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Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

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ClinicalTrials.gov Identifier: NCT00643682
Recruitment Status : Completed
First Posted : March 26, 2008
Results First Posted : October 1, 2012
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Brian Jacobson, Boston Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Colonic Neoplasms Other: Educational card Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Bowel Preparation for Colonoscopy With a Simple Educational Card
Study Start Date : February 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
 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."
No Intervention: B
Patients in this arm will be given the standard pre-endoscopy instructions.


Outcome Measures
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Primary Outcome Measures :
  1. Boston Bowel Preparation Scale Score [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. Time to Advance Colonoscope From Anus to Tip of Cecum. [ Time Frame: 2 years ]
    time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.

  2. Time to Withdraw Colonoscope From Tip of Cecum to Anus. [ Time Frame: 2 years ]
    Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy

  3. Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation. [ Time Frame: 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643682


Locations
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United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Brian C Jacobson, MD, MPH Boston University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Brian Jacobson, Associate Professor of Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00643682    
Other Study ID Numbers: BMC-GI-1
First Posted: March 26, 2008    Key Record Dates
Results First Posted: October 1, 2012
Last Update Posted: October 1, 2012
Last Verified: August 2012
Keywords provided by Brian Jacobson, Boston Medical Center:
colonoscopy
bowel preparation
patient education
polyp detection
Additional relevant MeSH terms:
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Colonic Neoplasms
Colonic Polyps
Polyps
Pathological Conditions, Anatomical
Intestinal Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases