Text Messaging to Improve Adherence To Repeat Colonoscopy In The VA: A Pilot Study
Phase: NA
Conditions: Colorectal Cancer
Sponsor: NYU Langone Health

 
 
Official Title: 
Text Messaging to Improve Adherence To Repeat Colonoscopy In 
The VA: A Pilot Study 
NCT Number: 
NCT06185374 
Study Number: 
s23-00583 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
October 27, 2023 
 
 

 
 
 
 
 
 
 
 
 
[1752349] Text Messaging to Improve Adherence To Repeat Colonoscopy In The VA: A 
Pilot Study 
Funding Agency: National Cancer Institute 
Principal Investigator/Study Chair: Peter Liang, MD 
Version 3 October 27, 2023 
NYULH Study Number: 23-00583 
 
 
 
 

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Abstract 
 
Provide a summary of the study (recommended length: less than 500 words). 
 
Colorectal cancer is a common but preventable condition, and increasing 
colorectal cancer screening is one of the most impactful public health contributions in 
the field of gastroenterology. Text messaging is a simple, cheap, and rapid method to 
reach patients that may improve adherence to colonoscopy appointments as well as 
simplify the process of bowel preparation. 
The purpose of the study is to evaluate the feasibility of a pilot bidirectional 
text messaging intervention on attendance for screening/surveillance 
colonoscopy and bowel preparation quality at an urban VA hospital. The goal is 
to improve adherence to colonoscopy among patients who are due for a repeat 
colonoscopy.  
The primary outcomes are process feasibility measures including 
recruitment rate, refusal rate for participation, and retention rate through end of 
study. 
The secondary outcomes include documenting the proportion of patients 
who attended their scheduled colonoscopy appointment in the intervention group 
vs. the control group as well as documenting the proportion of patients with 
adequate bowel preparation between the two groups. We will also document the 
number of patients who responded to the National Annie Survey.  
 
 
 
 

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Contents 
Protocol Title: ................................................................................................................................ 4 
1.0 
Study Personnel ................................................................................................................. 4 
2.0 
Introduction ........................................................................................................................ 4 
3.0 
Objectives .......................................................................................................................... 7 
4.0 
Resources and Personnel .................................................................................................. 7 
5.0 
Study Procedures ............................................................................................................... 8 
5.1 Study Design ....................................................................................................................... 8 
5.2 Recruitment Methods ........................................................................................................ 12 
5.3 Informed Consent Procedures .......................................................................................... 13 
5.4 Inclusion/Exclusion Criteria ............................................................................................... 13 
5.5 Study Evaluations .............................................................................................................. 14 
5.6 Data Analysis .................................................................................................................... 14 
5.7 Withdrawal of Subjects ...................................................................................................... 15 
6.0 
Reporting .......................................................................................................................... 15 
7.0 
Privacy and Confidentiality ............................................................................................... 15 
8.0 
Communication Plan ........................................................................................................ 16 
9.0 
References ..................................................................................................................... 16 
 
 
 

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Protocol Title:  Text messaging to improve adherence to repeat 
colonoscopy in the VA: a pilot study 
 
1.0 
Study Personnel 
 
Principal Investigator: Peter Liang, MD 
Phone: 212-686-7500 x5745 
Email: peter.liang@va.gov 
VA Appointment: Part-time 4/8ths Medicine/GI  
Research Coordinator: Anika Zaman, MPH 
Phone: (646)236-3894 
Email: anika.zaman@va.gov 
VA Appointment: WOC 
Participating Site: New York Harbor Health Care System 
 
NYU Langone Health Appointment: 
Assistant Professor 
Division of Gastroenterology 
Department of Population Health   
423 E 23rd St 11N  
New York, NY 10010 
Peter.liang@nyulangone.org 
(212) 686-7500 ext 5745 
2.0 
Introduction 
 

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Colorectal cancer (CRC) is the second leading cause of cancer death in 
the US. Despite overwhelming evidence that screening reduces both CRC 
incidence and mortality, the 2020 Behavioral Risk Factor Surveillance System 
estimates that only 72% of eligible adults aged 50-75 years are up-to-date with 
screening in the US. These figures overestimate the proportion of Americans 
who receive adequate long-term protection from CRC because they are based 
on a one-time (i.e., cross-sectional) measurement in a single year. The protective 
effect of screening diminishes over time; thus, national recommendations 
emphasize the importance of repeated testing—with fecal occult blood and 
immunochemical testing (FOBT/FIT) annually or colonoscopy every 10 years—to 
obtain the full intended benefits of a screening program.  
 
