Clinical trial NCT00643682: Improving Bowel Preparation for Colonoscopy With a Simple Educational Card
Official title: Improving Bowel Preparation for Colonoscopy With a Simple Educational Card
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Colonic Neoplasms
Keywords: colonoscopy
bowel preparation
patient education
polyp detection
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether adding a simple educational card to standard pre-procedure instructions improves the quality of bowel preparation for colonoscopy.

Detailed description: Despite written instructions, many patients do not understand the importance of bowel preparation as they prepare for colonoscopy. This often leads to poor compliance with preparation protocol and therefore inadequate bowel preparation. Our goal is to include a simple educational card which will hopefully improve the quality of bowel preparation by providing a visual component with the preparation instructions. This card will stress the importance of drinking the entire bowel preparation and provide representative images of a dirty and clean colon. We will specifically target patients directly booked for screening colonoscopy (those without a pre-procedure office visit). In a randomized fashion, patients in the control group will receive the standard bowel preparation instructions and patients in the intervention group will receive the educational card along with the standard bowel preparation instructions. The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale. Secondary outcomes will include the number and types of polyps found, colonoscope insertion and withdrawal time, and patient satisfaction with the procedure.

Eligibility criteria: Inclusion Criteria:

* Outpatients
* 18 years old or older
* Referred and scheduled for an elective screening colonoscopy

Exclusion Criteria:

* Inpatients
* Prisoners
* Cognitively impaired patients
* Legally blind patients
* Patients allergic to polyethylene glycol electrolyte lavage solution

Primary outcomes:
measure: Boston Bowel Preparation Scale Score
timeFrame: 2 years
Secondary outcomes:
measure: Time to Advance Colonoscope From Anus to Tip of Cecum.
timeFrame: 2 years
measure: Time to Withdraw Colonoscope From Tip of Cecum to Anus.
timeFrame: 2 years
measure: Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Brian C Jacobson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calderwood AH, Lai EJ, Fix OK, Jacobson BC. An endoscopist-blinded, randomized, controlled trial of a simple visual aid to improve bowel preparation for screening colonoscopy. Gastrointest Endosc. 2011 Feb;73(2):307-14. doi: 10.1016/j.gie.2010.10.013. Epub 2010 Dec 18.