FLU-FIT Program at Kaiser Permanente Northern California
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|ClinicalTrials.gov Identifier: NCT01210235|
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Screening||Behavioral: FLU-FIT Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7465 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||FLU-FIT Program at Kaiser Permanente Northern California|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||April 2012|
Experimental: FLU-FIT Arm
In this arm, eligible patients aged 50-75 will be offered a FIT kit
Behavioral: FLU-FIT Program
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.
No Intervention: FLU-Only Arm
In this arm, patients will receive flu shots as usual, without the FLU-FIT intervention.
- Completion of colorectal cancer screening by eligible patients within 3 months of their flu shot [ Time Frame: from time of getting flu shot until 3 months later ]We will determine the proportion of patients aged 50-75 who are eligible for colorectal cancer screening at the time of their annual flu shot and become up to date with colorectal cancer screening 3 months later.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210235
|United States, California|
|Kaiser Permanente Northern California|
|Oakland, California, United States, 94612|
|Principal Investigator:||Michael Potter, MD||University of California, San Francisco|