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
  Purpose

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 Intervention
Colorectal Cancer
Other: counseling intervention
Procedure: fecal occult blood test
Procedure: screening colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Screening
Official Title: Improving Systems for Colorectal Cancer Screening

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of colorectal cancer screening [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 21860
Study Start Date: March 2005
Study Completion Date: February 2009
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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355004

Locations
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
Investigators
Study Chair: John Ayanian, MD, MPP Harvard Medical School
Investigator: Robert H. Fletcher, MD Harvard Pilgrim Health Care
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00355004     History of Changes
Other Study ID Numbers: CDR0000486405, HMS-M11960-103, HCHP-1305
Study First Received: July 19, 2006
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 16, 2014