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Improving Rates of Colorectal Cancer Screening Among Never Screened Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742169
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : January 7, 2015
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
David Baker, Northwestern University

Brief Summary:

The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC) screening using fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy, beginning at age 50 and continuing until age 75. Despite this recommendation, rates of CRC screening remain inadequate and large disparities exist. Screening rates are lower among Black and Hispanic populations, in areas with high poverty rates, among individuals with low education, and for those who utilize Medicaid or lack health insurance. This study will determine the effectiveness of a multifaceted intervention to increase the number of patients who have never been screened for CRC and are cared for at a community health center (CHC) that complete a fecal immunochemical test (FIT) within 6 months of randomization to an intervention group compared to patients in a usual care group. We believe that the proposed intervention will improve the CRC screening rate in a cost-effective and sustainable way, ultimately leading to a reduction in the high rate of CRC.

Aim 1: To conduct a randomized controlled trial to determine if a multifaceted intervention increases the proportion of patients who complete a FOBT within 6-months of randomization.

Hypothesis 1: Compared to usual care, the intervention will increase the proportion of never-screened patients who complete FOBT within 6 months of randomization.

Aim 2: Assess the costs of the intervention and the costs per additional initial screening compared to patients who receive usual care.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: Outreach and Reminder Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Center for Advancing Equity in Clinical Preventive Services Project 1B: Improving Rates of Colorectal Cancer Screening Among Never Screened Patients
Study Start Date : January 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Outreach and Reminder Intervention
Participants randomized to this arm will receive the Outreach and Reminder intervention.
Behavioral: Outreach and Reminder Intervention
This intervention includes (1) phone calls and text messages to inform participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.

No Intervention: Usual Care
Patients assigned to this arm will receive usual care.

Primary Outcome Measures :
  1. Completion of fecal occult blood test (FOBT) [ Time Frame: Within 6 months of randomization to the intervention or control group ]
    This outcome will be assessed by querying the electronic health record (EHR) for all intervention and control patients to determine if an FOBT screening test was completed the community health center or documentation in the EHR that screening was completed elsewhere.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 50 to 75
  • No documentation of previous CRC screening (FOBT, flexible sigmoidoscopy, or colonoscopy)
  • Preferred language English or Spanish
  • 2 visits to Erie Family Health Center in the past 2 years

Exclusion Criteria:

  • Any of the following:

    1. colonoscopy within 10 years
    2. flexible sigmoidoscopy within 5 years
    3. a clinician order or referral for FOBT prior to the due date (indicating concern for gastrointestinal bleeding)
    4. medical conditions suggesting 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 (i.e., plavix or warfarin), and medical conditions that make CRC screening inappropriate (metastatic cancer or previous total colectomy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01742169

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
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Responsible Party: David Baker, Chief, Division of General Internal Medicine, Northwestern University Identifier: NCT01742169    
Other Study ID Numbers: 1P01HS021141-01-Project1B
1P01HS021141-01 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015
Keywords provided by David Baker, Northwestern University:
Colorectal Cancer Screening
Fecal Occult Blood Testing
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases