Effectiveness and Implementation of mPATH-CRC: a Mobile Health System for Colorectal Cancer Screening
Phase: NA
Conditions: Colorectal Cancer, Cancer, Rectum Cancer, Colon Cancer
Sponsor: Wake Forest University Health Sciences

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 1 of 71 
*** Confidential *** 
Principal Investigator: 
Co-Investigator(s): 
David P. Miller, M.D. 
Department of Internal Medicine 
Wake Forest School of Medicine 
Medical Center Blvd. 
Winston-Salem, NC 27157 
Kristie Foley, Ph.D. 
Department of Social Sciences and Health Policy 
Wake Forest School of Medicine 
Medical Center Blvd. 
Winston-Salem, NC 27157 
Anna Snavely, PhD 
Department of Biostatistical Sciences 
Wake Forest University School of Medicine 
Medical Center Blvd. 
Winston-Salem, NC 27157 
 
 
Ajay Dharod, M.D. 
Department of Internal Medicine 
Wake Forest School of Medicine 
Medical Center Blvd. 
Winston-Salem, NC 27157 
Mark Dignan, PhD 
University of Kentucky 
Internal Medicine 
800 Rose Street 
Lexington, KY 40536 
Holly Brower, PhD 
Wake Forest University School of 
Business 1834 Wake Forest Road 
Winston-Salem, NC 27106 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 2 of 71 
*** Confidential *** 
Biostatistician: 
Geoffrey Curran, PhD 
University of Arkansas 
Center for Implementation Research 
4301 West Markham Street 
Little Rock, AR 72205 
Jennifer Troyer, PhD 
University of North Carolina at 
Charlotte Belk School of Business 
9201 University City Blvd 
Charlotte, NC 28223 
Anna Snavely, PhD 
Department of Biostatistical Sciences 
Wake Forest University School of Medicine 
Medical Center Blvd. 
Winston-Salem, NC 27157 
 
Study Coordinator: 
Regulatory Contact: 
Protocol Editor: 
Participating Institution(s): 
Elena Wright 
Elena Wright 
Mac Robinson, PhD 
Wake Forest Baptist Comprehensive Cancer 
Center Wake Forest University School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
Wake Forest Baptist Health 
University of Kentucky 
Version Date: 
February 12, 2018 
Amended: 
 
February 22, 2023 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 3 of 71 
*** Confidential *** 
Table of Contents 
1.0 
Introduction and Background ..................................................................................... 5 
2.0 
Objectives ................................................................................................................. 6 
2.1 
Primary Objective .................................................................................................. 6 
2.2 
Secondary Objective.............................................................................................. 6 
3.0 
Study Population ....................................................................................................... 7 
3.1 
Patient Inclusion Criteria ........................................................................................ 7 
3.2 
Patient Exclusion Criteria ........................................ ...............................................7. 
3.3 
Inclusion of Women and Minorities ........................................................................ 7 
3.4 
Registration Procedures ........................................................................................ 8 
4.0 
Experimental Methods ............................................................................................... 8 
4.1 
The mPATH-CRC Intervention .............................................................................. 8 
4.2 
Framework for Implementing mPATH-CRC ........................................................... 9 
4.3 
Pilot-Testing Implementation Strategy and Materials ........................................... 10 
4.4 
Implementation Trial ............................................................................................ 11 
4.5 
Pragmatic Trial .................................................................................................... 14 
4.6 
Mixed-Methods Study .......................................................................................... 14 
5.0 
Outcome Measures ................................................................................................. 14 
5.1 
Definition of Time Points ...................................................................................... 14 
5.2 
Primary Outcome ................................................................................................. 15 
5.3 
Secondary Outcomes .......................................................................................... 15 
5.3 
Data Sources ....................................................................................................... 16 
6.0 
Analytic Plan............................................................................................................ 17 
6.1 
Sample Size and Power ...................................................................................... 17 
6.2 
Analysis of Primary Outcome ............................................................................... 18 
6.3 
Analysis of Secondary Outcomes ........................................................................ 18 
6.4 
Length of Study ................................................................................................... 19 
7.0 
Data Management ................................................................................................... 19 
8.0 
Confidentiality and Privacy ...................................................................................... 20 
9.0 
Data Safety and Monitoring ..................................................................................... 20 
10.0 
Reporting of Unanticipated Problems, Adverse Events or Deviations ...................... 20 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM 
FOR COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 4 of 71 
*** Confidential *** 
11.0 
References .............................................................................................................. 21 
Appendix A – Implementation Strategy Qualitative Study Materials .................................... 28 
Appendix B – Data Collection Instruments .......................................................................... 55 
Appendix C – Clinic Personnel Interview Guide .................................................................. 57 
Appendix D – Effect of mPATH on Screening for Depression, Fall Risk, and Safety ........... 68 
Appendix E – Data Transfer from non-Wake Forest Health Network Clinics ....................... 71 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 5 of 71 
*** Confidential *** 
1.0 
Introduction and Background 
In September 2016, the Cancer Moonshot Blue Ribbon Panel’s report highlighted excessive mortality 
from colorectal cancer (CRC), the problems of health disparities, the need for interventions that inform 
patients of CRC screening tests, and the need for research to rapidly translate evidence-based CRC 
screening interventions into practice.1  This study directly addresses all four of these Cancer Moonshot 
priorities by examining the implementation of an innovative mobile health (mHealth) CRC screening 
intervention that is accessible by members of health-disparate populations.  Lessons learned from this 
study will inform the scale-up of this CRC screening intervention, as well as the implementation of other 
mHealth interventions. 
Screening for CRC is widely recommended but underused. CRC screening tests are cost-effective, and 
they reduce both CRC mortality and incidence by detecting and removing pre-cancerous polyps.2–5  
Regular screening for CRC beginning at age 50 is widely recommended by several groups, including 
the United States Preventive Services Task Force.6–9 Nonetheless, over 35% of Americans are 
unscreened.10   
Screening rates are even lower among underserved populations, contributing to health disparities.10,11 
Those with less education, limited income, or rural residences are less likely to be screened, and thus 
more likely to present with advanced-stage CRC and die from it.12–16 Limited health literacy, which 
affects over 33% of American adults further interfering with patients’ ability to access, interpret, and 
apply health information to their care.17–21  
Barriers to CRC screening include patient factors (lack of knowledge, low self-efficacy, fears, negative 
attitudes)22–28 and provider/system factors (lack of time, failure to offer screening options, lack of patient 
support).29–33 Meaningful increases in CRC screening will require an easily implemented intervention 
that addresses patient, provider, and system barriers while also being accessible to low income and low 
literacy individuals.34,35 We created our mPATH-CRC (mobile PAtient Technology for Health-Colorectal 
Cancer) intervention to tackle these needs. 
mPATH-CRC is our iPad-based application, designed for individuals with low literacy, which patients 
use during routine health care visits.36 Because most Americans over age 50 have seen a doctor within 
the past year, including 75% of adults with less than a high school education, interventions in medical 
practices have a potential broad reach.37 mPATH-CRC also sends automated text messages to help 
patients complete their screening tests, which extends support beyond the medical encounter.  95% of 
US adults own a cellphone, and there is no digital divide along racial or socioeconomic lines, which 
creates an opportunity to encourage healthy behaviors and potentially reduce health disparities.38–41 
Our mPATH-CRC intervention leverages the high prevalence of medical encounters and cellphone 
ownership to maximize its reach. 
While several tests exist for CRC screening, most clinicians encourage colonoscopy, the most invasive 
and costly option.33,42  Because CRC screening rates are higher when patients can choose fecal occult 
blood testing, there is a critical need for interventions to help patients decide which test they prefer.11,43  
Our mPATH-CRC program uses a validated decision aid to inform patients of the commonly used 
screening tests and help them select their best option,44 a direct recommendation of the Cancer 
Moonshot Implementation Science Working Group Report.1  In our previous randomized, controlled 
efficacy trial of 450 patients, mPATH-CRC more than doubled CRC screening rates (30% vs 15%, 
p=0.0001).45 This efficacy trial demonstrated the potential for mPATH-CRC to improve screening rates, 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 6 of 71 
*** Confidential *** 
but the implementation was led by our research team, thereby restricting its potential for scale-up in a 
real-world context. This major gap is now addressed in this planned Type III hybrid implementation trial. 
Translating mPATH-CRC into widespread use could increase receipt of CRC screening in the US from 
its current low level of 58% to over 70%, the target set by Healthy People 2020.46,47 However, the 
optimal strategies for implementing mHealth interventions in clinical care remain unknown. Three 
recently published reviews identified over 500 articles and conference proceedings on mHealth studies, 
none of which prospectively examined competing implementation strategies.48–50  Accordingly, this 
study will impact public health in two key ways: implementing mPATH-CRC in community practices to 
decrease CRC mortality, and determining the best strategies for implementing and sustaining the 
growing number of other mHealth interventions that currently lack an evidence base for implementation. 
2.0 
Objectives 
2.1 
Primary Objective 
2.1.1 In a cluster-randomized controlled trial of 22 primary care clinics, compare 
the implementation outcomes of a “high touch” evidence-based mHealth 
implementation strategy with a “low touch” implementation strategy.  We 
will first refine the “high touch” strategy based on input from focus groups with 
stakeholders.  We will then rigorously evaluate the strategy in sites with different 
geographic settings (urban, suburban, and rural), clinic structures, and patient 
populations served.  Our primary implementation outcome will be the proportion 
of all patients who complete mPATH-CRC in the 6th month following the 
implementation date.  Secondary outcomes will include Reach, Adoption, 
Maintenance, and Fidelity. Additional secondary outcomes include Acceptability, 
Appropriateness, and Feasibility.  We will also measure implementation costs to 
estimate the cost per patient reached as an exploratory outcome. 
2.2 
Secondary Objective 
2.2.2 In a pragmatic trial, estimate the effect of mPATH-CRC on completion of 
CRC screening within 16 weeks of visit.  We will query the electronic health 
record (EHR) at each study clinic to identify individuals aged 50 – 74 with no 
evidence of current CRC screening at the time of their clinic visit. We will then 
examine in the EHR whether these individuals complete CRC screening within 
16 weeks of their index visit. The primary effectiveness analysis will compare the 
proportion of patients who complete screening between the pre- and post-
implementation period in the “high touch” vs. “low touch” clinics. A secondary 
analysis will explore whether there is a dose-response relationship between use 
of mPATH-CRC and screening rates across all clinics.   
2.2.3 Determine the factors that facilitate or impede the maintenance of mHealth 
interventions like mPATH-CRC.  We will assess all clinics 12 months after 
implementation to identify those with high, low, and variable levels of 
maintenance.  Using mixed methods that incorporate in-depth interviews with 
clinic staff, providers, and administrators, we will identify theory-based and 
organizational factors associated with sustained use of technology-based 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 7 of 71 
*** Confidential *** 
interventions like mPATH-CRC. These results will provide critical information to 
guide future large-scale dissemination and implementation trials. 
3.0 
Study Population 
This study will include three distinct populations of participants: 1) healthcare providers and staff at 
primary care practices, and 2) all adult patients seen in the participating study sites 3) all adult patients 
seen in the participating study sites who are deemed eligible for CRC screening. Providers and staff will 
participate through focus groups, surveys, and interviews. The provider/staff inclusion criteria vary 
according to the phase of the study. Therefore, for simplicity, the provider/staff inclusion criteria are 
described with the experimental methods for the relevant study activity (Section 4.0). The patient 
inclusion and exclusion criteria are detailed below. 
3.1 
Patient Inclusion Criteria: All Patients 
3.1.1. Age 18 and older 
3.1.2. Spanish or English-speaking 
3.1.3. Have appointment scheduled with provider (Physician, PA, or NP) at 
participating study site 
3.2 
Patient Inclusion Criteria: CRC Screening Portion 
3.2.1. Have appointment scheduled with provider (Physician, PA, or NP) at participating 
study site 
3.2.2. Age 50 – 74  
3.2.3. Spanish or English-speaking 
3.2.4. Due for routine CRC screening, defined as: 
•
No colonoscopy within the prior 10 years
•
No flexible sigmoidoscopy within the prior 5 years
•
No CT colonography within the prior 5 years
•
No fecal DNA testing within the prior 3 years
•
No fecal blood testing (guaiac-based test with home kit or fecal
immunochemical test) within the prior 12 months
3.3 
Inclusion of Women and Minorities 
3.3.1 Women and men of all races and ethnicity who meet the above-described 
eligibility criteria are eligible for this trial. 
3.3.2 Patients will be participating in a pragmatic trial that will include Spanish and 
English-speaking adult patients who are seen in community-based primary care 
practices in North Carolina. Therefore, the study sample demographics will 
reflect the demographics of the clinics’ population. We will query the electronic 
health records to obtain data for all age and language eligible patients seen in 
the 22 study clinics over a 24-month period. Therefore, we are unable to estimate 
a precise sample, but we estimate this pragmatic trial will include a minimum 
30,000 patients. Based on the clinics’ population estimates, we expect 
approximately 55% of participants to be women. Similarly, we expect 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 8 of 71 
*** Confidential *** 
approximately 2% of study participants to be Hispanic/Latino, 10% to be 
Black/African-American, 1% to be Asian, and < 1% to be American Indian/Alaska 
Native.  
3.4 
Registration Procedures 
Patients will be participating in a pragmatic trial in which patient data collection will occur 
by retrospective electronic chart review. All patients will receive current guideline-
recommended care, and we will request a waiver of patient Informed Consent. 
Therefore, it is impractical to register patients with the Cancer Center, and any such 
registration would jeopardize patient confidentiality. 
Clinic staff and providers will participate in surveys, interviews, and/or focus groups. No 
sensitive information will be collected from clinic staff or providers. Therefore, we are 
requesting a waiver of signed consent. We will give all participating staff and providers a 
study information sheet explaining the purpose of the study, the nature of the data to be 
collected, and the voluntary nature of their participation. 
4.0 
Experimental Methods 
Using a Type 3 hybrid implementation-effectiveness design, we will evaluate a theory-based “high 
touch” implementation strategy compared to a “low touch” implementation strategy for incorporating 
mPATH-CRC in routine practice in 22 geographically diverse primary care practices. The study will 
include an implementation trial (to compare the implementation outcomes of both strategies), a 
pragmatic trial (to estimate the effect of mPATH-CRC on completion of CRC screening), and a mixed-
methods study (to determine the factors that facilitate or impede the maintenance of technology-based 
interventions).   
4.1 
The mPATH Intervention 
mPATH is a self-administered iPad program that patients use in primary care clinics to help 
them receive CRC screening.  The mPATH program also includes health questions to assist 
Figure 1.  Overview of the mPATH-CRC Program 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 9 of 71 
*** Confidential *** 
clinics with patient check-in, thereby incentivizing its use for all patients. Clinic staff hand the 
mPATH-Check In program to patients upon check-in so that they may use it immediately before 
their medical visit.  To overcome literacy and usability barriers each question is written in simple 
lay language.  One question is displayed per screen, with large intuitive response buttons 
(Figure 1).  The mPATH-CheckIn program determines patients’ screening status (due, possibly 
due, or current) by asking patients three items about their screening history and by connecting 
with the EPIC electronic health record. 
If patients are due for CRC screening, mPATH-CRC displays an 8-minute previously-validated 
CRC screening decision aid that includes graphics, animations, and video testimonials from 
patients and physicians, consistent with Social Cognitive Theory.51,52  mPATH informs patients 
of the benefits and risks of screening (including costs and complications) and lets them “self-
order” either of the two most commonly recommended tests (fecal occult blood testing and 
colonoscopy).9,44  Self-ordered tests are automatically routed to the patient’s primary care 
provider for approval, allowing providers to overrule an order in the rare case it is felt 
inappropriate.   
mPATH tells patients with specific risk factors (such as family history of CRC) to discuss 
screening with their provider, since screening guidelines differ for these high-risk individuals.6,8 
When patients are done using mPATH, a clinic staff member collects the iPad. 
mPATH checks its usage database on startup and only ascertains patients’ screening status if 
the patient has not completed the CRC questions in the prior 6 months, an approach validated 
by Miller in a prior study of a substance abuse screening system in primary care practices.54  
mPATH automatically sends data wirelessly to a central server and deletes the data once 
transmission confirmation is received, thereby preventing any data loss.  Although all currently 
interested clinics have wireless networks, any clinic without an existing wireless network will be 
given a wireless router. All clinics can access their data and generate customized reports via a 
secure web interface. 
mPATH runs outside the EHR but directly receives and sends data to EPIC-based EHRs, a 
commonly used EHR in the US55 and the platform used by all Wake Forest-affiliated practices. 
4.2 
Framework for Implementing mPATH 
Our strategy for implementing mPATH is based on the Technology Acceptance Model (TAM) to 
guide initial implementation and the Dynamic Sustainability Framework to guide maintenance, 
or continued use over time.  The TAM posits that implementation of a new technology is 
determined by social influences and characteristics of the technology (which determine its 
perceived usefulness) and employees’ characteristics and experiences (which determine its 
perceived ease of use).56–58  After implementation, the Dynamic Sustainability Framework 
incorporates adaptability of mPATH as a means to promote maintenance.  
Our “high touch” implementation strategy leverages evidence-based implementation strategies 
in conjunction with these two models (Figure 2).  Each clinic will have a clinic champion who will 
guide implementation and contribute to the Social Influence construct of the TAM.  The research 
team will provide facilitation through a pre-implementation meeting with the clinic champion, an 
on-site kick-off training session, and regular follow-up phone conferences with the champion.59  
During the follow-up phone conferences, topics known to promote implementation and 
sustainability will be discussed, including reviewing quality assurance reports, identifying 
performance gaps, and brainstorming barriers.59–63  Clinics can also use a reporting function in 
mPATH to generate custom reports of data collected and receive “real time” feedback. We 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 10 of 71 
*** Confidential *** 
expect that these features, and adaptations to mPATH to meet check-in needs, will increase the 
perceived usefulness of the program.  Training and support through a hands-on kick-off session, 
follow-up technical assistance, and repeated trainings as needed will increase staff self-efficacy, 
perceptions of control, and usability.60,64 Altogether, these multiple activities will increase intent 
to use mPATH, use of mPATH, and sustained use of mPATH.  We will measure the key 
constructs of these models to determine their impact on implementation and maintenance 
(Section 5.0).
4.3 
Pilot-Testing Implementation Strategy and Materials 
4.3.1. Focus Groups and Interviews 
A formative evaluation of our implementation strategy65 will include a review of the strategy and 
training materials with four focus groups and individual semi-structured interviews.  Each focus 
group will include six to 10 clinic staff who are involved with checking in and rooming patients, 
such as front desk staff, medical assistants, and nurses. Two focus groups will be recruited from 
clinics that participated in the randomized-controlled efficacy trial of mPATH (R01CA178941), 
and the other two from primary care clinics new to mPATH-CRC.  A trained moderator will use a 
moderator’s guide (Appendix A.3) to explore the facilitators and barriers to implementation, 
strategies for minimizing barriers, the adequacy of draft training plans, and additional support or 
training materials desired.   
A trained interviewer will also conduct individual semi-structured interviews with two providers 
(doctors or advanced practice professionals) and one administrator at each of the four clinics, 
for a total of 12 interviews. Interviews will be conducted using an interview guide (Appendix 
Figure 2.  mPATH-CRC Implementation Theoretical Model and Strategies. 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 11 of 71 
*** Confidential *** 
A.4) in person or via telephone (using a screen sharing program such as Webex to share visual
materials) according to what is most convenient for the interviewee.
All focus group and interview participants will complete a brief demographic survey that includes 
items assessing attitudes about technology (Appendix A.5) which will help the research team 
interpret their responses. 
Focus groups and interviews will be audio recorded and the content summarized. Each 
participant will receive a $50 gift card. Revisions to the implementation strategy and materials 
will be informed by the focus group and interview results.  
4.3.2. Pilot Testing Training Materials, Surveys, and the mPATH Program 
We will pilot test our training materials, surveys, and the mPATH program with two primary care 
clinics in the Wake Forest Baptist Health network. Each clinic will receive the kick-off training 
described in Section 4.4.1. Following the kick-off training session, we will ask clinic staff to 
complete the staff baseline survey described in Section 4.4.4.6. We will then let each clinic use 
the mPATH program. After six months, we will ask clinic staff to complete the follow-up survey 
described in Section 4.4.4.6 
4.4 
 Implementation 
Trial 
 In a randomized-controlled 
cluster study of 22 primary 
care clinics, we will 
compare the 
implementation outcomes 
(as defined by the RE-AIM 
framework)66 and 
implementation costs of the 
“high touch” strategy to a 
“low touch” strategy.  The 
components of each 
strategy and their timing 
are outlined in Table 1. 
 4.4.1. “High Touch” 
Implementation Strategy 
The “high touch” strategy 
consists of pre-
implementation activities, 
training, and ongoing support. 
Pre-implementation activities.  At each site, we will identify a clinic champion who will guide the 
local implementation effort.  Champions typically arise through self or peer-nomination.67 This 
person typically plays a central role in implementing new systems and has a demonstrated 
ability to communicate effectively, navigate the organizational environment, promote a project, 
and work well with others.67,68 We will identify the champion by asking clinic administrators, lead 
nurses, and lead physicians who meets these qualities and would be willing to serve in this role.  
Each champion will then help the team identify a nursing super-user and a front desk super-
Table 1.  Comparison of Implementation 
Strategies 
High Touch Strategy 
Low Touch Strategy 
Pre-Implementation Activities 
• Clinic champion identified
• N/A
Implementation Kick-Off 
• On-site training with key clinic
personnel
• On-site training with providers
• At elbow support on day of launch
• On-site training with key clinic
personnel
Months 1 – 6 
• Phone/email technical support, as 
needed. 
• Access to QA data
• Scheduled phone-calls with clinic
champion to review QA data and
explore potential barriers.
• Additional on-site trainings as
requested.
• Monthly "shout-out memos”
highlighting staff performance
• Phone/email technical support,
as needed
• Access to QA data
Months 7 - 12 
• Phone/email technical support, as
needed
• Phone/email technical support,
as needed
Red text indicates items unique to High Touch Strategy 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 12 of 71 
*** Confidential *** 
user. Lastly, each clinic will identify an alternate champion to assist with implementation and 
provide continuity if the champion is unavailable due to vacation or illness. The alternate 
champion may be one of the super-users. We designed mPATH for use by patients before 
medical visits, but the timing and location of use can vary. However, each clinic may adjust the 
implementation to meet their unique needs.   
 Kick-off training session.  Two members of the study team will visit each practice to conduct a 
training session for clinic staff identified by the local clinic champion.  This training will include 
hands-on practice with mPATH, including scenarios where patients “self-order” tests, to 
increase staff’s comfort with the program, increase their self-efficacy, and demonstrate its 
usability.   
A separate brief training session will be held for the clinic providers. The provider training will 
include an overview of the mPATH program and its functionality. Because providers will not 
directly interact with the mPATH program, the provider training will not include hands-on 
practice scenarios. 
 At-elbow support.  The study team will provide at-elbow technical support the day the clinic 
launches mPATH in their practice. 
On-Going Support:  The study team will conduct a conference call with the clinic champion and 
alternate 2-3 business days after the launch date, and then at weeks 2, 4, 8, 16, and 24 post-
launch to discuss the clinic’s experiences with mPATH, review QA reports generated from 
mPATH data (frequency of use, patient demographics), explore the need for adaptations, and 
provide support. If program usage is below goal levels, barriers will be reviewed with the clinic 
champion and additional on-site training offered. Clinics may request technical support and 
additional training at any time, and clinics can self-generate reports to self-monitor mPATH-CRC 
implementation. 
4.4.2.  “Low Touch” Implementation Strategy 
Clinics randomized 
to receive the low 
touch 
implementation 
strategy will 
receive: 1) the 
initial kick-off on-
site training session 
and implementation 
materials (identical 
to the “high touch” 
group), and 2) 
access to 
phone/email 
technical support 
as requested.  No 
adaptations will be 
made to the 
mPATH program for “low touch” clinics, nor will study staff proactively reach out to them after 
the kick-off training session.  
Table 2.   Characteristics of study clinics  3.   Characteristics of study clinics
 
