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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00355004
Enrollment
21860
Registered
2006-07-20
Start date
2005-03-31
Completion date
2009-02-28
Last updated
2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colon cancer, rectal cancer

Brief 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.

Interventions

OTHERcounseling intervention
PROCEDUREscreening colonoscopy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Harvard Medical School (HMS and HSDM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
SCREENING

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

DISEASE CHARACTERISTICS: * Receiving primary care at 1 of 11 participating Harvard Vanguard Medical Associates (HVMA) centers * Has an active primary care physician * Had a primary care visit within the past 18 months * Is due for colorectal cancer screening PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

MeasureTime frame
Rate of colorectal cancer screening

Secondary

MeasureTime frame
Number of patients with adenomatous polyps and colon cancer diagnosed
Number of stool cards returned and abnormal stool cards
Number and dates of sigmoidoscopies and colonoscopies scheduled and performed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026