Trial Information

The FLU-FOBT Program: Translation of an Evidence-Based Colorectal Cancer Screening Program to Primary Care Settings Where Disparities Persist

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