Bowel Preparation Quality for Screening Colonoscopy

NCT ID: NCT02690779

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-11-30

Brief Summary

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The study will consist of a prospective observational period performed in the GI Endoscopy Lab. The objective is to document the quality of bowel preps in patients undergoing a screening colonoscopy with and without an educational intervention.

Detailed Description

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The educational intervention will consist of a 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. This video will be posted on YouTube. Group 1 will consist of 30 subjects who will be instructed to view this video prior to beginning their colonoscopy preparation. Information to access the YouTube video will be provided to the patients by endoscopy nurse assessment staff when contacting the patients as per standard practice to review appointment scheduling and procedure-day logistics. Group 2 will consist of 30 subjects who will not receive instructions to view the video.

Nursing staff will be asked to grade bowel preps according to the Boston Bowel Preparation Scale (BBPS), a validated and reliable instrument for assessing quality of bowel preparation \[6\]. Using the BBPS, a four point scoring system is applied to each of the three broad regions of the colon: the right side of the colon (including the cecum and ascending colon), the transverse section of the colon (including the hepatic and splenic flexures), and the left side of the colon (including the descending colon, sigmoid colon, and rectum). The points are assigned as follows: (0), unprepared colon segment, (1), portion of the mucosa of the colon segment seen, (2), minor amount of residual staining, (3), entire mucosa of colon segment seen well. The three segment scores are then summed for a total BBPS score, which ranges from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9, and the minimum BBPS score for an unprepared colon is 0. The endoscopy nurse who is in the procedure room will be scoring the bowel preparation. This protocol has been employed previously in the VUMC Endoscopy Lab and the endoscopy nurses at Vanderbilt have completed a detailed in-service training session on using the BBPS scoring system. Prior to initiation of this current study protocol, the endoscopy nurses will have a BBPS scoring system review session to ensure continued reliable and valid BBPS scores. The endoscopy nurses will be blinded to whether the patient viewed the video or not.

Conditions

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Screening Colonoscopies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Patients watching educational video

The educational intervention will consist of a 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. This video will be posted on YouTube. Group 1 will consist of 30 subjects who will be instructed to view this video prior to beginning their colonoscopy preparation. Information to access the YouTube video will be provided to the patients by endoscopy nurse assessment staff when contacting the patients as per standard practice to review appointment scheduling and procedure-day logistics.

Group Type EXPERIMENTAL

Educational intervention

Intervention Type OTHER

2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration.

Patients not watching educational video

Group 2 will consist of 30 subjects who will not receive instructions to view the video. They will be given routine care instructions for bowel prep.

Group Type SHAM_COMPARATOR

Routine Care Instructions

Intervention Type OTHER

patients will follow routine care and instructions

Interventions

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Educational intervention

2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration.

Intervention Type OTHER

Routine Care Instructions

patients will follow routine care and instructions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Elective outpatient procedures performed for diagnostic purposes:

* screening colonoscopy
* surveillance colonoscopy

Exclusion Criteria

* Colonoscopy for diagnosis/therapy of acute gastrointestinal hemorrhage or for planned therapeutic intervention
* Colonoscopy performed on hospital inpatients
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Keith Obstein

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith Obstein, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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131668

Identifier Type: -

Identifier Source: org_study_id

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