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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355004
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: counseling intervention Procedure: fecal occult blood test Procedure: screening colonoscopy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21860 participants
Allocation: Randomized
Primary Purpose: Screening
Official Title: Improving Systems for Colorectal Cancer Screening
Study Start Date : March 2005
Actual Study Completion Date : February 2009
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Rate of colorectal cancer screening

Secondary Outcome Measures :
  1. Number of patients with adenomatous polyps and colon cancer diagnosed
  2. Number of stool cards returned and abnormal stool cards
  3. Number and dates of sigmoidoscopies and colonoscopies scheduled and performed

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00355004


Locations
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United States, Massachusetts
Harvard Medical School
Boston, Massachusetts, United States, 02115
Harvard Pilgrim Health Care
Boston, Massachusetts, United States, 02215
Harvard Vanguard Medical Associates - Kenmore
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Harvard Medical School (HMS and HSDM)
National Cancer Institute (NCI)
Investigators
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Study Chair: John Ayanian, MD, MPP Harvard Medical School (HMS and HSDM)
OverallOfficial: Robert H. Fletcher, MD Harvard Pilgrim Health Care
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00355004    
Other Study ID Numbers: CDR0000486405
HMS-M11960-103
HCHP-1305
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: January 2007
Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases