Improving Veteran Engagement in Diabetes Prevention (CDA 13-267)
Phase: NA
Conditions: Prediabetes
Sponsor: VA Office of Research and Development

ForgIng New Paths to Prevent DIabeTes (FINDIT) 
 
NCT Number: NCT02747108 
 
March 25, 2019 
 
 
 

FINDIT Protocol and Updated Narrative 
 
Note: This document has been created to accurately show the most recent protocol for this project. 
Language has been borrowed from our R&D and Human Subjects applications. 
 
Background 
 
Study Objectives 
 
The objectives of this study are: 
 
• 
To describe perception of risk for T2DM among Veterans at risk for T2DM; 
 
• 
To describe motivation to prevent T2DM among Veterans at risk for T2DM; 
 
• 
To describe awareness of and preferences for strategies to prevent T2DM among 
Veterans at risk for T2DM; 
 
• 
To describe engagement in behaviors to prevent T2DM among Veterans at risk for 
T2DM. 
 
• 
To determine the effects of a prediabetes diagnosis and brief counseling on weight 
change; 
 
• 
To determine the effects of a prediabetes diagnosis and brief counseling on engagement 
in behaviors to prevent T2DM and mediators of these behaviors; 
 
• 
To gain deep insights into the effects of a prediabetes diagnosis and brief counseling on 
engagement in behaviors to prevent T2DM and mediators of this engagement; 
 
Scientific rationale 
 
An essential step in designing effective strategies to improve patient engagement in behavior 
change is to better understand their current levels of engagement in these behaviors and 
determine which factors most influence their engagement. However, within and outside the 
VHA, little is known about how patients with risk factors for T2DM view their risk of developing 
T2DM, what these patients understand about strategies to reduce this risk, and to what degree 
at-risk patients are currently engaging in behaviors to prevent T2DM. This project will generate 
important data on key health behaviors and their mediators in our target population, as well 
information about the effects of a prediabetes diagnosis and brief counseling on engagement in 
behaviors to prevent T2DM and mediators of these behaviors. 
 
Setting/Study Criteria 
 
During the course of the study we encountered a small, but significant number of patients who 
have consented into the study, but subsequently develop exclusion criteria such as the 
completion of an HbA1C test prior to enrollment into the intervention. Thus, we amended our 
protocol to consent a greater number of patients in order to meet our enrollment goal of 315 
randomized patients. Thus, we requested the ability to consent up to 400 patients to enroll our 

goal of 315. In addition, we also clarified that “consented” patients will refer to those who 
completed the informed consent process and “enrolled” will refer to those who completed the 
baseline requirements and have been randomized into a study group. 
 
We will consent up to 400 patients to ensure we can enroll 315 non-diabetic Veterans receiving 
primary care in the VA Ann Arbor Healthcare System or the John D. Dingell VA Medical Center, 
who meet the following inclusion criteria: willing to complete a HIPAA authorization form, no 
HbA1c results in previous 12 months, due for VA Primary Care appointment approximately 12 
weeks of sending the recruitment letter and BMI ≥ 30.0 kg/m2, or a BMI of 25.0-30.0 kg/m2 with 
≥ 1 obesity-related conditions, such as: 
 
• 
Hypertension 
• 
Hyperlipidemia 
• 
Hypoalphalipoproteinemia 
• 
Coronary Artery Disease 
• 
Hypertriglycederidemia 
• 
Past hemoglobin A1c (HbA1c) of 5.7 – 6.4 
• 
Past diagnosis of Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) 
• 
Polycystic Ovary Syndrome (PCOS) 
 
We chose these inclusion criteria because they would merit screening for T2DM within the VHA, 
are readily attainable from VHA electronic records, are based on the VA/DOD and ADA 
guidelines, and represent the MOVE!-eligible population on which our estimates of the 
prevalence of prediabetes are based. We estimate that over 19,000 VAAAHS patients will meet 
these criteria. 
 
Study Flow 
Identification of Sample and Recruitment 
 
At the start of each month during the recruitment period (T0), we will use data from the VA 
Medical SAS Inpatient & Outpatient Files, Corporate Data Warehouse (CDW), and SAS 
Inpatient and Outpatient Files or locally through Vista System to generate a random sample of 
Veterans who have an upcoming primary care appointment at the VA Ann Arbor Healthcare 
System or the John D. Dingell VA Medical Center in T0 + 12 weeks, do not have any 
International Classification of Diseases (ICD-9 or ICD-10) code for T2DM, and meet inclusion 
criteria. From this list, study staff will either filter out via CDW or review the Computerized 
Patient Record System (CPRS) to exclude patients who are >75 years of age or have diabetes, 
dementia, end stage renal disease (ESRD), severe chronic obstructive pulmonary disease 
(COPD) and using home supplemental oxygen, New York Heart Association Class III or IV 
congestive heart failure, pregnancy, or cirrhosis, are receiving chemotherapy for cancer (within 
6 months of call) or have been hospitalized or received rehab for stroke or myocardial infarction 
within past 6 months. Note: Some of this information will need to be confirmed with patients 
during recruitment calls. See eligibility script for more details. Since CPRS contains the most 
up-to-date patient information we will also use this system to confirm eligibility for the study prior 
to contact with potential participants. 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. 
 
At the beginning of the study, we will notify the facility primary care providers about the study so 
that they are aware that some of their patients may be enrolling. 

 
HbA1c results will be communicated to PACT primary care providers and PACT RN Case 
Managers via CPRS before the study team shares these results with patients so that to give 
providers have the opportunity to communicate HbA1c these test results to their patients first if 
they so choose. 
 
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 400 patients to ensure we can enroll 315 non-diabetic 
Veterans in the VA Ann Arbor Healthcare System who have a body-mass index (BMI) ≥ 30 
kg/m2, or BMI ≥ 25 kg/m2 and an obesity-related comorbidity. Study participants will be 
surveyed about their engagement in behaviors to prevent TDM2 and mediators of this 
engagement. After completing a baseline survey and HIPAA authorization form, 252 Veterans 
will be randomally assigned to undergo screening for T2DM using a hemoglobin A1c (HbA1c) 
test. The 63 Veterans whom we project will have HbA1c values in the prediabetes range will 
receive brief standard counseling about this. All 315 Veterans will have their weight tracked 
over the next year and will be surveyed immediately after the screening and brief counseling 
process, at 3 months, and at 1 year. Among the 63 Veterans with prediabetes, we will conduct 
20 semi-structured interviews to gain insights into the effects of a prediabetes diagnosis and 
brief counseling. 
 
Recruitment 
 
Recruitment 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. 
 
Recruitment Calls: We will contact patients approximately 10 days after we send the recruitment 
packet, provided that they haven’t opted out of study participation. Our study will be equipped 
with an advanced database that will filter out those who opt-out in our calling lists. This 
database will also detect duplicate SSN’s entered into the database from different CDW data 
pulls to prevent the same patient from being added to the database from separate data pulls. 
 
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. 
 
Baseline Data Collection - First Survey: After providing informed consent, we will mail 
patients an enrollment packet which will include a letter with instructions for completing the 
survey (including the study website and Qualtrics code), a paper version of the survey (for 
patients who indicate a preference to complete the survey in this format), and a BRE for mailing 
back the paper survey if applicable. We anticipate that this survey will take 20 minutes to 
complete. 
 
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. 
 
During the telephone consent process, we will elicit the survey completion preference for each 
patient. Patients will be given the option to complete the survey online, via a paper mailed 
survey, or over the phone. 
 
Online – Study staff will provide patients with the study website, www.finditstudy.com, which 
includes a URL that will redirect them to the secure Qualtrics survey. Study staff will provide by 
phone and mail (in the enrollment packet) a unique survey code for study participants to enter 
into Qualtrics when prompted. 
 
