Evidence-Based Colorectal Cancer Screening for the Uninsured
Phase: NA
Conditions: Colorectal Cancer
Sponsor: University of Texas Southwestern Medical Center

 
Version 8, June 29, 2015 
 
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The University of Texas Southwestern Medical Center at Dallas 
Institutional Review Board 
 
Title: 
 Evidence Based Colorectal Cancer Screening for the Uninsured 
 
Introduction and Purpose:   
 
Screening reduces colorectal cancer (CRC) incidence and mortality, but participation is low among 
the uninsured, resulting in poor CRC outcomes. Indeed, at John Peter Smith Health System (JPS), 
the safety-net health serving uninsured patients in Tarrant County and Fort Worth, TX, screening 
participation is just 39%, and 63% of CRC patients present with advanced stage cancer.   
 
Through a prior CPRIT Evidence Based Prevention Program, we tested a systematic screening 
outreach strategy for increasing screening completion among uninsured patients, not up-to-date with 
screening. The intervention consisted of mailed screening invitations, with processes such as phone 
reminders to promote screening and follow up. Additionally, patients were randomly assigned to 
receive either mailed invitations to complete a home fecal immunochemical test (FIT) or a 
colonoscopy. We found: 1) 1 in 3 receiving mailed outreach completed screening, and 2) Screening 
completion was twice as high for patients offered the simple, at home FIT compared vs. colonoscopy.  
Thus, we have shown our outreach invitation strategy, particularly when it includes FIT 
invitations, markedly increases screening completion among the uninsured. 
 
Several challenges remain. First, all unscreened patients must be reached. Previously, we invited 
2,080 patients, but JPS has over 20,000 unscreened, uninsured patients. Second, UT Southwestern 
staff previously served as an intermediary between JPS patients and staff by delivering all outreach 
activities, a structure that is not sustainable. Now, program sustainability must be ensured by handing 
outreach delivery over to JPS. Third, while initial participation was highest when FIT was offered, we 
must determine if annual completion rates remain high, because annual testing is required for 
effective FIT screening. Fourth, further innovation is required. Offering modest financial incentives to 
complete screening, beyond offering free tests, may powerfully complement our current outreach 
approach.  Financial incentives have been shown to improve rates of complex behaviors such as 
quitting smoking, but have not been evaluated for improving cancer screening rates.  
 
Specific Aims: We will conduct an Evidence Based CRC Prevention Program, among 
uninsured 50-64 year olds served by the JPS safety-net health system, not up-to-date with 
screening, with the following aims:  
 
Aim 1: Deliver mailed invitations to complete FIT screening to all eligible patients (over 20,000), with 
centralized processes to promote screening completion and evidence based follow up, including 
repeat annual FIT for patients with initial normal FIT.  
 
 
Aim 2: For a randomly assigned subset of 2,000 patients, supplement the mailed outreach invitations 
with modest financial incentives to complete screening with either a $5 or $10 gift card.  
 
Aim 3: Rigorously evaluate program outcomes. We will: 
 
A) Determine screening rate improvement after expanding screening outreach to all unscreened 
patients.  
 
B) Compare rates of initial and repeat screening completion among 1) Patients offered a modest 
financial incentive to complete screening, in addition to outreach invitations, vs. 2) Patients 
offered outreach invitations alone.   

 
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C) Among patients receiving financial incentives to complete screening, compare rates of initial and 
repeat screening completion between patients receiving $5 vs. $10 incentives.  
 
D) Assess all CPRIT required outcomes, including increase in early stage cancer detection from 
baseline, as well as health system changes required to boost screening.  
 
By completing these goals, we expect to reach over 20,000 patients with screening invitations, screen 
over 6,600 patients, and detect 400 patients with CRC or potentially precancerous polyps. 
 
Innovation: We will translate findings from our prior CPRIT program to usual practice by developing 
knowledge and infrastructure required at JPS for successful, sustainable screening outreach. Also, we 
will determine if offering modest financial incentives enhances mailed outreach, further advancing 
prevention knowledge.  
 
Significance and Impact: Locally, we will deliver potentially lifesaving screening invitations to over 
20,000 patients, and create a robust, sustainable CRC screening program poised to markedly 
improve CRC outcomes for uninsured patients in Tarrant County, TX. Statewide and nationally, our 
program will advance cancer prevention knowledge, and serve as a proven, replicable model for 
improving CRC screening for the uninsured.  
 
Background: 
Colorectal cancer (CRC) is an important public health problem in the United States and Texas, 
particularly for the uninsured. CRC is the 2nd leading cause of cancer death in the United States 
and Texas1, 2. Nationwide, 150,000 individuals are diagnosed, and 50,000 individuals die of the 
disease annually2.  Each year, CRC treatment results in over $14 billion in costs nationally, and over 
$3.7 billion in costs for Texas2, 3. Uninsured patients are at particularly high risk for poor CRC 
outcomes. Uninsured patients are more likely to present with advanced stage CRC, and have worse 
stage-specific survival than other groups4. At John Peter Smith Health System (JPS), the main safety 
net health system providing care to uninsured patients in Fort Worth and Tarrant County, Texas, 63% 
of patients with CRC have advanced stage at presentation. Overall, it is clear that CRC is an 
important public health problem, particularly for the uninsured.  
 
CRC screening with fecal occult blood tests, sigmoidoscopy, or colonoscopy can save lives. 
Randomized controlled trials have shown that screening with fecal occult blood tests (FOBT) or 
sigmoidoscopy reduces CRC incidence and mortality5-9. Observational studies have demonstrated 
similar results for colonoscopy10-12. As a result, the US Preventive Services Task Force and the 
American Cancer Society have endorsed CRC screening for all individuals beginning at age 50 
years13, 14.  The US Preventive Services Task Force does not endorse one test over others because 
modeling studies suggest that regular screening with fecal occult blood testing, sigmoidoscopy, or 
colonoscopy results in similar outcomes14-17. Because FOBT, sigmoidoscopy, and colonoscopy all 
appear to reduce CRC mortality, and because it is uncertain whether any one test is better than 
others, many support the idea that “the best CRC screening test is the one that gets done17.” 
 
CRC screening participation is suboptimal, 
particularly for uninsured patients age 50-
64 years and minorities. National Health 
Interview Survey data show that screening 
participation, defined as being up-to-date with 
stool occult blood, sigmoidoscopy, or 
colonoscopy testing, was 55% for all 
individuals aged 50 to 75 years in 200818. 
Marked variation in screening was noted by 
race/ethnicity. Screening rates were 51% for Blacks and 39% for Hispanics, compared to 57% for 
Table 1. Baseline screening rates among uninsured JPS connection 
patients age 50 to 64 seen >1 time in a primary care clinic in 2011 
 
n 
Not Up-to-Date with 
Screening, n 
Screening 
Rate 
All patients 
16,905 
10319 
39% 
Race/ethnicity 
White 
6,187 
4081 
34% 
Black 
3,968 
2386 
40% 
Hispanic 
4,774 
2745 
43% 
Other 
1,976 
1107 
44% 

 
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Whites. Most strikingly, uninsured 50 to 64 year olds had the lowest rate of screening participation, at 
just 20%, markedly lower than the 55% screening rate noted for insured patients age 50 to 64.  Data 
from JPS has also shown low screening rates of among uninsured 50 to 64 year olds19. Currently, just 
39% of uninsured 50 to 64 year olds seen regularly in a primary care clinic are up-to-date with 
screening (Table 1).  
 
Our prior CPRIT-sponsored Evidence Based Prevention Program demonstrated that screening 
rates for the uninsured and minorities can be dramatically improved through screening 
outreach.  The goals of our prior program were to deliver CRC screening invitations to 2,080 patients, 
determine if an organized outreach invitation strategy to complete screening boosted screening 
compared to usual care, and determine if screening completion was higher when stool occult blood 
testing with fecal immunochemical test (FIT) versus colonoscopy screening were offered. The 
program was set at JPS, a safety-net health system that serves a large, very diverse group of 
uninsured patients. We identified 5,994 uninsured patients, age 54 to 64 years, not up-to-date with 
CRC screening, and randomly assigned them to one of three screening strategies: usual care 
(n=3914 patients), organized invitation to FIT screening (n=1600 patients), and organized invitation to 
colonoscopy screening (n=480 patients). Organized outreach consisted of a mailed invitation to 
complete screening, information regarding the importance of screening, and, for the FIT group, a FIT 
kit. Patients assigned to the FIT and colonoscopy screening strategies also received processes to 
promote screening completion consisting of 2 automated and up to 2 “live” telephone reminders to 
complete screening, navigation to colonoscopy for screening or diagnostic purposes, and results 
reporting. Program processes were developed in close collaboration with clinical service providers at 
JPS such as the GI lab. The tracking database used to prompt and track outreach activities was 
developed and pretested at UT Southwestern. 
 
The design of our screening outreach approach was heavily based on recommendations from 
the Task Force on Community Preventive Services as well as prior evidence.  The Task Force 
previously recommended that cancer control programs use a multi-pronged approach to improve 
community demand for and access to cancer screening20. Recommendations included: 1) Use of 
client reminders, such as mailings advising patients that they are due for screening, 2) Use of small 
media, such as informational letters on importance of screening, 3) Reduction of structural barriers to 
screening, such as making screening more convenient, and eliminating complex administrative 
procedures and need for multiple clinic visits. Several lines of evidence support these 
recommendations. First,  a systematic review of approaches to improving screening delivery 
demonstrated that using organized, system-level solutions to improving screening delivery were 17 
times more likely to be successful than no intervention21.  Second, prior published work has shown 
that mailed invitation to CRC screening, including informational material about screening and a guaiac 
FOBT kit can increase screening by 12 to 23%22-24.  Third, it has been previously noted that phone 
reminders may increase screening participation by an additional 10-20%25. Fourth, reducing structural 
barriers to screening completion by simplifying processes for screening referral has been shown to 
improve screening CRC screening; most interventions in this area have consisted of mailed invitation 
to complete screening with a stool occult blood test26-31. Thus, the design of our prior outreach 
approach followed Task Force recommendations and was supported by multiple lines of evidence. 
Nonetheless, at the time we started our prior CPRIT prevention program, it was unclear whether this 
approach would be effective in a safety net setting among uninsured patients, and whether organized 
outreach would be most effective with invitation to complete FIT vs. colonoscopy screening.    
 
Results show our outreach approach successfully boosted screening among the uninsured 
(Table 2):  
Table 2. Outcomes of prior CPRIT sponsored Evidence Based 
Prevention Program among patients receiving outreach invitations 
after 12 months (n=2080) 

 
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• Strikingly, 29% of patients receiving 
organized outreach completed 
screening within one year. All these 
patients were not up-to-date with screening 
at baseline, despite being age-eligible for 
screening, and having access to care 
through JPS’ medical assistance program 
for the uninsured. Results of comparisons 
of the intervention group to the usual care 
group not receiving organized outreach 
were subject of ongoing statistical analyses at time of this grant submission.   
• 4 patients with CRCs, and 60 patients with one or more adenomas have been identified. 
Therefore, our outreach approach has successfully identified patients with CRCs and potentially 
precancerous polyps.   
• The rate of screening completion was two times higher for patients invited to FIT vs. 
colonoscopy screening. 33% of patients assigned to the FIT invitation completed screening, 
compared to 14% of patients assigned to the colonoscopy invitation, a 19% absolute difference in 
screening completion rates. These data demonstrate that screening rates are highly dependent on 
which screening test is offered. Because test participation in any test is likely to be more closely 
associated with positive CRC outcomes than which screening test type is completed, our 
preliminary data support future mailed outreach invitations with FIT, rather than colonoscopy 
(Table 2).  Accordingly, in our expanded outreach program, we will invite patients to complete FIT 
screening, and use colonoscopy to follow up patients with abnormal tests. This approach has the 
added advantage of allowing us to offer organized outreach invitations to all eligible uninsured 
patients not up-to-date with screening (over 20,000), whereas with a colonoscopy based approach 
we could only offer screening to a small subset of patients due to budget and colonoscopy 
capacity constraints.   
 
CHALLENGES REMAINING DESPITE PRIOR CPRIT PROGRAM SUCCESS 
We must expand this organized outreach program to all uninsured individuals age 50 to 64 not 
up-to-date with screening at our safety-net health system. We have extracted health system 
encounter data for all patients age 50 to 64 seen >1 times in a primary care setting in 2011 who 
participate in JPS’ medical assistance program for the uninsured. Out of 16,905 patients meeting 
these criteria, 6,586—39%—are up-to-date with screening, defined by having an FOBT in the last 
year, sigmoidoscopy within 5 years, or colonoscopy within 10 years (Table 1). Thus, as of 2011, 
10,319 patients need screening.  Screening rates are suboptimal among all major racial/ethnic groups 
(Table 1). Our prior CPRIT program delivered screening invitations to 2,080 patients, a much smaller 
group, and limited invitations to patients age 54 to 64. Now that our outreach program has been 
developed and shown to substantially boost screening, we need to expand outreach to all eligible 
individuals. 
 
To enable sustainability of program activities, primary responsibility for screening outreach 
delivery must be transferred from UT Southwestern to JPS staff, and JPS must be equipped to 
run the outreach program. Previously, all screening outreach was delivered by UT Southwestern 
personnel. Specifically, a UT Southwestern Moncrief Cancer Institute nurse manager, and a UT 
Southwestern medical assistant created and mailed all invitations, made all reminder phone calls, 
delivered all testing results, arranged all follow up colonoscopy tests for patients requiring 
colonoscopy, and managed our screening tracking database. All UT Southwestern personnel were 
supervised on a day to day basis by a gastroenterologist and clinical researcher at UT Southwestern.  
Because the colonoscopy tests and all pre and post colonoscopy visits were conducted at JPS, this 
work required close interfaces with the JPS clinics and gastrointestinal endoscopy laboratory, as well 
as intermittent consultation with two JPS primary care physicians who were key physician champions 
of our program. This meant that UT Southwestern in effect served as an intermediary between JPS 
patients and JPS staff, and also worked through JPS physician champions to mediate any challenges 
Group 
Invited, 
n 
Completed 
Screening, n 
Screening 
Completion Rate 
All Outreach 
Patients 
2080 
601 
29% 
FIT 
1600 
532 
33% 
Colonoscopy 
480 
69 
14% 

 
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that came up during interfaces with JPS staff.  Having an intermediary between JPS patients and JPS 
is not the ideal way to deliver screening because it sometimes lead to back and forth phone calls, at 
times leading to delays in care, and more importantly, because it is not sustainable. UT Southwestern 
cannot indefinitely commit to serving JPS patients. We propose implementing a much more 
streamlined and sustainable approach, in which JPS staff will deliver all organized outreach. This will 
equip JPS staff to conduct the outreach program, deliver screening more efficiently, and, most 
importantly, set JPS up to sustain the organized outreach program for its patients on an ongoing 
basis. As described in Section F, JPS has the experience, institutional commitment, and resources 
required to successfully take on primary responsibility for all screening outreach activities. The training 
program described in detail below will ensure an effective, sustainable transfer of program activities.  
  
We must also determine if FIT participation rates remain high when screening is offered 
annually. Our prior CPRIT outreach program only offered one-time invitations to complete screening. 
Whether our approach can be successful in prompting repeat participation is unknown. Effective CRC 
screening with stool occult blood tests such as the FIT requires annual testing14, 15.  Prior trials of stool 
occult blood testing only showed substantial reductions in CRC incidence and mortality after several 
years of testing, likely because there are a substantial number of patients who may initially have 
normal tests, but have an abnormal test on repeat testing due to either a new cancer or a cancer that 
was missed by the initial stool occult blood test screen32.  
 
Though repeat testing is important, there are limited “real world” data outside of clinical trials on rates 
of repeat stool occult blood test participation.  A study of a program offering mailed outreach 
invitations to complete stool occult blood test among rural Australians reported 75% of patients initially 
completing a test completed a repeat test the following year33. An integrated health insurance 
program in Washington State serving over 350,000 beneficiaries reported contrasting results34.  Just 
44% of patients who completed an initial stool occult blood test subsequently completed repeat testing 
within 2 years. The report from Australia may conflict with the Washington State health plan for 
several reasons. First, the Australian study reported results from an organized outreach program, in 
which screening was not contingent on a clinic visit, whereas the results from the Washington 
insurance program were based on usual care stool occult blood test use, in which patients were 
offered testing at intermittent primary care visits (e.g. “opportunistic screening”). Second, a large 
number of patients in the Australian report were offered screening with FIT, rather than the guaiac 
stool occult blood tests studied in the Washington state report. FITs require fewer samples, and do 
not require diet restrictions. Prior data clearly demonstrate that initial participation rates in CRC 
screening are much higher with offers to complete FITs, rather than guaiac based stool occult blood 
tests36, 37. Thus, it is plausible that differences between the Australian and Washington reports may be 
due to type of stool occult blood test offered. Fundamental differences in the patient populations may 
also be relevant, though are difficult to assess.  Overall, it is clear that there is a paucity of data on 
whether repeat rates of participation in stool occult blood testing are adequate for longitudinally 
effective screening.  Available data suggest that repeat participation may be variable, and perhaps 
influenced by whether or not repeat testing is offered with the more convenient FIT vs. guaiac-based 
stool occult blood test.  We anticipate that our program, which uses the more convenient FIT and 
organized outreach to encourage repeat testing, may be associated with high rates of repeat 
completion, but this requires formal evaluation. Further, if rates of repeat participation are suboptimal, 
new interventions will need to be developed to supplement our current efforts.  
 
New, innovative, strategies to further improve screening participation are required. Our 
program resulted in screening completion for 29% of patients not up-to-date with screening at 
baseline.  Thus, despite the clear benefit of our outreach strategy, this approach alone will be 
inadequate for achieving optimal rates of screening. Effectiveness of our outreach program may (and 
should) be improved with added interventions. The Task Force on Community Preventive Services 
review of interventions to increase breast, cervical, and colorectal cancer screening recommended 
use of client reminders (e.g. letters alerting patients of need for screening), small media (e.g. letters 

 
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discussing importance of screening), and reducing structural barriers to screening (e.g. making 
screening more convenient)20. As discussed previously, our screening outreach program already 
includes all of these intervention approaches. Thus, further innovation is needed to determine if other 
interventions can serve as adjuncts to approaches currently recommended by the Task Force. 
 
Adding financial incentives to complete screening to mailed outreach invitations is a 
promising strategy for boosting CRC participation.   Client financial incentives for screening are 
“small, noncoercieve rewards (e.g. cash or coupons) to motivate people to seek cancer screening for 
themselves…”20. In its most recent evidence review, the Task Force on Community Preventive 
Services found insufficient evidence to determine effectiveness of financial incentives for increasing 
cancer screening20, 38. Nonetheless, prior data on use of financial incentives for behaviors much more 
challenging to prompt than completing a one-time FIT at home have demonstrated that financial 
incentives can powerfully boost healthy behaviors39-41.  
 
A randomized trial of offering cash financial incentives for completing a smoking cessation program 
and maintaining abstinence from smoking showed an absolute 10% increase in rates of program 
completion and smoking abstinence39. In this study, employees of a multinational company were 
offered quitting information alone, or information plus incentives, including $100 for completing 
smoking cessation education, $250 for abstinence at 6 months, and $400 for abstinence at 12 months 
from enrollment.    
 
More complex financial incentives have been shown to be effective in inducing short term weight 
loss40. A study of 57 obese U.S. Veterans randomly assigned to receive standard weight loss 
counseling, vs. counseling plus addition of one of two financial incentives, found that financial 
incentives were associated with a 40% absolute increase in meeting a goal of 16 pound weight loss at 
16 weeks. The financial incentives consisted of either entry into a lottery for cash, or a deposit 
contract, in which participants were offered the opportunity to deposit cash on a daily basis with the 
chance to earn 1:1 matching return on the investment if they met a pre-specified weight loss goal.   
 
Financial incentives have also been shown to be effective for improving substance abuse disorders.  
A  meta-analysis of 40 studies using financial rewards for promoting abstinence, clinic attendance, 
and/or medication compliance found that financial incentives often increase healthy behaviors 
substantially41. Taken together, prior work suggests that financial incentives may boost participation in 
healthy behaviors.  
 
Financial incentives may be particularly effective for boosting participation in our FIT outreach 
program. Completing a FIT test once a year is much easier than quitting smoking, losing weight, or 
stopping substance abuse. Patients receiving our outreach approach are delivered information on 
CRC screening tailored to their age-specific risk for CRC, and have the FIT kit in their possession. All 
that is required for screening completion is obtaining one non-diet restricted stool sample with a 
simple collection device, and placing the collection vial in a postage paid return envelope. Therefore, it 
seems very possible that offering a financial incentive to complete a FIT may successfully motivate 
patients with positive attitudes toward screening.   
 
Overall, because our outreach program already includes all outreach intervention components 
recommended by the Task Force on Community Preventive Services, and because financial 
incentives show promise for changing health behaviors that are far more complex than 
completing FIT screening, we need to determine whether financial incentives boost CRC 
screening over and above our organized outreach program. Our proposed prevention program 
will determine whether offering financial incentives, in the form of either a $5 or $10 gift card in 
exchange for screening completion, are an effective adjunct to our organized outreach approach.  
 
BACKGROUND SUMMARY. CRC is an important public health problem, particularly for the 
uninsured, who have the lowest screening rates and worst CRC outcomes. Our prior, CPRIT 
sponsored Evidence based Prevention program focused on the uninsured was successful in boosting 

 
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screening participation by 29%. Organized outreach was twice as effective when patients were 
offered FIT vs. colonoscopy screening (33% vs 14%). Our program was highly evidence based and 
successful, but several challenges remain. We must expand our organized outreach to all individuals 
eligible for screening. Program sustainability must be ensured by transferring primary responsibility for 
screening promotion delivery to JPS. We must determine if participation rates remain high when 
screening is offered annually because effective, evidence based FIT screening requires annual test 
completion. Finally, innovation is required. Offering modest financial incentives to complete screening, 
beyond offering free tests, may be a particularly effective adjunct to our current outreach approach.  
The specific aims and outreach approach outlined below have been carefully crafted to leverage the 
screening needs of the uninsured, our prior experience with a successful outreach program, and 
innovative ideas for screening to improve CRC screening to deliver screening and advance evidence 
based screening practice. 
 
 
Concise Summary of Project: 
 
Screening for colorectal cancer (CRC) can lower rates CRC death and even prevent some cancers 
from developing. However, screening rates are low, especially for uninsured patients. As a result, 
uninsured patients are more likely to develop CRC and die. For example, at John Peter Smith Health 
system (JPS), the main health system serving uninsured patients in Tarrant County and Fort Worth, 
Texas, just 39% of uninsured patients served have had screening, and the majority of patients who 
develop CRC have advanced cancer at time of diagnosis.  
 
UT Southwestern and JPS previously received a grant from CPRIT to develop and test a CRC 
outreach program for uninsured patients at JPS. The program sent mailed invitations to complete 
screening to over 2,000 uninsured patients who needed screening. To figure out which screening test 
was most likely to be completed, some patients received a simple, at home kit that checks the stool 
for blood called a fecal immunochemical test (FIT), while others were invited to schedule and 
complete a colonoscopy. All patients received phone calls to encourage screening completion, 
answer questions, and help with scheduling tests and follow up.  
 
The prior program was a big success. At the end of 12 months, 1 in 3 patients who were not up-to-
date with screening at the beginning of the program got screened. Screening was two times higher 
when patients were offered the simple at home FIT compared to when offered a colonoscopy. We 
found 4 patients with CRC, and another 60 patients with potentially precancerous polyps.  
 
Since the program was such a success, we would like to now expand the outreach program to benefit 
all 20,000 uninsured patients at JPS. Also, we need to equip JPS to run the program on its own, so 
that JPS can deliver the program to its patients on an ongoing basis. Because screening with FIT 
needs to be done every year, we need to also expand the program to deliver the outreach invitations 
yearly. Finally, we know that the program can be improved even more. Offering patients a small 
financial reward may help nudge them to complete healthy behaviors.  Therefore, we also plan to see 
if adding a small $5 or $10 reward for screening to our outreach program results in more patients 
completing initial and repeat screening.  
 
As a result of the new program, we will create a sustainable CRC screening outreach program for 
uninsured patients in Tarrant County and Fort Worth, Texas. The program will serve as a model for 
other health systems which care for uninsured patients across Texas and beyond. Also, we may 
discover new ways to convince more patients to be screened that can be used locally and nationally. 
Most importantly, we will offer potentially lifesaving CRC screening to over 20,000 patients, expect 
over 6,600 patients will get screened, and predict we will find 38 patients with CRC and 364 patients 
with potentially precancerous polyps.  
 

 
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Study Procedures: 
Overview: Our program is set at John Peter Smith Health System (JPS), a safety-net health system 
serving Tarrant County, TX. Our prevention program will systematically identify uninsured, 50 to 64 
year old patients, not up-to-date with screening, and deliver over 20,000 organized invitations to 
complete screening with a FIT. Organized outreach will consist of a mailed invitation to complete 
screening, information regarding importance of CRC screening, and a FIT kit. Screening participation 
will be promoted with automated phone reminders before and after invitation delivery, as well “live” 
phone reminders. Guideline appropriate follow up will be delivered, including facilitation of 
colonoscopy for patients with abnormal FITs, and annual repeat FIT invitation for patients with normal 
FITs. To understand impact of offering financial incentives on screening completion, for a subset of 
randomly assigned patients, screening promotion will be supplemented with an additional modest $5 
or $10 gift card incentive for completing screening. 
 
Program Setting. JPS is the primary safety net provider for uninsured patients in Fort Worth and 
Tarrant County, TX. The system consists of 12 community and hospital based primary care clinics, a 
free standing outpatient surgical and endoscopy center, as well as a tertiary care hospital that 
provides surgical, oncologic, and endoscopic services. Annually, over 457,000 encounters are 
delivered. JPS offers a taxpayer subsidized medical assistance program for the uninsured (JPS 
Connection) that facilitates access to primary and specialty care, including surgery and cancer care, 
with low copays. Thus, for uninsured patients, participation in JPS Connection ensures access 
to specialty care if a cancer is diagnosed through screening. JPS has a longstanding history of 
working with UT Southwestern Medical Center to improve health outcomes for JPS patients, including 
successful work on the prior CPRIT sponsored CRC evidence based prevention program outlined 
previously.  
 
JPS Screening Outreach Team. The screening outreach team will be responsible for sending out all 
invitation letters, tracking results, and facilitating follow up for patients with normal and abnormal FIT 
tests. The team will consist of a nurse manager, as well as two medical office assistants who are JPS 
health system employees; at least one will be bilingual. This structure closely resembles the team for 
our prior CPRIT program, which was composed of a nurse manager and a single medical office 
assistant. The team will be directly supervised by Dr. Elizabeth Carter and Dr. Mark Koch. Both Drs. 
Koch and Carter were close collaborators for our prior CPRIT prevention program, and have 
extensive experience with our program procedures. Dr. Carter’s primary responsibilities will include 
leading all administrative aspects of the program. Dr. Koch will manage day to day operations of the 
screening outreach team by helping the team set daily, weekly, and monthly goals. Further, he will 
take a leadership role in coordinating screening activities across JPS primary care clinics and the JPS 
GI lab.  
 
Training in CRC screening knowledge. At the outset of the program, we will conduct a two day, 
small group seminar focused on developing CRC screening knowledge for the 5 outreach team 
members. Topics covered will include: 1) Public health importance of CRC, 2) Basics of why and how 
CRC develops, 3) Evidence to support CRC screening, 4) Screening guidelines, including guidelines 
and rationale for appropriate follow up, and 5) Evidence based approaches to boosting screening. 
Presentations will emphasize the importance of these topics for the uninsured. The presentations will 
be based on available scientific literature, including CRC screening guidelines, results of national 
surveys such as the National Health Interview Survey, and Surveillance Epidemiology and End 
Results and Texas state cancer registry data.  
 
Training in outreach program processes. Training in outreach program processes will be based on 
our previously developed screening outreach program manual, through a separate two day seminar. 
The following topics will be addressed:  
• Process for identifying the screen eligible population. We will teach the screening outreach 
team how to obtain the JPS administrative data required to identifying patients meeting program 
inclusion/exclusion criteria. This will involve working with data managers at JPS who previously 

 
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generated such data for our prior published screening analyses of screening rates at JPS19, 42, and 
our baseline screening data (Table 1).  In order to reach our goal of sending FIT screening 
invitations to the approximate 20,000 patients who meet program eligibility criteria, a maximum of 
40,000 individual patient records will be reviewed by study personnel to obtain the study dataset.  
• Process for importing patient contact data for screen eligible individuals to the tracking 
database. The tracking database has a straightforward data import function that allows for 
importing patient contact data required for program procedures. This function was used to import 
patient data to the tracking database for our prior CPRIT program patients, and thus has been 
previously developed, tested, and implemented. 
• Screening outreach. We will train the outreach team how deliver all of the screening outreach 
processes described in detail below, including mailed invitations and phone reminders.  
• Screening follow up. We will train the outreach team how to conduct all of the guideline 
appropriate follow up described in detail below, including follow up of patients with abnormal FITs.  
• Screening tracking database. Will train the outreach team how to take full advantage of the 
tracking database, which can generate lists of patients requiring follow up (e.g. patients due for 
phone reminders to complete screening), document patient interactions (e.g. delivery of phone 
reminders or documentation of triage for colonoscopy for patients with abnormal tests), and 
document screening outcomes (e.g. FIT test completion, FIT results, and colonoscopy results for 
patients with abnormal tests).  
• Program management. We will work with the team to learn how to set daily, weekly, and monthly 
goals for the screening program. For example, each cohort of patients invited to complete 
screening through a given year has a timeline of events that must occur over a two month period 
that includes invitation delivery, phone reminder delivery within 2 to 3 weeks post invitation, and 
follow up of abnormal tests (described in detail below). Dr. Carter has extensive experience with 
management of other disease management programs, and in developing and implementing 
quality improvement initiatives at JPS. Through his work as a family physician and endoscopist, 
Dr. Koch has extensive experience in leading medical care teams. Thus, the physician champions 
of the program at JPS have the expertise and experience necessary to take on primary program 
management responsibilities.  
  
