Predicting and Addressing Colonoscopy in Safety Net Settings
Phase: NA
Conditions: Colorectal Cancer
Sponsor: Kaiser Permanente

 
 
Predicting and 
Addressing 
Colonoscopy in Safety 
Net Settings (PRECISE) 
Protocol 
 NCT03925883 
 
Version: December 4, 2022 
 

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Protocol: December 4, 2022 
1. Protocol Title 
The Predicting and Addressing Colonoscopy in Safety Net Settings (PRECISE) 
 
2. Objectives 
Phase I (Aim 1) will be a milestone-driven planning phase to externally validate the risk-prediction score, stratify 
patients’ probability of adhering to follow-up colonoscopy, and adapt patient navigation materials for the local 
context.  
Phase II (Aims 2–3) will be a large-scale, targeted, patient-randomized controlled trial that will include ~1200 
patients across 28 clinics in western Washington State. 
 
Minority Supplement: A supplement for this study was awarded on 9/23/2020 to assess gastroenterology (GI) 
practice changes due to the COVID19 pandemic. This work will not alter the study design, number of study 
participants, or consent considerations.  
Specific Aim #1: Characterize organizational characteristics of GI practices  
Specific Aim #2: Apply novel analytic techniques to identify GI practice characteristics associated with 
timely follow-up colonoscopy completion 
 
Supplement work is estimated to be finished by the end of 2023, which overlaps with the project period of the 
PRECISE study.  
 
3. Background 
Many patients with positive fecal tests forgo colonoscopies. Data from Kaiser Permanente Northern California show 
that individuals who received colonoscopies 12 months after a positive result from a fecal test had a 4% higher incidence 
and 16% higher mortality from the disease than individuals who received a colonoscopy within 2 weeks.10 The human 
cost of this “missed opportunity” is tremendous and analyses show those who delayed screening for a year lost nearly 
10% in life-years compared to those with prompt follow-up.10  Colonoscopy follow-up rates vary across populations. 
Our team observed a 54% 1-year follow-up rate in our STOP CRC project involving >50,000 patients in 26 CHC clinics [NIH 
UH3AT007782].18 STOP CRC data further show troubling disparities in follow-up by race/ethnicity, with Hispanics 
following up at a lower rate than non-Hispanic whites (45% vs. 70%, within 18 months).18 Colonoscopy follow-up rates 
in community health centers are suboptimal. Patient navigation is a promising approach to increase follow-up rates. 
Patient navigation is increasingly being used to address the health care needs of the medically underserved. Indeed, the 
National Colorectal Cancer Roundtable strongly endorses patient navigation for colonoscopy screening and follow-up.22  
Despite this promising research, almost all available studies have focused on initial CRC screening, rather than follow-up 
colonoscopy. Despite promise, more information is needed to best target patient navigation resources. Published 
rates of follow-up colonoscopy range from 42-82%.11-17 The successful New Hampshire program, for example, reported 
that a high proportion (69%) of non-navigated patients obtained a colonoscopy—that is, they did not need navigation. 
This finding is important because patient navigation programs can require extensive resources to adopt; previous cost 
evaluations of patient navigation have reported costs ranging from $50 to $332 per participant.24-26 If health systems 
were able to determine which patients were likely to forgo colonoscopy, they could funnel their education and outreach 
efforts, including navigation efforts, into the individuals who need them most. Knowing which patients could benefit 
from navigation could optimize the delivery of such services, address health disparities, and reduce associated costs. The 
proposed research, Predicting and Addressing Colonoscopy in Safety Net Settings (PRECISE), will do just this by 
estimating the probability of colonoscopy adherence among patients with a positive fecal test (FIT), and test patient 
navigation as an approach to improve colonoscopy adherence among patients who need it. Our study will also assess 
the cost of patient navigation. To date, no study has reported the cost of navigation across patient groups defined by 
probability of adherence, as we propose. 

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Risk-prediction models can improve care quality and optimize health care resources, but more evidence is needed.28 
While risk-prediction models hold promise for identifying patients who are likely to forgo colonoscopy, previous 
research on this topic is scarce. Our team has developed a risk-prediction model specifically for follow-up colonoscopy 
receipt that relied on data from the STOP CRC trial of 26 CHC clinics (CRC Risk).  
 
 
4. Study Design 
Overview. This study will increase follow-up 
colonoscopy rates in large numbers of diverse 
patients by testing a patient navigation 
program with patients obtaining follow-up 
colonoscopy. Phase I (Aim 1) will be a 
milestone-driven planning phase to externally 
validate the risk-prediction score, stratify 
patients’ probability of adhering to follow-up 
colonoscopy, and adapt patient navigation 
materials for the local context. Phase II (Aims 
2–3) will be a large-scale, targeted, patient-
randomized controlled trial that will include 
~1200 patients across 28 clinics in western 
Washington State. A central advisory group 
of key clinicians and patients, researchers, 
and policy-makers will guide the study implementation, results interpretation, and dissemination. We will work with our 
Advisory Board to compare rates of follow-up colonoscopy completion in ~1200 patients who are randomized to receive 
either a telephone-based program of patient navigation delivered by trained clinical staff (developed by Dr. Lynn 
Butterly and replicated by Dr. Peggy Hannon, project consultant) or usual care. We will also assess the cost of the 
program for patient groups defined by risk level risk of adhering to follow-up colonoscopy). Secondarily, we will assess 
differences in process outcomes and explore possible moderators of effectiveness. Results of this research could lead to 
large-scale testing and adoption of targeted patient navigation approaches in clinical settings.  
 
5. Study Population 
a. Number of Subjects 
All analysis will only include patients from the SeaMar Community Health Centers. First, a retrospective analysis of 
patients in the past 5 years will be analyzed to create the risk model to predict failure to follow-up to a colonoscopy. 
Then, 1200 patents will be included in the RCT. Our study will also recruit patients and clinic staff for qualitative 
interviews at participating clinics within the FQHC. 
 
b. Inclusion and Exclusion Criteria 
For all aspects of the study, we will only be including patients aged 50-76 with a positive FIT test. Some exclusions may 
apply based on appropriateness of screening (i.e. if they had prior colorectal cancer, or are on hospice or dialysis).  
 
This intervention is part of clinical care. Subjects may refuse colonoscopy as part of clinical care, but will have 
opportunity to opt out of the study. 
 
c. Vulnerable Populations 
This study will not include children or neonates by design (aged 50-76). Prisoners were not knowingly included in the 
cohort. Pregnant women were not targeted but may have been included incidentally.  Decisionally impaired adults will 
not be excluded as CRC screening is recommended for these patients. 
Validate risk model at 
Sea Mar
Adapt patient 
navigation materials
Identify patients with positive FIT and determine risk of 
non-adherence to colonoscopy
Primary outcomes: (1) receipt of colonoscopy within 1 
year of positive FIT; (2) cost, cost-effectiveness, & ROI
- 2-phase patient randomized trial of patient navigation vs. usual care
- Enroll ~1,200 patients across 28 Sea Mar clinics
- 5-year RO1 study funded by the National Cancer Institute 
Phase 1: Validate 
& apply risk model
Phase 2: Randomized Trial
Phone-based patient 
navigation delivered by 
MA
Usual Care (referral 
coordination & tracking)
Assess patients’ risk

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d. Setting 
The proposed project is a partnership with Sea Mar Community Health Centers. Sea Mar operates 34 medical clinics (28 
clinics will participate in this trial; non-participating clinics are specialty sites) and serves a patient population of 
~250,000; ~29,000 are eligible for CRC screening. The proportion of Latino patients is 37%. Clinic personnel are sensitive 
to, and reflective of, the diverse populations they serve. Sea Mar has a fully integrated EHR platform tailored for primary 
care (Allscripts, Chicago, Illinois). Sea Mar has participated in efforts to raise its CRC screening rates by using a direct-
mail FIT approach followed by automated and live reminders.  
 
All analysis will be conducted at KPNW. SeaMar (#FWA00000701) and Portland State University (#FWA00003920) 
will cede IRB oversight to the KPNW IRB (FWA 00002344).  
 
e. Recruitment Methods/Data Collection 
Retrospective Risk Model 
For the retrospective risk model, patients who are aged 50-75, and have had an abnormal FIT test will be identified for 
the last 5 years. The risk model will identify clinical, lab, encounter, and demographic characteristics to predict those 
unlikely to undergo colonoscopy. The analysis of the abnormal FIT patients over the past 5 years may include more than 
6,000 patients. 
 
