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Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01032746

First Posted: December 15, 2009

Last Update Posted: December 18, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

Purpose

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.

Condition	Intervention
Colorectal Cancer	Other: educational intervention Other: internet-based intervention Procedure: evaluation of cancer risk factors Procedure: fecal occult blood test Procedure: screening colonoscopy


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Screening
Official Title:	Use of a Personal Health Record to Improve Colorectal Cancer Screening

Resource links provided by NLM:

MedlinePlus related topics: Colorectal Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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:

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


Estimated Enrollment:	1000
Study Start Date:	March 2005
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	50 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032746

Locations


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

Sponsors and Collaborators

Harvard University

National Cancer Institute (NCI)

Investigators


Study Chair:	John Ayanian, MD, MPP	Harvard Medical School

More Information

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.


Responsible Party:	John Ayanian, Harvard Medical School
ClinicalTrials.gov Identifier:	NCT01032746 History of Changes
Other Study ID Numbers:	CDR0000661288 HMS-11960
First Submitted:	December 13, 2009
First Posted:	December 15, 2009
Last Update Posted:	December 18, 2013
Last Verified:	June 2011

Keywords provided by National Cancer Institute (NCI):


colon cancer rectal cancer

Additional relevant MeSH terms:


Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases

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