Improving Rates of Colorectal Cancer Screening Among Never Screened Patients
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|ClinicalTrials.gov Identifier: NCT01742169|
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : January 7, 2015
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 or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Behavioral: Outreach and Reminder Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Center for Advancing Equity in Clinical Preventive Services Project 1B: Improving Rates of Colorectal Cancer Screening Among Never Screened Patients|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||June 2014|
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.
- Completion of fecal occult blood test (FOBT) [ Time Frame: Within 6 months of randomization to the intervention or control group ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742169
|United States, Illinois|
|Chicago, Illinois, United States, 60611|