Patient Navigation 
We will conduct a large-scale, targeted, patient-randomized controlled trial that will include ~1200 patients at 
28 Sea Mar clinics. Patients will have to be 50-75 years old, and have an abnormal fecal test (FIT). We will 
compare rates of follow-up colonoscopy completion in ~1200 patients having either a moderate or low risk of 
colonoscopy adherence who are randomized to receive either a telephone-based (including text messages for 
scheduling, reminders, and outreach for “difficult to reach” patients) program of patient navigation delivered by 
trained clinical staff or usual care. Patients will be randomized based on county of their assigned clinic. Patients 
will be randomized using a stratified approach that considers county. The randomization will result in 600 
patients assigned to the patient navigation arm and 600 assigned to the usual care arm.  
All navigation and usual care will be conducted by the clinical teams at SeaMar (nurses, MA’s, providers, etc.). 
The patient navigator will undergo intensive training during the startup phase of the study. The navigator will 
receive coaching (quality assurance supervision) by KPCHR study staff. Coaching will include routine 
(daily/weekly) check-in phone calls, and listening in on patient navigation calls and tracking navigation fidelity. 
KPCHR staff will continue to monitor patient navigation calls throughout the trial as part of the intervention 
fidelity assessment. The patient navigator will help patients address and resolve barriers to follow-up care, such 
as, transportation barriers through ride-share services or medical transport services.  
We will assess rates of colonoscopy receipt by probability group. At the end of the evaluation, if the intervention 
is found to be successful, it will be offered to all patients in the usual care and surveillance arms who did not get 
a follow-up colonoscopy. 
Patient Interviews: Qualitative interviews will be conducted with patients recruited through the participating 
clinics during the study. All recruitment materials will be approved by the IRB. Interviews will be conducted over 
the phone or in person by a CHR qualitative research specialist and take place at a convenient time and location 
for participants. We will work with the FQHC to develop recruitment materials. The decision was made to have 
CHR staff recruit patients and conduct interviews. However, recruitment letters will be printed on FQHC 
letterhead. If CHR staff encounter any challenges recruiting participants for these interviews, FQHC staff will 
assist with recruitment. Patient interviews completed over the phone will require a waiver of signed informed 
consent.  

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Clinic Staff Interviews: Select clinic personnel, some of whom may participate in Patient Navigation, will be 
invited to participate in a 30-60-minute phone or in person interview about project implementation. We will 
work with clinics to determine the most appropriate way to invite their staff to participate - this may be done via 
email or mailed letter. Participants will receive a $20.00 gift card for their time. Staff will be informed of the 
nature of the risks and benefits of participation, that participation is strictly voluntary, and that refusal to 
participate will not affect their employment. We will conduct our recruitment to counter coercion by 
emphasizing the voluntary nature of participation. Given the non-personal nature of the interview questions, we 
request a waiver of signed informed consent.   
Gastroenterologist Interviews: Select GI clinic personnel and providers will be invited to participate in a 30-60-
minute phone or in person interview about project implementation. We will work with clinics to determine the 
most appropriate way to invite their staff to participate - this may be done via email or mailed letter. 
Participants will receive a $25.00 gift card for their time. Staff will be informed of the nature of the risks and 
benefits of participation, that participation is strictly voluntary, and that refusal to participate will not affect 
their employment. We will conduct our recruitment to counter coercion by emphasizing the voluntary nature of 
participation. Given the non-personal nature of the interview questions, we request a waiver of signed informed 
consent.   
 
f. Consent Process 
For the risk model, the study only involves retrospective data, and it is not practicable to collect the data we need if we 
have to contact each individual to get permission. We believe this poses minimal risk. 
 
This project will promote colorectal cancer screening through standard clinical modalities. Thus, it is an extension of 
usual clinical practice. Moreover, this is a pragmatic trial, and obtaining consent would unnaturally restrict our study 
sample, diminishing the external validity of our findings. Therefore, we request a full waiver of informed consent for the 
study and the reminders. 
 
For the qualitative interview component of this study, we request a waiver of signed informed consent. The interviews 
with patients and clinic staff will use an informed consent procedure, but without signed documentation. We will give 
participants the option of completing the interview, and if they agree they will be interviewed over the phone or in 
person. Those completing the phone interview will give verbal consent. This research does not involve procedures for 
which written consent is normally required outside of the research context. Information about consent will be provided 
orally or in writing, and will include all required and appropriate additional elements of consent. This study presents no 
more than minimal risk of harm to subjects.  
 
 
Non-English Speaking Subjects 
The clinical team will be conducting the interventions and usual care, and will therefore provide the standard of care 
acceptable in the clinic.  
 
All Spanish qualitative interviews will be conducted by a bilingual qualitative researcher. Patient facing materials, such as 
the consent form, will be provided in Spanish. See above regarding consent process.  
 
Translations will be completed by Jennifer Rivelli, Katherine Vaughn and Natalia Tommasi, KP certified CHR staff. 
Jennifer, Katherine and Natalia certify that the outlined study documents below have been translated into Spanish 
and/or Russian to the best of their abilities as certified translators since 2012-2013 (2018 Katherine). They certify that 
the referenced documents have been accurately translated into Spanish and/or Russian and have retained the authentic 
content of the original documents.  
 
Translated study documents submitted to the IRB for review: 
• Patient recruitment introduction letter (English, Spanish, Russian) 

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• Phone script navigation (English, Spanish) 
• Patient text messages (English, Spanish) 
• Colon Cancer Fact Sheet (English, Spanish, Russian) 
• Colonoscopy Bowel Prep Information Sheet (English, Spanish, Russian) 
• Patient Navigation Outline Information Sheet (English, Spanish, Russian) 
• Patient interview recruitment introduction letter (English and Spanish) 
• Navigator Script Patient Interviews (English and Spanish) 
• Patient Interview Thank You Letter (English and Spanish) 
• Consent_Patient Interview (English and Spanish) 
 
HIPAA Privacy Rule Authorization – if study will use or disclose Protected Health Information (PHI) 
We request a full waiver of the privacy rule authorization requirement to allow members of the KP workforce within the 
KP region to use Protected Health Information (PHI) from Seamar. For the qualitative interview component of this study, 
we request an alteration of the privacy rule authorization - participant signature and date cannot be obtained.  
 
Electronic medical records (EMRs) at participating clinics will be used to identify the retrospective data and a 
prospective cohort of potential study participants based on inclusion and exclusion criteria. Electronic medical 
records (EMRs) will also be used to look for outcomes (completed FIT/FOBT or colonoscopy). We will run 
analyses on the control vs. intervention patients to determine if our intervention had a significant effect. A CHR 
auditor will access clinical data from the participating sites to inspect the quality and ensure the accuracy of the 
data. Data from all sites will be gathered at the clinics and sent via secure file transfer to CHR for analysis. Data 
Use Agreements will be established to 1) allow for the aforementioned transfer, and 2) to permit CHR to send 
analyzed limited datasets back to the clinics for further refinement on any issues encountered. PHI will not be 
shared when the data are sent back for further validation/refinement. 
 
Use of the medical record by clinic staff is regular clinical practice, required to identify participants for the overall study.  
Therefore, we would be unable to seek authorization prior to using the medical record. Only the PHI data required to 
identify the study population will be accessed. However, we may also: 1) access additional patient information such as 
sociodemographic characteristics that may be related to differences in program reach and effectiveness, and 2) access 
the minimum PHI necessary to properly carryout the research task of interviewing patients. (Use of the medical record is 
also required to identify participants for qualitative interviews, so we would not be able to seek signature and date for 
authorization prior to using the medical record.) The use and disclosure of PHI will involve no more than minimal risk to 
the privacy of individuals. All identifiable study data will be stored within clinic data systems. See Section 8. Privacy, 
Confidentiality, and Data Security below for more information.  
 
6. Study Procedures 
This study will test a predictive risk model and patient navigation. In Phase I we will validate a current predictive 
model in the SeaMar setting and our ability to assess the patients probability of adherence to colonoscopy. In 
addition, we will be adapting the patient navigation program materials based on local resources, develop the 
patient navigator protocol and train patient navigators. The study will also include qualitative interviews with 
patients and clinic staff. 
In Phase II, we will conduct a patient-randomized trial that tests the effectiveness of patient navigation. Both 
phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.  
The participating clinics will be federally qualified health centers (FQHCs) that serve populations that speak several 
languages, but mostly English or Spanish. Materials will be translated by Jennifer Rivelli and Natalia Tommasi, KP 
certified CHR staff. 
 

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As part of the minority supplement work, Dr. Cynthia Mojica will conduct semi-structured in-depth interviews ( in-
person, phone or virtual platform) with GI providers or office staff (including clinic mangers and colonoscopy schedulers) 
to assess practice changes due to the COVID19 pandemic. (These interviews are distinct from the GI interviews 
described above on page 4 of the protocol.) Interviews will be recorded and last about 30-60 minutes. Respondents will 
be offered a $25 gift card as a token of appreciation for their time. Given the non-personal nature of the interview 
questions, we request a waiver of signed informed consent.   
 
This study does not involve genetic testing or collection of genetic information. 
7. Data Analysis 
a. Analysis Plan 
Assessment of cost and cost-effectiveness. Once we have established the effectiveness of the patient navigation 
program, we will assess costs and cost-effectiveness from the health-plan perspective, both overall and by risk stratum. 
We will follow best practices and be guided by previous economic analyses of patient navigation for CRC screening 
follow-up. First, we will assess the costs of implementing and maintaining the patient navigation program and estimate 
how costs of patient navigation differ when delivering the service to all patients, versus just those who have a varying 
probability of undergoing a colonoscopy. Next, using the framework of cost-effectiveness, we will estimate the 
incremental cost-effectiveness ratio (ICER) as: (1) cost per additional completed colonoscopy, (2) cost per additional 
adenoma detected, and 3) cost per additional cancer detected. Finally, to further evaluate the impact of specific 
program elements on overall cost, we will conduct a budget-impact analysis.  
 
Secondary outcomes and process measures. We will gather data from the EHR on time to colonoscopy completion, time 
to initiation of cancer treatment, and appointment no-shows and cancelations. Using the pathology report, we will also 
track colonoscopy-related quality measures, including adequacy of colonoscopy prep, detection of adenomas and 
cancer, and cancer stage at detection.  
 
Analysis of possible moderators. Notably, our preliminary data showed follow-up colonoscopy receipt varied 
substantially by probability strata (30%, 59%, and 93% for the low, moderate, and high strata, respectively), suggesting 
that assessments of clinically meaningful impacts could differ by probability strata. To determine whether adherence 
probability moderates the effect of the intervention, we will add probability strata  and the product of stratum and arm 
to the primary outcome model. The product represents the interaction of arm and probability stratum; a significant term 
provides evidence for effect modification. We will determine the nature of any interaction by examining the simple main 
effects using graphical methods. We will repeat this analysis using the continuous risk score in place of the risk strata.  
 
Minority Supplement:  
 
For minority supplement aim 1, we will use descriptive statistics to summarize the structural characteristics and 
processes of GI practices.  
 
For minority supplement aim 2, we will use data gathered from aim 1 to conduct a configurational analysis. We will 
use configurational comparative methods (CCMs) to identify conditions (organizational structures, processes, and 

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policies, and changes in processes and policies) associated with follow-up colonoscopy completion rate and time to 
colonoscopy completion among Sea Mar Community Health Center patients. 
 
b. Sharing of Results with Subjects 
Test results will be shared with subjects per standard clinical practice. We will also publish findings and share findings 
with the participating clinics. 
 
c. Data and Specimen Banking – N/A 
 
8. Privacy, Confidentiality, and Data Security 
To reduce any risk of disclosure of confidential information, subjects' privacy and confidentiality will be assured by: 
a. Securely storing data in password-protected files and directories on staff computers within firewall 
protected networks; 
b. Removing or obscuring participant names prior to any presentation, publication, or other sharing of data 
outside the research team, except with the expressed written consent of the subject(s); 
c. Ensuring that unmodified data (containing identifying data or features) are accessible only to members of 
the research team working under the direction of the investigators for the duration of the project; 
identifiers will be removed as soon as is feasible; 
d. Transporting interview materials in locked containers. 
 
9. Provisions to Monitor the Data to Ensure the Safety of Subjects 
a. Designation of a Data Safety Monitor: 
An independent investigator will serve as an Independent Monitor for Data and Safety for the project. S/he 
will not be key personnel in this grant. S/he will be qualified to review the patient safety data generated by 
this study because of their unique clinical and research expertise. 
b. Safety Review Plan and Protocol for Identifying, Reviewing and Reporting Adverse Event to IRB and NIH: 
Study progress and safety will be reviewed semi-annually (and more frequently if needed). Progress reports, 
including patient recruitment and Adverse Events (AEs) will be provided to the Independent Monitors 
following each of the semi-annual reviews. A semi- annual report will be compiled and will include a list and 
summary of AEs. In addition, the report will address (1) whether AE rates are consistent with pre-study 
assumptions; (2) and the status of follow-up to abnormal screening results (within 6 months). The annual 
report will be sent to the Independent Monitor, and will be forwarded to the IRB and NIH, if applicable. The 
IRB and other applicable recipients will review progress of the study on an annual basis.  
The PI will meet with the project director and research staff weekly. All AEs and unanticipated problems 
occurring during the study will be collected, documented, and reported to the PI and the Independent 
Monitor immediately. During the intervention phase of the study, clinic staff will report any AEs or 
unanticipated problems that may have occurred during the intervention.  
c. Assessment of external factors that may impact participant safety and/or ethics for the research study: 
The PI will continue to follow-up with new information in the literature and results of related studies. If any 
new information is available that would impact the relevance of the study, it will be documented and 
reported to the Independent Monitor by email or phone.  
d. Advanced plans for interim and/or futility analysis: 
Interim analysis of data will not be conducted as part of this study. Given our goal of evaluating the 
implementation and maintenance of this evidence-based intervention, an interim analysis would be 
impractical. We do not anticipate that new data would show trends for negative outcomes resulting from 
the proposed interventions. 
 

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10. Risks and Benefits 
a. Risks to Subjects 
The minimal risks to subjects appear reasonable when weighed against the potential societal 
benefit. This study proposes to increase colorectal cancer screening, which is beneficial to the 
subjects, and increases recommended screening. 
 
b. Potential Benefits to Subjects 
Participants of the study and qualitative interviews, are not expected to directly benefit from 
participating, other than the possible benefit of increasing recommended screening, potentially 
finding cancers earlier than if not screened, and feeling positive about contributing to the research 
itself.  
 
11. Costs to Participants 
The proposed intervention will be of no cost to the patient. 
 
12. Compensation to Participants 
Clinics will participate under a clinic impact fee, and patients may receive a $20 gift card for their 
participation in the interviews.  
 
13. Resources Available  
Our study will use Patient Navigation to engage patients in completing their screening. Our study team 
will include trained Patient Navigation and will use their expertise to adapt material and define 
intervention components. 
 
14. Drugs or Devices  
N/A 
 
15. Multi-Site Coordination  
This site will be the IRB of record for SeaMar Community Health Centers (#FWA00000701), which will cede to the KPNW 
IRB (FWA 00002344). 
 
16. Community-Based Participatory Research  
We will use proven community based participatory (CBPR) approaches throughout the design, 
execution, and dissemination of the trial. We will apply novel and locally designed approaches, such as 
patient navigation and continue to partner with our established advisory board to solicit and 
incorporate patient and clinic feedback throughout each phase of the research study. Community 
research partners will be required to complete all necessary human subjects’ protection training.  
 

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Protocol Modifications 
 
 
Original Plan 
Modification 
PN intervention will be overlaid on usual care 
Usual care includes a call from care coordinators, 
navigated patients will not receive usual care 
Navigator will be nurse-trained 
Navigator will have clinical experience, but not be a 
nurse 
Patients in highest probability quintile will not be 
randomized into the study (will receive 
surveillance) 
All patients (across probability strata) will be 
randomized, and effectiveness of navigation will be 
assessed by quintile 
Eligibility criteria: FIT positive plus referred 
Eligibility criteria: FIT positive and referred and reviewed 
by clinic champion/GI (to reduce post-randomization 
drop out, randomized in error) 
Final outcome determination: Medical record 
review 
Final outcome determination: Medical record review 
plus records request to GI and blinded adjudication 
Cost analysis, timeline w/o pandemic interruptions 
Eliminate the cost-analysis activities to extend our 
recruitment interval to get closer to reaching our 1200-
patient goal