Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population

Not Applicable

Completed

• Conditions: Malignant Neoplasm of Large Intestine
• Interventions: Other: Care manager outreach

• Registration Number: NCT01385579
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Status Verified: 2013-11
• Results First Submitted: 2013-11-18
• Results First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Results First Posted: 2014-01-06
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Ages 50 to 80 as of 12/31/2009 At least 2 visits to the community health center between 7/1/2008 and 12/31/2009

Exclusion criteria:

Documented fecal occult blood testing (FOBT) within 1 year (between 1/1/2009 and 12/31/2009) Documented sigmoidoscopy within 5 years (between 1/1/2005 and 12/31/2009) Documented colonoscopy within 10 years (between 1/1/2000 and 12/31/2009)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care manager outreach	Care manager outreach	Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit

Primary Outcome Measures

Name	Time	Method
Completion of a Colorectal Cancer Screening	within 4 months of the initiation of outreach (by June 30, 2010)	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)

Trial Locations

Locations (1)

Heartland International Health Center; 🇺🇸 Chicago, Illinois, United States