Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00397969
First received: November 9, 2006
Last updated: February 1, 2010
Last verified: December 2006

November 9, 2006
February 1, 2010
February 2005
Not Provided
  • Successful completion of follow-up colonoscopy [ Designated as safety issue: No ]
  • Number of patients completing colonoscopy during the study period [ Designated as safety issue: No ]
  • Successful completion of follow-up colonoscopy
  • Number of patients completing colonoscopy during the study period
Complete list of historical versions of study NCT00397969 on ClinicalTrials.gov Archive Site
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Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp
Improving Surveillance for Colorectal Polyps

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.

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.

Interventional
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Allocation: Randomized
  • Colorectal Cancer
  • Precancerous Condition
  • Other: counseling intervention
  • Procedure: screening colonoscopy
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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. Epub 2008 Apr 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
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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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00397969
CDR0000492752, HMS-M11837-103, BWH-2005-P-000371/3, HPHC-1705
Not Provided
Not Provided
Harvard University
National Cancer Institute (NCI)
Study Chair: John Ayanian, MD, MPP Harvard Medical School
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP