Improving Bowel Preparation for Colonoscopy With a Simple Educational Card
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Purpose
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 | Intervention |
|---|---|
|
Colonic Polyps Colonic Neoplasms |
Other: Educational card |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Improving Bowel Preparation for Colonoscopy With a Simple Educational Card |
- 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
- 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.
| Enrollment: | 2000 |
| Study Start Date: | February 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Massachusetts | |
| Boston University Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: | Brian C Jacobson, MD, MPH | Boston University |
More Information
No publications provided by Boston Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Brian Jacobson, Associate Professor of Medicine, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT00643682 History of Changes |
| Other Study ID Numbers: | BMC-GI-1 |
| Study First Received: | March 20, 2008 |
| Results First Received: | July 9, 2012 |
| Last Updated: | August 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston Medical Center:
|
colonoscopy bowel preparation patient education polyp detection |
Additional relevant MeSH terms:
|
Neoplasms Colonic Neoplasms Colonic Polyps Polyps Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Intestinal Polyps Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013