WFCP 
Cornerstone 
KY
Organizational structure 
Academic 
medical center 
Medical center
affiliate 
Federally-qualified 
health center
# of primary care clinics  
15 
26 
9
# of counties with clinics 
7 
10 
8 
% of clinics in rural 
counties
20% 
23% 
89%
# of FTE clinicians 
39 
103 
38
Patient visits per year 
163,083 
393,651 
108,662
Payer mix
    Medicaid 
    Medicare 
    Commercial insurance 
    Uninsured 
7% 
42% 
50% 
1% 
10% 
36% 
51% 
3% 
48%
18% 
24%
9%
Patient race/ethnicity
    White, non-Hispanic 
    Black/African-American 
    White, Hispanic 
    Other 
83% 
12% 
3% 
2% 
78% 
13% 
2% 
7% 
99%
0% 
0%
1%

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 13 of 71 
*** Confidential *** 
 4.4.3. Study Sites 
 We will conduct the trial in community-based primary care practices in North Carolina, chosen 
to reflect diversity in geography and populations served.  Practices will be affiliated with the 
Wake Forest Health Network (Table 2). Pilot data from target clinic systems show significant 
diversity in terms of payer mix (7%-10% Medicaid vs 48%) and racial diversity (76%-83% white).  
To increase racial diversity further, we will selectively enroll clinics with greater diversity. 
Counties where the clinics are located range from rural to urban.  No currently identified clinics 
use tablet devices with patients, and we will exclude any additional clinics that already use 
tablets. Each potential study clinic will complete a baseline clinic overview questionnaire 
(Appendix B). Data from this questionnaire will be used to construct our final study clinic 
sample. All clinics will receive at least one study iPad (preloaded with mPATH) per full-time 
equivalent clinician.  All clinics will keep the study iPads at the end of the study, encouraging 
participation.  
 4.4.4. Study Cohort 
mPATH is designed to be given to all English or Spanish-speaking patients on clinic check-in.  
Therefore, our implementation outcomes cohort will include all adult (18 and over) English or 
Spanish-speaking patients who are seen in the study clinics in the 12 months following the initial 
clinic mPATH launch date.  Our effectiveness outcome will include all English or Spanish 
speaking patients aged 50-74 who are eligible for CRC screening based on EHR records in the 
12 months prior to and 12 months following the initial clinic mPATH launch date. We can 
capture all data needed for this cohort because all the clinics have searchable electronic health 
records. 
4.4.5. Implementation and Clinic Randomization 
We will randomly implement mPATH-CRC in 2 clinics (1 “high touch” and 1 “low touch”) until all 
22 clinics are enrolled. To control for major organizational differences that could impact 
implementation, we will first select 2 clinics of similar size, then randomly assign one to receive 
the “high touch” strategy and the other the “low touch” strategy.   
4.4.6. Data Collection 
Baseline clinic personnel survey (Appendix B):  At the initial kick-off training visit, we will 
administer a baseline survey to all clinic personnel (e.g., administrators, nurses, providers) who 
are involved with the implementation of mPATH-CRC, as identified by the local clinic 
champions. All surveys will assess constructs of the Technology Acceptance Model and the 
Dynamic Sustainability Framework.56,69 Clinic personnel who do not complete the baseline 
survey (i.e., new hires) will complete it with their first follow-up survey (described below).  
Follow-up clinic personnel survey (Appendix B): Because clinic environments and experience 
with the mPATH system will evolve over time, we will administer a follow-up survey 6 months 
and 12 months after the initial on-site training.  If a clinic site decides to stop using the mPATH 
program prior to a scheduled follow-up survey, one final follow-up survey will be administered 
within 6 weeks of the practice discontinuing use of mPATH. The follow-up survey will assess 
organizational characteristics, individual characteristics, and experience with the mPATH-CRC 
system. Each person will receive a $10 incentive for each survey completed.   
Clinic Contact and Cost Database (Appendix B):  All study team contact with the clinics, and all 
technology costs associated with implementing and maintaining mPATH will be recorded in a 
secure, electronic database. Data will include date of contact, mode of contact (i.e., in-person, 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 14 of 71 
*** Confidential *** 
phone, email), person initiating contact, purpose of contact, and the roles of staff involved in the 
contact.  These data will allow us to compare the cost of the “high touch” and “low touch” 
intervention strategies and associations between the amount of support given and specific 
implementation outcomes. 
4.5 
Pragmatic Trial 
To determine mPATH-CRC’s effectiveness, we will nest a pragmatic trial within the 
implementation study.  We will query the electronic health record (EHR) at each study clinic to 
identify unscreened individuals aged 50 – 74 who completed a clinic visit with a physician or 
advanced practice professional 4 to 12 months prior to the implementation launch date, and 0 to 
8 months after the implementation kick-off launch date.  Specific inclusion criteria are detailed in 
Section 3.0. We will then examine in the EHR whether these individuals complete CRC 
screening within 16 weeks of their index visit.  
4.6 
Mixed-Methods Study 
The mixed-methods study will examine the facilitators and barriers to maintenance (sustained 
use of mPATH-CRC over time). In the 12th month after each clinic’s launch date, we will identify 
sites who have maintained use of the mPATH program throughout the study period. To 
supplement the quantitative data gathered with our clinic surveys (Section 4.4.6), we will 
conduct semi-structured interviews with four members of each clinic:  the clinic champion, one 
clinician, one front desk team member, and one medical assistant/nursing team member. The 
clinic champion will assist in the identification of the other team members for interviews based 
on their experience with the mPATH program. All participants will receive a $50 gift card.  Using 
an interview guide (Appendix C), we will explore how mPATH-CRC was incorporated in the 
clinic’s work flow and factors that affected maintenance such as intervention adaptations, 
organizational characteristics, and the champion’s role. There will be a separate version of the 
interview guide for clinics who have very low (or no) usage of mPATH during their participation 
in the study.56,69,70 Members of clinics that opt to discontinue use of mPATH will be interviewed 
as soon as practical after they discontinue use. We will interview representatives from study 
clinics until thematic saturation is reached. These semi-structured interviews, expected to last 
approximately 30 minutes, will be conducted by phone or video conference and analyzed by 
staff trained in qualitative methods.  Interviews will be audio recorded and transcribed verbatim. 
Transcripts will be imported into ATLAS.ti software,71 iteratively reviewed, coded by concept, 
and analyzed thematically to describe the implementation and sustainability experience. 
Themes will be compared among clinics to determine any differences. 
5.0 
Outcome Measures 
5.1 
Definition of Time Points 
The Implementation Date will be defined as the date of the clinic launch at each site. A 
“month” is defined as a 4 week time period.  “Week 1” commences the day of clinic 
launch.   

