Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Use of a Personal Health Record to Improve Colorectal Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01032746
• Other study ID #: CDR0000661288
• Secondary ID: HMS-11960
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2009
• Last updated: December 17, 2013
• Start date: March 2005

Study information

• Verified date: June 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• educational intervention

• internet-based intervention

Procedure:
• evaluation of cancer risk factors

• fecal occult blood test

• screening colonoscopy

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Harvard University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	Proportion of participants who access the web-based risk-assessment tool			No
Secondary	Distribution of risk-status among participants who complete the web-based risk-assessment tool			No