INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT) (CDA 13-267)
Phase: NA
Conditions: Prediabetes
Sponsor: VA Office of Research and Development

 
 
 
 
 
INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT) 
NCT Number: NCT03403231 
March 15, 2021 
Protocol/Human Subjects Application

 
 
 
 
1.  Human experiment to be done: 
 
a) Briefly describe the purpose of this study. 
 
• 
To determine the effects of 5 innovative strategies from behavioral economics and health psychology 
on weight and HbA1c among Veterans with prediabetes;  
 
• 
To determine the effects of 5 innovative strategies from behavioral economics and health psychology 
on behaviors to prevent T2DM and mediators of these behaviors among Veterans with prediabetes; 
 
• 
To evaluate the acceptability to and feasibility among patients of strategies from behavioral economics 
and health psychology that aim to increase engagement in behaviors to prevent T2DM among Veterans 
with prediabetes. 
 
 
Given our limited funding timeline, we strongly feel that this is the best solution to complete our study 
at our target date and thus ensure support staff are funded throughout the end of the study.    
 
b) Briefly describe the scholarly or scientific rationale 
 
 
There is tremendous national enthusiasm for translating and disseminating efficacious strategies to 
prevent type 2 diabetes mellitus (T2DM). Yet, little attention has been devoted to how we can better 
leverage the processes through which patients receive information about prevention of T2DM to 
better engage them in such prevention. Further, despite efforts to disseminate structured programs, 
many patients at high risk for developing T2DM may still be unable or unwilling to access them. In 
these cases, increasing patient engagement in individually directed lifestyle change or 
pharmacotherapy is critical. Strategies developed in the fields of behavioral economics and health 
psychology hold significant promise for improving Veteran engagement in each of these approaches. 
To date, however, these strategies have rarely been translated into real-world settings where they 
could benefit Veterans. This novel work will address this critical gap and could transform 
communication with Veterans about prevention in ways that will improve their health outcomes. 
 
 
The following 5 strategies will be implemented in the weekly messages that study participants will 
receive: (1) tailoring to aspirations in life; (2) implementation intentions; (3) preference checklists; (4) 
urgency framing; (5) social norms. We will implement these strategies alone and in combination in a 
16-arm fractional factorial design experiment (i.e., a full factorial design).  
 
 
Each of these 5 strategies has been developed and examined in other decision contexts as a 
way to increase engagement in recommended behaviors that have potential long-term benefits but 
suboptimal levels of engagement. Therefore, each of these 5 strategies has great promise to 
increase at-risk Veterans’ engagement in behaviors to prevent diabetes, for which there are similarly 
potential long-term benefits but suboptimal levels of engagement in VA. For example, tailoring 
messages to aspirations in life is an approach our team has developed that aims to help individuals 
perceive behaviors as being congruent with their life goals, values, and aspirations. Such congruence 
is termed integrated regulation, which produces a more autonomous form of motivation that is more 
likely than other forms of extrinsic motivation to yield sustained healthy behaviors. We recently pilot 
tested the acceptability, feasibility, and preliminary efficacy of this type of tailored messaging among 
obese University of Michigan employees who want to lose weight. Implementation intentions ask 
individuals to craft “if-then” statements that specify the when, where, and how of goal striving in 
advance. This approach has successfully increased goal attainment in a variety of contexts, including 
for health-related decisions such as uptake of influenza vaccinations.9 Preference checklists are a 
choice architecture modification in which individuals are asked to consider a list of choice-relevant 
factors that individuals in their situation might want to consider, but often do not. This strategy aims to 
“frame the future first” and has been shown to increase savings for retirement. Urgency framing is a 
messaging strategy that seeks to make the future feel more proximal, thus prompting immediate 

 
 
 
action and minimizing procrastination. Making messages more urgent has been shown to prompt 
action around pro-social behaviors such as reducing adverse environmental impacts or donating to a 
charity. Social norms aims to encourage individuals to focus on what they think someone important to 
them would say they should do at a decision point.  Based on existing behavioral economic literature, 
we anticipate such focusing on a pro-social norm will prompt preventive action.  
 
 
Because these 5 approaches have great promise to increase engagement in recommended 
behaviors that have potential long-term benefits but have not been translated into the context of 
diabetes prevention among Veterans, a main goal of this project will be to measure the acceptability, 
feasibility, and preliminary efficacy of using VA Secure Messaging to deliver these strategies to 
Veterans at risk for diabetes. 
 
 
c) Describe the site(s) and setting where the research will take place. 
 