Approach to Screening Invitation and Promotion 
All patients meeting inclusion/exclusion criteria will receive mailed invitation to complete screening, 
with processes to promote screening completion. The list of eligible patients will be divided into 
multiple groups so that the expected group of 20,000 patients will receive invitations spread out in 
time, so as to avoid overwhelming the system. All screening processes were included in our prior 
CPRIT sponsored outreach program, and therefore are already developed and ready for use. The 
specific components of outreach include:  
 
• Screening invitation letters. These letters were previously developed in English and Spanish and 
pretested as part of our prior CPRIT sponsored CRC outreach program. The letters emphasize 
importance of CRC screening, encourage the patient to complete FIT screening with the enclosed 
FIT kit, and will be signed by Drs. Koch and Carter as representatives of JPS primary care 
physicians. For patients receiving repeat invitations, new English and Spanish letters will be 
developed to emphasize importance of repeat screening for preventing adverse CRC outcomes.  
• FIT kit. The invitation kit will include a 1-sample Polymedco OC Sensor FIT, including simplified 
instructions on how to perform the test, as well as a return mailer with prepaid postage. 
Diet/medication restriction will not be required. Kits will be returned to JPS and processed per 
manufacturer recommendations. A sensitivity threshold for hemoglobin of 50 mg/mL will be set to 
maximize sensitivity for CRC44.  This FIT has been shown to have sensitivity for CRC of over 85%, 
and specificity of over 90%44. Preliminary data from our prior CPRIT outreach program show that 
12% of patients will have an abnormal FIT, and >60% of those completing colonoscopy after 
abnormal FIT will have an adenomatous polyp or cancer detected.    
• Automated and “live” phone call reminders to encourage screening completion. Automated 
messages will be sent at time of invite and within week 1 of the invitation. Up to two “live” phone 

 
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call reminders will be attempted 2 to 3 weeks post invitation, with our English and Spanish standard 
scripts.  
Centralized processes to promote guideline-based follow up. Follow up for patients with a 
normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. This is 
consistent with guideline recommended annual FIT for CRC screening13, 14. Follow up for 
patients with an abnormal FIT will consist of navigation to complete a colonoscopy.  Up to 10% 
of individuals with an abnormal FIT have a colon cancer, and up to 50% may have a potentially 
precancerous polyp44, 45. Thus, colonoscopy follow up is imperative. Patients with abnormal FIT 
will be called by the screening team within 1 week to report the result and facilitate direct 
scheduling of colonoscopy or a pre-colonoscopy visit.  During their pre-colonoscopy visit 
patients will receive a Gatorade Bowel Prep kit with instructions on how to prepare for their 
colonoscopy.  If colonoscopy scheduling is delayed, there is a possibility that the Dulcolax 
tablets in prep kits may expire.  Expiration dates will be monitored by the study team.  In the 
event tablets will reach expiration before a scheduled colonoscopy, the patient will be mailed a 
letter with replacement tablets.  The goal will be to schedule colonoscopies within 12 weeks of 
the abnormal FIT. In our prior outreach program, all patients willing to have their colonoscopies 
done within 12 weeks were accommodated, most within a much shorter period of time. Patients 
who do not keep their scheduled pre-colonoscopy or post-colonoscopy appointment will be 
contacted by phone to reschedule their missed visit.  Patients who the study team are unable to 
contact by phone will be mailed a “No-Show” letter asking them to call the JPS clinic to 
reschedule their appointment.  Similarly, patients who do not keep their scheduled colonoscopy 
will be contacted by phone to reschedule their colonoscopy.  Those patients that the team is 
unable to contact by phone will be mailed a “No-Show” letter asking them to contact the JPS 
clinic to reschedule their colonoscopy.  After multiple attempts to reach No-Show patients by 
phone and certified letter, a final letter will be mailed to them.  The letter informs patients that 
this is the final attempt to remind them that they had an abnormal FIT and to contact the JPS 
staff to schedule an appointment for further evaluation, possibly with colonoscopy.  All three 
letters will be on JPS letterhead signed by Dr Koch and include a contact phone number for the 
study team.   
Follow up of patients with a CRC will consist of navigation to first treatment consultation visit. 
We will arrange for a surgery or oncology clinic follow up for all patients with a CRC diagnosis if 
such follow up is not already scheduled by the colonoscopist who diagnosed the CRC. These 
calls will be made daily for up to one week. The goal will be to have a first treatment 
consultation visit within 2 weeks of CRC diagnosis. Patients will be reminded of these visits 5 
days and 1 day prior to the scheduled appointment. All results/recommendations will also be 
sent to the patient via mail, and to the patient’s primary provider within 1 week of the result.  
 
Financial incentives.  
A group of 2,000 individuals will be randomly assigned to receive a modest financial 
incentive to complete screening, in addition to the organized outreach program. The 
incentive will be sent in exchange for screening completion. Incentives will be sent to a subset of 
patients, rather than all patients included in the screening outreach program for two main reasons. 
First, it is unknown whether offering financial incentives results in meaningful increases in 
screening participation. By selecting a subset, rather than all patients to receive financial 
incentives, we will be able to determine if offering financial incentives, in addition to the current 
program, is more effective for promoting screening than outreach invitations alone. Evaluating 
impact of incentives as an adjunct to organized screening outreach for promoting CRC screening 
will address the lack of evidence on impact of incentives highlighted by the Task Force on 
Community Preventive Services20. Second, budget constraints preclude offering incentives to all 
patients. To randomly assign the 2,000 individuals who will receive the financial incentive, we will 
use SAS procedures. The rationale for choosing 2,000 individuals to receive incentives is 
discussed in below.  To determine whether offering a $10 vs. $5 incentive results in substantially 

 
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higher screening completion, 1,000 patients will receive an incentive for $5, and 1,000 patients will 
receive the $10 incentive offer. 
 
The incentive will consist of either a $5 or $10 gift card to a local retailer that will be sent to the 
patient upon return of an FIT kit. Incentives will be mailed by the JPS outreach team, in exchange 
for successful FIT completion, after the FIT has been returned. $5 and $10 incentives were chosen for 
several reasons. First, these levels of incentives, if shown effective, could be potentially sustained by 
the JPS system beyond the timeframe of the grant. Higher incentives, while potentially more powerful 
in inducing participation, would be unsustainable and therefore do not merit study at this time. 
Comparing $5 and $10 incentives is important because if offering incentives is effective in boosting 
screening, it is important to know the minimum incentive required for meaningful changes in 
participation. Incentives are to be offered to all patients who are assigned to the incentive strategy. 
We considered, but rejected, restricting incentives to only patients who initially do not respond to 
screening invitations. This was because restricting incentives to non-responders would logistically 
complicate outreach activities. It is important to note that patients meeting study inclusion criteria must 
have a minimum of 1 visit to a JPS Primary Care clinic within the last year.  Considering these 
patients have an established baseline relationship with the JPS primary care system, the addition of a 
modest financial incentive should not create undue influence in patients that otherwise would still have 
exposure to information on the benefit of screening.   Since participation in this standard of care 
screening poses minimal to no risk, the chances that incentives may motivate research participants to 
take unnecessary risks are low.   
 
Screening Completion Follow Up. Follow up for determining screening completion for all 
included patients will be through the end of Year 3 regardless of whether or not patients respond 
to screening invitations. As is explained below, screening rates will be measured for all patients 
included for outreach invitations. For patients who die on follow up or who do not have additional 
health system encounters, follow up will be censored at time of death or last health encounter, 
respectively.  
 
Data Sources and Data Tracking. Our approaches to data acquisition, as well as data tracking have 
been previously developed and previously used to evaluate CRC screening rates and deliver 
screening. The primary data source used to identify patients eligible for our outreach program will be 
JPS administrative claims database and Epic electronic medical record. At baseline, these data will be 
queried to identify all 50 to 64 year old patients potentially eligible for program inclusion. Demographic 
data, such as sex and race/ethnicity, as well as visit data, such as dates of any health system visits 
and any associated CPT codes with health system visits will be extracted and analyzed to determine 
which patients are eligible and up-to-date with screening. Data required for inviting patients to 
screening and tracking follow up, such as names and addresses, will be imported into a tracking 
database that has been previously developed and tested for this purpose. The tracking database 
facilitates all day to day program activities and associated data collection. For example, daily, a report 
is generated of patients who have been mailed FIT, and are due for follow up phone reminders to 
complete the FIT and return it. The database also allows for updating patient results, such as results 
of FIT and colonoscopy tests.   
 
Sub-Study Procedures:  
A sub-study will be conducted with the goal of identifying strategies that may further increase rates of 
1) initial participation in colorectal cancer screening, and 2) follow up of abnormal colorectal cancer 
screening tests with colonoscopy.  This sub-study involves 2 parts: 
 
Part 1) Participants scheduled to receive mailed fecal immunochemical test (FIT) outreach for the first 
time late in the 2nd year of the study (currently ongoing) will be randomly assigned to receive one of 
three invitation letters, which vary slightly from one another. These letters represent small, but 
potentially impactful modifications to our original invitation letters.   
 
All participants randomized to the original $5 and $10 incentive groups were enrolled during Year 1 of 
the study.  After the incentive groups reached full enrollment, all new participants received the 

 
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standard (non-incentive) invitation only.  For the sub-study, the standard invitation letter will be 
replaced with one of the 3 modified letters.  All new participants will be randomized to receive one of 
the 3 letters during 2 predetermined rounds of invitations (involving n=2,124 individuals).         
 
Rationale and plan for sub-study part 1: Over nearly 2 years of our prevention program, we have 
tested a systematic screening outreach strategy for increasing screening completion among 
uninsured patients, not up to date with screening.  Through these carefully evaluated interventions, 
we have shown that our outreach invitation strategy, particularly when it includes FIT invitations, 
markedly increases screening completion among the uninsured. Indeed 36% of individuals invited to 
complete FIT return the test. While this rate of participation is substantial, it may be improved by 
making changes to our invitation letters.  In 2 predetermined rounds of invitations (involving n=2,124 
individuals), we will slightly modify the invitation letters to test our hypothesis that providing 
information in the letter about the value of the kit and attenuating concern about future cost will further 
increase FIT and follow-up response rates.   
 
There will be 3 conditions for the invitation letter and individuals will be randomly assigned 1:1:1 to 
each condition.  The 3 conditions contain just slight differences in the information provided in the 
letter, as follows: (i) a control invitation letter (similar to letters in previous studies with some slight 
wording and grammatical improvements, (ii) the control letter plus the addition of one line informing 
recipients of the average value of the procedure (~$200), and (iii) a letter with the average value and 
a sentence assuring patients that should a follow-up test be requested, it will be provided free of 
charge.   
 
The addition of this pragmatic trial to the ongoing prevention program provides no additional risk to 
individuals and will allow us to assess a hypothesis that will contribute to our success in increasing 
screening completion rates among this population. From a statistical standpoint, assuming a control 
invitation letter response rate of 36% with the planned sample size of n=708 per group, we will have 
over 80% power to detect absolute increases of >8% between the control invitation and the first 
alternate letter, as well as between the control invitation and the second alternate letter, assuming 
two-sided alpha=0.125 for each comparison. 
 
Part 2): In part 2 of the sub-study, participants will receive their FIT responses in either a white 
envelope (normal results, no immediate follow-up necessary) or a red envelope (positive result, need 
to follow-up with doctor). The only change to this portion of the study is the color of the envelope 
patients receive.  
 
Rationale and plan for part 2: With our current program, the rate of follow up to diagnostic 
colonoscopy after an abnormal FIT is 58%. Since indivdiuals with abnormal FIT have an increased 
chance of having colorectal cancer, identifying alternate strategies to improve compliance with 
diagnostic colonoscopy is desirable. Accordingly, we propose to employ a simple alerting tactic 
through the color of the envelope (red for abnormal and white for normal). We hypothesize that more 
people will follow-up after receiving a positive FIT result as a result of the messaging importance of 
abnormal tests with a red envelope.  Because these changes will be employed in 2 predetermined 
rounds of invitations, we will have the opportunity to conduct an pre-post analysis of the follow-up 
rates to test our hypothesis that this alerting tactic will increase follow-up rates. From a statistical 
standpoint, pre-intervention, we assume there are at least 329 individuals with abnormal FIT, and that 
58% (n=191) complete diagnostic colonoscopy. Post modification, we expect a minimum 107 patients 
with abnormal FIT. With these sample sizes, assuming two-sided alpha=0.05, we will have 80% 
power to detect a difference post intervention of >14.9%. 
 
Change in risks to participants 
The sub-study does not substantially change risks to study participants. Accordingly, no change to our 
process for recruitment or waiver of informed consent for invitation is proposed. 

 
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13 
 
 
 
Criteria for Inclusion of Subjects: 
Uninsured patients not up-to-date with CRC screening meeting the following criteria will be 
included:  
• Age 50-64. This age group is at highest risk for screening non completion. Patients younger than 
age 50 will be excluded because screening is not routinely recommended for patients under 50. 
Patients older than 64 will be excluded because most of these patients would have screening 
access through Medicare insurance.  
• Uninsured, but participants in JPS’s medical assistance program for the uninsured. 
Uninsured patients have the lowest rates of screening participation, and therefore are most likely 
to benefit from screening outreach. Selecting patients who are uninsured, but enrolled in 
JPS’s medical assistance program for the uninsured will ensure that any patient found to 
have a cancer or unresectable polyp will have access to surgical and/or medical oncology 
services.  This is critical, because CPRIT funds do not allow for cancer care; offering screening 
without a system to care for patients with cancer would be unethical.  
• One or more visits to a JPS primary care clinic within a year. This criterion establishes that 
patients have a baseline relationship with the JPS primary care system.  
• Not up-to-date with colorectal 
cancer screening. We will apply 
National Committee on Quality 
Assurance Healthcare 
Effectiveness Data and Information 
Set (HEDIS) criteria to determine if 
patients are up-to-date with 
screening, defined by having had a 
colonoscopy within 10 years, a 
fecal occult blood test within one 
year, or a sigmoidoscopy within 5 
years43. HEDIS criteria allow for using administrative claims data, including Current Procedural 
Terminology (CPT), International Classification of Diseases-9 (ICD9), and Health Care Common 
Procedure Coding System (HCPCS) codes to determine whether patients have had CRC 
screening tests.  Logical Observation Identifiers Names and Codes (LOINC) will not be used 
because these are not routinely used within the JPS system. 
• HEDIS criteria were selected because these are standardized criteria that the National 
Committee on Quality Assurance uses to compare rates of CRC screening across different 
insurance carriers. The criteria are clear, and widely available, and using these criteria will 
improve generalizability of our program procedures.  In prior published analyses, we previously 
demonstrated ability to determine screening rates and identify patients not up to data using a 
similar approach, and validated the approach for this purpose19, 42. Table 3 shows codes that will 
be used to assess whether patients are screening up-to-date.  
 
 
Criteria for Exclusion of Subjects: 
Patients with a history of CRC or colon resection, no address and/or phone number on file, or 
who are incarcerated will be excluded. Patients with history of CRC/colon resection will be 
excluded because they require specialized screening, usually with colonoscopy. Addresses and 
phone numbers are required to deliver outreach. Incarcerated patients will be excluded because they 
cannot keep FIT kits in their cells. 
 
Once included, patients will remain in the program unless they no longer meet age criteria.   
Patients in both the standard (non-incentive) and incentive invitation groups who do not 
respond to initial invitation will be followed for screening outcomes, but will not receive repeat 
Table 3: HEDIS codes used to measure CRC Screening 
Description 
CPT 
HCPCS 
ICD-9-CM 
Procedure 
FOBT/FIT   
82270, 82274 
G0328, G0394
 
Sigmoidoscopy
45330-45335,45337-
45342,45345 
G0104 
45.24 
Colonoscopy 
44388-44394,44397, 45355, 
45378-45387, 45391, 45392 G0105, G0121
45.22, 45.23, 
45.25, 45.42, 
45.43 

 
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14 
 
invitations. Through the program period, we expect that some patients will no longer participate in 
the JPS connection program, or not see a primary care provider within a year. We considered 
excluding these patients in subsequent years, but decided against this. Many of these patients remain 
uninsured, and if they were to develop late stage CRC, would present to JPS for treatment.  We 
anticipate that most of these patients would then again access the JPS medical assistance program 
for the uninsured as well as primary care clinics, because JPS is the main safety-net health system for 
uninsured patients in Tarrant County and Fort Worth, TX.  Continuing screening outreach will 
potentially allow for boosting detection of such patients when their CRCs are early, rather than late 
stage.  
 
Additional patients will be assessed for inclusion/exclusion criteria annually in Years 2 and 3 
of the program. Each year, patients who newly meet our inclusion/exclusion criteria will be included 
in the program. For example, patients newly turning 50 in year 2 or 3 meeting all other 
inclusion/exclusion criteria will receive screening outreach. Similarly, a 60 year old patient new to the 
JPS system and meeting inclusion/exclusion criteria will also receive screening outreach. We think 
this approach reflects the ideal implementation of a standing CRC outreach program. 
 
Sources of Research Material: 
 
There are several sources of research material for this project:  
 
• 
Administrative and electronic medical record databases at JPS. These data systems will 
be used to identify patients meeting inclusion/exclusion criteria, and to record outcomes of 
screening invitation.  
• 
Results of fecal immunochemical tests (FIT). Patients will be invited to complete screening 
with a one-sample FIT. These kits will be processed by the JPS clinical lab, and the results will 
be recorded in the electronic medical record. Results of testing, including whether the test was 
abnormal or normal, and the level of hemoglobin present in the sample, will be collected 
• 
JPS cancer registry. This resource will be accessed to identify patients enrolled in the 
screening program who develop CRC during the follow up time frame.   
• 
Study tracking database. This database will record in real-time delivery of all screening 
interventions, and outcomes of the interventions. In addition, process variables, such as time 
spent on phone with patients, failed mailings due to wrong address will be collected. The study 
tracking database has been created for exclusive use by screening program personnel.  
• 
Interviews of JPS personnel who will be conducting outreach interventions. The purpose 
of these interviews will be to understand the challenges to implementation of the outreach 
program within the health system.  
 
 
A complete list of variables to be abstracted, including justification for variables, is in the table below.  
Variable 
Justification 
Source 
Baseline characteristics and eligibility criteria 
first name, last name 
Required for delivery of 
screening invitations 
JPS administrative and 
electronic medical record 
databases 
date of birth 
Required for eligibility criteria 
Sex 
Screening rates can differ by 
sex 
Race/ethnicity 
Screening rates may differ by 
race/ethnicity 
Primary language 
Use to identify preferred 
language for study interventions 
Home address 
Required for screening 
invitations 

 
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15 
 
Telephone numbers 
Required for screening 
invitations 
Prior history of CRC 
Required for eligibility criteria 
Prior history of CRC resection 
Required for eligibility criteria 
Past exposure to CRC 
screening tests, including 
colonoscopy, sigmoidoscopy, 
fecal occult blood tests, and 
barium enema 
Required for eligibility criteria 
Insurance type 
Required for eligibility criteria 
Incarceration status 
If currently incarcerated, not 
eligible for study 
Screening Outcomes 
Incident CRC 
Key outcome 
JPS administrative and 
electronic medical record 
databases, pathology records, 
cancer registry data 
Stage of incident CRC 
Key outcome 
Date of incident CRC 
 
Treatment for incident CRC 
 
Incident colorectal polyps 
Key outcome 
Size of incident polyps 
 
Histology of incident polyps 
 
number of incident polyps 
 
Completion of CRC screening 
tests, including colonoscopy, 
FIT, fecal occult blood testing, 
barium enema, or 
sigmoidoscopy 
 
Date of completion of CRC 
screening tests 
 
Results of CRC screening tests 
 
 
Screening Process Variables/Outcomes 
Number and duration of phone 
calls 
 
Program tracking database 
Failed mailings 
 
Wrong phone numbers 
 
 
Recruitment Methods and Consenting Process: 
Recruitment Methods: 
Our goal is to recruit all patients who are not up to date with CRC screening, and meeting all of the 
inclusion/exclusion criteria above, for screening interventions. Recruitment will occur with the 
following steps:  
a) The administrative and electronic medical record databases at JPS will be used to identify 
patients age 50 to 64, with at least one primary care visit in the one year period prior to the 
data pull, who are participants in the JPS Connection medical assistance program for the 
uninsured. We anticipate that up to 40,000 records may be pulled for this step.  
b) Study inclusion/exclusion criteria will be applied to the dataset. 
c) All patients meeting inclusion/exclusion criteria will be recruited to the study.  We anticipate 
that 20,000 patients will meet inclusion/exclusion criteria, but seek permission to recruit up 
to 22,000 patients in case the total meeting inclusion/exclusion criteria is higher than 
expected. This will allow us to deliver screening promotion interventions to all eligible 
patients.  
d) All patients meeting inclusion/exclusion criteria will receive mailed invitations to complete 
screening, and processes to promote screening completion outlined above.   

