Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer

Use of a Personal Health Record to Improve Colorectal Cancer Screening

RATIONALE: Use of a web-based risk assessment tool may help improve screening rates for colorectal cancer.

PURPOSE: This randomized clinical trial is studying personal electronic health records to see how well they work in improving screening rates for colorectal cancer.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: fecal occult blood test; Procedure: screening colonoscopy; Procedure: evaluation of cancer risk factors; Other: educational intervention; Other: internet-based intervention

Detailed Description

OBJECTIVES:

• To assess whether screening rates for colorectal cancer (CRC) can be substantially increased among adults in primary care through the use of a personal electronic health record that provides a link to a validated web-based tool to estimate an individual's risk of CRC and electronic scheduling of CRC screening exams.

OUTLINE: This is a multicenter study. Participants are stratified according to participating Harvard Vanguard Medical Associates (HVMA) center. Participants are randomized to 1 of 2 arms.

• Intervention arm: Participants receive an electronic message within their MyHealth account on behalf of their primary care physician providing a link to a web-based tool to allow them to assess their personal risk of colorectal cancer (CRC). The tool provides an estimate of an individual's personal risk of developing different types of cancer over the next 10 years relative to others of the same age and sex. The tool also recommends steps that individuals can take to reduce their risk. The tool includes questions about family history; prior screening tests; dietary habits (red meat, fruits, and vegetables); weight and height; and use of folate, aspirin, estrogen therapy, alcohol, and tobacco. In addition, the electronic message provides information regarding options for CRC screening, emphasizing colonoscopy every 10 years per the current HVMA guidelines, followed by the secondary recommendation of annual fecal occult blood testing. Detailed information is provided in the form of a link to online educational materials. Participants may request either colonoscopy or fecal occult blood testing by responding to the electronic message and indicating their preference. Participants who request colonoscopy are contacted by the gastroenterology department to proceed with CRC screening; participants who request fecal occult blood testing will receive a stool card test kit in the mail from their primary care physician.
• Control arm: Participants receive no intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Harvard Medical School
      • Contact: John Ayanian, MD, MPP; Phone Number: 617-432-3455
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Harvard Vanguard Medical Associates - Kenmore
      • Contact: Thomas D. Sequist, MD, MPH; Phone Number: 617-432-3447; Email: tsequist@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Overdue for colorectal cancer screening (identified using automated extracts from the electronic medical record), as defined by the following criteria:

  • No fecal occult blood test within the past 12 months
  • No flexible sigmoidoscopy within the past 5 years
  • No colonoscopy within the past 10 years
• Receiving primary care at a Harvard Vanguard Medical Associates (HVMA) center
• Registered to use the HVMA patient portal (MyHealth) AND has an active MyHealth account

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Receipt of colorectal cancer screening exam (fecal occult blood test, flexible sigmoidoscopy, or colonoscopy) within 4 months following delivery of an electronic message within the personal health record

Secondary Outcome Measures

Outcome Measure
Proportion of participants who access the web-based risk-assessment tool
Distribution of risk-status among participants who complete the web-based risk-assessment tool

Collaborators and Investigators

• Sponsor: Harvard University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: John Ayanian, MD, MPP, Harvard Medical School (HMS and HSDM)

Publications and helpful links

General Publications

• Sequist TD, Zaslavsky AM, Colditz GA, Ayanian JZ. Electronic patient messages to promote colorectal cancer screening: a randomized controlled trial. Arch Intern Med. 2011 Apr 11;171(7):636-41. doi: 10.1001/archinternmed.2010.467. Epub 2010 Dec 13.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Anticipated): September 1, 2010

Study Registration Dates

• First Submitted: December 13, 2009
• First Submitted That Met QC Criteria: December 13, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDR0000661288; HMS-11960