We may consent up to 200 patients to ensure we can randomize 144 VA Ann Arbor Healthcare 
System patients into our intervention.  Consenting extra patients will ensure that those who do not 
complete the baseline survey or for some reason cannot be randomized are not included in our final 
study sample of 144. Patients who meet preliminary eligibility criteria consist of MyHealtheVet 
Secure Messaging users or those willing to sign up for Secure Messaging, and have had a HbA1c 
test result approximately 6 months prior to recruitment in the prediabetes range according to 
ADA/CDC guidelines. Ann Arbor will be the only participating site and patient contact will typically 
occur through telephone, mail, and VA MyHealtheVet Secure Messaging.    
 
d) How will you identify and recruit participants for the research study? 
 
VA staff may not retain individually identifiable patient records for a research study  
 
before receiving final approval by VA R&D and IRB. 
     (Explain if you will be using recruitment letters, flyers, brochures, e-mail. The VA does not allow cold-calling by 
     telephone call to VA patients without a prior mailed letter.) 
 
At the start of each month or beginning of each week, during the recruitment period, we will pull a 
random patient sample from the VA Medical SAS Inpatient & Outpatient Files, Corporate Data 
Warehouse (CDW), and Local (Ann Arbor) Vista System of Veterans currently using MyHealtheVet 
secure messaging (or are willing to sign up) and have had a HbA1c test in the past 6 months that 
meets the ADA/CDC classification for prediabetes. Veterans will be excluded from the generated 
sample if they have recently completed a weight loss program (e.g., MOVE!), are trying to lose 
weight and are very physically active, are >75 years of age, pregnant, taking metformin, have 
participated in the FINDIT study (the preceding sister study under the same grant funding), have 
been hospitalized or received rehab for stroke or myocardial infarction within past 6 months, are 
receiving chemotherapy for cancer, or have any International Classification of Diseases (ICD-9/10) 
codes for T2DM, dementia, major functional limitations, cirrhosis, Global Initiative for Chronic 
Obstructive Lung Disease (GOLD) stage 4 chronic obstructive pulmonary disease (COPD), or end 
stage renal disease (ESRD).   
 
We will use CPRS to confirm up-to-date patient information at any point after we pull patient samples 
from CDW.  This will minimize burden on patients, providers and study staff and will ensure study 
staff are aware of diagnosis changes between the date the sample was pulled and the date patients 
are considered for the study.   
 
Typically, we will generate and send recruitment packets within 1-2 business days of extracting our 
patient sample.  Potentially eligible Veterans will be mailed a letter that describes the study and asks 
them to call or email study staff in the next 7 days if they are not interested in being contacted about 
the study. If no call is received after 7 days, study staff will call the patient to screen for and exclude 

 
 
 
Veterans who are actively engaged in a lifestyle change programs, have major functional limitations, 
New York Heart Association (NYHA) class III or IV congestive heart failure (CHF), or any other 
exclusion criteria that cannot be confirmed via CDW or CPRS.  If the patient is eligible and agrees to 
participate, the patient will provide documented informed consent. 
 
e) Briefly describe the research procedures of this study that are not part of the standard therapeutic 
care of the subject. (Are the procedures inpatient or outpatient?) (Will there be audio, video 
records?) 
(if retrospective study, please summarize planned data analysis). 
 
Summary:  We will consent up to 200 Veterans to ensure we can randomize 144 patients who 
complete the requirements for randomization. Eligible patients include those who are currently using 
MyHealtheVet secure messaging (or are willing to sign up), meet inclusion/exclusion criteria, and 
have received an HbA1c test within the last 6 months that meets the ADA/CDC classification for 
prediabetes. Study participants will be surveyed  about their engagement in behaviors to prevent 
TDM2 and mediators of this engagement.  After completing a baseline survey, participants will be 
randomly assigned to receive different novel presentations of information about ways to prevent 
T2DM through both Secure Messaging and US Mail. We will test the 5 presentations that each: (1) 
represent an innovative approach from behavioral economics or health psychology with great 
promise to increase engagement in behaviors to prevent T2DM among patients with prediabetes; 
and (2) have not been tested in this setting. While there are other approaches from these fields we 
could test, we feel these 5 strategies constitute an exceptional blend of innovation, scalability, and 
feasibility within the contexts of a CDA and existing VHA care systems. 
 
