Comparing Interventions to Increase Colorectal Cancer Screening in Low-Income and Minority Patients
Phase: NA
Conditions: Colorectal Cancer
Sponsor: Indiana University

 
 
 
 
Protocol with Statistical Analysis Plan 
 
Comparing Interventions to Increase Colorectal Cancer Screening  
among Low-Income and Minority Patients 
 
 
NCT#  
NCT0320036 
 
Principal Investigator 
Susan M. Rawl, PhD, RN, FAAHB, FAAN 
 
Institution  
Indiana University 
 
IRB Approval Date 
7/2/2019 
 
 
 
 
 
 

 
 
 
 
                                                               
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PCORI RESEARCH PLAN TEMPLATE 
 
FINAL RESEARCH STRATEGY / IRB PROTOCOL
 
A. Background  (RQ-3, RQ-4, RQ-6) 
Colorectal cancer (CRC), a preventable cancer, is the third most common cause of cancer deaths in Americans with an 
estimated 132,700 new cases in 2015.1  Approximately half of the 49,700 deaths from CRC this year could be prevented if 
appropriate colon cancer screening was widely implemented.  Unfortunately, CRC screening rates in Indiana are well 
below the national average; only 61.5% of Indiana residents are up-to-date with CRC screening.  The American Cancer 
Society and the U.S. Preventive Services Task Force recommends screening beginning at age 50 years and continuing until 
age 75 years.1,2  For people at average risk for CRC – those who have no risk factors other than age – guidelines 
recommend several test options including: annual stool testing with fecal occult blood tests (FOBT) or fecal 
immunochemical tests (FIT), sigmoidoscopy every 5 years, or colonoscopy every 10 years.2,3 For people who have a strong 
family history of CRC or polyps, colonoscopy is the most appropriate test. Which CRC screening test is recommended to 
patients, therefore, should be based on assessment of each individual’s risk factors.4,5          
Failure to screen for CRC leads to people being diagnosed with late-stage disease causing unnecessary deaths 
from this preventable cancer. The current level of screening reduces CRC mortality by 44% compared to no screening. If 
it were possible to increase compliance with CRC screening tests by 20%, an additional 9.3% reduction in mortality would 
be realized.6 To further reduce CRC incidence and mortality, provider referral and timely completion of CRC screening 
tests that include, but are not limited to, colonoscopy are imperative.    
Although there are several test options available for screening people at average risk, providers almost 
universally recommend colonoscopy and do not offer alternative test options. This practice is contributing to low 
screening rates.7,8  Provider recommendation has been well-documented as the most important predictor of CRC 
screening.  Although colonoscopy is the most appropriate test for people at increased risk for CRC, those at average risk – 
the majority of the population - can be screened with less invasive tests.  Unfortunately, colonoscopy is frequently the 
only CRC screening test recommended by providers.7,8   
This common practice of universally recommending colonoscopy may actually reduce CRC screening 
adherence, especially among racial/ethnic minorities7 and is considered a missed opportunity for some patients to be 
screened.8  Evidence of the negative impact of this practice is that almost half of patients in safety net hospitals do not 
complete the test. Overall, from 38-50% of persons who are referred for colonoscopy cancel or do not attend their 
scheduled appointments.9-13 A review of administrative data from our local public safety net hospital showed that 
colonoscopy cancellation and no-show rates were 41% among Hispanic patients, 58% in Caucasian patients, and 60% in 
African American patients in 2014. Because of the high patient volume, this means that 1150 people in one health system 
who were referred for colonoscopy went unscreened in that year alone.  
 
Significant disparities in CRC incidence and mortality exist for racial/ethnic minorities, people with less 
education, and those with no insurance. CRC incidence and mortality rates are higher among African Americans than all 
other racial groups.14 Although mortality rates have been decreasing for all groups over the last 20 years, declines 
among African Americans began later and have been slower, resulting in a widening racial disparity. The mortality gap is 
growing for each stage of diagnosis, with the greatest disparity observed for distant-stage CRC.15 Differences in access to 
screening and treatment account for more than half of the racial disparity in CRC mortality rates.1,16-18 Other contributing 
factors to disparities include unequal access to and receipt of quality treatment, a higher prevalence of comorbid 
conditions, and lower rates of participation in CRC screening.19 Hispanics are slightly less likely than non-Hispanic whites 
to be diagnosed with localized CRC (38% vs. 40%) and more likely to be diagnosed with distant-stage disease (21% vs. 
19%) due to lower screening rates and less access to timely medical care.20 Hispanics age 50 and older are less likely to 
have had a recent CRC screening test than non-Hispanic whites - 47% vs. 62%, respectively. There are also differences in 
CRC screening rates by country of origin; Hispanics from Mexico and Central or South America are least likely to have 

 
 
 
 
                                                               
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had a recent screening test.21,22 Improving CRC screening rates among racial/ethnic minorities has been identified as the 
first target to reducing these disparities.23  
 
Patient-level barriers to CRC screening include low knowledge levels about CRC and CRC screening tests, 
perceptions of not being at risk for CRC, mistrust, fear of pain/discomfort, fear of finding cancer, embarrassment, 
unpleasantness of the bowel preparation.9,24-26  Difficulty finding time, transportation difficulties, and costs of the tests 
have been identified as barriers to CRC screening by people with low incomes.9,24,27 Lack of social support has been 
identified as a barrier to CRC screening; family and friends who had negative experiences with screening tests can 
actively discourage participation.27 In a recent trial, the most common barriers to CRC screening were lack of knowledge 
about the test, fear, worry about test results and the bowel preparation.28  Inadequate bowel preparation is a major 
impediment to effective CRC screening with colonoscopy, and 25-30% of patients presenting for colonoscopy have not 
adequately cleansed, or emptied, their bowel.10,29-31 Suboptimal cleansing of the bowel leaves residual fecal matter that 
obscures polyps, leads to missed diagnoses, extends the time needed for the exam, and results in incomplete or aborted 
colonoscopies.10,30-34  This is a significant problem among patients in safety net health systems, where up to 30% of 
patients who do attend their colonoscopy appointment have not adequately cleansed their bowel.10,30,33 In addition, 
poor bowel preparation has been estimated to increase the cost of CRC screening by 22% in public hospitals due to 
patients needing to repeat colonoscopy or have another test earlier than suggested by current practice guidelines.33 
Finding effective approaches to help patients who are willing to have a colonoscopy prepare for that test will reduce 
costs for patients and health systems, an especially important goal for those with limited resources.     
 
Gaps in our knowledge: Both computer-tailored and patient navigator interventions have been shown to 
increase CRC screening rates and improve bowel preparation, but no comparative studies have been conducted and 
none have evaluated the additive effect of combining these approaches for CRC screening. (RQ-1)  People differ on the 
types and levels of intensity of interventions needed to move them to complete CRC screening.35  Upon completion of this 
study, we will have determined the comparative effectiveness of two readily translatable theory-based interventions to 
increase CRC screening. Further, we will identify moderators and mediators of intervention effects that will help us 
understand, respectively, who benefits most (and least) from which type of intervention and through what mechanisms 
the interventions are working. The proposed comparative analyses will inform decisions about interventions that can: 1) 
increase CRC screening; 2) improve bowel preparation for those having a colonoscopy; and 3) reduce CRC morbidity and 
mortality for low-income and minority patients, who bear a disproportionate burden from this preventable disease.  
B.  Significance  (RQ-1, RQ-6)) 
Although an estimated 50,000 people will die from CRC in 2015, adherence to guideline-appropriate screening could 
significantly reduce this mortality rate.1  The U.S. Preventive Services Task Force recommends screening for colorectal 
cancer (CRC) using fecal occult blood testing, sigmoidoscopy, or colonoscopy in adults, beginning at age 50 years and 
continuing until age 75 years.2  Increasing CRC screening among low-income, uninsured, and minority patients has 
potential to reduce the well-established disparities in CRC morbidity and mortality experienced by these groups. 
Significant disparities exist with lower CRC screening rates observed in populations served by safety net hospitals, that is, 
those with less education, lower incomes, and no health insurance. Improving patients’ knowledge of CRC, their 
personal risk factors, benefits and harms of CRC screening, and what each test entails along with providing support and 
tangible assistance to overcome barriers will increase the numbers of CRC screening tests completed, increase the 
number of people who adequately prepare for colonoscopy, and lower healthcare costs.  
 
The effectiveness of CRC screening is dependent on patient acceptance and completion.4  Two main issues 
limit utilization of colon testing. First, providers recommend colonoscopy to patients as the only screening test without 
offering any alternatives. Second, patients often do not understand the need for colonoscopy, especially when they have 
no bowel problems. Up to 50% of people who receive a recommendation for screening colonoscopy fail to complete the 
test, with non-completion rates highest in safety net hospitals.9,10,12  Reasons for non-completion include low levels of 
knowledge about the need for colonoscopy in the absence of symptoms, fear of pain, unpleasantness of bowel 
preparation, and confusion about dietary restrictions and medications.36 As mentioned, several test options are 
available and offering patients alternatives to colonoscopy is essential if we are to achieve optimal screening rates 
among all Americans.  

 
 
 
 
                                                               
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In our local public safety net hospital, one of the largest in the nation, significant proportions of patients who 
are referred by their primary care provider, and scheduled, for colonoscopy do not attend their appointments.  In 
2014, colonoscopy no-show/cancellation rates were 41% in Hispanic patients, 58% in Caucasian patients, and 60% in 
African American patients. These numbers represent approximately 1150 people in one year in one health system who, 
despite being referred and scheduled for colonoscopy, were never screened for CRC because they did not complete this 
test. Evidence shows that safety net health systems are particularly impacted by this problem.9-13  We conducted  
interviews with 48 patients in our safety net hospital who were scheduled for colonoscopy - 100% of these patients 
reported that their provider had not offered any other CRC screening test option besides colonoscopy. In addition, when 
asked why they did not complete the test, many reported that their provider had never explained what a colonoscopy 
was or why it was needed. In addition, the majority of these patients had been scheduled for, but did not attend, prior 
colonoscopy appointments. Large numbers of patients are indicating they are unwilling to have a screening colonoscopy.  
B.1. Effective interventions that increase risk-based CRC screening for all patients have been developed but not 
compared nor combined. (RQ-1) Providers have limited time to counsel patients about why CRC screening is important, 
which tests options are available, and what each test entails.37,38 Both patient navigation and tailored DVD interventions 
that can be delivered in the privacy of people’s homes and are available when they are needed most have great 
potential to increase CRC screening and improve bowel preparation for those who choose colonoscopy. Such 
interventions supplement face-to-face clinical encounters, providing support and guidance for patients undergoing this 
unfamiliar, invasive procedure.  
Computer-tailored interventions are effective approaches to increase CRC screening (RQ-5).28,39-41 Computer-
tailored interventions are defined as “any combination of information and behavior change strategies intended to reach 
one specific person, based on characteristics that are unique to that person, related to the outcome of interest, and 
derived from individual assessment.”42 Tailoring refers to a process of creating individualized interventions that use 
demographic and psychosocial data collected from each person to generate customized feedback to meet his or her 
unique needs.42,43  Computer-tailored health communications can be delivered using a variety of media but computer 
technology is required for the tailoring process. Tailored interventions have influenced health behavior change in 
relation to smoking cessation, dietary change, physical activity, mammography and CRC screening.44-49  Tailored 
interventions are more effective than non-tailored interventions that do not take into account individual characteristics 
of intervention recipients.50,51  Studies have shown that tailored interventions eliminate superfluous information and 
are: 1) more personally relevant to the recipient; 3) attended to; 4) more likely to lead to thoughtful consideration of 
behavior change; and 5) more useful than non-tailored information in helping people enact behavior change.52   
  
Several reviews of tailored intervention trials have demonstrated their effectiveness.49,53,54  A meta-analysis of 
57 tailored intervention trials showed they changed health behaviors and that the most effective tailored interventions 
were those that focused on preventive and screening behaviors.53 In a synthesis of 63 randomized trials that met 
inclusion criteria, 49 studies reported that tailored interventions were superior to control/comparison conditions for 
improving diverse outcomes.54  Among 28 published studies, a significant aggregate effect size (OR=1.42) was observed 
for tailored interventions to increase mammography rates.49 A recent review concluded that interactive multimedia 
computer interventions have become the standard medium for delivering tailored health information.55  Since  
interactive computer programs can deliver tailored information via audio and video, they have great potential to reduce 
heath disparities because they make relevant information accessible to people with poor reading skills, low health 
literacy, and/or poor vision.55  As shown in Table 1, several studies have shown that computer-tailored interventions 
increase CRC screening rates.56-60 Our research team has extensive experience developing and testing computer-tailored 
interventions to increase cancer screening.  We have conducted randomized trials to test tailored interventions 
delivered via print, telephone, tablet computers, interactive touch-screen computers, and DVD. 59,61-66 One of our recent 
studies tested a tablet-based computer intervention to increase CRC screening among low income African American  
 
 
 
 
 

 
 
 
 
                                                               
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Table 1.  Effects of Computer-Tailored Interventions on CRC screening: Results from Randomized Trials  
primary care patients in Eskenazi Health, our safety 
net hospital and setting for the proposed study (R01 
CA115983, PI: Rawl).  At 6 months, patients who 
received the tailored intervention were significantly 
more likely to have been screened compared to usual 
care (OR=1.81; CI=1.08, 3.04); 26% of the intervention 
group were screened compared to 18% of the usual care group (p=.03).64 In another study we tested a tailored DVD 
intervention to promote mammography and found that women who received the tailored DVD and had household 
incomes less than $75K were significantly more likely to have a mammogram (OR=1.51, p=.017) than those receiving 
usual care (R01 NR008434, PI: Champion).67 Among the 244 African American women enrolled in this trial, the DVD was 
significantly more effective than usual care at increasing mammography rates for women whose incomes were less than 
$30K (OR=5.34, CI=1.12, 25.42).68 Of the 926 women who received the mailed DVD, 92% reported they viewed it and 
rated it high on a usability scale.65  Our research, and that of others, has demonstrated that tailored interventions are an 
effective approach to increasing cancer screening, especially for low-income and minority populations.           
A tailored DVD, delivered via the mail or the internet, may be an effective, inexpensive, and easy to disseminate 
approach to promoting CRC screening and, for those who choose colonoscopy, improving quality of bowel preparation. 
Because intervention effects can differ across groups, it is critical to examine moderators of intervention effects, that is, 
for which groups the intervention is more or less effective. Also, in order to understand how or why an intervention is   
effective, mediators of intervention effects must be identified. (RQ-1, RQ-3, RQ-4)   
B.2. Strong evidence supports patient navigation (PN) as an effective approach to increase CRC screening. (RQ-5)11,39-41  
Patient navigation (PN) in the context of cancer has been defined as a “barrier reduction-focused intervention” that: 1) is 
provided to individual patients for a defined episode of cancer-related care; 2) has a definite endpoint when provision of 
services is complete; 3) targets a defined set of services to complete an episode of cancer-related care; 4) focuses on 
reducing patient-level barriers to accessing care; and 5) reduces delays in accessing care with an emphasis on timeliness 
and reduction in the number of patients lost to follow-up”.69  The effectiveness of patient navigation for increasing 
cancer screening rates has been well established in selected populations. Dr. Harold Freeman’s pioneering work 
demonstrated the effectiveness of PN to increase mammography at a safety net hospital in Harlem.70,71 Numerous 
studies have supported the effectiveness of PN interventions to increase CRC screening.39,40,72-80  
 
Table 2. Effects of PN on CRC Screening: Results from Randomized Trials 
A comprehensive review conducted by a member of 
our research team (Dr. Paskett) who led the National 
Patient Navigation Program, concluded that navigation 
was an effective approach to increasing cancer 
screening; four of the studies reviewed focused on CRC 
screening, three on breast cancer screening and one on cervical cancer screening.81 Table 2 shows effect sizes obtained 
in randomized trials testing PN interventions. Health systems recently began implementing PN services, prior to 
generation of substantial evidence of their effectiveness, and dissemination of these programs has been widespread.  
Both computer-tailored and patient navigator interventions have been shown to increase CRC screening rates and 
improve bowel preparation, but no comparative studies have been conducted and none have evaluated the additive 
effect of combining these two approaches for CRC screening. (RQ-1, RQ-4, RQ-5) People differ on the types and levels of 
intensity of interventions needed to move them to complete CRC screening.35  The proposed study will determine the 
comparative effectiveness of two promising theory-based interventions and examine moderators that will increase 
understanding of who responds to brief versus more intensive (interpersonal) interventions. The impact of this study will 
be an enhanced understanding of which interventions are most effective for increasing CRC screening among those who 
are least likely to be screened.  The study’s innovation lies in careful attention to comparing these approaches with each 
other and with usual care, as well as exploration of moderators and mediators of intervention effects.   
This application is being submitted in response to the PCORI funding announcement for applications focused on 
Improving Healthcare Systems. Consistent with the intent of this priority, this proposed study will compare the effects 
Author/Year  
Outcome 
Tailored  
Usual Care/ 
Non-tailored  
Difference 
Basch/2006 
Any test 
27.0% 
  6.1% 
21 
Myers/ 2007 
Any test 
43.8% 
32.6% 
11 
Manne/2009 
Any test 
28.4% 
15.4% 
13 
Rawl/2015 
Any test 
22.1% 
5.2% 
17 
Author/Year  
Outcome 
Navigated 
Usual Care 
Difference 
Lasser/2009  
Any test 
31.0% 
  9.0% 
22 
Ma 2009 
Any test 
77.0% 
10.8% 
66 
Percac-Lima/2009 
Any test  
27.0% 
12.0% 
15 
Honeycutt/2013 
Any test 
43.0% 
11.0% 
32 