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 15 of 71 
*** Confidential *** 
5.2 
Primary Outcome 
mPATH-CRC Reach:  Proportion of all Spanish or English-speaking patients, ages 50 – 
74, who are eligible for CRC screening and complete the mPATH-CRC program in the 
6th month (weeks 21 – 24) following the implementation date. Patients who use 
mPATH™-CheckIn and are told they are due for CRC screening but advised to discuss 
screening with their doctor due to detected risk factors are also counted as having used 
mPATH™-CRC. 
5.3 
Secondary Outcomes 
5.3.1 mPATH-CRC Reach (by month): The proportion of patients aged 50-74 who are 
eligible for CRC screening who complete mPATH-CRC or have risk factors 
identified by mPATH-CheckIn in months 1-5 following implementation 
5.3.2 mPATH-CRC Reach (by socioeconomic strata): The proportion of patients aged 
50-74 who are eligible for CRC screening who complete mPATH-CRC or have
risk factors identified by mPATH-CheckIn in months 1-6 by socioeconomic
strata; this outcome will also be calculated among CheckIn users only
5.3.3 mPATH-CRC Adoption: The mean usage of mPATH-CRC among staff and 
providers over the first 6 months following implementation; usage is calculated for 
each staff/provider as the proportion of times mPATH-CRC is completed out of 
the total times mPATH-CRC should have been launched. 
5.3.4 mPATH-CRC Acceptability, Appropriateness, and Feasibility: Mean 
Acceptability of Intervention Measure (AIM), Intervention Appropriateness 
Measure (IAM), and Feasibility of Intervention Measure (FIM) scores (68) for 
mPATH-CRC as assessed on the 6-month clinic personnel survey 
5.3.5 mPATH-CRC Implementation Fidelity: The proportion of patients who use 
mPATH-CRC and request a CRC screening test who have a test ordered or 
have the order dismissed (i.e., “self-order” feature is used as designed) in months 
1-6
5.3.6 mPATH-CRC Maintenance: The proportion of patients aged 50-74 who are 
eligible for CRC screening who complete mPATH-CRC or have risk factors 
identified by mPATH-CheckIn in months 7-12 
5.3.7 mPATH-CheckIn Reach: The proportion of patients aged 18 or older who 
complete mPATH-CheckIn in months 1-6; this outcome will be calculated overall 
and within socioeconomic strata 
5.3.8 mPATH-CheckIn Adoption: The mean usage of mPATH-CheckIn among staff 
and providers over the first 6 months following implementation; usage is 
calculated for front desk staff as the proportion of times mPATH-CheckIn is 
completed out of the total times mPATH-CheckIn should have been handed out; 
usage is calculated for nurses/providers as the proportion of times mPATH-
CheckIn is completed and data is transmitted to the EHR out of the total times 
mPATH-CheckIn should have been handed out 
5.3.9 mPATH-CheckIn Acceptability, Appropriateness, and Feasibility: Mean AIM, 
IAM, and FIM scores for mPATH-CheckIn as assessed on the 6-month clinic 
personnel survey 
5.3.10 mPATH-CRC Maintenance: The proportion of patients aged 18 or older who 
complete mPATH-CheckIn in months 7-12 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 16 of 71 
*** Confidential *** 
5.3.11 mPATH-CRC Effectiveness: The proportion of patients aged 50-74 who 
are eligible for CRC screening who complete CRC screening within 16 
weeks of their index visit to the clinic. Effectiveness is determined by 
comparing the proportion who complete screening in a pre-implementation 
cohort (months 12 - 4 before implementation) to a post-implementation 
cohort (months 1 - 8 after implementation). 
5.3.12 CRC screening tests ordered: The outcome is defined as the proportion of 
patients aged 50-74 who are eligible for CRC screening who have a CRC 
screening test ordered (colonoscopy, flexible sigmoidoscopy, fecal testing for 
blood, or fecal DNA testing) within 16 weeks of their index visit to the clinic. This 
outcome will also be compared between the pre- and post-implementation 
cohorts. 
5.3.13 Facilitators and barriers to maintenance (sustained use of mPATH-CRC 
over time): These will be identified through semi-structured interviews. 
Interviews will explore how mPATH-CRC was incorporated in the clinic's 
work flow and factors that affected maintenance such as intervention 
adaptations, organizational characteristics, and the champion's role. 
Interviews will be conducted with four members of each selected clinic: the 
clinic champion, one clinician, one front desk team member, and one 
medical assistant/nursing team member. 
5.4 
Exploratory Outcomes 
5.4.1 mPATH Implementation Cost: Cost to implement and maintain usage of 
the mPATH program from the perspective of a healthcare system 
considering implementation, including hardware (i.e., iPads, cases, 
charging cabinets), cloud data storage fees, training, and technical 
support. Clinic staff training costs will be computed using training time and 
national average wage values for nursing and other staff from the Bureau 
of Labor Statistics. Technical support costs will include travel and support 
staff time costs associated with the initial training, and any follow-up 
trainings. Ongoing costs to maintain usage of mPATH include costs to 
train new employees or replace hardware and technical support costs 
related to follow-up training, troubleshooting, and adapting the program as 
needed 
5.5 
Data Sources 
5.5.1 Electronic health record (EHR) and appointment schedules:  Each clinic’s EHR 
and appointment schedules can be queried to identify patients scheduled for visits, 
patients who completed visits, patient demographics, and patient clinical care data. 
5.5.2 mPATH-CRC database:  The mPATH program database includes patients’ 
medical record numbers, age, gender, date/time of use, length of time in program, and 
responses to questions. (Appendix B) 
5.5.3 REDCap Database: We will have a secure REDCap database that contains all 
clinic staff surveys and details on cost and contact with clinics. 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 17 of 71 
*** Confidential *** 
6.0 
Analytic Plan 
6.1  
Sample Size and Power 
6.1.1 Primary outcome: Our primary objective is to assess differences in mPATH-CRC Reach 
proportion of participants who complete the mPATH-CRC program or have risk factors identified 
by mPATH-CheckIn) in the 6th month between the two implementation strategies. Using 
formulae found in Hemming et al.,72 Table 3 shows the number of clinics necessary to detect 
differences in Reach ranging from .15 to .20 with 80% and 90% power for intraclass correlations 
(ICC) ranging from .03 to .08, assuming an average sample size per clinic of 30 with a cluster 
sample size coefficient of variation (CV) of 25%.  These latter numbers are based on estimated 
numbers of eligible patients seen monthly, obtained from a  
survey of the 
participating 
clinics.  Since 
these data will 
be obtained 
from the EHR, 
we will use all eligible patients at each site. We will recruit a total of 22 clinics, which will provide 
at least 80% power to detect a difference of 15% if the ICC is 0.03 or lower. If the ICC were as 
high as 0.08, we would have over 80% power to detect a difference of 20%. These calculations 
assume average utilization across all sites of 50%. Power increases as rates move away from 
50% in either direction. 
6.1.2 Effectiveness outcome: A secondary objective is to assess the effect of mPATH-CRC on 
screening rates (effectiveness) comparing 8 months of data prior to implementation to 8 months 
of data following implementation. The detectable difference (difference in screening rates pre vs 
post) depends on the sample size, power, ICC, and cluster sample size CV.  We will assume a 
screening rate in the pre-implementation group of 15%, as observed in the control group in our 
R01 study.45 Using SS/Power formulae for cluster designs72,73, Table 4 shows the differences in 
screening rates we will be able to detect 
with 80% and 90% power for ICCs 
ranging from 0.03 to 0.06, assuming an 
average monthly sample size of 30 
patients per clinic in the EHR, a cluster 
sample size CV of 25%, and no change 
in the screening trends over time. Because of the diminishing return of cluster designs, 
additional patients have little effect on the detectable difference, although we will use all the 
patients in the EHR. We see that we will be able to detect a 10% difference in screening rates 
(15% vs 25%) with 80% power even if the ICC is as large as 0.04. We estimate that a minimum 
of 30 patients per clinic per month will meet inclusion criteria for this analysis (based on age, 
language, and screening status) and will be available through the EHR, so we will be amply 
powered for assessing the secondary aim.    
To evaluate whether the effect of mPATH-CRC on screening rates differs by implementation 
strategy, the period (pre vs post) by strategy (“high touch” vs “low touch”) interaction can be 
evaluated. Based on the control group from the previous randomized-controlled efficacy study, 
we anticipate a screening rate of 15% for “low touch” and pre- implementation. An increase in  
Table 3.  Total number of clinics needed to detect the specified difference in Reach as a
function of the power, ICC, and difference.
 
80% Power 
90% Power
Diff/ICC 
.03 
.04 
.05 
.06 
.07 
.08 
.03 
.04 
.05 
.06 
.07 
.08
.15 
22 
26 
29 
33 
36 
40 
30 
34 
39 
44 
48 
53
.20 
  12 
14 
16 
18 
20 
22 
16 
19 
22 
24 
27 
29
Table 4. Detectable difference in screening rates as a function 
of the Power and the ICC (22 Clinics)
 
80% Power 
90% Power
ICC 
.03 
.04 
.05 
.06 
.03 
.04 
.05 
.06
 
.087 
.100 
.113 
.125 
.102 
.118 
.133 
.146 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 18 of 71 
*** Confidential *** 
the screening rate from 15% to 25% from pre to post, corresponds to an odds ratio (OR) of 3. 
Similarly, assuming a screening rate in the “low 
touch” group of 15%, and a screening rate of 25% in 
the “high touch” group, also corresponds to an OR of 
3. By design, we anticipate half of the patients being 
in the “high touch” group and half in the post period, 
and that strategy and period are independent. Based
on these assumptions, Table 5 shows the interaction OR that can be detected with 80% power
for ICCs ranging from 0.03 to 0.06, assuming an average monthly sample size of 30 patients
per clinic in the EHR (for 8 months pre and 8 months post), a cluster sample size CV of 25%,
and no change in the screening trends over time.
6.2  
Analysis of Primary Outcome 
We will assess the primary hypothesis (that the “high touch” vs. “low touch” implementation 
strategy will result in greater use of the intervention) using a mixed effects logistic regression 
model with mPATH-CRC Reach (Y/N) as the individual-level outcome, implementation 
approach as the primary independent variable, site as a random effect, and the stratification 
factor clinics size as a covariate per the design.  A descriptive approach will also be utilized 
where mPATH-CRC Reach is estimated and reported along with an exact 95% confidence 
interval for each month (for months 1-6 following implementation), and within socioeconomic 
strata for “high touch” and “low touch” clinics separately. In secondary analyses, we will assess 
effects of clinic-level covariates (e.g. volume, rurality, organizational culture) and patient level 
covariates (e.g. age, gender, race/ethnicity) on Reach.  We will include arm-by-covariate 
interactions to determine if the effect of the implementation strategy differs depending on levels 
of the covariates.  This secondary analysis will allow us to determine effects of the 
implementation strategy in clinics with varying organizational factors and populations. The 
proposed approach allows us to incorporate participant- and cluster-level covariates, but there 
are other analysis methods we could employ. For example, we could use a clinic-level analysis 
(e.g. analysis of covariance) on the mean implementation rates within each clinic, or another 
individual-level approach (e.g. generalized estimating equations). Alternative methods and their 
strengths and weaknesses are well-documented.74–76 These alternate approaches will be used 
in a sensitivity analysis to determine effects of the modeling assumptions on the results. 
6.3 
Analysis of Secondary Outcomes 
The key secondary outcome of effectiveness of mPATH-CRC will be evaluated by comparing 
the proportion who complete CRC screening within 16 weeks of their index visit to the clinic 
between a pre-implementation cohort (months 12 - 4 before implementation) and a post-
implementation cohort (months 1 - 8 after implementation). Similar to the model described for 
mPATH-CRC Reach above, effectiveness of mPATH-CRC will be evaluated using a mixed 
effects logistic regression model. For an overall assessment of the effectiveness, completing 
CRC screening within 16 weeks (Y/N) will be the patient-level outcome, implementation cohort 
will be the primary independent variable, site will be a random effect, and the stratification factor 
clinic size will be a covariate per the design. Pre- vs post-implementation changes will also be 
compared between the “high touch” and “low touch” implementation strategies and between 
dose levels defined based on mPATH-CRC usage by incorporating interactions into the mixed 
effects logistic regression models. An interrupted time series analysis (segmented 
Table 5. Detectable interaction odds ratio 
difference in screening rates as a function of 
the ICC (22 Clinics)  
 
80% Power
ICC 
.03 
.04 
.05 
.06
 
2.903 
3.462 
4.097 
4.819

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 19 of 71 
*** Confidential *** 
regression)77,78 will also be used to estimate the effect of the intervention within each clinic 
(using interaction terms with clinic within a linear model) adjusting for any trend that was 
occurring in screening prior to the implementation.  This model provides estimates of the time 
trends before and after the intervention as well as the change in screening rates due to the 
intervention. Linear contrasts will be used to compare the changes in screening rates and trends 
between the “high touch” clinics and the “low touch” clinics.  As in Section 6.2, we will assess 
the effects of cluster- and patient-level covariates and their interactions with implementation 
strategy in secondary analyses. The same basic approach outlined in Section 6.2 will also be 
used to compare other binary implementation outcomes between the “high touch” and “low 
touch” strategies. Continuous implementation outcomes are measured at the provider/staff 
level, rather than the patient level. Linear mixed effects models will be used to compare these 
outcomes between the “high touch” and “low touch” strategies, with implementation approach as 
the primary independent variable, site as a random effect, and the stratification factor clinic size 
as a covariate per the design. 
6.4 
Length of Study 
Study Timeline 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
 Study Task 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Develop mPATH Implementation Materials 
X 
Implementation Focus Groups 
X 
X 
Revise Implementation Materials 
X 
Develop and validate EHR queries 
X 
X 
X 
mPATH-CRC Implementation 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Implementation Data Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Effectiveness Data Collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Maintenance Data Collection/Clinic Interviews 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Data Cleaning 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Data Analysis and Results Dissemination 
X 
X 
X 
X 
7.0 
Data Management 
Clinic survey data will be stored in the Research Electronic Data Capture (REDCap) system, a web-
based application for building and managing online surveys and databases. REDCap was developed in 
the CTSA network and implemented at Wake Forest specifically around HIPAA security guidelines. 
REDCap provides an intuitive interface for users to enter data, has real-time validation rules at the time 
of entry, and maintains audit trails. 
All extracted clinical datasets and datasets containing data from combined sources will be stored on a 
central Wake Forest data server using industry standard encryption (e.g., AES-256 bit) to protect 
personal health information.  
All iPad interaction data will be temporarily stored on each iPad using secure Advanced Encryption 
Standard 256 bit encryption (AES-256) software to protect personal health information. The iPad 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 20 of 71 
*** Confidential *** 
software automatically sends the data to the central data storage server and removes the data from the 
iPad after confirmation that the data were sent and received. All study site databases will be stored in 
an encrypted, HIPAA-compliant Cloud-based server with continuous data backup. 
8.0 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner. To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection form and in study 
datasets. An honest broker will mediate the electronic health record data queries to limit the exposure 
of patient identifying information. Our analyses require us to have full dates of visits (to determine the 
success of implementation over time), age, and 5-digit zip codes, and GEOIDs (to determine rural or 
urban residency). Therefore, the honest broker will create a limited data set for analysis. The day that 
each clinic launches mPATH will be called day 0, with each subsequent or previous date recorded as 
an integer relative to day 0. This will add additional protections for patients by obscuring dates in the 
dataset. Any collected patient identifying information corresponding to the unique study identifier will be 
maintained in a linkage file, stored separately from the data. The linkage file will be kept secure, with 
access limited to designated study personnel. Subject identifying information will be destroyed three 
years after closure of the study, consistent with data validation and study design, producing an 
anonymous analytical data set. Data access will be limited to study staff. Data and records will be kept 
locked and secured, with any computer data password protected. No reference to any individual 
participant will appear in reports, presentations, or publications that may arise from the study. 
9.0 
Data Safety and Monitoring 
The only anticipated risks specific to this study are loss of data confidentiality. The mPATH study 
database is hosted on an encrypted secure server maintained by Wake Forest Information Technology 
& Services (ITS). The database is password protected, and only authorized individuals are granted 
access. ITS routinely monitors for any security weaknesses or breaches. In the unlikely event of a data 
breach, ITS will notify the PI who will convene an internal Data and Safety Monitoring committee to 
review the event and determine the appropriate response. The Data and Safety Monitoring committee 
will be comprised of the PI, Project Manager, study statistician, and study programmer. Other 
individuals may be added to the Data and Safety Monitoring committee at the PI’s discretion. In 
addition, the PI will promptly review any participant or other-reported concerns regarding the study. The 
PI will report any loss of data confidentiality or other adverse event to the Wake Forest IRB and the NIH 
within 2 business days of the discovery the event. 
10.0 Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to the 
IRB and sponsor or appropriate government agency if appropriate. 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 21 of 71 
*** Confidential *** 
11.0 References 
1.
Implementation Science Working Group Report, National Cancer Moonshot [Internet]. 2016 [cited
2016 Sep 18]. Available from: https://www.cancer.gov/research/key-initiatives/moonshot-cancer-
initiative/blue-ribbon-panel/supporting-materials/implementation-science-working-group-
report.pdf
2.
Sharp L, Tilson L, Whyte S, O’Ceilleachair A, Walsh C, Usher C, Tappenden P, Chilcott J, Staines
A, Barry M, Comber H. Cost-effectiveness of population-based screening for colorectal cancer: a
comparison of guaiac-based faecal occult blood testing, faecal immunochemical testing and
flexible sigmoidoscopy. Br J Cancer. 2012 Feb 28;106(5):805–816.
3.
Lin JS, Piper MA, Perdue LA, et al. Screening for colorectal cancer: Updated evidence report and
systematic review for the us preventive services task force. JAMA. 2016 Jun 21;315(23):2576–
2594.
4.
Knudsen AB, Zauber AG, Rutter CM, et al. Estimation of benefits, burden, and harms of colorectal
cancer screening strategies: Modeling study for the us preventive services task force. JAMA. 2016
Jun 21;315(23):2595–2609.
5.
Inadomi JM. Screening for Colorectal Neoplasia. N Engl J Med. 2017 Jan 12;376(2):149–156.
PMID: 28076720
6.
US Preventive Services Task Force. Screening for colorectal cancer: Us preventive services task
force recommendation statement. JAMA. 2016 Jun 21;315(23):2564–2575.
7.
Qaseem A, Denberg TD, Hopkins J Robert H, Humphrey LL, Levine J, Sweet DE, Shekelle P.
Screening for Colorectal Cancer: A Guidance Statement From the American College of Physicians.
Ann Intern Med. 2012 Mar 6;156(5):378–386.
8.
Smith RA, Andrews K, Brooks D, DeSantis CE, Fedewa SA, Lortet-Tieulent J, Manassaram-
Baptiste D, Brawley OW, Wender RC. Cancer screening in the United States, 2016: A review of
current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J
Clin. 2016 Mar 1;66(2):95–114.
9.
Rex DK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Levin TR,
Lieberman D, Robertson DJ. Colorectal Cancer Screening: Recommendations for Physicians and
Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017
Jul;112(7):1016.
10.
White A. Cancer Screening Test Use—United States, 2015. MMWR Morb Mortal Wkly Rep
[Internet]. 2017 [cited 2017 Mar 8];66. Available from:
https://www.cdc.gov/mmwr/volumes/66/wr/mm6608a1.htm
11.
Gupta S, Sussman DA, Doubeni CA, Anderson DS, Day L, Deshpande AR, Elmunzer BJ, Laiyemo
AO, Mendez J, Somsouk M, Allison J, Bhuket T, Geng Z, Green BB, Itzkowitz SH, Martinez ME.

