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

Colorectal Cancer Clinical Trial

Official title:

Improving Systems for Colorectal Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355004
• Other study ID #: CDR0000486405
• Secondary ID: HMS-M11960-103HC
• Status: Completed
• Phase: N/A
• First received: July 19, 2006
• Last updated: December 18, 2013
• Start date: March 2005
• Est. completion date: February 2009

Study information

• Verified date: January 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21860
• Est. completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• counseling intervention

Procedure:
• fecal occult blood test

• screening colonoscopy

Locations

Country	Name	City	State
United States	Harvard Medical School	Boston	Massachusetts
United States	Harvard Pilgrim Health Care	Boston	Massachusetts
United States	Harvard Vanguard Medical Associates - Kenmore	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Medical School	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of colorectal cancer screening			No
Secondary	Number of patients with adenomatous polyps and colon cancer diagnosed			No
Secondary	Number of stool cards returned and abnormal stool cards			No
Secondary	Number and dates of sigmoidoscopies and colonoscopies scheduled and performed			No