A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy

A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy.

The investigators hypothesised that a video based patient education will help patients understand the process of colon cleansing prior to a colonoscopy procedure and hence will result in clean colons that will may help physician perform a better quality examination.

Study Overview

• Status: Terminated
• Conditions: Bowel Dysfunction
• Intervention / Treatment: Other: Educational video

Detailed Description

After obtaining consent over phone, the investigators randomly assigned assigned participants to receive either the standard paper based instructions or receive an educational video in addition to the standard paper based instruction. Physicians performing the procedure were blinded to this assignment. The investigators obtained information relating to the cleanliness of the colon as noted during the colonoscopy examination. The investigators obtained this information from the colonoscopy reports. The investigators also obtained information regarding colon polyps,wanting to see if there is any difference in the number of patients in whom adenomatous polyps were detected.

Outcome measures:

Primary Out come:

1.Quality of bowel preparation

Secondary outcome:

1. Adenoma detection rate
2. Rate of incomplete procedures due to poor bowel prep.

• Study Type: Interventional
• Enrollment (Actual): 298
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. At least 18 years of age
2. Subjects who have the ability to give consent
3. Subjects who are scheduled for colonoscopy as out patient
4. Subjects consenting to participate in the study
5. Subjects who are able to read and understand English

Exclusion Criteria:

1. < 18 years age
2. Subjects from whom consent cannot be obtained for any reason.
3. Subjects who are scheduled for colonoscopy as in patient
4. Subjects who are scheduled for colonoscopy within a time period or a situation where the educational material cannot be properly delivered to the study participant.
5. Subjects who are advised to undergo bowel prep for more than one day.
6. Subjects undergoing bowel prep with medications other than Colyte.
7. Subjects who do not have access to equipment to watch the video (TV/CD player)
8. Pregnant patients
9. Prisoners
10. Subjects who are not able to read or understand English.

(j)Subjects who had bowel resection surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Instructions printed on a paper.; There will be no intervention.
Experimental: Paper and video instructions; .Instructions printed on paper and a educational video.	Other: Educational video; An educational video was developed based on the current paper instructions for bowel preparation. The video included a physician explaining the process, using more images and short clip videos of the example. The script of the video was approved by the patient education department of the University Hospital and language adjusted to 6th grade level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of bowel preparation	Quality of bowel preparation at the time when the colonoscopy procedure is performed as reported by the physician performing the colonoscopy.	At the time of colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	Number of patients undergoing screening colonoscopy for average risk in whom an adenoma was detected.	At time of colonoscopy

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Dilip Bearelly, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: December 16, 2013
• First Posted (Estimated): December 17, 2013

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: 1203774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO