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

December 3, 2012
December 5, 2012
January 7, 2015
January 2013
April 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01742169 on Archive Site
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Improving Rates of Colorectal Cancer Screening Among Never Screened Patients
Center for Advancing Equity in Clinical Preventive Services Project 1B: Improving Rates of Colorectal Cancer Screening Among Never Screened Patients

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.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Colorectal Neoplasms
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.
  • Experimental: Outreach and Reminder Intervention
    Participants randomized to this arm will receive the Outreach and Reminder intervention.
    Intervention: Behavioral: Outreach and Reminder Intervention
  • No Intervention: Usual Care
    Patients assigned to this arm will receive usual care.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2014
April 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
50 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1P01HS021141-01 ( U.S. NIH Grant/Contract )
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David Baker, Northwestern University
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
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Northwestern University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP