Comparative Effectiveness of FIT, Colonoscopy, & Usual Ca... | NCT01710215

NCT01710215

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
1U54CA163308-01	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institutes of Health (NIH)	NIH
National Cancer Institute (NCI)	NIH
Parkland Health and Hospital System	OTHER

Oversight Module

Description Module

Brief Summary

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care	No Intervention	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.
FIT Screening Strategy	Experimental	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
Colon Screening Strategy	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FIT Screening Strategy	Other	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

Name	Affiliation	Role
Amit Singal, MD	University of Texas Southwestern Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Parkland Health & Hospital System		Dallas	Texas	75235	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28873161	Derived	Singal AG, Gupta S, Skinner CS, Ahn C, Santini NO, Agrawal D, Mayorga CA, Murphy C, Tiro JA, McCallister K, Sanders JM, Bishop WP, Loewen AC, Halm EA. Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):806-815. doi: 10.1001/jama.2017.11389.

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site