Colon Cancer Screening for Primary Care Physicians Richard C. Wender, MD Alumni Professor and Chair Department of Family & Community Medicine Thomas Jefferson University Past President, American Cancer Society

What We’ll Cover Epidemiology Screening Trends New Guidelines Improving preventive practice – Organizing your office – Improving quality and screening rates

Colon Cancer: Epidemiology 108,070 cases predicted in ,960 deaths expected Death rates declining by 4.7% per year from Cancer Facts and Figures, American Cancer Society

CRC Screening: Rates Are Rising... Probably NHIS data based on self report – Screening exceeding 60% in many states – 70% in Connecticut HEDIS data based on claims and chart reviews – 55% in commercial and rising – 53% in Medicare and flat

Understanding Screening Rate Trends With shift to colonoscopy as predominant modality, shouldn’t all rates be going up? – Perhaps abandonment of FOBT and FIT is negatively impacting rates Hard to reach everyone with colonoscopy

Understanding Screening Rate Trends Annual FOBT/FIT: People coming in and out of being “up to date” every year Colonoscopy: Key driver of gradual increase in “up to date” status

Colon Cancer Screening – Understanding The New Guidelines

New Guideline Methodology Guidelines were developed by a consensus group representing: – American Cancer Society – American College of Radiology – Multi-Society GI Task Force American College of Gastroenterology American Gastroenterological Association American Society for Gastrointestinal Endoscopy

CRC Screening Guidelines: New Concepts A 50% sensitivity threshold for cancer Tests that predominantly target prevention versus tests that predominantly target cancer

“It is the strong opinion of this expert panel that colon cancer prevention should be the primary goal of CRC screening” Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008

Tests That Primarily Detect Cancer Annual gFOBT with at least 50% test sensitivity for cancer, or… Annual FIT with at least 50% test sensitivity for cancer, or… sDNA at uncertain screening interval

U.S.P.S.T.F. Guidelines Do not include DNA or C-T Colonography Medicare has decided NOT to cover colography

Tests That Detect Adenomatous Polyps and Cancer Flexible sigmoidoscopy every 5 years, or… Colonoscopy every 10 years, or… Double-contrast barium enema every 5 years, or… CT colonography every 5 years

Key Questions in Colon Cancer Screening

Colorectal Cancer Screening And Prevention Do we still need a menu of options? What new tests might be added to the menu? Should colonoscopy be the preferred testing option? What screening options might be dropped from the menu?

CRC Screening: Issue 1 Do we still need a menu of screening options?

A Screening Menu We cannot yet abandon the menu – No one clearly superior test for all people – No one structural test that is available to all – No one test that will be accepted by all

CRC Screening: Issue 2 What new tests are added to the screening menu?

Fecal DNA Testing (PreGen-Plus) Advantages: – Passes the 50% sensitivity threshold – DNA shedding unlikely to be intermittent – Doesn’t require stool handling – May not be necessary annually

Fecal DNA Testing Disadvantages: – Sensitivity may be less than sensitive stool blood tests, particularly FIT – Requires mailing of a whole stool sample – Safe interval is not known – Expense: >$250 per test 10 times more than FIT Close to 100 times more than guiac FOBT

Fecal DNA Tests – An Update Pre Gen Plus is up to its third generation of refined testing – Performance is reportedly better, but as yet unproven Cost is coming down and may be as low as $300 Testing interval reported by the company is 5 years Data supporting this interval is inadequate

DNA For Colon Cancer – Blood Tests Several blood tests in clinical trials

Fecal DNA A promising technology Lots of studies demonstrating the ability to find abnormal DNA that is associated with cancer BUT, some FIT studies have showed better sensitivity for cancer at far less cost. And the testing interval of 5 years seems long. 3 years or fewer may make more sense, but significantly increases the cost

C-T Colonography Issues It’s NOT a virtual experience – Requires a prep – Requires air insufflation of the colon Cost is high AND colonoscopy is required for abnormal findings To be an option, sensitivity and specificity must be outstanding

Will CT Colonography Become The Preferred First Line Screening for Colon Cancer? Cheaper Safer Visualizes the whole colon Requires the same prep BUT is it accurate?