 
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e) Additionally, a subset of patients recruited to the study will be randomly assigned to 
receive financial incentives, in addition to all screening interventions, to boost screening 
completion. n=1,000 will be assigned to receive $5 incentives, and n=1,000 will be 
assigned to receive $10 incentives.  
 
Consenting Process:  
A waiver of informed consent is requested for this study, including recruitment, delivery of 
screening interventions, and assignment of a subset of patients to financial incentives for 
increasing screening.  
 
 
Justification for waiver of written/informed consent: 
 
The main components of this study that constitute research include: 1) systematic measurement of 
screening participation rates and screening outcomes among patients offered CRC screening through 
mailed outreach, 2) systematic measurement of screening participation and screening outcomes 
among patients offered financial incentives, in addition to mailed outreach, versus mailed outreach 
alone to complete screening. The screening test being offered—FIT—is a positive sign of health 
welfare. Completion of this screening test is considered a positive outcome as part of the National 
Health Interview Survey, and is part of National Health People goals. Additionally, the US Preventive 
Services Task Force has recommended FIT as one of the options for CRC screening. Overall, we are 
not studying a new CRC screening test, but rather whether implementing a large scale outreach 
program results in better CRC screening outcomes, and, whether offering a modest financial incentive 
substantially impacts screening rates compared to mailed outreach alone.  
 
 
a. Minimal risk is anticipated.  
Minimal risk is anticipated because fecal immunochemical testing and colonoscopy are 
accepted standards of care for CRC screening, promoted by the US Preventive Services 
Task Force. No experimental screening procedures are planned. Even without the presence 
of the study, through the course of usual medical care individuals would have a chance of 
being offered CRC screening by a primary physician.  
 
The study will evaluate outcomes of large-scale outreach invitation, as well as whether 
financial incentives have an impact on screening participation in this outreach invitation. All 
individuals, regardless of the screening group to which they are randomly assigned, will be 
free to engage in usual medical care, including usual care CRC screening.  
 
b. The waiver would not adversely affect the rights and welfare of the subjects.  
The rights and welfare of subjects is not at risk because individuals maintain autonomy, and 
are being offered standard-of-care CRC screening test with evidence-based benefits. 
Absence of consent is not anticipated to infringe on the participant’s autonomy, as all 
patients recruited may chose to participate or not participate in screening. Moreover, 
individuals invited to screening could refuse our invitations and choose to follow up with 
primary providers to seek screening as part of usual practice.  
 
For patients assigned to receive financial incentives, the level of incentives are likely non 
coercive. We are studying impact of modest $5 and $10 incentives for completing screening. 
These levels of incentives are unlikely to be coercive. Additionally, for patients in who are not 
assigned to receive financial incentives in addition to screening promotion, absence of these 
interventions is unlikely to result in financial hardship. It is important to note that patients 
meeting study inclusion criteria must have a minimum of 1 visit to a JPS Primary Care clinic 
within the last year.  Considering these patients have an established baseline relationship 

 
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17 
 
with the JPS primary care system, the addition of a modest financial incentive should not 
create undue influence in patients that otherwise would still have exposure to information on 
the benefit of screening.   Since participation in this standard of care screening poses 
minimal to no risk, the chances that incentives may motivate research participants to take 
unnecessary risks are low.   
 
The intervention does not interfere with usual medical care, which would otherwise include 
opportunities for participation in CRC screening. The invitation interventions are not 
anticipated to decrease the rate of screening as compared to usual medical care. Further, 
the health system could have introduced one or more of the invitation interventions proposed 
without research. In many practices, such as Kaiser Permanente Northern California, mailed 
outreach to promote screening with FIT is standard of care.  
 
For patients who have abnormal FIT, requiring follow up diagnostic colonoscopy, clinical 
consent, as required during the usual medical practice of colonoscopy, will occur, allowing 
patients the opportunity to understand the risks and benefits of the colonoscopy procedure 
prior to procedure conduct, further reducing any risks to patient autonomy.  
 
In terms of welfare, waiver of consent for study invitation interventions is not expected to 
decrease rates of screening, because all participants in all groups will have opportunities for 
screening through the course of usual medical care. Moreover, it is possible that requiring 
consent could have a negative impact on welfare, as it might dissuade some patients from 
completing beneficial screening. Indeed, this patient population that has been shown to be 
more vulnerable to low rates of screening, and poor colorectal cancer outcomes, 
requirement of consent may place a burden on patients that reduces the chances of 
participation in potentially lifesaving screening. These burdens could include worry, as well 
as distrust of the screening procedures (which are non-experimental, and associated with 
positive health welfare). From a welfare perspective, positive health outcomes associated 
with screening completion, in conjunction with avoided consent-associated distrust and 
worry that could lower participation rates, both suggest that a waiver of consent may actually 
be beneficial rather than harmful.  
 
c. Study cannot be practically conducting without waiver.  
The study could not be practically carried out without a waiver because requiring consent 
would bias study results and change the research questions under study. To do a study of 
interventions that boost participation in CRC screening, and require that only those with prior 
informed consent participate would markedly bias the study results, and greatly limit 
generalizability.  This is because the study would be biased towards including individuals 
who were particularly motivated to complete CRC screening or particularly interested in 
research, rather than focusing on all individuals who are candidates for CRC screening.  
 
Further it would mean that we would have to contact and receive consent from each of the 
anticipated 20,000 subjects before they received one of the study invitations.  This method 
change would result in a smaller sample size (perhaps too small for the proposed analyses).   
 
It would also change the research from an effectiveness study – showing how the different 
invitations to screening would work in routine practice in the safety net system – to an 
efficacy trial that only shows outcomes of the different invitation methods among volunteers 
who could be reached by the study staff and who agreed to study participation.  Results from 
a study design that required informed consent would be inconclusive.  For example, it would 
be unclear whether non-response to the study intervention was because of inadequacy of 
the intervention, or because of non-interest in participating in research.  Additionally, gaining 

 
Version 8, June 29, 2015 
 
18 
 
prior consent would change the science away from the method that has received the peer-
reviewed funding.   
 
Having to gain prior consent would also markedly increase the budget via additional major 
costs in staff time, tracking, postage, telephone charges, etc.  The budget for this project 
does not include the resources for these changes.   
 
d. The subjects will be provided with additional information after participation.  
We will publicize results of the study, with specific mailings to all participants informing them 
of the knowledge gained.  
 
Summary of justification for waiver of informed consent 
In this research proposal, the most scientifically valid approach (waiving informed consent) is likely to 
be the most ethical, as it will: 1) maximize participation in potentially life-saving, standard-of-care 
colorectal cancer screening, 2) maximize local generalizability of results if the program were to be 
funded on a sustained basis, and 3) maximize overall generalizability of program results to public 
health entities seeking to optimize colorectal cancer screening. Minimal risk is anticipated because the 
screening test being offered is an accepted standards of care, and the level of financial incentives 
being proposed are non-coercive The rights and welfare of the participants is preserved because 
individuals will retain the right to not participate in screening and because the screening tests offered 
are non-experimental--indeed completion of these screening tests is considered a marker of positive 
welfare. The study cannot be conducted without the waiver because requiring consent will 
substantially bias study results and change the research question under study. Finally, the subjects 
will be provided with additional information after participation.  
 
 
Potential Risks: 
Potential risks to study subjects may include the following: 
Loss of confidentiality of personal health information. The likelihood of this complication is low, as 
substantial steps will be taken to ensure the safety of personal heath data. The seriousness to 
subjects is moderate to severe.  
 
Psychological harm of screening invitation.  Psychological harms, such as anxiety, depression, and 
adverse reactions to negative or positive tests have been suggested as a concern for population 
based screening.  Positive tests may occur in the form of a positive fecal immunochemical test (up 
to 10% of responders), cancer diagnosis (no more than 25% among responders to fecal 
immunochemical testing with positive tests), and advanced polyp diagnosis (no more than 30% 
among responders to fecal immunochemical testing with positive tests). Data from a large trial of 
stool based screening suggest no statistically significant increase in psychological harms such as 
anxiety after a positive stool blood test, depression, or suicide among individuals invited to stool 
based screening as compared with controls not offered screening. Overall, the seriousness of 
psychological harm is judged to be moderate, but the likelihood of psychological harm is projected 
to be low.  
 
Physical harm-fecal immunochemical testing. Harms associated with stool occult blood screening for 
CRC are generally limited to risks conferred by colonoscopy performed in follow up of positive 
stool tests. Up to 10% of individuals will have positive stool tests and require colonoscopy, and be 
exposed to the risks outlined under “physical harm-colonoscopy” below. In modeling studies, of 
CRC screening with fecal immunochemical testing for occult blood the life-years gained from fecal 
immunochemical testing based screening relative to no screening has been estimated to be 
substantial, estimated at 227 life-years gained per 1000 persons screened.  Further, in a large 
randomized trial that closely evaluated physical risks associated with mass-scale fecal occult 
blood testing, the rate of physical harm was low. Thus, the seriousness of complications 

 
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19 
 
associated with fecal immunochemical testing if one occurs is moderate to severe, but the 
likelihood of occurrence is low, and the balance of benefits associated with fecal immunochemical 
testing versus risks appears favorable.  
 
Physical harm-colonoscopy performed for follow up of abnormal FIT tests. Colonoscopy has a known 
complication rate of 3 per 1000, including bleeding, perforation, and heart or lung complications, 
and a mortality rate of 1 per 14,000. However, in modeling studies of CRC screening with 
colonoscopy, the life-years gained from colonoscopy based screening relative to no screening has 
been estimated to be substantial, estimated at 230 life-years gained per 1000 persons undergoing 
screening. Thus, the seriousness of colonoscopy complications if one were to occur is moderate 
to severe, the likelihood of occurrence is low, and the balance of benefits of colonoscopy versus 
risks appears favorable. 
 
