Fecal Immunochemical Test (FIT) and Colonoscopy Outreach

Each year in the United States, approximately 50,000 people die from colorectal cancer (CRC), the second-leading cause of cancer-related deaths in this country. CRC disproportionately affects racial minorities, with African Americans being more likely than other groups to develop CRC and to die from the disease. Further, screening rates vary by racial and ethnic groups; American Indians/Alaska Natives have the lowest screening rates among racial groups, and Hispanics have lower rates than non-Hispanics. Moreover, those who are below the federal poverty guidelines are less likely to be screened for CRC in comparison with those who are above the poverty threshold.

CRC screening can detect colorectal cancer at an early stage to maximize the potential for treatment to be effective. Further, the detection and removal of polyps can prevent colorectal cancer from developing. The U.S. Preventive Services Task Force recommends regular screening beginning at age 50 and continuing until age 75 using high-sensitivity fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy. Despite these recommendations, only 65% of adults are up to date with colorectal cancer screening. Interventions designed to promote colorectal cancer screening are needed, particularly among minority groups and those who are socioeconomically disadvantaged.

Fecal Immunochemical Test (FIT) and Colonoscopy Outreach is designed to increase colorectal cancer screening among racially diverse and socioeconomically disadvantaged adults aged 50 to 64 years. The intervention intends to encourage patients to participate in some form of CRC screening, either FIT (an FOBT) or colonoscopy.

The intervention includes two components FIT outreach and colonoscopy outreach. Implementers determine which of the two components to offer individual patients depending on patient needs and the practice environment. Both components are initiated with a one-page letter to patients eligible for CRC screening. The letters, which include basic information on CRC risk and an invitation to undergo CRC screening, are written at a low literacy level and are available in both English and Spanish. They were developed by experts in health communication and have undergone cognitive testing with English and Spanish speakers. The FIT outreach letter is sent with a FIT test kit, instructions on how to complete the test, and a return envelope with paid postage. The colonoscopy outreach letter includes a telephone number patients can call to schedule the procedure. After 2 weeks, outreach staff call patients who do not respond to the mailing by either returning the FIT test or scheduling a colonoscopy. Outreach staff use telephone scripts, available in English and Spanish, to remind patients to participate in CRC screening. Multiple call attempts are made to non-responsive patients.

Patients who call to schedule a colonoscopy learn about the cost of the procedure during the call and subsequently receive bowel preparation liquids, preparation instructions, and details on the time of their appointment, as well as two reminder calls with instructions 10 days and 2 days before the scheduled colonoscopy appointment.

-- 1-2 months to identify eligible patients due for colorectal cancer screening
-- 1-2 months to set up a database or electronic medical record system to track patients and document program delivery
-- 1-5 minutes to send each mailing (screening invitation letters, FIT result letters, and colonoscopy appointment reminder letters with bowel preparation kits and instructions)
-- 2-5 minutes to make each call to patients (follow-up to mailed invitations, follow-up to FIT results, and reminders about colonoscopy appointment)
-- 2-3 minutes to schedule each screening and diagnostic colonoscopy appointment
-- 1-2 minutes to order each FIT and colonoscopy for patients due for CRC screening and each diagnostic colonoscopy for patients with a positive FIT result

The intervention is intended for racially diverse and socioeconomically disadvantaged adults aged 50 to 64 years.

The intervention is designed to be implemented in primary care settings within urban communities.

Required resources to implement the program include the following:

-- FIT Strategy Workflow
-- FIT Invitation Letter
-- FIT Negative Result Letter
-- FIT Positive Result Letter
-- Colonoscopy Strategy Workflow
-- Colonoscopy Invitation Letter
-- Colonoscopy Appointment Reminder Letter
-- Colonoscopy Bowel Prep Instructions
-- FIT and Colonoscopy Telephone Call Scripts
-- Sample SQL Database (Screenshots)
-- FIT Kit

For costs associated with this program, click on Contact Program Developer on the Program Materials page.

A randomized controlled trial was conducted to compare the impact of the FIT outreach component, the colonoscopy outreach component, and usual care on CRC screening among a racially diverse and socioeconomically disadvantaged population at Parkland Health and Hospital System (PHHS), a publically funded, integrated health system in Dallas County, Texas. Patients assigned to outreach groups were still eligible to receive visit-based CRC screening with any test (FIT or colonoscopy) through their primary care providers, and patients assigned to the usual care group continued to receive visit-based CRC screening at the discretion of their primary care providers.

Patients were included in the trial if they were aged 50 to 64 years, they were residents of Dallas County and were insured by Parkland Health Plus, and they had made at least one visit to the PHHS primary care clinic within the year prior to randomization. Patients were excluded if they had no address or telephone number on file; did not speak English or Spanish as a primary language; had a history of CRC, inflammatory bowel disease, colorectal polyps, or prior colectomy; or were incarcerated. Patients were also excluded if they were in compliance with CRC screening recommendations (had a colonoscopy within the past 10 years, sigmoidoscopy within the past 5 years, or a FIT test within the past year).

Patients who met the inclusion criteria were randomly enrolled to the usual care group (1,199), FIT outreach group (2,400), or colonoscopy outreach group (2,400) in a 1:2:2 ratio. The average age of participants was 56 years; 62% were female, 49% were Hispanic, 24% were African American, and 22% were White. About 39% of participants spoke Spanish as their primary language. Demographic characteristics were similar across the three groups.

The primary outcome was the completion of any CRC screening (FIT or colonoscopy, regardless of group assignment) within 12 months of randomization. Screening rates were assessed through the review of electronic health system laboratory data for FIT testing and a combination of test orders and administrative claims data for sigmoidoscopy or colonoscopy. The study also measured the time to respond to the initial screening letter and compared patients in three categories: early responders (returned the FIT test or responded to the colonoscopy invitation before any reminder calls), late responders (completed the FIT test or scheduled a colonoscopy after reminder calls but within the study period), and non-responders (never returned a FIT test or scheduled a colonoscopy).

• At 12-month follow-up, screening rates were higher in the FIT outreach group and colonoscopy outreach group than in the usual care group (p<.0001 for both comparisons) and higher in the FIT outreach group than in the colonoscopy outreach group (p<.001).

Additional Findings

• Among responders, the FIT outreach group had a higher percentage of early responders compared with the colonoscopy outreach group (59.0% vs. 29.7%; p<.0001). Patients in the FIT group had a shorter mean response time compared with those in the colonoscopy group (24.3 days vs. 29.8 days; p<.0001).