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Improving Rates of Colorectal Cancer Screening Among Never Screened Patients

Northwestern University logo

Northwestern University

Status

Completed

Conditions

Colorectal Neoplasms

Treatments

Behavioral: Outreach and Reminder Intervention

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01742169
1P01HS021141-01 (U.S. NIH Grant/Contract)
1P01HS021141-01-Project1B

Details and patient eligibility

About

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.

Enrollment

420 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

420 participants in 2 patient groups

Outreach and Reminder Intervention
Experimental group
Description:
Participants randomized to this arm will receive the Outreach and Reminder intervention.
Treatment:
Behavioral: Outreach and Reminder Intervention
Usual Care
No Intervention group
Description:
Patients assigned to this arm will receive usual care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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