Improving Rates of Colorectal Cancer Screening Among Never Screened Patients

NCT ID: NCT01742169

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Outreach and Reminder Intervention

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

Group Type: EXPERIMENTAL

Outreach and Reminder Intervention

Intervention Type: BEHAVIORAL

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.

Usual Care

Patients assigned to this arm will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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:

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David Baker

Chief, Division of General Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

1P01HS021141-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1P01HS021141-01-Project1B

Identifier Type: -

Identifier Source: org_study_id