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

NCT ID: NCT00355004

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21860 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2009-02-28

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.

Conditions

Colorectal Cancer

Keywords

colon cancer; rectal cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SCREENING

Interventions

counseling intervention

Intervention Type: OTHER

fecal occult blood test

Intervention Type: PROCEDURE

screening colonoscopy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: lead

Principal Investigators

John Ayanian, MD, MPP

Role: STUDY_CHAIR

Harvard Medical School (HMS and HSDM)

Robert H. Fletcher, MD

Role:

Harvard Pilgrim Health Care

Locations

Harvard Medical School

Boston, Massachusetts, United States

Harvard Pilgrim Health Care

Boston, Massachusetts, United States

Harvard Vanguard Medical Associates - Kenmore

Boston, Massachusetts, United States

Countries

United States

References

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. doi: 10.1001/archinternmed.2008.564.

Reference Type: RESULT

PMID: 19237720 (View on PubMed)

Other Identifiers

HMS-M11960-103

Identifier Type: -

Identifier Source: secondary_id

HCHP-1305

Identifier Type: -

Identifier Source: secondary_id

CDR0000486405

Identifier Type: -

Identifier Source: org_study_id