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 22 of 71 
*** Confidential *** 
Challenges and Possible Solutions to Colorectal Cancer Screening for the Underserved. J Natl 
Cancer Inst. 2014 Apr 1;106(4):dju032. PMID: 24681602 
12.
Yao N, Alcalá HE, Anderson R, Balkrishnan R. Cancer Disparities in Rural Appalachia: Incidence,
Early Detection, and Survivorship. J Rural Health Off J Am Rural Health Assoc Natl Rural Health
Care Assoc. 2016 Sep 7; PMID: 27602545
13.
Doubeni CA, Laiyemo AO, Major JM, Schootman M, Lian M, Park Y, Graubard BI, Hollenbeck
AR, Sinha R. Socioeconomic status and the risk of colorectal cancer. Cancer. 2012 Jul
15;118(14):3636–3644.
14.
James TM, Greiner KA, Ellerbeck EF, Feng C, Ahluwalia JS. Disparities in colorectal cancer
screening: a guideline-based analysis of adherence. Ethn Dis. 2006;16(1):228–233. PMID:
16599375
15.
Morgan JW, Cho MM, Guenzi CD, Jackson C, Mathur A, Natto Z, Kazanjian K, Tran H, Shavlik
D, Lum SS. Predictors of Delayed-Stage Colorectal Cancer: Are We Neglecting Critical
Demographic Information? Ann Epidemiol. 2011 Dec;21(12):914–921.
16.
Siegel R, DeSantis C, Jemal A. Colorectal cancer statistics, 2014. CA Cancer J Clin. 2014 Mar
1;64(2):104–117.
17.
Miller DP, Brownlee CD, McCoy TP, Pignone MP. The effect of health literacy on knowledge and
receipt of colorectal cancer screening: a survey study. BMC Fam Pract. 2007;8:16. PMCID:
PMC1852801
18.
Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: a Prescription to End
Confusion. Washington, DC: The National Academies Press; 2004.
19.
Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health
outcomes: an updated systematic review. Ann Intern Med. 2011;155(2):97–107.
20.
Oldach BR, Katz ML. Health literacy and cancer screening: A systematic review. Patient Educ
Couns. 2014 Feb;94(2):149–157.
21.
Kutner M, Greenburg E, Jin Y, Paulsen C. The Health Literacy of America’s Adults: Results from
the 2003 National Assessment of Adult Literacy. NCES 2006-483. Natl Cent Educ Stat [Internet].
2006 [cited 2015 Sep 23]; Available from: http://eric.ed.gov/?id=ED493284
22.
Beydoun HA, Beydoun MA. Predictors of colorectal cancer screening behaviors among average-
risk older adults in the United States. Cancer Causes Control CCC. 2008 May;19(4):339–359.
PMID: 18085415
23.
Weinberg DS, Turner BJ, Wang H, Myers RE, Miller S. A survey of women regarding factors
affecting colorectal cancer screening compliance. Prev Med. 2004 Jun;38(6):669–675. PMID:
15193887

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 23 of 71 
*** Confidential *** 
24.
Berkowitz Z, Hawkins NA, Peipins LA, White MC, Nadel MR. Beliefs, risk perceptions, and gaps
in knowledge as barriers to colorectal cancer screening in older adults. J Am Geriatr Soc. 2008
Feb;56(2):307–314. PMID: 18070002
25.
Farmer MM, Bastani R, Kwan L, Belman M, Ganz PA. Predictors of colorectal cancer screening
from patients enrolled in a managed care health plan. Cancer. 2008 Mar 15;112(6):1230–1238.
PMID: 18266204
26.
Wee CC, McCarthy EP, Phillips RS. Factors associated with colon cancer screening: the role of
patient factors and physician counseling. Prev Med. 2005 Jul;41(1):23–29. PMID: 15916989
27.
Klabunde CN, Schenck AP, Davis WW. Barriers to Colorectal Cancer Screening Among Medicare
Consumers. Am J Prev Med. 2006 Apr;30(4):313–319.
28.
Seeff LC, Nadel MR, Klabunde CN, Thompson T, Shapiro JA, Vernon SW, Coates RJ. Patterns
and predictors of colorectal cancer test use in the adult U.S. population. Cancer. 2004 May
15;100(10):2093–2103.
29.
Ayres CG, Griffith HM. Perceived barriers to and facilitators of the implementation of priority
clinical preventive services guidelines. Am J Manag Care. 2007 Mar;13(3):150–155. PMID:
17335358
30.
Yarnall KSH, Pollak KI, Østbye T, Krause KM, Michener JL. Primary care: is there enough time
for prevention? Am J Public Health. 2003 Apr;93(4):635–641. PMCID: PMC1447803
31.
Østbye T, Yarnall KSH, Krause KM, Pollak KI, Gradison M, Michener JL. Is There Time for
Management of Patients With Chronic Diseases in Primary Care? Ann Fam Med. 2005 May
1;3(3):209–214. PMID: 15928223
32.
Katz ML, Broder-Oldach B, Fisher JL, King J, Eubanks K, Fleming K, Paskett ED. Patient–
Provider Discussions about Colorectal Cancer Screening: Who Initiates Elements of Informed
Decision Making? J Gen Intern Med. 2012 Sep 1;27(9):1135–1141.
33.
Zapka JM, Klabunde CN, Arora NK, Yuan G, Smith JL, Kobrin SC. Physicians’ colorectal cancer
screening discussion and recommendation patterns. Cancer Epidemiol Biomark Prev Publ Am
Assoc Cancer Res Cosponsored Am Soc Prev Oncol. 2011 Mar;20(3):509–521. PMCID:
PMC3050999
34.
Price RA, Zapka J, Edwards H, Taplin SH. Organizational Factors and the Cancer Screening
Process. JNCI Monogr. 2010 Apr 1;2010(40):38–57. PMID: 20386053
35.
Taplin SH, Price RA, Edwards HM, Foster MK, Breslau ES, Chollette V, Das IP, Clauser SB,
Fennell ML, Zapka J. Introduction: Understanding and Influencing Multilevel Factors Across the
Cancer Care Continuum. JNCI Monogr. 2012 May 1;2012(44):2–10. PMID: 22623590

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 24 of 71 
*** Confidential *** 
36.
Miller Jr DP, Weaver KE, Case LD, Babcock D, Lawler D, Denizard-Thompson N, Pignone MP,
Spangler JG. Usability of a Novel Mobile Health iPad App by Vulnerable Populations. JMIR
MHealth UHealth. 2017 Apr 11;5(4):e43.
37.
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention,
National Center for Health Statistics. Summary Health Statistics: National Health Interview
Survey, 2015 [Internet]. [cited 2017 Jun 16]. Available from:
https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2015_SHS_Table_A-18.pdf
38.
Orr JA, King RJ. Mobile phone SMS messages can enhance healthy behaviour: a meta-analysis of
randomised controlled trials. Health Psychol Rev. 2015;9(4):397–416. PMID: 25739668
39.
Hall AK, Cole-Lewis H, Bernhardt JM. Mobile Text Messaging for Health: A Systematic Review
of Reviews. Annu Rev Public Health. 2015;36(1):393–415. PMID: 25785892
40.
Ostrander RE, Thompson HJ, Demiris G. Using Targeted Messaging to Increase Physical Activity
in Older Adults: A Review. J Gerontol Nurs. 2014 Aug 1;40(9):36–48.
41.
Vodopivec-Jamsek V, de Jongh T, Gurol-Urganci I, Atun R, Car J. Mobile phone messaging for
preventive health care. Cochrane Database Syst Rev. 2012;12:CD007457. PMID: 23235643
42.
Hawley S, Lillie S, Cooper G, Elston Lafata J. Managed care patients’ preferences, physician
recommendations, and colon cancer screening. Am J Manag Care. 2014 Jul;20(7):555–561.
PMCID: PMC4358777
43.
Inadomi JM, Vijan S, Janz NK, Fagerlin A, Thomas JP, Lin YV, Muñoz R, Lau C, Somsouk M,
El-Nachef N, Hayward RA. Adherence to colorectal cancer screening: a randomized clinical trial
of competing strategies. Arch Intern Med. 2012 Apr 9;172(7):575–582. PMCID: PMC3360917
44.
Miller DP, Spangler JG, Case LD, Goff DC, Singh S, Pignone MP. Effectiveness of a Web-Based
Colorectal Cancer Screening Patient Decision Aid. Am J Prev Med. 2011 Jun 1;40(6):608–615.
PMCID: PMC3480321
45.
Miller DP, Denizard-Thompson N, Case LD, Weaver KE, Pignone MP, Lawler D, Troyer J,
Spangler JG. The effect of a mobile health intervention (mPATH-CRC) on colorectal cancer
screening in a diverse patient population. J Gen Intern Med. 2017 Apr;32(2 Supplement):S338.
46.
Sabatino SA, White MC, Thompson TD, Klabunde CN. Cancer screening test use - United States,
2013. MMWR Morb Mortal Wkly Rep. 2015 May 8;64(17):464–468. PMID: 25950253
47.
Cancer | Healthy People 2020 [Internet]. [cited 2016 Sep 17]. Available from:
https://www.healthypeople.gov/2020/topics-objectives/topic/cancer/objectives?topicId=5#354
48.
Bardus M, Smith JR, Samaha L, Abraham C. Mobile Phone and Web 2.0 Technologies for Weight
Management: A Systematic Scoping Review. J Med Internet Res. 2015;17(11):e259. PMCID:
PMC4704945

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 25 of 71 
*** Confidential *** 
49.
Matthew-Maich N, Harris L, Ploeg J, Markle-Reid M, Valaitis R, Ibrahim S, Gafni A, Isaacs S.
Designing, Implementing, and Evaluating Mobile Health Technologies for Managing Chronic
Conditions in Older Adults: A Scoping Review. JMIR MHealth UHealth. 2016;4(2):e29. PMCID:
PMC4919548
50.
Joe J, Demiris G. Older adults and mobile phones for health: A review. J Biomed Inform. 2013
Oct;46(5):947–954.
51.
Bandura A. Social Foundations of Thought and Action: A Social Cognitive Theory. 1 edition.
Englewood Cliffs, N.J: Prentice Hall; 1985.
52.
Bandura A. Self-Efficacy: The Exercise of Control. 1st edition. New York: Worth Publishers;
1997.
53.
Weaver KE, Ellis SD, Denizard-Thompson N, Kronner D, Miller DP. Crafting Appealing Text
Messages to Encourage Colorectal Cancer Screening Test Completion: A Qualitative Study. JMIR
MHealth UHealth. 2015 Nov 4;3(4):e100. PMCID: PMC4704950
54.
Seale JP, Johnson JA, Clark DC, Shellenberger S, Pusser AT, Dhabliwala J, Sigman EJ, Dittmer T,
Barnes Le K, Miller DP, Clemow D. A Multisite Initiative to Increase the Use of Alcohol
Screening and Brief Intervention Through Resident Training and Clinic Systems Changes. Acad
Med J Assoc Am Med Coll. 2015 Jul 21; PMID: 26200578
55.
Monegain B. Cerner still leads in EHR marketshare, though smaller vendors are making moves.
Healthc IT News [Internet]. 2017 Apr 28 [cited 2017 Jun 22]; Available from:
http://www.healthcareitnews.com/news/cerner-still-leads-ehr-marketshare-though-smaller-vendors-
are-making-moves
56.
Venkatesh V, Bala H. Technology Acceptance Model 3 and a Research Agenda on Interventions.
Decis Sci. 2008 May 1;39(2):273–315.
57.
Venkatesh V, Morris MG, Davis GB, Davis FD. User Acceptance of Information Technology:
Toward a Unified View. MIS Q. 2003;27(3):425–478.
58.
Venkatesh V, Davis FD. A Theoretical Extension of the Technology Acceptance Model: Four
Longitudinal Field Studies. Manag Sci. 2000 Feb;46(2):186–204.
59.
Berta W, Cranley L, Dearing JW, Dogherty EJ, Squires JE, Estabrooks CA. Why (we think)
facilitation works: insights from organizational learning theory. Implement Sci [Internet]. 2015
Dec [cited 2017 May 8];10(1). Available from:
http://implementationscience.biomedcentral.com/articles/10.1186/s13012-015-0323-0
60.
Waltz TJ, Powell BJ, Matthieu MM, Damschroder LJ, Chinman MJ, Smith JL, Proctor EK,
Kirchner JE. Use of concept mapping to characterize relationships among implementation
strategies and assess their feasibility and importance: results from the Expert Recommendations for
Implementing Change (ERIC) study. Implement Sci [Internet]. 2015 Dec [cited 2017 May

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 26 of 71 
*** Confidential *** 
8];10(1). Available from: 
http://implementationscience.biomedcentral.com/articles/10.1186/s13012-015-0295-0 
61.
Chan WV, Pearson TA, Bennett GC, Cushman WC, Gaziano TA, Gorman PN, Handler J,
Krumholz HM, Kushner RF, MacKenzie TD, Sacco RL, Smith SC, Stevens VJ, Wells BL.
ACC/AHA Special Report: Clinical Practice Guideline Implementation Strategies: A Summary of
Systematic Reviews by the NHLBI Implementation Science Work Group. J Am Coll Cardiol. 2017
Feb;69(8):1076–1092.
62.
Ivers NM, Sales A, Colquhoun H, Michie S, Foy R, Francis JJ, Grimshaw JM. No more ‘business
as usual’with audit and feedback interventions: towards an agenda for a reinvigorated intervention.
Implement Sci. 2014;9(1):14.
63.
Ford II JH, Alagoz E, Dinauer S, Johnson KA, Pe-Romashko K, Gustafson DH. Successful
Organizational Strategies to Sustain Use of A-CHESS: A Mobile Intervention for Individuals With
Alcohol Use Disorders. J Med Internet Res. 2015 Aug 18;17(8):e201.
64.
Maher L, Gustafson D, Evans A. Sustainability Model and Guide [Internet]. British National
Health Service Modernization Agency; 2004 [cited 2017 Jun 9]. Available from:
http://www.qihub.scot.nhs.uk/media/162236/sustainability_model.pdf
65.
Stetler CB, Legro MW, Wallace CM, Bowman C, Guihan M, Hagedorn H, Kimmel B, Sharp ND,
Smith JL. The Role of Formative Evaluation in Implementation Research and the QUERI
Experience. J Gen Intern Med. 2006 Feb;21(Suppl 2):S1–S8. PMCID: PMC2557128
66.
Green LW, Glasgow RE. Evaluating the Relevance, Generalization, and Applicability of Research
Issues in External Validation and Translation Methodology. Eval Health Prof. 2006 Mar
1;29(1):126–153. PMID: 16510882
67.
Soo S, Baker WB and GR. Role of Champions in the Implementation of Patient Safety Practice
Change. Healthc Q [Internet]. 2009 Aug 15 [cited 2017 May 8]; Available from:
http://www.longwoods.com/content/20979
68.
Shaw EK, Howard J, West DR, Crabtree BF, Nease DE, Tutt B, Nutting PA. The role of the
champion in primary care change efforts: from the State Networks of Colorado Ambulatory
Practices and Partners (SNOCAP). J Am Board Fam Med. 2012;25(5):676–685.
69.
Chambers DA, Glasgow RE, Stange KC. The dynamic sustainability framework: addressing the
paradox of sustainment amid ongoing change. Implement Sci. 2013;8:117.
70.
Neta G, Glasgow RE, Carpenter CR, Grimshaw JM, Rabin BA, Fernandez ME, Brownson RC. A
Framework for Enhancing the Value of Research for Dissemination and Implementation. Am J
Public Health. 2014 Nov 13;105(1):49–57.
71.
ATLAS.ti. Berlin: Scientific Software Development; 2013.

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 27 of 71 
*** Confidential *** 
72.
Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster
randomised controlled trials with a fixed number of clusters. BMC Med Res Methodol.
2011;11:102. PMCID: PMC3149598
73.
Rutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized
trials. Int J Epidemiol. 2015 Jun;44(3):1051–1067. PMCID: PMC4521133
74.
Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of
recent methodological developments. Am J Public Health. 2004 Mar;94(3):423–432. PMCID:
PMC1448268
75.
Austin PC. A comparison of the statistical power of different methods for the analysis of cluster
randomization trials with binary outcomes. Stat Med. 2007 Aug 30;26(19):3550–3565.
76.
Ma J, Thabane L, Kaczorowski J, Chambers L, Dolovich L, Karwalajtys T, Levitt C. Comparison
of Bayesian and classical methods in the analysis of cluster randomized controlled trials with a
binary outcome: the Community Hypertension Assessment Trial (CHAT). BMC Med Res
Methodol. 2009;9:37. PMCID: PMC2703649
77.
Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted
time series studies in medication use research. J Clin Pharm Ther. 2002 Aug;27(4):299–309.
PMID: 12174032
78.
Penfold RB, Zhang F. Use of interrupted time series analysis in evaluating health care quality
improvements. Acad Pediatr. 2013 Dec;13(6 Suppl):S38-44. PMID: 24268083
79.
Behavioral Risk Factor Surveillance System, 2015 Questionnaire [Internet]. Centers for Disease
Control and Prevention (US); 2014 [cited 2016 Sep 30]. Available from:
http://www.cdc.gov/brfss/questionnaires/pdf-ques/2015-brfss-questionnaire-12-29-14.pdf
80.
Helfrich CD, Li Y-F, Sharp ND, Sales AE. Organizational readiness to change assessment
(ORCA): Development of an instrument based on the Promoting Action on Research in Health
Services (PARIHS) framework. Implement Sci. 2009;4:38.

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 28 of 71 
*** Confidential *** 
Appendix A – Implementation Strategy Qualitative Study Materials 
A.1. Focus Group Invitation Telephone Script (clinics that participated in prior trial)
This is [name of caller] calling on behalf of Dr. David Miller at Wake Forest Baptist Health. Your clinic 
was kind enough to participate in his prior study of the mPATH iPad app about colorectal cancer 
screening. The study showed that the app doubled the number of patients who were screened for 
colorectal cancer. I’m calling now to invite your clinic to participate in a research focus group to help us 
learn how mPATH might be implemented in primary care clinics. If you are willing to participate, we 
would meet with your clinic staff and providers at your clinic site for a group discussion that would last 
no more than 60 minutes. Each person who participates in the focus group will receive a $50 gift card 
as a thank you for their time. We would schedule this meeting for the day and time that works best for 
your practice. Would you be interested in participating? 
[If yes]: Great. What days/times are generally best for your group, and I’ll work with you to get the 
meeting scheduled. 
A.2. Focus Group Invitation Telephone Script (clinics that did not participate in prior
trial)
This is [name of caller] calling on behalf of Dr. David Miller at Wake Forest Baptist Health. We have 
developed an iPad program call mPATH that helps patients get screened for colorectal cancer 
screening. We recently completed a study that showed the app doubled the number of patients who 
were screened for colorectal cancer. We now would like to talk to a few practices to figure out how to 
best implement mPATH in primary care clinics. I’m calling now to invite your clinic to participate in a 
research focus group to help us learn how to do that. If you are willing to participate, we would meet 
with your clinic staff and providers at your clinic for a group discussion that would last no more than 60 
minutes. Each person who participates in the focus group will receive a $50 gift card as a thank you for 
their time. We will not ask your clinic to implement mPATH. We simply want to hear your opinions about 
how clinics might use it in the future. We would schedule this meeting for the day and time that works 
best for your practice. Would you be interested in participating? 
[If yes]: Great. What days/times are generally best for your group, and I’ll work with you to get the 
meeting scheduled. 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 29 of 71 
*** Confidential *** 
A.3. Implementation Strategy Focus Group Moderator’s Guide (Wake Forest Clinics)
FG Purpose:  To learn how mPATH can be implemented successfully in primary care clinics. 
The main overarching questions to answer are: 
1. What would make clinic staff want to use mPATH with patients?
2. How do clinic staff think mPATH would be best incorporated into clinic flow?
3. What type of training and support will clinics need to use mPATH?
The guide will:
I.
Explore the facilitators and barriers to implementation
II.
Strategies for minimizing barriers
III.
The adequacy of draft training materials
IV.
Additional support or training materials desired
V.
Focus groups will also comment on the set of clinic check-in questions proposed for
the mPATH-CRC iPad app
Focus groups will be audio recorded and the content summarized. Revisions to the 
implementation strategy and materials will be informed by the focus group results. 
______________________________________________________________________ 
Date:       
Moderator(s): 
Note Taker(s):  
Start time:                                                     End time: 
______________________________________________________________________ 
I. WELCOME
Hello and welcome to our session. My name is Nicole Puccinelli-Ortega. I am today’s focus 
group moderator. This is Donna; she will be assisting with the focus group. She will record our 
discussion and take notes on what we say, to ensure we don’t miss anyone’s comments.  
We want to thank you for being here today. We appreciate your willingness to share your 
thoughts with us. The reason you are here today is obtain your feedback about a program 
called mPATH. mPATH is a user-friendly iPad program designed to increase the efficiency and 
quality of care in primary care offices. While in the waiting room, patients use mPATH to 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 30 of 71 
*** Confidential *** 
answer standard check-in items and assess their need for routine cancer screening. mPATH 
then transmits this information to the electronic health record, reducing data entry by nursing 
staff.  
Our goal today is to obtain your opinions about how best to implement mPATH into a primary 
care clinic’s workflow. I will be asking for your feedback about the iPad program, our proposed 
clinic workflow strategy and our training plan. There are no right or wrong answers. Everything 
we talk about will be considered confidential. We will use the information from our 
conversations to inform our study team about the best way to implement mPATH in other 
clinics. There will not be any names used and no one outside of this room will know specifically 
who said what. Please do not share other people’s names or comments outside of the group. 
We will audio record today’s conversation and take notes. This helps us remember what you 
all said. The notes and the audio will be kept in our offices and will not be shared with anyone 
outside our project.  
You will be asked to complete a brief paper questionnaire at the end of our group 
discussion, and you will each receive a $50 gift card for your participation today. I will send 
around a sheet where I will collect your information, so I can make sure that everyone who is 
here receives their gift card for participation.  
The session should last between 30-45 minutes. Before we get started, are there any 
questions?  
We would like for you to speak freely, sharing your ideas and opinions, even if they are 
different from others.  
There are no right or wrong answers. 
All your views are important, whether positive or negative. 
We want to get as many different points of view as we can. 
Please remember to silence your cell phones! 
Since this is a group discussion, you do not have to wait for me to call on you to speak, but 
please try to speak one at a time.  As I mentioned, we will be taking written notes as well as 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 31 of 71 
*** Confidential *** 
recording the session. This is to make sure that we do not miss anyone’s comments.  Is that 
okay with everyone? 
OK, first, let’s go around the room and say your first name and your favorite thing to do on a 
warm summer day.  
II. MAIN QUESTIONS
Let’s get started. 
Motivators and Barriers 
First, let me demonstrate the mPATH iPad program so you can see how it looks and how we 
are thinking clinic staff will use it.  
1. What are your first impressions of this program?
Follow-up question: 
a.
Based on what you’ve seen in the demonstration, tell me what about it would be
helpful to you in your clinic.
b. Tell me what would not be helpful.
2. What would motivate your team to use this iPad app?
Follow-up questions: 
a.
We programmed the app to ask patients the standard clinic check-in questions,
hoping that would save nurses some time. Do you think that feature is helpful or
not helpful?
 (probe): Tell me why you say that. 
b. What else could the app do that would make your job easier and make you
excited to use it?
3. What would make you not want to use it?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 32 of 71 
*** Confidential *** 
4. Patients will independently answer the check-in questions on the iPad, and the program
will transmit the answers to the standard nursing check-in note in WakeOne. The nurses
will get to see the patient’s answers in the WakeOne note before they sign off on the
note.
What are your thoughts about that process?
(probe):Tell me about any concerns you may have.
Clinic Workflow 
I am going to walk you through what we are envisioning to be the typical pattern of patient 
check in and how staff and patients will hand off and use the iPad. 
(Display clinic workflow poster/slide illustration and walk through the flow.) 
5. What are your immediate thoughts about this workflow?
Follow-up questions: 
a.
What do you like about the workflow?  And why?
b. What don’t you like about the workflow? And why?
c. Are the front desk staff the best people to hand the iPad to patients? Why or why
not?
6. The app includes audio narration and a video about colon cancer screening. If we gave
patients disposable earbuds when they are handed the iPad, do you think they could
use the app in the waiting room? Why or why not?
Follow-up questions:
a.
Do you think audio in the video is important? Or do you think reading closed
captions would be enough?
b. How could patients use the app without earbuds? Would it disturb other patients?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 33 of 71 
*** Confidential *** 
7. What is the longest time you think patients could use the app before it would interfere
with clinic flow?
Follow-up questions
a.
On average, how long do patients wait from check-in until the doctor sees them?
8. How many iPads would a clinic of your size and patient volume need to ensure this
process didn’t interfere with patient flow?
9. If a patient is 50 or older, the app will determine if they are due for colon cancer
screening. If they are due, it will help them get a test ordered. If your clinic decided to
use this program, would it be best to offer it to all patients on check-in, or only those
who are 50 and older? Why?
Training and Support 
In a few months, we will be helping some clinics incorporate the mPATH program into their 
workflow. Now I will tell you about the training and support we are planning to give those clinics 
so you can tell me what you think about our plans.   
We will first ask each clinic to identify a person working in the clinic, a “clinic champion,” who 
will help keep the program going and serve as our main contact. If the clinic wants us to add 
additional check-in questions to the mPATH program, we can do that for them. We will also 
hold a 45 minute on-site training session with the clinic staff to give them practice using the 
mPATH program. Afterwards, we will provide the clinics with as needed technical support by 
phone, email, or in person.  
10. What do you think about this training plan?
a. Follow-up questions: What would work well? What could be better?
11. How do you suggest we find the right person for the “clinic champion” role?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 34 of 71 
*** Confidential *** 
Follow-up questions: 
a.
Who would we contact to find a champion?
b. If your clinic decided to use this program, who at your clinic would be the
champion? What is his/her role here?
12. How much time is reasonable for you to attend an on-site training session?
Follow-up question:
a.
If we were to hold a training session for your clinic, when would be the best time
for that?
13. Do you think most clinic staff would watch a webinar or on-line video that provides an
overview of the program prior to the training session?
Follow-up questions:
a.
Is this something staff could do during free time at work (like during lunch or
other free time)?
b.
What would be a reasonable length of time for a webinar or on-line video?
14. What is the best way for the clinic champion to communicate with us if the clinic needs
technical support or help?
a. (Prompt:) by phone, email, text, video chat?
b. Follow-up question: What is a reasonable time for us to be able to reply or
respond back to clinic champions when they have technical or other questions?
III - CLOSING 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 35 of 71 
*** Confidential *** 
•
You have all had a lot of really important things to say, and I appreciate your openness
and willingness to share. Would anyone like to share any other comments before we
end?
*Provide participants with questionnaires and ask that they complete them on paper. Then,
give $50 to participant and have them sign saying they received it.*