C-T vs. Colonoscopy: Sensitivities for All Polyps Polyp Size >10mm>8mm>6mm C-T 92.2%92.6%85.7% Colonoscopy88.2%89.5%90.0%

What Percent of Patients Would Require Colonoscopy If C-T Were Done First? Polyp Size % Requiring Threshold Colonoscopy 10mm7.5 8mm13.5 6mm29.7

Virtual colonoscopy identified 55 polyps not seen on initial colonoscopy 21 were adenomatous One 11mm malignant polyp

Non-Colonic Findings 5 asymptomatic cancers Aortic aneurysms Renal and gall bladder calculi

Next Big C-T Colonograhy Study Published in JAMA Results were far less good than seen in the Pickardt study. Key factors were Experience of the center Time devoted to reading Use of digital subtraction and fly- through technology

And The Next Big CT Study The ACRIN study is a multi-center study with each site using the new technology First results will be reported within 6 months

ACRIN Results – First Report 15 center trial 2,531 asymptomatic patients – Either 2D or 3D – Multiple manufacturers Almost all had colonoscopy

ACRIN Results 547 polyps detected in 390 patients – 2/3 were adenomas Mean size was 8.9 mm 128 polyps > 1 cm 7 cancers detected

2-Dimensional Primary Reading

Virtual Colonoscopy “Fly Through”

ACRIN Results Sensitivity =SensitivitySpecificity Adenomas > 1 cm90%86% Polyps 6-9 mm84%86-89%

Will C-T Colonography Become A Mainstream Option? Reasons to think that it will – Cheaper than colonoscopy as a single, one-time test – Excellent performance characteristics in experienced centers – Safer than colonoscopy

Will C-T Colonography Become A Mainstream Option? Reasons to think it will not: – Time consuming for radiologist – Few experienced centers exist today Requires extensive training – Small polyps are ignored Requiring shorter screening interval (every 5 years) This impacts cost and capacity – If all polyps >6cm lead to colonoscopy, 3 to 5 CTC’s will lead to 1 colonoscopy

Should Colonoscopy Be The Preferred Screening Test? Colonoscopy utilization is increasing dramatically Sigmoidoscopy utilization is decreasing and barium enema is rarely utilized Clinicians are still utilizing FOBT and FIT – Requires annual testing and rates of repeat testing are very low

Colonoscopy Preferred? Colonoscopy is not a gold standard – Complications in 1/1000 exams – Misses from 5 to 10% of important lesions But the key advantages are accuracy and ability to screen as infrequently as every 10 years Our practice has decided to recommend colonoscopy as preferred strategy with a FIT test as a back-up

Colonoscopy Preferred? Hype May Exceed Reality Annual FIT screening may be as effective as colonoscopy every 10 years Hard to find evidence that mortality from right sided diseases is declining

What Tests Might Be Dropped From The Guidelines? Lower sensitivity FOBT’s, such as Hemoccult II do not meet the 50% threshold and should be dropped from the guideline

Pearls In Cancer Screening: Colon Cancer The FOBT done at the time of a digital rectal must be stopped – A negative result offers ZERO reassurance…or, even worse, false reassurance – A major national campaign is underway to stop this – Medicare will no longer pay Few people do FOBT or FIT every year – A test that can be done less frequently is preferred for most

Bringing Quality To A Colonoscopy Screening Program Characteristics of a high-quality screening program – Patient registry – Appointment made by PCC office staff, not the patient – Short wait time – Navigation through prep & reminder of date – High quality colonoscopy with standard reporting – Call-back reminder

Why focus on primary care practice? What can we do about it? We have it in our power to improve the screening rate. ‘This is our sphere of influence.’ 80-90% of people >age 50 saw 1°MD last year (BRFSS, CDC) Few practices currently have mechanisms to assure that every eligible patient gets a recommendation for screening.

A physician’s recommendation is the most influential factor in cancer screening!

How Can We Increase CRC Screening Rates in Practice? 4 Essentials: #1 A Screening Recommendation for every eligible patient #2 An Office Policy known to all who work in the office #3 A Reminder System #4 An Effective Communication System

Essential #1: Screening Recommendation The Goal: A recommendation to every eligible patient Requires a system that doesn’t depend on the doctor alone. Requires an opportunistic approach* i.e. don’t limit efforts to “check-ups” *N.B. An opportunistic approach does not justify an in-office FOBT. This has NO evidence base. #170

Essential #2: An Office Policy States the intent of the practice. – tangible, maintains consistency, – prerequisite for reliable, reproducible practice Algorithms easiest policies to follow. Beware: one size does not fit all practices! Beware: one size does not fit all patients!

Essential #3: A Reminder System Two types: – Physician Reminders – Patient Reminders There is evidence for effectiveness of both Evidence on physician reminders is from two meta-analysis

Essential #4: An Effective Communication System Better communication has many benefits. So how can we improve it? – Staff involvement – Decision aids – Theory-based approaches Theory-based communication has documented has greater impact.

The Ecology of Primary Care Practices Typical practice consists of –2-5 clinicians –Fewer than 3 non-clinician nursing and clerical staff for each clinician Most practices have a hierarchical management structure –Physician owners and office manager provide oversight Stange KC et al, J of Fam Pract 46(1998):377-89

Primary Care Practices: Culture and Financial Reality “Climates permeated with stress and overwork” Most work on margins of financial viability –Little time for self-reflection –Little or no training in quality improvement and organizational management Grumbach K and Bodenheimer J. JAMA (2002): Crabtree BF. Healthcare Manage Rev, Vol 281(2003):279-83

Primary Care and CRC Screening Primary care clinicians virtually all recommend CRC screening

Virtually no primary care clinicians are successfully screening all eligible, enrolled patients

No Single Model To Absorb These Costs PCC offices are complex, non-linear systems Organizational principles can be used to describe PCC settings Generally speaking, high performing practices share some key characteristics Crabtree BF, et al. Primary Practice Organizations and Preventive Services Delivery: A Qualitative Analysis. J of Fam Pract 46(5): , May

Clinical Preventive Service Delivery In Primary Care Study of 18 family medicine offices Practices use individualized approaches –No one approach used successfully across all practices Preventive service delivery was identified as a priority Factors included competing demands, a physician champion, and economic concerns Crabtree BF, et al. Annals of Fam Med 3(5):430-5, 2005

Characteristics of High Performing Practice Leadership A culture of improvement Greater staff involvement Higher investment in people –Greater investment in technology has not, yet, been demonstrated to promote prevention, including CRC screening Orzano AJ, et al. Improving outcomes for high risk diabetes using information systems. J Am B of Fam Med 20(3) May-Jun

Improving Quality: Characteristics of High Performing Practices Involving staff in decision making – Higher staff retention – Higher productivity – Practice satisfaction Staff meetings do not correlate with improved participation and outcomes Soliciting staff feedback through every day discussions works better Hung Y et al. Medical Care Vol.44 (10): Oct 2006

Prescription For Health: RWJ Funded Pilot Programs To Improve Quality Care Delivery 17 PBRN’s funded in round 1 Lessons from prescription for health – Health behavior change resources are enthusiastically received by all – Patients prefer personal contact methods – Practice extenders require extensive training and careful case management and support

Prescription For Health: cont’d Lessons from prescription for health – Integrating tools requires practice change, use of a practice change model and specialized expertise – Even simple interventions require change and a change model Ann of Fam Med 3 Suppl 2:512-19, 2005 Jul-Aug

Electronic Health Records Do Not Invariably Improve Care Quality Analysis of 50 practices in a practice improvement study – 37 practices not using an EMR were more likely to meet diabetes outcomes than 13 practices utilizing an EMR Crosson JC, et al. Annals of Fam Med 5(3):

A New Model To Enhance Prevention and Chronic Disease Management - The Patient Centered Medical Home

The Physician Practice Connection: Patient-Centered Medical Home Joint Principles of PPC-PCMH: – Personal physician – Physician directed medical practice – Whole person orientation – Care is coordinated or integrated – Quality and safety are hallmarks – Enhanced access – Payment recognizes value

PPC-PCMH Content and Scoring Standards: 1.Access and communication 2.Patient tracking and registry functions 3.Care management 4.Patient self-management support 5.Electronic prescribing 6.Test tracking 7.Referral tracking 8.Performance reporting and improvement 9.Advanced electronic communications

The Four Essentials: A Review A recommendation to every eligible patient An office policy A reminder system An effective communication system