NCT01032746

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Last Updated

December 18, 2013

Status Verified

June 1, 2011

Enrollment Period

5.5 years

First QC Date

December 13, 2009

Last Update Submit

December 17, 2013

Conditions

Keywords

colon cancerrectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Interventions

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Harvard Medical School

Boston, Massachusetts, 02115, United States

RECRUITING

Harvard Vanguard Medical Associates - Kenmore

Boston, Massachusetts, 02215, United States

RECRUITING

Related 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.

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Early Intervention, EducationalOccult Blood

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • John Ayanian, MD, MPP

    Harvard Medical School (HMS and HSDM)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SCREENING
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2009

First Posted

December 15, 2009

Study Start

March 1, 2005

Primary Completion

September 1, 2010

Last Updated

December 18, 2013

Record last verified: 2011-06

Locations