FLU-FIT Program at Kaiser Permanente Northern California

March 5, 2015 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7465

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Kaiser Permanente Northern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 50-75 at the time of their flu shots who are also due for colorectal cancer screening.

Exclusion Criteria: none

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from time of getting flu shot until 3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

American Cancer Society, Inc.
Kaiser Permanente

Investigators

  • Principal Investigator: Michael Potter, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 25, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSGPB-09-010-01-CPPB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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