The FLU-FOBT Program in Primary Care Settings Where Disparities Persist

This study has been completed.
Sponsor:
Collaborators:
San Francisco Department of Public Health
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01211379
First received: September 25, 2010
Last updated: October 14, 2010
Last verified: September 2010
  Purpose

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).


Condition Intervention
Colorectal Cancer
Behavioral: FLU-FOBT Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The FLU-FOBT Program: Translation of an Evidence-Based Colorectal Cancer Screening Program to Primary Care Settings Where Disparities Persist

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in Colorectal Cancer Screening Rate [ Time Frame: March 30, 2010 ] [ Designated as safety issue: No ]
    Change in colorectal cancer screening rates (defined as being up to date with FOBT in the last 12 months, up to date with flexible sigmoidoscopy within the last 5 years, or up to date with colonoscopy in the last 10 years) by March 30, 2010, 6 months after the beginning of the intervention.


Enrollment: 1372
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: 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.
Behavioral: 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.

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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participants must be primary care patients one of 6 participating clinics
  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).

Exclusion Criteria: None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211379

Locations
United States, California
San Francisco Department of Public Health
San Francisco, California, United States, 94102
Sponsors and Collaborators
University of California, San Francisco
San Francisco Department of Public Health
Investigators
Principal Investigator: Michael B. Potter, MD University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael B. Potter, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01211379     History of Changes
Other Study ID Numbers: 1R18DP001566-01
Study First Received: September 25, 2010
Last Updated: October 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
colorectal cancer screening
primary care
health disparities

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014