NCT Number: NCT00397969
Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp
RATIONALE: Receiving a reminder letter from their doctor may increase the frequency of colonoscopy in patients who have had a colorectal polyp removed.
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.
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Notify MeKey information
Conditions
Age range
21 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, United States
About this study
OBJECTIVES:
- 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- 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
Treatment and study plan
screening colonoscopy
ProcedurePrimary outcomes
-
Successful completion of follow-up colonoscopy
-
Number of patients completing colonoscopy during the study period
Sponsors and collaborators
Lead sponsor
Harvard Medical School (HMS and HSDM)
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Improving Surveillance for Colorectal Polyps
Important dates
- Study start
- 2005
- Study completion
- 2008
- First posted
- Nov 10, 2006
- Registry last updated
- Dec 19, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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