The Flu-FIT Program : An Effective Colorectal Cancer Screening Intervention Présentation de Michael B. Potter au colloque "Recherche interventionnelle contre le cancer : Réunir chercheurs, décideurs et acteurs de terrain » - 17 et 18 novembre 2014, BnF, Paris

1. INCa Conference:
Intervention Research Against Cancer
The Flu-FIT Program:
An Effective Colorectal Cancer Screening
Intervention
Michael B. Potter, MD
Director, SF Bay Area Collaborative Research Network
University of California, San Francisco
November 18, 2014
Paris, France

2. Presentation of Overview
• Colorectal cancer screening and the role of fecal
occult blood testing in the USA
• Development and pilot testing of the Flu-FIT Program
• Testing and adaptation in diverse clinical settings
• Dissemination and implementation activities

3. USA Colorectal Cancer Statistics
CA: Cancer J Clin, 2012;62:10-29, MMWR 2011;60:884-9; and CA: Cancer J Clin,2014;64:104-117.
• 2nd leading cause of cancer death in adults
– >50,000 deaths per year
• Trends in mortality and incidence
– Mortality declined by >30% since 1976
– Incidence declined by >30% since 2002
– Screening has been a major contributor to this success with
detection and removal of polyps and detection and treatment
of early stage cancers.
• Most screening is with colonoscopy
• About 60% of adults aged 50-75 are up to date with
screening - still more work to be done, especially in
community health center settings

4. Fecal Occult Blood Testing has advantages
FOBT is similarly effective to colonoscopy, if done in a well-organized
program with evidence-based test kits,
procedures, and follow-up.
Advantages:
• Inexpensive and accessible
• Can be offered by any member of the health team
• Can be done in privacy at home
• Non-invasive and safer than colonoscopy
• Only requires colonoscopy if abnormal
• Many patients prefer it.

5. However, FOBT program development and
implementation presents challenges
• Select and invest in evidence-based fecal test kits
• Define and identify eligible patients
• Reach participants every 1-2 years
• Procedures to educate patients about the importance
of screening and how to complete the test
• Follow-up to assure test completion
• Assure high quality test development processes
• Follow up abnormal results with colonoscopy

6. San Francisco General Hospital’s
Family Health Center

7. Developing a new FOBT program
Early CLINICAL questions (2004):
What colorectal cancer screening program could be
a. effective for an under-screened population?
b. acceptable to clinicians and staff?
c. feasible to implement with limited resources?
d. complementary to other quality
improvement efforts?
e. sustainable after the researchers leave?
f. adaptable and scalable for diverse settings?

8. Early RESEARCH questions (2005-6):
1. What is the potential benefit of offering FOBT
with flu shots as a program at SFGH, in similar
community health centers, and across the state of
California?
2. Can we show that a “FLU-FOBT Program” done
at the SFGH Family Health Center during an
influenza vaccination clinic can work?

9. Pre-intervention: Potential increase in CRC
screening for adults eligible if offered with
influenza vaccination
(Combines CA BRFSS and SF General Hospital Data)
100
90
80
70
60
50
40
30
20
10
0
California CA<200% of
Poverty Line
SFGH
Current 2004
Potential 2004
Presented at the SF Bay Area Clinical Research Symposium, 2006

10. Flu is Preventable! Colon Cancer is Preventable!
•Yearly home stool tests are easy to do.
•Yearly home stool tests could save your life.
•All our doctors and nurses recommend Colon
Screening for healthy men and women aged 50 to 79.
•When you should get tested? We will tell you today.
流感是可以預防的﹗結腸癌也是可以預防的﹗
每年檢查糞便一次， 簡單並容易進行。
每年檢查糞便一次，可以保護您的生命。
我們的醫生及護士一致推薦，50歲至79歲的健康男仕及女仕們，應接受結腸檢
查。
你何時需要測試？ 我們就今天告訴你。
Có Thể Ngừa Được Cúm!
Có Thể Ngừa Được Ung Thư Ruột Giá!
•Xét nghiệm phân hằng năm làm dễ dàng.
•Xét nghiệm phân hằng năm có thể cứu sinh mạng quý vị.
•Bác sĩ và y tá đề nghị làm xét nghiệm ung thư ruột gìa cho những
người khỏe mạnh từ 50 đến 79 tuổi.
•“Quý vi nên đi khám lúc nào ? Chúng tôi sẽ cho quý vị biết hôm
nay!”
¡La Gripa es prevenible!
¡El cancer del colon es
prevenible!
•Es fácil hacerse exámenes
anuales de defecación.
•Los exámenes anuales de
defecación le pueden salvar la
vida.
•Todos nuestros doctores y
enfermeras recomiendan un
chequeo del colon para hombres y
mujeres en buen estado de salud
entre los 50 y 79 anos.
•Cuando necesita ser chequeado?
Nosotros se lo podemos decirr
hoy.
Грипп можно предотвратить! Рак толстой кишки можно предотвратить!∙
• Проводить ежегодно анализ кала очень просто.
•Проведение анализа кала ежегодно может спасти вам жизнь.
• Обследование с целью предотвращения рака толстой кишки рекомедуется докторами всем женщинам и
мужчинам в возрасте от 50 до 79 лет.
•Когда нужно сделать тест? Мы скажем Вам об этом сегодня.

12. Results – San Francisco General Hospital
6-month outcomes
Intervention: Flu shot clinic patients offered FOBT if
due.
Procedures closely supervised by research team
Patient telephone follow-up at 2 weeks and 6 weeks.
Intent-to-treat analysis
Flu Only Arm
N=246
Flu-FOBT Arm
N=268
CRCS Up-to-Date
Before (Oct 2006)
52.9% 54.5%
CRCS Up-to-Date
After (Mar 2007)
57.3% 84.3%
Change: p<0.001 +4.4 points +29.8 points
Odds Ratio for going from unscreened to screened in Multivariate Analysis:
11.3 (5.8-22.0)
CRCS up to date: FOBT within 12 months, FSIG within 5 years or colonoscopy within 10 years
Potter MB et al., Annals of Family Medicine, 2009.

13. The next research questions (2008-2012), in pursuit of
external validity:
1. Can it work without the research team?
2. Can it be adapted to work in other community health
center settings?
3. Can it work in privately run managed care settings?
4. Can it work in pharmacies?
5. Can it be sustained and scaled up where it is
introduced?

14. FLU-FOBT and FLU-FIT Projects
• San Francisco Dept of Public Health
– CDC R18 (2008-2011) “Translation of an Evidence-Based Colorectal
Cancer Screening Intervention to Primary Care Settings Where
Disparities Persist”
• Kaiser Permanente Northern California
– HMO Cancer Research Network (2008-2009) “Preparation for the
FLU-FIT Program at Kaiser Permanente Santa Clara”
– ACS Research Scholars Grant (2009-2012) “Colorectal Cancer
Screening with During Annual Flu Shot Clinics at Kaiser
Permanente”
• Walgreens Pharmacies
– Alexander and Margaret Stewart Trust (2008-2009) “A Pharmacy-
Based Intervention to Increase Colorectal Cancer Screening”

15. RCT in 6 public clinics in ethnically diverse and medically
underserved neighborhoods in San Francisco

16. Results – RCT in 6 public clinics
“real world conditions”
(Am J Prev Med, 2011)
Intervention: FOBT offered whenever a nurse provided a flu
shot, either before or after a primary care visit
Training from research team – but not as closely supervised
No post-intervention phone calls
Intent-to-treat analysis (not all eligible patients were given a test)
Data for flu shot
recipients in 6 clinics
Flu Only Arm
N=677
CRCS Up-to-Date
before (Oct 2009)
31.3% 32.5%
CRCS Up-to-Date After
(Mar 2010)
35.6% 45.5%
Change (p=0.02) +4.3 points +13.0 points
Odds Ratio for going from unscreened to screened in
Mulitivariate Analysis: 2.22 (1.24-3.95)
Flu-FOBT Arm
N=695
“Up to date” = FOBT within 1yr, FSIG within 5yr,or colonoscopy within 10yr

