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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: FIT Screening Strategy
* Other: Colon Screening Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Age 50-64 years Seen one or more times at a Parkland primary care clinic within one year (Index Year) Participants in Parkland's medical assistance program for the uninsured (Parkland Health Plus) All races and ethnicities Exclusion Criteria: Up-to-date with CRC screening, defined by: Colonoscopy in the last 10 years Sigmoidoscopy in the last 5 years Stool blood test (FIT) in the last year Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps Address or phone number not on file Incarcerated

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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. | |
| Experimental: FIT Screening Strategy<br>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. | Other: FIT Screening Strategy<br>* 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.<br>|
| Experimental: Colon Screening Strategy<br>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. | Other: Colon Screening Strategy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit: Proportion of patients achieving one of the effective screening successes. | 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 | All outcomes will be adjudicated within 3 years. | 
| Harm: Rate of screening non-participation. | 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. | All outcomes will be adjudicated within 3 years. | 
| Cost: Cost per-patient effectively screened. | 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? | All outcomes will be adjudicated within 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit: Number of CRCs, advanced adenomas, and adenomas detected. | Number of CRCs, advanced adenomas, and adenomas detected. | All outcomes will be adjudicated within 3 years. | 
| Benefit: Number of patients screened. | Number of patients screened, defined by the proportion of patients completing one time FIT or colonoscopy. | All outcomes will be adjudicated within 3 years. | 
| Harm: Number of CRCs diagnosed based on symptoms/signs rather than screening. | Number of CRCs diagnosed based on symptoms/signs rather than screening. | All outcomes will be adjudicated within 3 years. | 
| Harm: Ineffective screening. | Not achieving an effective screening success. See definition of effective screening successes above. | All outcomes will be adjudicated within 3 years. | 
| Harm: Post-colonoscopy bleeding or perforation. | Post-colonoscopy bleeding or perforation. | All outcomes will be adjudicated within 3 years. | 
| Harm: Failed colonoscopy due to incomplete bowel prep or inability to reach cecum. | Failed colonoscopy due to incomplete bowel prep or inability to reach cecum. | All outcomes will be adjudicated within 3 years. | 
| Cost: Cost per patient screened. | Cost per patient screened. | All outcomes will be adjudicated within 3 years. | 
| Cost: Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy. | Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy. | All outcomes will be adjudicated within 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Neoplasms, Colorectal Cancer, Colon Cancer, Mass Screening, Health Services Research, Comparative Effectiveness Research