Improving Bowel Preparation With an Educational Video

Improving Bowel Preparation With an Education Video

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.

Study Overview

• Status: Completed
• Conditions: Bowel Preparation
• Intervention / Treatment: Other: Written instructions; Other: Educational video

• Study Type: Interventional
• Enrollment (Actual): 2000
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histology of polyp	number of adenomatous polyps	one week after colonoscopy
Colonoscope insertion and withdrawal times	time from insertion to cecum and time from cecum to anus	Day of colonoscopy only
Patient compliance	Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire	Day of colonoscopy only
Preparation associated side effects	Presence and severity of preparation associated side effects including: blaoting, abdominal pain, and nausea/vomiting	Day of colonoscopy only
Patient satisfaction	patient's perception of the helpfulness of the video as self-reported on a pre-procedure questionnaire.	Day of colonoscopy only
Number of repeat colonoscopies due to inadequate bowel preparation	Blinded endoscopist's assesment about the need for a repeat colonoscopy due to inadequate bowel preparation	Day of colonoscopy only

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Brian C Jacobson, MD, MPH, Boston Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: April 2, 2010
• First Submitted That Met QC Criteria: April 6, 2010
• First Posted (ESTIMATE): April 7, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 31, 2012
• Last Update Submitted That Met QC Criteria: August 29, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation; Educational video; Bowel preparation for colonoscopy
• Other Study ID Numbers: H-29152