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Improving Rates of Colorectal Cancer Screening Among Never Screened Patients

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outreach and Reminder Intervention
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms focused on measuring Colorectal Cancer Screening, Fecal Occult Blood Testing

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Outreach and Reminder Intervention

Usual Care

Arm Description

Participants randomized to this arm will receive the Outreach and Reminder intervention.

Patients assigned to this arm will receive usual care.

Outcomes

Primary Outcome Measures

Completion of fecal occult blood test (FOBT)
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.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2012
Last Updated
January 6, 2015
Sponsor
Northwestern University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01742169
Brief Title
Improving Rates of Colorectal Cancer Screening Among Never Screened Patients
Official Title
Center for Advancing Equity in Clinical Preventive Services Project 1B: Improving Rates of Colorectal Cancer Screening Among Never Screened Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colorectal Cancer Screening, Fecal Occult Blood Testing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outreach and Reminder Intervention
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive the Outreach and Reminder intervention.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients assigned to this arm will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Outreach and Reminder Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of fecal occult blood test (FOBT)
Description
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.
Time Frame
Within 6 months of randomization to the intervention or control group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: colonoscopy within 10 years flexible sigmoidoscopy within 5 years a clinician order or referral for FOBT prior to the due date (indicating concern for gastrointestinal bleeding) 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)
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Improving Rates of Colorectal Cancer Screening Among Never Screened Patients

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