1. Enhancing Colorectal Cancer Awareness and Screening Rates Jason P Crawford, MD, MPH Saturday, 3/8/16

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4. Objectives Overview of colorectal cancer (CRC) and the latest evidence behind the various CRC screening guidelines and modalities Implementing a systems-based approach to enhancing CRC screening rates in your practice To identify tactics essential to the success of a colon cancer screening system To understand barriers and challenges in implementing and sustaining a colon cancer screening system 4

5. Colorectal Cancer (CRC)  3 rd most common cancer and the 2 nd deadliest  136,800 new cases expected  More than 50,000 deaths  1.2 million Americans living with CRC  Death rates have fallen steadily past 20 years

6. Trends in CRC incidence and mortality Research suggests that observed declines in incidence and mortality are due in large part to:  CRC treatment advances  Screening detecting cancers at earlier, more treatable stages  Screening and polyp removal, preventing progression of polyps to invasive cancers  NEJM study Feb 2012 showed polyp removal associated with 53% lower risk of CRC death

7. Risk Factors

8. Age: the most impactful risk factor CRC usually develops after age 50. The chances of getting it increases as you get older. CRC screening should begin at age 50 for most people, earlier for those with a family history. 8 http://science.education.nih.gov/supplements/nih1/cancer /guide/pdfs/ACT3M.PDF http://science.education.nih.gov/supplements/nih1/cancer /guide/pdfs/ACT3M.PDF.

9. Non-Modifiable Risk Factors  Age  90% of cases occur in people 50 and older  Gender  slight male predominance, but common in both men and women  Race/Ethnicity – higher rates among  African Americans  Native Americans (esp. Northern Plains Tribes)  Alaska Natives  Ashkenazi Jews

10. Modifiable risk factors  Lack of physical activity  Less active  raises risk  Overweight  Obesity  raises risk of having and of dying from CRC  Smoking  raises risk  Alcohol use  raises risk  Type 2 diabetes  raises risk

11. Risk factor - polyps Different types of polyps:  Hyperplastic  Low risk: very small chance they’ll grow into cancer  Adenomas  About 9 out of 10 colon and rectal cancers start as adenomas

12. Normal toAdenomatoCarcinoma Human colon carcinogenesis progresses by the dysplasia/adenoma to carcinoma pathway Usually takes 10 or more years for polyp to become cancer

13. Screening Impact

14. Why Screen? There are two aims of screening: 1. Prevention Find and remove polyps to prevent cancer 2. Early Detection Find cancer in the early stages, when best chance for a cure

15. Impact of Screening JAMA Surg. 2013

16. Benefits of Screening *1996 - 2003

17. Screening Rates

18. 18 Who’s Not Screened?

19. UTD with CRC Screening (BRFSS 2012)

20. Nevada FOBT screening, BRFSS, 2012

21. Screening Tests

22. Tests That Detect Adenomatous Polyps and Cancer Colonoscopy every 10 years, or Flexible sigmoidoscopy (FSIG) every 5 years, or Double contrast barium enema (DCBE) every 5 years, or CT colonography (CTC) every 5 years Tests That Primarily Detect Cancer Guaiac-based fecal occult blood test (gFOBT) with high test sensitivity for cancer, or Fecal immunochemical test (FIT) with high test sensitivity for cancer, or Stool DNA test (sDNA), with high sensitivity for cancer Options for Average risk adults age 50 and older:

23. 23 RecommendationACS/USMSTF/ACRUSPSTF Age to begin and end screening in average risk adults Begin and age 50, and end screening at a point where curative therapy would not be offered due to life-limiting co- morbidity Begin screening at age 50. Routine screening between ages 76-85 is not recommended. Screening after age 85 is not recommended. Screening in high risk adults Detailed recommendations based on personal risk and family history No specific recommendations for age to begin testing or type of testing Age to Begin and End Screening (ACS and USPSTF Comparison)

24. 24 ACS and USPSTF Guidelines Comparison RecommendationACS/USMSTF/ACRUSPSTF Age to begin and end screening in average risk adults Begin and age 50, and end screening at a point where curative therapy would not be offered due to life-limiting co-morbidity Begin screening at age 50. Routine screening between ages 76-85 is not recommended. Screening after age 85 is not recommended. Screening in high risk adults Detailed recommendations based on personal risk and family history No specific recommendations for age to begin testing or type of testing Prioritization of tests Tests are grouped into those that (1) primarily are effective at detecting cancer, and (2) those that are effective at detecting cancer and adenomatous polyps. Group 2 is preferred over group 1 due to the greater potential for prevention. No specific prioritization of tests, though recommendations acknowledge that direct visualization techniques offer substantial benefit over fecal tests Stool Testing, Guaiac based FOBT (gFOBT) Annual screening with high sensitivity guaiac based tests Stool Testing, Immunochemical-based FOBT (FIT) Annual screening Stool Testing, Stool DNA (sDNA)Screening every 3 years Insufficient evidence to recommend for or against sDNA Flexible Sigmoidoscopy Screening every 5 years. Screening every 5 years, with annual gFOBT or FIT is an option Screening every 5 years, with gFOBT every 3 years ColonoscopyScreening every 10 years CT ColonographyScreening every 5 years Insufficient evidence to recommend for or against CT colonography Double Contrast Barium Enema (DCBE)Screening every 5 yearsNot addressed

25. Recommended Screening Tests ACS and USPSTF  Colonoscopy  High Sensitivity Fecal Occult Blood Testing  Guaiac  Immunochemical (FIT)  Flexible Sigmoidoscopy (FSIG)  Recent studies support efficacy  Availability extremely limited in U.S.

26. Colonoscopy Allows direct visualization of entire colon lumen Screening, diagnostic and therapeutic 10 yr interval The most common screening test in US (>80%)

27. Why Colonoscopy is NOT gold standard  Evidence does not support “best test” or “gold standard”  Colonoscopy misses ~ 10% of significant lesions in expert settings  More costly on a one-time basis  Higher potential for patient injury than other tests  Measurable outcomes vary widely (i.e. test performance is highly operator dependent)

28. Quality Issues with Colonoscopy  In the vast majority of endoscopy centers and hospitals in the US there are no requirements for reporting of endoscopic quality measures (this is gradually changing)  There is significant variation among endoscopists relative to tracking of key quality metrics including:  adenoma detection rate  withdrawal time  quality of bowel prep  cecal intubation rate

29. Adenoma Detection Rate (ADR)  ADR - detection of adenomatous polyps at least 25 percent of the time in men, and 15 percent of the time in women (20 percent composite)  In one large series, ADR varied from 7% - 52%  ADR inversely associated with the interval cancer rate  ADR inversely associated with colorectal cancer death

30. ADR and Risk of Interval Cancer Kaminski; NEJM 2010: 362: 1795-803

31. Why Colonoscopy is NOT gold standard  Greater patient requirements for successful completion  Requires a bowel prep and facility visit, and often a pre-procedure specialty office visit  Access  Limited by insurance status, local resources  Patient preference  Many individuals don’t want an invasive test or a test that requires a bowel prep

32. Patient Preferences Inadomi, Arch Intern Med 2012

33. Trends in the Prevalence of Fecal Occult Blood Test* by Health Insurance Status, US, 2000-2010

34. Stool Tests  Look for hidden blood in stool  Two major types (but multiple brands)

35. Stool Test: Guaiac  Most common type in U.S.  Solid evidence (3 RCT’s)  30 year f/u (NEJM Oct 2013)  Need specimens from 3 bowel movements  Non-specific  Results influenced by foods and medications  Better sensitivity with newer versions (Hemoccult Sensa)  Older forms (Hemoccult II) not recommended!