Financial harm--screening. There will be no financial cost associated with completion of the fecal 
immunochemical test to subjects invited for fecal immunochemical testing, as the tests will be 
provided free of charge, with return postage included, and no cost for processing of the test. 
Colonoscopies associated with the study will be free of charge. Participants may incur travel and 
parking costs that will not be reimbursed. Thus, the seriousness of financial harms associated with 
screening is limited, and the likelihood of some financial cost is low to moderate.  
 
Financial harm—treatment of cancer or unresectable polyps. Through the course of the trial, it is 
conceivable that a few individuals may be diagnosed with CRC and/or polyps not amenable to 
colonoscopic removal. Because all individuals included in this study will be participants in the JPS 
Connection medical assistance program, which allows for cancer care with mild-moderate 
utilization based co-pays (see above), any participants diagnosed with CRC should have 
affordable access to cancer care.    Overall, the seriousness of financial harms associated with 
treatment of cancer is minimal to moderate, and the likelihood of some financial cost is low, mainly 
because the prevalence of cancer is expected to be low.  
 
Legal harms.  No legal harms are anticipated as a result of this trial.    
 
Overall risks/benefit assessment: Overall, the potential risks of this research are similar to the risks of 
standard medical care, mainly because only standard of care CRC screening tests are being offered 
as part of the program interventions.  
 
Subject Safety and Data Monitoring 
Description of monitoring plan 
The principle monitoring entity will be the PI, with daily monitoring. The Institutional Review Boards at 
University of Texas Southwestern Medical Center and John Peter Smith Hospital Health System will 
monitor the trial on an annual basis, and on an ad hoc basis in the case of adverse event report to the 
one or more of the IRBs. Serious adverse events will be reported to the principle investigator 
immediately, and to both the UT Southwestern and JPS Hospital Health System immediately (within 1 
business day). Safety and efficacy data will be evaluated formally at the end of the study period, 
beginning 13 months after first intervention invitation; no interim safety or efficacy analyses are 
planned as the risks associated with the study are similar to those a participant would undergo in the 
course of usual medical care.   
 
Any adverse events associated with program outcomes will be recorded and characterized. These will 
include, but are not limited to items in Table D.  
 
Table D. Adverse events that will be recorded and characterized
Event 
Monitoring procedure 

 
Version 8, June 29, 2015 
 
20 
 
Breach of confidentiality of 
participant data 
Monthly review with all program staff of data security 
Patient anxiety associated with 
program intervention 
Passive follow up, i.e. record of any anxiety expressed by 
patients during course of program procedures 
Colonoscopy complications 
Monthly review of all colonoscopies associated with program 
procedures, and any complications within 30 days of procedure 
completion, including, but not limited to: bleeding, perforation, 
myocardial infarction, death.  
 
Any unanticipated serious or non 
serious adverse event 
Monthly review with all program staff 
Passive reporting by the clinical lab, endoscopy lab, JPS 
physicians, or any program participants to program staff. 
 
Plans for medical or professional intervention in the event of adverse effects 
1. Procedure for responding to loss of confidentiality. The study participant who experiences loss 
of confidentiality will be informed by one of the study primary investigators in writing and by 
phone of the loss of confidentiality. The IRB will be informed in case of this event.  
2. Procedure for responding to physical harm from colonoscopy. The study participant will 
immediately be informed of the physical harm, and appropriate medical and surgical 
interventions will be facilitated. The IRB will be informed in case of this event.  
3. Procedure for responding to psychological harm from screening. The study participant who 
experiences psychological harm will be informed by one of the study primary investigators in 
case of this event. Appropriate referrals for medical and/or psychological care will be 
facilitated. The IRB will be informed in case of this event.  
 
The protocol will be stopped for any of the following reasons: 
• 
Unanticipated serious adverse event such as loss of confidentiality 
• 
Unanticipated death resulting from any study activity  
• 
Request of either Institutional Review Board 
• 
Unanticipated event deemed appropriate indication for stopping the trial by the PI 
 
Plans for assuring data accuracy, data security, and protocol compliance include:  
• 
Access to study data only by designated study personnel 
• 
Study data will be kept in a locked room, on a password protected computer, with password 
protected file. All paper case-report forms will be destroyed after data entry, and kept in a 
locked room within a locked filing cabinet until data entry and subsequent destruction 
• 
Daily backup of study data to a central, firewalled, password protected server at Moncrief 
Cancer Institute, University of Texas Southwestern Medical Center 
• 
Daily monitoring of protocol compliance through conversations between the principle 
investigator and research assistants 
 
The mechanisms for reporting unanticipated problems will include:  
• 
Report of the unanticipated problem to the Institutional Review Boards at University of Texas 
Southwestern Medical Center and John Peter Smith Hospital Health System immediately 
(within 1 business day).  
 

 
Version 8, June 29, 2015 
 
21 
 
Continuing Review will be performed by the IRB on an annual basis, or more frequently, if required.  
As part of the Continuing Review submission to the IRB: 
• 
On the IRB Form for continuing review, items referencing unexpected and serious adverse events 
will be completed appropriately with a comment to describe the event(s) according to IRB template 
instructions. 
• 
The Progress Report will be completed according to IRB template instructions and include the 
principal investigator’s a summary of unexpected and serious adverse events and protocol 
deviations with an analysis of the safety profile of the research. 
• 
If not already done, protocol documents (e.g. protocol, project summary) that require changes 
based on changes to the risk profile of the research will be submitted as a Modification with the 
Continuing Review according to IRB instructions.   
• 
A declaration of on-going operational feasibility. If the enrollment rate in the previous year is not 
sufficient to reasonably reach planned enrollment, a plan will be offered to assure completion of 
the study.  
ClinicalTrials.gov 
The trial will be registered in ClinicalTrials.gov prior to being started. 
 
Procedures to Maintain Confidentiality:  
Plans for assuring data accuracy, data security, and protocol compliance include:  
• 
Access to study data only by designated study personnel 
• 
Study data will be kept in a locked room, on a password protected computer, with password 
protected file. All paper case-report forms will be destroyed after data entry, and kept in a 
locked room within a locked filing cabinet until data entry and subsequent destruction 
• 
Regular backup of study data to a central, firewalled, password protected server at Moncrief 
Cancer Institute, University of Texas Southwestern Medical Center 
• 
Daily monitoring of protocol compliance through conversations between the principle 
investigator and research assistants 
• 
Database  and patient records accessed by research staff from JPS Network computers, 
connected by VPN to UT Southwestern Medical Center, and Moncrief Cancer Institute 
 
Potential Benefits: 
Individuals in the age range from 50 to 64 are most likely to benefit from CRC screening23.  Modeling 
studies suggest that a life expectancy of at least 8 years is required for a given patient to realize the 
benefits of screening over non-screening13. In fact, one group has suggested that Medicare consider 
supporting screening for those under 65, as this could prevent CRC associated morbidity and 
mortality when individuals acquire age of Medicare eligibility24. 
 
Biostatistics:  
EVALUATION STRATEGY 
Overview. Our overarching evaluation goal is to rigorously evaluate program outcomes. The 
evaluation will be strengthened by our prior experience and systematic approach to evaluating 
program outcomes. Our evaluation strategy has been designed to provide the most interpretable 
results possible, and position local and state public health officials to assess program impact and 
areas for improvement. The evaluation will be lead by Dr. Chul Ahn, a biostatistician, Dr. Bijal 
Balasubramanian, an epidemiologist, and Dr. Samir Gupta, a physician and clinical researcher. We 
have a track record of completing sophisticated program evaluations, and have worked together on 
prior analyses. We have developed several primary evaluation aims, as well as a number of 
secondary evaluation aims. It should be noted that all CPRIT required program evaluations are 
addressed. 
 
Consistent with Goal 3, for our primary evaluation aims, we will: 

 
Version 8, June 29, 2015 
 
22 
 
Evaluation Aim A) Determine screening rate improvement after expanding screening outreach to all 
unscreened patients. We predict the population screening rate will be >10% higher after outreach 
expansion compared to baseline.  
 
Evaluation Aim B) Compare rates of initial and repeat screening completion among 1) Patients 
offered a modest financial incentive to complete screening, in addition to outreach invitations, vs. 2) 
Patients offered outreach invitations alone.   
 
Evaluation Aim C) Among patients receiving financial incentives to complete screening, compare 
rates of initial and repeat screening completion between patients receiving $5 vs. $10 incentives.  
 
Evaluation Aim D) Assess all CPRIT required outcomes, including increase in early stage cancer 
detection from baseline, as well as health system changes required to boost screening. 
 
Approach to Evaluation Aims  
Evaluation Aim A) Determine screening rate improvement after expanding screening outreach 
to all unscreened patients. The denominator population for evaluating baseline and end of Year 3 
screening rates will consist of patients meeting the following criteria: 1) Age 50-64, 2) Uninsured, but 
participants in JPS’s medical assistance program for the uninsured, 3) One or more visits to a JPS 
primary care clinic within a year, 4) Address and phone number on file, 5) No history of CRC or colon 
resection, 6) Not incarcerated 
Thus, the denominator population for our baseline and end of Year 3 follow comparisons of 
screening rates generally includes patients age-eligible for screening outreach. The numerator for 
calculation of screening rates will be the number of patients who are up-to-date with screening based 
on colonoscopy within 10 years, sigmoidoscopy within 5 years, or stool blood test (guaiac FOBT or 
FIT) within the last year, measured by HEDIS criteria. Thus, the screening rate at baseline and at end 
of Year 3 will be defined by:  
 
We will compare groups using a Chi-square test, and use a 2-
sided p-value <0.05 to indicate a statistically significant 
difference between baseline and follow up screening rates.  
We predict the screening rate will increase by 10% from 
39% at baseline to 49% at end of Year 3. The prediction is 
based on several assumptions. First, we expect that initial FIT completion rates will be similar to the 
33% rate observed in our prior CPRIT program among patients invited to FIT screening (Section A.2). 
Second, we expect colonoscopy follow up rates for patients with abnormal FIT will be 75%, similar to 
our prior program. Third, we considered various levels of repeat FIT participation rates. As is 
explained in Section A.3, there are limited data on “real world” repeat stool occult blood/FIT 
participation rates, with available estimates of repeat participation ranging from 40 to 75%33, 34. We 
estimate this range of FIT repeat participation is consistent with a screening rate increase of 5 to 15%, 
from 39% at baseline, to between 43 and 54% at end of year 3. Thus, we conservatively predict an 
increase of 10%. As is noted below, we will have statistical power to detect the entire range of 
estimated screening rate increases.   
 
