Automated Text Message Navigation to Improve Outpatient Colonoscopy Show Rate and Bowel Preparation
Phase: NA
Conditions: Adherence, Patient, Colonoscopy, Text Messaging
Sponsor: University of Pennsylvania

 
Supplement 
 
Automated Text Message Navigation to Improve Outpatient Colonoscopy Show 
Rate and Bowel Preparation 
 
This supplement provides additional information about the work. It contains the following items:  
 
Initial Protocol ….……………………………………………………………………………………………………………………………….   
 
Final Protocol ……………………………………………………………………………………………………………………………………    
 
Summary of protocol changes …………………………………………………………………………………………………………..   
 
Original statistical analysis plan …………………………………………………………………………………………………………   
 
Final statistical analysis plan ……………………………………………………………………………………………………………..  
 
Summary of statistical analysis plan changes ……………………………………………………………………………………  
 
Appendix A: Final Survey Instruments ..…………………………………………………………………………………………….   
 
 
Forma.ed: LeI:  1", Right:  1", Top:  1", BoMom:  1"

1 
 
Initial Protocol 
Automated Text Message Navigation to Improve Outpatient Colonoscopy Show Rate and Bowel 
Preparation 
  
Brief Description 
Outpatient colonoscopy adherence is negatively impacted by poor communication and challenges with 
bowel preparation. We plan to perform a randomized controlled trial at the Pennsylvania Presbyterian 
Medical Center to (1) provide text message-based educational and reminder messages to patients 
regarding a scheduled colonoscopy, and (2) evaluate the impact of the texting intervention on 
colonoscopy show rate and bowel preparation.  
 
Protocol 
Abstract 
Colonoscopy is an effective screening technique for colorectal cancer (CRC) prevention, but many 
patients either do not show up or have poor bowel preparation for the procedure. We plan to evaluate 
the impact and feasibility of a text message-based program to provide patients with timely educational 
and reminder messages regarding their upcoming colonoscopy and bowel preparation process. In this 
pragmatic randomized controlled trial, we aim to (1) to provide text message-based educational and 
reminder messages to patients or support partners regarding a scheduled colonoscopy, and (2) to 
evaluate the impact of the texting intervention on colonoscopy show rate and bowel preparation. We 
will include patients who are scheduled for outpatient colonoscopy at the Pennsylvania Presbyterian 
Medical Center. After enrollment, patients will be randomized 1:1 to usual care (arm 1) or the text 
message-based intervention (arm 2, one week in duration). We will measure colonoscopy show rate 
with good/excellent bowel preparation as the primary outcome. 
  
Objectives 
Overall objectives 
The specific aims of the study are to (1) to provide text message-based educational and reminder 
messages to patients or support partners regarding a scheduled colonoscopy, and (2) to evaluate the 
impact of the texting intervention on colonoscopy show rate and bowel preparation. 
  
Primary outcome variable(s) 
The primary outcome of the study will be colonoscopy show rate with good/excellent bowel preparation 
(binary). 
  

2 
 
 
Secondary outcome variable(s) 
Secondary outcomes of the study will include colonoscopy show rate, bowel preparation quality (poor, 
fair, good, excellent), colonoscopy cancellation rate, timing of advance cancellation notification (days), 
and colonoscopy appointment no-show rate. 
  
Background                                     
Colorectal cancer (CRC) is the second leading cause of cancer death in the US, yet there are effective 
screening and treatment strategies that allow for early detection and treatment. CRC screening is 
recommended for all individuals aged 50-75, which could include stool testing or colonoscopy, but 
national rates are still suboptimal at 59-65%. Colonoscopy is an essential component of CRC screening, 
as it is also required if stool testing is positive. However, colonoscopy requires a complex process to 
identify an escort, purchase the preparation, take a day off from work, adhere to a clear liquid diet, and 
complete the split-dose preparation as recommended. This results in a significant no-show and 
cancellation rate, along with suboptimal preparation quality, which can lead to non-adherence and 
incomplete screening.  
 
Current approaches to engaging patients include having nurses call patients before the procedure or 
patient navigators. However, it is often difficult to get patients on the phone, and these interventions 
can be costly, making it less scalable for clinical practices. Other interventions such as videos or mobile 
apps have been limited by poor user experience or limited engagement with the patient. There is an 
opportunity to leverage an automated text message navigation intervention using the Way to Health 
(WTH) platform to improve patient engagement prior to colonoscopy completion. The WTH platform is a 
Penn Medicine platform that is hosted on site at the University of Pennsylvania. The platform allows 
custom text messages to automatically be sent to patients, in addition to bidirectional message 
capabilities. WTH is protected by a secure firewall and is a HIPAA compliant platform.  
 
In the past year, our team conducted a quality improvement pilot initiative using WTH that tested the 
feasibility and impact of a one-week text messaging protocol for patients who were scheduled for 
outpatient colonoscopy. The text messages sent to patients contained information about the 
preparation process and instructions, expectations about the procedure, and reminders about location 
and timing. Among the 21 patients enrolled in the pilot, we found high user acceptability and higher 
colonoscopy show rates as compared to baseline values at PPMC (90% versus ~50%). As such we believe 
that the texting intervention is feasible for testing in the context of a randomized controlled trial. 
  
Study Design 
Design 

3 
 
We will perform a pragmatic randomized controlled trial evaluating the impact of the text message-
based intervention (arm 2) as compared to usual care alone (arm 1). Patient enrollment will be 
performed with assistance from the call center at the Pennsylvania Presbyterian Medical Center (PPMC), 
and/or through phone calls from a clinical research coordinator. After enrollment, patients will be 
randomized 1:1 to the arms listed above through the Way to Health platform. Although patients in arm 
2 may be enrolled weeks or months in advance of their colonoscopy, they will only receive intervention 
text messages in the 7 days prior to the scheduled colonoscopy. Usual care consists of a phone call from 
the PPMC endoscopy staff in the week prior to colonoscopy, if the patient is able to be reached. Patients 
are also given the endoscopy phone number, and may call to speak to staff if they have specific 
questions about their colonoscopy or need to reschedule. A detailed outline of study design can be 
found in the procedures sections. 
  
Study duration 
The duration of participation for patients in the intervention will be from the time of enrollment to the 
date of scheduled colonoscopy. However, the patient will only receive intervention text messages in the 
week prior to the scheduled colonoscopy. We will plan to recruit patients from November 2018 through 
January 2019. We estimate that the study will be completed by March 2019. 
  
Resources necessary for human research protection 
Describe research staff and justify that the staff are adequate in number and qualifications to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 
researchers to conduct and complete the research. Please confirm that there are adequate facilities for 
the research. 
 
The project will take place at the Pennsylvania Presbyterian Medical Center (PPMC) at the University of 
Pennsylvania (UPENN). The team includes investigators experienced in clinical medicine, health behavior 
interventions, clinical trials, behavioral economics, and program evaluation. This study will be led by Dr. 
Shivan Mehta, MD, MBA, MSHP, Assistant Professor of Medicine and Associate Chief Innovation Officer 
for Penn Medicine. This study will be supported on a secure web portal on the Way to Health platform, 
modified to the specifications of this study. Additional study staff include a gastroenterology fellow, 
medical student, key PPMC endoscopy staff, and quality improvement specialists. Regular group 
meetings will be held at pivotal points in the trial in order to ensure compliance with protocol and 
research-related duties. 
  
Characteristics of the Study Population 
Target population 

4 
 
Eligibility Criteria: Patients will be eligible for study inclusion if they are age 18-85 years and are 
scheduled for outpatient colonoscopy to be completed at the PPMC outpatient endoscopy center. We 
will exclude patients if there are fewer than 10 days from time of scheduling to the scheduled date of 
colonoscopy. The target enrollment sample size is 400 patients—200 in arm 1 (usual care) and 200 in 
arm 2 (usual care plus texting intervention). This number is based on sample size calculations using data 
from a previous pilot, which suggests that a total sample size of 200 patients will have greater than 80% 
power to detect a 15% difference in the primary outcome. 
  
Subjects enrolled by Penn Researchers 
400 
  
Subjects enrolled by Collaborating Researchers 
0 
  
Accrual 
Participants in the study will be planned for outpatient colonoscopy at the Pennsylvania Presbyterian 
Medical Center (PPMC). Once a patient is confirmed to meet eligibility criteria, patient enrollment will 
be performed with assistance from the call center at PPMC, and/or through phone calls from a clinical 
research coordinator. When patients have a physician order for a colonoscopy, the patient must contact 
the call center in order to schedule the colonoscopy. The call center staff have agreed to discuss the 
research project and enroll patients using a script to be approved by the IRB. Importantly, we are 
requesting a waiver of consent for several reasons: (1) the study presents no more than minimal risk of 
harm to participants, (2) the patients who are randomized to either arm will not be deprived of any 
standard care available in the status quo and thus the study will not violate their rights or welfare, (3) 
the study could not be practicably completed without such a waiver, as the scheduling process is 
handled over the phone by call center staff, and (4) requiring standard informed consent would require 
an additional touchpoint by the research coordinator and the consent process would preclude us from 
evaluating the intended intervention by introducing selection bias and altering the intervention that 
patients receive. After enrollment, patients will be 1:1 randomized to arm 1 or arm 2 using the Way to 
Health platform. 
  
Key inclusion criteria 
Eligibility Criteria: Patients between ages 18 and 85 years who are scheduled for outpatient colonoscopy 
at PPMC and have a cell phone 
  
Key exclusion criteria 

5 
 
Exclusion Criteria: Patients will be excluded if there are fewer than 10 days between the time of 
enrollment and time of scheduled colonoscopy. This will ensure that patients randomized to arm 2 will 
have sufficient time to receive the full text message intervention. Patients will also be excluded if they 
do not meet all of the inclusion criteria, or if they refuse participation in text messaging. 
  
 
 
 
  
Procedures 
Screening – Phase 1: Patients who have a physician order for a colonoscopy will call the PPMC call center 
in order to schedule their procedure. At this time, the call center staff will screen the patient for 
eligibility (age criteria and text messaging ability) and will explain the details of the study following a pre-
determined script. Patients who agree to participate in the study will have their cell phone number 
recorded. A list of these patients will be forward to the clinical research coordinator on a weekly basis, 
who will confirm patient eligibility and then manually enter patients into the WTH platform. Based on 
our experience with the QI pilot described above, we estimate needing to screen between 500 and 600 
patients to meet our enrollment targets (400 total patients). 
Randomization - Phase 2: using a random number generator in the WTH platform, patients will be 1:1 
randomized to arm 1 or arm 2, until the target sample size of 200 patients per arm is reached.  
Randomization will be performed and recorded in WTH. 
Chart review - Phase 3: after randomization and in tandem with phase 4 (below), the research 
coordinator will perform a chart review to obtain patient demographic and comorbidity data 
(hypertension, hyperlipidemia, diabetes, inflammatory bowel disease, obesity, active opiate 
prescription). All data will be inputted into and stored in a secured RedCap database. Only key study 
staff will have access to the RedCap database, which is stored on a secure firewall-protected server. 
Intervention - Phase 4: Patients in arm 2 will begin receiving text messages per a pre-determined 
protocol starting 7 days prior to the date of scheduled colonoscopy (the text messaging protocol is 
attached to this application). Patients in arm 1 and arm 2 will both receive usual care, which includes (1) 
bowel preparation instructions that are delivered via mail or through a secure online messaging portal, 
(2) a phone call from the endoscopy staff in the week prior to colonoscopy, and (3) the option to call the 
endoscopy staff during business hours to have any questions answered on demand. 
Outcomes data collection - Phase 5: After a patient’s scheduled colonoscopy date has passed, the 
research coordinator will review the medical record to gather additional data from the endoscopy 
procedure. This will include the indication for the procedure, quality of bowel preparation (poor, fair, 
good, excellent), and completeness (cecum reached). Procedure status will also be recorded (canceled, 
no-show, completed). 

