Enhancing Colorectal Cancer Awareness and Screening Rates

Jason P Crawford, MD, MPHSaturday, 3/8/16

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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

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Colorectal Cancer (CRC)

3rd most common cancer and the 2nd 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

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

Risk Factors

Age: the most impactful risk factor

CRC usuallydevelops after

age 50.

The chances of getting it increases as you get older.

CRC screening should begin at age 50 formost people, earlier for those with a family history. 8

http://science.education.nih.gov/supplements/nih1/cancer/guide/pdfs/ACT3M.PDF.

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

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

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

Normal to Adenoma to Carcinoma

Human colon carcinogenesis progresses by the dysplasia/adenoma

to carcinoma pathway

Usually takes 10 or more years for polyp to become cancer

Screening Impact

Why Screen?

There are two aims of screening:

1. PreventionFind and remove polypsto prevent cancer

2. Early DetectionFind cancer in the early stages,when best chance for a cure

Impact of Screening

JAMA Surg. 2013

Benefits of Screening

Survival Rates by Disease Stage*90.3%

70.4%

12.5%

0102030405060708090

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Local Regional Distant

Stage of Detect ion

5-yrSurvival

*1996 - 2003

Screening Rates

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Who’s Not Screened?

UTD with CRC Screening (BRFSS 2012)

Nevada FOBT screening, BRFSS, 2012

Screening Tests

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:

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Recommendation ACS/USMSTF/ACR USPSTF

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)

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ACS and USPSTF Guidelines ComparisonRecommendation ACS/USMSTF/ACR USPSTF

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

Annual screening with high sensitivity guaiac based tests

Stool Testing, Immunochemical-based FOBT (FIT)

Annual screening 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

Colonoscopy Screening every 10 years Screening every 10 yearsCT Colonography Screening every 5 years Insufficient evidence to recommend for or

against CT colonography

Double Contrast Barium Enema (DCBE) Screening every 5 years Not addressed

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.

Colonoscopy• Allows direct

visualization of entire colon lumen

• Screening, diagnostic and therapeutic

• 10 yr interval

• The most common screening test in US (>80%)

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)

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

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

ADR and Risk of Interval Cancer

Kaminski; NEJM 2010: 362: 1795-803

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

Patient Preferences

Inadomi, Arch Intern Med 2012

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

Stool Tests

Look for hidden blood in stool

Two major types (but multiple brands)

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!

Fecal Immunochemical Tests (FIT)

Specific for human bloodand 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)

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Stool Tests: Accuracy

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NEJM 2014

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Stool Tests: Efficacy

Annals IM,, 2008

Stool Testing Quality Issues

In-office FOBT is essentially worthless as a screening tool for CRC and should

never be used for this purpose.

FOBT Quality Issues

Sensitivity of Take Home vs. In-Office FOBT

Sensitivity

FOBT method

(Hemoccult II)All Advanced Lesions

Cancer

3 card, take-home 23.9 % 43.9 %

Single sample, in-office 4.9 % 9.5 %

Collins et al, Annals of Int Med Jan 2005

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

Clinicians Reference: FOBTOne 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

High Quality Stool Testing

Stool DNA Test

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

NEJM 2014

NEJM 2014

Stool DNA - Sample Collection

Patient supplies whole stool sample;nodiet 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)

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

• 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

National Colorectal Cancer Roundtable80% by 2018 campaign

http://nccrt.org/tools/80-percent-by-2018/

Web resources ColonMD:

http://www.cancer.org/healthy/informationforhealthcareprofessionals/colonmdclinicansinformationsource/index

CDC Colorectal Cancer Awareness Month: http://www.cdc.gov/cancer/dcpc/resources/features/colorectalawareness/

Clinician’s reference and toolkit: http://www.cancer.org/healthy/informationforhealthcareprofessionals/colonmdclinicansinformationsource/foryourclinicalpractice/index

“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/

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

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

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Communication

Why patients aren’t getting screened(according to Physicians)

Cancer Causes Control.,2011

Why patients aren’t getting screened(according to Patients)

“My doctor never talked to me about it!”

A+ Tactic #2: Clinical Decision Support Tools

Videos or demonstrations of FIT kit usage

Decision aid tools and visual aids

Ensure language sensitivity

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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

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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.

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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

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A+ Tactic #4: Use Electronic Health Records

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PDSA cycles

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

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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

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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

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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. 1st quarter, 2015: 300% increase in screening incidence rate compared to 1st quarter, 2014

4. Still low…there’s work to be done

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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

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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

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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.

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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

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Other Positive Outcomes

Cost Effective

Serves as a foundation and model for other screening programs including cervical and breast cancer screening

Scalable and Sustainable

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