Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

Colonic Neoplasms Clinical Trial

Official title:

Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643682
• Other study ID #: BMC-GI-1
• Status: Completed
• Phase: N/A
• First received: March 20, 2008
• Last updated: August 29, 2012
• Start date: February 2006
• Est. completion date: October 2009

Study information

• Verified date: August 2012
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: October 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colonic Polyps

Intervention

Other:
• Educational card
A 4x6 inch educational card containing a photo of an unprepared colon and a clean colon with the caption: "Drinking all the bowel cleaning medicine as described in the enclosed instructions lets the doctor see your colon better during your colonoscopy."

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Scale Score	An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922	2 years	No
Secondary	Time to Advance Colonoscope From Anus to Tip of Cecum.	time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.	2 years	No
Secondary	Time to Withdraw Colonoscope From Tip of Cecum to Anus.	Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy	2 years	No
Secondary	Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.	The number of times a colonoscopist recommended that the bowel was too unclean to qualify as an acceptable colonoscopy and therefore recommended repeating the procedure after better cleansing. This is both the number of participants with an inadequate preparation and the number of inadequate procedures. These are synonymous.	2 years	No