The FLU-FOBT Program in Primary Care Settings Where Disparities Persist
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The investigators overall goals are to adapt, implement, evaluate, and disseminate the
      FLU-FOBT Program as an integrated nurse-run, primary care-based intervention that can reduce
      colorectal cancer screening disparities in resource-poor clinical settings. In this program,
      fecal occult blood tests (FOBT) are provided with influenza vaccinations (FLU) to eligible
      patients between the ages of 50 and 75 during FLU season. The investigators hypothesis is
      that the FLU-FOBT Program can be adapted for primary care settings and lead to higher rates
      of colorectal cancer screening (CRCS).
    

Detailed description: 
      AIM 1 (Year 1): To adapt and pilot test the FLU-FOBT Program as a nurse-run intervention
      during primary care visits at San Francisco's Chinatown Public Health Center. The FLU-FOBT
      Program will be designed in such a way as to trigger the offering of fecal occult blood
      testing (FOBT) to eligible patients whenever an influenza vaccination (FLU) is provided.
      Specific components of the FLU-FOBT Program will be developed through a process of active
      collaboration with health center staff. The FLU-FOBT Program will be implemented in the fall
      of 2008-9 and evaluated with a combination of process measures in Year 1 of the study. This
      formative work will be used to finalize the FLU-FOBT Program for further study of its
      efficacy and robustness in other affiliated San Francisco public health centers.

      AIM 2 (Year 2 and 3): To test the efficacy of the FLU-FOBT Program in improving colorectal
      cancer screening rates in a time-randomized, controlled trial involving other public health
      centers in the San Francisco Community Health Network that serve ethnically diverse,
      economically disadvantaged patients. During the 2009-10 influenza vaccination season, the
      FLU-FOBT Program will be tested in a randomized trial within 6 public health centers in San
      Francisco. On half of randomly selected dates at each of these clinics, a nurse will follow a
      protocol that directs them to offer FOBT to eligible patients whenever they are offered an
      influenza vaccine (intervention), and on the other dates nurses will be directed to offer
      just influenza vaccine alone (control). The primary efficacy outcome will be the proportion
      of intervention subjects between the ages of 50 and 80 and are initially due for CRCS who
      become up to date 3 months after the intervention is completed, as compared with similar
      subjects in the control group.

      AIM 3 (Years 2 and 3): To evaluate the robustness of the FLU-FOBT Program as implemented
      within these 6 clinics. In the 2009-10 influenza vaccination season, we will also test the
      robustness of the FLU-FOBT Program as implemented at the 6 sites that participate in the
      time-randomized trial. Robustness will be measured according to the RE-AIM framework (Reach,
      Effectiveness, Adoption, Implementation, and Maintenance) described by Glasgow and others
      [2]. Reach will be measured as the proportion of the target population that is offered
      screening, and Effectiveness will be measured as the proportion of the target population that
      gets screened with the intervention. Adoption will be measured as the proportion of invited
      influenza vaccination clinic sites and clinic staff members that participate; Implementation
      will be assessed according to the fidelity with which participating sites and clinic staff
      follow the key elements of FLU-FOBT Program protocol and how they adapt the protocol to
      accommodate local needs and constraints. Maintenance will be assessed by determining the
      number of intervention sites that continue the FLU-FOBT Program in the year after the
      intervention has been completed, and the overall success of the program where it is
      continued.

      AIM 4 (Year 3): To develop a FLU-FOBT Program Toolkit that can be adopted locally and
      disseminated to other public health clinics that rely on annual FOBT as a primary strategy
      for average risk colorectal cancer screening. Study results from all participating health
      centers will be used to develop an evidence-based FLU-FOBT Toolkit that can be distributed
      and serve as a practical guide for clinical decision makers who wish to adapt and replicate
      this intervention within clinics that serve diverse communities that experience disparities
      in colorectal cancer screening. The Toolkit will include both key elements that must be
      preserved in order for the FLU-FOBT Program to be successful, as well as examples of
      enhancements successfully implemented in different clinics
    

Intervention name(s): FLU-FOBT Program
Intervention type(s): Behavioral
Intervention description(s): Primary care patients who came in for flu shots were assessed by nurses for colorectal cancer screening eligibility and offered FOBT if due.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: colorectal cancer screening; primary care; health disparities