The primary reason for the website is to provide a simple redirect hyperlink to the secure online 
survey in Qualtrics. This will prevent patients from having the burden of manually typing in a 
long URL such as https://www.qualtrics.com/clients/thisstudy/cg-fjfjk22n4n5/thesurveypage- 
StudyID_189374.html. The website will also summarize the research study and provide contact 
information for study staff. 
 
No research data will be collected from the study website itself. 
 
Phone: Study staff will offer to administer the survey to patients over the phone with patients. 
This may occur either immediately after the phone consent process or at a later mutually agreed 
upon time. 
 
Paper: Patients who prefer to complete the survey on paper will be mailed a survey in their 
enrollment packet. Approximately 7 days after we send the enrollment packet, we will call these 
patients to remind them to complete the survey. Those who do not complete the First Survey 
will not fulfill the requirements for the study enrollment process and will no longer be further 
considered for the study. 
 
For patients that are enrolled in our study, we will allow them to meet us at the VAMC to return 
the paper survey or any other study-related documents if it is more convenient for them. If an 
enrolled patient is unable to receive the survey packet or any other study materials by mail or 
MyHealtheVet, then we issue these materials in-person at the VAMC. Please note that this also 
includes gift cards. 

First Survey Incentive: We will require patients to return the First Survey in order to receive the 
$10 incentive. Following the completion of the First Survey, study staff will send a First Survey 
incentive packet which will include a $10 gift card and a letter that will thank the patient for 
completing the survey. 
 
To track surveys completed online, we will frequently download completed surveys from the 
Qualtrics server and import these responses into our secure study database which will be 
housed behind the VA firewall. Our study database will notify us of patients who complete the 
survey online in Qualtrics, but have not yet been sent a gift card. 
 
Randomization to screening for T2DM: Approximately 2 weeks before their Primary Care 
appointment, we will randomize participants into one of the two study groups: 1) Blood Test 
Group and 2) Brochure Group. 252 study participants will be randomly assigned to undergo 
screening for T2DM using an HbA1c test at the laboratory of their respective VA primary care 
clinic.  Participants will have a 4/5 (80%) chance of being selected for the Blood Test Group 
and 1/5 (20%) chance of being selected for the Brochure Group. Our database will use a 
programmed algorithm that will give all participants the same chances of being randomized into 
these two groups. 
Following randomization, study staff will contact patients by phone and mail to notify them of the 
arm to which they were randomized. For those that are randomized to the Blood Test Group, 
we will obtain a preferred date for patients to complete the HbA1c blood draw and study staff 
will accordingly enter this order date in CPRS. 
 
Baseline Data Collection – HbA1c lab order and talking points 
 
Blood Test Group: Following the randomization process, for patients randomized to the Blood 
Test Group, study staff will enter an HbA1c blood test order into CPRS. Study staff will aim to 
set up the blood draw order on the same day as the patient’s upcoming Primary Care 
appointment for convenience. 
 
Information about HbA1c results: Once we obtain the HbA1c results, we will store the results in 
our study database and deliver to the patient and their primary care provider information about 
these results. We will then use the following categories based on American Diabetes 
Association and National Diabetes Prevention Program guidelines to interpret HbA1c results: 
 
• 
Normoglycemia: If results are < 5.6 then participants will be given the “normoglycemia 
information” 
 
• 
Prediabetes: If results are 5.7 – 6.4 then participants will be given the “prediabetes information” 
 
• 
Diabetes: If results > 6.5 then participants will be given the “diabetes information” 
 
HbA1c results and information will be immediately communicated to primary care providers via 
CPRS to give providers the opportunity to communicate HbA1c test results to their patients 
before the study team shares these results with the patients. Trained study staff will deliver the 
applicable information by phone approximately 1 week after the test results are available. 
 
