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

NCT ID: NCT01710215

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5999 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-07-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Usual Care

• 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

FIT Screening Strategy

• 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.

Group Type: EXPERIMENTAL

FIT Screening Strategy

Intervention Type: 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.

Colon Screening Strategy

• 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.

Group Type: EXPERIMENTAL

Colon Screening Strategy

Intervention Type: OTHER

• 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.

Interventions

FIT Screening Strategy

• 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.

Intervention Type: OTHER

Colon Screening Strategy

• 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.

Intervention Type: OTHER

Eligibility Criteria

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:

1. Colonoscopy in the last 10 years

2. Sigmoidoscopy in the last 5 years

3. 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Parkland Health and Hospital System

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Singal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Parkland Health & Hospital System

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28873161 (View on PubMed)

Other Identifiers

1U54CA163308-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

102011-069

Identifier Type: -

Identifier Source: org_study_id

NCT03404973

Identifier Type: -

Identifier Source: nct_alias