The vast majority of patients undergoing CRC screening at the VA New York 
Harbor Health Care System (NYHHCS) receive colonoscopy, and a national VA 
study found that 38% of appointments made at colonoscopy-performing clinics 
following a positive FOBT were missed, cancelled, or rescheduled.2 Late 
cancellations and nonattendance at colonoscopy is a major source of inefficiency 
that wastes precious endoscopic resources, and more importantly non-
adherence to screening guidelines places individuals at greater risk for 
developing CRC. One strategy to reduce appointment wait times and increase 
screening rates is to both remind patients of their upcoming colonoscopy and 
guide them through the bowel preparation process. Of the various interventions 
that have been used to improve CRC screening, text messaging is especially 
appealing because of its low cost, widespread use, and ability to deliver real-time 
information in a visible yet discreet manner. In 2012, the Community Preventive 
Services Task Force found strong evidence to recommend using reminders to 
increase FOBT screening but found insufficient evidence to do so for 
colonoscopy.3 Additionally, the effectiveness of newer communication methods 
such as text messaging was identified as a research gap. Since then, data has 
shown that text messaging is an acceptable method to promote CRC screening,4 
and interest for health-related text messaging is high even in vulnerable 
populations such as homeless Veterans.5 Text messaging has been shown to 
increase adherence to FIT by up to 24%,6 while the only study to include 
colonoscopy found a modest 3% improvement.7 However, the latter was 
conducted in an Alaskan tribal health care system with culturally-tailored 
messaging, and therefore the results may not be generalizable to the broader US 
population. 
Our prior study found that text message reminders for CRC screening is less 
effective than for breast or cervical cancer screening, and this is likely due to the 
substantial difference in patient preparation required for the respective 
examinations.8 Unlike screening for breast and cervical cancer or using FIT, 
colonoscopy involves a complex multi-day preparation process that includes 
dietary restrictions and drinking a large volume oral laxative on a strict schedule. 
Poor bowel preparation quality leads to an inadequate colonoscopic examination 
that must be repeated,9 which in terms of clinical outcome is equivalent to 

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nonattendance at colonoscopy. Therefore, assessment of attendance must also 
include an assessment of bowel preparation. A Korean study showed that an 
educational text message can improve bowel preparation quality.10 Patient 
navigation is another method that can provide bowel preparation education and 
has been proven to be effective at increasing CRC screening, but many 
institutions are unable to implement navigator programs due to cost.11,12 A 
bidirectional or two-way text messaging platform, in which patients have the 
ability to both receive and respond to messages, would provide a low-cost 
method of patient engagement that may achieve a benefit similar to conventional 
patient navigators. Two-way text messaging has been shown to be significantly 
more effective than one-way messaging for improving medication adherence.13 
However, all text messaging interventions for CRC screening to date have used 
one-way messaging to simply encourage patients to undergo screening or 
remind them of their appointment. The one-way study design does not take 
advantage of the instantaneous and interactive nature of mobile messaging, 
which sets it apart from letters, telephone calls, or even emails. A bidirectional 
messaging platform can maximize the capability of this interactive medium by 
serving as both a procedure reminder and a virtual patient navigation system. 
Patients at NYHHCS often make last-minute cancellations because they forgot 
about the procedure or how to take the bowel preparation. Reminders that are 
sent with sufficient advance notice allow patients to cancel or reschedule and still 
permit another patient to use their original appointment time. In this way, it 
addresses a common systems-level failure to adequately notify and prepare 
patients for their upcoming procedure. More importantly, a series of messages 
closer to the procedure date can provide real-time instructions on the bowel 
preparation process and provide on-demand answers to frequently asked 
questions. Recent studies from the medication adherence literature demonstrate 
that real-time text messaging significantly improves adherence and can lead to a 
durable effect for at least two years after an intervention.14,15 Thus, bidirectional 
text messaging may be especially effective for increasing colonoscopy rates by 
reminding patients of their appointment and improving the bowel preparation 
quality through virtual patient navigation. This intervention would also generate 
short-term downstream benefits by decreasing the number of procedures 
performed for inadequate bowel preparation and reducing wait-times for 
colonoscopy. It is also possible that the intervention may lead to greater 
awareness of colonoscopy as a potentially life-saving procedure that must be 
repeated over the long-term for maximum protective effect. 
 