 
 
 
 
                                                               
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of two health system-level approaches designed to improve access, support patient self-care, use innovative health 
information technology, coordinate care, and deploy the workforce effectively. 
Upon completion of the proposed study, we will have determined the comparative effectiveness of two readily 
translatable theory-based interventions to increase CRC screening. Further, we will identify moderators and mediators 
of intervention effects that will help us understand, respectively, who benefits most (and least) from which type of 
intervention and through what mechanisms the interventions are working. The proposed comparative analyses will 
inform decisions about interventions that can increase screening, improve quality of bowel preparation for those having 
a colonoscopy, and reduce morbidity and mortality from CRC for low-income and minority populations, who 
disproportionately bear the burden of this preventable disease.  
C. Study Design and Approach.  (RQ-2, RQ-3, RQ-4, RQ-5, RQ-6)  
We will use a three-group randomized trial design to compare the effectiveness of two theory-based interventions to 
promote completion of CRC screening among individuals at average risk for CRC and, for those who complete 
colonoscopy, high quality bowel preparation. We will enroll an ethnically diverse group of 450 men and women who 
canceled, or did not attend, their colonoscopy appointment and randomize them to receive: 1) a tailored DVD 
intervention; 2) the tailored DVD plus a patient navigator intervention; or 3) usual care. The aims of this study are to:  
1.  Compare the effectiveness of two interventions designed to promote CRC screening among people at average risk 
for CRC - a tailored DVD versus the tailored DVD plus telephone-based patient navigation - to each other and to usual 
care.  
      Hypothesis 1.1:  Participants who receive the tailored DVD plus telephone-based patient navigation intervention will  
      have higher rates of colorectal cancer screening with fecal immunochemical test (FIT), colonoscopy, or either 
      screening test compared to those who receive the tailored DVD alone.  
      Hypothesis 1.2: Participants who receive either intervention will have higher rates of colorectal cancer screening 
      with fecal immunochemical tests (FIT), colonoscopy, or either screening test than those who receive usual care.  
      Hypothesis 1.3: Participants who receive either intervention who complete colonoscopy will have: 1) better quality of 
      bowel preparation; 2) less anxiety about the procedure; and 3) greater satisfaction with the colonoscopy experience  
      than those who receive usual care.  
2.  Examine age, race/ethnicity, sex, and income as potential moderators of intervention effects.  (RQ-4) 
3.  Examine changes in knowledge and health beliefs (perceived risk, perceived benefits, perceived barriers, and  
     self-efficacy) as potential mediators of intervention effects.  (RQ-6) 
Both interventions can serve as adjuncts in any existing health care system to facilitate completion of CRC screening and 
improve the quality of bowel preparation. A number of complex factors may contribute to low CRC screening 
completion rates after provider referral, but more work is needed to understand these factors.1 We will explore whether 
the effects of these interventions differ for various subgroups of participants. Heterogeneity of treatment effects will be 
determined by examining age, sex, and race/ethnicity as potential moderators.  (HT-1) 
 

 
 
 
 
                                                               
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C.2. Design. A three-group randomized controlled 
trial will be conducted to compare the 
effectiveness of two interventions to promote 
CRC screening test completion. Eligible men and 
women who were scheduled for colonoscopy in 
the endoscopy unit at Eskenazi Health (our safety 
net health system) but did not attend their 
appointment will be invited to participate. After 
baseline data are collected via structured 
telephone interviews, participants will be 
randomized to receive: 1) a mailed DVD titled  
Time to ACT:  Approaches to Colon Testing; 2) the 
mailed DVD plus a patient navigator (PN) 
intervention; or 3) usual care (See Figure 2).  (RQ-
2, RQ-3, RQ-4, RQ-5) 
 
Letter and brochure introducing study mailed to Eskenazi patients approved for contact 
Recruitment phone calls within 1 week to verbally consent patients
Baseline (Time 1) interviews conducted, participants randomized
Tailored DVD 
(Group 1)
Tailored DVD plus Patient 
Navigator (Group 2)
Deliver Interventions
DVD process interview at  
2 weeks post-DVD mailing (Groups 1 & 2 ) 
Final interview at 9 months post-baseline 
Study Design and Schema
Usual Care  
(Group 3)
Follow-up interview at 6 months post-baseline 
 
 
 
C.3. Setting and Recruitment. (PC-2)  On a weekly basis, Eskenazi Health IT department will generate lists of age-eligible 
patients at average risk who did not attend their colonoscopy appointment. The list will include 2 groups of average risk 
patients who missed their appointment: 1) patients who had a colonoscopy screening ordered; and 2) patients who had 
a recent fecal immunochemical test (FIT) that was positive with a follow-up order for colonoscopy. Due to differences in 
physician ordering practices, the follow-up colonoscopy can be ordered as a colonoscopy screening, colonoscopy 
diagnostic, or colonoscopy high risk. Patients will be approved for contact by Dr. Fatima, Director of the Eskenazi Health 
Endoscopy Department. Patient information will be released to the study’s data manager, the Eskenazi Endoscopy 
Department’s Patient Navigator nurse, and trained research staff at the IU School of Nursing using secure electronic data 
transfer methods.  Information disclosed is limited to that which is necessary to determine eligibility and to contact 
patients by mail and telephone. As a first step, the Endoscopy Patient Navigator nurse or nurse designee will screen 
patients by looking back 10 years and excluding any with a history of adenomatous polyps, sessile serrated polyps, or 
any mass suggestive of neoplasia. Patients with a history of hyperplastic polyps, lymphoid tissue, or no polyps will be 
 
C.1. Conceptual Model. The model guiding this study was 
adapted from Warnecke and colleagues (Figure 1).82 This 
multilevel model shows the proximal, intermediate, and distal 
determinants of health that will be targeted by the interventions. 
Consistent with this model, we will test a telephone-based 
patient navigation intervention that will provide social support 
(social relationships) and access to community resources (physical 
context) for people who have been scheduled for colonoscopy. 
Specifically, the patient navigators (PNs) will provide 
individualized support based on assessment of demographics, 
knowledge, health beliefs, and barriers.  By interacting with the 
health care system and community resources, they will assist 
patients to overcome their unique logistical and other barriers to 
CRC screening. A tailored DVD titled “Time to ACT:  Approaches to 
Colon Testing” will be designed to increase knowledge, health 
beliefs, and self-efficacy for CRC screening. 

 
 
 
 
                                                               
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recruited. To be eligible, these patients must: 1) have been referred for a colonoscopy that was not done (i.e, canceled 
or no show); and 2) be 50 to 75 years old if non-African American or 45-75 years old if African American. Patients 
meeting these inclusion criteria will be excluded for the following reasons:  1) unable to speak, read, and write English; 
2) a personal history of having a colonoscopy at a non-Eskenazi Health location where polyps were found and they were 
the type that could turn into cancer; 3) FIT negative result in the past 12 months; 4) a personal history of CRC; 5) a 
personal history of conditions that place them at high risk for CRC such as ulcerative colitis, Crohn’s disease, or known 
hereditary syndromes such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer; 6) a family 
history of CRC which increases their risk; and 7) speech, hearing, cognitive, and/vision impairment. Trained research 
staff at the IU School of Nursing will recruit patients using procedures consistent with clinic and HIPAA requirements.  
Recruiters will send introductory letters, signed by the Principal Investigator and a co-investigator who is a member of 
the Eskenazi Medical Staff , along with a recruitment brochure and Study Information Sheet that explains the study to all 
approved patients. The letter informs patients that they will receive a phone call about the study within the next week 
unless they call a toll-free number to say they do not wish to be contacted. One week after letters are mailed, trained 
recruiters at the IU School of Nursing will call potentially eligible participants who have not opted-out to explain the 
study requirements, potential risks and compensation, and answer questions. Adequate speech, hearing, and cognition 
of potential participants will be confirmed by recruiters based upon the phone conversation. They will then proceed to 
determine eligibility, obtain both verbal informed consent and verbal HIPAA Authorization, and schedule a convenient 
time to conduct the baseline interview. Each participant who is not reached will be called back up to, but no more than, 10 
times. Recruiters will record each call attempt including the date, time, disposition, and callback preference. Participants 
who decline to participate will be thanked for their time, with their response and reason for refusal recorded.  
 
Re-contact efforts will be attempted for patients who were originally excluded from the study due to reporting a history of 
colon polyps (histology type unspecified). Amendment 013, approved by the IRB last year on 5/30/2018, allows patients 
with a history of benign colon polyps to be included in the study. The Endoscopy Patient Navigator nurse or nurse 
designee will review the records of these previously excluded patients to determine if: (1) the polyp histology type was 
benign; and (2) a colonoscopy is still needed. Patients with benign polyps who are due for a colonoscopy will be re-
contacted following the usual recruitment procedures described above. A slightly modified version of the study 
introductory letter which notes in the opening paragraph that patients may now be eligible will be used in lieu of the 
standard introductory letter. 
 
Additionally, re-contact efforts will be attempted for patients who previously gave their verbal consent to participate but 
failed to return the written informed consent and HIPAA Authorization in order to be officially enrolled. The IRB approved a 
change to the protocol on 11/27/2018 which discontinued the requirement for informed consent and HIPAA Authorization 
to be obtained in writing. These patients may now be willing to be enrolled since written forms do not need to be 
completed and returned to the research office. This cohort of patients will be re-contacted following the usual recruitment 
procedures described above. A slightly modified version of the study introductory letter which explains in the opening 
paragraph that written consent forms are no longer required for enrollment will be used in lieu of the standard 
introductory letter. 
 
C.4. Intervention and Usual Care Descriptions. (PC-1, PC-2, PC-3, RQ-2, RQ-5). The tailored DVD titled  
“Time to ACT:  Approaches to Colon Testing” and patient navigator interventions are described in the following sections. 
All phases of intervention refinement will be conducted in consultation with our Community Advisory Board, which will be 
comprised of 8 members of the target population. Our Community Advisory Board (CAB), Ms. Sylvia Strom, our patient 
stakeholder and Chair of the CAB, and Ms. Rivienne Shedd-Steele, Director of the Indiana University Simon Cancer Center’s 
Office of Health Disparities and Community Engagement, will ensure the relevance of both interventions to a diverse group 
of users. By interacting with the patient navigator, participants will receive a barrier-reducing intervention that will be 
individualized based on their knowledge, health beliefs about CRC screening, and identified logistical barriers. The 
tailored DVD addresses these same theoretical concepts and will incorporate colors, screen designs, and music preferred 
by our CAB.  Usual care in the Eskenazi Health System endoscopy department begins with referrals for screening 

 
 
 
 
                                                               
8
colonoscopy that are generated by primary care providers in this integrated health system. Primary care providers enter 
colonoscopy orders into the electronic health record which are immediately communicated to the endoscopy department. 
Endoscopy department staff schedule an appointment, typically within 4-5 weeks of the referral, and mail an information 
packet about the procedure along with written instructions for completing the bowel preparation. The packet includes 
instructions to call with any questions and if necessary, to reschedule the appointment. Within 1-2 days prior to the 
scheduled appointment, an endoscopy department nurse telephones each patient to remind him/her of their appointment 
and answer any questions about the procedure, including completing the bowel preparation.  
C.4.a  Tailored DVD.  The 20 minute tailored DVD will be refined during the first 11 months in collaboration with Eo Studios 
in Athens, Georgia. The tailored DVD will be an expansion of our prior work in which we developed and tested a computer 
tablet-based tailored intervention to promote CRC screening in primary care settings (1R01-CA115983; Rawl, PI). For that 
study, we collaborated with Eo Studios, an experienced production company, to create a computer program with graphics, 
animations, video clips, and audio clips that were specifically targeted to African Americans. The program incorporated 
narrative colors, screen designs, and music preferred by our Community Advisory Board who worked with us on that study. 
Because some members of our target audience had limited health literacy, the program was completely narrated and 
required minimal reading. Some graphs, animations, videos, still images, and narrated messages from that interactive 
program will be used to refine/expand the new DVD program. However, we will need to adapt the existing program for a 
broader audience. Although we have video and audio clips of testimonials from people who overcame common barriers 
to CRC screening, we will need to develop segments that demonstrate the newer fecal immunochemical test (FIT) and 
update instructions for completing the bowel preparation. Simple and clear instructions, with illustrations, video clips, 
audio clips and animations will be developed for split-dosing of GoLYTELY® and Miralax, the two most common bowel 
preparations prescribed at Eskenazi. We have approximately 200 unique photographs acquired from on-site 
photography/videography and digital imaging libraries available from our prior studies. We also have a large number of 
audio clips that will be incorporated along with full-motion video clips demonstrating CRC screening tests, steps for 
completing them, and key testimonials. Additional graphics, video, and animations will be designed by Eo Studios. 
Animation will be incorporated in a variety of ways. For example, animation will be used within charts or graphs developed 
to illustrate CRC risk and animated icons and sound will be incorporated throughout the program to enhance the look, feel, 
consistency, and usability of the program. Our patient stakeholders (CAB members) will guide refinement of the tailored 
DVD. (PC-1, PC-3) 
       
Closing:  Provide test access information & encourage completion
Introduction to “Time to ACT:  Approaches to Colon Testing” 
Figure 3.  DVD CONTENT & FLOW
Welcome & Introduction by Dr. Hala Fatima, Director, Eskenazi Health Endoscopy
Description of colon anatomy, CRC development from polyps, risk factors, mortality
Benefits of screening:  CRC prevention & early detection
Features Morgan Freeman PSA, testimonials from CRC advocate and survivors
Brief descriptions of colonoscopy and FIT screening tests 
Demonstration of colonoscopy with tailoring by prep type
Colonoscopy barriers assessed & tailored barrier messages given by screening advocates
Do you intend to have colonoscopy in next 6 months OR want to hear more about FIT? 
More about FIT!  FIT demonstration
FIT barriers assessed & tailored barrier messages given by screening advocates
Colonoscopy vs FIT comparison:  Which are you more likely to do in next 6 months?
Colonoscopy!  Skip to Closing 
Colonoscopy! 
FIT !
 
 

 
 
 
 
                                                               
9
The DVD content and flow are shown in Figure 3.  After a brief introduction to the purpose of the DVD, the narrator will 
explain the location of the colon, what it does, and how colon cancer develops from polyps.  The program will describe the 
benefits of CRC screening and two commonly used screening tests:  colonoscopy and the fecal immunochemical test (FIT) 
which is a type of stool blood test. Barriers that people may have about screening tests will be assessed and messages 
delivered to overcome these barriers. Messages will be delivered by men and women who are CRC survivors and CRC 
screening advocates who vary in race and ethnicity. The DVD will provide demonstrations of each screening test, dietary 
restrictions, and the steps to complete them. All information will be presented with graphics, video demonstrations, and 
animations to accompany the narration. The goal will be to make the content easy to find and navigate. Minimal 
navigation expertise will be necessary.  Once the “Play” button is selected by the viewer, the program will automatically 
advance. Selected sections of the program will be available for re-playing by using the DVD Menu. The overarching 
intent of the study is to create both English and Spanish versions of the DVD.  However, development of the English 
version will take precedence due to time constraints by Eo Studios, our design firm.  We will open the study using the 
English version only and require that participants be able to speak, read, and write English in order to be eligible for 
enrollment.  Development of the Spanish version will occur in 2018.  When the Spanish version is completed, we will 
submit an Amendment to the IRB, along with the necessary accompanying documents, to offer the study to Spanish 
speaking patients. (PC-2, PC-4).   
C.4.b. Telephone-based Patient Navigation Intervention. The telephone based intervention has been developed and 
tested in prior research by our Ohio State University team members. Patient navigation (PN) also supplements face-to-
face clinical encounters with primary care providers and extends the limited time devoted to preventive care and health 
counseling. The proposed telephone PN intervention is theory-based and will be designed to: 1) increase knowledge, 
perceived benefits, and self-efficacy; 2) reduce barriers; 3) enhance access; and 4) provide social support. Theoretical 
constructs, objectives, and content of the PN interactions (minimum of two) are described elsewhere. Development of 
the web-based navigator protocol and documentation system (tracking log) will occur in collaboration with our 
biostatisticians and expert data manager. The goal of the protocol will be to guide trained PNs to counsel participants by 
telephone within a standardized framework. The protocol will serve as a counseling guide but will allow navigators 
flexibility to individualize contacts based on a participant’s expressed needs and concerns. The interface will provide 
prompts to assist PNs and allow them to document all encounters with, and on behalf of, participants.  
PNs will be trained to initiate as many encounters as needed to assist patients to complete CRC screening; 
however, a minimum of 2 telephone calls will be placed to all participants randomized to this group. The initial call will 
be placed approximately 2 weeks after mailing of the DVD to allow time for receipt and viewing of the DVD. During the 
initial call, the PN will use the web-based counseling protocol to first assess whether the participant has viewed the DVD. 
If the participant has not yet viewed the DVD, the PN will remind him or her to do so, answer any questions about 
accessing it, and reschedule the call for a later date. If the participant has viewed the DVD, the PN will then counsel to 
answer any questions and increase the participant’s knowledge of CRC screening, risk factors, and the benefits and 
harms of each screening test. The PN will then focus on assessing and reducing barriers to CRC screening and 
enhancing access. The web-based protocol will generate a checklist of topics and suggested talking points for PNs to use 
during each call. All encounters between the PN and the patient, as well as activities and contacts with others (GI 
resource nurse, primary care provider, community resources) that the PN initiates on behalf of the patient will be 
documented in the web-based documentation system. A sample of the PN tracking and documentation system as well as 
content covered in PN calls is included elsewhere. 
For patients who request a FIT, the PN will mail the test and place a follow-up call to answer questions about the 
test and encourage completion. Although there may be more intervening phone encounters, the PN will call participants 
who schedule a colonoscopy 1-2 days prior to their appointment. During this call, PNs will focus on: 1) reviewing the 
colonoscopy procedure and what the participant will experience; and 2) providing support and guidance for completing 
the bowel preparation, including managing dietary and medication restrictions. Although the protocol will provide 
structure for the PN calls, PNs will have complete flexibility to respond to and document participants’ specific questions, 
needs, barriers, and concerns. In addition, PNs will record all actions taken to assist participants in the web-based 
documentation system.   

 
 
 
 
                                                               
10
C.4.c. Training of Patient Navigators. PNs will be IU School of Nursing research RNs who are familiar with the study 
protocol and knowledgeable about CRC. They will have prior patient engagement experience. Initial training will be a 
half-day session presentation by our Ohio State University co-investigators, Dr. Mira Katz and Chasity Washington, who 
are experts in navigation.  Training objectives will be to have PNs: 1) understand the principles of patient navigation; 2) 
understand the scope of their role; 3) deliver barrier reducing messages to promote CRC screening uptake; 4) prepare 
participants scheduled for a colonoscopy; and 5) assist participants in completing a stool blood test (FIT). The Eskenazi 
Endoscopy Patient Navigator nurse will attend the training session and provide information on local resources that she 
currently uses for transportation, financial assistance, etc. This session will also include a presentation on intervention 
fidelity and quality assurance by an Ohio State co-investigator. A second half-day session will be conducted by the 
study’s Clinical Research Coordinator. The DVD intervention will be viewed so that navigators are refreshed on what 
colon health information patients will receive prior to their contacting them. In this session, PNs will also practice 
delivering the phone scripts, making entries into the training version of the REDCap PN database, and role-play common 
patient scenarios likely to be encountered. PNs will practice and role-play until they have reached 100% compliance with 
the intervention protocol. After the initial training sessions, monthly conference calls will occur among the PNs, Clinical 
Research Coordinator, and the Ohio State PN quality assurance monitor.   The calls will include additional training, a 
Grand Rounds case presentation, and the opportunity to discuss any concerns related to patient navigation. From these 
discussions, future training topics will be identified. Potential monthly training topics include: 1) addressing challenging 
situations; 2) revisiting patient empowerment approaches; 3) health literacy; 4) self-care: approaches to avoid feeling 
burned out; 5) time management; and 6) updates on community resources. 
 
C.5. Intervention Pretesting (RQ-2, PC-1, PC-3). Usability testing will occur with individual user feedback from members 
of the target audience. We will recruit 5 patients from our target population for individual user testing. Usability of the 
tailored DVD will be evaluated by assessing ease of use, content (leveling and appropriateness), aesthetic appeal, and 
cultural relevance. We will present prototypes of both interventions to our CAB (who represent our target population) 
as components are designed. The information gathered during individual user testing will be used to revise both 
interventions.  
 
C.6. Intervention Delivery (RQ-2). The tailored DVD program will be made available to subjects in two formats:  DVD and a 
web version.  At the start of subject accrual, the program will be limited to DVD format.  During the baseline interview, 
participants will be asked about access to a DVD player. For patients who have access to a DVD player, we will mail the 
tailored DVD. Since the numbers of patients who have access to the Internet is growing, and DVD players may be less 
common in the future, we will also make the tailored interactive program available for viewing online via the Internet 
for people who have such access. A Gallup poll conducted in 2013 showed that 80% of U.S. homes have a DVD player and 
73% have Internet access.83 For those who have access to both a DVD player and the Internet, the format for delivery of the 
tailored DVD will be based on participant preference. The DVD, or link to the website, will be mailed directly to 
participants’ homes after the baseline interview is completed. A letter will be included that instructs participants to view 
the DVD within the next 2 weeks and provides a toll-free number to call for technical assistance if needed. Trained 
research assistants and the project manager will be available to provide technical assistance to any participant who has 
difficulty viewing the DVD or accessing the tailored program online. If neither of these technologies is available in the 
home, through family or friends, or at the public library, we will loan portable DVD players to participants along with 
enclosed instructions and mailers for returning players to the research office.  
Patient navigators will begin contacting participants by phone about 2 weeks after mailing the DVD to set up an 
initial phone appointment, depending on the participant’s preference and availability. PNs will be trained to make as 
many contacts as needed to assist patients to complete CRC screening; however, a minimum of two calls will be placed 
to all participants randomized to the tailored DVD plus PN group.  If navigators are unable to reach participants by 
phone, a letter will be mailed requesting that participants contact them.   
 
C.7. Intervention Fidelity. (RQ-2) Published recommendations to ensure intervention fidelity address five components 
that are described below.84,85 1) Study design. The three group design ensures blinding of outcome data collectors to 

 
 
 
 
                                                               
11
participant group assignment, as feasible. 2) PN training. Training is addressed in Section B.6 above. 3) Intervention 
delivery. To ensure consistency of intervention delivery, evaluation of intervention processes is essential and several 
strategies will be used. DVDs or instructions with a link to view the program on the web will be mailed to participants. All 
PN calls will be recorded for quality assurance purposes, with a subsample randomly selected for evaluation. Audiotaped 
PN calls will be evaluated using a checklist we developed in prior studies. Project staff will discuss intervention delivery 
issues, technical support requests, and any unusual events during biweekly research team meetings. Modifications will 
be made as necessary and recorded to ensure appropriate intervention delivery and maintenance of protocol integrity. 
Decisions about modifications will be made jointly by the research team and recorded. 4) Intervention receipt. Since all 
participants in the intervention arms will receive the tailored DVD via mail or a web link, we will call each participant 
approximately 2 weeks after mailing to conduct a process evaluation of this intervention. Through the process interview, 
we will assess receipt of the DVD or web link, how much of the DVD was viewed (none, part, or all), as well as 
satisfaction with and relevance of the content for those assigned to both intervention groups. Participants will receive a 
$50 gift card for completing this process interview. Specific evaluation questions that assess user experience and 
satisfaction are included elsewhere. 5) Intervention enactment. All participants who return a completed FIT will have 
enacted the behaviors recommended in the interventions.  Those who attend a colonoscopy appointment are routinely 
asked about their experience with, and ability to complete the bowel preparation and refrain from eating solid food 
before the test. This information is documented in the EMR, and colonoscopy procedure notes will provide evidence 
that participants who choose this test have enacted the behaviors recommended in the interventions. The PN 
documentation record will provide additional data to support intervention enactment by participants assigned to this 
group.    
 
C.8. Data Collection. (RQ-6, PC-2, PC-3) Trained data collectors/interviewers who are employed by the Indiana 
University Center for Survey Research (CSR) will collect data via structured telephone interviews. Interviews will be 
conducted at baseline (T1), at 6 months post-baseline (T2), and at 9 months post-baseline (T3). If unable to reach 
participants when a phone interview is due, we will mail a letter to them requesting that they contact the CSR data 
collection team so that the interview may be completed. Reminder letters will be mailed to participants about 1 month 
before the T2 and T3 interviews are due. Process interviews will be conducted with participants assigned to the DVD 
intervention group approximately two weeks after mailing of the DVD.  The baseline interview includes a question to 
confirm age eligibility and assesses the following:  demographics, health literacy, health status, patient activation, CRC 
knowledge, CRC fear, cancer fatalism, colonoscopy-related procedural anxiety, social support, and media exposure. For 
both colonoscopy and FIT, the baseline interview asks questions about participants’ experience with each test and 
readiness to screen by each test.  Health beliefs for perceived CRC risk and colonoscopy and FIT perceived benefits, 
perceived barriers, and perceived self-efficacy are also collected. At completion of the baseline interview, participants 
will be randomized. People assigned to DVD or DVD + PN intervention groups will be told they will receive a DVD or 
instructions to access the website to view the program (based on their preference). Those in the tailored DVD + PN 
group will also be told they also will receive a phone call from the nurse navigator in about a week.  
 
The DVD process interview will assess receipt of, viewing of, and satisfaction with the DVD and will be done 
approximately 2 weeks post-mailing of the DVD. Receipt, experience and satisfaction with the PN intervention, for those 
randomized to the DVD+PN group, will be assessed as part of the 6 month interview (T2). The 6 month interview will 
also assess changes in knowledge, patient activation, CRC fear, cancer fatalism, and colonoscopy-related procedural 
anxiety. Health beliefs for colonoscopy and FIT will be assessed as will self-reported CRC screening intention, uptake and 
satisfaction with the screening experience (for those who completed screening). At 9 months, we will assess self-
reported CRC screening intention, uptake and satisfaction with the screening experience (for those who completed 
screening since T2). Participants will receive a $50 gift card for the baseline interview, a $50 gift card for the 6 month 
interview and a $50 gift for completing the 9 month interview; a total of $150 for participants who complete all three 
interviews. Participants who complete the additional DVD process interview will receive another $50 gift card for a total 
of $200 in gift cards. By using gift cards with an appealing dollar amount over the 9 month data collection period, we 
hope to incentivize participants to remain in the study. Additional retention strategies which we will use include mailing 

 
 
 
 
                                                               
12
participants a magnetic, refrigerator clip customized with the ACT Study name, phone number, and message “Working 
Together for Better Health”. The refrigerator clip will serve as a visible reminder of their participation in the study and 
provide a convenient way for them to know how to contact us. Participants will also be mailed newsletters and a 
birthday card. Our Research Assistants will make “check-in” calls to thank participants for continuing in the study, ensure 
that the gift card incentive was received, confirm that they have a working DVD player (if randomized to the DVD only or 
DVD + Patient Navigator group), remind participants of the next step, answer questions, etc. These brief calls are 
scheduled to occur at 4 different times over the 9 month time frame in order to keep participants continually engaged. 
For participants who miss who the DVD process interview, 6 month follow-up interview, or Patient Navigation 
intervention, we will mail them a letter. This letter lets participants know that we understand that it's not always 
possible to complete a study procedure when due and reassures them that they can still be in the study. By sending this 
letter, we hope to counteract any inclination participants may have about dropping out of the study because they 
missed a step. 
 
Table 3 on the following page describes the measures and data collection timeline. 
 

 
 
 
 
                                                               
13
  Table 3: Data Collection Timeline    
 
Measures 
Baseline 
Interview 
    (T1) 
Process 
Interview  
(2 weeks after 
mailing DVD) 
Follow-up 
Interview at  
6 months post-
baseline 
(T2) 
Final Interview at 9 
months post-
baseline 
(T3) 
12 months post-
baseline 
(Final medical 
record review) 
Demographics, social support, media exposure  
X 
 
 
 
 
Health literacy, health status to include co-morbidities 
X 
 
 
 
 
CRC screening experience and readiness to screen, patient 
activation, health beliefs (perceived CRC risk, benefits of 
screening, barriers to screening, self-efficacy for screening), 
CRC fear, cancer fatalism 
 
X 
 
 
X 
 
 
 
Colonoscopy-related procedural anxiety 
X 
 
X 
X 
 
CRC and screening knowledge 
X 
 
X 
 
 
Receipt, viewing and satisfaction with the DVD  
 
X 
 
 
 
Receipt, experience & satisfaction with the PN  
 
 
X 
 
 
Self-report of CRC screening intention and completion   
 
 
X 
X 
 
Satisfaction with the screening experience  
 
 
X 
X 
 
Trial participation feedback 
 
 
 
X  
 
Medical record review: CRC screening test completion,  
quality of bowel preparation  
 
 
X 
X 
X 
 
 
C.9. Measures. The primary study outcomes of CRC screening completion with any test (FIT or colonoscopy), and quality 
of bowel preparation (for those who complete colonoscopy), colonoscopy-related procedural anxiety and satisfaction 
with the CRC screening experience are described in this section. Secondary outcomes of the interventions include 
changes in knowledge and health belief variables (perceived risk, benefits, barriers, and self-efficacy). Other measures 
include patient activation, CRC fear, cancer fatalism, and satisfaction with the interventions. Measures have been 
extensively tested and refined in preliminary studies, and are described in more detail elsewhere. 
 
 
PRIMARY OUTCOME MEASURES: (RQ-6, PC-2, IR-4) 
Completion of any CRC screening test (fecal immunochemical test (FIT) or colonoscopy) will be measured by medical 
record review. FIT and colonoscopy completion dates will be extracted from the electronic medical record. Because self-
report of CRC screening has correlated well with medical record data,86,87 we will also use validated items from our 
previous research to ask participants if they have had a CRC screening test (FIT or colonoscopy) as well as their plan to 
have one in the next 6 months (only for those who have not yet completed screening).  
Quality of bowel preparation will be assessed two ways for those participants who attend their colonoscopy: 1) by 
participant self-report of their bowel prep experience and 2) via review of electronic medical records. When patients 
arrive in the endoscopy department, a nurse assesses their experience with the bowel preparation and adherence to 
dietary restrictions. Patients who report they were unable to complete the bowel prep or have eaten in the past 24 
hours are considered inadequately prepped for the procedure and sent home. These patients must repeat the 
preparation to cleanse the bowel and reschedule their colonoscopy. For those who report successful completion of the 
bowel prep and adherence to dietary restrictions, quality of the bowel preparation (i.e. degree of cleanliness/emptiness 
of the bowel) is evaluated by the endoscopist during the colonoscopy. Standard practice is to evaluate bowel 
preparation quality using an assessment similar to the Aronchick 5-point scale where 1=excellent, 2=good, 3=fair, 
4=poor, and 5=inadequate. Adequate is a term that may also be used to describe the quality of bowel preparation as a 
single descriptor or in addition to the Aronchick assessment as excellent (1), good (2), or fair (3). Procedural notes 
including endoscopists’ ratings of the quality of the bowel prep are entered into ProVation, a menu-driven software 
program. Therefore, participants will be considered inadequately prepped if they are: 1) deemed inadequately prepped 
from self-report during initial nursing assessment OR 2) if the endoscopist rates the quality of the bowel prep as poor (4) 

 
 
 
 
                                                               
14
or inadequate (5). Eskeanzi Health is introducing the Boston Bowel Preparation Scale (BBPS) as another type of bowel 
preparation quality measure. The BBPS measures quality on a 10 point scale of 0-9. BBPS evaluations will also be entered 
into ProVation by the endoscopist and compared to the Aronchick findings.  A decision will be made at a later time as to 
whether or not the BBPS ratings will be included in reporting this study outcome.   
 
SECONDARY OUTCOMES AND OTHER MEASURES (RQ-6, PC-3, IR-4) 
Demographics, health literacy, health status, social support, and media exposure will be assessed with items we have 
used in prior studies. Items will assess age, gender, marital/partnered status, number of persons living in the household, 
ethnicity, race, ethnic origin, education, employment, income, and insurance status. Additional items will assess health 
literacy, health status, comorbid conditions, and social support for having a colonoscopy. These items have been used 
for descriptive reporting in our previous research without interpretation or scoring difficulties. In the proposed study, 
questions about media exposure will assess previous exposure to information about CRC and colon testing.  
Colonoscopy-related procedural anxiety will be measured using the 6-item short form of the State Anxiety Scale of the 
State-Trait Anxiety Inventory developed by Spielberger.88 This scale measures how an individual is feeling right now 
when thinking about having a colonoscopy. Validity and reliability have been widely reported and this scale has been 
commonly used in studies of colonoscopy-related anxiety.  
Perceived risk for CRC will be assessed using two measures that consist of 5 items: a 4-item scale and a single item that 
assesses comparative age-adjusted risk. The summated risk scale was originally developed for breast cancer89,90 and 
adapted to CRC91. Validity and reliability have been extensively tested with diverse population groups. Internal 
consistency reliability analyses from previous studies yielded Cronbach’s alphas ranging from 0.75 to 0.79.59,92  
CRC screening experience and readiness to screen will be measured separately using 5 categorical items for colonoscopy 
and 6 categorical items for FIT. These items have been used in our prior studies to stage participants in terms of their 
readiness to uptake screening behaviors. 
Perceived Benefits of FIT and colonoscopy will be respectively measured separately using the 3-item and 4-item 
summated scales used in our prior studies.89,90,92,93 Cronbach alpha coefficients obtained in preliminary studies were 0.72 
for our 3-item benefits of stool testing scale and 0.69 for our 4-item colonoscopy benefits scale.92 
 Perceived Barriers to FIT and colonoscopy will be measured by separate summated Likert scales developed and 
validated by our team and used in previous studies.90,93,94  Barriers to FIT are measured using a 10-item scale; barriers to 
colonoscopy are measured using a 16-item scale with the same 4-point Likert response options. Cronbach alphas for the 
FIT barriers scales was 0.82 and for the colonoscopy barriers scale, 0.89.59,92 
Self-efficacy for FIT and colonoscopy will be measured separately on a 7 item scale for FIT and an 11-item scale for 
colonoscopy using 4-point Likert response options where 1=“not at all sure” to 4=“very sure” that I am able to do each 
of the steps involved in CRC screening. Self-efficacy scales for FIT and colonoscopy had Cronbach alphas of 0.87 and 
0.88, respectively, in our previous studies.59,92  
CRC Fear will be measured using an 8-item scale that assesses participants’ emotional reactions to thinking about CRC. 
This scale was originally developed to assess breast cancer fear and had an internal consistency reliability of .91 in our 
prior mammography studies. Construct validity has been shown through factor analysis and testing of theoretical 
relationships.95 We will adapt the cancer fear scale for CRC by substituting colon cancer for breast cancer. 
Cancer Fatalism will be measured using Mayo’s modification of the Powe Fatalism Inventory, which assesses the degree 
to which a person equates cancer with death.96-98  This scale uses 4-point Likert response options for 11 statements that 
assess cancer fear, pessimism, predetermination, and inevitability of death. The Cronbach alpha for this scale was 0.86.92  
Knowledge of CRC and Screening will be measured using an 9-item multidimensional scale that has been tested in 
preliminary studies and found to have content and construct validity. Several aspects of knowledge about CRC and CRC 
screening tests will be assessed, including risk factors.  
Patient Activation will be measured using the 13-item short form Patient Activation Measure (PAM) scale developed by 
Hibbard.  It assesses patient knowledge, skill, and confidence for self-management. This scale uses 4-point Likert 
response options. 
User Experience with the DVD will be measured using a 15-item scale developed to assess participant’s experience with 
the tailored DVD. The scale will include items to assess cognitive engagement, personal relevance of information, and 

 
 
 
 
                                                               
15
esthetic/emotional appeal of the program.  Items will be scaled so that higher scores reflect a more positive user 
experience on all dimensions. Items selected will be based on relevant literature and effective use in our prior studies.  
We will also include 6 quantitative items to assess the DVD in terms of being helpful, providing new information, and 
whether or not it would be recommended to others. 
Satisfaction with the Patient Navigator will be measured using 19 items tailored for study relevancy from the 26-item 
satisfaction scale used in the national Patient Navigation Research Program. This scale assesses participants’ degree of 
satisfaction with the help received from the navigator using a 3-point response scale where 1=not satisfied and 3=very 
satisfied. An additional 20 items assess participants’ satisfaction with the interpersonal relationship with the navigator 
using 4-point Likert response options where 1=strongly disagree and 4=strongly agree.   
Trial Participation feedback will be collected using 4 independent items. Participants will be asked to tell us what they 
enjoyed, if anything, about being in the study.  They will also be asked to tell us what was the hardest part about being 
in the study. Additionally, participants will be asked if they would recommend the study to others who need a colon test 
(yes or no response options). Lastly, participants will be asked if they are willing to be contacted in the future about 
participating in other research studies (yes or no response options). 
 
C.10. Training of Recruiters and Data Collectors. (PC-2)  Recruiters will be trained by the PI and project manager 
whereas data collectors will be trained, supervised, and monitored by the Center for Survey Research (CSR) staff in 
collaboration with the PI. Detailed training manuals for recruiters and data collectors that were developed for our 
preliminary studies will be modified for the proposed study. Initial training sessions for recruiters and data collectors will 
include: 1) overview of study objectives and rationale; 2) description of interventions; 3) description of data collection 
instruments; 4) protection of human subjects, HIPAA and confidentiality issues; 5) cultural sensitivity; 6) roles and 
responsibilities of project staff members; 7) schedules; 8) documentation and reporting requirements; and 9) quality 
assurance procedures. Time will be allocated for multiple discussion and question/answer periods. 
Recruiters will be trained on effective recruitment procedures, including: 1) study recruitment letters, procedures, and 
telephone scripts; 2) handling problems or questions during telephone recruitment; 3) use of the REDCap tracking 
database to log recruitment and other study procedures; and 4) recruitment monitoring and quality assurance 
procedures. Training will include demonstrations of effective recruitment calls. Following demonstrations and practice 
sessions, recruiters will role-play and receive feedback until they have reached 100% compliance with guidelines for 
recruitment integrity.  
 
Data collectors selected from CSR for this study will be experienced interviewers.  Prior to the study-specific 
training described below, CSR data collectors will have completed a rigorous 9-hour telephone interviewing training 
course, with four hours spent in hands-on practical experience in which the trainee-to-supervisor ratio is 5:1. This 
training course covers: 1) the interviewer’s role in survey research; 2) standardized interviewing techniques; 3) 
administration of survey introductions and refusal aversion techniques; 4) use of computerized sample management 
and data collection systems; 5) protection of human subjects and sensitive information; and 6) daily case management. 
Comprehension of concepts and techniques and skill in their execution are assessed through a battery of tests at 
appropriate intervals in the training course; trainees do not matriculate to the next phase until all prior phases are 
mastered. Additionally, CSR data collectors will be trained on: 1) specific interviews to be conducted for each wave of 
data collection; 2) handling problems or questions during data collection; and 3) data monitoring and quality assurance 
procedures. Training will include demonstrations of effective data collection interviews using the computer-assisted 
telephone interview software (CATI). Following demonstrations and practice sessions, data collectors will role-play and 
receive feedback until they have reached 100% compliance with guidelines for data collection integrity.  
 
C.11. Quality Assurance of Recruitment and Data Collection. (PC-2) Job performance of data collectors will be closely 
monitored by the project manager and the IU Center for Survey Research (CSR) supervisors to ensure their adherence to 
the study protocol. Telephone interviewing stations at the CSR allow supervisors to listen to interviews and view data 
collectors’ computer screens remotely in real-time without the knowledge of the interviewers. All data collectors will be 
monitored regularly, with a goal of once during every shift. One monitoring session will include listening to at least 20 
interview questions. The project manager will routinely listen to randomly recorded recruitment calls to ensure 

 
 
 
 
                                                               
16
adherence to the recruitment script and handling of refusals. Ten percent of all interviews and recruitment calls will be 
monitored for quality assurance purposes. Feedback will be provided after monitoring sessions to correct any 
performance weaknesses.  
 
C.12. Sample Size, Power Analyses (RQ-2, RQ-4, IR-3). The revised sample size estimate of 115 per group for analyses is 
based on ensuring adequate power for Aim 1 (see Table 4). The main objective is to compare the 12-month CRC 
screening rates with any test among the three groups, so the binary outcome of any CRC screening test completion at 12 
months as documented in the electronic medical record has driven calculation of our sample size. For Aim 1, we will first 
test whether there is any overall group difference in CRC screening completion rates using a chi-square test at 5% 
significance level. If a significant difference is observed, pairwise comparisons will be conducted at α=1.7% (5%/3 
pairwise tests) to account for multiple testing. Expected CRC screening rates, based on prior studies demonstrating the 
effects of computer-tailored and PN interventions, are shown in Tables 1 and 2, respectively.  We have revised our DVD 
only effect calculations from the original estimate of 15.5% to 20% for this group. We originally proposed a DVD only 
effect size of 15.5% based upon the average effect size of studies listed in Table 1. This 15.5% estimate assumed that the 
lowest rate observed in the DVD only group might be near 20% (Rawl, 2015) and lowered that rate even further to 
15.5% to be more conservative, as statisticians typically assume very conservative effects when doing power 
calculations. However, by assuming a value closer to, but still less than the lowest rate observed in the literature for a 
comparable population (which was 22% seen in Rawl, 2015 per Table 1), the samples sizes can be reduced to 115 per 
group for Aim 1. This sample size will afford at least 80% power for all three comparisons per Table 4 below. To allow for 
an approximate 25% attrition which the project is experiencing as of May 31, 2019 and still have 115 per group for 
analyses, a total sample size of 450 enrolled subjects is required.  
 
Table 4. Revising the expected rate in the DVD group to 20% (still smaller than the smallest rate for a tailored 
intervention in Table 1) 
 
 
 
 
 
 
Several studies have shown that patient navigation is an effective method to increase CRC screening rates especially in 
minority groups with effect sizes shown in Table 2 (average of 33.7).  We conservatively estimated a 44% (less than 33.7 
+ 20 = 54%) effect size for the PN + DVD since we will enroll patients who have previously canceled a screening 
colonoscopy appointment. For usual care, we used the estimate from Rawl, 2015 in Table 1 as it is most similar to the 
proposed study.  See Table 5 below for summary. At 12 months, 115 in each group will yield at least 80% power for 
detecting the pair-wise differences (44% v. 20% v. 5%) in completion rates among the three groups using pair-wise chi-
square tests or bivariate logistic regression models and a two-sided α=.017 level.  Back-calculation, assuming an attrition 
rate that is approximately 25% from the sample size needed at 12 months, it requires that we approach 600 eligible 
subjects to enroll 450 (75% participation rate) and randomly assign them to the three intervention groups (150 per 
group). By 12 months, the 150 in each intervention group 
will decrease to 115 through an approximate 25% 
attrition. The multivariable logistic regression models for 
the intervention effect on the CRC screening completion 
outcome while accounting for covariates will very likely 
have greater than 80% power, more than for the bivariate 
models because a smaller sample size is required when 
covariates are added to the model.99  In addition, this sample size will most likely ensure greater than 80% power for 
other outcomes of Aim 1 (quality of bowel preparation, anxiety, and satisfaction) because they are continuous or ordinal 
variables. Specifically, the analysis of continuous outcomes using a general linear model will have 99% power to detect a 
Comparison 
Rates 
Sample Size for Groups 
Power 
PN+DVD vs DVD only 
44% vs 20% 
115 vs 115 
92% 
PN+DVD vs Usual Care 
44% vs 5% 
115 vs 115 
99% 
DVD only vs Usual Care 
20% vs 5% 
115 vs 115 
80% 
Table 5. Power Analyses 
Time/Test 
 
PN plus DVD 
(n=115 at    
9 mos) 
DVD only 
 (n=115 at   
9 mos) 
Usual Care 
(n=115 at  
9 mos) 
Power 
9 month/ 
Any Test 
44% 
20% 
 
5% 
 
.80-.99 

 
 
 
 
                                                               
17
small effect size of .50 standard deviation units between outcome means, and the ordinal logistic regression models will 
have more information than the binary models.     
        For Aim 2, our main interest is in whether the intervention effects differ by age, race, gender, and income.  We 
consider this aim to be exploratory as we do not have preliminary data to estimate the effect sizes; however, we feel it is 
important to explore interactions in this study as they may identify subgroups of patients who may not need the more 
intensive support of a PN. For Aim 3, the revised sample size of 115 per group will allow for the detection of mediation 
effects with 80% power assuming the effect sizes from the intervention to mediator and from the mediator to outcome 
are moderate or higher (which is what is typically assumed in a power calculation). For Aim 3, to test mediation effects, 
we will use the percentile bootstrap method to estimate the indirect/mediated effect.100  Simulations of the two-path 
mediation model in Mplus101 (Table 2) show that 115 subjects per group are needed to have 80% power to test the total 
indirect effect using the Sobel approach when the effect of the independent variable (the intervention variable here) on 
the mediator is small (.2) and independent variable on outcome is medium (.39). Using the percentile bootstrap method 
instead of Sobel should afford the same or greater power. 
 
C.13. Data Analyses. (IR-3, IR-5, MD-3, MD-5, HT-1, HT-2, HT-3, HT-4)  Preliminary analyses will compare baseline 
demographic information across groups using means and standard deviations for continuous variables and frequency 
distributions for categorical variables. We will adjust for those characteristics in subsequent analyses if significant 
differences emerge at a conservative level for inclusion of a covariate (p<.20). Characteristics of participants who drop 
out by 9 months will be compared with those who remain to determine what biases may exist. (MD-4) The above 
analyses will be conducted using ANOVA, chi-square tests, or exact or non-parametric equivalents.  If there appear to be 
biases in dropout, we will conduct pattern mixture models analyses to see how the results could change based on the 
MAR assumption (IR-5, MD-2, MD-3, MD-5). Primary analysis of outcomes will employ an intent-to-treat analysis; all 
participants will be included regardless of compliance with interventions. The main outcome, CRC screening completion 
with any test (FIT or colonoscopy) will be extracted from medical records for all participants, including those who drop 
out or are lost to follow-up. Intervention exposure will be measured and its effects will be accounted for in the intent-to-
treat analysis. First, we will know whether participants viewed none, part, or all of the DVD. Second, we will document 
how many contacts PNs make to or on behalf of participants assigned to that group. These variables (viewed none/part/ 
or all of the DVD and number of navigator contacts) will be added as covariates in analyses. For all aims, sensitivity 
analysis will be conducted as needed for each outcome to assess the effects of the model assumptions on the results 
(IR-5). Assumptions, such as normality of residuals, will be checked and appropriate modifications to the analysis plan 
applied if needed, such as transformations or use of non-parametric methods.  From our prior studies, we expect 
missing data to be minimal (less than 2%) for subjects during participation. For missing data on scales, we will use mean 
imputation as long as two-thirds of the questions have been answered (or per validated instrument instructions, if 
otherwise). (MD-2, MD-3)  
     
For Aim 1, we will test the primary hypothesis related to comparing intervention effects among the three 
randomized groups (H1.1: PN+DVD vs. DVD only and H1.2: PN+DVD vs. usual care and DVD only vs. usual care) using the 
outcome of completion of CRC screening using any test at 12 months post-baseline. In addition, quality of bowel 
preparation, procedural anxiety, and satisfaction with the screening experience will be examined as outcomes. As an 
initial assessment of CRC screening completion at 12 months, we will use a chi-square test for a 3 x 2 (group by screening 
completion) contingency table to test whether completion rates differ across groups. If the p-value for the overall test is 
significant at the .05 level, pair-wise 2 x 2 tests will be conducted at the .05/3=.017 level. However, the primary analyses 
for Aim 1 will involve fitting multivariable logistic regression models of the primary outcome of 12-month CRC screening 
test completion (yes/no). Independent variables will be group assignment and continuous and categorical individual 
characteristics. These models will also allow us to investigate intervention effects on CRC screening test completion 
while adjusting for potential confounders. Group assignment will be coded using dummy variables with usual care as the 
reference category. For H1.3, quality of bowel preparation will be analyzed for those participants who complete 
colonoscopy with proportional-odds ordinal logistic regression using an ordinal dependent variable (1=excellent, 2=good, 
3=fair, 4=poor, 5=inadequate). If some outcome categories are sparse, the outcome will be dichotomized into adequate 

 
 
 
 
                                                               
18
(excellent or good) versus inadequate (fair, poor, or inadequate). The outcomes of anxiety and satisfaction are 
continuous outcomes and will be modeled with linear regression.  
Aim 2. Examine age, race/ethnicity, sex and income as potential moderators of intervention effects. (RQ-4, HT-1,  
HT-2, HT-3, HT-4)  We will fit multivariable models as in Aim 1, except now including interaction terms for age (< 65, age 
65+), race/ethnicity (Non-hispanic Black, Non-hispanic White), sex (male, female), and annual income (<$15,000, 
≥$15,000), respectively. Moderators will be identified by significant interaction terms in regression models.  The key 
moderation effects of interest will be between PN+DVD vs. DVD only. Moderation of PN+DVD vs. usual care, and DVD 
only vs. usual care also will be examined. Hispanics will be excluded from race/ethnicity interaction tests due to small 
sample sizes. 
Aim 3. Examine changes in knowledge and health beliefs (knowledge, perceived risk, perceived benefits, barriers, and 
self-efficacy) as potential mediators of intervention effects. (RQ-6)  Mediation analysis will be conducted to identify 
potential mediators. Specifically, for each of the variables (changes in knowledge, perceived risk, perceived benefits, 
perceived barriers, and self-efficacy) mediation effects will be estimated in an logistic regression setting, fitting the 
appropriate mediation models using MPlus100 and then testing indirect effects using the percentile bootstrap approach 
to estimate the indirect effect.101 We will fit models that estimate the effects of PN plus DVD vs usual care and DVD only 
vs usual care, and also models that compare the strength of the indirect effects between the PN plus DVD and DVD only 
arms.  We expect to see a difference in mediation effects mainly on barriers, with the PN plus DVD having a greater 
mediation effect on barriers than DVD only. 
C.14. Potential problems, strategies and benchmarks for success. Potential problems are described below along with 
plans to minimize them.  (IR-6, MD-1, MD-2, MD-4) 
• 
Loss to follow-up: It is anticipated that there will be some loss to follow-up because of participant dropout, death, or 
relocation. Based attrition data through May 31,2019 , we estimate the loss to be approximately 25% over the 9-
month study period, which has been accounted for in the revised power analysis and sample size determination. 
• 
Limited internal validity: Randomization will minimize the influence of extraneous variables on outcomes. 
• 
Missing data: Missing data will be minimized through the use of telephone data collection methods and through 
interviewer training. All characteristics at baseline will be examined to determine potential bias that would require 
subsequent caution regarding interpretation of results.  
• 
Limited generalizability: We will recruit participants from one safety net system who will be predominantly low-
income, which limits generalizability. However, we will compare outcomes for a racially diverse group of low-income 
patients and explore whether age, sex, or race/ethnicity moderate the effects of the two interventions. (RQ-4, IR-6)     
• 
Sample bias: Based on our preliminary studies, we estimate that approximately 55% of eligible people who are 
contacted will be willing to participate. It is possible that those who are motivated to complete CRC screening will 
self-select into the study. To examine the representativeness of our sample, we will compare demographic 
characteristics of those who agree to participate with those who do not. (PC-2, IR-6)      
C.15. Impact:  At the completion of this study, we will have developed two theory-based and highly translatable and 
easy to disseminate interventions to promote CRC screening and improve quality of bowel preparation for those who 
undergo colonoscopy. These interventions will be designed to be flexible and modifiable as science advances and as the 
needs of individual patients and health care systems change. Interventions that are easily modified to meet the needs of 
diverse populations and settings that counsel patients about the need for CRC screening, support them to complete 
screening in a timely manner, and assist those who undergo colonoscopy to properly prepare (cleanse their bowel) for 
the procedure are urgently needed. Knowledge of the comparative effectiveness of these interventions will inform the 
next steps required for translation of interventions into clinical practice.    
 
 

 
 
 
 
                                                               
19
D.  Project Timeline and Milestones   
 
Meetings of investigators and stakeholders will be on-going throughout the study period. All investigators will attend 
monthly research team meetings. Clinical and patient stakeholders will meet with investigators every other month 
during the first 9 months of the study. Stakeholder meetings will be held quarterly throughout the remainder of the 
funding period.  Other milestones are reflected in the timeline and include:  
• 
Start-up will occur during the first 2-3 months of the proposed project and will involve finalizing the study protocol, 
obtaining IRB approval, and hiring and training research staff.  In addition, the patient navigation and tailored DVD 
interventions will be refined, with patient navigators hired and trained, during the first 9 months.  
• 
Participant enrollment and baseline data collection will begin in Month 13 and continue for 24 months, accruing 
approximately 20 participants per month or 5 each week. 
• 
Intervention delivery will begin in month 14 and continue for 28 months 
• 
Follow-up data collection will occur at 6 months after the baseline interview (T2) and at 9 months post-baseline 
(T3). Process interviews also will be conducted to assess receipt, viewing (of the DVD), and satisfaction with the 
interventions.   
• 
Data analysis, reports, abstracts, and publications will be prepared during the final 15 months of the study. 
• 
A 6 month no cost extension period will allow us to complete the 12 month EMR review, conduct data cleaning and 
analyses, and prepare the Final Progress Report. 
 
E.   Patient Population  (RQ-2, RQ-3, RQ-4, PC-1, PC-2) 
E.1. Sample and eligibility criteria. 450 people who canceled or did not attend their colonoscopy appointment will be 
enrolled in this study. Participants will be eligible if they are 50-75 years old if non-African American or 45-75 years old if 
African American and were referred to Eskenazi’s endoscopy unit for a colonoscopy. Stratified block random assignment 
to each of three groups will be performed within 12 strata formed by crossing sex, three race/ethnicity groups, and two 
age levels (male/female, Black/White/Hispanic, age<65/age 65+) to ensure that the three randomized groups are 
comparable in distribution of sex, race/ethnicity, and age. At the completion of the baseline interview, patients will be 
randomly assigned to the tailored DVD-only group, the tailored DVD plus patient navigator group, or usual care. Based on 
the 65% participation rate we achieved in our recent R01 conducted in this same health system, we conservatively 
estimated our participation rate at 55%. However, our actual, cumulative participation rate for eligible subjects was 75% 
through May 31, 2019. Therefore, we will need to contact approximately 600 eligible people to enroll 450. Data from 2014 
 
Activity by Quarter: Beginning with July 2016 
 
Q1   Q2   Q3   Q4 
Q1   Q2   Q3   Q4 
Q1   Q2   Q3   Q4 
Q1   Q2   Q3   Q4 
Q1   Q2   (NCE: 6 Mo) 
Finalize protocol/ IRB approval  
X 
 
 
 
 
Registration of trial on clinical trials.gov 
X 
 
 
 
 
Advertise/hire research staff  
X 
 
 
 
 
Training research staff 
X     X 
 
 
 
 
Intervention refinement 
X     X      X   
 
 
 
 
Stakeholder/Comm. Advisory Board meetings  
X     X      X       X  
X      X      X      X 
X      X      X     X 
X      X      X      X 
 
Intervention pre-testing 
               X 
 
 
 
 
Development/testing of databases 
       X      X 
 
 
 
 
Participant enrollment  (n=450) 
 
X      X      X      X 
X      X      X      X   
X   
 
    Completion of 25% of enrollment (n=113) 
                                                             X  
             
 
 
    Completion of 50% of enrollment (n225) 
 
                                   X 
 
 
    Completion of 75% of enrollment (n=338) 
 
 
                X  
 
 
    Completion of 100% of enrollment (n=450) 
 
 
                                   X 
 
Baseline interviews, intervention delivery  
                                    X      X      X      X 
X      X      X      X 
X      X      X 
 
Process evaluation interviews 
                                    X      X      X      X 
X      X      X      X 
X      X      X 
 
6 month interviews  
 
                  X     X 
X      X      X      X 
X      X      X 
 
9 month interviews 
 
                         X 
X      X      X      X 
X      X      X      X 
 
Medical record audits 
 
 
X      X      X      X 
X      X      X      X 
X 
Data cleaning and preliminary analyses 
 
 
                 X      X 
X      X      X      X 
 
Analysis, write-up, dissemination 
 
 
 
         X     X      X 
X      X 
Datasets and codebooks prepared for sharing 
 
 
 
 
X      X 
PCORI Reports 
       X                X 
       X                X 
        X              X 
         X              X 
        X            

 
 
 
 
                                                               
20
indicate the availability of 1150 potentially eligible patients during that 12 month period (See Table 6). An estimated 2200 
would be available over the 24 month enrollment period. Based on our preliminary studies, no more than 20% attrition 
was anticipated at 9 months. Actual data from Year 3 of this project as of May 31, 2019 shows an attrition rate closer to 
25% at the 6 month follow-up timepoint. This approximate 25% rate is being used in re-calculating the sample size 
required.  
 
Table 6.  Colonoscopy orders, completion rates and non-completion rates by race/ethnicity and gender   
 
 
 
 
 
 
 
 
 
 
E.2. Study Site, Colonoscopy Referral, and Scheduling Process.  Patients who have been scheduled for, but not completed, 
colonoscopy at the endoscopy department in our local safety net health system will be recruited. The Eskenazi Endoscopy 
Department has 4 procedure rooms and is staffed each day by 2-3 gastroenterologists. In a recent 12-month period, 5,702 
procedures were performed, with an average of 20-35 scheduled daily. Colonoscopy referrals come from nine 
clinics/community health centers that comprise the Eskenazi Primary Care Network/ Community Health Centers. Eskenazi 
Community Health Centers see approximately 205,000 patient visits/ year, with 50% of visits financed by Medicare or 
Medicaid and 40% financed by the county indigent care health insurance program or self-pay. The indigent care program 
provides financial assistance to patients at or below 200% of the federal poverty level who have inadequate or no 
healthcare coverage. The Eskenazi clinics and endoscopy department use an integrated electronic medical record (EMR) 
system as their clinical data repository for patient care. Primary care providers enter referrals (orders) for colonoscopy into 
the EMR and patients are automatically scheduled using an open access system (i.e., no appointment with a 
gastroenterologist required). The referral is sent electronically via the EMR from the primary care clinic to the endoscopy 
unit. Within one week, patients receive a letter with their colonoscopy appointment date/time along with written 
instructions for preparing for the test and for rescheduling if they cannot attend. Reminder calls are placed by an 
endoscopy nurse 1-2 days prior to the appointment. Most of the cost for colonoscopy is covered by the indigent care 
program. Patients with commercial or governmental coverage pay the amount specified by their insurer; those without 
insurance who have household incomes below 200% of poverty are eligible for the indigent care program and pay $40 for 
colonoscopy. Patients without insurance who do not qualify for the indigent care program pay 50% of the cost at the time 
of scheduling and 25% after the test is complete. 
E.3 Recruitment.  Trained study staff will recruit participants using procedures consistent with clinic and HIPAA 
requirements. On a weekly basis, Eskenazi Health IT department will generate lists of age-eligible patients at average risk 
who did not attend their colonoscopy appointment. The list will include 2 groups of average risk patients who missed 
their appointment: 1) patients who had a colonoscopy screening ordered; and 2) patients who had a recent fecal 
immunochemical test (FIT) that was positive with a follow-up order for colonoscopy. Due to differences in physician 
ordering practices, the follow-up colonoscopy can be ordered as a colonoscopy screening, colonoscopy diagnostic, or 
colonoscopy high risk. Patients will be approved for contact by Dr. Fatima, Director of the Eskenazi Health Endoscopy 
Department. Patient information will be released to the study’s data manager, the Eskenazi Endoscopy Department’s 
Patient Navigator nurse, and trained research staff at the IU School of Nursing using secure electronic data transfer 
methods.  Information disclosed is limited to that which is necessary to determine eligibility and to contact patients by 
mail and telephone. As a first step, the Endoscopy Patient Navigator nurse will screen patients by looking back 10 years 
and excluding any with a history of adenomatous polyps, sessile serrated polyps, or any mass suggestive of neoplasia. 
Patients with a history of hyperplastic polyps, lymphoid tissue, or no polyps will be recruited. Research staff at the IU 
 
Race/ethnicity 
Colonoscopies 
ordered 
                 N              % 
Colonoscopies completed 
                    N                   % 
Colonoscopies NOT completed 
                           N               % 
Black/African 
American 
1254          64% 
                    505            40.3% 
                              749          59.7% 
White/Caucasian 
664          34% 
280            42.2% 
                              384          57.8% 
Hispanic 
44            2% 
26            59.1% 
                                18          40.9% 
 
 
 
 
Sex:                Male 
                 806          41% 
                   324           40.2% 
                             482          59.8% 
                       Female 
               1156          59% 
                   487           42.1% 
                             669          57.9% 
Total 
               1962        100% 
                   811           41.3% 
                           1151          58.7% 

 
 
 
 
                                                               
21
School of Nursing will send introductory letters, signed by the Principal Investigator and a co-investigator who is a 
member of the Eskenazi Medical Staff, along with a recruitment brochure and Study Information Sheet that explains the 
study to all approved patients. The letter informs patients that they will receive a phone call about the study within the 
next week unless they call a toll-free number to indicate they do not wish to be contacted. One week after letters are 
mailed, trained recruiters at the School of Nursing will contact potentially eligible participants who have not called the 
toll-free number. Recruiters will explain the study and answer questions about study requirements, potential risks, and 
compensation. Adequate speech, hearing, and cognition of potential participants will be confirmed by recruiters based 
upon the phone conversation. They will then proceed to determine eligibility, obtain both verbal informed consent and 
verbal HIPAA Authorization, and schedule a convenient time to conduct the baseline interview. Each participant who is 
not reached will be called back up to, but no more than, 10 times. Recruiters will document each call attempt including the 
date, time, disposition, and callback preference. Participants who decline to participate will be thanked for their time, with 
their response and reason for refusal recorded. Proposed recruitment procedures have been previously tested and found 
to be successful in our prior studies. Any unanticipated challenges to recruitment will be discussed with the research team, 
our CAB and clinical stakeholders.  
 
F.  Research Team and Environment    
Research Team Experience. This proposal builds upon extensive preliminary work conducted by these investigators at 
Indiana and the Ohio State Universities. Dr. Rawl’s program of research began with development of valid and reliable 
instruments to measure health beliefs about CRC screening. We then developed and tested theory-based interventions to 
promote discussions about risk-appropriate CRC testing between patients and providers. Drs.  Rawl, Champion, Imperiale, 
and Perkins recently completed a randomized trial of a tablet-based, computer-tailored intervention to increase CRC 
screening among 672 African American patients in primary care settings.  Drs. Rawl, Schwartz and Imperiale are 
collaborating on a PCORI-funded study to examine the impact of including detailed quantitative information into a decision 
aid for CRC screening (Schwartz, PI).  Ms. Rivienne Shedd-Steele, Director of the Indiana University Simon Cancer Center’s 
Office of Health Disparities and Community Outreach, has been a long-term collaborator with this team.  She has been 
instrumental in assisting with identification of patients and community leaders who have served as Community Advisory 
Board members on numerous studies. During the past year, Drs. Rawl and Fatima and two Eskenazi endoscopy nurses 
collaborated on a mixed methods pilot study to examine barriers and facilitators of colonoscopy completion among 
Eskenazi patients. Through in-depth telephone interviews, we heard directly from patients about the challenges they 
face regarding colonoscopy. Drs. Paskett and Katz are lead investigators at The Ohio State University, one of nine sites that 
comprise the National Patient Navigation Research Program. This program has tested the effects of patient navigation for 
people with abnormal screening results. Their expertise in designing and testing navigation as an intervention is essential to 
this project. Eo Studios President and CEO, Mark Magnarella, has extensive experience developing award-winning health 
media including tailored DVD and web-based programs such as our tailored tablet-based intervention and our web-based 
intervention to promote mammography. His company’s collaboration on refinement of the DVD and producing both web-
based and DVD-based delivery formats is also essential to the success of this project.  
Data collection methods, instruments, recruitment procedures, training protocols, and theory-based interventions 
tested in our preliminary studies provide strong evidence that the proposed methods are both feasible and effective. This 
study represents the logical next step in our active program of research to test innovative approaches to increase CRC 
screening. This highly qualified team of investigators has a strong history of collaboration and extensive experience 
conducting behavioral, intervention, and health services research.  
Please see the People and Places section for biosketches of all key personnel and detailed site descriptions.  
 
Study Site:  Eskenazi Hospital and Health System is the local safety net health system serving residents of Marion County, 
Indiana, and the metropolitan Indianapolis area. The Eskenazi Endoscopy Department has 4 procedure rooms and is staffed 
each day by 2-3 gastroenterologists. In a recent 12-month period, 5,702 procedures were performed, with an average of 
20-35 scheduled daily. Colonoscopy referrals come from nine clinics/community health centers that comprise the Eskenazi 
Primary Care Network/ Community Health Centers. These centers see approximately 205,000 patient visits/ year, with 50% 
of visits financed by Medicare or Medicaid and 40% financed by the county indigent care health insurance program or self-

 
 
 
 
                                                               
22
pay. The indigent care program provides financial assistance to patients at or below 200% of the federal poverty level who 
have inadequate or no healthcare coverage. The Eskenazi clinics and endoscopy department use an integrated electronic 
medical record (EMR) system as their clinical data repository for patient care. Primary care providers enter referrals 
(orders) for colonoscopy into the EMR and patients are automatically scheduled using an open access system (i.e., no 
appointment with a gastroenterologist required). The referral is sent electronically via the EMR from the primary care clinic 
to the endoscopy unit. Within one week, patients receive a letter with their colonoscopy appointment date/time along 
with written instructions for preparing for the test and for rescheduling if they cannot attend. Reminder calls are placed by 
a clinic secretary 1-2 days prior to the scheduled appointment. The non-completion rate was 59% in 2014 meaning that 
approximately 1150 people went unscreened for CRC in that one-year period.  
 
G.  Engagement Plan (PC-1, PC-3, PC-4, RQ-2, RQ-5, RQ-6)    
G1. PLANNING THE STUDY:     
A diverse 6-member Community Advisory Board (CAB) was actively engaged in the planning of this study, providing 
valuable input and critique of the proposed plan. The following individuals participated in a 2-hour dinner meeting 
during which the PI provided background information about CRC, past studies completed, and the proposed study aims, 
design, and interventions.  All members expressed great enthusiasm about the study, believed it was an important topic 
that is highly relevant to their communities, and provided helpful feedback regarding what should be included. All six 
agreed to continue to work on this project as members of the CAB and are described below.       
 
Ms. Sandra Bailey is a 56-year-old African American woman who receives health care at Eskenazi Health. Ms. Bailey is a 
resident of, and a community leader in, the Indianapolis Housing Authority (IHA). She regularly arranges educational 
opportunities, including health education for IHA residents, most of whom are low-income minorities.  
Mr. Robert Breskow is a 55-year-old Caucasian man who resides in Indianapolis and receives his health care through 
Eskenazi Health Hospital and its clinics.  He is a strong advocate for colon cancer screening. 
Ms. Beatrice Cork is a 62-year-old African American woman whose mother and father died from colon cancer.  Ms. Cork 
was a member of our Community Advisory Board for our recent study to increase CRC screening for African Americans.  
Mr. Thomas Griffin is a 61-year-old African American who is the President of the Indianapolis Chapter of Indiana Black 
Expo, an annual 5-day event that includes the largest minority health fair in the U.S. and draws African Americans from 
across the country to Indianapolis every July. Mr. Griffin receives his health care at Eskenazi Health.  
Mr. Juan Lagunes is a 51-year-old Latino who also receives health care at Eskenazi Health. Mr. Lagunes is actively 
involved as a leader of the Hispanic/Latino Ministry at Christ Church Cathedral in Indianapolis.   
Dr. Ruth Lambert, PhD, is a retired 72-year-old African American colon cancer survivor who is passionate about  
community partnerships and engaging as many people in CRC screening as possible.   
Mr. Jack Quick is a 70-year-old Caucasian man who also resides in Indianapolis and receives his health care through 
Eskenazi Health Hospital and its clinics.  He is a strong advocate for colonoscopy. 
Ms. Sylvia Strom is a 60-year-old Latina who works as the Bilingual Family Advocate and Latino Services Coordinator at 
the Julian Center, a women’s shelter in Indianapolis. She has extensive experience working with the populations served 
at Eskenazi Health and has assisted many women to access care at Eskenazi. As a Latina fluent in English and Spanish, 
Ms. Strom will bring an important cultural perspective and language skills to this study. 
 
Clinical stakeholders from the Eskenazi Health Endoscopy Department (Drs. Hala Fatima, who is the Medical Director of 
the Endoscopy Unit, and Ms. Kimberly Mitchell, Nurse Manager) have been intimately involved in various aspects of this 
study from identifying the problem, to designing the study, and selecting the comparators (tailored DVD alone vs. DVD + 
navigation vs. usual care).  These clinical stakeholders were actively engaged in discussions to interpret results from an 
RCT we completed in 2013 (1R01-CA115983; Rawl, PI). Though we had a significant intervention effect in that trial with 
27% of African American primary care patients obtaining CRC screening at 6 months post-baseline, 73% of our participants 
remained unscreened. Further, our data showed that most of these unscreened participants had received a referral for 
screening colonoscopy from their provider but had not completed that test.  Our clinical stakeholders reported that almost 

 
 
 
 
                                                               
23
50% of their patients who were scheduled for colonoscopy in their unit either canceled (and did not reschedule) or simply 
did not show up for their appointments. In addition, at least 6-7 of the patients who come to the endoscopy unit each day 
(of approximately 30 scheduled) return home without completing the test because they had not been able to complete the 
bowel preparation process. These patients are often upset about the test being canceled and many do not return or 
reschedule.  Our clinical stakeholders specifically requested assistance to conduct this study to test approaches to better 
assist patients to prepare for colonoscopy, to improve the colonoscopy experience for patients, and to increase 
colonoscopy completion rates.           
As our next step to prepare this application, Dr. Fatima and two gastroenterology nurses were active 
collaborators on a preliminary mixed-methods study in which we collected quantitative and qualitative data via 
telephone interviews. In this study, we heard directly from patients who had and had not completed colonoscopy after 
receiving a recommendation from their provider. Our quantitative data clearly showed that knowledge of colorectal 
cancer and screening was significantly higher among the completers. In qualitative interviews, 100% of patients reported 
that their primary care provider had recommended colonoscopy as the only CRC screening test and no alternative tests 
were offered. Almost a quarter (23%) of patients who did not complete colonoscopy reported that the main reason they 
did not get a colonoscopy was that their provider never explained what a colonoscopy was and why it was needed – this 
was the most common reason given.  Other barriers to completion were life events (family crises/illness/death) and 
logistical problems with transportation and finances. We have designed this study to compare two interventions that 
will increase knowledge about CRC, screening test options, and personal risk for the disease; increase perceptions of 
benefits of and self-efficacy for screening, and assist patients to overcome common barriers to CRC screening.   
 
G2. CONDUCTING THE STUDY: 
Patient Partners: The Community Advisory Board is described above and consists of 8 people; 4 men and 4 women 
from, and/or familiar with, the target population. The CAB will be involved in the refinement, dissemination, and 
implementation of the tailored DVD and the PN interventions. They will also remain engaged throughout the study 
period and will consult on study implementation (recruitment, intervention delivery) and methods to ensure widespread 
dissemination of results. Ms. Rivienne Shedd-Steele, Director of the Indiana University Simon Cancer Center’s Office of 
Health Disparities and Community Outreach, works closely with several community groups that will be consulted about this 
study.  These include the Indiana Minority Health Coalition (an active, longstanding statewide coalition), the Indiana Cancer 
Consortium (a statewide consortium of 60 organizations committed to reducing the burden from cancer), and the Indiana 
University Simon Cancer Center’s Health Disparities Advisory Committee. Ms. Steele has assisted by engaging these groups 
to recruit Community Advisory Board members and disseminate results.    
Ms. Sylvia Strom will serve as the Chair of our CAB and attend monthly research team meetings. As a Latina 
fluent in English and Spanish, Ms. Strom will bring an important cultural perspective and familiarity with numerous 
Latino groups to this study.  We have reviewed the 4-year timeline for this project and Ms. Strom commits to chairing 6 
Board meetings in the first year and quarterly meetings in subsequent years.  She agreed to be compensated for working 
closely with our research team and understands that her responsibilities will be to attend research team meetings, to 
assist with intervention refinement in the first year, and with implementing the study in Years 2 and 3. In Year 4, she will 
participate in discussions about analyzing data, understanding the meaning of results, and sharing the findings with 
important audiences.  
Clinical Stakeholders:  Dr. Hala Fatima, Medical Director of Endoscopy at Eskenazi, and Ms. Rita Reynolds, Eskenazi 
Endoscopy Patient Navigator nurse, will be actively engaged in several aspects of implementing the study. They will 
assist with development of procedures to identify eligible patients and with refinement of recruitment materials that are 
consistent with clinic, IRB, and HIPAA requirements. Drs. Fatima and Imperiale will assist with measurement of quality of 
bowel preparation as well as collection and interpretation of these data from medical records. All clinical stakeholders 
will participate in regular team meetings and in data analyses, interpretation, and dissemination of study results. Ms. 
Reynolds will assist with refinement of the tailored DVD and patient navigation interventions as well as navigator 
training.   
See letters of support from our patient partners and clinical stakeholders.  
 

 
 
 
 
                                                               
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G3.  DISSEMINATING THE STUDY RESULTS:  (PC-4) 
The investigators bring a diverse, interdisciplinary perspective to the proposed research and commit to disseminating 
results of this study through a variety of mechanisms including publications in professional journals and presentations at 
professional and research meetings. For example, Drs. Rawl, Carter-Harris and Champion will present findings at 
national/international research meetings including the Society of Behavioral Medicine, the American Society of 
Preventive Oncology, and the Oncology Nursing Society.  Drs. Imperiale and Fatima are gastroenterologists and clinical 
researchers who will present findings at Digestive Diseases Week and other meetings attended by clinical 
gastroenterologists. Dr. Schwartz is a clinical scientist and primary care physician who will share findings at the Society 
for Medical Decision-Making annual conference. Ms. Reynolds, our clinical stakeholder will assist in disseminating results 
to endoscopy nurses attending regional and national meetings.  
In addition to sharing results with professional groups, we will disseminate our findings through numerous local, 
regional and statewide mechanisms.  Ms. Strom, Ms. Shedd-Steele, and Community Advisory Board members will assist 
with preparation of lay summaries of the study findings and identification of venues for distributing results.  CAB 
members represent influential community organizations through which widespread dissemination can occur including 
the Indiana Black Expo, The Indiana Minority Health Coalition, The Hispanic/Latino Ministry of Christ Church Cathedral, 
and the Indianapolis Housing Authority.  The Indiana Cancer Consortium publishes quarterly newsletters and holds an 
annual meeting where study results can be disseminated.  This meeting is attended by a diverse group of members 
representing more than 60 organizations committed to reducing the burden of cancer in Indiana.  The Indiana Minority 
Coalition has an annual meeting where results can be shared with members of that statewide coalition.  Results will be 
disseminated to lay audiences by publishing summaries in The Indianapolis Recorder and the Indiana Herald, two weekly 
publications that are widely read by members of the African American Community.  Results also will be published in lay 
publications read by Spanish-speaking residents of the metropolitan Indianapolis area.       
 
G4. PRINCIPLES FOR ENGAGEMENT   (PC-1) 
Reciprocal Relationships: Members of the research team will meet monthly as a group to monitor study progress and 
will make decisions in conjunction with patient partners and stakeholders.  Minutes will be kept at each meeting and all 
investigators will attend the first meeting of the Community Advisory Board. Progress reports and issues discussed at 
both investigator team meetings and Community Advisory Board meetings will be shared.      
Co-learning:  The next meeting of the Community Advisory Board will include all members of the research team, with 
introductions and explanations of each person’s role and contribution to the project.  At that meeting, we will focus on 
an overview of the study and the research process. At subsequent meetings during the first 9 months, we will focus on 
refinement of the intervention, obtaining patient advisor perspectives on all aspects of the tailored DVD and navigator 
interventions to maximize effectiveness. Meetings in the remaining years of this study will focus on the challenges faced 
in implementing the study, solutions to these challenges, analyses of data, interpretation of findings, and creative 
approaches to disseminating results to participants, professional and lay audiences, health systems and others.     
Partnership:  Patient partners include Ms. Sylvia Strom and the other 5 members of our Community Advisory Board.  
Meetings of this group will be scheduled by the PI and project manager at times that are convenient for these partners.  
Ms. Strom has agreed to co-chair the Community Advisory Board meetings which will occur every two months during 
the first 9 months of the project to assist with intervention refinement and then quarterly thereafter.  Ms. Strom will be 
compensated for her time, energy, and expertise with a consulting fee of $2400 for the first year and $2000 in each 
remaining year of the project.  CAB members will receive $150 for each 2-hour meeting they attend.        
Trust, Transparency, Honesty:  At each Community Advisory Board meeting, a progress report will be provided to 
update partners on the status of the study.  At these meetings we will present challenges faced in implementing the 
study and obtain partner input on how to improve study processes and outcomes. Navigators will be invited to discuss 
(anonymously) the types of support and assistance needed by participants and resources used; partners will be invited 
to make comments or suggestions. At the end of each meeting, members of the Community Advisory Board will be given 
the opportunity to meet privately with the PI to share any concerns or make any additional suggestions.       

 
 
 
 
                                                               
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DISSEMINATION AND IMPLEMENTATION POTENTIAL  
For detailed instructions, refer to the Application Guidelines for your PFA. Do not exceed two pages.  
 
A. Describe the potential for disseminating and implementing the results of this research in other settings. 
Dissemination of Results to Clinical Stakeholders and Researchers  
The investigators bring a diverse, interdisciplinary perspective to the proposed research and commit to disseminating 
results of this study through a variety of mechanisms including publications in professional journals and presentations at 
professional and research meetings.  For example, Drs. Rawl, Carter-Harris, and Champion will present findings at 
national/international research meetings including the Society of Behavioral Medicine, the American Society of 
Preventive Oncology, and the Oncology Nursing Society. Dr. Schwartz is a clinical scientist and primary care physician 
who will share findings at the Society for Medical Decision-Making annual conference. Drs. Imperiale and Fatima are 
gastroenterologists and clinical researchers who will present findings at Digestive Diseases Week and other meetings 
attended by gastroenterologists. Ms. Reynolds, another clinical stakeholder, will assist in disseminating results to 
endoscopy nurses attending regional and national meetings.  
 
Dissemination of Results to Patients and Communities  
In addition to sharing results with relevant professional groups, we will disseminate our findings through numerous 
local, regional and statewide mechanisms.  Ms. Strom, Ms. Shedd-Steele, and our Community Advisory Board members 
will assist with preparation of lay summaries of the study findings and identification of other venues for distributing 
study results.  The Indiana Cancer Consortium publishes quarterly newsletters and holds an annual meeting where study 
results can be disseminated.  This meeting is attended by a diverse group of members representing more than 60 
organizations committed to reducing the burden of cancer in Indiana.  The Indiana Minority Coalition has an annual 
meeting where results can be shared with members of that statewide coalition.  Results will be disseminated to lay 
audiences by publishing summaries in The Indianapolis Recorder and the Indiana Herald, two weekly publications that 
are widely read by members of the African American Community.  Results also will be published in lay publications read 
by Spanish-speaking residents of the metropolitan Indianapolis area.       
 
B. Describe possible barriers to disseminating and implementing the results of this research in other settings.  
Because we cannot predict with certainty what the results of this trial will show, it is difficult to predict the barriers to 
dissemination and implementation. If both interventions are found to be effective, then health systems could choose to 
make one or both types of interventions available to patients, depending on available resources. Regardless of whether 
overall effects are weak or strong, analyses to examine whether interventions are more or less effective for different age 
groups, men, women and/or participants of different races/ethnicities will be useful. If no overall effects are observed 
and no moderators identified, the challenge will be to explain such null findings.  
 
Translation to clinical practice rarely occurs based on results from one trial. Although this study will make an important 
contribution and generate new knowledge about comparative effectiveness, additional research to confirm these results 
or examine whether effects can be replicated with other populations will be needed.  Another barrier to dissemination 
and implementation may be related to concerns about the generalizability of our findings. Since this study is specifically 
focused on one safety net health system, it will be necessary to compare the effects of these interventions in other 
settings including, but not limited to, similar safety net systems that serve predominantly low-income, ethnically-diverse 
populations.       
 
C. Describe how you will make study results available to study participants after you complete your analyses.  
In collaboration with our Community Advisory Board, we will develop a newsletter that will be mailed to study 
participants to share study results.  If the IRB approves the use of a Spanish version of the DVD, use of study documents 
in Spanish, and Spanish-speaking subjects are enrolled, then both English and Spanish versions of the newsletter will be 
developed.   

 
 
 
 
                                                               
26
 
REPLICATION AND REPRODUCIBILITY OF RESEARCH AND DATA SHARING 
For detailed instructions, refer to the Application Guidelines for your PFA. Do not exceed two pages.  
 
A. Describe the ability to reproduce potentially important findings from this research in other data sets and 
populations. 
It is expected that results of any clinical trial must be disseminated within a short time after the end of the trial. If 
these two health system-based interventions prove to be as successful as we anticipate, our goal will be to 
disseminate our study outcomes so that others can adapt these interventions to fit their own clinical settings and 
populations as needed and adopt them. In addition, since one study is seldom sufficient for proving the comparative 
effectiveness of any interventions, we will share our methods with investigators who may want to replicate our 
study in other settings. We will clearly describe our methods in publications and share our research protocols and 
interventions with interested parties who request them. 
 
As part of our progress report at the end of Year 1, we will deliver the complete study protocol as it has been 
implemented for the study. Included in this protocol will be the study sample, hypotheses being tested, all measures 
used for the project, and the plan for analyzing data. It is anticipated that this protocol will be altered very little (if at 
all) from the original proposal submitted for funding. Within three months after the project end date, our variable 
codebook with data definitions will be available along with detailed explanations of the quantitative data analysis 
procedures used. All of this information will be provided electronically to interested parties who request it. 
 
In addition, this clinical trial will be registered at www.clinicaltrials.gov 
 
The patient navigator intervention, including all support and services provided by navigators, will be carefully 
documented and captured in an electronic database. Training manuals for recruiters and data collectors that are 
developed to ensure all data are collected accurately and consistently will be made available to other investigators. 
We will make the tailored DVD readily available to other health care providers and organizations to download 
electronically for use in their own settings. This will ensure that the intervention and all elements of the study can be 
replicated as closely as possible. Samples of the content of both interventions are included elsewhere. 
 
B. Describe how you will make a complete, cleaned, de-identified copy of the final data set used in conducting 
the final analyses available within nine months of the end of the final year of funding, or your data-sharing 
plan, including the method by which you will make this data set available, if requested. 
 
We will make SAS and SPSS copies of the complete, cleaned, de-identified final data set used to conduct the final 
analyses available within nine months of the end of the final year of funding. Data will be available to interested 
parties per request to the Principal Investigator. 
 
C. Propose a budget to cover costs of your data-sharing plan, if requested.    
No additional funds are requested. 
 
 

 
 
 
 
                                                               
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PROTECTION OF HUMAN SUBJECTS 
For additional guidance, refer to Section 5.0, “Human Subjects Research Policy,” of the Supplemental Grant Application Instructions for All Competing Applications and 
Progress Reports, from the U.S. Department of Health and Human Services. For detailed instructions, refer to the Application Guidelines for your PFA. Do not exceed 
five pages. 
 
A.  Risks to Participants 
 
Human Subjects Involvement and Characteristics: Participants in this study will be non-Hispanic Black, non-Hispanic 
White, and Hispanic men and women who have been scheduled for colonoscopy at the Eskenazi Health Endoscopy Unit. 
To protect patient privacy and confidentiality, study recruitment procedures have been developed that are consistent 
with Indiana University and HIPAA policies governing the use of protected health information for research purposes. 
These policies require provider consent prior to contacting patients. Permission to contact individual patients will be 
obtained from the Director of the Endoscopy Department, and introductory letters will be generated by trained 
recruiters. In addition, the letter introducing the study will include a toll-free number for participants to call if they do 
not wish to be contacted about the study. 
 
Data/Material Sources: Data will be obtained from self-report via telephone interviews conducted at baseline, at 6 
months and at 9 months. CRC screening test completion and quality of bowel preparation will be evaluated through 
electronic medical records.  Data on patient navigator encounters and services provided will be obtained from an 
electronic database created for navigators to document all contacts they make with, and on behalf of, participants.     
 
Potential Risks: Involvement in the proposed investigation does not present any additional physical risks to participants. 
The proposed research does involve slight emotional or psychological risk. Possible fear or anxiety may be generated via 
exposure to messages regarding colorectal cancer, family history, or screening. There is also a potential risk for loss of 
confidentiality since research team members will know participants’ identities. These risks will be described in the Study 
Information Sheet.  
 
B.  Adequacy of Protection Against Risks 
 
Recruitment and Informed Consent: Recruitment of subjects follows a plan approved by the Institutional Review Board 
at Indiana University Purdue University at Indianapolis. On a weekly basis, Eskenazi Health IT department will generate 
lists of age-eligible patients at average risk who did not attend their colonoscopy appointment. The list will include 2 
groups of average risk patients who missed their appointment: 1) patients who had a colonoscopy screening ordered; 
and 2) patients who had a recent fecal immunochemical test (FIT) that was positive with a follow-up order for 
colonoscopy. Due to differences in physician ordering practices, the follow-up colonoscopy can be ordered as a 
colonoscopy screening, colonoscopy diagnostic, or colonoscopy high risk. Patients will be approved for contact by Dr. 
Fatima, Director of the Eskenazi Health Endoscopy Department. Patient information will be released to the study’s data 
manager, the Eskenazi Endoscopy Department’s Patient Navigator nurse, and trained research staff at the IU School of 
Nursing using secure electronic data transfer methods.  Information disclosed is limited to that which is necessary to 
determine eligibility and to contact patients by mail and telephone. As a first step, the Endoscopy Patient Navigator 
nurse or nurse designee will screen patients by looking back 10 years and excluding any with a history of adenomatous 
polyps, sessile serrated polyps, or any mass suggestive of neoplasia. Patients with a history of hyperplastic polyps, 
lymphoid tissue, or no polyps will be recruited.   
 
To be eligible, these patients must: 1) have been referred for a colonoscopy that was not done (i.e, canceled or no 
show); and 2) be 50 to 75 years old if non-African American or 45-75 years old if African American. Patients meeting 
these inclusion criteria will be excluded for the following reasons:  1) unable to speak, read, and write English; 2) a 
personal history of having a colonoscopy at a non-Eskenazi Health location where polyps were found and they were the 

 
 
 
 
                                                               
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type that could turn into cancer; 3) FIT negative result in the past 12 months; 4) a personal history of CRC; 5) a personal 
history of conditions that place them at high risk for CRC such as ulcerative colitis, Crohn’s disease, or known hereditary 
syndromes such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer; 6) a family history of 
CRC which increases their risk; and 7) speech, hearing, cognitive, and/or vision impairment. Trained research staff at the 
IU School of Nursing will recruit patients using procedures consistent with clinic and HIPAA requirements.  Recruiters will 
send introductory letters, signed by the Principal Investigator and a co-investigator who is a member of the Eskenazi 
Medical Staff , along with a recruitment brochure and Study Information Sheet that explains the study to all approved 
patients. The letter informs patients that they will receive a phone call about the study within the next week unless they 
call a toll-free number to say they do not wish to be contacted. One week after letters are mailed, trained recruiters at 
the IU School of Nursing will call potentially eligible participants who have not opted-out to explain the study 
requirements, potential risks and compensation, and answer questions. Adequate speech, hearing, and cognition of 
potential participants will be confirmed by recruiters based upon the phone conversation. They will then proceed to 
determine eligibility, obtain both verbal informed consent and verbal HIPAA Authorization, and schedule a convenient 
time to conduct the baseline interview. Each participant who is not reached will be called back up to, but no more than, 10 
times. Recruiters will record each call attempt including the date, time, disposition, and callback preference. Participants 
who decline to participate will be thanked for their time, with their response and reason for refusal recorded.  
 
Re-contact efforts will be attempted for patients who were originally excluded from the study due to reporting a history of 
colon polyps (histology type unspecified). Amendment 013, approved by the IRB last year on 5/30/2018, allows patients 
with a history of benign colon polyps to be included in the study. The Endoscopy Patient Navigator nurse or nurse 
designee will review the records of these previously excluded patients to determine if: (1) the polyp histology type was 
benign; and (2) a colonoscopy is still needed. Patients with benign polyps who are due for a colonoscopy will be re-
contacted following the usual recruitment procedures described above. A slightly modified version of the study 
introductory letter which notes in the opening paragraph that patients may now be eligible will be used in lieu of the 
standard introductory letter. 
 
Additionally, re-contact efforts will be attempted for patients who previously gave their verbal consent to participate but 
failed to return the written informed consent and HIPAA Authorization in order to be officially enrolled. The IRB approved a 
change to the protocol on 11/27/2018 which discontinued the requirement for informed consent and HIPAA Authorization 
to be obtained in writing. These patients may now be willing to be enrolled since written forms do not need to be 
completed and returned to the research office. This cohort of patients will be re-contacted following the usual recruitment 
procedures described above. A slightly modified version of the study introductory letter which explains in the opening 
paragraph that written consent forms are no longer required for enrollment will be used in lieu of the standard 
introductory letter. 
 
Protection Against Risk: Recruiters and data collectors will be experienced and trained to detect anxiety or fear. 
Precautions will be taken to minimize anxiety, fear, and embarrassment. Participants will be informed about the study 
prior to entry and will understand that they may terminate participation in this study at any time. Participants will 
understand the general nature of the research before agreeing to participate and will be given the opportunity to 
decline to answer questions that are objectionable. 
 
The proposed research may present a possible risk to confidentiality because access to medical records will be required 
to verify screening participation and because recruitment and follow-up procedures require access to and tracking of 
participants’ addresses and telephone numbers. Participants will be given an identification code to separate identifying 
information from outcome data. All identifying information will be kept in secure file cabinets and password-protected 
computer files. Analyses will include only summaries of data and personal identifiers will not be included. All project 
personnel will be educated about the importance of confidentiality and be certified as required by university guidelines.  
 

 
 
 
 
                                                               
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The proposed research does involve slight emotional or psychological risk. Precautions will be taken to minimize these 
risks by: 1) thoroughly explaining the study initially; 2) emphasizing that participation is voluntary; 3) allowing the 
participant to stop the interview at any time; 4) using well-trained interviewers and patient navigators; and 5) coding 
data for confidentiality. During the PI’s 17 years of research experience, few participants in our studies have become 
distressed or wished to stop the interviews.  
 
C. Required Education in the Protection of Human Research Subjects: Indiana University has a procedure in place to 
fulfill the NIH requirement for education in the Protection of Human Research Subjects. All grant personnel who are 
involved in the design or conduct of research involving human subjects on this project already have or will complete this 
required education prior to the initiation of this project. 
 
D. Potential Benefits of the Proposed Research to Subjects and Others. Participants in intervention groups may benefit 
from the information and tangible assistance received to encourage them to complete a CRC screening test. Both groups 
will receive information about colorectal cancer, the benefits of CRC screening, and detailed instructions on completing 
the bowel preparation for those who undergo colonoscopy.  If found to be effective, these interventions will directly 
benefit patients who, despite having received a recommendation for CRC screening from their provider, did not 
complete that test. These interventions have great potential to decrease both CRC incidence and mortality in a group 
that bears disproportionate burden from this disease. This study may also indirectly benefit all people by comparing two 
effective interventions that can be easily translated into practice in other clinical settings. Information gained from this 
study may be useful to researchers and health professionals who are interested in developing new interventions to 
increase CRC screening rates. 
 
E. Importance of the Knowledge to be Gained. This study will contribute to knowledge by answering several important 
questions. CRC screening has the ability to not only detect cancer in early stages while it is most treatable, but also to 
prevent CRC through removal of precancerous polyps. However, these benefits are not realized if patients do not adhere 
to provider recommendations to be screened. This study will aid our understanding of interventions that can increase 
screening, thereby decreasing risk for development of - and death from - CRC. This comparative effectiveness study will 
contribute to knowledge about the impact of two promising health system interventions that have potential for 
translation into clinical practice. Importantly, enhancing our understanding of which subgroups of the study population 
are more likely to respond to the DVD intervention alone and which members may require more intensive, interpersonal 
interventions, such as PN, will allow us to intervene more appropriately and efficiently.  
 
F. Inclusion of Women and Minorities. Both men and women will be included in the proposed study. The proposed 
study will enroll non-Hispanic Black, non-Hispanic White, and Hispanic patients to test two theory-based interventions, 
alone and combined, against usual care.  
 
G. Inclusion of Children. Children will not be included in the proposed study because CRC screening is relevant to older 
adults and this cancer primarily affects adults. 
 
H. Data Safety and Monitoring Plan. Two groups of research staff will be extensively trained and monitored throughout 
the project. The project manager and PI will train and monitor recruiters who will conduct telephone recruitment calls.  
The IU Center for Survey Research supervisory staff will train their data collectors who will collect data at Time 1 
(baseline), approximately 2 weeks post-mailing of the DVD to assigned participants, Time 2 (6 months post-baseline), 
and T3 (9 months post-baseline) using computer-assisted telephone interviews (CATI). Patient navigators who deliver 
the navigator intervention will be extensively trained and monitored by the principal investigators. Quality assurance 
plans are described or referred to in the following sections. 
 
I. Quality Assurance for Recruitment and Data Collection. Performance of recruiters will be closely monitored by the 
project manager and PI. Recruitment phone calls will be randomly audio recorded to monitor quality and consistency. 

 
 
 
 
                                                               
30
Since we are only evaluating recruiters’ delivery and not subjects’ responses, these recruitment audio recordings will 
only record the recruiters’ voice. Subjects will not be identifiable in recruitment audio recordings. Data collectors will be 
closely monitored throughout the project by the IU Center for Survey Research supervisors. Telephone interviewing 
stations at this Center allow supervisors to listen to interviews and view interviewers’ computer screens remotely. All 
data collectors, including the most experienced, will be monitored regularly, with a goal of twice during every shift. One 
of these monitoring sessions will include listening to at least 20 interview questions. The other monitoring session will 
be used to listen to recruitment calls to ensure adherence to the recruitment script and handling of refusals. Overall, 
10% of all interviews and recruitment calls will be monitored for quality assurance purposes. Feedback will be provided 
to recruiters and interviewers after each monitoring session to correct any performance weaknesses. 
 
J. Intervention Fidelity. Published recommendations to ensure intervention fidelity address five components that are 
described in this section.84,85 1) Study design. The three group design ensures blinding of outcome data collectors to 
participant group assignment. 2) PN training. Training is addressed in section B.7 above. 3) Intervention delivery. To 
ensure consistency of intervention delivery, evaluation of intervention processes is essential and several strategies will 
be used. DVDs or instructions with link to view the tailored DVD on the web will be delivered via an express mailing 
courier with delivery confirmation. All PN calls will be recorded for quality assurance purposes, with a subsample 
randomly selected for evaluation. Audiotaped PN calls will be evaluated using a checklist we developed in prior studies. 
Project staff will discuss intervention delivery issues, technical support requests, and any unusual events during biweekly 
research team meetings. Modifications will be made as necessary and recorded to ensure appropriate intervention 
delivery and maintenance of protocol integrity. Decisions about modifications will be made jointly by the research team 
and recorded. 4) Intervention receipt. Since all participants in the intervention arms will receive the tailored DVD via 
mail or a web link, we will call each participant approximately 2 weeks after mailing to conduct a process evaluation of 
this intervention. Through the process interview, we will assess receipt of the DVD or web link, how much of the DVD 
was viewed (all, part or none), as well as satisfaction with and relevance of the content. Participants will receive a $50 
gift card for completing this process interview. 5) Intervention enactment. All participants who return a completed FIT 
will have enacted the behavior recommended in the interventions.  Those who attend a colonoscopy appointment are 
routinely asked about their experience with, and ability to complete, the bowel preparation and refrain from eating solid 
food before the test. This information is documented in the EMR and colonoscopy procedure notes and will provide 
evidence that participants enacted the behaviors recommended in the DVD. The PN documentation record also will 
provide data to support intervention enactment by participants assigned to this group.    
 
K. Quality Assurance for Intervention Delivery. Evaluation of intervention processes is necessary to ensure consistency 
of intervention delivery. Several strategies will be used. First, project staff will discuss intervention delivery issues, 
technical support requests, and any unusual events during biweekly research team meetings. Modifications will be made 
as necessary and recorded to ensure appropriate intervention delivery and maintenance of protocol integrity. Decisions 
about modifications will be made jointly by the research team and recorded. Second, all telephone counseling calls will 
be recorded for quality assurance purposes, with a subsample randomly selected for evaluation. Audiotaped counseling 
calls will be evaluated using a checklist we developed in prior studies. Third, participants in each intervention group will 
be queried about recall and satisfaction with the navigator and/or DVD, as appropriate. Problems with intervention 
delivery identified through follow-up interviews will be discussed at team meetings and corrected. Specific questions 
about the users’ experience with the interventions are included elsewhere.  
 
L. Quality Assurance for Data Management. Data management will be handled by expert data managers from the 
Department of Biostatistics. A centralized data entry system will be developed and housed on the secure Web server 
managed by members of our biostatistics team, led by Dr. Susan Perkins. Data monitoring will occur weekly as data from 
each interviewer are reviewed for accuracy and completeness. Backup data files will be kept on a secure server 
managed by the Indiana University Department of Biostatistics and in the project manager’s office. All computers that 
will be used to collect and send data during implementation of the study or to store data at the central location will be 
password-protected. All tracking and data files also will be password-protected and backed up nightly. 

 
 
 
 
                                                               
31
 
M. Data Integrity and Security. IRB approvals, patient lists, consent and authorization forms when required, and all 
tracking information will be kept in a locked location. Baseline and outcome data as well as intervention data will be 
coded to maintain confidentiality. All computers will be password-protected. Only trained grant personnel will have 
access to data. Once all data have been linked to individuals, all identifiers will be deleted. 
 
N. Identification of Adverse Effects.  An IRB-approved Data Safety Monitoring Plan (DSMP) will be used to identify 
participant adverse effects.  The Data and Safety Monitoring Plan (DSMP) for this project begins with extensive training 
of research staff followed by comprehensive monitoring to ensure the safety of participants and the validity and 
integrity of the data throughout the project period. 
 
A.  Research Staff Training 
Three groups of research staff will be trained and monitored throughout the project.   
 
1) Research Assistants (RAs) working on-site at the Indiana University School of Nursing will be trained to 
effectively recruit participants by mail and phone. These RAs will be specially trained in the recruitment of 
minority and low-income patients. Training will focus on: 1) HIPAA and IRB regulations designed to protect 
research participants; 2) mailing of recruitment materials and follow-up recruitment by phone using 
standardized scripts to explain the study and answer questions; 3) eligibility assessment; 4) obtaining both 
verbal informed consent and verbal HIPAA Authorization to participate; 5) scheduling the T1 (baseline) 
interview; 6) handling problems or questions that arise during phone recruitment; 7) use of the REDCap tracking 
database to log recruitment procedures; and 8) study procedures for on-going recruitment monitoring and 
quality assurance. Recruiters will practice and role-play phone recruitment until they have reached 100% 
compliance with guidelines for recruitment.   
 
2) The second group of research staff includes experienced interviewers/data collectors employed by the Center 
for Survey Research (CSR) at Indiana University. Prior to the study-specific training described below, CSR 
interviewers/data collectors will have completed a rigorous 9-hour telephone interviewing training course, with 
four hours spent in hands-on practical experience in which the trainee-to-supervisor ratio is 5:1. This training 
course covers:  1) the interviewer’s role in survey research; 2) standardized interviewing techniques; 3) 
administration of survey introductions and refusal aversion techniques; 4) use of computerized sample 
management and data collection systems; 5) protection of human subjects and sensitive information; and 6) 
daily case management. Comprehension of concepts and techniques and skill in their execution are assessed 
through a battery of tests at appropriate intervals in the training course; trainees do not matriculate to the next 
phase until all prior phases are mastered. CSR interviewers/data collectors will then be trained on: 1) 
administering the study’s four phone interviews: T1 (baseline), DVD Process, T2 (6 month) and T3 (9 month); 2) 
handling problems or questions that arise during data collection; 3) recognizing and reporting potential adverse 
events; and 4) data monitoring and quality assurance procedures. Training will include demonstrations of 
effective data collection interviews using the computer-assisted telephone interview software (CATI). Following 
demonstrations and practice sessions, interviewers/data collectors will role-play and receive feedback until they 
have reached 100% compliance with guidelines for interviewer data collection integrity. 
 