Sample size for Evaluation Aim A. Unlike sample size estimates for clinical research trials, sample 
size estimates for these comparisons are not based on the minimum number of patients required to 
detect clinically significant differences in outcome rates. Rather, the sample size for these 
comparisons will be based on the number of patients potentially qualifying for screening outreach 
program.  This is because the primary goal of CPRIT Evidence Based Prevention Programs is to 
maximize screening delivery. Nonetheless, because the sample we expect to identify is very large, we 
will have more than enough power to detect clinically significant differences in the outcome of interest. 
We estimate that at baseline and at follow up, at least 20,000 patients will qualify for our screening 
outreach program if not screening up-to-date (Table 1). With an expected sample of at least 20,000 
patients eligible for screening at baseline and at end of year 3, assuming alpha=0.05, we will have 
over 90% power to detect our predicted screening rate increase of >10%, from 39% at baseline to 
49% at end of Year 3 with a two-sided significance level. Moreover, with the expected sample sizes, 
Screeni
ng Rate 
= 
# up-to-date with 
screening 
# patients eligible for 
screening 

 
Version 8, June 29, 2015 
 
23 
 
we will even have 90% power to detect a smaller screening rate increase of >5% (Power was 
computed with nQuery Advisor Software v.7.0).  
 
Evaluation Aim B) Compare rates of initial and repeat screening completion among 1) Patients 
offered a modest financial incentive to complete screening, in addition to outreach invitations 
(n=2,000), vs. 2) Patients offered outreach invitations alone (n=~18,000).  The rate of initial screening 
completion will be defined by:    
 
We will compare the initial screening completion rate 
for patients offered the financial incentive, in addition 
to screening outreach, to the initial rate for patients 
offered screening outreach alone using a Chi-square 
test of proportions, with a 2-sided p value <0.05 
considered statistically significant.  The rate of repeat screening for Years 2 and 3 will be defined by:  
 
 
We will compare initial FIT completion rates for the financial incentive plus organized outreach vs. 
organized outreach alone groups using a Chi-square test, with a 2-sided p value <0.05 considered 
statistically significant. The same approach will be taken for comparing repeat FIT completion rates for 
Years 2 and 3. 
 
Sample size for Evaluation Aim B. The sample size for this aim will be 2,000 for the financial 
incentive group plus outreach group, and at least 18,000 for the outreach group alone. The sample 
size for the financial incentive group was chosen based on sample size required for sufficient power to 
detect expected differences between offers of $5 and $10 gift card incentives outlined in Aim C below. 
The sample size for the outreach group alone was based on including all patients included in the 
screening outreach program who will not receive financial incentives. With 2,000 patients assigned to 
the financial incentive plus outreach group, and 18,000 patients assigned to the outreach alone group, 
we estimate over 90% power to detect differences in initial screening participation of 5% or more at a 
5% two-sided significance level. Thus, we will have more than enough power to detect clinically 
meaningful differences of 10% or more in initial FIT completion. Because of the lack of prior data on 
repeat FIT participation rates, and under the sample size discussion for Evaluation Aim A above, we 
do not present formal power calculations for comparisons of repeat FIT completion rates, but expect 
that we will be able to make meaningful comparisons based on the large number of patients included 
for evaluation.  
 
Evaluation Aim C) Compare rates of initial and repeat screening among patients receiving $5 vs. $10 
financial incentives in addition to outreach invitations.  For this comparison, we will use the same 
definitions outlined under “Evaluation Aim B” above for the initial screening completion rate, and the 
Year 2 and 3 repeat completion rates. For these outcomes, we will compare the outcome rate for 
patients receiving the $5 vs. $10 incentive, using a Chi-square test of proportions, with a 2-sided p 
value <0.05 considered statistically significant.  
 
Sample size for Evaluation Aim C. The sample size for Evaluation Aim C is based on comparing the 
initial screening participation rate between the $5 vs. the $10 incentive groups. As is outlined in 
Section A.3, previous data suggest that financial incentives are effective for promoting complex 
healthy behaviors such as quitting smoking39-41. Further, we believe that incremental (modest) 
incentives are likely to significantly increase screening completion. First, we assumed that a 10% or 
more difference in initial screening participation would be clinically meaningful. Second, we assumed 
that the screening completion rate associated with the $5 group would be 43%, and that the rate for 
the $10 group would be at least 53%. The 43% rate was chosen because our response to FIT 
invitations with our prior outreach program was 33%, and we would consider a 10% or more increase 
Initial 
Screening 
Completion 
Rate = 
# patients completing a FIT 
Year 1 
# of patients sent FIT 
invitation Year 1 
Year 2 
Repeat 
Completion 
Rate = 
# patients completing FIT 
screening Year 2 
Year 3 Repeat 
Completion 
Rate = 
# patients completing FIT 
screening Year 3 
# patients completing FIT Year 1 
with normal result  
# patients completing FIT Year 2 
with normal result 

 
Version 8, June 29, 2015 
 
24 
 
in screening completion associated with the $5 intervention over organized outreach alone to be 
clinically meaningful. Similarly, the 53% rate was chosen for the $10 group because we would 
consider a 10% or more increase in screening completion associated with the $10, rather than the $5 
group to be clinically meaningful. Under these assumptions, with an alpha=0.05, we estimated 1090 
patients (n=545 in the $5 group and n=545 in the $10 group) would be required for 90% power to 
detect a statistically significant difference of 10% or more in initial screening participation. Because we 
recognize uncertainty in the estimating the expected difference between the two groups, and because 
we wanted to increase our ability to conduct exploratory comparisons of repeat FIT participation rates 
associated with the $5 and $10 groups, we increased the planned sample receiving financial 
incentives to 2,000 (n=1,000 in the $5 group and n=1,000 in the $10 group). Thus, we will have more 
than enough power to detect differences of 10% or more in initial screening participation.  
 
 
Evaluation Aim D) Assess all CPRIT required outcomes, including increase in early stage 
cancer detection from baseline, as well as systems changes required to boost screening. To 
assess increase in early stage cancer detection from baseline, we will compute proportion of 
CRC patients with early stage cancer at baseline and at end of Year 3. JPS Cancer Registry data 
will be used for this computation. Rate of early stage cancer will be defined as:  
 
We will use a Chi-square test of proportions 
for comparing groups, and a p value <0.05 to 
signify statistical significance.  
 
To assess systems changes required to 
boost screening, we will plan additional evaluations focused on the JPS health system. In 
addition to evaluating outcome change (as described above), it is also important to evaluate changes 
in processes related to transferring and expanding our outreach program at JPS. The purpose of this 
process evaluation is to gather information about the roll out process to enhance sustainability of the 
screening program, and enable translation of this program to other safety-net settings. To meet these 
objectives, we will monitor the screening program on a real-time basis. During weekly meetings 
between UTSW nurse (TBA) and JPS screening outreach team, the UTSW nurse will ask members of 
the outreach team about their experience with the program. She will maintain a detailed log of 
problems and successes. She will also document strategies and workarounds that JPS staff develop 
to tailor the program to their needs and resources. Similarly, barriers and facilitators of the outreach 
program at the health system level identified during JPS physician champion meetings with the 
principal investigator will be documented. Sustainability of the program will be enhanced because JPS 
staff will have access to systematically collected information about on the ground strategies that 
worked and did not work at the screening delivery level as well as at the health system level. In 
addition, this information will also enable us to apply our knowledge of successfully establishing this 
program at JPS to other safety-net systems. 
 
Secondary analyses. We plan to conduct several secondary analyses. First, we recognize that 
results from Evaluation Aim A, in which baseline screening rates will be compared to follow up 
screening rates at year 3, could be confounded by time trends in CRC screening rates, which 
generally have been increasing over time. Accordingly, we will compare the observed rate of CRC 
screening in Year 3 to the expected rate of CRC screening based on time trends in screening at JPS. 
The expected rate will be estimated using the secular trend for CRC screening using annual 
screening rates for each of the 7 years 2006-2011 prior to start of our prevention program in 2012. All 
rates will be standardized by gender and age strata (50-54, 55-59, and 60-64 years) to the population 
distribution of men/women and these age strata for 2012, and a standardized incidence ratio (SIR) will 
be computed. An SIR greater than 1, with an associated 95% confidence interval that does not cross 
1 will be interpreted as evidence to support impact of our outreach intervention beyond time trends in 
CRC screening rates. We have previously used this approach to assess impact of a University of 
Texas health plan policy that waived copays for colonoscopy screening on CRC screening rates 
which began in 2009, in which we compared colonoscopy uptake 2002-2008 to uptake after policy 
institution46.   
Early Stage 
Cancer 
Detection 
Rate = 
# CRC patients with SEER Summary 
Stage 0 or Stage 1 
# CRC patients 

 
Version 8, June 29, 2015 
 
25 
 
Second, to identify factors independently associated with screening outcomes, we will 
construct several logistic regression models. For example, to identify predictors of initial screening 
completion, we will create a model using initial screening completion rate as the primary outcome 
(dependent) variable, and several potential predictors of completion. Predictors considered for model 
inclusion will include age, sex, race/ethnicity, frequency of primary care visits, exposure to the 
screening outreach program, and exposure to financial incentives. A similar model will be created with 
the outcome of programmatic screening as the dependent variable. For these exploratory analyses, 2-
sided p values of 0.05 will be considered statistically significant.  
Third, we will quantify the number of patients who have CRC and potentially precancerous 
polyps detected through screening outreach. CRC and polyp data will be collected by reviewing all 
colonoscopy and associated pathology reports for patients who undergo colonoscopies after having 
abnormal FIT tests. Additionally, we will query the JPS tumor registry to identify any program 
participants who had CRC diagnosed, and determine, through chart review, whether the CRCs were 
detected as a result of our screening outreach or through other mechanisms. With our plan to invite 
over 20,000 patients, taking into account our prior rates of FIT screening participation (33%), 
abnormal FIT results (12%), and detection rates of CRC (4.8%) and adenomas (46%) after abnormal 
FIT, we estimate that 38 patients with CRC and 364 patients with adenomas will be identified through 
our program.  

 
Version 8, June 29, 2015 
 
26 
 
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