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 36 of 71 
*** Confidential *** 
A.4. Implementation Strategy Interview Guide (Wake Forest Clinics)
Interview Purpose:  To learn how mPATH can be implemented successfully in primary care 
clinics. The main overarching questions to answer are: 
1. What would make clinic staff want to use mPATH with patients?
2. How do clinic staff think mPATH would be best incorporated into clinic flow?
3. What type of training and support will clinics need to use mPATH?
The guide will:
VI.
Explore the facilitators and barriers to implementation
VII.
Strategies for minimizing barriers
VIII.
The adequacy of draft training materials
IX.
Additional support or training materials desired
X.
Interviews will also comment on the set of clinic check-in questions proposed for
the mPATH-CRC iPad app
Interviews will be audio recorded and the content summarized. Revisions to the 
implementation strategy and materials will be informed by the interview results. 
______________________________________________________________________ 
Date:       
Interviewer: 
Start time:                                                     End time: 
______________________________________________________________________ 
I. WELCOME
I want to thank you for speaking with me today. I appreciate your willingness to share your 
thoughts with me. The reason we are doing this interview is obtain your feedback about a 
program called mPATH. mPATH is a user-friendly iPad program designed to increase the 
efficiency and quality of care in primary care offices. While in the waiting room, patients use 
mPATH to answer standard check-in items and assess their need for routine cancer screening. 
mPATH then transmits this information to the electronic health record, reducing data entry by 
nursing staff.  
The purpose of the interview is to learn from you your opinion on how best to implement 
mPATH into a primary care clinic’s workflow. I will be asking for your feedback about the iPad 
program, our proposed clinic workflow strategy and our training plan. There are no right or 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 37 of 71 
*** Confidential *** 
wrong answers. Everything we talk about will be considered confidential. I will use the 
information from our conversations to inform our study team about the best way to implement 
mPATH in other clinics. I will audio record today’s conversation and take notes. This helps us 
remember what you all said. The notes and the audio will be kept in our offices and will not be 
shared with anyone outside our project. I would like for you to speak freely, sharing your ideas 
and opinions. You are the expert and there are no right or wrong answers. 
You will be asked to complete a brief paper on online questionnaire at the end of our 
discussion, and you will receive a $50 gift card for your participation today.  
The interview should last between 20 and 30 minutes. Before I get started, are there any 
questions?  
II. MAIN QUESTIONS
Let’s get started.
Motivators and Barriers
First, let me demonstrate the mPATH iPad program so you can see how it looks and how we 
are thinking clinic staff will use it.  
Clinic Staff (nurses, nursing assistants, med assistants, front desk staff) 
1. What are your first impressions of this program?
Follow-up questions:
a. Based on what you’ve seen in the demonstration, do you think this would be
helpful to you in your clinic? Why or why not?
b. What would motivate your team to use this iPad app?
c. What would discourage your team from using the app?
2. We programmed the app to ask patients the standard clinic check-in questions, hoping
that would save nurses some time. Do you think that feature is helpful or not helpful?
(Probe, if needed) Tell me why you say that. 
Follow-up question: 
a. What other features could the app do that would make your job easier and make
you excited to use it?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 38 of 71 
*** Confidential *** 
3. Patients will independently answer the check-in questions on the iPad, and the program
will transmit the answers to the standard nursing check-in note in WakeOne. The nurses
will get to see the patient’s answers in the WakeOne note before they sign off on the
note.
Tell me your thoughts about that process.
Follow-up question:
a. Tell me your concerns.
Clinic Workflow 
I am going to walk you through what we are envisioning to be the typical pattern of patient 
check in and how staff and patients will hand off and use the iPad. 
(Display clinic workflow poster/slide illustration and walk through the flow.) 
4. What are your immediate thoughts about this workflow?
Follow-up questions: 
a. What do you like about this workflow?  And why?
b. What don’t you like about this workflow? And why?
c. Are the front desk staff the best people to hand the iPad to patients? Why or why
not?
5. The app includes audio narration and a video about colon cancer screening. If we gave
patients disposable earbuds when they are handed the iPad, do you think they could
use the app in the waiting room? Why or why not?
Follow-up questions:
a. Do you think audio in the video is important? Or do you think reading closed
captions would be enough?
b. How could patients use the app without earbuds? Would it disturb other patients

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 39 of 71 
*** Confidential *** 
6. What is the longest time you think patients could use the app before it would interfere
with clinic flow?
Follow-up questions:
a. On average, how long do patients wait from check-in until the doctor sees them?
7. How many iPads would a clinic of your size and patient volume need to ensure this
process didn’t interfere with patient flow?
8. If a patient is 50 or older, the app will determine if they are due for colon cancer
screening. If they are due, it will help them get a test ordered. If your clinic decided to
use this program, would it be best to offer it to all patients on check-in, or only those
who are 50 and older?
(Probe, if needed) Tell me more.
For Clinic Manager ONLY 
9. Could our team email you later to get a list of the intake questions your clinic routinely
asks patients?
For Physicians (MDs, NPs, PAs) ONLY 
As you saw, if patients are between 50 and 75, mPATH asks them about their colon 
cancer screening history and desire to be screened. mPATH will generate a summary of 
each patients usage so you know what they said. Here are two examples of what the 
printed summary would look like. (show examples of mPATH app output) 
10. Would you find this printout helpful or not helpful? Why or why not?
11. What do you think about the length of the printout?
Follow-up question:
a. Is it too much information or not enough?
(Prompt if needed): Tell me what you would remove (if too much information)
(Prompt, if needed): If not enough information, what else would you want to
know?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 40 of 71 
*** Confidential *** 
12. Would you rather have this information printed and left for you outside the exam room
door, or would you rather have it electronically sent to WakeOne?
(Probe, if needed): Tell me more about your answer.
Follow-up question: 
a. If sent to WakeOne, where would you want the information to appear in
WakeOne? In your In Basket, in a procedure note, somewhere else?
Training and Support (for everyone – if time permits) 
In a few months, we will be helping some clinics incorporate the mPATH program into their 
workflow. Now I will tell you about the training and support we are planning to give those clinics 
so you can tell me what you think about our plans.   
We will first ask each clinic to identify a person working in the clinic, a “clinic champion,” who 
will help keep the program going and serve as our main contact. If the clinic wants us to add 
additional check-in questions to the mPATH program, we can do that for them. We will also 
hold a 45 minute on-site training session with the clinic staff to give them practice using the 
mPATH program. Afterwards, we will provide the clinics with as needed technical support by 
phone, email, or in person.  
13. Tell me your thoughts about this training plan.
Follow-up questions: 
a. What about it works well?
b. What could be better?
14. How do you suggest we find the right person for the “clinic champion” role?
Follow-up questions:
a. If your clinic decided to use this program, who at your clinic would be the
champion?
b. What is his/her role here?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 41 of 71 
*** Confidential *** 
c. Who is the best person at a clinic to contact to find a champion?
15. What is the best way for the clinic champion to communicate with us if the clinic needs
technical support or help?
(Prompt if needed): What is the best means of communication, by phone, email, text, 
video chat? 
Follow-up question: 
a. What is a reasonable time for us to be able to reply or respond back to clinic
champions when they have technical or other questions?
III - CLOSING 
 You have all had a lot of really important things to say, and I appreciate your openness and 
willingness to share. Would anyone like to share any other comments before we end? 
*Provide participant with questionnaire or send them link to survey and ask that they complete
it. If completing survey online, tell them survey will include an item telling us where to mail their
gift card. If in person interview, give $50 gift card to participant and have them sign saying they
received it.*

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 42 of 71 
*** Confidential *** 
A.5. Implementation Strategy Participant Demographic Questionnaire
Please answer the following questions. 
1. How long have you worked at Wake Forest/Cornerstone outpatient clinics: _______
2. Your position title/role: ______________
3. Your current age: _____
4. Gender: ____
5. I could complete a job using a computer program…
…if there was no one around to tell me what to do as I go.   [  ] Yes     [  ] No
…if I had just the built-in help facility for assistance.   
 [  ] Yes     [  ] No
…if someone showed me how to do it first.   
 
 [  ] Yes     [  ] No
…if I had used a similar program before this one to do the same task. [  ] Yes     [  ] No
6. Please rate the following statements on a scale of 1-7. (1 = strongly disagree,
2 = moderately disagree, 3 = somewhat disagree, 4 = neutral, 5 = somewhat agree,
6 = moderately agree, 7 = strongly agree)
___ Computers do not scare me at all.
___ Working with a computer makes me nervous.
___ Computers make me feel uncomfortable.
___Computers make me feel uneasy.

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 43 of 71 
*** Confidential *** 
A.6. Implementation Strategy Focus Group Moderator’s Guide
(non-Wake Forest Health Network Clinics)
FG Purpose:  To learn how mPATH can be implemented successfully in primary care clinics. 
The main overarching questions to answer are: 
1. What would make clinic staff want to use mPATH with patients?
2. How do clinic staff think mPATH would be best incorporated into clinic flow?
3. What type of training and support will clinics need to use mPATH?
The guide will:
I.
Explore the facilitators and barriers to implementation
II.
Strategies for minimizing barriers
III.
The adequacy of draft training materials
IV.
Additional support or training materials desired
V.
Focus groups will also comment on the set of clinic check-in questions proposed for
the mPATH-CRC iPad app
Focus groups will be audio recorded and the content summarized. Revisions to the 
implementation strategy and materials will be informed by the focus group results. 
______________________________________________________________________ 
Date:       
Moderator(s): 
Note Taker(s):  
Start time:                                                     End time: 
______________________________________________________________________ 
I. WELCOME
Hello and welcome to our session. My name is _______________. I am today’s focus group 
moderator. This is ________________; s/he will be assisting with the focus group. S/he will 
record our discussion and take notes on what we say, to ensure we don’t miss anyone’s 
comments.  

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 44 of 71 
*** Confidential *** 
We want to thank you for being here today. We appreciate your willingness to share your 
thoughts with us. The reason you are here today is obtain your feedback about a program 
called mPATH. mPATH is a user-friendly iPad program designed to increase the efficiency and 
quality of care in primary care offices. While in the waiting room, patients use mPATH to 
answer standard check-in items and assess their need for routine cancer screening. mPATH 
then informs the office staff of patients’ answers so they can update the electronic health 
record as needed. 
Our goal today is to obtain your opinions about how best to implement mPATH into a primary 
care clinic’s workflow. I will be asking for your feedback about the iPad program, our proposed 
clinic workflow strategy and our training plan. There are no right or wrong answers. Everything 
we talk about will be considered confidential. We will use the information from our 
conversations to inform our study team about the best way to implement mPATH in other 
clinics. There will not be any names used and no one outside of this room will know specifically 
who said what. Please do not share other people’s names or comments outside of the group. 
We will audio record today’s conversation and take notes. This helps us remember what you 
all said. The notes and the audio will be kept in our offices and will not be shared with anyone 
outside our project.  
You will be asked to complete a brief paper questionnaire at the end of our group 
discussion, and you will each receive a $50 gift card for your participation today. I will send 
around a sheet where I will collect your information, so I can make sure that everyone who is 
here receives their gift card for participation.  
The session should last between 30-45 minutes. Before we get started, are there any 
questions?  
We would like for you to speak freely, sharing your ideas and opinions, even if they are 
different from others.  
There are no right or wrong answers. 
All your views are important, whether positive or negative. 
We want to get as many different points of view as we can. 
Please remember to silence your cell phones! 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 45 of 71 
*** Confidential *** 
Since this is a group discussion, you do not have to wait for me to call on you to speak, but 
please try to speak one at a time.  As I mentioned, we will be taking written notes as well as 
recording the session. This is to make sure that we do not miss anyone’s comments.  Is that 
okay with everyone? 
OK, first, let’s go around the room and say your first name and your favorite thing to do on a 
warm summer day.  
II. MAIN QUESTIONS
Let’s get started. 
Motivators and Barriers 
First, let me demonstrate the mPATH iPad program so you can see how it looks and how we 
are thinking clinic staff will use it.  
1. What are your first impressions of this program?
Follow-up question: 
a. Based on what you’ve seen in the demonstration, tell me what about it would be
helpful to you in your clinic.
b. Tell me what would not be helpful.
2. What would motivate your team to use this iPad app?
Follow-up questions: 
a. We programmed the app to ask patients the standard clinic check-in questions,
hoping that would save nurses some time. Do you think that feature is helpful or
not helpful?
 (probe): Tell me why you say that. 
b. What else could the app do that would make your job easier and make you
excited to use it?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 46 of 71 
*** Confidential *** 
3. What would make you not want to use it?
4. Patients will independently answer the check-in questions on the iPad, and the program
will show the patients’ answers to the person who is rooming the patient. The rooming
staff would then enter the answers into the electronic health record.
What are your thoughts about that process?
(probe):Tell me about any concerns you may have.
Clinic Workflow 
I am going to walk you through what we are envisioning to be the typical pattern of patient 
check in and how staff and patients will hand off and use the iPad. 
(Display clinic workflow poster/slide illustration and walk through the flow.) 
5. What are your immediate thoughts about this workflow?
Follow-up questions: 
a.
What do you like about the workflow?  And why?
b. What don’t you like about the workflow? And why?
c. Are the front desk staff the best people to hand the iPad to patients? Why or why
not?
6. The app includes audio narration and a video about colon cancer screening. If we gave
patients disposable earbuds when they are handed the iPad, do you think they could
use the app in the waiting room? Why or why not?
Follow-up questions:
a.
Do you think audio in the video is important? Or do you think reading closed
captions would be enough?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 47 of 71 
*** Confidential *** 
b. How could patients use the app without earbuds? Would it disturb other patients?
7. What is the longest time you think patients could use the app before it would interfere
with clinic flow?
Follow-up questions
a.
On average, how long do patients wait from check-in until the doctor sees them?
8. How many iPads would a clinic of your size and patient volume need to ensure this
process didn’t interfere with patient flow?
9. If a patient is 50 or older, the app will determine if they are due for colon cancer
screening. If they are due, it will help them get a test ordered. If your clinic decided to
use this program, would it be best to offer it to all patients on check-in, or only those
who are 50 and older? Why?
Training and Support 
In a few months, we will be helping some clinics incorporate the mPATH program into their 
workflow. Now I will tell you about the training and support we are planning to give those clinics 
so you can tell me what you think about our plans.   
We will first ask each clinic to identify a person working in the clinic, a “clinic champion,” who 
will help keep the program going and serve as our main contact. If the clinic wants us to add 
additional check-in questions to the mPATH program, we can do that for them. We will also 
hold a 45 minute on-site training session with the clinic staff to give them practice using the 
mPATH program. Afterwards, we will provide the clinics with as needed technical support by 
phone, email, or in person.  
10. What do you think about this training plan?
a. Follow-up questions: What would work well? What could be better?
11. How do you suggest we find the right person for the “clinic champion” role?
Follow-up questions:
a.
Who would we contact to find a champion?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 48 of 71 
*** Confidential *** 
b. If your clinic decided to use this program, who at your clinic would be the
champion? What is his/her role here?
12. How much time is reasonable for you to attend an on-site training session?
Follow-up question:
a.
If we were to hold a training session for your clinic, when would be the best time
for that?
13. Do you think most clinic staff would watch a webinar or on-line video that provides an
overview of the program prior to the training session?
Follow-up questions:
a.
Is this something staff could do during free time at work (like during lunch or
other free time)?
b.
What would be a reasonable length of time for a webinar or on-line video?
14. What is the best way for the clinic champion to communicate with us if the clinic needs
technical support or help?
a. (Prompt:) by phone, email, text, video chat?
b. Follow-up question: What is a reasonable time for us to be able to reply or
respond back to clinic champions when they have technical or other questions?
III - CLOSING 
•
You have all had a lot of really important things to say, and I appreciate your openness
and willingness to share. Would anyone like to share any other comments before we
end?
*Provide participants with questionnaires and ask that they complete them on paper. Then,
give $50 to participant and have them sign saying they received it.*

