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

NCT01211379 | Completed

• 1 other identifier: 1R18DP001566-01
• Study Type: interventional
• Target: 1,372
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Colorectal Cancer

Keywords

colorectal cancer screening; primary care; health disparities

Outcome Measures

Primary Outcomes (1)

• Change in Colorectal Cancer Screening Rate

  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.

  March 30, 2010

Study Arms (2)

FLU-Only Arm

NO INTERVENTION

In this arm, primary care patients who got flu shots were only provided with FOBT if the doctor decided to order it.

FLU-FOBT Arm

EXPERIMENTAL

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

Interventions

FLU-FOBT Program BEHAVIORAL

Primary care patients who came in for flu shots were assessed by nurses for colorectal cancer screening eligibility and offered FOBT if due.

FLU-FOBT Arm

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be primary care patients one of 6 participating clinics
• Participants must be aged 50-75
• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Department of Public Health: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Related Publications (1)

• 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.

  PMID: 21665058 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Michael B. Potter, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2010
• First Posted: September 29, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 18, 2010

Record last verified: 2010-09

Locations

US (1)