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

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

USA Colorectal Cancer StatisticsCA: 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

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.

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

San Francisco General Hospital’sFamily Health Center

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?

Developing a new FOBT program

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?

Pre-intervention: Potential increase in CRC

screening for adults eligible if offered with

influenza vaccination (Combines CA BRFSS and SF General Hospital Data)

0

10

20

30

40

50

60

70

80

90

100

California CA<200% of

Poverty Line

SFGH

Current 2004Potential 2004

Presented at the SF Bay Area Clinical Research Symposium, 2006

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.

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.

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.

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。

Results – San Francisco General Hospital

6-month outcomes

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.

Flu Only ArmN=246

Flu-FOBT ArmN=268

CRCS Up-to-DateBefore (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

Intervention: Flu shot clinic patients offered FOBT if due.Procedures closely supervised by research teamPatient telephone follow-up at 2 weeks and 6 weeks.Intent-to-treat analysis

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?

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”

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

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 supervisedNo post-intervention phone callsIntent-to-treat analysis (not all eligible patients were given a test)

Odds Ratio for going from unscreened to screened in Mulitivariate Analysis: 2.22 (1.24-3.95)

“Up to date” = FOBT within 1yr, FSIG within 5yr,or colonoscopy within 10yr

Data for flu shot recipients in 6 clinics

Flu Only Arm

N=677Flu-FOBT Arm

N=695

CRCS Up-to-Datebefore (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

Evidence of Lasting Benefits(Health Educ Research , 2012)

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%)

“Up to date” = FOBT within 1yr, FSIG within 5 yr, or colonoscopy within 10 yr

Observational study of established patients aged 50-75

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)

Flu-FIT Program at

Kaiser Permanente

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

RCT at Kaiser Permanente facilities in 5 different California cities

Results – Kaiser Permanente RCT (Am J Pub Health, 2012)

Test(s) completed within 90 days

Flu Only ArmN= 2884

Flu-FIT ArmN=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.

Intervention: FIT offered to eligible patients during a flu shot clinicNurse-run, shortened patient education, no phone follow-upIntent-to-treat analysis analyses focused on flu shot recipients who were due for colorectal cancer screening

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

Walgreens Pharmacy Pilot Study

moving Flu-FIT into community pharmacies

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 ProvidedN=86

Education/ReferralN=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.

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?

Answers to external validity research questions:

Public Website with Sample Program Materials: http://flufobt.org

Website developed with research funds

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

• 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

Training/Advertising Daily Operations Tracking Test Completion Results Follow-up

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.

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

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)

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.

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

Collaborators in Flu-FIT Program

Development, Evaluation, and Dissemination

THANK YOU!

michael.potter@ucsf.edu

http://flufit.org