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Clinical Trials/NCT01453894
NCT01453894
Completed
Not Applicable

Center for Advancing Equity in Clinical Preventive Services Project 1: Improving Rates of Repeat Colorectal Cancer Screening

Northwestern University1 site in 1 country450 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Northwestern University
Enrollment
450
Locations
1
Primary Endpoint
Completion of a Fecal Occult Blood Test (FOBT)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC) screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults, beginning at age 50 and continuing until age 75. However, rates of CRC screening remain inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening. Screening rates are even lower among Black and Hispanic populations and in areas with higher poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be effective. Few studies have examined the rate of repeat FOBT testing; to the investigators knowledge, none have been conducted in populations with high prevalence of barriers to screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The assumption that FOBT is an effective CRC screening strategy presumes it will be done at least biennially, and cost-effectiveness studies of CRC screening strategies have found that the results are sensitive to the rate of adherence. The investigators study will provide critical information for providers and policymakers as they consider optimal strategies to increase CRC screening among vulnerable populations.

Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal occult blood testing (FOBT).

Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a 30-month period

Hypothesis 1: Compared to usual care, the intervention will increase the proportion of patients who complete a repeat annual FOBT within 6 months of their due date.

Hypothesis 2: Compared to usual care, the intervention will increase the proportion of patients who complete 2 additional FOBTs over the 30-month intervention period.

Aim 2: Explore perceived barriers to screening among patients who received the intervention but did not complete repeat FOBT testing within 18 months

Aim 3: Assess the costs of the intervention and the costs per additional repeat screening compared to patients who received usual care.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
August 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Baker

Chief, Division of General Internal Medicine

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Fecal occult blood test (FOBT) completed in the past year
  • Age 51-75
  • Preferred language English or Spanish

Exclusion Criteria

  • Any of the following: (1) Colonoscopy within 10 years (2) Flexible sigmoidoscopy within 5 years or (3) A clinician order or referral for FOBT prior to the due date
  • Documentation of medical conditions suggesting colorectal cancer (CRC) screening through FOBT may be inappropriate including: chronic diarrhea, inflammatory bowel disease, iron deficiency, previous colonic polyp, use of medications in the previous 1 month that elevate the risk of a false-positive FOBT

Outcomes

Primary Outcomes

Completion of a Fecal Occult Blood Test (FOBT)

Time Frame: within 6 months of randomization

This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.

Study Sites (1)

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