To guarantee that all participants receive some form of information related to their HbA1c 
results, we 

will mail a brief one page sheet summarizing the applicable information with the letter for their 
Second Survey; patients should receive this around the time of the aforementioned phone call. 
 
We will send this information via MyHealtheVet Secure Messaging if we are unable to find a 
current 
address or if patients prefer this mode of communication. Given that this information is the 
heart of our research study, it is imperative that patients receive this information. Thus, we 
need as many modes of providing this information to patients as possible. 
 
Randomization to Brochure Group: The 63 participants randomized to the Brochure Group will 
not receive study ordered HbA1c blood tests. We will mail to Brochure Group participants 
general health promotion information developed by the VA National Center for Health Promotion 
and Disease Prevention. We will ask these patients to review this information prior to completing 
the Second Survey. 
 
Second Survey: Participants in both study groups will be issued a Second Survey packet 
immediately after their HbA1c test results are available (Blood Test Group) or at the time of their 
primary care appointment and/or appointment recall date (Brochure Group). This packet will 
include a letter with instructions for completing the survey using the same mode as the First 
Survey, a paper version of the survey (if applicable) and (if applicable) a paper version of the 
aforementioned information about HbA1c results. We anticipate this survey will take 
approximately 20 minutes to complete. 
 
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 Second 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. 
 
Third Survey: We will issue a Third Survey packet approximately 2 1/2 months after 
participants complete the First Survey. This survey will take approximately 20 minutes to 
complete. This packet will include a letter with instructions for completing the survey in the 
same mode they used to complete the preceding surveys. 
 
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 Third Survey, we will mail an incentive packet which will include a thank 
you letter and $10 gift card. 
 
Final Survey: We will issue a Final Survey packet approximately 11 months after participants 
complete the First Survey. This packet will include a letter with instructions for completing the 
survey in the same mode they used to complete the preceding surveys. This survey will take 
approximately 20 minutes to complete. 
 
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. 
 
12-month Weights: Patients routinely have their weights measured at each Primary Care visit. 
Thus participants will have weight measurements at the time of their scheduled Primary Care 
appointment or around the time of their recall appointment date. We anticipate that through 
usual care many participants will have another weight measurement 12 months (±1 month) 
later. 
 
Prior to the first Final Survey follow-up call, study staff will identify those who do not have a 12 
month (±1 month) weight measurement in CPRS and encourage these participants to go to their 
Primary Care clinic for a weight measurement. 
 
Interviews among Participants with Prediabetes about Their Perceptions of a Prediabetes 
Diagnosis:  To gain deeper understanding of patient perceptions of a prediabetes diagnosis 
and brief counseling, we will conduct approximately 30 semi-structured telephone interviews 
among a maximum variation purposive sample of patients who are newly diagnosed with 
prediabetes and have different levels of health literacy. We will focus on health literacy because 
of its strong relationship to patients’ self-care behaviors, receipt of recommended preventive 
services, understanding of health information, and health outcomes. We will conduct the 
interviews by phone to minimize participant burdens and maximize the response rate. These 
participants will be invited to participate in the interview after the completion of the 3rd Survey, 
which we anticipate for most participants will be approximately 6 months after their HbA1c test. 
Interviews will consist of open-ended questions to elicit information on feelings about receiving a 
prediabetes diagnosis, understanding of prediabetes and behavioral recommendations, 
facilitators of and barriers to behavior change, uncertainties about prediabetes. We anticipate 
each interview will take 30 minutes. Interviews will be audio recorded and transcribed. Consent 
to audio record interviews will be obtained during the initial informed consent process, though 
participants may choose to participate without agreeing to be recorded. We will conduct data 
analysis concurrently with data collection and will stop conducting interviews once we have 
reached thematic saturation. Prior to any contact with participants we will submit the interview 
guide for IRB approval. (Note: This has been approved by the IRB) 
 