Our previous qualitative work at NYHHCS examined barriers and facilitators to 
undergoing repeat screening or surveillance colonoscopy for Veterans who were 
due for the procedure. In addition to conducting 45 semi-structured interviews, 
we also tested messages to promote CRC screening and colonoscopy in focus 
groups. Based on these results, we now propose to pilot test a bidirectional text 
messaging intervention for colonoscopy, which combines features of a clinical 
reminder system with virtual patient navigation that provides additional 
information on demand. We will use Annie (https://mobile.va.gov/app/annie-app-

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clinicians), a text messaging service designed by the VA to help patients and 
their providers to promote self-care and improve health management. 
 
Only one study has examined the effect of text messaging on screening 
colonoscopy to date, and the results were modest but limited by lack of 
generalizability.7 Furthermore, this and most text messaging studies for cancer 
screening have not used a series of messages to prompt a complex set of 
actions in real-time (e.g. bowel preparation) nor allowed participants to request 
additional information on demand. The bidirectional text messaging platform is 
novel in that it will include both of these features, which mimic the characteristics 
of a human patient navigator. If the pilot test yields promising results that are 
subsequently confirmed in a larger efficacy trial, then low-cost virtual patient 
navigation using text messaging may become an accepted method to promote 
colorectal cancer screening and other preventive services. 
3.0 
Objectives 
 
The objective of this study is to pilot test a text messaging intervention to 
improve adherence to colonoscopy among VA patients who are due for repeat 
screening/surveillance colonoscopy at the VA New York Harbor Health Care 
System (NYHHCS). The primary outcomes are process feasibility measures 
including recruitment rate, refusal rate for participation, and retention rate through 
end of study.  
Hypothesis: The intervention will be feasible, and patients who receive the 
intervention will have higher attendance and better bowel preparation quality than 
those who do not. 
4.0 
Resources and Personnel 
 
Principal Investigator: Peter Liang, MD 
VA Appointment: Part-time 4/8ths Medicine/GI at 423 E 23rd St 11N New 
York, NY 10010 
Roles: Will be involved in obtaining informed consent and performing data 
analysis. Has access to PHI. Is responsible for oversight of the study, 
including any adverse events.  
Research Coordinator: Anika Zaman, MPH 
VA Appoint: WOC at 423 E 23rd St 11N New York, NY 10010 
Roles: Will be involved in obtaining PHI, recruitment process, obtaining 
informed consent, and performing data analysis. During recruitment 

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process, will screen patients, mail out invitations letters and contact 
patients through calls about study.  
5.0 
Study Procedures 
5.1 Study Design 
All individuals who agree to participate in the study will provide written 
consent and HIPAA authorization. A total of 50 consented participants will be 
randomized 1:1 to either the text messaging (intervention) group or the standard 
care (control) group. We will use block randomization with block sizes ranging 
from 2 to 6. The intervention group will receive a series of instructional and 
motivational text messages, which will be sent starting 7-14 days before and until 
the day of the procedure.  
 
For instructional messages, earlier messages will remind patients of the 
colonoscopy appointment and later messages will help patients complete the 
bowel preparation process in real-time. Table 1 shows the timing and 
representative content of the instructional messages. Some messages may be 
sent over a range of days until the procedure, depending on when the participant 
enrolled and the type of bowel preparation (1 or 2 day) the participant is 
recommended to undergo. Table 2 provides a list of representative focus group 
tested motivational messages that will be sent along with instructional messages. 
The specific motivational messages will be tailored, whenever possible, based on 
the patient demographic traits (e.g., age, sex, and race and ethnicity).  
 
Due to character limits in Annie, longer messages may be sent as multiple 
texts. Some messages will be bidirectional, and participants will be able to 
respond to receive additional information. Additional information will be delivered 
automatically based on the participant’s response and does not need to be sent 
manually by the study team. The national Annie colonoscopy survey (Appendix) 
will be conducted within 7 days of the procedure date to assess patient 
satisfaction with the intervention.  
 
We will use the electronic health record to measure clinical secondary 
outcomes, such as the proportion of patients who 1) attend the scheduled 
colonoscopy appointment and 2) had adequate bowel preparation. 
 
• Study Timelines 
We estimate that we will need 3 months to enroll all participants and an 
additional 1 month to complete the intervention. Analysis will be completed within 
1 month. In all, the study will be completed in 5 months. 

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Table 1. Instructional Messages: Timing and Content  
Days until 
procedure 
Message 
Reply 
Follow-up message 
7-14 
[Tailored motivational message]  
 
Reminder: your colonoscopy is on DATE.  
 
You must have an adult escort if you wish to 
receive sedation. Are you planning to come for the 
procedure? (Y or N only) 
Y 
Great, we will see you on DATE for 
your colonoscopy! If you have any 
questions about the procedure, 
please call us: 212-686-7500 
x3902 
N 
You’ve indicated that you’re not 
planning to attend your 
colonoscopy. If this is correct, 
please call us to cancel or 
reschedule: 212-686-7500 x3902 
5 
[Tailored motivational message] 
 
Reminder: your colonoscopy is on DATE.  
 
You must have an adult escort if you wish to 
receive sedation. Are you planning to come for the 
procedure? (Y or N only) 
Y 
Great, we will see you on DATE for 
your colonoscopy! If you have any 
questions about the procedure 
please call us: 212-686-7500 
x3902 
N 
You’ve indicated that you’re not 
planning to attend your 
colonoscopy. If this is correct, 
please call us to cancel or 
reschedule: 212-686-7500 x3902 
3-5  
[Tailored motivational message]  
 
To prepare for your colonoscopy, STOP eating 
the following foods starting today: fatty/fried 
/greasy foods, fruits, leafy vegetables, corn, 
anything with seeds 
 
 
1-2 (7AM) 
[Tailored motivational message]  
 
To prepare for your colonoscopy, start eating a 
low residue diet today. You should also start 
drinking the bowel prep at 5pm. Here are the 
instructions: <link> 
 
 
 
 
2 (5PM)* 
[Tailored motivational message]   
 
It’s time to start your colonoscopy bowel prep.  
 
Drink 1 liter in the next hour. The next dose is 
tomorrow at 8 AM. Here are the instructions: 
<link> 
 
 
 
 
1 (8 AM)* 
[Tailored motivational message]   
 
It’s time to continue the bowel prep. Drink 1 liter in 
the next hour. The next dose is today at 5 PM. 
Here are the instructions: <link> 
 
 
1 (5 PM)* 
[Tailored motivational message]   
 
 
 

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It’s time to continue the bowel prep. Drink 1 liter in 
the next hour. The last dose is tomorrow at 4 AM. 
Here are the instructions: <link> 
1 (5 PM) 
[Tailored motivational message]   
 
It’s time to start your colonoscopy bowel prep.  
 
Drink 1 liter in the next hour. The last dose is 
tomorrow at 4 AM. Here are the instructions: 
<link> 
 
 
0 (4AM) 
[Tailored motivational message]  
 
It’s time for the last dose of your bowel prep. Drink 
1 liter in the next hour. Here are the instructions: 
<link> 
 
 
 
 
*Only for participants who are receiving a 2 day bowel prep.  
Table 2. Motivational messages 
1 
Take control of your health and make an appointment today! 
2 
Colorectal cancer and colonoscopy: “Cancers take years to 
develop, so the older you get, the higher probability, the better to 
have it done again.” 
3 
Manhattan VA Veteran: “This thing (colorectal cancer) could kill 
you, and it's preventable if they catch it in time, and it just takes a 
few minutes…It would be stupid not to do it.” 
4 
In 2023, more than 150,000 Americans will be diagnosed with 
colorectal cancer and more than 50,000 will die from this disease. 
Don’t be a statistic. Get screened for colorectal cancer. 
5 
Myth: A colonoscopy takes too long, so it can wait.  
Fact: A colonoscopy usually takes about 30–60 minutes and can 
prevent colorectal cancer (the 2nd leading cause of cancer death 
in the US). Taking just a few hours out of your day can prevent a 
life with colorectal cancer.  
6 
Myth: I don’t need a colonoscopy because I feel fine and don’t 
have any symptoms. 
Fact: Colorectal cancer usually does not cause symptoms at the 
early stage. When symptoms occur, the cancer may already be at 
a late stage. Colonoscopy can both prevent colorectal cancer and 
catch it before symptoms appear.  
7 
When someone mentions colonoscopy, do you think about how 
much bowel prep you have to drink and feel unsure if you want 
the procedure?  
Actually, the volume of bowel prep has decreased by 50% over 
the years. You can also add flavoring to the solution to improve 
the taste. Think of bowel prep as a one-time cleaning in exchange 
for years of peace of mind that your colon is healthy. 
8 
Myth: The colonoscopy is going to hurt. 
Fact: It is completely okay to have reservations and concerns 
about the procedure. You can request sedation during the 

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colonoscopy, which will make you more comfortable. If you have 
questions about sedation, talk to your GI doctor or nurse. 
9 
Myth: I’m not at risk for colorectal cancer, so I don’t need a 
colonoscopy 
Fact: 1 in 23 men and 1 in 25 women will develop colorectal 
cancer in their lifetime. Many do not have any risk factors. But 
screening can prevent 60% of deaths from colorectal cancer. 
Don’t be a statistic.  
10 
Myth: Colorectal cancer mainly affects men, so women don’t need 
a colonoscopy. 
Fact: Colorectal cancer is the 3rd leading cause of cancer death in 
both men and women in the USA. 1 in 23 men and 1 in 25 women 
will develop colorectal cancer in their lifetime. Don’t take this 
chance.  
11 
Myth: Colonoscopies are dangerous.  
Fact: Colonoscopies are very safe. The risk of perforation (tear) in 
the colon is less than 1 in 2,000 procedures. On the other hand, 1 
in every 24 people will be diagnosed with colorectal cancer in their 
lifetime.  
12 
More than 52,000 people will die from colorectal cancer this year. 
You can prevent this. Your loved ones are counting on you. Don’t 
be a statistic, be a survivor. 
13 
“I see [colonoscopies] as a small price to pay for enjoying the rest 
of my life” - Joyce. Read about Joyce’s story: 
https://tinyurl.com/bdfszur3 
14 
“The colonoscopy saved my life” -Joanne. Read about Joanne’s 
story: https://tinyurl.com/bdfszur3 
Colorectal cancer is the 2nd leading cause of cancer death in the 
US. 1 in 23 men and 1 in 25 women will develop colorectal cancer 
in their lifetime. Don’t be a statistic, be a survivor. Schedule a 
colonoscopy today and join Joanne and many others in a life 
without colorectal cancer. 
15 
Did you know that colorectal cancer is the 3rd-leading cause of 
cancer death in both men and women in the United States? 
Colorectal cancer can be caught early or even prevented through 
regular screening. Most people should begin screening at age 45. 
16 
Colorectal cancer is often a silent disease. Usually there are no 
symptoms. That’s why getting screened is so important. 
Screening can help prevent colorectal cancer or catch it early 
when it is easiest to treat. Most people should begin screening at 
age 45. 
17 
Right now, you could have a polyp, a small growth in your colon or 
rectum. Right now, your polyp may be harmless, but over time it 
could develop into colorectal cancer. Right now, through regular 
screening, you have the power to find and remove precancerous 
polyps and prevent colorectal cancer. Call your doctor and take 
control of your health! 

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18 
If you are 45 or older, you’re at a higher risk for colon cancer—
even if you are healthy. Ask your doctor for a screening test. 
19 
Colon cancer starts with a polyp in the large intestine. Polyps are 
very common in people age 45 and older, but they can be 
detected and removed before they turn into cancer. Don’t die of 
cancer. Talk to your doctor about colon cancer prevention. 
20 
You are so important to your family, don’t let them down! Don’t 
procrastinate any longer! Get screened for colon cancer today! It 
could save your life. 
21 
Colon cancer is the 2nd leading cancer killer in the U.S., but it 
doesn’t have to be. Colon cancer can be prevented or found at an 
early stage. Getting screened is absolutely necessary! Call a 
doctor today. 
22 
Screening can prevent colorectal cancer. 
23 
“There will be some preparation, but the benefit of it is 
tremendous. This is a cancer that can be prevented, can be 
stopped…and things can be literally sort of nipped in the bud” - 
Manhattan VA Veteran 
24 
If you have concerns about having a colonoscopy, please feel free 
to reach out to the gastroenterology (GI) division. Our GI doctors 
and nurses will be happy to answer your questions. 
25 
“[Colonoscopy] is a maintenance check. That's all it is. It could 
save you a lot of pain and agony. I'm sure [cancer] is not a 
pleasant experience, and it could be deadly, so why not kick its 
ass?” -Manhattan VA Veteran 
26 
“I know this is something that I have to do for my health.” -
Manhattan VA Veterans on screening 
 
5.2 Recruitment Methods 
Patients undergoing repeat screening or surveillance colonoscopy at the 
VA NYHHCS are eligible. We plan to oversample female patients so that at least 
20% of participants (10 individuals) are women. Participants will be recruited 
from a list of patients scheduled for colonoscopy. Research team members will 
screen and identify eligible participants using the VA electronic medical records 
system (CRPS). Participants will be either recruited during their in-person pre-
colonoscopy clinic visit or through mailed invitations followed by up to 3 follow up 
phone calls. This will be conducted by the research coordinator. A research team 
member will explain the study to each potential participant and obtain written 
consent and HIPAA authorization from the participant in a private room to 
maintain patient privacy. For participants randomized to the intervention arm, a 
clinician member of the research team will obtain verbal consent from the patient 
to enroll in Annie, in accordance with requirements for who can consent when 
using Annie (https://mobile.va.gov/sites/default/files/annie-app-clinicians-quick-
start-guide-1-3.pdf). Only individuals deemed to have capacity are eligible for 
study participation. No vulnerable populations will be included. 

