Improving Bowel Preparation With an Educational Video

NCT01099553 | Completed Phase 3

• 1 other identifier: H-29152
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation

Keywords

Educational video; colonoscopy; bowel preparation; Bowel preparation for colonoscopy

Outcome Measures

Primary Outcomes (1)

• Quality of bowel preparation

  The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale

  Day of colonoscopy only

Secondary Outcomes (6)

• Histology of polyp

  one week after colonoscopy

• Colonoscope insertion and withdrawal times

  Day of colonoscopy only

• Patient compliance

  Day of colonoscopy only

• Preparation associated side effects

  Day of colonoscopy only

• Patient satisfaction

  Day of colonoscopy only

Study Arms (2)

Standard preparation instructions

OTHER

The control arm will receive written instructions on preparing for a colonoscopy per standard of care at Boston Medical Center

Other: Written instructions

Interventional

EXPERIMENTAL

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

Interventions

Educational video OTHER

Instructions to view an educational video about preparing for a colonoscopy

Interventional

Written instructions OTHER

Written instructions on preparing for a colonoscopy

Standard preparation instructions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

• Brian C Jacobson, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 7, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

US (1)