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

December 18, 2013 updated by: Harvard Medical School (HMS and HSDM)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

21860

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Harvard Vanguard Medical Associates - Kenmore
      • Boston, Massachusetts, United States, 02115
        • Harvard Medical School
      • Boston, Massachusetts, United States, 02215
        • Harvard Pilgrim Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of colorectal cancer screening

Secondary Outcome Measures

Outcome Measure
Number of patients with adenomatous polyps and colon cancer diagnosed
Number of stool cards returned and abnormal stool cards
Number and dates of sigmoidoscopies and colonoscopies scheduled and performed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Medical School (HMS and HSDM)

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: John Ayanian, MD, MPP, Harvard Medical School (HMS and HSDM)
  • Robert H. Fletcher, MD, Harvard Pilgrim Health Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000486405
  • HMS-M11960-103
  • HCHP-1305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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