Randomized Comparison of Organized FIT Invitation, Organized Colonoscopy Invitation, and Usual Care for Colorectal Cancer Screening Among the Underserved

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Randomized Comparison of Organized FIT Invitation, Organized Colonoscopy Invitation, and Usual Care for Colorectal Cancer Screening Among the Underserved Authors Samir Gupta, Marcia Hammons, Luisa Valdez, Elizabeth Carter, Mark Koch, Liyue Tong, Chul Ahn, Don C. Rockey, Jasmin Tiro, Ethan A. Halm, Celette Sugg Skinner Partnering Institutions John Peter Smith Health System, Harold C. Simmons Cancer Center, Moncrief Cancer Institute, UT Southwestern Medical Center Grant Support Cancer Prevention and Research Institute of Texas Slide 2 Colorectal Cancer (CRC) is an Important Public Health Problem 2 nd leading cause of cancer death nationwide Screening can reduce CRC mortality Fecal occult blood testing, sigmoidoscopy, and colonoscopy Mandel N Engl J Med. 2000 Nov 30;343(22):1603-7; Kahi Clin Gastroenterol Hepatol. 2009 Jul;7(7):770-5; Brenner J Natl Cancer Inst. 2010 Jan 20;102(2):89-95; Brenner J Clin Oncol. 2011 Oct 1;29(28):3761-7; Atkin Lancet. 2010 May 8;375(9726):1624-33; Scholefield Gut. 2002 Jun;50(6):840-4; Kronborg Lancet. 1996 Nov 30;348(9040):1467-71; Mandel J Natl Cancer Inst. 1999 Mar 3;91(5):434-7; Baxter Ann Intern Med. 2009 Jan 6;150(1):1-8; Manser Gastrointest Endosc. 2012 Apr 11. [Epub ahead of print]. Slide 3 Screening Participation is Substantial, but Suboptimal Screening has been promoted in the US for over 15 years, and steady gains have been realized National screening rate is >55% However, not all populations have benefited from these gains Uninsured Pre-Medicare age Medicaid Minorities MMWR Morb Mortal Wkly Rep. 2012 Jan 27;61(3):41-5. Klabunde Cancer Epidemiol Biomarkers Prev. 2011 Aug;20(8):1611-21 Slide 4 Slide 5 Slide 6 Two Key Challenges to Improving Screening for the Underserved Identifying the unscreened Determining which test or tests to offer Slide 7 Challenge 1: Identifying the Unscreened In the US, most screening is primary care visit- based Uninsured/underserved have limited access No visit, no identification of need, no screening offer Recent NIH State of the Science Conference on Enhancing CRC Screening emphasized need to develop methods to identify unscreened underserved/uninsured individuals Steinwachs Ann Intern Med. 2010 May 18;152(10):663-7. Slide 8 Challenge 1: Identifying the Unscreened Potential solution is to leverage relationships safety-net systems have with the underserved Care for uninsured, Medicaid, and minority groups Have readily available administrative claims data that can be used to: 1)Measure and track screening rates 2)Individually identify the unscreened for interventions to boost screening Slide 9 Challenge 1: Identifying the Unscreened We tested and validated this approach at John Peter Smith Health System, the safety net health system serving Fort Worth and Tarrant County, Texas and found: Screening rate far below the national average: 22% 16,000 unscreened patients could be individually identified Positioned us to test interventions to boost screening Gupta S et al. Cancer Epidemiol Biomarkers Prev. 2009 Sep;18(9):2373-9; Gupta et al. Am J Med Sci at press; Marquez E, Gupta S, Cryer B. Clin Gastroenterol Hepatol. 2011 Feb;9(2):106-9. Slide 10 Challenge 2: Determining Test Type to Use Could recommend a colonoscopy first strategy for all underserved patients Expensive, infrastructure required substantial Does not take into account potential for test-specific differences in participation Fecal immunochemical testing (FIT), CT colonography, and colonoscopy may have different rates of participation Understanding test-specific differences is critical Test specific participation rates may be more important that test-specific sensitivity for CRC Possible that Best test is the one that gets done Zauber Ann Intern Med. 2008 Nov 4;149(9):659-69; Gupta Ann Intern Med. 2009 Mar 3;150(5):359; Marquez E, Gupta S, Cryer B. Clin Gastroenterol Hepatol. 2011 Feb;9(2):106-9; Gupta Lancet Oncol. 2012 Mar;13(3):e90. Slide 11 The Two Challenges Offered an Opportunity to Increase CRC Screening at a Safety Net Baseline screening rates were far below national average, at just 22% Local data could be leveraged to individually identify the unscreened for interventions to boost screening Uncertainty regarding best test or tests to offer Compelled us to develop an intervention that could: Boost screening, addressing barriers such as infrequent access to care Determine which test would result in the highest screening rate for the population: FIT vs. colonoscopy Gupta S et al. Cancer Epidemiol Biomarkers Prev. 2009 Sep;18(9):2373-9; Marquez E, Gupta S, Cryer B. Clin Gastroenterol Hepatol. 2011 Feb;9(2):106-9. Slide 12 Aims Among uninsured patients, not up-to-date with screening, to: 1)Determine if a organized outreach program boosts screening compared to usual care 2)Determine if organized outreach offering a fecal immunochemical test is more effective at boosting screening participation compared to organized outreach offering free colonoscopy Slide 13 Methods - Design Randomized controlled trial Usual Care Organized outreach invitation to either FIT or colonoscopy Mailed invitation, with information on screening English/Spanish, low literacy FIT kit or phone number to schedule colonoscopy FIT one sample Telephone reminders (automated and live) Assistance with test completion and guideline appropriate follow up Clarified FIT process, colonoscopy scheduling, prep, and follow up Slide 14 Methods - Design Inclusion Criteria Age 54 to 64 >1 primary care visit in last year Uninsured, but enrolled in medical assistance program Exclusion Criteria Up to date with CRC screening, based on: FOBT within 1 year, sigmoidoscopy or barium enema within 5 years, colonoscopy within 10 years Prior CRC, inflammatory bowel disease, or polyps Missing address/phone number Slide 15 Design - Analysis Primary outcome was screening participation, one year after randomization Intension to screen analysis Secondary outcomes include: Rate of lesion detection/patient invited Costs Sample size/power Based on maximizing screening delivery given local colonoscopy capacity Planned to assign n=480 to colonoscopy, n=1600 to FIT, and > n=1600 to usual care >90% power to detect differences of >10%, alpha=0.025 Slide 16 A Waiver of Informed Consent was Obtained Interventions an adjunct to, rather than a replacement for usual care Enhances interpretation and generalization of results Requiring consent would have enrolled patients predisposed to complete screening Reflects real world response to interventions Fits with concept of comparative effectiveness trials Approved by UT Southwestern and JPS Institutional Review Boards ClinicalTrials.gov ID# NCT01191411 Slide 17 Results Slide 18 Excluded (n=6,301) Screening up-to-date (n=1,573) No recent primary care visit (n=1,217) Prior polyps, IBD, or CRC (n=1,905) Missing address/phone number (n=112) Age (n=836) 1 language not English/Spanish (n=658) Assessed for eligibility (n=12,295) Randomized (n=5994) FIT n=1600 Usual Medical Care n=3914 Colonoscopy n=480 Results Slide 19 Results - Demographic Characteristics FIT (n=1600) Colonoscopy (n=480) Usual Care (n=3914) Age, median (IQR)59 (57 61)59 (57 - 61)59 (56 62) Sex, % Female626065 Race/Ethnicity, % Caucasian41 African American232723 Hispanic282529 Other776 Primary Language, % English838683 Spanish171417 Slide 20 Comparison of Usual Care & Organized Outreach Usual Care (n=204/3914) Organized Outreach (n=665/2080) p