CDW Sample:  Our sample will consist of Veterans who received an HbA1c test between 5.7 and 6.4 
in the past 6 months and who meet preliminary eligibility criteria.  Preliminary eligibility criteria will be 
defined as inclusion/exclusion criteria that can be confirmed through CDW data extraction (e.g., 
recent HbA1c test, diagnoses, age, engagement in VA MOVE!, and medication).  Other eligibility 
criteria that are more difficult to confirm via CDW will be asked during the recruitment and screening 
process.  For example, we will exclude those who have had 4 or more MOVE! visits in the last year 
from CDW, but will find out if patients have recently participated in other weight loss programs when 
they are screened for eligibility over the phone.  We have included an eligibility screener with this IRB 
amendment.   
 
Depending on our recruitment demand, the number of patients who meet preliminary study criteria, 
and our available resources, we will generate a random sample of up to 50 Veterans weekly, or 200 
Veterans monthly.   
 
If at any point we cannot consistently identify enough Veterans who meet all preliminary eligibility 
criteria, we will consider extracting a list of patients who meet all criteria with the exception of the 
HbA1c requirement.  In this situation, we will generate a list of patients who are due for HbA1c tests 
per the VA/DoD Guidelines and can satisfy this requirement before enrolling in the intervention.  
Similarly if needed, we will also consider extracting a sample of patients who meet all requirements 
with the exception of enrollment in MyHealtheVet Secure Messaging and elicit their willingness to 
sign up per our eligibility criteria.  Only those who are willing to sign up and eventually do will be fully 
enrolled into the study.   
 
Recruitment 
 
Recruitment Summary: We would like to design our recruitment process using the same model we 
used for the FINDIT study.  Typically, consent and HIPAA forms were filled out and sent back to us 
via mail; however we found that giving the patient the option to meet study staff in person at the 
VAMC increased the chances of Veterans completing the full consent process.  For FINDIT, we did 
not initially provide the opportunity for Veterans to meet us in person at the VAMC, however due to 

 
 
 
the number of requests by Veterans we submitted an IRB amendment to provide this 
accommodation.    
 
Given our recruitment timeline and personnel resources it would not be feasible to require all 
Veterans to meet us in person at the VAMC to enroll into our study. In addition, given that all aspects 
of the study can be completed remotely, it would be an unnecessary burden to require all Veterans to 
meet us in-person at the VAMC.  We are simply allowing Veterans to meet us at the VAMC at their 
request.   
 
Recruitment Sample/Mailing: After receiving the patient sample frame, we will mail to each potential 
patient a recruitment packet that will include a recruitment letter, business reply envelope (BRE), 
informed consent document and a HIPAA authorization form.  These documents will explain the 
study, allow for a quick response for eligible and interested patients, and provide contact information 
for inquiries or to opt-out of further consideration.  Patients may opt-out by telephone or by using the 
enclosed BRE to mail back the recruitment letter with the opt-out box checked.   
 
For patients that are interested in participating in our study, we will allow them to meet us at the 
VAMC to return the consent, HIPAA or any other study-related documents if it is more convenient for 
them.  If a patient expresses interest to participate, but is unable to receive the recruitment packet or 
any other study materials by mail or MyHealtheVet, then we issue these in-person at the VAMC.  
However, we will typically correspond with patients via phone, mail, or MyHealtheVet Secure 
Messaging.    
 
Given the low risk nature of this study and the fact that Veterans will have an opportunity to address 
any questions or concerns during recruitment calls, we did not provide detailed descriptions of each 
arm in our informed consent form.  Our concern was that presenting 16 different descriptions, all of 
which have just slight variations, would cause confusion or create misconceptions.  8% of consented 
FINDIT patients initially sent back their opt-out form, but after discussing the study with study staff 
(staff contacted patients before the opt-out form was received in the mail) were able to ask questions 
and address their concerns about the study over the phone.  Thus, we would like to learn from our 
previous experience and provide a more Veteran-centered approach to discussing the study arms 
with Veterans.  We would like to provide more explicit details during the phone consent process so as 
to allow Veterans the opportunity to ask questions and allow study staff to address confusion or 
misconceptions.     
 