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 49 of 71 
*** Confidential *** 
A.7. Implementation Strategy Interview Guide (Non-Wake Forest Health Network Clinics)
Interview Purpose:  To learn how mPATH can be implemented successfully in primary care 
clinics. The main overarching questions to answer are: 
1. What would make clinic staff want to use mPATH with patients?
2. How do clinic staff think mPATH would be best incorporated into clinic flow?
3. What type of training and support will clinics need to use mPATH?
The guide will:
I.
Explore the facilitators and barriers to implementation
II.
Strategies for minimizing barriers
III.
The adequacy of draft training materials
IV.
Additional support or training materials desired
V.
Interviews will also comment on the set of clinic check-in questions proposed for
the mPATH-CRC iPad app
Interviews will be audio recorded and the content summarized. Revisions to the 
implementation strategy and materials will be informed by the interview results. 
______________________________________________________________________ 
Date:     
Interviewer: 
Start time:                                                     End time: 
______________________________________________________________________ 
I. WELCOME
I want to thank you for speaking with me today. I appreciate your willingness to share your 
thoughts with me. The reason we are doing this interview is obtain your feedback about a 
program called mPATH. mPATH is a user-friendly iPad program designed to increase the 
efficiency and quality of care in primary care offices. While in the waiting room, patients use 
mPATH to answer standard check-in items and assess their need for routine cancer screening. 
mPATH then informs the office staff of patients’ answers so they can update the electronic 
health record as needed. 
The purpose of the interview is to learn from you your opinion on how best to implement 
mPATH into a primary care clinic’s workflow. I will be asking for your feedback about the iPad 
program, our proposed clinic workflow strategy and our training plan. There are no right or 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 50 of 71 
*** Confidential *** 
wrong answers. Everything we talk about will be considered confidential. I will use the 
information from our conversations to inform our study team about the best way to implement 
mPATH in other clinics. I will audio record today’s conversation and take notes. This helps us 
remember what you all said. The notes and the audio will be kept in our offices and will not be 
shared with anyone outside our project. I would like for you to speak freely, sharing your ideas 
and opinions. You are the expert and there are no right or wrong answers. 
You will be asked to complete a brief survey at the end of our discussion, and you will 
receive a $50 gift card for your participation today.  
The interview should last between 20 and 30 minutes. Before I get started, are there any 
questions?  
II. MAIN QUESTIONS
Let’s get started.
Motivators and Barriers
First, let me demonstrate the mPATH iPad program so you can see how it looks and how we 
are thinking clinic staff will use it.  
1. What are your first impressions of this program?
Follow-up questions:
a. Based on what you’ve seen in the demonstration, do you think this would be
helpful to you in your clinic? Why or why not?
b. What would motivate your team to use this iPad app?
c. What would discourage your team from using the app?
2. We programmed the app to ask patients the standard clinic check-in questions, hoping
that would save nurses some time. Do you think that feature is helpful or not helpful?
(Probe, if needed) Tell me why you say that. 
Follow-up question: 
a. What other features could the app do that would make your job easier and make
you excited to use it?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 51 of 71 
*** Confidential *** 
3. Patients will independently answer the check-in questions on the iPad, and the program
will show the patients’ answers to the person who is rooming the patient. The rooming
staff would then enter the answers into the electronic health record.
Tell me your thoughts about that process.
Follow-up question:
a. Tell me your concerns.
Clinic Workflow 
I am going to walk you through what we are envisioning to be the typical pattern of patient 
check in and how staff and patients will hand off and use the iPad. 
(Display clinic workflow poster/slide illustration and walk through the flow.) 
4. What are your immediate thoughts about this workflow?
Follow-up questions: 
a. What do you like about this workflow?  And why?
b. What don’t you like about this workflow? And why?
c. Are the front desk staff the best people to hand the iPad to patients? Why or why
not?
5. The app includes audio narration and a video about colon cancer screening. If we gave
patients disposable earbuds when they are handed the iPad, do you think they could
use the app in the waiting room? Why or why not?
Follow-up questions:
a. Do you think audio in the video is important? Or do you think reading closed
captions would be enough?
b. How could patients use the app without earbuds? Would it disturb other patients

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 52 of 71 
*** Confidential *** 
6. What is the longest time you think patients could use the app before it would interfere
with clinic flow?
Follow-up questions:
a. On average, how long do patients wait from check-in until the doctor sees them?
7. How many iPads would a clinic of your size and patient volume need to ensure this
process didn’t interfere with patient flow?
8. If a patient is 50 or older, the app will determine if they are due for colon cancer
screening. If they are due, it will help them get a test ordered. If your clinic decided to
use this program, would it be best to offer it to all patients on check-in, or only those
who are 50 and older?
(Probe, if needed) Tell me more.
For Clinic Manager ONLY 
9. Could our team email you later to get a list of the intake questions your clinic routinely
asks patients?
For Physicians (MDs, NPs, PAs) ONLY 
As you saw, if patients are between 50 and 75, mPATH asks them about their colon 
cancer screening history and desire to be screened. mPATH will generate a summary of 
each patients usage so you know what they said. Here are two examples of what the 
printed summary would look like. (show examples of mPATH app output) 
10. Would you find this printout helpful or not helpful? Why or why not?
11. What do you think about the length of the printout?
Follow-up question:
a. Is it too much information or not enough?
(Prompt if needed): Tell me what you would remove (if too much information) 
(Prompt, if needed): If not enough information, what else would you want to 
know? 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 53 of 71 
*** Confidential *** 
12. Would you rather have this information printed and left for you outside the exam room
door, or would you like to get this information some other way?
(Probe, if needed): Tell me more about your answer.
Training and Support (for everyone – if time permits) 
In a few months, we will be helping some clinics incorporate the mPATH program into their 
workflow. Now I will tell you about the training and support we are planning to give those clinics 
so you can tell me what you think about our plans.   
We will first ask each clinic to identify a person working in the clinic, a “clinic champion,” who 
will help keep the program going and serve as our main contact. If the clinic wants us to add 
additional check-in questions to the mPATH program, we can do that for them. We will also 
hold a 45 minute on-site training session with the clinic staff to give them practice using the 
mPATH program. Afterwards, we will provide the clinics with as needed technical support by 
phone, email, or in person.  
13. Tell me your thoughts about this training plan.
Follow-up questions: 
a. What about it works well?
b. What could be better?
14. How do you suggest we find the right person for the “clinic champion” role?
Follow-up questions:
a. If your clinic decided to use this program, who at your clinic would be the
champion?
b. What is his/her role here?
c. Who is the best person at a clinic to contact to find a champion?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 54 of 71 
*** Confidential *** 
15. What is the best way for the clinic champion to communicate with us if the clinic needs
technical support or help?
(Prompt if needed): What is the best means of communication, by phone, email, text, 
video chat? 
Follow-up question: 
a. What is a reasonable time for us to be able to reply or respond back to clinic
champions when they have technical or other questions?
III - CLOSING 
 You have all had a lot of really important things to say, and I appreciate your openness and 
willingness to share. Would anyone like to share any other comments before we end? 
*Provide participant with questionnaire or send them link to survey and ask that they complete
it. If completing survey online, tell them survey will include an item telling us where to mail their
gift card. If in person interview, give $50 gift card to participant and have them sign saying they
received it.*

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 55 of 71 
*** Confidential *** 
Appendix B – Data Collection Instruments 
The following instruments have been submitted to the IRB as pdf files: 
Clinic Characteristics Survey 
Clinic Staffing Form 
Staff Linkage Form 
Staff Consent & Contact Information Form 
Staff Baseline Survey 
Staff Demographics Survey 
Clinic Support Log 
Follow-Up Clinic Personnel Survey: 6 month timepoint 
Follow-Up Clinic Personnel Survey: 12 month 
Additional data collection instruments in development: 
The final data collection instruments listed below have not yet been developed. Each instrument will be 
submitted to the IRB for formal review and approval before they are used with any human subjects. The 
planned data collection instruments and their descriptions are listed below. 
Cost Database 
All technology costs associated with implementing and maintaining mPATH will be recorded in a 
secure, electronic database.  
mPATH-CRC Database 
The mPATH-CRC database will be stored in an encrypted, HIPAA-compliant Cloud-based server with 
continuous data backup. The database is password protected and meets HIPAA security requirements. 
The database includes patient medical record numbers, date and time of use, and answers to mPATH-

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 56 of 71 
*** Confidential *** 
CRC survey questions (CRC screening history, CRC screening decisions, etc.). The database is 
password protected and access is limited to those with authorization. When the mPATH-CRC database 
is queried to construct our study dataset, the medical record numbers will be replaced with an 
anonymous study identifier by an honest broker. A full copy of the mPATH-CRC survey will be 
submitted to the IRB for review and approval prior to use with human subjects. 
Clinic Query Database 
We will query the study clinics’ electronic health records and appointment systems to collect the 
following data elements needed for our planned analyses. Data will be collected for the time periods 
specified in the Experimental Methods (Section 4.0). 
Patient age 
Patient gender 
Patient race/ethnicity 
Flagged as needing a language interpreter (and language needed) 
Patient marital status 
Patient health insurance 
Patient history of colorectal cancer 
Patient history of colorectal polyps 
Patient family history of colorectal cancer 
Date of visit to clinic 
Name of provider being seen 
Name of nursing staff who roomed the patient 
Dates of any orders for CRC screening tests (and type of test ordered) 
Dates of any completed CRC screening tests 
Results of any completed CRC screening tests 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 57 of 71 
*** Confidential *** 
Appendix C – Clinic Personnel Interview Guide 
Key Informant Interview Guide: Admin/Check-In Staff
Follow-Up Semi-Structured Interviews for Sites who Completed the Study 
A.
[High & Low Touch] I would like to start by asking you some general questions about you and your clinic
and then we will discuss some of the facilitators and challenges to implementing mPATH in your clinic.
1. What is your name?
2. How long have you worked at this clinic? [if new]
3. What is your role in this clinic? [if new interviewee]. Has your role changed since the last
time we spoke? [if previous interviewee]
B. Construct:  Impact of mPATH on Universal Screening and CRC screening
Now I would like to ask you some questions about the universal screening questions that
Wake Forest mandates all clinics ask on a routine basis, which include questions about
depression, falls in older adults, and household violence or abuse.
1. Before mPATH, how were patients screened for these risk factors (Probes:  at check-in via
a paper-based self-completed screener, asking patients directly, using other tablet based
screening)?  Did you play any role in screening patients?  If yes, explain.
2. How has mPATH affected your ability to gather this information on a routine basis?  (Probe
for positive and negative attributes)
C. Construct:  Barriers/Facilitators (appropriateness, workflow)
1. To what extent has mPATH impacted workflow?
2. In what ways did your clinic modify its workflow to accommodate mPATH?
i. Do you have recommendations on implementation to minimize workflow disruption?  If
yes, in what way.
3. In your opinion, is your clinic an appropriate setting for mPATH?   Probe:  Can you tell me
more about that (why ‘yes’ or ‘no’)
4. How did the stability of the program (crashes, downtime) affect the implementation of
mPATH?
5. Are there other factors that made it challenging to implement mPATH in your clinic?
6. What were the most important factors that helped you implement mPATH in your clinic?

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 58 of 71 
*** Confidential *** 
7. Is your practice still using mPATH?
a. If YES:  In your opinion, what motivates your clinic personnel to use mPATH? Does
this differ for front desk staff, nursing staff, and clinicians?
b. If NO:  Why did your practice stop using mPATH?
D. Construct: COVID
1. How and to what extent did COVID affect implementation of mPATH?
E. Construct:  Resources /Training
1. What resources were needed from your clinic to implement mPATH?  Resources could
include personnel, space, materials, time, etc.
2. The research team offered several strategies to enhance mPATH implementation.  We
value your feedback on how effective or ineffective these strategies were?
High & Low Touch: 
•
In-person training (High & Low Touch)
•
Technical support by phone or email
High Touch ONLY: 
•
At elbow support
•
Phone call check ins
•
Shout out memos acknowledging staff who use mPATH the most
•
Highlighting the “missed opportunities” in monthly memos
•
Tableau mPATH usage dashboard
3.
What additional support could we have provided to help you implement mPATH?
F. Construct:  Program Champion & Leadership
1. Has there been a person or persons in your clinic who were especially important to
implementing mPATH for patients? What was this person’s role(s) in the medical center?
Probe:  administrative staff, nurses, physician, practice manager.
2. What made this person(s) particularly important in the implementation of mPATH?
3. In what ways did you or did you not have the support of clinic leadership for implementing
mPATH?
G. Implementation Construct:  Scale-Up/Dissemination
We are very interested in your ideas about how to help other clinics implement mPATH into 
routine care.  

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 59 of 71 
*** Confidential *** 
1. What would you tell another clinic if they were interested in implementing mPATH?  
2. If it were up to you, would you keep using mPATH after the study ends?  Probe: Tell me 
more about why/why not. 
Wrap-Up: 
Is there anything else we should know about implementing mPATH that we haven’t already 
discussed, or any suggestions you have for the program? 
Thank you very much for your time and commitment to the mPATH study. 
 
Key Informant Interview Guide: Admin/Check-In Staff 
Follow-Up Semi-Structured Interviews for Sites With Very Low mPATH Usage 
 
 
A. [High & Low Touch] I would like to start by asking you some general questions about you and your clinic and 
then we will discuss what made it easy and what made it difficult to implement mPATH in your clinic. 
 
1. What is your name (as a reminder, we won’t include your name in the transcript we use 
for analysis)?  
 
2. How long have you worked at this clinic? [if new]  
 
3. What is your role in this clinic? [if new interviewee]. Has your role changed since the last 
time we spoke? [if previous interviewee] 
B.  Construct:  Impact of mPATH on Universal Screening and CRC screening 
Now I would like to ask you some questions about the universal screening questions that 
Wake Forest mandates all clinics ask on a routine basis, which include questions about 
depression, falls in older adults, and household violence or abuse.  
  
1. How are patients screened for these risk factors (Probes:  at check-in via a paper-based 
self-completed screener, asking patients directly, using other tablet based screening)?  
Did 
you 
play 
any 
role 
in 
screening 
patients? 
 
If 
yes, 
explain. 
 
2. How did mPATH affect your ability to gather this information on a routine basis?  (Probe 
for positive and negative attributes). 
 
C. Construct:  Barriers/Facilitators (appropriateness, workflow)  
 
1. In your opinion, is your clinic an appropriate setting for mPATH? Probe: Can you tell me 
more about that (why ‘yes’ or ‘no’)  
 
2. How could your clinic modify its workflow to accommodate mPATH?  

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 60 of 71 
*** Confidential *** 
 
a. Do you have recommendations on implementation to minimize workflow 
disruption?  If yes, in what way. 
 
3. How and to what extent did COVID affect your decision to use/not use mPATH?  
 
4. Are there other factors that made it challenging to implement mPATH in your clinic?   
 
5. Why did your practice stop using mPATH?     
 
E. Construct:  Resources /Training 
1. What resources were needed from your clinic to implement mPATH? Resources could 
include personnel, space, materials, time, etc. 
 
2.  The research team offered several strategies to enhance mPATH implementation.  We 
value your feedback on how effective or ineffective these strategies were? 
High & Low Touch: 
o In-person training (High & Low Touch) 
o Technical support by phone or email 
 
3.  What additional support could we have provided to help you implement mPATH?  
 
F. Construct:  Program Champion & Leadership  
1. What person or persons would play an important role if you chose to implement mPATH? 
Were there individuals who were especially opposed to implementing mPATH?  
 
2. What made this person(s) particularly important in the implementation of mPATH? (probe: 
or to the reason it wasn’t implemented?)  
 
3. In what ways did you or did you not have the support of clinic leadership for implementing 
mPATH? 
 
G. Implementation Construct:  Scale-Up/Dissemination  
We are very interested in your thoughts about other clinics implementing mPATH into 
routine care  
1. What would you tell another clinic if they were thinking about implementing mPATH?  
 
2. If it were up to you, would you use mPATH in the future? Probe: Tell me more about 
why/why not.  

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 61 of 71 
*** Confidential *** 
Wrap-Up: 
Is there anything else we should know about implementing mPATH that we haven’t already 
discussed, or any suggestions you have for the program? 
Thank you very much for your time and commitment to the mPATH study. 
 
