Personal Electronic Health Records in Improving Screening Rates for Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of a Personal Health Record to Improve Colorectal Cancer Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: educational intervention
* Other: internet-based intervention
* Procedure: evaluation of cancer risk factors
* Procedure: fecal occult blood test
* Procedure: screening colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: educational intervention|nan|
|Other: internet-based intervention|nan|
|Procedure: evaluation of cancer risk factors|nan|
|Procedure: fecal occult blood test|nan|
|Procedure: screening colonoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer