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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Systems for Colorectal Cancer Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: counseling intervention
* Procedure: fecal occult blood test
* Procedure: screening colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: counseling intervention|nan|
|Procedure: fecal occult blood test|nan|
|Procedure: screening colonoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of colorectal cancer screening |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer