Improving Rates of Colorectal Cancer Screening Among Never Screened Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Baker, Northwestern University
ClinicalTrials.gov Identifier:
NCT01742169
First received: December 3, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Colorectal Neoplasms
Behavioral: Outreach and Reminder Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Completion of fecal occult blood test (FOBT) [ Time Frame: Within 6 months of randomization to the intervention or control group ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 420
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742169

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
  More Information

No publications provided

Responsible Party: David Baker, Chief, Division of General Internal Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01742169     History of Changes
Other Study ID Numbers: 1P01HS021141-01-Project1B
Study First Received: December 3, 2012
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Colorectal Cancer Screening
Fecal Occult Blood Testing

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014