 
 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 62 of 71 
*** Confidential *** 
 
Key Informant Interview Guide: Clinical Personnel & Practice Managers 
Follow-Up Semi-Structured Interviews for Sites who Completed the Study 
 
A. [High & Low Touch] I would like to start by asking you some general questions about you 
and your clinic and then we will discuss what made it easy and what made it difficult  to 
implement mPATH in your clinic. 
 
1. What is your name (as a reminder, we won’t include your name in the transcript we use 
for analysis)?  
 
2. How long have you worked at this clinic? [if new]  
 
3. What is your role in this clinic? [if new interviewee]. Has your role changed since the last 
time we spoke? [if previous interviewee] 
B.  Construct:  Impact of mPATH on Universal Screening and CRC screening 
Now I would like to ask you some questions about the universal screening questions that Wake 
Forest mandates all clinics ask on a routine basis, which include questions about depression, 
falls in older adults, and household violence or abuse.  
  
1. Before mPATH, how were patients screened for these risk factors (Probes:  at check-in 
via a paper-based self-completed screener, asking patients directly, using other tablet 
based screening)?  Did you play any role in screening patients?  If yes, explain. 
 
2. How has mPATH affected your ability to gather this information on a routine basis?  
(Probe for positive and negative attributes). 
 
3. What are the advantages and disadvantages of using tablet based screening for 
identifying these risk factors? 
 
 
Now I want to ask you some questions about the CRC screening module on the blue iPad. 
 
1. Before mPATH, what role did you play (if any) in helping identify patients who were due 
for CRC screening?  (for providers and nursing staff only) 
 
2. Since mPATH, how has your role changed in helping identify patients who are due for 
CRC screening?   

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 63 of 71 
*** Confidential *** 
 
3. Reflecting on your approach to CRC screening before and after mPATH, which method 
has worked best for your clinic?  Probe: explain more (for providers and nursing staff 
only) 
 
 
C. Construct:  Barriers/Facilitators (appropriateness, workflow)  
 
1. To what extent has mPATH impacted workflow? 
 
2. In what ways did your clinic modify its workflow to accommodate mPATH?  
 
a. Do you have recommendations on implementation to minimize workflow 
disruption?  If yes, in what way. 
 
3. In your opinion, is your clinic an appropriate setting for mPATH?   Probe:  Can you tell me 
more about that (why ‘yes’ or ‘no’)  
 
4. How did the stability of the program (crashes, downtime) affect the implementation of 
mPATH?  
 
5. How and to what extent did COVID affect implementation of mPATH? 
 
6. Are there other factors that made it challenging to implement mPATH in your clinic?   
 
7. What were the most important factors that helped you implement mPATH in your clinic? 
 
8. Is your practice still using mPATH? 
 
a. If YES:  In your opinion, what motivates your clinic personnel to use mPATH? Does 
this differ for front desk staff, nursing staff, and clinicians? 
 
b. If NO:  Why did your practice stop using mPATH?     
 
9. We noticed that many clinics used the pink CheckIn iPad a lot more than the blue CRC 
iPad. Why do you think that was the case? 
 
 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 64 of 71 
*** Confidential *** 
D.  Construct:  Impact of mPATH on screening and clinic operations. 
 
1. Has mPATH affected CRC screening among your eligible patients?  
i. If yes, in what way. 
 
2. In what ways did mPATH affect your and your patients’ approach to informed decision 
making about CRC screening? (providers and nursing staff only) 
 
3. Has mPATH affected other aspects of your clinic operations?  If yes, in what way. 
 
E. Construct:  Resources /Training 
1. What resources were needed from your clinic to implement mPATH?  Resources could 
include personnel, space, materials, time, etc. 
 
2.  The research team offered several strategies to enhance mPATH implementation.  We value 
your feedback on how effective or ineffective these strategies were? 
High & Low Touch: 
• In-person training (High & Low Touch) 
• Technical support by phone or email 
High Touch ONLY: 
• At elbow support  
• Phone call check ins  
• Shout out memos acknowledging staff who use mPATH the most 
• Highlighting the “missed opportunities” in monthly memos 
• Tableau mPATH usage dashboard 
 
3.  What additional support could we have provided to help you implement mPATH?  
 
F. Construct:  Program Champion & Leadership  
1.  Has there been a person or persons in your clinic who were especially important to 
implementing mPATH for patients? What was this person’s role(s) in the medical center (or 
your practice)? Probe:  administrative staff, nurses, physician, practice manager. 
 
2. What made this person(s) particularly important in the implementation of mPATH?  
 
3. In what ways did you or did you not have the support of clinic leadership for implementing 
mPATH? 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 65 of 71 
*** Confidential *** 
 
G. Implementation Construct:  Scale-Up/Dissemination  
We are very interested in your thoughts about other clinics implementing mPATH into 
routine care  
1. What would you tell another clinic if they were thinking about implementing mPATH?  
 
2. If it were up to you, would you keep using mPATH after the study ends?  Probe: Tell me 
more about why/why not.  
Wrap-Up: 
Is there anything else we should know about implementing mPATH that we haven’t already 
discussed, or any suggestions you have for the program?  
Thank you very much for your time and commitment to the mPATH study. 
Key Informant Interview Guide: Clinical Personnel & Practice Managers 
Follow-Up Semi-Structured Interviews for Sites With Very Low mPATH Usage 
 
A. [High & Low Touch] I would like to start by asking you some general questions about you and your clinic and 
then we will discuss what made it easy and what made it difficult to implement mPATH in your clinic. 
 
1. What is your name (as a reminder, we won’t include your name in the transcript we use 
for analysis)?  
 
2. How long have you worked at this clinic? [if new]  
 
3. What is your role in this clinic? [if new interviewee]. Has your role changed since the last 
time we spoke? [if previous interviewee] 
B.  Construct:  Impact of mPATH on Universal Screening and CRC screening 
Now I would like to ask you some questions about the universal screening questions that 
Wake Forest mandates all clinics ask on a routine basis, which include questions about 
depression, falls in older adults, and household violence or abuse.  
  
1. How are patients screened for these risk factors (Probes:  at check-in via a paper-based 
self-completed screener, asking patients directly, using other tablet based screening)?  
Did 
you 
play 
any 
role 
in 
screening 
patients? 
 
If 
yes, 
explain. 
 
2. How did mPATH affect your ability to gather this information on a routine basis?  (Probe 
for positive and negative attributes). 
 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 66 of 71 
*** Confidential *** 
3. What are the advantages and disadvantages of using tablet based screening for 
identifying these risk factors? 
 
 
Now I want to ask you a question about screening for colon cancer.  
 
4. What role do you play (if any) in helping identify patients who are due for CRC screening? 
(for providers and nursing staff only) 
 
C. Construct:  Barriers/Facilitators (appropriateness, workflow)  
 
1. In your opinion, is your clinic an appropriate setting for mPATH? Probe: Can you tell me 
more about that (why ‘yes’ or ‘no’)  
 
2. How could your clinic modify its workflow to accommodate mPATH?  
 
a. Do you have recommendations on implementation to minimize workflow 
disruption?  If yes, in what way. 
 
3. How and to what extent did COVID affect your decision to use/not use mPATH?  
 
4. Are there other factors that made it challenging to implement mPATH in your clinic?   
 
5. Why did your practice stop using mPATH?     
 
E. Construct:  Resources /Training 
1. What resources were needed from your clinic to implement mPATH? Resources could 
include personnel, space, materials, time, etc. 
 
2.  The research team offered several strategies to enhance mPATH implementation.  We 
value your feedback on how effective or ineffective these strategies were? 
High & Low Touch: 
• In-person training (High & Low Touch) 
• Technical support by phone or email 
 
3.  What additional support could we have provided to help you implement mPATH?  
 
F. Construct:  Program Champion & Leadership  
1. What person or persons would play an important role if you chose to implement mPATH? 
Were there individuals who were especially opposed to implementing mPATH?  
 
2. What made this person(s) particularly important in the implementation of mPATH? (probe: 
or to the reason it wasn’t implemented?)  

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 67 of 71 
*** Confidential *** 
 
3. In what ways did you or did you not have the support of clinic leadership for implementing 
mPATH? 
 
G. Implementation Construct:  Scale-Up/Dissemination  
We are very interested in your thoughts about other clinics implementing mPATH into 
routine care  
1. What would you tell another clinic if they were thinking about implementing mPATH?  
 
2. If it were up to you, would you use mPATH in the future? Probe: Tell me more about 
why/why not.  
Wrap-Up: 
Is there anything else we should know about implementing mPATH that we haven’t already 
discussed, or any suggestions you have for the program? 
Thank you very much for your time and commitment to the mPATH study. 
 
 
 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 68 of 71 
*** Confidential *** 
 
 
Appendix D – Effect of mPATH on Screening for Depression, Fall Risk, and 
Safety 
 
Wake Forest policy requires primary care clinics to screen patients aged 18 and older for 
depression, fall risk, and safety at home at each provider visit. Nursing staff conduct this 
screening during the rooming process by asking patients standardized questions and recording 
their responses in the electronic health record. 
 
We designed mPATH to save staff time by having patients answer these same screening 
items on an iPad and then transmitting their answers to WakeOne. It is possible that mPATH 
will increase detection of depression, fall risk, and safety concerns because: 1) mPATH 
systematically asks these screening items of all patients, and 2) patients may feel more 
comfortable answering these items in an iPad survey than during an in-person interview. 
 
To determine the effect of mPATH on the performance of this screening, we will examine a 
limited use dataset comparing the 2 months before a clinic started using mPATH to the 2 
months after the clinic began using mPATH. Because clinics may need some time to fully 
adopt mPATH, we will exclude the first two weeks following the launch of mPATH. 
 
Study Population 
We will create a limited use dataset containing patients who are seen in one of the first six 
Wake Forest Baptist Health primary care clinics that are participating in the mPATH 
Effectiveness and Implementation trial. 
 
Patient inclusion criteria: 
• Age 18 or older 
• Completed a provider visit at the study clinic during the 60 days prior to the clinic 
launching the mPATH program (the “pre” time period), or completed a provider visit at 
the study clinic during days 14 – 73 after the launch of mPATH (the “post” time period) 
• Have a preferred language of English or Spanish 
 
Patient exclusion criteria: 
• Requiring a language interpreter for a language other than Spanish 
 
Experimental Methods 
The limited use dataset will contain the following data elements for each completed patient 
visit: 
• Date of clinic visit (where each date is indicated by a number relative to the clinic’s 
Launch Date)  
• Clinic (designated by a unique study clinic identifier) 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 69 of 71 
*** Confidential *** 
• Type of visit completed (for example, new patient visit, return patient visit, annual exam) 
• Patient age 
• Patient gender 
• Patient race/ethnicity 
• Patient primary insurance 
• Nursing staff who roomed the patient (designated by a unique study identifier) 
• Whether patient used mPATH-CheckIn program (Y/N) 
• Whether nursing staff used mPATH Nursing Module to transmit mPATH data to 
WakeOne (Y/N) 
• Whether patient has a diagnosis of depression in the problem list in the EHR (Y/N) 
• Whether patient has an antidepressant medication listed in the active medication list 
(Y/N) 
• Results of depression screening items 
• Results of fall risk screening items 
• Results of safety at home screening items 
 
The study dataset will be maintained using the procedures outlined in Section 8.0 
(Confidentiality and Privacy). Of note, we are taking the following additional safeguards to 
further protect patient confidentiality: 
1. Dates of clinic visits will be designated using numbers relative to each clinic’s launch 
date, rather than using the actual date 
2. Clinics will be designated with a unique study clinic identifier instead of clinic name 
3. Nursing staff will be designated with a unique study identifier instead of actual name 
 
Definition of Time Periods 
• The day a clinic  launches mPATH will be designated as that clinic’s Day 0 
• The “pre” time period will be Days -60 to -1 (the 60 day period before mPATH Launch) 
• The “post” time period will be days 14 to 73 (the 60 day period commencing 2 weeks 
after mPATH Launch) 
 
Outcome Measures 
Primary outcome: The primary outcome will be the proportion of patients seen in each time 
period (“pre” vs. “post”) who screen positive for depression, fall risk, or safety concerns at 
home. 
 
Secondary outcomes: Secondary outcomes will include the proportion of patients in each time 
period who: 
• Screen positive for depression using the PHQ-2 items. In addition, the outcomes below 
will be assessed: 
o Have a PHQ9 score >14 (indicating moderately severe depression or severe 
depression) 
o Have a PHQ9 score >19 (indicating severe depression) 
o Have a PHQ9 score >14 and are not currently taking a medication for depression 

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
 
 
Protocol version date 2/22/23 
 
 
 
 
Page 70 of 71 
*** Confidential *** 
o Have thoughts of self-harm 
• Screen positive for fall risk at home. In addition, the outcomes below will be assessed: 
o Have fallen in last 6 months  
o Have had a fall with injury 
• Screen positive for safety concerns at home. In addition, the outcome below will be 
assessed: 
o Report that conflicts turn into fights 
 
Analytic plan 
Our primary analysis will compare the proportion of patients seen in the “pre” time period to the 
“post” time period who screen positive for either depression, fall risk, or safety at home. If a 
patient is seen more than once in a given time period, only the patient’s first visit in that time 
period will be included in the analyses. We will estimate the proportion who screen positive for 
each time period and report along with 95% confidence intervals. A chi-square test will be used 
to provide an unadjusted comparison between the “pre” and “post” proportions. Logistic 
regression models will then be used to compare the “pre” and “post” proportions while 
controlling for clinic and patient demographic variables. We will use the same analytic methods 
for our secondary outcomes. We will also conduct a sensitivity analysis for our primary 
outcome where we consider all patients’ visits during a given time period (and not limit 
analyses to a patient’s first visit in the time period only). For this sensitivity analysis, we will 
compare the proportion of patients who meet our primary outcome definition at any visit during 
the “pre” and “post” time periods.   
 
Analytic adjustments due to COVID19 pandemic: Due to the COVID19 pandemic, all practices 
stopped using mPATH in March 2020, which is prior to the closure of the 60-day “post” time 
period for clinics #5 and #6 in our sample. Therefore, we will truncate the “post” time period for 
these two clinics to 30 days. To determine if this truncated time period affected our overall 
results, we will conduct the following sensitivity analyses: (1) limiting the analyses to only the 
first 4 clinics to enroll, and (2) limiting data collection to 30-days post- for all 6 clinics.

EFFECTIVENESS AND IMPLEMENTATION OF MPATH-CRC: A MOBILE HEALTH SYSTEM FOR 
COLORECTAL CANCER SCREENING 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # TBD 
Protocol version date 2/22/23 
Page 71 of 71 
*** Confidential *** 
Appendix E – Data Transfer from non-Wake Forest Health Network Clinics 
The following was the original plan for 
In Wake Forest Health Network clinics, mPATH connects to the electronic health record (EHR) 
to import basic patient demographic data (e.g., patient name, medical record number, age) and 
prior colorectal cancer screening history information to determine if screening is needed. For 
clinics outside of the Wake Forest Health Network, this data will be imported to mPATH using 
secure file transfers. Non-WFHN clinics will upload a weekly flat file using Secure File Transfer 
Protocol to an encrypted, HIPAA-compliant Cloud-based server. The mPATH program will 
process the file, encrypt needed data elements, and then delete the original data file to protect 
data security. Additional data safeguards are outlined in Section 8.0. Formal data use 
agreements will be executed with all participating external sites. The flat file will include the 
following elements for patients who have upcoming scheduled appointments in the clinic(s): 
Patient medical record number 
Patient first name 
Patient middle name 
Patient last name 
Patient date of birth 
Date of last resulted FIT in chart 
Date of last resulted Colonoscopy in chart