36. Fecal Immunochemical Tests (FIT)  Specific for human blood and for lower GI bleeding  Results not influenced by foods or medications  Some types require only 1 or 2 stool specimens  Higher sensitivity than older forms of guaiac- based FOBT  Costs more than guaiac tests (but higher reimbursement)

37. 37 Stool Tests: Accuracy

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39. NEJM 2014

40. 40 Stool Tests: Efficacy

41. Annals IM,, 2008

42. Stool Testing Quality Issues In-office FOBT is essentially worthless as a screening tool for CRC and should never be used for this purpose.

43. FOBT Quality Issues Sensitivity of Take Home vs. In-Office FOBT Sensitivity FOBT method (Hemoccult II) All Advanced Lesions Cancer 3 card, take-home23.9 %43.9 % Single sample, in-office 4.9 % 9.5 % Collins et al, Annals of Int Med Jan 2005

44. Stool Testing Quality Issues  In-office FOBT is essentially worthless as a screening tool for CRC and should never be used.  CRC screening by FOBT should be performed with high-sensitivity FOBT - either FIT or a highly sensitive gFOBT (such as Hemoccult SENSA).  Older, less sensitive guiaic tests (such as Hemoccult II) should not be used for CRC screening.  Annual testing  All positive screening tests should be evaluated by colonoscopy

45. Clinicians Reference: FOBT One page document designed to educate clinicians about important elements of colorectal cancer screening using fecal occult blood tests (FOBT). Provides state-of-the-science information about guaiac and immunochemical FOBT, test performance and characteristics of high quality screening programs. Available at www.cancer.org/colonmd www.cancer.org/colonmd High Quality Stool Testing

46. Stool DNA Test

47. Stool DNA Test (sDNA)  Fecal occult blood tests detect blood in the stool – which is intermittent and non-specific  Colon cells are shed continuously  Polyps and cancer cells contain abnormal DNA  Stool DNA tests look for abnormal DNA from cells that are passed in the stool* *All positive tests should be followed with colonoscopy

48. NEJM 2014

50. Stool DNA - Sample Collection Patient supplies whole stool sample;no diet or medication restrictions Patient seals sample in outer container and freezer pack Patient seals container and ships back to designated lab (all packing materials and labels supplied)

51. Stool DNA Test  One test (Cologuard) currently available  Combines an FIT with tests for stool DNA markers asso w/ cancers and adenomas  Every 3 year testing interval recommended by manufacturer  FDA has cleared it for marketing as CRC screening test  CMS has agreed to cover Cologuard for Medicare beneficiaries age 50 – 85 yrs  Medicare will reimburse $502 q 3 yrs for the test  Private insurance coverage – tbd  All positive tests should be evaluated by colonoscopy

52. 80% by 2018 National coalition of public, private, and voluntary organizations whose mission is to advance colorectal cancer control efforts by improving communication, coordination, and collaboration among health agencies, medical-professional organizations, and the public. Co-Founded by ACS and CDC in 1997 Goal: increase the use of recommended colorectal cancer screening tests in at-risk populations www.nccrt.org

53. National Colorectal Cancer Roundtable 80% by 2018 campaign http://nccrt.org/tools/80-percent-by-2018/

54. Web resources  ColonMD: http://www.cancer.org/healthy/informationforh ealthcareprofessionals/colonmdclinicansinformat ionsource/index http://www.cancer.org/healthy/informationforh ealthcareprofessionals/colonmdclinicansinformat ionsource/index  CDC Colorectal Cancer Awareness Month: http://www.cdc.gov/cancer/dcpc/resources/feat ures/colorectalawareness/ http://www.cdc.gov/cancer/dcpc/resources/feat ures/colorectalawareness/  Clinician’s reference and toolkit: http://www.cancer.org/healthy/informationforh ealthcareprofessionals/colonmdclinicansinformat ionsource/foryourclinicalpractice/index http://www.cancer.org/healthy/informationforh ealthcareprofessionals/colonmdclinicansinformat ionsource/foryourclinicalpractice/index

57. “Action Plan” Toolkit Version  Eight page guide introduces clinicians and staff to concepts and tools provided in the full Toolkit  Contains links to the full Toolkit, tools and resources  Not colorectal-specific; practical, action-oriented assistance that can be used in the office to improve screening rates for multiple cancer sites (colorectal, breast and cervical) Available at http://nccrt.org/about/provider- education/crc-clinician-guide/

58. Staff Involvement  Key Point…..the clinicians cannot do it all!  Time that patients spend with non-clinician staff is underutilized  Standing orders can empower nurses, intake staff, etc. to distribute educational materials, schedule appointments, etc.  Involve staff in meetings to discuss progress in achieving office goals for improving the delivery of preventive services

59. A+ Tactic #1: Identify a motivated “champion”  Find a champion within the clinic  Educate your team on the system and make sure it’s easy to follow 59

60. Communication

62. Why patients aren’t getting screened (according to Physicians) Cancer Causes Control.,2011

63. Why patients aren’t getting screened (according to Patients) “My doctor never talked to me about it!”

66. A+ Tactic #2: Clinical Decision Support Tools  Videos or demonstrations of FIT kit usage  Decision aid tools and visual aids  Ensure language sensitivity 66

69. A+ Tactic #2: Access to FIT Tests  Seek out opportunities to secure free or discounted FIT kits  Deliver the FIT kit at the time of care, rather than sending patients to a lab 69

72. A+ Tactic #3: Hire a Screening Care Coordinator  The care coordinator is the organizational, clerical and customer service provider for the program  Educates patients on FIT test usage, serves as a sort of “health coach”  Follows up with patients to ensure screening compliance through phone calls, mail, etc. 72

73. A+ Tactic #4: Use Electronic Health Records  Activate tracking capacities within the system  Add patient flags and reminders for physicians  Use templates to standardize your practice across the organization  Run reports to assist with program evaluation 73

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75. A+ Tactic #4: Use Electronic Health Records 75

77. PDSA cycles

78. A+ Tactic #5: Leverage data to your advantage  “Unblinded” data  Allows for continuous quality improvement  Track program success by clinic and by physician or team, and use benchmarks to reach and exceed goals  Move beyond MARCH!  Foster the team-based approach 78

79. Increasing Cancer Screening and Linkages in a Community Clinic Setting Project  Federally Qualified Health Center with 5 clinic locations, 20 medical providers, serving approximately 27,000 patients in the Reno/Sparks area  Grant project in conjunction with Nevada Cancer Coalition, January 2015 – July 2015 79

80. Project work plan 1.Established a baseline of patients up to date with screening 2.Identified targeted population to be screened 3.Created policy/procedures and system 4.Hired a care coordinator 5.Educated providers and staff 6.Created internal data tracking and incentive program 7.Used electronic health records to flag eligible patients and track compliance 8. Quarterly data reporting 80

81. 2015 Pilot Project - Results 1.2013 baseline of patients up to date with screening = 6.36% 2.1st quarter, 2015: overall 5-fold increase in patients up to date with screening = 32.15% 3.1 st quarter, 2015: 300% increase in screening incidence rate compared to 1 st quarter, 2014 4.Still low…there’s work to be done 81

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83. What We’ve Learned 1.Some tactics are more valuable and effective than others 2.There will always be challenges 3.Partnerships are key 4.You HAVE to have a champion 83

84. Challenge: Ancillary Staff  Budgetary constraints to hire care coordinator staff; look for grants to support the program  Finding and keeping qualified personnel can be difficult 84

85. Challenge: Patient Compliance  Try to follow the 80/20 rule: not every patient will comply, no matter how much you educate them; strive for that 80% that will  Don’t get discouraged. Use motivational interviewing techniques and remind patients at each visit. 85

86. Challenge: Provider Compliance  Emphasize the importance of preventive care to busy providers  Seek to schedule dedicated preventive care visits when patients are in clinic for emergent care, thus allowing providers an appointment slot to focus on screening opportunities 86

87. Other Positive Outcomes  Cost Effective  Serves as a foundation and model for other screening programs including cervical and breast cancer screening  Scalable and Sustainable 87