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Improving Bowel Preparation With an Educational Video

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ClinicalTrials.gov Identifier: NCT01099553
Recruitment Status : Completed
First Posted : April 7, 2010
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Brian Jacobson, Boston Medical Center

Brief Summary:
The investigators goal is to improve bowel preparations with an educational video on the Center for Digestive Disorders (CDD) website that explains the steps required for bowel preparation for those patients undergoing screening colonoscopies. The video will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative. In a randomized fashion, patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a link to watch the instructional video. The investigators hypothesize that an educational tool that provides visual examples of a good and poor preparation, examples of the pre-colonoscopy diet, and an explanation of how to administer the laxative will lead to improved patient compliance and a better bowel preparation. In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and fewer recommendations for repeat colonoscopy based solely on inadequate bowel preparation.

Condition or disease Intervention/treatment Phase
Bowel Preparation Other: Educational video Other: Written instructions Phase 3

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 With an Education Video
Study Start Date : March 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Standard preparation instructions
The control arm will receive written instructions on preparing for a colonoscopy per standard of care at Boston Medical Center
Other: Written instructions
Written instructions on preparing for a colonoscopy
Experimental: Interventional
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions asking them to watch an educational video on the Center for Digestive Disorders website
Other: Educational video
Instructions to view an educational video about preparing for a colonoscopy



Primary Outcome Measures :
  1. Quality of bowel preparation [ Time Frame: Day of colonoscopy only ]
    The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale


Secondary Outcome Measures :
  1. Histology of polyp [ Time Frame: one week after colonoscopy ]
    number of adenomatous polyps

  2. Colonoscope insertion and withdrawal times [ Time Frame: Day of colonoscopy only ]
    time from insertion to cecum and time from cecum to anus

  3. Patient compliance [ Time Frame: Day of colonoscopy only ]
    Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire

  4. Preparation associated side effects [ Time Frame: Day of colonoscopy only ]
    Presence and severity of preparation associated side effects including: blaoting, abdominal pain, and nausea/vomiting

  5. Patient satisfaction [ Time Frame: Day of colonoscopy only ]
    patient's perception of the helpfulness of the video as self-reported on a pre-procedure questionnaire.

  6. Number of repeat colonoscopies due to inadequate bowel preparation [ Time Frame: Day of colonoscopy only ]
    Blinded endoscopist's assesment about the need for a repeat colonoscopy due to inadequate bowel preparation



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all outpatients
  • age >18
  • referred and scheduled for an elective screening colonoscopy

Exclusion Criteria:

  • inpatients
  • prisoners
  • patients allergic to PEG-ELS based laxatives

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): NCT01099553


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Brian C Jacobson, MD, MPH Boston Medical Center

Responsible Party: Brian Jacobson, Associate Professor of Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01099553     History of Changes
Other Study ID Numbers: H-29152
First Posted: April 7, 2010    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

Keywords provided by Brian Jacobson, Boston Medical Center:
Educational video
colonoscopy
bowel preparation
Bowel preparation for colonoscopy