6 
 
Statistical Analysis and Manuscript Preparation - Phase 6: The statistical analysis (detailed below) will 
commence after completion of outcomes ascertainment for the entire cohort.  
 
Analysis Plan 
Descriptive analysis will include comparison of baseline demographics and major medical comorbidities 
between study arms. Continuous and categorical data will be compared using the Wilcoxon Rank-sum 
and Chi-squared tests, respectively. An alpha threshold of 0.05 will be used for statistical significance, 
with two-tailed testing performed in all instances. For the primary analysis, we will perform a Chi-
squared test of independence to compare the proportion of colonoscopies with good/excellent bowel 
preparation between groups. In the secondary analysis, Chi-squared tests of independence will be 
performed to compare colonoscopy status (show, no-show, cancelation) as well as bowel preparation 
quality (excellent, good, fair, poor) between groups. Finally, among canceled colonoscopies, median lead 
time of cancellation will be compared between groups using the Wilcoxon Rank-sum test. 
Consent 
1. Consent Process 
Overview 
We are requesting a waiver of informed consent for this study. The reason for our request is explained 
in the Waiver of Consent section. Verbal consent for text messaging will still be obtained from all 
participants in the study. Please see the script templates attached to this application. 
 
 
 
 
 
 
Children and Adolescents 
Not applicable. We are only enrolling subjects 18 years of age and older. 
 
Adult Subjects Not Competent to Give Consent 
We are requesting a waiver of informed consent for this study but patients will still need to verbally opt 
in to text messaging. We plan to enroll only those patients who are competent at time of enrollment to 
opt-in for themselves. 
 
2. Waiver of Consent 
Waiver or Alteration of Informed Consent* 
Waiver or alteration of required elements of consent. 
 
 
 
 
 
 
Minimal Risk* 

7 
 
This study is minimal risk as all participants will be receiving standard clinical care. Colonoscopy is the 
standard of care for colorectal cancer screening, and all patients will receive standard bowel preparation 
instructions in addition to optional phone communication with endoscopy staff prior to the procedure. 
The only research-related activity is the randomization of participants to a text messaging program that 
will supplement routine practice when an individual schedules a colonoscopy at our institution. Since 
this study is intended to promote the standard of care for colorectal cancer screening, and the receipt of 
text messages poses negligible risk to the patient, we believe that waiver of consent is appropriate. 
 
 
 
 
 
Impact on Subject Rights and Welfare*  
 
 
 
Participation in the intervention is completely voluntary and subject rights and welfare will not be 
adversely affected by the waiver of authorization and consent. Participants randomized to the 
intervention arms still need to opt in to text messaging: Arm 1 will receive standard clinical care and Arm 
2 will be enrolled into the text-messaging program in addition to standard clinical care. Placement in 
either arm for the purposes of research does not adversely affect the rights and welfare of the subjects, 
as each arm has the opportunity to engage in colorectal cancer screening, receive bowel preparation 
instructions, and communicate with the endoscopy staff over the phone. Randomly assigning patients to 
intervention and control does not alter patient’s rights any differently than conducting an uncontrolled 
pilot study where some patients receive the intervention and some don’t.  We believe it is appropriate 
to obtain waiver of consent because learning the impact of different modalities for improving colorectal 
screening has significant potential clinical value for the practice (i.e. significantly increasing the rate of 
successful screening and thus decreasing the rate of mortality related to nonuse of screening). 
 
Waiver Essential to Research*  
 
 
 
The informed consent process itself may influence the outcome of our study, as it would require an 
additional phone call by the research coordinate to ask for participation. The purpose of the Way to 
Health text messaging program is to provide timely reminders regarding colonoscopy preparation. 
Obtaining waiver of consent would allow us to avoid the potential selection/volunteer bias for inclusion 
of patients who answer the phone and may be particularly motivated to complete colon cancer 
screening. Since our main objective is to understand the potential influence of the text messaging 
intervention on colonoscopy show rate and adequate bowel preparation quality among all patients who 
agree to text messaging, we believe that obtaining informed consent separately from scheduling would 
not allow us to evaluate the impact of the intended intervention, which is text messaging navigation 
offered to all patients that agree during scheduling. Additionally, participants will be recruited via verbal 
communication when they call our institution call center to schedule their colonoscopy. We believe the 
research presents no more than minimal risk of harm to subjects and involves no procedures for which 
written consent is normally required outside of the research context. 
 
 
 
 
 
 
Additional Information to Subjects 
 
 

8 
 
Participants randomized to the intervention arms will be informed that this program is voluntary and 
that they can stop participating in the program (stop receiving text messages) at any time. 
 
 
 
 
 
 
Written Statement of Research* 
 
 
 
 
 
No 
 
 
 
 
 
 
Risk / Benefit  
 
 
 
 
Potential Study Risks 
 
 
 
 
The risks associated with this study are no more than minimal. There is the potential risk of breach of 
confidentiality involving medical records reviews or text messaging which will be maintained on the Way 
to Health platform. We will minimize this risk by using de-identified information whenever possible and 
by maintaining all identifiable information on a secure drive and/or in a HIPAA-compliant system (e.g. 
REDCap). In addition, all personnel will be held to high standards of upholding confidentiality and 
safeguarding patient privacy. 
 
 
 
 
 
 
 
Potential Study Benefits 
The benefits of this study for participants include a platform that may improve the bowel preparation 
experience prior to colonoscopy and increase the likelihood that a colonoscopy will not be hindered by 
inadequate preparation or a missed/canceled appointment. This will occur through a set of curated text 
messages with timely reminders as well as information with online links and a phone number to improve 
accessibility for questions to be answered on a timely basis. It is also possible that the benefits for some 
participants will be minimal. However, as mentioned, we believe the risks are also minimal. The control 
group is unlikely to directly benefit, as this group will continue to receive usual care. The potential public 
health impact of a successful intervention to improve colonoscopy show rates and bowel preparation 
quality is significant and could increase the chances of identifying colorectal cancer at an early stage and 
reduce the number of repeat colonoscopies and related costs due to inadequate bowel preparation. 
Information learned from this study may benefit society through a better understanding of how to 
effectively increase the rate of adequate colonoscopies which could increase the rate of colorectal 
cancer screening and reduce the rate of mortality. 
 
 
 
 
 
 
 
Alternatives to Participation (optional)  
 
 
 
 
 
 
 
 
 
Data and Safety Monitoring 
The study is minimal risk to participants and therefore the Principal Investigators and study team will 
monitor the safety of this study on an ongoing basis. 

9 
 
 
Risk / Benefit Assessment 
 
 
 
 
The risks associated with this study are no more than minimal. Better knowledge on how to increase 
colonoscopy show rates and improve bowel preparation quality could potentially address one of the 
major barriers to appropriate colorectal cancer screening, which is the second leading cause of cancer 
death in the US. This study is designed to test an intervention with demonstrated feasibility and 
successful preliminary results in a small QI pilot. For these reasons and those outlined in the above 
benefits section, the investigators believe that the potential benefits outweigh the risks of participating 
in the study. 
 
 
 
 

10 
 
Final Protocol 
Automated Text Message Navigation to Improve Outpatient Colonoscopy Show Rate and Bowel 
Preparation 
 
**New changes from initial protocol notated in bold, parts removed from initial 
protocol notated in strikethrough 
 
Brief Description 
Outpatient colonoscopy adherence is negatively impacted by poor communication and challenges with 
bowel preparation. We plan to perform a randomized controlled trial at the Pennsylvania Presbyterian 
Medical Center to (1) provide text message-based educational and reminder messages to patients 
regarding a scheduled colonoscopy, and (2) evaluate the impact of the texting intervention on 
colonoscopy show rate and bowel preparation.  
 
Protocol 
Abstract 
Colonoscopy is an effective screening technique for colorectal cancer (CRC) prevention, but many 
patients either do not show up or have poor bowel preparation for the procedure. We plan to evaluate 
the impact and feasibility of a text message-based program to provide patients with timely educational 
and reminder messages regarding their upcoming colonoscopy and bowel preparation process. In this 
pragmatic randomized controlled trial, we aim to (1) to provide text message-based educational and 
reminder messages to patients or support partners regarding a scheduled colonoscopy, and (2) to 
evaluate the impact of the texting intervention on colonoscopy show rate and bowel preparation. We 
will include patients who are scheduled for outpatient colonoscopy at the Pennsylvania Presbyterian 
Medical Center. After enrollment, patients will be randomized 1:1 to usual care (arm 1) or the text 
message-based intervention (arm 2, one week in duration). We will measure colonoscopy show rate 
with good/excellent bowel preparation as the primary outcome. 
  
Objectives 
Overall objectives 
The specific aims of the study are to (1) to provide text message-based educational and reminder 
messages to patients or support partners regarding a scheduled colonoscopy, and (2) to evaluate the 
impact of the texting intervention on colonoscopy show rate and bowel preparation. 
  
Primary outcome variable(s) 

11 
 
The primary outcome of the study will be colonoscopy show rate with good/excellent bowel preparation 
(binary). 
Secondary outcome variable(s) 
Secondary outcomes of the study will include colonoscopy show rate, bowel preparation quality (rescue, 
poor, fair, adequate, good, excellent; we will also collect Boston Bowel Prep Score if available [scale 0-
9]), colonoscopy cancellation rate, timing of advance cancellation notification (days), colonoscopy 
reschedule rate, and colonoscopy appointment no-show rate. A colonoscopy “show” will be defined as a 
patient who attends their originally scheduled colonoscopy appointment. A “cancellation” will be 
defined as an appointment that is canceled at least one day prior to the originally scheduled 
colonoscopy appointment date. A “reschedule” will be defined as an appointment that is canceled and 
rescheduled (for a future date) on the same day, at least one day prior to the originally scheduled 
colonoscopy appointment date. Finally, as an additional secondary outcome, we will also collect the 
proportion of patients who opt out of the texting program in the late phase of enrollment (described 
below). 
  
Background                                     
Colorectal cancer (CRC) is the second leading cause of cancer death in the US, yet there are effective 
screening and treatment strategies that allow for early detection and treatment. CRC screening is 
recommended for all individuals aged 50-75, which could include stool testing or colonoscopy, but 
national rates are still suboptimal at 59-65%. Colonoscopy is an essential component of CRC screening, 
as it is also required if stool testing is positive. However, colonoscopy requires a complex process to 
identify an escort, purchase the preparation, take a day off from work, adhere to a clear liquid diet, and 
complete the split-dose preparation as recommended. This results in a significant no-show and 
cancellation rate, along with suboptimal preparation quality, which can lead to non-adherence and 
incomplete screening.  
Current approaches to engaging patients include having nurses call patients before the procedure or 
patient navigators. However, it is often difficult to get patients on the phone, and these interventions 
can be costly, making it less scalable for clinical practices. Other interventions such as videos or mobile 
apps have been limited by poor user experience or limited engagement with the patient. There is an 
opportunity to leverage an automated text message navigation intervention using the Way to Health 
(WTH) platform to improve patient engagement prior to colonoscopy completion. The WTH platform is a 
Penn Medicine platform that is hosted on site at the University of Pennsylvania. The platform allows 
custom text messages to automatically be sent to patients, in addition to bidirectional message 
capabilities. WTH is protected by a secure firewall and is a HIPAA compliant platform.  
In the past year, our team conducted a quality improvement pilot initiative using WTH that tested the 
feasibility and impact of a one-week text messaging protocol for patients who were scheduled for 
outpatient colonoscopy. The text messages sent to patients contained information about the 
preparation process and instructions, expectations about the procedure, and reminders about location 
and timing. Among the 21 patients enrolled in the pilot, we found high user acceptability and higher 
Forma.ed: Font color: Black

12 
 
colonoscopy show rates as compared to baseline values at PPMC (90% versus ~50%). As such we believe 
that the texting intervention is feasible for testing in the context of a randomized controlled trial. 
  
Study Design 
Design 
We will perform a pragmatic randomized controlled trial evaluating the impact of the text message-
based intervention (arm 2) as compared to usual care alone (arm 1). Patient enrollment will proceed 
through two pathways (early phase and late phase). In the early phase, 250 patients will be enrolled 
through or through phone calls from a clinical research coordinator, using a script pre-approved by the 
University of Pennsylvania Institutional Review Board. After enrollment, patients will be randomized 1:1 
to the arms listed above through the Way to Health platform. Although patients in arm 2 may be 
enrolled more than one week in advance of their colonoscopy, they will only receive intervention text 
messages in the 7 days prior to the scheduled colonoscopy, in addition to two text messages at the time 
of enrollment explaining the texting program. Usual care consists of a phone call from the PPMC 
endoscopy staff in the week prior to colonoscopy, if the patient is able to be reached. Patients are also 
given the endoscopy phone number, and may call to speak to staff if they have specific questions about 
their colonoscopy or need to reschedule. In the late phase, an additional 500 patients will be 
automatically enrolled in the Way to Health system using verified cell phone numbers from the 
electronic medical record system, where they will be randomized in a 1:1 ratio to the study arms in 
variable blocks of 8 and 4. Patients in arm 2 will receive two enrollment text messages explaining the 
texting program and providing the opportunity to opt out (by replying with the text STOP). A detailed 
outline of the study design can be found in the procedures sections. 
  
Study duration 
The duration of participation for patients in the intervention will be from the time of enrollment to the 
date of scheduled colonoscopy. However, the patient will only receive intervention text messages in the 
week prior to the scheduled colonoscopy, with the exception of the two enrollment messages in the late 
phase. We will plan to recruit patients from November 2018 through June 2019. We estimate that the 
study will be completed by August 2019. 
  
Resources necessary for human research protection 
Describe research staff and justify that the staff are adequate in number and qualifications to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 
researchers to conduct and complete the research. Please confirm that there are adequate facilities for 
the research. 
 
Deleted: be performed with assistance from the call center 
at the Pennsylvania Presbyterian Medical Center (PPMC), 
and/
Deleted: s or months
Deleted: January 
Deleted: March 

13 
 
The project will take place at the Pennsylvania Presbyterian Medical Center (PPMC) at the University of 
Pennsylvania (UPENN). The team includes investigators experienced in clinical medicine, health behavior 
interventions, clinical trials, behavioral economics, and program evaluation. This study will be led by Dr. 
Shivan Mehta, MD, MBA, MSHP, Assistant Professor of Medicine and Associate Chief Innovation Officer 
for Penn Medicine. This study will be supported on a secure web portal on the Way to Health platform, 
modified to the specifications of this study. Additional study staff include a gastroenterology fellow, a 
clinical research coordinator, a medical student, key PPMC endoscopy staff, and quality improvement 
specialists. Regular group meetings will be held at pivotal points in the trial in order to ensure 
compliance with protocol and research-related duties. 
  
Characteristics of the Study Population 
Target population 
Eligibility Criteria: Patients will be eligible for study inclusion if they are age 18-85 years and are 
scheduled for outpatient colonoscopy to be completed at the PPMC outpatient endoscopy center. We 
will exclude patients if there are fewer than 14 days from time of scheduling to the scheduled date of 
colonoscopy. The target enrollment sample size is 750 patients—375 in arm 1 (usual care) and 375 in 
arm 2 (usual care plus texting intervention). This number is based in part on sample size calculations 
using data from a previous pilot, which suggests that a total sample size of 750 patients will have greater 
than 80% power to detect a 10% difference in the primary outcome. We also chose a larger sample size 
to account for the fact that patients may opt out of the text messages in the late phase of enrollment, 
which would likely decrease the effect size between arms. 
  
Subjects enrolled by Penn Researchers 
750 
  
Subjects enrolled by Collaborating Researchers 
0 
  
Accrual 
Participants in the study will be planned for outpatient colonoscopy at the Pennsylvania Presbyterian 
Medical Center (PPMC). Once a patient is confirmed to meet eligibility criteria, patient enrollment will 
proceed based on one of two pathways (early and late phase). In the early phase (first 250 patients), 
enrollment will be performed through phone calls from a clinical research coordinator. The research 
coordinator will call newly scheduled patients to discuss the research project and enroll patients using a 
script to approved by the University of Pennsylvania IRB. If patients are scheduled for colonoscopy in 
person while at the office, they will receive an informational flyer about the study that gives them the 
opportunity to contact a study team member for additional information or to enroll. It also informs 
Deleted: 0
Deleted: 40
Deleted: 2
Deleted: 00
Deleted: 2
Deleted: 00
Deleted: 20
Deleted: 5
Deleted: .
Deleted: 40
Deleted: be performed
Deleted: with assistance from the call center at PPMC, 
and/or 
Deleted: When patients have a physician order for a 
colonoscopy, the patient must contact the call center in 
order to schedule the colonoscopy. The call center staff 
have agreed to discuss the research project and enroll 
patients using a script to be approved by the IRB. Similarly, t
Deleted: be 

14 
 
them that someone from the study may contact them directly about participating. After enrollment, 
patients will be 1:1 randomized to arm 1 or arm 2 using the Way to Health platform.  
 
In the late phase (additional 500 patients), patients with upcoming colonoscopy appointments will be 
screened for eligibility as per the selection criteria. As in the early phase, if patients are scheduled for 
colonoscopy in person while at the office, they will receive an informational flyer about the study that 
lets them know they may be contacted by text message about their upcoming procedure. Those who 
qualify will have their validated cell phone numbers imported into Way to Health, where they will 
subsequently be randomized. Those in the intervention arm will receive two enrollment messages 
describing the study and providing the opportunity to opt out (by replying with the text STOP). Of note, 
if a patient in the late phases chooses to opt out and not receive the texting intervention, their data will 
still be analyzed in the intervention group (as an intention-to-treat approach). Importantly, we are 
requesting a waiver of consent for several reasons: (1) the study presents no more than minimal risk of 
harm to participants, (2) the patients who are randomized to either arm will not be deprived of any 
standard care available in the status quo and thus the study will not violate their rights or welfare, (3) 
the study could not be practicably completed without such a waiver, as the scheduling process is 
handled over the phone by call center staff, and (4) requiring standard informed consent would require 
an additional touchpoint by the research coordinator and the consent process would preclude us from 
evaluating the intended intervention by introducing selection bias and altering the intervention that 
patients receive. 
  
Key inclusion criteria 
Eligibility Criteria: Patients between ages 18 and 85 years who are scheduled for outpatient colonoscopy 
at PPMC and have a cell phone with enabled text messaging capability. 
  
Key exclusion criteria 
Exclusion Criteria: Patients will be excluded if there are fewer than 14 days between the time of 
enrollment and time of scheduled colonoscopy. This will ensure the clinical research coordinator has 
sufficient time to reach newly scheduled patients, and that patients randomized to arm 2 will have 
sufficient time to receive the full text message intervention. Patients will also be excluded if they are 
non-English speaking requiring a translator, or if they are not the primary individual receiving the text 
messages. Finally, patients will be excluded if they do not meet all of the inclusion criteria, or if they 
refuse participation in text messaging. 
  
  
 
 
Moved (inserQon) [1]
Moved up [1]:  After enrollment, patients will be 1:1 
randomized to arm 1 or arm 2 using the Way to Health 
platform.
Deleted: 0

15 
 
 
Procedures 
Screening – Phase 1: As above, patients will be screened and enrolled through one of two pathways 
(early and late phase). In the early phase (first 250 patients), a PPMC practice manager will forward a list 
of scheduled colonoscopies to the clinical research coordinator (CRC) on a regular basis. If patients are 
scheduled for colonoscopy in person while at the office, they will receive an informational flyer about 
the study that gives them the opportunity to contact a study team member for additional information or 
to enroll. It also informs them that someone from the study may contact them directly about 
participating. The CRC will screen patients for eligibility and make up to 3 phone call attempts to reach 
the patient. Once on the phone, the CRC will explain the details of the study using a script approved by 
the IRB and enter patients directly into the WTH platform for randomization. In the late phase 
(additional 500 patients), patients will be screened for eligibility through the same process as in the 
early phase. If they are scheduled for colonoscopy in person while at the office, they will also receive an 
informational flyer about the study that lets them know they may be contacted by text message about 
their upcoming procedure. For eligible patients, the CRC will then manually enter the validated patient 
cell phone number from the electronic medical record system into WTH. Randomization will then occur 
as described below, and intervention arm patients will receive two enrollment messages. These 
messages will describe the texting program and provide the opportunity for patients to opt out (by 
texting the word STOP). Of note, phone numbers will be confirmed to represent cell phones by using a 
publicly-available lookup utility. Importantly, patients who opt out will still be included in the 
intervention arm as an intention-to-treat analysis. Based on our experience with the QI pilot described 
above, we estimate needing to screen approximately 1,000 patients to meet our enrollment targets (750 
total patients). 
Randomization - Phase 2: In the early phase, using a random number generator in the WTH platform, 
patients will be 1:1 randomized to arm 1 or arm 2. Beginning in the late phase of enrollment, patients 
will be randomized to arm 1 or arm 2 in a 1:1 ratio in variable blocks of 8 and 4 using the WTH platform, 
until the target sample size of 375 patients per arm is reached. 
Chart review - Phase 3: after randomization and in tandem with phase 4 (below), the research 
coordinator will perform a chart review to obtain patient demographic and comorbidity data 
(hypertension, hyperlipidemia, diabetes, inflammatory bowel disease, obesity, active opiate 
prescription). We will also collect data on the number of patients opting out in the late phase of 
enrollment, as well as data on nursing phone calls which are performed as a component of usual care 
(not called, called but could not reach patient, called and spoke with patient). All data will be inputted 
into and stored in a secured RedCap database. Only key study staff will have access to the RedCap 
database, which is stored on a secure firewall-protected server. 
Intervention - Phase 4: Patients in arm 2 will begin receiving text messages per a pre-determined 
protocol starting 7 days prior to the date of scheduled colonoscopy (the text messaging protocol is 
attached to this application). Of note, if a patient in arm 2 cancels or reschedules their colonoscopy after 
randomization, they will not receive any additional protocol text messages as part of this trial. Patients 
in arm 1 and arm 2 will both receive usual care, which includes (1) bowel preparation instructions that 
are delivered via mail or through a secure online messaging portal, (2) a phone call from the endoscopy 
Deleted: Patients who have a physician order for a 
colonoscopy will call the PPMC call center in order to 
schedule their procedure. At this time, the call center staff 
will screen the patient for eligibility (age criteria and text 
messaging ability) and will explain the details of the study 
following a pre-determined script. Patients who agree to 
participate in the study will have their cell phone number 
recorded. A list of these patients will be forward to the 
clinical research coordinator on a weekly regular basis, who 
will confirm patient eligibility and then manually enter 
patients into the WTH platform for randomization. 
Alternatively, 
Deleted: for 
Deleted: between 500 and 
Deleted: 6
Deleted: 40
Deleted: , until the target 
Deleted: sample size of 200 patients per arm is reached.  
Randomization will be performed and recorded in WTH.

