FLU-FIT Program at Kaiser Permanente Northern California
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The investigators overall goal is to develop, implement, test, and disseminate an
      intervention to increase colorectal cancer screening rates at Kaiser Permanente (KP) by
      providing home fecal immunochemical test kits (FIT) to eligible patients aged 50 and older
      who participate in annual influenza vaccination campaigns. The investigators hypothesis is
      that the FLU-FIT Program will be an effective method to increase colorectal cancer screening
      rates at Kaiser Permanente.
    

Detailed description: 
      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.
    

Intervention name(s): FLU-FIT Program
Intervention type(s): Behavioral
Intervention description(s): In the intervention, eligible patients aged 50-75 who come in for flu shots and are due for colorectal cancer screening will be offered FIT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: colorectal cancer screening; preventive health; primary care