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Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
internet-based intervention
evaluation of cancer risk factors
fecal occult blood test
screening colonoscopy
Sponsored by
Harvard University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Harvard Medical SchoolRecruiting
  • Harvard Vanguard Medical Associates - KenmoreRecruiting

Outcomes

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

Full Information

First Posted
December 13, 2009
Last Updated
December 17, 2013
Sponsor
Harvard University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01032746
Brief Title
Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer
Official Title
Use of a Personal Health Record to Improve Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Harvard University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Type
Other
Intervention Name(s)
internet-based intervention
Intervention Type
Procedure
Intervention Name(s)
evaluation of cancer risk factors
Intervention Type
Procedure
Intervention Name(s)
fecal occult blood test
Intervention Type
Procedure
Intervention Name(s)
screening colonoscopy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of participants who access the web-based risk-assessment tool
Title
Distribution of risk-status among participants who complete the web-based risk-assessment tool

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Ayanian, MD, MPP
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Study Chair
Facility Information:
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Ayanian, MD, MPP
Phone
617-432-3455
Facility Name
Harvard Vanguard Medical Associates - Kenmore
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas D. Sequist, MD, MPH
Phone
617-432-3447
Email
tsequist@partners.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
21149743
Citation
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.
Results Reference
result

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Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer

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