17. Evidence of Lasting Benefits
(Health Educ Research , 2012)
Observational study of established patients aged 50-75
Population data for 6 clinics
that participated in the
FLU-FOBT RCT
Number of Flu Shot
Recipients
N
CRCS Up-To-Date Among
Flu Shot Recipients
N (%)
March 2008 (before) 3260 1385 (42.5%)
March 2009 (after) 3634 1982 (54.5%)
March 2010 (1 yr later) 4333 2440 (55.8%)
More knowledgeable clinic teams, More engaged with colorectal cancer
screening. Many Adaptations (e.g. adjusted work flows, switched to simpler
to use FIT kits,and some initiated year-round standing orders for staff to offer
screening with FIT)
“Up to date” = FOBT within 1yr, FSIG within 5 yr, or colonoscopy within 10 yr

18. Flu-FIT Program at
Kaiser Permanente

19. The Flu-FIT “Assembly Line”-- Used electronic health records
to assess FIT eligibility while patients waited for flu shots
(Am J Managed Care, 2011)

20. RCT at Kaiser Permanente facilities in 5 different
California cities

21. Results – Kaiser Permanente RCT
(Am J Pub Health, 2012)
Intervention: FIT offered to eligible patients during a flu shot clinic
Nurse-run, shortened patient education, no phone follow-up
Intent-to-treat analysis analyses focused on flu shot recipients who
were due for colorectal cancer screening
Test(s) completed
within 90 days
Flu Only Arm
N= 2884
Flu-FIT Arm
N=3351
P value
FIT 336 (11.7%) 900 (26.9%) <0.001
Sigmoidoscopy 68 (2.4%) 62 (1.9%) 0.16
Colonoscopy 61 (2.1%) 86 (2.6%) 0.24
Any Test 438 (15.2%) 996 (29.7%) <0.001
Odds Ratio: 2.77 (2.41-3.18)
Outcomes similar for all demographic subgroups in stratified analyses.
In Flu-FIT Arm, only about half of eligible patients were given FIT by clinic staff.
35.4% of eligible patients given FIT while in line for their flu shots completed FIT
within 3 months.

22. 2011 Dissemination and Implementation Study Targeting
All KPNC Facility Flu Shot Clinic Sites (Evaluation in Process)
Endorsed but not required by
KPNC Regional Leadership
Regional Flu Shot Clinic
Coordinators Managed the
implementation
Hands-on, centralized staff
training
Webinar for new and
experienced flu shot clinic sites
and those unable to attend in
person trainings
Internal KPNC website with
KPNC-specific procedures and
downloadable materials created

23. Walgreens Pharmacy Pilot Study
moving Flu-FIT into community pharmacies

24. Results comparing Flu-FIT vs.
Flu plus Education/Referral for Screening
(J Am Pharm Assoc 2010;50:181-7)
Phone Interviews 3-6 months after the
Intervention
FIT
Provided
N=86
Education/
Referral
N=28
P value
Discussed Screening with Physician 20% 50% <0.01
Completed Screening Test 59% 15% <0.01
Scheduled Screening Test 0% 19% <0.01
Said “Pharmacies should educate” 94% 86% 0.22
Said “Pharmacies should offer FIT” 91% 82% 0.30
Pharmacists could play a positive role in colorectal cancer screening:
educating, referring, and/or providing FIT to eligible patients during flu shot
activities.
Challenges to address: methods to assess eligibility, closing the loop with
primary care, and providing incentives for pharmacies to offer these services.

25. Answers to external validity research questions:
1. Can it be implemented without the researchers? -- often
2. Can it be adapted to work in other primary care in public
health clinics? -- yes
3. Can it work in private health care settings? -- yes
4. Can it work in pharmacies? -- maybe
5. Can it be sustained and scaled up where it is introduced?
-- often
7 published studies in diverse clinical, prevention, and public
health journals, cited over 75 times in the literature, plus
thousands of FIT completed research sites
What about delivering the FLU-FIT Program to New Settings?

26. Website developed with research funds
Public Website with Sample Program Materials: http://flufobt.org

27. Description of Key Program Components
CORE FUNCTIONAL COMPONENT: Standing orders
for clinic staff to offer flu shots and FOBT together for
patients aged 50-75 seen during flu shot season
TARGET CLINICAL SETTINGS AND POPULATIONS:
CHCs where flu shots are provided and where FOBT
is the primary test for average risk CRCS
Training/Advertising Daily Operations Tracking Test Completion Results Follow-up
• Designated clinic-based
program
leader
• Program leader
training
• Program leader
assigns clinic staff to
participate
• Clinic staff completes
formal training
• Clinic team approves
program plans
• Advertise with
posters, and
postcards
• Daily supervision
by program leader.
• Program offered
by staff daily
during flu shot
season.
• EHR used to
assess CRCS
eligibility
• FOBT provided
immediately
before flu shots.
• FOBTkits pre-packaged
with
program materials
FOBT not
Completed
• Postcards and
Phone calls
Normal Results
• Notify patient and
primary care
provider
• Reminder to
repeat FOBT in
one year
Abnormal
Results
• Notify patient
and primary care
provider
• Arrange
colonoscopy
GOAL: Increase CRCS rates by offering home FOBT to eligible patients during annual flu shot activities.
• Flu shots
and FOBT
dispensed
are recorded
together at
the same
time for
tracking
purposes
FOBT
Completed
• Competed
tests mailed to
lab for
processing
• Clinic checks
for results
Program Materials
Patient flow algorithm Pre-addressed mailing pouches
Patient eligibility algorithm Pre-stamped mailing pouches
Script to explain FOBT to patients during flu shot visits FOBT tracking and follow-up logsheets
Visual aids to explain FOBT Mailed FLU-FOBT Program announcements
Multilingual clinic video to explain FOBT FLU-FOBT Program clinic posters
Multilingual patient instructions on FOBT completion Multilingual materials explaining the importance of FOBT

28. Dissemination
• US-NCI Research Tested Interventions (RTIPs) web listing
Independent review and validation of results
– “5.0” Rating for Dissemination Capacity
– A source for both researchers and practitioners
• US-CDC promotes FluFIT to state cancer programs
• American Cancer Society branding and their own FluFIT
web page with active field support for implementation in
community health centers across the USA since 2013
• US National Colorectal Cancer Roundtable and National
Association of Community Health Centers promotes
FluFIT Program through its “80% by 2018” Campaign.

29. Implementation
• Webinars and consultations for healthcare
organizations that are implementing FluFIT (e.g. from
groups in Northern CA, Washington, Iowa, Montana,
South Dakota, and Texas in 2014 alone)
• Spontaneous implementation in several health care
organizations across the US.(e.g. public health and
community health center activities in Arizona, Colorado,
Georgia, Massachusetts, New Mexico, Oregon, Texas,
West Virginia) and recently in Ontario, Canada

30. Signs of Spontaneous Interest
• Flufit.org google analytics: April-September 2014
– >2100 website visits (average of 3 min/session)
– >1400 unique users (65% of visits)
– >5000 page views (average 2-3 pages/session);
– 54% bounce rate (about half of visitors spent some
time exploring the website)
– Wide geographic distribution:
• 596 different cities, 47 countries, 87% from US
• US cities with > 30 visits: San Antonio, Austin, Houston, St
Paul, King of Prussia (PA), New York, Dalton (GA), San
Francisco, Boston, Portland (OR)

31. Summary
• 1. Annual influenza vaccination campaigns represent
an underutilized opportunity to offer FIT.
• 2. FluFIT Programs engage clinical teams in offering
colorectal cancer screening during annual influenza
vaccination campaigns, encouraging and supporting
annual colorectal cancer screening of average risk
patients not reached by other interventions.
• 3. FluFIT Programs can be adapted, implemented, and
sustained in diverse clinical settings serving diverse
patient populations.

32. Summary
• 4. Keys to success
– Identify an important clinical need
– Involve end-users in the early development of the
intervention
– Define core components that are easy to understand,
adopt, implement, scale, and sustain
– Develop training materials and tools to aid with adaptation
and implementation in diverse clinical settings
– Engage with the health community, advocacy
organizations, research community, and policy makers on
multiple levels to get the word out

33. Collaborators in Flu-FIT Program
Development, Evaluation, and Dissemination

34. THANK YOU!
michael.potter@ucsf.edu
http://flufit.org