Improving Bowel Preparation With an Educational Video

Study Description

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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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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

Eligibility Criteria

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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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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