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Improving Bowel Preparation With an Educational Video

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Jacobson, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01099553
First received: April 2, 2010
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Bowel Preparation
 Other: Educational video
Other: Written instructions
 Phase 3

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 With an Education Video

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Quality of bowel preparation [ Time Frame: Day of colonoscopy only ] [ Designated as safety issue: No ]
    The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale


Secondary Outcome Measures:
  • Histology of polyp [ Time Frame: one week after colonoscopy ] [ Designated as safety issue: No ]
    number of adenomatous polyps

  • Colonoscope insertion and withdrawal times [ Time Frame: Day of colonoscopy only ] [ Designated as safety issue: No ]
    time from insertion to cecum and time from cecum to anus

  • Patient compliance [ Time Frame: Day of colonoscopy only ] [ Designated as safety issue: No ]
    Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire

  • Preparation associated side effects [ Time Frame: Day of colonoscopy only ] [ Designated as safety issue: No ]
    Presence and severity of preparation associated side effects including: blaoting, abdominal pain, and nausea/vomiting

  • Patient satisfaction [ Time Frame: Day of colonoscopy only ] [ Designated as safety issue: No ]
    patient's perception of the helpfulness of the video as self-reported on a pre-procedure questionnaire.

  • Number of repeat colonoscopies due to inadequate bowel preparation [ Time Frame: Day of colonoscopy only ] [ Designated as safety issue: No ]
    Blinded endoscopist's assesment about the need for a repeat colonoscopy due to inadequate bowel preparation
Enrollment: 2000
Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Brian Jacobson, Associate Professor of Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01099553     History of Changes
Other Study ID Numbers: H-29152
Study First Received: April 2, 2010
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on March 03, 2015