The Flu-FIT Program: An Effective Colorectal Cancer Screening Intervention

80% by 18 FourmThe Flu-FIT Program: An Effective Colorectal Cancer Screening Intervention Michael B.. The first CLINICAL questions 2004:What primary care colorectal cancer screening out

80% by 18 Fourm

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

Sept 17, 2015 Atlanta, GA

• Research to demonstrate effective translation into

diverse clinical settings

• Dissemination and implementation activities

In USA, colonoscopy is the most common screening modality, but FOBT remains

important

Decision modeling studies indicate that when

provided annually to average risk patients with appropriate follow up, annual stool testing can

provide the same number of life-years gained as

colonoscopy-only strategies

Zauber AG et.al Ann of Int Med 2008, 149; 659-669

FIT has advantages

• Inexpensive and Accessible

• Can be offered by any member of the health team

• Can be done in privacy and at home

• Is non-invasive and has no risk of pain, bleeding, bowel perforation, or other adverse outcomes

• Fecal Immunochemical Tests (FIT) are easier and

better accepted than other stool-based tests (no

changes in diet required, for example)

• Only requires colonoscopy if abnormal

• Many patients prefer it.

Doing more FIT is especially important in

public health settings

(2014 NCCRT analysis of UDS data)

Challenges of Implementing FIT Programs

in Primary Care

• Select and invest in evidence-based FIT kits

• Identify eligible patients

• Organized in-reach and outreach

• Staff training to educate patients about the

importance of screening and how to do the test

• Follow-up to assure test completion

• Assure high quality test development processes

• Assure annual test completion if normal

• Follow up abnormal results with colonoscopy

The first CLINICAL questions (2004):

What primary care colorectal cancer screening

outreach 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 screening program

The first RESEARCH questions (2005-6):

1 For average risk adults, is the time of influenza vaccination a missed opportunity to offer colorectal cancer screening?

2 Can we show that a “FLU-FOBT Program” in an influenza vaccination clinic can work?

Potential increase in CRC screening for adults eligible if offered with influenza vaccination

(Combines CA BRFSS and SF General Hospital Data)

Presented at the SF Bay Area Clinical Research Symposium, 2006

San Francisco General Hospital’s Family Health Center

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

你 何 時 需 要 測 試？ 我 們 就 今 天 告 訴 你。 何 時 需 要 測 試？ 我 們 就 今 天 告 訴 你。 時 需 要 測 試？ 我 們 就 今 天 告 訴 你。 需 要 測 試？ 我 們 就 今 天 告 訴 你。 要 測 試？ 我 們 就 今 天 告 訴 你。 測 試？ 我 們 就 今 天 告 訴 你。 試？ 我 們 就 今 天 告 訴 你。 我 們 的 們 的 就 今 天 告 訴 你。 今 天 告 訴 你。 天 告 訴 你。 告 訴 你。 訴 你。 你 何 時 需 要 測 試？ 我 們 就 今 天 告 訴 你。。

Results – San Francisco General Hospital

The next questions (2008-2012), translating research into practice:

1 Can it work without the research team?

2 Can it be integrated with primary care in public health settings?

3 Can it work in managed care?

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)

Intent-to-treat analysis

Training from research team

Intervention run and supervised entirely by clinic staff

No post-intervention phone calls

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=677 Flu-FOBT Arm N=695

Evidence of Lasting Benefits

(Health Educ Research , 2012)

Population data for 6 clinics

that participated in the

N (%)

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

Observational Data Established patients aged 50-75

More Patients got flu shots and CRC screening over time

More knowledgeable clinic teams

Many Adaptations (e.g most sites switched from older less effective FOBT to

FIT by 2011, adjusted workflows, 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)

Odds Ratio: 2.77 (2.41-3.18); Outcomes similar for all demographic subgroups

In the Intervention Arm:

53% of those due for screening were given a FIT kit

35% of those given a FIT kit completed it within 90 days.

reminders

2011 Dissemination and Implementation Study Targeting All KPNC Facility Flu Shot Clinic Sites (Evaluation in Process)

Endorsed but not required by KPNC Regional Leadership

Disseminated through Regional Flu Shot Clinic Coordinators

Hands-on training offered at KPNC’s Center for Innovation in San Leandro, CA.

Webinar for new and experienced flu shot clinic sites

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

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 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

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 integrated with primary care in public health

Stages of Translation:

From Research Into Practice

Exploration of New Settings

Adoption / Program Planning

Sustainment / Scaling Up

Implementation Processes

Dissemination and Implementation

Effectiveness Studies

Efficacy Studies

Preintervention

Figure adapted from Chapter12, Figure 12-1

Dissemination and Implementation Research in Health

Ann Fam Med, 2009

BACR, 2006

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

Websites developed with research funds

Description of 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

• EHR used to assess CRCS eligibility

• FOBT provided immediately before flu shots.

• FOBTkits packaged with program materials

pre-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

What does a FluFIT Program Cost?

• Costs vary by setting, influenced by extent to

which services provided can be billed or

• Need to develop your own business case

relative to other health organization priorities.

Dissemination

• FluFIT research cited in >75 publications

• NCI Research Tested Interventions Program web

listing Independent review and validation of results

– “5.0” Rating for Dissemination Capacity

• CDC promotes FluFIT to state cancer programs

• ACS branding and web page with and active field

support for implementation in several community health centers across the USA since 2013

• Featured prominently in NCCRT’s new 2014 publication,

Steps for Increasing Colorectal Cancer Screening Rates: A Manual for Community Health Centers

And Implementation

• Webinars and consultations for groups that are

implementing FluFIT (e.g requests for implementation advice from groups in Northern CA, Washington, Iowa, Montana, South Dakota, and Texas)

• FluFIT on the Frontera

– $1.5 million project funded by CPRIT

– Adds promotoras and patient navigation to FluFIT activities conducted during health fairs for Texas/Mexico border

population in Val Verde County, TX

– http://www.cprit.state.tx.us/files/funded-grants/PP150071.pdf

Often Spontaneous…

•Anecdotes of implementation among those we have

never met, in healthcare organizations across the US and

in Canada

•Google Analytics for flufit.org: Since Jan 1, 2015

– >5000 website visits, about 2 min/session

– >8000 page views (average 2-3 pages/session)

– Twice as much web traffic as 2014

– Wide geographic distribution:

• Visitors from all 50 states

• Top 10 states: TX, CA, NY, IL, NJ, FL, VA, PA, NC.

• 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

• 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 on multiple levels to get the word out

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

Very special thanks to these mentors, collaborators, project coordinators, and

THANK YOU!

michael.potter@ucsf.edu http://flufit.org