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Original Investigation |

Comparative Effectiveness of Fecal Immunochemical Test Outreach, Colonoscopy Outreach, and Usual Care for Boosting Colorectal Cancer Screening Among the Underserved:  A Randomized Clinical Trial

Samir Gupta, MD, MSCS1,2; Ethan A. Halm, MD3,4,5; Don C. Rockey, MD6; Marcia Hammons, BSN7; Mark Koch, MD8; Elizabeth Carter, MD8; Luisa Valdez, NRCMA7; Liyue Tong, MS3; Chul Ahn, PhD3,4; Michael Kashner, PhD9,10,11; Keith Argenbright, MD3,4,7; Jasmin Tiro, PhD3,4; Zhuo Geng, BA12; Sandi Pruitt, PhD3,4; Celette Sugg Skinner, PhD3,4
[+] Author Affiliations
1Veterans Affairs San Diego Healthcare System, San Diego, California
2Division of Gastroenterology, University of California San Diego, La Jolla
3Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas
4Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas
5Division of General Internal Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas
6Department of Internal Medicine, Medical University of South Carolina, Charleston
7Moncrief Cancer Institute, University of Texas Southwestern Medical Center, Fort Worth
8Department of Family Medicine, John Peter Smith Health Network, Fort Worth, Texas
9Department of Medicine, Loma Linda University School of Medicine, Loma Linda, California
10Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas
11Office of Academic Affiliations, Department of Veterans Affairs, Washington, DC
12University of Texas Southwestern Medical School, Dallas
JAMA Intern Med. 2013;173(18):1725-1732. doi:10.1001/jamainternmed.2013.9294.
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Importance  Colorectal cancer (CRC) screening saves lives, but participation rates are low among underserved populations. Knowledge on effective approaches for screening the underserved, including best test type to offer, is limited.

Objective  To determine (1) if organized mailed outreach boosts CRC screening compared with usual care and (2) if FIT is superior to colonoscopy outreach for CRC screening participation in an underserved population.

Design, Setting, and Participants  We identified uninsured patients, not up to date with CRC screening, age 54 to 64 years, served by the John Peter Smith Health Network, Fort Worth and Tarrant County, Texas, a safety net health system.

Interventions  Patients were assigned randomly to 1 of 3 groups. One group was assigned to fecal immunochemical test (FIT) outreach, consisting of mailed invitation to use and return an enclosed no-cost FIT (n = 1593). A second was assigned to colonoscopy outreach, consisting of mailed invitation to schedule a no-cost colonoscopy (n = 479). The third group was assigned to usual care, consisting of opportunistic primary care visit–based screening (n = 3898). In addition, FIT and colonoscopy outreach groups received telephone follow-up to promote test completion.

Main Outcome Measures  Screening participation in any CRC test within 1 year after randomization.

Results  Mean patient age was 59 years; 64% of patients were women. The sample was 41% white, 24% black, 29% Hispanic, and 7% other race/ethnicity. Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P < .001 for both comparisons with usual care). Screening was significantly higher for FIT than for colonoscopy outreach (P < .001). In stratified analyses, screening was higher for FIT and colonoscopy outreach than for usual care, and higher for FIT than for colonoscopy outreach among whites, blacks, and Hispanics (P < .005 for all comparisons). Rates of CRC identification and advanced adenoma detection were 0.4% and 0.8% for FIT outreach, 0.4% and 1.3% for colonoscopy outreach, and 0.2% and 0.4% for usual care, respectively (P < .05 for colonoscopy vs usual care advanced adenoma comparison; P > .05 for all other comparisons). Eleven of 60 patients with abnormal FIT results did not complete colonoscopy.

Conclusions and Revelance  Among underserved patients whose CRC screening was not up to date, mailed outreach invitations resulted in markedly higher CRC screening compared with usual care. Outreach was more effective with FIT than with colonoscopy invitation.

Trial Registration  clinicaltrials.gov Identifier: NCT01191411

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Figure 1.
CONSORT Diagram

Study recruitment and follow-up are depicted. CRC indicates colorectal cancer; FIT, fecal immunochemical test; IBD, inflammatory bowel disease; JPS, John Peter Smith Health Network.

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Figure 2.
CRC Screening Participation For Usual Care, Colonoscopy Outreach, and FIT Outreach

CRC indicates colorectal cancer; FIT, fecal immunochemical test.

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