The FLU-FOBT Program in Primary Care Settings Where Disparities Persist
NCT ID: NCT01211379
Last Updated: 2010-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1372 participants
INTERVENTIONAL
2009-10-31
2010-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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FLU-Only Arm
In this arm, primary care patients who got flu shots were only provided with FOBT if the doctor decided to order it.
No interventions assigned to this group
FLU-FOBT Arm
In this arm, patients who came in for primary care got a flu shot and were assessed by nurses for eligibility for colorectal cancer screening. Eligible patients were provided with home FOBT.
FLU-FOBT Program
Primary care patients who came in for flu shots were assessed by nurses for colorectal cancer screening eligibility and offered FOBT if due.
Interventions
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FLU-FOBT Program
Primary care patients who came in for flu shots were assessed by nurses for colorectal cancer screening eligibility and offered FOBT if due.
Eligibility Criteria
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Inclusion Criteria
2. Participants must be aged 50-75
3. Participants must have received a flu shot during a primary care visit on any date during the 2009-10 flu shot season (beginning September 28, 2009 and ending at the end of January, 2010).
50 Years
75 Years
ALL
Yes
Sponsors
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San Francisco Department of Public Health
OTHER_GOV
Centers for Disease Control and Prevention
FED
University of California, San Francisco
OTHER
Responsible Party
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University of California, San Francisco
Principal Investigators
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Michael B. Potter, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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San Francisco Department of Public Health
San Francisco, California, United States
Countries
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References
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Potter MB, Walsh JM, Yu TM, Gildengorin G, Green LW, McPhee SJ. The effectiveness of the FLU-FOBT program in primary care a randomized trial. Am J Prev Med. 2011 Jul;41(1):9-16. doi: 10.1016/j.amepre.2011.03.011.
Other Identifiers
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