3) The third group of research staff includes our School of Nursing research nurse employees who will serve as 
patient navigators to deliver the navigation intervention by phone. Initial training will be conducted during two 
separate sessions with the first being a full, one-day session. This first day of training will consist of a series of 
presentations by our Ohio State University co-investigators, Dr. Mira Katz and Chasity Washington, who are 
experts in navigation. Training objectives will be to have navigators understand the scope of their role, provide 
them with support, as well as guide them to resources to assist participants with financial and transportation 
issues. The REDCap database for documenting navigation encounters will also be introduced. A second half-day 

 
 
 
 
                                                               
32
session will be scheduled when the REDCap navigation database is finished so that a live demonstration can be 
provided to the nurses. This second session will also include a presentation on intervention fidelity and quality 
assurance by an Ohio State quality assessor. The DVD intervention will be presented so that navigators know 
exactly what colon health information participants will receive prior to their contacting them. Navigators will be 
refreshed on their responsibilities and will practice and role-play until they have reached 100% compliance with 
the navigation intervention protocol. Prior to navigating their first participant, the study’s Project Manager will 
meet with each navigator. The purpose of this final, pre-navigation session is to confirm that: 1) there are no 
issues with accessing and utilizing the REDCap navigation database; 2) the audio recorder works properly with 
the phone set-up, and 3) the navigator is able to deliver the intervention content effectively in a simulated call. 
 
 
B.  Project Monitoring 
All aspects of the project will be comprehensively monitored by the Principal Investigator and Project Manager on a 
continuous basis.  We will monitor both the progress and quality of:  1) recruitment, enrollment, and attrition; 2) data 
collection; 3) randomization and stratification; and 4) intervention delivery. All adverse events and protocol non-
compliances/deviations will be evaluated by the Principal Investigator and reported to the IRB at the time of Continuing 
Review (unless earlier reporting is required). Quality assurance procedures will include evaluating audio recordings of 
calls made by recruiters, interviewers, and navigators. Results of monitoring activities will be reported during monthly 
research team meetings.  The Principal Investigator and research team will also evaluate external, relevant information 
such as developments in the literature or results of related studies that might impact the safety of participants or 
direction of the study, as it becomes available. 
 
1) Data Integrity and Security 
Patient demographic and tracking information will be maintained in the Indiana University REDCap database. 
REDCap is a web-based application that is secure (user authentication: log-on/password) with customizable user 
rights restrictions and full audit trail capability. REDCap was developed specifically around HIPAA security 
guidelines and is an IUPUI IRB approved method for collecting, storing, and analyzing data. Only approved 
project staff will have access to the study’s REDCap database. Participants will be assigned a unique study 
identification number within REDCap. This number will be used to code participants’ baseline, intervention, and 
outcome data to maintain confidentiality. Once all data has been linked to individuals, all personal identifiers 
will be deleted. Hardcopies of letters, along with completed written informed consents and HIPAA 
Authorizations that were required prior to the protocol being changed, will be stored in locked file cabinets 
located within the Project Manager’s locked office.  Access to the office will be limited to the research project 
staff. All audio recordings will be coded using a unique study identification number. Audio recordings of the 
structured telephone interviews will not include any personal identifiers. Audio recordings of navigation calls 
may include the participant’s last name since these calls with the Patient Navigator nurse are more 
conversational and the nurse may refer to the participant by last name while talking. Audio recordings of calls 
made to participants will be uploaded to the study’s secure Indiana University [Box Health] folder. [Box Health] 
is a web-based, password-protected platform residing on a secure network server. After uploading, audio files 
will be erased from the recording devices. Audio recordings will be deleted from the secure [Box Health] folder 
after the study is completed.  
 
2) Recruitment  
Indiana University School of Nursing research staff will recruit participants using procedures consistent with 
HIPAA requirements. During the recruitment phase, recruiters will audio record calls placed on one day of each 
week. The Project Manager will listen to randomly selected calls by each recruiter to evaluate adherence to the 
recruitment script, correct eligibility assessment, and proper handling of refusals. Feedback will be provided 
after monitoring sessions to correct any performance weaknesses. 
 

 
 
 
 
                                                               
33
3) Data Collection 
Outcome data collection will be handled by expert interviewers/data collectors at the CSR. A centralized data 
entry system will be developed and housed on the secure server managed by the CSR. All computers that will be 
used to collect and send data during implementation of the study or to store data at the central location will be 
password-protected and backed up nightly. Job performance of the interviewers/data collectors will be closely 
monitored by the Project Manager and the CSR supervisors to ensure their adherence to the study protocol. 
Telephone interviewing stations at the CSR allow supervisors to listen to interviews and view computer screens 
remotely in real-time without the knowledge of the interviewers/data collectors. All interviewers/data collectors 
will be monitored regularly, with a goal of once during every shift. One monitoring session will include listening 
to at least 20 interview questions. Ten percent of all interview calls will be monitored for quality assurance 
purposes. Feedback will be provided after monitoring sessions to correct any performance weaknesses.  
 
4) Intervention Delivery 
Receipt of the mailed DVD intervention will be monitored by the CSR supervisors and the Project Manager. 
Participants who report to CSR interviewers/data collectors that they did not receive the DVD by regular mail (or 
e-mail with link to the web version) will have their contact information verified and a second mailing will occur. 
The Project Manager will monitor the number of re-mails. The CSR will monitor the number of DVD process 
interviews not completed due to participants reporting non-receipt. 
 
All patient navigator calls will be recorded for quality assurance purposes. A subsample will be randomly 
selected for evaluation by our Ohio State University Quality Assurance team member to ensure intervention 
fidelity and identify problems. Ten percent of each navigator’s calls will be monitored for quality assurance. 
Navigators and project staff will discuss intervention delivery issues, technical support requests, and any unusual 
events during monthly conference calls. Modifications to the REDCap navigation database will be made, as 
necessary, to improve intervention delivery and maintenance of the protocol integrity.  
 
5) Adverse Events 
The Project Manager and Principal Investigator will monitor the study for adverse events. Since there are no 
physical risks to taking part in this study, reports of any emotional distress or similar unfavorable reactions will 
be carefully evaluated. Additionally, any loss of confidentiality will be considered an adverse event and 
thoroughly investigated. Adverse events will be identified and reported by recruiters, CSR interviewers/data 
collectors, and research nurses who deliver navigation interventions. Participants will have several study phone 
numbers available to call should they have a complaint or research-related injury. This includes phone numbers 
for the Principal Investigator, Project Manager, and IU Human Subjects Office. If a participant calls to register a 
complaint or report an adverse event, the Principal Investigator will be immediately notified. Adverse events will 
be discussed at the monthly team meetings and reported to the IRB at the time of Continuing Review.  
 

 
 
 
 
                                                               
34
 
CONSORTIUM CONTRACTUAL ARRANGEMENTS  
For detailed instructions, refer to the Application Guidelines for your PFA. Do not exceed five pages. 
 
The Ohio State University (OSU) provides a rich environment for achieving the objectives outlined in this application. 
OSU was founded in 1870 as the major land grant institution in the state of Ohio. During the past 128 years, the 
university has grown to be among the country’s leading research universities. Its mission is the attainment of 
international distinction in education, scholarship, and public service. It is the state’s leading comprehensive teaching 
and research university. OSU is also the state’s largest public university composed of 19 colleges and 100 departments, 
with approximately 42,000 undergraduates, 2,720 professional graduate students and 10,000 graduate students, making 
it one of the largest single-campus universities in the country. The Health Sciences at OSU include the Colleges of 
Dentistry, Medicine, Nursing, Optometry, Pharmacy, Public Health and Veterinary Medicine. The Health Sciences 
colleges are geographically connected within a one-mile radius in a cluster of buildings surrounding the Health Sciences 
Library and adjacent to the OSU Medical Center, the Ross Heart Hospital and the James Cancer Hospital. In addition to 
this environment with its wealth of resources, the OSU investigative team has the experience and expertise to carry out 
the objectives of this proposed study, including experience with interdisciplinary research studies with the goal of 
developing and testing patient navigator interventions such as this one.   
Drs. Electra Paskett and Mira Katz will advise on all aspects of the project, including the development, implementation, 
and evaluation of the navigator intervention. Dr. Paskett has established working relationships with faculty and staff at 
The Ohio State University (OSU) and community leaders to conduct important studies including studies among 
underserved populations in an area that is in need of interventions to improve cancer incidence and mortality rates. Dr. 
Mira Katz will advise on all aspects of the project, including the development, implementation, and evaluation of the 
patient navigation intervention program and other study-related matters, as needed. In addition, Dr. Katz has 
experience in the development, implementation, and evaluation of colorectal cancer screening interventions and she 
will collaborate with Dr. Rawl on the refinement of the DVD and the surveys. Ms. Chasity Washington, the Program 
Director for the Diversity Enhancement Program at the Arthur G. James Cancer Hospital and Richard J. Solove Research 
Institute, will develop and implement the initial in-person training for the PN staff as well as subsequent monthly 
training conference calls. The trainings will help PN staff understand the scope of their job, provide them with support, 
and empower and guide them to find resources in their community. The trainings will help direct the PN staff in 
development of their own resource manuals. The Ohio program will guide the PN staff to identify resources in their 
community that may be able to assist patients. The PN staff will also learn techniques to guide patients to community 
resources that may help patients overcome barriers related to timely and complete healthcare. 
 
For the initial one day in-person PN training, Dr. Katz and Ms. Washington will travel to Indianapolis. The Eskenazi 
Endoscopy Nurse Navigator will be consulted in the development of the clinical aspects of the training and availability of 
local resources. Below is a sample of what the initial training agenda might look like. 
 
A.  Overview of Health Disparities/Cancer Disparities 
• 
The inception of PN and patient assistance programs 
• 
Types of PN programs (community based, telephone based, hospital based) 
• 
The need for research to test PN models 
• 
Health disparities by incidence, prevalence, and mortality data 
 
B.  Patient Navigation: Roles and Responsibilities 
• 
Describe roles, responsibilities, and core competencies 
• 
Common barriers and approaches to addressing them 
• 
Care management and patient interviewing 

 
 
 
 
                                                               
35
 
C.  Overview of Colon Cancer, Colon Cancer Screening, and Cancer Treatment 
• 
Review the colon 
• 
Colon cancer in the United States 
• 
Causes of colon cancer 
• 
Symptoms of colon cancer 
• 
Screening for colon cancer 
• 
Risk factors and prevention for colon cancer 
• 
Treatments and survival for colon cancer 
• 
Myths and misconceptions about cancer 
• 
Cancer control (primary, secondary, and tertiary prevention strategies) 
 
D.  Culture and Communication 
• 
Cultural awareness and sensitivity 
• 
Understanding the role of communication in the assessment of patient needs 
• 
Communication techniques to facilitate identification and reduction of barriers 
• 
Patient empowerment and self-efficacy 
 
E.   Resource Management 
• 
Types of resources 
• 
Heath system and community assessment 
• 
Asset mapping 
• 
Developing your resource manual 
 
A second half-day session will be scheduled when the REDCap PN database is finished so that a live demonstration can be 
provided to the nurses.  This second session will also include a presentation on intervention fidelity and quality assurance 
by an Ohio State co-investigator. The DVD intervention will be presented so that navigators know exactly what colon 
health information patients will receive prior to their contacting them. Navigators will be refreshed on their responsibilities 
and will practice and role-play until they have reached 100% compliance with the intervention protocol. 
 
Subsequent training will occur through monthly conference calls between the PN staff, Ms. Washington, and the Ohio 
State PN quality assurance monitor.  The calls will include a training piece, a grand round case presentation from each PN 
and the opportunity to discuss any concerns related to navigation. From this discussion future training topics will be 
identified. Potential monthly training topics may include: 
 
• 
Addressing challenging situations 
• 
Revisit patient empowerment approaches 
• 
Health literacy 
• 
Self care: Approaches to avoid feeling burnt out 
• 
Time management 
• 
Review of CRC screening and any changes in screening guidelines 
 
OSU staff and investigators will also work on project-related publications with the University of Indiana team. 
 
The Indiana University Center for Survey Research (CSR) is a research unit housed within the Office of the Vice Provost 
for Research at Indiana University Bloomington. For more than three decades, the CSR has earned a reputation for 
research and methodological consultation services to government, academic, nonprofit, and private sector clients, with 
a focus on the social sciences, medicine, and education.  The CSR provides the management, staff, and facilities required 

 
 
 
 
                                                               
36
to conduct all phases of telephone, mail, Internet, and multi-modal projects. CSR staff are trained in all aspects of survey 
research, including questionnaire design, sampling, telephone and in-person interviewing, cognitive testing, coding, data 
entry, and data analysis, employing both quantitative and qualitative/mixed methods approaches. CSR staff adhere to 
the highest academic and government research and ethical standards. The CSR also uses the most current technology to 
continuously improve the quality and efficiency, as well as ensure the security, of data collection.  In addition, as part of 
the mission of the University, the CSR provides educational and experiential opportunities for students, staff, and 
researchers, through graduate- and undergraduate-level courses, graduate student practicums, workshops in survey 
methodology, and individual consultations both internal and external to the University. 
 
CSR Collaborations in Medical, Health, and Public Health Research  
Each year, the CSR conducts 25-40 projects. Current or recent major projects in the area of health and medicine include 
the following:  
• 
Colorectal and Breast Cancer Screening in Women, which compares the efficacy of four strategies in promoting 
colorectal cancer and breast cancer screening among women aged 51 to 75. (IU School of Nursing; Rawl, Co-I)  
• 
Promoting Colon Cancer Screening among African-Americans, which studied the effects of various interventions 
developed to improve colorectal screening rates. (IU School of Nursing; Rawl, PI)  
• 
Hospital-Acquired Infection Surveillance Study, which examined strategies used in hospitals nationwide to control 
the spread of hospital-acquired infections. (IUB, Sociology)  
• 
2011 Study of Indiana Registered Nurses, which surveyed Indiana nurses about their career, educational history, 
and professional practices. (IUB, Sociology)  
Data Collection Services  
The CSR provides the full range of data collection services, including focus groups, cognitive interviewing, standardized 
interviewing, and surveys administered by telephone, mail/paper, Internet, and multiple other modes. The following 
describes the telephone data collection capabilities of the CSR, as applicable for the IU School of Nursing PCORI Project. 
The CSR will be an invaluable resource for this project to ensure that efficient training and recruitment are conducted 
and that high-quality data are obtained for this study. The CSR will provide the following support for this project: 
 
• 
General management (coordination, hiring, training, server management) 
• 
Development (develop database structures, survey instruments, calling protocols, and samples) 
• 
Production (interviewing, quality control, sample management) 
• 
Post-production (prepare datasets, address updates, methods summary and archiving) 
 
Eskenazi Hospital and Health System is the only local safety net hospital that serves mostly low income residents of all 
cultures and ethnicities from the greater Indianapolis Metropolitan area, which makes it an ideal clinical setting of this 
study. Eskenazi provides care to nearly 1 million outpatients per year, with a special emphasis on vulnerable populations 
of Marion County, Indiana. Eskenazi facilities include a 315-bed hospital and inpatient facilities as well as 11 community 
health centers located throughout the Indianapolis area. In the Endoscopy unit, approximately 450-500 GI procedures 
are performed a month, with 75% of those being colonoscopy screenings. For the PCORI study, we will recruit from this 
pool of already established and scheduled patients.   
 
Eskenazi Health Endoscopy Unit is a brand new teaching facility that was established in December of 2014 (formerly 
known as Wishard Health Services) and has four fully equipped Endoscopy suites.  Each suite is staffed with a physician, 
registered nurse and an endoscopy scope technician. The majority of patients are referred from one of the eight clinics 
that comprise the Eskenazi Health Primary Care Network, although consults are received from many area hospitals and 
clinics as well. 
 
The medical director, nurse manager, and nurses in the Endoscopy Department at Eskenazi Health, our local safety net 
health system, have been collaborating with the investigator for the past three years. The proposed project came from 

 
 
 
 
                                                               
37
conversations with these stakeholders who requested assistance in addressing the costly clinical problem of low 
attendance and poor bowel preparation at scheduled colonoscopies. This team conducted a preliminary study and had 
several meetings to design the proposed study. Interviews with 48 patients, provided invaluable data on these patients’ 
perspectives on the barriers and facilitators of colonoscopy completion.  
 
Dr. Fatima is the Medical Director of Endoscopy at Eskenazi Health. Her research has focused on improving endoscopic 
techniques, minimizing complications of colonoscopy, and understanding factors that influence quality of bowel 
preparation for colonoscopy. She is well qualified to collaborate on this clinically relevant comparative trial to test two 
methods increase CRC screening rates and the quality of bowel preparation for patients who complete colonoscopy. In 
addition to the expertise and guidance of Dr. Hala Fatima, Eskenazi staff will play an integral role in this study.  Rita 
Reynolds is an experienced gastroenterology nurse who is employed in the Eskenazi Endoscopy Department. Ms. 
Reynolds will assist with identification of eligible patients and serve as the gastroenterology resource nurse for the 
patient navigators. In Year 1, she will participate in refinement of recruitment materials and processes, development of 
the patient navigation intervention, and training of navigators. In Years 2-4, she will consult with patient navigators to 
address medical issues, health care system barriers, and questions that patients and navigators have about the bowel 
preparation process and test results. Ms. Reynolds will also participate in quality assurance and monitoring of the 
navigator intervention through monthly conference calls. With a vested interest in and commitment to decreasing the 
burden this proposal addresses, along with their expertise and the ideal patient population, the Eskenazi team will be an 
invaluable partner in the conduct of this study.  
 
 
 
 
 
 

 
 
 
 
                                                               
38
 
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