Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp
NCT ID: NCT00397969
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
800 participants
INTERVENTIONAL
2005-02-28
2008-06-30
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well a reminder letter from their doctor improves the frequency of colonoscopy in patients who have had a colorectal polyp removed.
Detailed Description
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* Determine whether rates of surveillance colonoscopy can be substantially increased by linking computerized data on endoscopic screening procedures to computerized pathology data to identify patients with prior adenomatous polyps who are due for repeat colonoscopy.
* Evaluate whether the impact of the intervention varies by patient characteristics, including age, sex, or site of primary care.
OUTLINE: This is a randomized, controlled, crossover study. Patients are stratified according to age (≤ 65 years of age vs \> 65 years of age), gender, time elapsed since last colonoscopy, and primary care physician's (PCP) membership in Harvard Vanguard Medical Associates (yes vs no). Patients are randomized to 1 of 2 arms.
* Arm I: PCPs are mailed response forms (regarding the disposition of their eligible patients \[e.g. patient letter mailed, patient called, scheduled for colonoscopy, colonoscopy completed elsewhere, patient refused procedure, clinical contraindication, patient deceased\]) and letters reminding them that their patients are due for a follow-up colonoscopy. PCPs who do not return response forms within 4 weeks are sent a second set of reminders and patient letters.
* Arm II: Six months after the beginning of the study, PCPs are mailed response forms and patient letters once. A second set of reminders and patient letters are not sent.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
Interventions
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counseling intervention
screening colonoscopy
Eligibility Criteria
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Inclusion Criteria
* Prior diagnosis of adenomatous polyp
* Underwent prior colonoscopy with polypectomy at Brigham and Women's Hospital
* Due for repeat colonoscopy according to current national guidelines of the American Gastroenterology Association (no colonoscopy within the past 5 years)
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Harvard Medical School (HMS and HSDM)
OTHER
Principal Investigators
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John Ayanian, MD, MPP
Role: STUDY_CHAIR
Harvard Medical School (HMS and HSDM)
Locations
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Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Harvard Medical School
Boston, Massachusetts, United States
Countries
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References
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Ayanian JZ, Sequist TD, Zaslavsky AM, Johannes RS. Physician reminders to promote surveillance colonoscopy for colorectal adenomas: a randomized controlled trial. J Gen Intern Med. 2008 Jun;23(6):762-7. doi: 10.1007/s11606-008-0576-2. Epub 2008 Apr 2.
Other Identifiers
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HMS-M11837-103
Identifier Type: -
Identifier Source: secondary_id
BWH-2005-P-000371/3
Identifier Type: -
Identifier Source: secondary_id
HPHC-1705
Identifier Type: -
Identifier Source: secondary_id
CDR0000492752
Identifier Type: -
Identifier Source: org_study_id