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A Randomized Controlled Trial of a Direct-to-Patient Outreach Program to Improve Rates of Colorectal Cancer Screening in a Low Income and Racially Diverse Population


N/A
50 Years
80 Years
Not Enrolling
Both
Colorectal Cancer Screening

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Trial Information

A Randomized Controlled Trial of a Direct-to-Patient Outreach Program to Improve Rates of Colorectal Cancer Screening in a Low Income and Racially Diverse Population


Patients ages 50 to 80 who are identified through the electronic health record as not being
up to date on colorectal cancer screening are eligible for the study and will be randomly
assigned to the intervention or usual care group. Individuals in the intervention group
will be mailed a letter informing them that they are due for colorectal cancer screening,
educational material regarding colorectal cancer screening, a fecal occult blood testing
(FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients
assigned to the intervention versus usual care groups who complete a guideline recommended
form of colorectal cancer screening within 4 months of the initiation of outreach will be
compared.


Inclusion Criteria:



- Ages 50 to 80

- No documented fecal occult blood testing (FOBT) within 1 year, sigmoidoscopy within 5
years, or colonoscopy within 10 years (as of 12/31/2009)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

completion of a colorectal cancer screening

Outcome Description:

Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)

Outcome Time Frame:

within 4 months of the initiation of outreach (by June 30, 2010)

Safety Issue:

No

Principal Investigator

Bechara N Choucair, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University, Feinberg School of Medicine, Department of Family and Community Medicine

Authority:

United States: Institutional Review Board

Study ID:

STU00015652

NCT ID:

NCT01385579

Start Date:

January 2010

Completion Date:

June 2010

Related Keywords:

  • Colorectal Cancer Screening
  • colorectal cancer screening
  • fecal occult blood testing (FOBT)
  • vulnerable populations
  • community health center
  • Colorectal Neoplasms

Name

Location

Heartland International Health CenterChicago, Illinois  60645