Improving Bowel Preparation for Colonoscopy With a Simple Educational Card
Primary Purpose
Colonic Polyps, Colonic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational card
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyps focused on measuring colonoscopy, bowel preparation, patient education, polyp detection
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
Sites / Locations
- Boston University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
Patients in this arm will be given the standard pre-endoscopy instructions.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00643682
Brief Title
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
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps, Colonic Neoplasms
Keywords
colonoscopy, bowel preparation, patient education, polyp detection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
Arm Title
B
Arm Type
No Intervention
Arm Description
Patients in this arm will be given the standard pre-endoscopy instructions.
Intervention Type
Other
Intervention Name(s)
Educational card
Intervention Description
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."
Primary Outcome Measure Information:
Title
Boston Bowel Preparation Scale Score
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Time to Advance Colonoscope From Anus to Tip of Cecum.
Description
time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.
Time Frame
2 years
Title
Time to Withdraw Colonoscope From Tip of Cecum to Anus.
Description
Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy
Time Frame
2 years
Title
Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian C Jacobson, MD, MPH
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21168840
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.
Results Reference
derived
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Improving Bowel Preparation for Colonoscopy With a Simple Educational Card
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