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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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00355004
First received: July 19, 2006
Last updated: December 18, 2013
Last verified: January 2007

July 19, 2006
December 18, 2013
March 2005
Not Provided
Rate of colorectal cancer screening [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00355004 on ClinicalTrials.gov Archive Site
  • Number of patients with adenomatous polyps and colon cancer diagnosed [ Designated as safety issue: No ]
  • Number of stool cards returned and abnormal stool cards [ Designated as safety issue: No ]
  • Number and dates of sigmoidoscopies and colonoscopies scheduled and performed [ Designated as safety issue: No ]
Not Provided
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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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Screening
Colorectal Cancer
  • Other: counseling intervention
  • Procedure: fecal occult blood test
  • Procedure: screening colonoscopy
Not Provided
Sequist TD, Zaslavsky AM, Marshall R, Fletcher RH, Ayanian JZ. Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. Arch Intern Med. 2009 Feb 23;169(4):364-71.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21860
February 2009
Not Provided

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
Both
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00355004
CDR0000486405, HMS-M11960-103, HCHP-1305
Not Provided
Not Provided
Harvard Medical School
National Cancer Institute (NCI)
Study Chair: John Ayanian, MD, MPP Harvard Medical School
Investigator: Robert H. Fletcher, MD Harvard Pilgrim Health Care
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP