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Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Jacobson, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00643682
First received: March 20, 2008
Last updated: August 29, 2012
Last verified: August 2012
History of Changes

March 20, 2008
August 29, 2012
February 2006
June 2008   (final data collection date for primary outcome measure)
Boston Bowel Preparation Scale Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
Quality of the bowel preparation will be assessed by the endoscopist immediately after the procedure using a standardized bowel preparation scale from 0 (unprepared colon) to 9 (clean). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00643682 on ClinicalTrials.gov Archive Site
  • Time to Advance Colonoscope From Anus to Tip of Cecum. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.
  • Time to Withdraw Colonoscope From Tip of Cecum to Anus. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy
  • Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
  • Number, location, and size of polyps detected during the colonoscopy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to advance colonoscope from anus to tip of cecum. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to withdraw colonoscope from tip of cecum to anus. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Subjects' symptoms and tolerance of the preparation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of repeat procedures recommended due to inadequate bowel preparation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Identification of risk factors for having a poor bowel preparation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Identification of risk factors for not presenting for colonoscopy (despite being scheduled for one). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Evaluation of the effect on bowel cleanliness of a small change in bowel preparation methods made at Boston Medical Center and instituted halfway through the current protocol. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Evaluation of whether colonoscope withdrawal times have lengthened following a well-publicized study in the New England Journal of Medicine that found improved polyp detection with slower withdrawal times. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Improving Bowel Preparation for Colonoscopy With a Simple Educational Card
Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Colonic Polyps
  • Colonic Neoplasms
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."
  • Experimental: A
    Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
    Intervention: Other: Educational card
  • No Intervention: B
    Patients in this arm will be given the standard pre-endoscopy instructions.
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. Epub 2010 Dec 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
October 2009
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00643682
BMC-GI-1
No
Brian Jacobson, Boston Medical Center
Boston Medical Center
Not Provided
Principal Investigator: Brian C Jacobson, MD, MPH Boston University
Boston Medical Center
August 2012

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