16 
 
staff in the week prior to colonoscopy, and (3) the option to call the endoscopy staff during business 
hours to have any questions answered on demand. 
Outcomes data collection - Phase 5: After a patient’s scheduled colonoscopy date has passed, the 
research coordinator will review the medical record to gather additional data from the endoscopy 
procedure. This will include the indication for the procedure, quality of bowel preparation (rescue, poor, 
fair, adequate, good, excellent; Boston Bowel Prep Score will also be collected if recorded), and 
completeness (cecum reached). Procedure status will also be recorded (canceled, no-show, rescheduled, 
completed). If the procedure was canceled, the cancellation lead time (in days) prior to scheduled 
colonoscopy will be recorded.  
Statistical Analysis and Manuscript Preparation - Phase 6: The statistical analysis (detailed below) will 
commence after completion of outcomes ascertainment for the entire cohort.  
 
Analysis Plan 
Descriptive analysis will include comparison of baseline demographics and major medical comorbidities 
between study arms. Continuous and categorical data will be compared using the Wilcoxon Rank-sum 
and Chi-squared tests, respectively. An alpha threshold of 0.05 will be used for statistical significance, 
with two-tailed testing performed in all instances. For the primary analysis, we will perform a Chi-
squared test of independence to compare the proportion of colonoscopies with good/excellent bowel 
preparation between groups. In the secondary analysis, Chi-squared tests of independence will be 
performed to compare colonoscopy status (show, no-show, reschedule, cancelation) as well as bowel 
preparation quality (excellent, good, adequate, fair, poor) between groups. Among canceled 
colonoscopies, median lead time of cancellation will be compared between groups using the Wilcoxon 
Rank-sum test. Finally, for both primary and secondary analyses, we will consider multivariable 
regression modeling to adjust for imbalances in possible confounders, if present despite randomization. 
Consent 
1. Consent Process 
Overview 
We are requesting a waiver of informed consent for this study. The reason for our request is explained 
in the Waiver of Consent section. Verbal consent for text messaging will still be obtained from all 
participants in the study. Please see the script templates attached to this application. 
 
 
 
 
 
 
Children and Adolescents 
Not applicable. We are only enrolling subjects 18 years of age and older. 
 
Adult Subjects Not Competent to Give Consent 
Deleted: Finally, a

17 
 
We are requesting a waiver of informed consent for this study but patients will still need to verbally opt 
in to text messaging. We plan to enroll only those patients who are competent at time of enrollment to 
opt-in for themselves. 
 
2. Waiver of Consent 
Waiver or Alteration of Informed Consent* 
Waiver or alteration of required elements of consent. 
 
 
 
 
 
 
Minimal Risk* 
This study is minimal risk as all participants will be receiving standard clinical care. Colonoscopy is the 
standard of care for colorectal cancer screening, and all patients will receive standard bowel preparation 
instructions in addition to optional phone communication with endoscopy staff prior to the procedure. 
The only research-related activity is the randomization of participants to a text messaging program that 
will supplement routine practice when an individual schedules a colonoscopy at our institution. Since 
this study is intended to promote the standard of care for colorectal cancer screening, and the receipt of 
text messages poses negligible risk to the patient, we believe that waiver of consent is appropriate. 
 
 
 
 
 
Impact on Subject Rights and Welfare*  
 
 
 
Participation in the intervention is completely voluntary and subject rights and welfare will not be 
adversely affected by the waiver of authorization and consent. Participants randomized to the 
intervention arms still need to opt in to text messaging: Arm 1 will receive standard clinical care and Arm 
2 will be enrolled into the text-messaging program in addition to standard clinical care. Placement in 
either arm for the purposes of research does not adversely affect the rights and welfare of the subjects, 
as each arm has the opportunity to engage in colorectal cancer screening, receive bowel preparation 
instructions, and communicate with the endoscopy staff over the phone. Randomly assigning patients to 
intervention and control does not alter patient’s rights any differently than conducting an uncontrolled 
pilot study where some patients receive the intervention and some don’t.  We believe it is appropriate 
to obtain waiver of consent because learning the impact of different modalities for improving colorectal 
screening has significant potential clinical value for the practice (i.e. significantly increasing the rate of 
successful screening and thus decreasing the rate of mortality related to nonuse of screening). 
 
Waiver Essential to Research*  
 
 
 
The informed consent process itself may influence the outcome of our study, as it would require an 
additional phone call by the research coordinate to ask for participation. The purpose of the Way to 
Health text messaging program is to provide timely reminders regarding colonoscopy preparation. 
Obtaining waiver of consent would allow us to avoid the potential selection/volunteer bias for inclusion 
of patients who answer the phone and may be particularly motivated to complete colon cancer 

18 
 
screening. Since our main objective is to understand the potential influence of the text messaging 
intervention on colonoscopy show rate and adequate bowel preparation quality among all patients who 
agree to text messaging, we believe that obtaining informed consent separately from scheduling would 
not allow us to evaluate the impact of the intended intervention, which is text messaging navigation 
offered to all patients that agree during scheduling. Additionally, participants will be recruited via verbal 
communication when they call our institution call center to schedule their colonoscopy. We believe the 
research presents no more than minimal risk of harm to subjects and involves no procedures for which 
written consent is normally required outside of the research context. 
 
 
 
 
 
 
Additional Information to Subjects 
 
 
Participants randomized to the intervention arms will be informed that this program is voluntary and 
that they can stop participating in the program (stop receiving text messages) at any time. 
 
 
 
 
 
 
Written Statement of Research* 
 
 
 
 
 
No 
 
 
 
 
 
 
Risk / Benefit  
 
 
 
Potential Study Risks 
 
 
 
 
The risks associated with this study are no more than minimal. There is the potential risk of breach of 
confidentiality involving medical records reviews or text messaging which will be maintained on the Way 
to Health platform. We will minimize this risk by using de-identified information whenever possible and 
by maintaining all identifiable information on a secure drive and/or in a HIPAA-compliant system (e.g. 
REDCap). In addition, all personnel will be held to high standards of upholding confidentiality and 
safeguarding patient privacy. 
 