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Participants will be responsible for the costs of the text messages they 
may receive as part of the intervention. Each participant will receive $40 in the 
form of a gift card or check to compensate for their time. There are no additional 
costs to the participant.  
5.3 Informed Consent Procedures 
All patients will be required to provide written consent to participate in the 
study. This will be obtained by a member of the research team. A blank copy of 
the informed consent form will also be provided to participants for their records at 
the time they sign the consent. All study personnel will have had up-to-date TMS 
and CITI trainings on how to obtain and document informed consent as well as 
regarding human subjects’ protection requirements. 
Informed consent is a process that is initiated prior to the individual’s agreeing to 
participate in the study and continues throughout the individual’s study 
participation. Extensive discussion of risks and possible benefits of participation 
will be provided to the participants and their families. Consent forms will be IRB 
approved. The investigator will explain the research study to the participant and 
answer any questions that may arise. All participants will receive a verbal 
explanation in terms suited to their comprehension of the purposes, procedures, 
and potential risks of the study and of their rights as research participants. 
Participants will have the opportunity to ask questions prior to signing the 
consent form. The participants will have the opportunity to discuss the study or 
think about it prior to agreeing to participate. The participants may withdraw 
consent at any time throughout the course of the study. The rights and welfare 
of the participants will be protected by emphasizing to them that the quality of 
their medical care will not be adversely affected if they decline to participate in 
this study. 
 
Signed consent will be documented in the subject’s research record. The 
consent process, including the name of the individual obtaining consent, will be 
thoroughly documented in the subject’s research record. 
 
 
5.4 Inclusion/Exclusion Criteria 
 
Inclusion criteria: 
-Age 45-85 years  
-Has previously undergone a colonoscopy and is currently due for a repeat 
screening or surveillance colonoscopy at the VA. 

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Exclusion criteria: 
-Patients not due for screening or surveillance colonoscopy. This will be based 
on 2020 guidelines from the US Multi-Society Task Force on Colorectal Cancer. 
-Patients with personal history of CRC/inflammatory bowel disease/ hereditary 
colon cancer syndrome or family history of hereditary colon cancer syndrome. 
These criteria will be determined based on ICD9/10 codes or the medical record. 
 
5.5 Study Evaluations 
 
The national Annie colonoscopy survey (Appendix) will be conducted 
within 7 days of the procedure date to assess patient satisfaction with the 
intervention. The survey will be sent by the research team via Annie text 
messages and should take approximately 2 minutes to complete. While the 
national Annie colonoscopy survey is also used by other VA facilities, the results 
from this study will not be shared. 
 
We will use the electronic health record to measure clinical secondary 
outcomes, such as the proportion of patients who 1) attend the scheduled 
colonoscopy appointment and 2) had adequate bowel preparation. We will 
extract the following data: Names, MRN, date of birth, sex, race and ethnicity, 
telephone number, mailing address, date of colonoscopy, Boston Bowel Prep 
Scale score, and colonoscopy findings. 
5.6 Data Analysis 
 
Data Analysis 
The primary feasibility will be evaluated with descriptive statistics. For the secondary 
efficacy outcomes, we will use the chi-squared or Fisher’s exact test to compare 
proportions in the two groups. 
 
Power calculations 
This pilot feasibility study will generate data that can be used to conduct a subsequent 
larger efficacy trial. Power calculations were not performed for the primary outcome. For 
the secondary outcome of colonoscopy attendance, based on the current 70% 
attendance at the study site, we will have 80% power to detect a 22% absolute increase 
in attendance in the intervention group, assuming a type I error of 10%. 

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5.7 Withdrawal of Subjects 
Participants may withdraw from the study at any time. For participants who 
withdraw, any data collected up to the time of withdrawal may still be retained 
and analyzed. Those who are randomized to the intervention arm can stop 
receiving messages at any point by texting “Stop” to Annie. There will be no 
adverse consequence for a participant who decides to withdraw from the study.  
6.0 
Reporting 
 
All unanticipated problems, serious adverse events, and protocol 
deviations will be reported to the IRB. The PI is responsible for oversight of 
reporting any adverse events. In the event on an adverse event that is related to 
text messaging, messages will be stopped immediately on the Annie application 
if the participant is unsure how to text back, “Stop.” Any other adverse events will 
be addressed directly with patients and dealt with accordingly. 
The PI will be responsible for data monitoring. The PI will design the data 
collection instruments such that variable coding and data format are consistent. The PI 
will review all data collected on an ongoing basis (each month during the duration of the 
study) for data completeness and accuracy as well as protocol compliance. The PI will 
maintain exclusive control over individual permissions to access the research data. 
7.0 
Privacy and Confidentiality 
 
The data will be accessed, analyzed, and stored on the secure VA 
network. Data will be password protected and stored in a secure folder on the VA 
Network. Hardcopy consent and HIPAA authorization forms will stored in a 
locked cabinet inside the PI’s locked office. Names, MRN numbers, phone numbers, 
and addresses will be collected. This information is needed to mail invitation letters, 
make phone calls, and track patients in CPRS.  Dates will also be accessed in order to 
measure clinical secondary outcomes, such as the proportion of patients who attended 
the scheduled colonoscopy appointment. Only individuals with IRB approval and 
listed in the protocol will have access to the data. All personnel who work on this 
project will complete the necessary CITI and TMS training for research involving 
patient data. Once all the data has been cleaned for analysis, any identifying 
patient information will be removed to further ensure confidentiality. Data from 
this project may be published in aggregate, anonymous form. The study will be 
closed once all planned publications are completed. Upon completion of this 
project, the data will be stored for at least the minimum amount of time as 
stipulated by the IRB. There is no plan to destroy collected data. No 
biospecimens are being collected for this study.  

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8.0 
Communication Plan 
 
All information regarding changes to the study will be kept up-to-date on 
IRBNet. In the rare chance of an Adverse Event, Unanticipated problems, or 
interim results, it will be reported to the VA IRB. All team members will have full 
knowledge of the IRB approved protocol and follow accordingly. All changes 
regarding protocol, informed consent, and HIPAA authorization will also be 
reported to the VA New York Harbor IRB via IRBNet. There are no other VA 
facilities involved.  
 
9.0 
Risks to Subjects 
The intervention being studied is a series of text messages. There is minimal risk, 
discomfort, or inconvenience to the participants. There is a small risk that the messages 
may be considered too numerous or intrusive. Participants will be reminded that they 
can stop participating in the research at any time and unenroll in Annie. There is also a 
small risk of breach of confidentiality, and all necessary precautions will be taken to 
prevent this. To ensure the that there is no breach in confidentiality, all patient 
information will be kept in password protected devices and encrypted folders at the VA. 
 
In this study, participant will receive texting over mobile/cell phones and this method of 
communication may result in a breach of confidential information because text 
messages to mobile/cell phones are not encrypted. This means that information 
participants send or receive by text message could be intercepted or viewed by an 
unintended recipient, or by the mobile/cell phone provider or carrier. 
 
10.0 Potential Benefits to Subjects 
For participants who were planning to cancel their colonoscopy or did not know how to do the 
bowel prep, the text messaging intervention may help them to prepare for and attend the 
procedure. Obtaining a colonoscopy has been proven to lower the risk of colorectal cancer, 
which is a potential benefit to participants. If the intervention is shown to be effective, then it 
may be adopted at other institutions and increase colonoscopy uptake in the general population. 
It would also contribute to generalizable knowledge by showing that text messages can improve 
colonoscopy attendance and bowel preparation quality. 
 
