Improving Rates of Colorectal Cancer Screening Among Never Screened Patients

NCT01742169 | Completed DMC

• 2 other identifiers: 1P01HS021141-01-Project1B1P01HS021141-01
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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

Keywords

Colorectal Cancer Screening; Fecal Occult Blood Testing

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 6 months of randomization to the intervention or control group

Study Arms (2)

Outreach and Reminder Intervention

EXPERIMENTAL

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

Behavioral: Outreach and Reminder Intervention

Usual Care

NO INTERVENTION

Patients assigned to this arm will receive usual care.

Interventions

Outreach and Reminder Intervention 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.

Outreach and Reminder Intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 to 75
• No documentation of previous CRC screening (FOBT, flexible sigmoidoscopy, or colonoscopy)
• Preferred language English or Spanish
• visits to Erie Family Health Center in the past 2 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of General Internal Medicine

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 7, 2015

Record last verified: 2015-01

Locations

US (1)