Clinical Trials Directory

Trials / Completed

CompletedNCT00355004

Computerized and Mailed Reminders in Increasing the Rate of Colorectal Cancer Screening in Adults With an Average Risk for Colorectal Cancer

Improving Systems for Colorectal Cancer Screening

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21,860 (estimated)
Sponsor
Harvard Medical School (HMS and HSDM) · Academic / Other
Sex
All
Age
50 Years – 80 Years
Healthy volunteers
Accepted

Summary

RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to treat. Computerized and mailed reminders may help increase the rate of colorectal cancer screening in adults with an average risk for colorectal cancer. PURPOSE: This randomized clinical trial is studying how well computerized and mailed reminders work in increasing the rate of colorectal cancer screening in adults with an average risk for colorectal cancer.

Detailed description

OBJECTIVES: Primary * Determine whether rates of colorectal cancer (CRC) screening can be increased among average-risk adults by using patient-specific, active, electronic, clinical reminders for primary care physicians during office visits and mailed reminders and fecal occult blood test cards for patients. Secondary * Calculate baseline rates of CRC screening, in terms of patient demographic characteristics, primary care physician, and practice group, by using computerized clinical information systems to identify patients due for screening. * Assess baseline rates of CRC screening among patients insured by different health plans. * Determine whether the impact of the interventions is related to efforts by health plans to promote CRC screening. * Evaluate patients' willingness to use a validated web-based tool to estimate their personal risk of CRC. OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 arms (arms I or III). Physicians are randomized to 1 of 2 arms (arms II or IV). * Arm I: Patients receive mailed reminders for colorectal cancer (CRC) screening. Patients also receive fecal occult blood testing (FOBT) instructions and cards. Patients who remain overdue for screening at 6 months after the initial mailing receive a follow-up letter reminding them of their need to be screened. Patients who return positive FOBT cards undergo colonoscopy within 1 month. The patient's primary care physician may receive computerized screening reminders at the time of the patient's office visit and may order CRC screening tests online. * Arm II: Patients receive no mailings. The patient's primary care physician may receive computerized screening reminders at the time of the patient's office visit and may order CRC screening tests online. * Arm III: Patients receive mailed reminders for CRC screening. The patient's primary care physician may order CRC screening tests online, but will not receive active computerized reminders. Patients also receive FOBT instructions and cards. Patients who remain overdue for screening at 6 months after the initial mailing receive a follow-up letter reminding them of their need to be screened. Patients who return positive FOBT cards will be scheduled to undergo colonoscopy within 1 month. * Arm IV: Patients receive no mailings. The patient's primary care physician may order CRC screening tests online, but will not receive active computerized reminders. Patients are followed for 15 months to determine screening rates. PROJECTED ACCRUAL: A total of 21,860 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
OTHERcounseling intervention
PROCEDUREfecal occult blood test
PROCEDUREscreening colonoscopy

Timeline

Start date
2005-03-01
Completion
2009-02-01
First posted
2006-07-20
Last updated
2013-12-19

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00355004. Inclusion in this directory is not an endorsement.