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Mailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

Up to three "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.

Centralized processes to promote guideline-based follow-up.

Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy.

Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences.

Choice Strategy outreach invitation includes: 1) invitation letter, 2) option grid comparing FIT and colonoscopy 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

Up to three "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.

Centralized processes to promote guideline-based follow-up.

FIT Screening Strategy

Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy.

Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences. Outreach includes: 1) invitation letter, 2) choice grid 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

Up to three "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.

Centralized processes to promote guideline-based follow-up.

Choice Screening Strategy

Amit Singal, MD, MS

This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program (which does not offer an explicit choice of screening modality). The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system that has a "FIT first" population health screening strategy. All patients will also have access to whatever CRC screening is recommended through usual visit-based care.

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. In the NCI-funded UT Southwestern-Parkland PROSPR Center (U54 CA163308), mailed FIT-based outreach doubled the proportion of patients up-to-date with screening compared to usual care. Investigators are now conducting a comparative effectiveness trial to evaluate the effect of a mailed invite offering a choice of FIT or colonoscopy (n=2,000) on one-time CRC screening completion compared to mailed FIT-based outreach (which does not offer an explicit choice of screening modality (n=8,000.) Randomization will be stratified based on whether or not patients completed a FIT within the prior 18-month period. Patients randomized to FIT outreach will receive: a) low-literacy educational letters, b) mailed screening outreach invitations, c) a one-sample home FIT kit and return mailer with prepaid postage, d) telephone reminder calls including one-on-one education, and e) centralized patient navigation for follow-up of abnormal screening results, and treatment for patients newly diagnosed with CRC. Patients randomized to the "choice" arm will receive the same materials described above; however, the educational letter will explain and offer the additional choice of screening by colonoscopy (instead of completing the mailed FIT kit). The mailing will include a low health literacy one-page option grid outlining the pros and cons of FIT vs. colonoscopy. We will not recommend a particular test as preferred but instead emphasize that both are good choices, and the patient should choose the screening option that seems right for them. Patients choosing colonoscopy will be provided a telephone number to schedule the procedure. During scheduling, patients will be triaged by study staff with a structured history and physical form to "direct access" colonoscopy or a pre-colonoscopy clinic visit. Patients choosing FIT can return the one-sample mailed FIT kit using the return envelope with prepaid postage.

Evaluate effect of offering choice of FIT or colonoscopy (n=2,000) compared to FIT alone (n=8,000) on one-time CRC screening completion, repeat screening, and follow-up of abnormal FIT results.

Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening

Comparing the Effect of a Mailed Outreach Intervention Offering Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening Outcomes: A Pragmatic Randomized Control Trial in a Safety Net Health System

Proportion of patients who complete CRC screening with colonoscopy, sigmoidoscopy, or FIT

Proportion of patients who choose FIT versus colonoscopy

Cancer Prevention Research Institute of Texas

Parkland Health and Hospital System

University of Texas Southwestern Medical Center

Associate Professor

* No outreach mailed invitations.
* Ordering of colonoscopy or FIT for screening at the discretion of the primary provider.
* Follow up of abnormal tests and results reporting to the patient at the discretion of primary and specialty providers.

* Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).
* Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
* Centralized processes to promote guideline-based follow up.

* Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.
* Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.
* Centralized processes to promote guideline-based follow up.

Colon Screening Strategy

Amit Singal, MD

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening process continuum. Modeling studies suggest benefits and harms of colonoscopy and stool blood test strategies are similar, but generally assume 100% participation and subsequent clinically appropriate follow up--something never achieved in clinical practice. Comparative effectiveness studies of testing strategies, including comparisons of specific tests and approaches to optimizing effective test use, are necessary. Safety-net health systems care for populations at increased risk for adverse CRC outcomes, such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets must resolve the uncertainty regarding the most effective screening strategy. The investigators will conduct a system-level, randomized comparative effectiveness trial of the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age 50-64 years, who are not up-to-date with CRC screening, served by a large safety net health system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual mailed invitation outreach (including a test kit), and a centralized process to promote participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed invitation outreach, and a centralized process to promote participation and complete clinical follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at primary care visits. The primary measure of benefit will be an outcome measure that summarizes patient-specific effective screening successes. The primary measure of harm will be screening non-participation. The primary measure of cost will be cost per-patient effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care and b) the Colo strategy vs. Usual Care for CRC screening.

Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies

Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies

The primary benefit measure will be defined by the proportion of patients achieving an effective screening "success" defined as:

* Invited to colonoscopy (i.e. colo), responded to invite, determined to be too sick to scope by phone triage and clinical review
* Screening colo completed, no cancer detected
* Screening colo completed, cancer detected, 1st cancer treatment consultation visit completed
* FIT screening completed, test normal, FIT repeated annually for 2 years
* FIT screening completed, test abnormal, failed phone triage for direct scheduling for colo, and after GI clinic visit, determined to be too sick to scope
* FIT screening completed, test abnormal, failed phone triage and clinical review, GI clinic visit, determined to be scopable, colo completed
* FIT screening completed, test abnormal, colo completed, no cancer detected
* FIT screening completed, test abnormal, colo completed, cancer detected, 1st cancer treatment consultation visit completed

The primary measure of harms will be the rate of non-screening because initial test completion is a basic prerequisite for prevention of adverse CRC outcomes by a screening process. It is a readily measurable, basic quality assessment. Processes associated with high rates of non-screening would be expected to result in poor long term CRC outcomes.

The primary measure of costs will be the cost per-patient effectively screened from the health system perspective, with effective screening defined by the proportion of patients achieving an effective screening "success." Follow up time for cost-assessment will start at randomization and end either when a patient reaches an effective screening "success" endpoint, or at the end of the three year-follow up time. This outcome addresses a practical question most health systems will have in assessing our screening strategy: What is the strategy specific cost per-patient effectively screened?

Number of CRCs, advanced adenomas, and adenomas detected.

Number of patients screened, defined by the proportion of patients completing one time FIT or colonoscopy.

Number of CRCs diagnosed based on symptoms/signs rather than screening.

Not achieving an effective screening "success." See definition of effective screening "successes" above.

Post-colonoscopy bleeding or perforation.

Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.

Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening	NCT03414125	Colorectal Canc...	FIT Screening S... Choice Screenin...	50 Years - 63 Years	University of Texas Southwestern Medical Center
Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies	NCT01710215	Colorectal Canc...	FIT Screening S... Colon Screening...	50 Years - 64 Years	University of Texas Southwestern Medical Center
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening	NCT03414125	Colorectal Canc...	FIT Screening S... Choice Screenin...	50 Years - 63 Years	University of Texas Southwestern Medical Center
Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies	NCT01710215	Colorectal Canc...	FIT Screening S... Colon Screening...	50 Years - 64 Years	University of Texas Southwestern Medical Center

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