11.0 References 
 
Bibliography of cited literature 

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1.  
Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. 
BMC Med Res Methodol 2010;10:1. 
2.  
Partin MR, Gravely A, Gellad ZF, et al. Factors Associated With Missed and 
Cancelled Colonoscopy Appointments at Veterans Health Administration Facilities. Clin 
Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc 2015. 
3.  
Sabatino SA, Lawrence B, Elder R, et al. Effectiveness of interventions to 
increase screening for breast, cervical, and colorectal cancers: nine updated systematic 
reviews for the guide to community preventive services. Am J Prev Med 2012;43:97–
118. 
4.  
Weaver KE, Ellis SD, Denizard-Thompson N, et al. Crafting Appealing Text 
Messages to Encourage Colorectal Cancer Screening Test Completion: A Qualitative 
Study. JMIR MHealth UHealth 2015;3:e100. 
5.  
McInnes DK, Sawh L, Petrakis BA, et al. The potential for health-related uses of 
mobile phones and internet with homeless veterans: results from a multisite survey. 
Telemed J E-Health Off J Am Telemed Assoc 2014;20:801–809. 
6.  
Baker DW, Brown T, Buchanan DR, et al. Comparative effectiveness of a 
multifaceted intervention to improve adherence to annual colorectal cancer screening in 
community health centers: a randomized clinical trial. JAMA Intern Med 2014;174:1235–
1241. 
7.  
Muller CJ, Robinson RF, Smith JJ, et al. Text message reminders increased 
colorectal cancer screening in a randomized trial with Alaska Native and American 
Indian people: Text Messages for Colorectal Cancer Screening. Cancer 2016. Available 
at: http://doi.wiley.com/10.1002/cncr.30499 [Accessed January 11, 2017]. 
8.  
Uy C, Lopez J, Trinh-Shevrin C, et al. Text Messaging Interventions on Cancer 
Screening Rates: A Systematic Review. J Med Internet Res 2017;19:e296. 
9.  
Johnson DA, Barkun AN, Cohen LB, et al. Optimizing adequacy of bowel 
cleansing for colonoscopy: recommendations from the US multi-society task force on 
colorectal cancer. Gastroenterology 2014;147:903–924. 
10.  
Lee YJ, Kim ES, Choi JH, et al. Impact of reinforced education by telephone and 
short message service on the quality of bowel preparation: a randomized controlled 
study. Endoscopy 2015;47:1018–1027. 
11.  
Lasser KE, Murillo J, Lisboa S, et al. Colorectal cancer screening among 
ethnically diverse, low-income patients: a randomized controlled trial. Arch Intern Med 
2011;171:906–912. 

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12.  
Percac-Lima S, López L, Ashburner JM, et al. The longitudinal impact of patient 
navigation on equity in colorectal cancer screening in a large primary care network: 
Patient Navigation Improves CRCS Equity. Cancer 2014;120:2025–2031. 
13.  
Wald DS, Butt S, Bestwick JP. One-way versus two-way text messaging on 
improving medication adherence: meta-analysis of randomized trials. Am J Med 
2015;128:1139.e1–5. 
14.  
Sabin LL, Bachman DeSilva M, Gill CJ, et al. Improving Adherence to 
Antiretroviral Therapy With Triggered Real-time Text Message Reminders: The China 
Adherence Through Technology Study. J Acquir Immune Defic Syndr 1999 
2015;69:551–559. 
15.  
Vervloet M, Dijk L van, Bakker DH de, et al. Short- and long-term effects of real-
time medication monitoring with short message service (SMS) reminders for missed 
doses on the refill adherence of people with Type 2 diabetes: evidence from a 
randomized controlled trial. Diabet Med J Br Diabet Assoc 2014;31:821–828. 
 
 
 
 
 
 
 
 
 
 
Appendix 
 
A. National Annie colonoscopy survey 
 
1. Was the VA able to perform your colonoscopy procedure? 
Yes 
No 
 
2. Getting setup by my clinician to use Annie was easy. 
1. Strongly disagree 

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2. Disagree 
3. Neutral 
4. Agree 
5. Strongly agree 
 
3. The instructions I received from Annie related to my preparation were easy to understand. 
1. Strongly disagree 
2. Disagree 
3. Neutral 
4. Agree 
5. Strongly agree 
 
4. Annie’s messages helped me to complete my preparation better. 
1. Strongly disagree 
2. Disagree 
3. Neutral 
4. Agree 
5. Strongly agree 
 
5. Without Annie’s messages, I would have contacted my VA care team more. 
1. Strongly disagree 
2. Disagree 
3. Neutral 
4. Agree 
5. Strongly agree 
 
6. I felt more connected to VA because of Annie’s messages. 
1. Strongly disagree 
2. Disagree 
3. Neutral 
4. Agree 
5. Strongly agree 
 
7. The number of messages I received from Annie related to my preparation was just 
right. 
1. Strongly disagree 
2. Disagree 
3. Neutral 
4. Agree 
5. Strongly agree 
 
8. I am satisfied with the service I received from Annie.  
1. Strongly disagree 
2. Disagree 
3. Neutral 
4. Agree 
5. Strongly agree 
 
9. How can we improve your experience with Annie? 
Write in response 
 

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