Improving Bowel Preparation With an Educational Video - Full Text View

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 Intervention Model: Parallel Assignment Masking: Single (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 Brian Jacobson, Boston Medical Center:

Primary Outcome Measures:

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:

Histology of polyp [ Time Frame: one week after colonoscopy ]
number of adenomatous polyps
Colonoscope insertion and withdrawal times [ Time Frame: Day of colonoscopy only ]
time from insertion to cecum and time from cecum to anus
Patient compliance [ Time Frame: Day of colonoscopy only ]
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
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
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.
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


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 (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

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


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

Keywords provided by Brian Jacobson, Boston Medical Center:


Educational video colonoscopy bowel preparation Bowel preparation for colonoscopy

ClinicalTrials.gov processed this record on September 21, 2017