Clinical trial NCT00397969: Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp
Official title: Improving Surveillance for Colorectal Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Precancerous Condition
Keywords: colon cancer
rectal cancer
precancerous condition
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-10
Enrollment: 800
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful completion of follow-up colonoscopy
measure: Number of patients completing colonoscopy during the study period
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: John Ayanian, MD, MPP
role: STUDY_CHAIR
References:
citation: 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.