Recruitment Calls: We will contact patients approximately 7 days after we send the recruitment 
packet, provided that they haven’t opted out of study participation.  Study staff will not leave more 
than three consecutive telephone messages for potential participants without a callback. 
 
Study staff will assess by phone each patient’s interest and suitability for study participation.  For 
those that are interested in enrolling, study staff will use an eligibility screener to ensure each patient 
meets all inclusion/exclusion criteria.  We will maintain the records of all potential and actual study 
participants to ensure those that are uninterested, ineligible, or deceased are not called again after 
we’ve made a disposition.   
 
First Survey:  After providing informed consent, the patient will complete the First (Baseline) survey.  
This survey will include questions on demographic characteristics, patient activation, health literacy, 
perception of risk for T2DM, motivation to prevent T2DM, knowledge of strategies to prevent T2DM, 
self-efficacy to engage in behaviors to prevent T2DM, preferences for strategies to prevent T2DM, 
physical activity, eating behaviors, and engagement in key health behaviors related to T2DM 
prevention.   
 
We will mail participants a survey packet that includes a letter with instructions for completing the 
survey and a paper version of the survey . We anticipate this survey will take approximately 30 
minutes to complete.  Patients will be given the option to complete the survey by mail or by phone.  
 

 
 
 
We will send these documents via MyHealtheVet Secure Messaging if we are unable to find a 
current address or if patients indicate a preference to receive information through this channel.  For 
their convenience, patients will also be given the option to use MyHealtheVet Secure Messaging to 
send any documents that need to be returned to study staff.   
 
Upon completion of the First Survey, we will mail to patients an incentive packet which will include a 
thank you letter and a $10 gift card for completing the survey.   
 
Randomization:  Immediately after completion of the baseline survey, study participants will be 
randomly assigned to a study arm.  We will test 5 presentations that represent innovative messaging 
strategies from behavioral economics or health psychology with great promise to increase 
engagement in behaviors to prevent T2DM among patients with prediabetes. Study participants will 
be assigned to 1 of 16 different study arms based on different combinations of the 5 different 
strategies.  We will contact patients by phone, letter, or secure message to inform them that their 
study group and intervention start date have been selected.   
 
Strategy 1 - Preference Checklists: Preference checklists are lists of choice-relevant factors that 
individuals might theoretically want to consider when making a decision about prevention, but may 
not due to time pressure, lack of knowledge or information, or competing priorities. In such checklists, 
individuals read lists of choice-relevant thoughts that would favor taking preventive action and then 
indicate which they would consider in their decision making. Evidence from the marketing literature 
suggests this strategy can encourage individuals to be more discerning about decisions with major 
future implications.   
 
Strategy 2 – Urgency Framing: In urgency framing, messages take a valence that encourages more 
immediate action around preventive behaviors that can be vulnerable to procrastination.  
 
Strategy 3 – Implementation Intentions: Implementation intentions are a self-regulatory strategy in 
which individuals use "if-then” planning for achieving goals. Evidence from the behavioral economics 
literature suggests this approach can support well habit and behavior modifications because in the “if-
then” statements individuals are asked to specify the when, where and how portions of goal-directed 
behavior. 
 
 Strategy 4 – Tailored Information: Tailored communications use information about an individual to 
determine the specific content he or she will receive and the frames surrounding the content. One 
promising way to tailor information is to link health behaviors directly to individuals’ core aspirations. 
Research from the Self-Determination Theory literature suggests this approach can facilitate 
integrated regulation for behavior change, which is the most autonomous form of extrinsic motivation 
and thus the most likely type of extrinsic motivator to lead to sustained healthy behaviors.  
 
Strategy 5 – Social Norms: This strategy aims to encourage individuals to focus on what they think 
someone important to them would say they should do at a decision point.  Based on existing 
behavioral economic literature, we anticipate such focusing on a pro-social norm will prompt 
preventive action.  
 
We will test these 5 strategies in isolation and in combination through a full factorial design (FFD) 
experiment with 16 messaging combinations. This design will allow us to measure the independent 
effects of each strategy as well as look for interactions between strategies.   
 
Self-determination theory (SDT) is an approach to modifying human behavior that builds on the 
importance of internalized forms of behavioral regulation for achieving long-term maintenance. SDT 
further postulates that humans have 3 innate psychological needs: autonomy, competence, and 
relatedness.3 Satisfaction of these essential needs promotes internalization of behavioral regulation, 
personal development, and well-being. As such, interventions that support the satisfaction of these 
needs are most likely to yield long-term healthy behaviors.  
 

 
 
 
Another major contribution of SDT has been illuminating different types of motivation, each with a 
different likelihood of producing sustained engagement in behaviors. In this typology, different forms 
of motivation and regulation lie on a continuum based on the degree to which they support autonomy 
and are thus likely to support the initiation and maintenance of healthy behaviors.16 Integrated 
regulation is the most autonomy-supportive type of extrinsic motivation and occurs when a behavior 
is congruent with what an individual values and is aspiring to accomplish. Because integrated 
regulation facilitates an internal locus of causality, once established and reinforced it is more likely to 
promote sustained behaviors. Further, integrated regulation may be more realistic to achieve in 
behavioral interventions than intrinsic motivation because, while many individuals at risk for diabetes 
may never find behaviors to prevent diabetes to be inherently enjoyable,17 all individuals have 
aspirations in life that could be facilitated by preventing diabetes (e.g., community contributions could 
be facilitated by improved physical functioning, and personal growth could be supported by greater 
self-control). 
 
Our team recently translated these insights1,2 into a tailored messaging intervention that we pilot 
tested among obese U-M employees. We first developed a novel system for linking weight loss to 
employees’ aspirations in life as measured by items from the Aspiration Index (AI).18–20 The AI is a 
105-item survey scale used in psychology research that is valid and reliable across cultures.21 The AI 
asks about 5 life goals related to each of 7 categories of aspirations: (1) wealth, (2) fame, (3) image, 
(4) meaningful relationships, (5) personal growth, (6) community contributions, and (7) good health. 
Our system used the 35 AI items that ask individuals to rate the importance on a 1 to 7 scale of each 
of the 35 goals. For each individual we computed scores for the importance of each aspiration 
(ranging from 5 to 35) to identify the 3 aspirations with the highest scores as an individual’s main 
aspirations. We then pre-tested this system with 2 focus groups of obese U-M employees and refined 
it based on their feedback.  
 
After developing and refining our approach, we conducted a 12-week pilot RCT to test the 
acceptability to participants, feasibility to deliver, and preliminary effects of this novel way to tailor 
messages among 62 obese U-M employees. In the beginning of the tailored messaging intervention, 
participants were informed of the 3 main aspirations in life we identified from their responses to the AI 
items in their baseline survey and invited to respond to an online writing prompt in which participants 
typed into a text box at least 1 way in which achieving their weight loss goals could help them 
achieve 1 or more of these aspirations, or something else important to them. This aimed to help 
individuals perceive weight loss as being concordant with their main aspirations so as to promote 
greater autonomous motivation for weight loss.4,22 Here is an example of a writing prompt that was 
sent to a participant whose main aspirations were good relationships, feeling healthy, 
and personal growth: 
 
From your responses to the survey you took at the beginning of this program, we learned that good 
relationships, feeling healthy, and personal growth are important to you. In order to stay 
motivated to lose weight and keep it off, it can help to think about how the program could help you 
achieve these and other life goals that are important to you. 
  
How could losing weight help you achieve good relationships, feeling healthy, personal 
growth, or something else important to you?   
 
Please take a moment to think about these questions and type your answers here: 
 
 
We will test these 5 strategies in isolation and in combination through a full factorial design (FFD) 
experiment with 16 messaging combinations. This design will allow us to measure the independent 
effects of each strategy as well as look for interactions between strategies.   
 
Intervention:  
 

 
 
 
The FINDIT study, the sister study of INVENT was approved to conduct secure message pre-testing 
drafts with patients to collect feedback and inform the development of the INVENT intervention.   We 
have collected feedback from Veterans about the content and have modified our drafts accordingly.  
 
Participants in all study arms will receive a series of Secure Messages through MyHealtheVet and 
monthly printouts by mail.  We chose Secure Messaging because of the growing number of 
Veterans that use technology to manage their healthcare, the large percentage of Ann Arbor VA 
Veterans signed up for MyHealtheVet and Secure Messaging, and the number of previous VA 
research studies that are currently using Secure Messaging.  Given that emails and text-messages 
(with the exception of the VA ANNIE project, which is not currently accepting new sites) are not 
permitted to communicate with Veterans, secure messaging allows for a simple, convenient, 
scalable yet patient-centered approach to delivering our intervention.   
 
We are proposing a 3 month schedule of weekly Secure Messages and monthly mailings for this 
intervention. The intervention materials and the delivery schedule are provided in this IRB 
amendment.  In total, there will be two monthly mailings that will be mailed respectively near Weeks 
4 and 8.  
 
The following 5 strategies will be implemented in the weekly messages that study participants will 
receive over the course of the 3-month active intervention phase: (1) tailoring to aspirations in life; 
(2) implementation intentions; (3) preference checklists; (4) urgency framing;  (5) social norms. We 
will implement these strategies alone and in combination in a 16-arm fractional factorial design 
experiment (i.e., a  full factorial design). The initial messages will be based on a text template that 
will vary based on the arm an individual is randomized to; for participants who are randomized to an 
arm that will receive messages tailored to aspirations this initial message will be tailored to their 
responses to the baseline survey. The weekly messages will be based on a text template that will 
vary based on the arm an individual is randomized to as well as their previous replies to the initial 
message (e.g., what an individual wrote in response to the writing prompt tailored to their 
aspirations, or in response to the implementation intention prompt).  
 
The messages will encourage the following behaviors that have been shown in previous research to 
reduce individuals’ risk for diabetes: 
 
• 
Losing at least 7% of one’s body weight  
• 
Getting at least 30 minutes of moderate physical activity (e.g., brisk walking, biking, or 
gardening) 5 times each week 
• 
Participating in a weight loss program such as the VA MOVE! program or a Diabetes Prevention 
Program  
• 
Asking one’s VA Primary Care Team about pharmacotherapy to prevent diabetes 
 
We have included with our amendment, a color-coded key that illustrates the timeline and aspects of 
the template text that will vary depending on the messaging strategies that will be implemented in 
the arm to which a participant is randomized.  
 
Final Survey: We will issue a Final Survey packet approximately 3 months after participants receive 
their first intervention message. This packet will include a letter with instructions for completing the 
survey in the same mode they used to complete the preceding survey.  This survey will take 
approximately 20 minutes to complete. Patients will be given the option to complete the survey by 
mail or by phone. 
 
We will send these documents via MyHealtheVet Secure Messaging if we are unable to find a 
current address or if patients indicate a preference to receive information through this channel.  For 
their convenience, patients will also be given the option to use MyHealtheVet Secure Messaging to 
send any documents that need to be returned to study staff.   
 

 
 
 
Upon completion of the Final Survey, we will mail an incentive packet, which will include a thank you 
letter and $10 gift card. 
 
Update April 2018: We made some slight changes to our Final Survey that help ensure we are 
capturing the most meaningful follow-up data.  
 
Follow-Up Data from CDW: While we are only collecting 3 months of survey data, we will collect 
data from the CDW on participants’ weights, HbA1c tests, prescriptions, and MOVE! visits for the 12 
months after the end of the intervention.  
 
We will explicitly explain the time period that we are requesting in our informed consent and HIPAA 
documents.   
 
f) Briefly describe the usual healthcare procedures already being performed for diagnostic or treatment 
purposes that will be used for research data collection; or N.A. 
 
We will collect data such as weights, HbA1c tests, and diagnoses that are typically collected at 
primary care visits.   
 
g) Please list and attach all research questionnaires and/or research surveys that will be administered 
to the subjects. 
(All questionnaires and surveys must be approved by the IRB.) 
 
We are planning to issue surveys at two different points: 
 
(1) Baseline  
 
(2) Approximately 3 months after receiving first intervention message 
 
We will be conducting semi-structured interviews by phone with approximately 20 study participants 
to evaluate their experience with the interventions. 
 
We will sample patients with varying levels of participation in both the interactive message arms (i.e., 
the arms that include questions in the secure messages intended to engage participants) and static 
message arms (i.e., the control arms that do not ask questions in the secure messages).  
 
Participants will be mailed a letter with a $10 gift card for completing an interview. Interviews are 
voluntary and even those who agree to complete an interview can stop at any time or refuse to 
answer any question.  For those that refuse to have the interview recorded, we will instead write 
detailed notes. Interviews will be recorded using a VA-approved DVR device and will be removed 
from the device within 24 hours. The interviews will be stored on the secure INVENT study folder on 
HSR&D's servers behind the VA firewall. Access to the interviews will be exclusive to study staff.   
 
At this time, we are not planning to transcribe these interviews.