Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation
Conditions: Colorectal Cancer Screening
Sponsor: Indiana University

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Facilitators and Barriers to Cancer Screening:  Stakeholder Perspectives on Implementation 
 
NCT04683744 
 
December 8, 2020 
 

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Facilitators and Barriers to Cancer Screening:  Stakeholder Perspectives on Implementation 
 
Principal Investigator: Peter H. Schwartz, PhD, MD 
Department of Medicine, Indiana University School of Medicine 
 
Co-Investigators / Key Personnel 
who will intervene or interact with human subjects, or access subjects’ identifiable data 
 
 
Sandra Althouse, MS, Department of Biostatistics, Indiana University School of Medicine 
Heather L. Anderson, MA, RN, Department of Medicine, Indiana University School of Medicine  
Teresa Damush, PhD, Department of Medicine, Indiana University School of Medicine 
Phillip Johnson, MSHI, PMP, Population Health, Indiana University Health  
Thomas Imperiale, MD, Department of Medicine, Indiana University School of Medicine 
Heather M. Kinney, MS, Department of Medicine, Indiana University School of Medicine 
Judy Kline, BSN, RN, Department of Medicine, Indiana University School of Medicine 
Jacqui Langer, MPH, Department of Biostatistics, Indiana University School of Medicine 
Susan M. Perkins, PhD, Department of Biostatistics, Indiana University School of Medicine 
Susan M. Rawl, PhD, RN, FAAHHB, FAAN, Indiana University School of Nursing 
Karen Schmidt, MSN, RN, CCRP, Department of Medicine, Indiana University School of Medicine 
Samantha Vershaw, BS, Department of Medicine, Indiana University School of Medicine 
 
 
 
Co-Investigators / Key Personnel 
who will not intervene or interact with human subjects, or access subjects’ identifiable data 
 
Paul Han, MD, MA, MPH, Maine Medical Center 
Lynne Kreiger, Patient-Consultant 
Earnestine Mays-Eldridge, Patient-Consultant 
Steven Petty, Patient-Consultant 
Kent Terrell, Patient-Consultant 
Brian Zikmund-Fisher, PhD, University of Michigan 
 
 
 
 
Support Provided by: 
Patient-Centered Outcomes Research Institute (CDR-2018C3-14715) 
Affected sections 
Summary of revision/change 
Date 

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Co-Investigators/Key 
Personnel 
 
Removed investigators: Stanley Taylor, Abigail 
Garcia, Abigail Sachs, and Katie Claxton. Added 
investigators: Heather L. Anderson, Heather M. 
Kinney, Judy Kline, and Samantha Vershaw. 
July 21, 2021 
2.0 Objectives; 4.0 Research 
Plan; 5.0 Data Analysis Plan 
Addition of provider survey 
July 21, 2021 
4.0 Research Plan 
Removed plan to recruit patients who completed the 
randomized clinical trial for Aim 3 study procedures. 
July 21, 2021 
4.0 Research Plan 
Clarified inclusion and exclusion criteria for patients 
enrolled for Aim 3 study procedures 
July 21, 2021 
 
 

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1.0 
Background & Rationale 
 
CRC Screening:  Colorectal cancer (CRC) is the second-largest cancer killer in the U.S., and low 
screening rates leads to thousands of preventable deaths.  Each year, over 140,000 people are 
diagnosed with CRC and more than 50,000 die.1  Under 65% of eligible adults are current with 
screening, a rate that pales in comparison to breast and cervical cancer screening.1-3 Raising the 
CRC screening rate to 80% by 2018, which was the Colorectal Cancer Roundtable’s goal, would 
have prevented over 20,000 deaths from CRC per year and 203,000 deaths by 2030.4 
 
“Precision prevention” in this area is a promising way to motivate screening and help patients 
choose the best test for them.  Leading guidelines approve multiple testing strategies, including 
colonoscopy every 10 years, flexible sigmoidoscopy every five years, annual stool testing with 
high-sensitivity fecal occult blood testing (FOBT) or fecal immunochemical testing (FIT), or stool 
testing for high risk DNA.3,5,6  Colonoscopy is the most sensitive and specific for identifying 
polyps or cancers,6-8 and is best known. But it is an invasive procedure involving a lengthy 
preparation, IV sedation, and the need to take a day off. There are significant risks, including 
hemorrhage and perforation.5  
 
Stool (or fecal) blood testing is the second most commonly utilized approach, and many 
patients prefer stool testing to colonoscopy when they are informed about both tests.9-15 We 
concentrate here on FIT since it is widely used and available nationwide, and is recommended 
by all major guideline organizations.3,5,6 Stool blood testing may be done in the privacy of one’s 
home, is low cost, and requires no preparation.  The main limitations are that it must be done 
annually, it requires the patient to handle stool, and all positive tests require evaluation with 
colonoscopy.  Newer forms of stool testing, such as Cologuard, which combines FIT with testing 
for high risk DNA, are being used relatively rarely, and they can be considered similarly to FIT 
for this application, except that they may be performed every 3 years.5 
 
In a recent study, an outreach program that recommended just colonoscopy for screening 
resulted in a 38% uptake, while recommending a stool test or offering a choice between 
colonoscopy and stool test resulted in uptake of 67% and 69%, respectively.16   Multiple 
national organizations recommend that providers describe and explain the alternatives to 
colonoscopy.  A slogan used by the 80 by 2018 initiative declares that “The best CRC screening 
test is the one that gets done.”17,18 
 
Precision prevention:  Guidelines recommend only colonoscopy for patients with particularly 
high risk for CRC, such as those with a significant family history, a genetic condition such as 
Lynch syndrome, or inflammatory bowel disease.3,19  Approximately 90% of patients lack these 
risk factors and are considered “average risk,” so can choose any CRC screening test, according 
to guidelines. But even within this average risk group, people have varying chances of having an 
“advanced colorectal neoplasm” (ACN), i.e. a colorectal cancer or precancerous polyp.20,21   A 

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polyp counts as “advanced” if it is greater than 1 cm or has high-risk pathology (villous histology 
or high-grade dysplasia). 
 
An individual’s chance of currently having an ACN affects the comparative effectiveness of CRC 
screening tests, and, thus, is relevant information for making a screening test decision. 
Colonoscopy has higher effectiveness in patients who have a high probability of having a 
current ACN because of the larger chance that colonoscopy will identify a dangerous that 
should be removed.20,22  Nearly all ACN are polyps rather than cancers (15:1 ratio in a recent 
study),20 and polyps are considered the prime target of screening since they can be removed to 
prevent cancer.23   
 
In patients whose probability of having a current ACN is lower, the burdens associated with 
colonoscopy may be difficult to justify since the chance of finding a lesion that should be 
removed is lower.  And the chance that FIT or Cologuard will fail to identify a dangerous polyp 
or cancer is lower in a patient with lower baseline risk of ACN.  FIT and Cologuard are approved 
for all average risk patients because they provide long-term risk reduction in colorectal cancer 
that rivals colonoscopy.24,25  Still, failing to identify a polyp or cancer in the colon is a negative 
outcome of screening (a “false negative”),25 so it is important that the chance of this occurring 
is smaller in patients with lower baseline risk of ACN. 
 
Validated, usable rules for estimating the probability of current ACN in average risk patients are 
available.  A prediction rule developed and validated by Dr. Tom Imperiale, a member of the 
study team uses five variables (gender, age, CRC family history, waist circumference, and 
smoking history) and identifies a wide range of risk for current ACN among average risk 
patients. For patients with “high-average” risk (22%), personalized messages in our decision aid 
and provider notification highlight the advantage of colonoscopy because of the likelihood of 
finding and removing an ACN.  For patients at low risk for ACN (2% or 4%), personalized 
messages highlight the advantage of stool testing, due to the relatively low chance of failing to 
detect ACN. 
 
Disclosing information about a patient’s risk of having a current ACN has potential to increase 
uptake of screening.  Letting patients know that their chance of having an ACN is low can 
support decisions to choose and complete the FIT test.  Knowing that a patient who prefers FIT 
has low ACN risk may help providers overcome their hesitancy to order this test, by reassuring 
them that the chance of FIT’s missing a cancer or dangerous polyp for this patient is low.  
Informing patients and providers that the patient has a high-average risk for an ACN can 
motivate discussion of screening colonoscopy and completion of that test.   
 
At a system level, guiding patients at high-average risk toward colonoscopy and those with low-
average risk to FIT could improve the efficiency of screening.20,26,27,28  While colonoscopy is an 
effective screening test for all individuals with average risk from ages 50 to 75, it is more cost-

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effective for those with higher chance of ACN.  If all eligible patients chose colonoscopy, 
endoscopy centers would be overwhelmed.29-31  Given that the recently validated rule found 
that over 50% of the population had low- or very-low risk of having an ACN, the impact on 
reducing over-use of colonoscopy and the cost of CRC screening could be substantial. (RQ-
3)(RQ-4) 
 
Current clinical practice involves calculating patient risk in other areas.  More complicated 
calculators, such as the Atherosclerotic Cardiovascular Disease risk estimator used to determine 
need for statins, are already in common use.  Calculating risk is relatively easy using the short 
version of the Imperiale rule, since it relies on just five variables that are either recorded in the 
medical record (age, gender) or are easy to collect from patients and could be placed in the 
medical record (smoking history, waist circumference, family history).   
 
Decision Aids:  Informing patients about their options for CRC screening could produce higher 
quality decisions, improve the match between patient preferences and tests performed, and 
increase uptake of CRC screening.  Decision aids (DAs) are a promising tool for accomplishing 
this goal.  While DAs are not widely used in clinical medicine, a 2014 Cochrane review identified 
115 randomized, controlled trials of DAs.  These studies show that compared to usual care, DAs 
increase patient knowledge, improve patient-provider communication, and increase uptake of 
recommended interventions in many areas.32 Ten randomized trials have tested a total of 7 
different DAs designed for CRC screening.33-39   
 
A big challenge has been getting decision aids to patients; despite studies showing benefits of 
decision aids in many areas, relatively few patients receive these aids.  Promising recent 
developments include incentivizing healthcare systems to provide decision aids, including 
reimbursement for patient use of approved decision aids.40  Encouraging providers to 
“prescribe” decision aids to their patients also has promising results.41   
 
COVID-19 Pandemic:  Since the COVID pandemic began in the United States in March 2020, 
cancer screenings and other preventive services, such as Hgba1c and BP checks, have 
plummeted, and rates have remained depressed even with re-opening of clinical services.  
These challenges for screening and prevention may continue for many reasons, including 
increased telemedicine, decreased patient willingness to come to health centers, severe work 
and living stress for patients, and changes in patient perceptions of health risks and prevention.   
 
Clinics are already trying to adapt, for instance by finding ways to offer preventive services 
outside clinic, such as home stool testing for CRC screening and telephone outreach to provide 
social services, health reminders, and reassurance that infection risk at clinic is low.  These 
efforts have only begun and are poorly understood. Moreover, patient perceptions of disease 
risk and risk from COVID19 are unknown. If we fail to identify ways to effectively deliver 

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screening and prevention during the COVID19 pandemic, many patients will die unnecessarily 
from non-COVID19 conditions. 
 
Randomized Clinical Trial Helping Patients and Providers Make Better Decisions about 
Colorectal Cancer Screening (Indiana University IRB# 2004109966) The study team is currently 
conducting a randomized clinical trial testing whether providing patients and their healthcare 
providers with personalized messages about ACN risk results in higher screening uptake and 
higher decision quality (i.e, informed choice and receipt of the preferred screening test), 
compared to an approach that does not utilize ACN risk.  In this clinical trial, all patient-
participants are viewing a decision aid that provides basic information about CRC screening. For 
half the patients, the decision aid also includes their chance of currently having an ACN, the 
predicted frequency of ACN (icon chart), and implications for screening test effectiveness and 
choice. All healthcare provider-participants are being sent a message through their respective 
Electronic Health Record (EHR) system notifying them that their patient is due for CRC 
screening. For half the healthcare providers, the message also includes their patient’s chance of 
currently having an ACN and implications for screening test effectiveness and choice. 
 
Engagement (PC-1), Dissemination, and Implementation:   
The trial also provides an opportunity to conduct observational and qualitative work to study 
the barriers and facilitators to implementing decision aids, provider notifications, and 
personalized risk analysis for colorectal cancer screening.  In addition, we have the opportunity 
to use qualitative and observational methods to assess the impact of the COVID pandemic on 
CRC screening and on other recommended, evidence-based screening, and to assess 
perspectives of leadership, providers, staff, and patients.  Finally, we can use similar 
observational and qualitative methods to identify responses by clinics and healthcare to the 
COVID pandemic, and assess their impact and facilitators and barriers to their implementation. 
 
We have worked closely with leadership, quality improvement, and information technology 
teams at both our partner healthcare institutions to develop and pilot the system we are 
studying in the randomized trial.  We are building on this engagement to identify effective 
methods for providing decision aids and provider messages through an EHR.  Staff and 
providers involved will potentially become champions and “super users” for future 
implementation of decision aids and provider notifications in their clinics. (PC-4)  These efforts 
will be overseen by co-investigator Dr. Damush, who has extensive experience performing 
stakeholder and key informant formative and summative evaluations to understand the current 
state, existing barriers, and potential facilitators to overcome contextual barriers in 
implementation strategies.42,43  (PC-1) 
 
 
 
 

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2.0 
Objectives 
 
Our study team will engage with the leadership, staff, and providers in our partner healthcare 
systems, to identify facilitators and barriers to implementing patient decision aids and provider 
notifications as well as cancer risk assessment tools, for colorectal cancer screening, and for 
other evidence-based cancer screening during the COVID pandemic and, potentially, after the 
conclusion of the pandemic. 
 
At the conclusion of our study, we will have extensive information regarding how best to 
provide decision aids through an EHR portal, with or without personalized information, and to 
deliver provider notifications, which can guide broader implementation.   
 
Our study will involve, first, interviews with staff and providers at our partner healthcare 
systems to identify facilitators and barriers to implementing decision aids and provider 
notifications for colorectal cancer screening.  In addition to the interviews, providers enrolled in 
randomized clinical trial Helping Patients and Providers Make Better Decisions about Colorectal 
Cancer Screening (Indiana University IRB# 2004109966) and were sent a screening reminder 
and personalized message will be surveyed via email to evaluate the provider notification. 
 
Secondly, we will interview patients to identify perceptions of prevention during the COVID19 
pandemic including risk perception and barriers to screening, perceptions of risk from both the 
pandemic and disease, and patient cancer screening and risk prevention behaviors engaged in 
or postponed during the pandemic and patient rationales for their decisions.  This part of our 
study will suggest potentially promising approaches for providing prevention and disease 
management during the COVID19 pandemic, which can then be tested in comparative 
effectiveness and implementation studies. 
 
Thirdly, we plan to collect data from both health systems about their screening rates and 
volume of in-person vs. telehealth visits prior to the COVID-19 pandemic and compare with 
data during the COVID-19 pandemic. And to provide context to this data, we will also collect 
data about local, regional, and state COVID-19 cases, restrictions, executive orders, and COVID-
19 vaccine development from public resources such as the Regenstrief COVID-19 Dashboard, 
Indiana COVID-19 Data Report, and the CDC website. 
 
 
3.0 
Aims 
 
Aim 1: Identify facilitators and barriers to implementing decision aids, provider notifications, 
and personal risk calculation using an electronic health record to promote colorectal cancer 
screening. 
 

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Aim 2: Identify the challenges and facilitators of effective cancer screening and prevention in 
primary care during the COVID19 pandemic among leadership, providers, and staff at two 
healthcare systems. 
 
Aim 3: Identify patient knowledge, attitudes, and beliefs that influence decisions to engage in 
cancer screening and prevention at two healthcare organizations during the COVID19 
pandemic, and barriers to uptake. 
 
 
4.0 
Research Plan 
 
Decision Aid and Provider Notification Implementation (Aim 1):  
Leadership, providers, and staff at IU Health and Eskenazi Health have always worked closely 
with our research team on colorectal cancer screening projects due to our shared interest in 
increasing CRC screening uptake rate.  More recently, we have developed the proposal and 
currently conducting the randomized trial to provide decision aids through the patient portal of 
the EHR systems (Epic at Eskenazi, Cerner at IU Health).  Both institutions wish to use these 
portals more frequently in patient care. (PC-1)   
 
We will study the facilitators and barriers of delivering decision aids to patients, systems for carrying out 
risk assessments and notifying providers, also through the EHR, by soliciting input from patients, 
providers, and staff through interviews and surveys.  
 
Interviews 
We plan to meet with providers, staff, and leadership at our partner healthcare systems every 
3-4 months for approximately two years. During these interviews, we will ask for their thoughts 
about implementing decision aids, provider notifications, and using cancer risk assessment 
tools in their health center or healthcare system.  The questions will be specific to colorectal 
cancer screening and may also be about other cancer screenings as well as preventive 
healthcare services.  We plan to share experiences and findings of our randomized trial being 
conducted concurrently with this study and ask for reactions and feedback. 
 
These interviews can be held individually with a member of our research team, or if there are 
other participating providers or staff from the same healthcare system and they all agree, the 
interviews can be held in a group meeting. 
 
We can conduct these interviews or meetings by phone, videoconferencing platform, or in-
person according to the participants’ preference and COVID-19 pandemic restriction guidelines. 
 
We expect the interviews to vary in length especially if they are conducted individually or in a 
group; however, we estimate the meetings will take no longer than an hour.  
 
Participants will be given a $100 gift card after each interview or meeting. 
 

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Enrollment: Our IU Health and Eskenazi Health provider, staff, and leadership stakeholders are 
scheduling times for the PI and Co-I’s to attend quality improvement and population health 
meetings.  These meetings focus on identifying improvement goals for their practice, including 
increasing colorectal cancer screening rates. During these meetings, we will briefly describe our 
study and ask if anyone is interested in learning more. Those individuals who express interest 
will be contacted by a study team member by phone or email based on the interested persons’ 
preference. We will email the study information sheet to the interested person and follow-up 
by email or phone, again based on the interested persons’ preference. We will answer all 
questions to the persons satisfaction. We will then obtain verbal consent at the first scheduled 
meeting prior to initiating the interview and recording. 
 
We will also use a snowball approach to recruit additional participants by asking participants to 
assist in identifying other potentially interested providers or staff at their health center or 
healthcare system. A study team member will contact these recommended individuals by email 
with a brief description of the study and instructions to respond within two week if they do not 
wish to be further contacted. After two weeks, we will follow up with the remaining potential 
participants to gauge their interest and availability in participating. If the potential participant is 
interested, we will email them the study information sheet and follow-up by email or phone to 
answer questions. Because the risk of this study is low, we will obtain verbal consent to 
participate at the first scheduled meeting prior to initiating the interview and recording.  
 
Throughout the study, we will confirm interest and continued willingness to participate at the 
end of each interview and meeting.  
 
Eligibility: Individuals will be eligible if they are employed by one of our partner healthcare 
systems (IU Health or Eskenazi Health) 
 
Data Collection: We plan to record all meetings/interviews as well as take detailed notes.  The 
research team will review the notes after each meeting and determine if the recordings need 
transcribing for more detailed review.  All recordings will be transcribed and de-identified. A 
cross walk file will be kept password protected by key staff with limited access.  Recordings will 
be kept on the study project folder. 
 
Surveys 
Our randomized clinical trial Helping Patients and Providers Make Better Decisions about 
Colorectal Cancer Screening (Indiana University IRB# 2004109966) enrolls providers to 
participate in the study. Half the providers are randomized to receive a reminder that their 
patient is due for colorectal cancer screening, and their patient’s chance of currently having an 
ACN and implications for screening test effectiveness and choice.  We plan to invite providers 
who were sent at least one of these notifications to complete a survey after their completion in 
the randomized trial. 

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The survey data will be collected by emailing the providers a link to complete the survey 
directly in a web-based, HIPAA-aligned data collection system (REDCap). Data will be collected 
with an investigator created measure to evaluate the notification. Satisfaction will be measure 
with an 11-item scale using Likert-type response options where 4 = strongly agree to 1 = 
strongly disagree, and  usability will be measure with five multiple choice questions. At the end 
of these 16 items, providers will be invited to share additional thoughts in a text box field.  We 
will program REDCap to resend the survey 2 more times if the provider does not complete. 
 
We expect the survey will take less than 3 minutes to complete, and the providers will be 
mailed a $20 gift card after completing the survey. 
 
Enrollment:  Study staff working with the clinical trial monitor patient enrollment. When study 
staff determine that patients from a provider are no longer being recruited and enrolled, that 
provider’s participation in the trial will end. Within approximately 1 month of the provider 
coming off the clinical trial, study staff will send the provider the survey through REDCap. The 
body of the email containing the survey link will inform the provider that they are being asked 
to complete a survey, the purpose of the survey, a statement regarding any potential risks and 
benefits, a statement that completing the survey is voluntary, and the Principal Investigator’s 
name and contact information. Clicking on the link to access the survey will confirm consent. 
 
Eligibility:  Providers who enrolled in the clinical trial Helping Patients and Providers Make 
Better Decisions about Colorectal Cancer Screening (Indiana University IRB# 2004109966), and 
received at least one notification containing the reminder that their patient is due for colorectal 
cancer screening, and their patient’s chance of currently having an ACN and implications for 
screening test effectiveness and choice. 
 
Cancer screening and prevention in primary care during COVID19 (Aim 2): 
We will expand our planned Aim 1 interviews with leadership, providers, and staff to cover 
cancer screening beyond colorectal cancer and cancer screening during the COVID-19 
pandemic. While we will be interested in all health system participants’ comments, we 
anticipate that a subset of these participants will have more knowledge about the impact  
COVID-19 had on their health center and health system. With this subset of health system 
participants, we will spend more time asking them to reflect on challenges in prevention during 
the COVID-19 pandemic, initiatives that have been tried to promote screening and prevention, 
and barriers and facilitators of the initiatives.  
 
Health system leadership, providers, and staff will be informed of these COVID-19 focused 
interviews when they enroll in the study as part of Aim 1. 
 
As with the interviews in Aim 1, these interviews will be conducted by trained project staff over 
the phone, video conferencing, or in-person according to the participants’ preference and 

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pandemic restrictions. Project staff will be located in a private area and the interviewees will be 
encouraged to locate in a private area as well.  These interviews are planned to take an hour 
and will be audio recorded. All recordings will be transcribed and de-identified. Participants will 
be mailed a $100 gift card to thank them for their time. 
 
Data analysists from both our health system partners will query their respective EHRs’ for 
cancer screening rates, types of screening tests, and primary care visit volume and type of 
visits. This data will be shared with health system leadership, providers, and staff to help them 
remember the time periods during the interviews and meetings.  
 
Patient engagement in cancer screening and prevention during COVID19 (Aim 3): 
We will identify patients receiving primary care from two healthcare organizations: Eskenazi 
Health and IU Health who were due for cancer screening at the start of the COVID pandemic.   
 
We will identify adults age eligible for screening in the electronic health records from these two 
healthcare organizations who previously had either breast, cervical, or lung cancer screening 
and became eligible for repeat screening in April or May 2020. We will also identify patients 
who  were scheduled for a screening colonoscopy in April or May 2020 and had the procedure 
cancelled due to the COVID pandemic. We will identify some individuals who completed the 
cancer screening after May 2020 and some who did not complete indicated screening.  We will 
aim to enroll a convenience sample with diverse sex, race, ethnicity, and range of participation 
in cancer screening and prevention. 
 
Inclusion criteria:  
Patients will be eligible if they: 
• completed cervical cancer screening in April or May 2017; completed breast cancer 
screening in April or May 2018; completed lung cancer screening in April or May 2019; 
or had a scheduled screening colonoscopy cancelled in April or May 2020 as noted in 
electronic health record 
• age 50 – 75 years* for individuals screened for breast cancer; age 50 – 80 years* for 
individuals screened for lung cancer; age 25 – 75 years* for individuals screened for 
cervical cancer; age 50 – 75 years* for individuals scheduled for screening colonoscopy 
in April/May 2020 
• Speaks English 
• Able to provide verbal consent 
• Accessible by phone 
*age as of April/May 2020  
 
Exclusion criteria: 
Patients will be excluded if they: 

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• Self-report they no longer receive primary care at either of our partner health systems 
(IU Health or Eskenazi Health) 
• Self-report that they completed the repeat screening prior to April/May 2020 and 
therefore, were not eligible to be screened again in April/May 2020 
• For patients identified as not having the repeat screening after May 2020, self-report 
that they did complete the indicated screening 
• Are unable to speak or read English 
• Previously participated in any research projects conducted by the Principal Investigator 
(Peter H. Schwartz, MD, PhD) 
 
Methods: We will mail potentially eligible patients an invitation letter to participate in a one-
time interview. The invitation will include a phone number to call our research team if the 
patient does not wish to be further contacted. After about 1 week, we will follow up with a 
telephone call for all remaining patients to assess interest in our study participation. We will 
review the Study Information Sheet (SIS) and HIPAA authorization with the patient and email 
the participant both forms, arranging for a follow-up phone call as needed to further discuss 
and answer any participant questions.  After the patient verbally agrees to participate, we will 
schedule a one time, phone/virtual platform (Zoom) meeting to administer a semi-structured 
interview. Prior to starting the interview, we will confirm verbal consent to participate and to 
audiotape(telephone)/videotape (Virtual Platform) the interview. The interview will take 
approximately 45 minutes and will be transcribed and de-identified. Participants will be 
compensated with a $100 gift card for completing an interview.  
 
We will employ a semi-structured, telephone/virtual platform interview.  The interview guide 
will be developed based on materials such as the current US preventive task force guidelines, 
other relevant literature, and research on perceived risk and preventive behaviors.  We will 
continue interviews until we achieve content saturation.  
 
We will assess patients’ participation in screening and prevention and healthcare more 
generally during the COVID19 pandemic, planned future participation, perceived facilitators and 
barriers, risk perception, and sources of information.  In each area, we will ask participants for 
reflection on changes from before the pandemic. 
 
 
5.0 
Data Analysis Plan 
 
Decision Aid and Provider Notification Implementation (Aim 1): 
All interviews will be audio recorded, transcribed, and de-identified. We will first conduct rapid 
qualitative analysis using notes taken during the interviews to identify key themes. Next we will 
qualitatively code using Nvivo software, with separate coding and analysis for the patient and 

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the leadership/provider/ staff interviews.  The codebooks will include both apriori including 
planned constructs around risk communications, local context and adaptations and emergent 
codes from the stakeholders. We will run a series of planned matrices evaluating risk 
assessment barriers and facilitators by healthcare organization (IU and Eskenazi).   
 
Descriptive methods will be used to analyze the quantitative survey data. The satisfaction 
questions have Likert-type response options, and the usability items have multiple choice 
response options. We will calculate the counts and percentages of each response option for 
each question.   
 
Cancer screening and prevention in primary care during COVID19 (Aim 2) and 
Patient engagement in cancer screening and prevention during COVID19 (Aim 3): 
All interviews will be audio recorded, transcribed, and de-identified. We will first conduct rapid 
qualitative analysis using notes taken during the interviews to identify key themes. Next we will 
qualitatively code using Nvivo12 software, with separate coding and analysis for the patient and 
the leadership/provider/ staff interviews.  The codebooks will include both apriori including 
planned constructs around risk communications and referrals, clinical preventive services 
received or postponed, local context and adaptations and emergent codes from the 
stakeholders. We will run a series of planned matrices evaluating perceived risk and preventive 
services received by healthcare organization, and by consumer patient age and sex. 
Furthermore, we will explore contextual elements by change rates in preventive services 
delivered in 2020 to understand local adaptation to preventive health services amid COVID19 
pandemic. We will construct flow maps of the adapted CRC screening clinical processes amid 
the COVID19 pandemic. 
 
For each of the three aims, we will feedback the results to the key stakeholders for their 
interpretations and perceptions including the healthcare organizations, our patient advisory 
panel, and our investigator/staff team. 
 
6.0 
Deliverables 
 
Decision Aid and Provider Notification Implementation (Aim 1): 
At the conclusion of our study, we will have extensive information regarding how best to 
provide decision aids through an EHR portal, with or without personalized information, and to 
deliver provider notifications, which can guide broader implementation.  We have worked 
closely with our patient and community partners, as well as the leadership, quality 
improvement, and IT teams at our health system partners to develop systems that can be 
implemented effectively and affordably in clinical care.  Beyond publication and presentation, 
this information and the decision aids and systems will be made available to all healthcare 

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systems that wish to adopt approaches supported by our findings.   
 
The broader dissemination of our results will also be supported by the involvement of national 
leaders and policymakers who have been involved in planning the study and will serve on an 
external advisory board during the study (3x per year teleconference).  These include: 
• Richard Wender, MD, chief cancer control officer of the American Cancer Society and 
chair of the National Colorectal Cancer Roundtable,  
• David Lieberman, MD, President of the American Gastroenterology Association, 
• Jon Keevil, VP for Clinical Decision Support at EBSCO, and 
• Michael Barry, MD, former chief science officer at Healthwise. 
These supplement the members of our research team -- Brian Zikmund-Fisher, PhD, and Paul 
Han, MA, MD – who play leadership roles in the International Patient Decision Aids Standards 
consortium. 
 
Cancer screening and prevention in primary care during COVID19 (Aim 2) and 
Patient engagement in cancer screening and prevention during COVID19 (Aim 3): 
In addition to publications and presentations of findings, we aim to identify at least four 
initiatives that hold promise for responding to the challenges of prevention in the COVID19 
pandemic, including facilitators and barriers and patient factors.  Examples could include 
variations in settings to accommodate level of virus risk (surgical facility; clinic; community 
based (e.g.pharmacy), drive throughs, and home-based systems. We will report these initiatives 
back to our leadership, provider, and staff participants for feedback and reflection.  These 
initiatives would be candidates for implementation and future comparative effectiveness 
research. 
 
 
7.0 
Study Timeline 
 
Decision Aid and Provider Notification Implementation (Aim 1): 
November 1, 2020 – July 30, 2023 
 
Cancer screening and prevention in primary care during COVID19 (Aim 2) and 
Patient engagement in cancer screening and prevention during COVID19 (Aim 3): 
October 1, 2020 – December 31, 2021 (15 months).  Initialization:  October 1 – Nov. 30, 2020.  
Interviews:  Dec. 2020 – August 2021.  Data analysis:  Oct. 2021 – Dec. 2021 
 
 
8.0 
Data Management Plan 
 

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Reportable Events:  If a participant experiences an adverse event that occurs in greater 
frequency or severity than previously known, this will be reported to the IRB either as a prompt 
report if it meets reporting criteria, or at time of study closure. 
 
Data Safety Monitoring:  Dr. Peter H. Schwartz, principal investigator will have ultimate 
responsibility for monitoring the safety and security of the participants and data. Dr. Schwartz 
and his study team will engage in quality improvement practices beginning with development 
and then with ongoing review of study procedures. The Co-Investigators will be actively 
involved in quality assurance activities including monitoring of recruitment, adherence to study 
protocol, and adherence to any adverse event reporting. 
 
Potential Risks:   A breach of confidentiality is always a risk with minimal risk studies. In 
addition, participating in a research study and answering questions may cause anxiety. 
 
Protecting against or Minimizing Potential Risks:  For both patient and healthcare system 
participants, all information required for recruitment and tracking will be stored in a HIPAA-
aligned database accessible only by authorized study team members. All team members will 
adhere to our institution’s HIPAA policy and use of protected health information. All data 
provided by the patient and healthcare system participants will be collected and stored in a 
separate HIPAA-aligned database accessible only by authorized study team members.  
Authorization to access both databases will be managed and overseen by the project manager 
and the principal investigator.  Audio recordings will be saved on a Department of Medicine 
servers. The PI and project manager will coordinate with the Department IT staff to control 
access to these folders.  Processes and procedures have been documented and implemented to 
ensure the security and protection of the data within the computer operations centers, the 
servers, and the databases.  
 
Participants will be assigned a unique identification number and using this number to identify 
the participant in all transcripts. We will keep all paper documents locked in lockable cabinets 
in a locked office suite. 
 
All participants will be fully informed about the study prior to enrollment and be given the 
opportunity to decline to answer any questions or to discuss any issues they find troubling. 
They will be told that they can terminate participation at any time for any reason. 
 
Research team members will be trained in procedures to allow participant to withdraw from 
the study. All study team members including those involved with the recruitment, informed 
consent process, and data collection will be adequately trained. Training will include passing of 
our institution’s required Collaborative Institutional Training Initiative (CITI) modules and 
ongoing study-specific training from study personnel. 
 

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Protections for Research Data:  Most of the data will be entered directly into one of several 
instruments in the study's REDCap project, a HIPAA aligned web environment. Privileges to the 
instruments will be granted or restricted by the PI or project manager based on what user rights 
are necessary to do the job. This could include no access, read only, or read and edit the data.  
Audio files that are created during the course of the study will be saved on the Department's 
servers. The PI or project manager will coordinate with the Department's IT to control access to 
these folders. 
 
Protections for Participant Privacy:  Initial contact with healthcare system providers and staff 
will be during a quality or population health meeting, or by email. Providers and staff generally 
are in a private area for these meetings. Providers and staff will choose their location for the 
follow-up emails or phone calls. The study interviews and meetings will be held in private 
locations. The research team member will be in a private area to conduct a phone or 
videoconferencing interview or meeting. 
 
Initial contact with the patient will be a recruitment letter mailed through the US Postal Service 
to the address provided by the patient to be included in the EHR. The recruitment phone calls 
will be made from a private office to the phone number listed in the EHR and if additional 
phone calls are required, the recruiter will confirm with the potential participant their preferred 
contact number and time; the study team will make arrangements to comply with the potential 
participant's wishes.   
 
Research staff will encourage the patient-participants to be in a quiet, private area for the 
interview; however, the participants ultimately will choose the location. The research team 
member conducting the interview will be in a private location. 
 
 
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