Trial Information

FLU-FIT Program at Kaiser Permanente Northern California

Background: Colorectal cancer is the second leading cause of cancer death in the U.S. Many
of these deaths could be prevented by screening, which is recommended for adults aged 50 and
older. Effective screening options include yearly fecal occult blood tests, flexible
sigmoidoscopy every 5 years, or colonoscopy every 10 years. Unfortunately, despite these
recommendations and options, only half of adults aged 50 and older are up to date with any
test. Simple, cost-effective approaches to increase colorectal cancer screening rates are
needed to reduce the burden of colorectal cancer in the U.S.

Objective/Hypothesis: Our hypothesis is that offering annual colorectal cancer screening
with fecal occult blood tests to eligible adults aged 50 and over during annual nurse-run
influenza vaccination clinics will result in increased colorectal cancer screening rates,
reaching populations that have been under-screened in the past. Our overall objective is to
develop, implement, test, and disseminate this intervention using an annual fecal
immunochemical test for occult blood (FIT) at Kaiser Permanente (KP) Northern California.

Specific Aims: The specific aims of this research are to (1) develop and implement a
comprehensive nurse-run FLU-FIT Program at the KP Santa Clara facility that will systematize
the offering of FIT to all eligible patients aged 50 to 80 who attend annual influenza
vaccination clinics; (2) test the effectiveness of the FLU-FIT Program in improving
colorectal cancer screening rates in the context of a time-randomized, controlled trial
involving an ethnically diverse population of influenza vaccination clinic attendees at 8
influenza vaccination sites within 4 other KP Northern California service areas; (3)
evaluate the reach and robustness of the FLU-FIT Program as implemented within these 8
sites, and (4) create a FLU-FIT Program Toolkit that can be used in further efforts to
disseminate this intervention both within Kaiser Permanente and to other clinical settings.

Study Design: The study will be conducted in 3 phases. In Phase 1 (Year 1), we will
evaluate a pilot FLU-FIT Program that is already underway at KP Santa Clara and implement it
systematically for its annual influenza vaccination clinics in 2009-2010. In Phase 2 (Years
2 and 3), the key elements of the KP Santa Clara FLU-FIT Program will be tested in a
time-randomized trial within 8 other KP Northern California sites. On randomly assigned
dates at each of the 8 influenza vaccination clinic sites, patients will receive either the
FLU-FIT Program (intervention) or influenza vaccination only (control). The primary outcome
will be the proportion of intervention subjects between the ages of 50 and 80 who are
initially due for colorectal cancer screening that become up to date with colorectal
screening within 3 months after receiving their influenza vaccine, as compared to similar
subjects in the control group. The robustness of the intervention as an effective and
sustainable intervention to increase rates of colorectal cancer screening in "real world"
settings will also be evaluated according to the RE-AIM criteria (Reach, Efficacy, Adoption,
Implementation, and Maintenance). In Phase 3 (Year 4), data will be analyzed, and a toolkit
for further dissemination activities will be developed.

Cancer Relevance: If successful and widely implemented, the FLU-FIT Program could increase
access to colorectal cancer screening for millions of Americans. This approach could also
provide a model for developing effective cancer screening interventions that do not depend
solely on the primary care clinician, and that can be triggered by other regular contacts
that patients have with the healthcare system.