Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

August 29, 2012 updated by: Brian Jacobson, Boston Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Principal Investigator: Brian C Jacobson, MD, MPH, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

October 1, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMC-GI-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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