder on the secure VA network. Only CIRB-approved study staff 
will have login access to the folder containing the study crosswalk files.  
Analytic datasets will not include SSNs, names, dates of birth, appointment dates, or other 
identifiers. Only aggregate data will be presented to external audiences.  
Staff Training and Data Access:  
The PI/SC will hold overall responsibility for ensuring that all study staff have received training in 
VA data security procedures and protection of PHI.  
The PI/SC, study manager, research coordinator, data requisitioner, and database manager at 
the PI/SC site will have access to study identifiers, including the study crosswalks and 

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recruitment lists. The LSIs and RAs at VAPHS and VASLCHCS will have access to site-specific 
provider and patient recruitment and follow-up lists but will not have access to the study 
crosswalk files. The site-specific recruitment and follow-up lists will be stored in separate, 
password protected sub-folders so that the LSIs and RAs from each engaged site will have 
access only to their site-specific recruitment and follow-up lists.  
The study biostatisticians and co-investigators who are not LSIs will have access to de-identified 
analytic datasets and analysis files, but not to any files containing PHI. The data analyst will 
have access to PHI for the purposes of data cleaning and ongoing data quality monitoring, 
which will occur prior to de-identifying the datasets. 
The PI/SC and study manager or research coordinator will be responsible for notifying CIRB of 
removal of any study staff who no longer work on the study or need access to study data files 
and removing study folder access for staff who no longer require access. 
8.0 
Communication Plan 
The study PI/SC will be the point of contact for ensuring that any deviations from the protocol or 
Unanticipated Problems will be promptly reported and communicated to CIRB. The PI/SC is 
also responsible for communicating any unanticipated problem that may impact the conduct of 
the study and any protocol, document, or study procedure changes to LSIs and RAs at all 
engaged sites.  
Prior to the start of study enrollment, the PI/SC and overall study manager will host an 
interactive orientation for all study staff involved in data collection (RAs and research 
coordinator) about the study protocol, including study recruitment, screening, consent, 
enrollment, data collection, participant withdrawal, study communication, and data security 
procedures. The study manager will be responsible for storing documentation of R&D-required 
staff trainings for all study staff who have access to the study data folder. The PI/SC will hold 
study meetings at least quarterly during data collection phases of the study. All study staff will 
be included on meeting invitations, and at least one study staff from each engaged site will be 
required to attend each study meeting. These meetings will be a forum during which study 
progress, successes, challenges, problems, and potential solutions can be discussed. Topics 
for discussion will include study communication methods, updates or changes to study 
procedures, screening and recruitment rates, follow-up rates, data quality, and adverse events. 
Email will be used to communicate changes, updates, and any problems between study staff 
and the PI/SC between study meetings. RAs and the research coordinator will be instructed to 
raise routine questions and challenges they encounter during study recruitment and data 
collection with their LSI and the overall study manager. The LSI and overall study manager will 
both be jointly responsible for responding to RAs and for raising issues to the attention of the 
PI/SC as needed. All study staff will be instructed to notify their LSI, the overall study manager, 
and the PI/SC without delay in the case of any adverse event, protocol deviation, loss of study 
data, breach of confidentiality, or other unanticipated problem. The PI/SC will be responsible for 
notifying the VA Puget Sound Information Security Officer and Privacy Officer immediately after 
becoming aware of any breach of secure data or improper use or disclosure of study data.  
The PI/SC and overall study manager at VAPSHCS will be the points of contact for CIRB and 
will be responsible for ensuring the study obtains and maintains CIRB approvals. LSIs at each 
engaged site will be responsible for obtaining local R&D approval for the study. The PI/SC will 

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work with the local study contacts at the non-engaged sites to notify the Associate Chief of Staff 
of Research at each non-engaged site about the study. 
The study PI/SC assumes primary responsibility for oversight of study logistics; data collection; 
data analysis; and synthesis of findings into feedback reports. The PI/SC will assume 
responsibility for ensuring the study meets overall project deadlines and adheres to the 
proposed timeline; communication with study team members and participants about study 
events and results; and timely reporting of study findings to operational stakeholders, VA 
researchers and the scientific community. 
 
 
 
9.0 
References 
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34. 
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