 
 
 
 
 
 
Potential Study Benefits 
The benefits of this study for participants include a platform that may improve the bowel preparation 
experience prior to colonoscopy and increase the likelihood that a colonoscopy will not be hindered by 
inadequate preparation or a missed/canceled appointment. This will occur through a set of curated text 
messages with timely reminders as well as information with online links and a phone number to improve 
accessibility for questions to be answered on a timely basis. It is also possible that the benefits for some 
participants will be minimal. However, as mentioned, we believe the risks are also minimal. The control 
group is unlikely to directly benefit, as this group will continue to receive usual care. The potential public 
health impact of a successful intervention to improve colonoscopy show rates and bowel preparation 
quality is significant and could increase the chances of identifying colorectal cancer at an early stage and 
reduce the number of repeat colonoscopies and related costs due to inadequate bowel preparation. 
Information learned from this study may benefit society through a better understanding of how to 

19 
 
effectively increase the rate of adequate colonoscopies which could increase the rate of colorectal 
cancer screening and reduce the rate of mortality. 
 
 
 
 
 
 
 
Alternatives to Participation (optional)  
 
 
 
 
 
 
 
 
 
Data and Safety Monitoring 
The study is minimal risk to participants and therefore the Principal Investigators and study team will 
monitor the safety of this study on an ongoing basis. 
 
Risk / Benefit Assessment 
 
 
 
 
The risks associated with this study are no more than minimal. Better knowledge on how to increase 
colonoscopy show rates and improve bowel preparation quality could potentially address one of the 
major barriers to appropriate colorectal cancer screening, which is the second leading cause of cancer 
death in the US. This study is designed to test an intervention with demonstrated feasibility and 
successful preliminary results in a small QI pilot. For these reasons and those outlined in the above 
benefits section, the investigators believe that the potential benefits outweigh the risks of participating 
in the study. 

20 
 
Summary of Protocol Changes Modifications LOG 
 
Protocol: Automated Text Message Navigation to Improve Outpatient Colonoscopy Show Rate and Bowel Preparation 
University of Pennsylvania Principal Investigator: Shivan Mehta, MD 
 
 
Date of 
Submission 
Description of Modification 
Rationale for Modification 
Approval date 
9/11/18 
 Initial submission 
 
10/8/2018 
10/22/18 
 Modification: 
 - add staff (CRC) 
 - add call center script 
 
10/23/2018 
11/14/18 
 Modification: 
 - add recruitment by CRC & call script 
 - change exclusion (from 10 to 14 days) 
 
11/15/2018 
12/19/18 
Modification: 
- add patient recruitment flyer 
- modify CRC call script 
 
12/19/2018 
1/2/2019 
Modification:  
- modify CRC call script 
- modify “welcome text” message for pts in intervention arm 
- modify inclusion/exclusion criteria 
- add description of procedure if arm 2 patient cancels or 
reschedules colonoscopy 
- add lead time of cancellation as an outcome measure (in 
days) 
 
 
4/4/2019 
Modification: 
- modify sample size target 
- distinguish early and late phase enrollment 
 
 
 
 
 
 

21 
 
Initial Statistical Analysis Plan 
 
The target enrollment sample size is 400 patients—200 in arm 1 (usual care) and 200 in arm 2 (usual care 
plus texting intervention). This number is based on sample size calculations using data from a previous 
pilot, which suggests that a total sample size of 200 patients will have greater than 80% power to detect a 
15% difference in the primary outcome. 
Descriptive analysis will include comparison of baseline demographics and major medical comorbidities 
between study arms. Continuous and categorical data will be compared using the Wilcoxon Rank-sum and 
Chi-squared tests, respectively. An alpha threshold of 0.05 will be used for statistical significance, with 
two-tailed testing performed in all instances. For the primary analysis, we will perform a Chi-squared test 
of independence to compare the proportion of colonoscopies with good/excellent bowel preparation 
between groups. In the secondary analysis, Chi-squared tests of independence will be performed to 
compare colonoscopy status (show, no-show, cancelation) as well as bowel preparation quality (excellent, 
good, fair, poor) between groups. Finally, among canceled colonoscopies, median lead time of cancellation 
will be compared between groups using the Wilcoxon Rank-sum test. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

22 
 
Final Statistical Analysis Plan 
 
**New changes from initial protocol notated in bold, parts removed from initial 
protocol notated in strikethrough 
 
The target enrollment sample size is 750 patients—375 in arm 1 (usual care) and 375 in arm 2 (usual care 
plus texting intervention). This number is based in part on sample size calculations using data from a 
previous pilot, which suggests that a total sample size of 750 patients will have greater than 80% power to 
detect a 10% difference in the primary outcome. We also chose a larger sample size to account for the fact 
that some patients enrolled in arm 2 may opt out of receiving text messages, which would likely decrease 
the effect size between arms. 
Descriptive analysis will include comparison of baseline demographics and major medical comorbidities 
between study arms. Continuous and categorical data will be compared using the Wilcoxon Rank-sum and 
Chi-squared tests, respectively. An alpha threshold of 0.05 will be used for statistical significance, with 
two-tailed testing performed in all instances. For the primary analysis, we will perform a Chi-squared test 
of independence to compare the proportion of colonoscopies with good/excellent bowel preparation 
between groups. In the secondary analysis, Chi-squared tests of independence will be performed to 
compare colonoscopy status (show, no-show, reschedule, cancelation) as well as bowel preparation 
quality (excellent, good, adequate, fair, poor) between groups. Among canceled colonoscopies, median 
lead time of cancellation will be compared between groups using the Wilcoxon Rank-sum test. Finally, for 
both primary and secondary analyses, we will consider multivariable regression modeling to adjust for 
imbalances in possible confounders, if present despite randomization. 
 
 
 
 
 
Summary of Statistical Analysis Plan Modifications 
- 
Sample size adjusted 
- 
Additional details regarding secondary outcomes 
- 
Added possibility of regression analyses if imbalances in potential confounders are noted 
Deleted: 40
Deleted: 200
Deleted: 200
Deleted: 20
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