Data Analysis 
Weights: Patients of the VAAAHS primary care clinics routinely have their weights measured at 
each primary care visit. Thus all participants will have a weight measurement in CPRS when 
they undergo brief counseling or review of health promotion literature. We anticipate that 
through usual care many participants will have another weight measurement 12 months (±1 
month) later. Participants who do not have a weight measurement in CPRS 12 months (±1 
month) later will be asked to come to the VAAAHS primary care clinic for a weight 
measurement. 
8/10/2018 Update: We would like the ability to extract weight data, our primary outcome, for 
enrolled participants who have collected weights from other VA medical centers.  We have 
identified a number of enrolled patients that either receive care at other VA medical centers 
during the winter or have moved out of state during the course of the study. Unfortunately, if 
either of these occur during the follow-up period, we are unable to collect weight data.  
While we have been able to still send and receive survey data from these participants, because 
our current medical record data (i.e., weight) data access is limited to the Ann Arbor VA 
Healthcare System, we are unable to collect weights that may have been collected at other 
facilities. By having the ability to expand our data queries to any VA facility from which our 

participants may have received a weight, we will be able to achieve a greater percentage of 
study participants with baseline and FU data.   
 
We will extract these data from VA CDW data queries.  
12/19/2018 Update: We would also like to expand our previous amendment to also allow us to 
extract data for our secondary outcome analysis, which will include MOVE visits, metformin 
use, and HbA1c labs.   
 
2/25/2019 Update: We would like to update the date range (March 2015 – December 2017) that 
was originally provided in our VA Research Data Privacy and Security Assessment form to 
coincide with our first and last randomization dates.  Our first randomization occurred on 
1/27/2016 and our final randomization occurred on 3/31/2017.  Thus, we would like to update 
our data date range from 1/27/2015 – 7/1/2018.  We strongly feel data one year prior to 
randomization and 15 months post randomization is sufficient for collecting data for all four 
timepoints and is consistent with what other similar projects (e.g., the VA DPP projects) have 
done.  (Added 3/20/2019) Given that pre/post medical data (primarily lab and weight data, but 
also MOVE participation and metformin use) are not always assessed consistently for veterans, 
we are requesting to change the range of baseline and follow-up observation dates so that we 
can increase the probability of obtaining these data." 
 
Analyses: The primary outcome will be weight change 12 months after brief counseling or 
review of health promotion literature. For this analysis, we will use a two-sample t test to 
evaluate the difference between the 2 arms. For any missing weight data, we will use multiple 
imputation. The main secondary outcomes will be changes in attempting weight loss, taking 
medication to prevent T2DM, or participating in a weight-related wellness program (e.g., MOVE! 
or DPP).  For these outcomes, we will estimate mixed-effects regression models in which we 
will use data from the baseline, 3 month, and 12 month surveys for each participant to model 
individual change over time. Other secondary outcomes will be changes in mediators of 
engagement in behaviors to prevent T2DM such as risk perception, knowledge, motivation, and 
self-efficacy. For these outcomes we will also estimate mixed-effects regression models in 
which we will use data from the baseline, immediate follow-up, 3 month, and 12 month surveys 
to model individual change over time. 
 
Interviews among participants with prediabetes will be audio-recorded and transcribed verbatim. 
We will conduct analyses concurrently with interviews, so early insights can inform subsequent 
data collection and analysis. We will code transcripts using a template analysis approach. Dr. 
Kullgren and study staff will independently review a subset of transcripts using modified 
grounded theory to identify salient themes. We will discuss the themes, refine them, and 
achieve consensus on codes and definitions. Dr. Kullgren and study staff will then 
independently code transcripts in NVivo software. First, they will independently code the same 
20% subset of the transcripts. The unweighted Cohen’s Kappa will then be calculated for each 
response and averaged to provide a single index of inter-rater reliability. Once excellent 
agreement is achieved, Dr. Kullgren and study staff will divide the remaining interview 
transcripts evenly and code these transcripts separately. Dr. Kullgren and study staff will meet 
regularly to discuss code summaries and memos.