Colonoscopy Educational Video Upon Inner City Population

Other Surgical Procedures Clinical Trial

Official title:

Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906969
• Other study ID #: 1203000992
• Status: Completed
• Phase: N/A
• First received: June 13, 2016
• Last updated: September 15, 2016
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2016
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Background:

The investigators assessed the use of a colonoscopy instructional video to improve both bowel preparation and education prior to procedure. Preceding studies have been vague, pinning patient education via diagrams and text as both pivotal and useless for compliance in bowel preparations. These studies however lacked assessment of comprehension prior to procedure.

Methodology:

This is a prospective study of diverse, inner city outpatient university center, first time colonoscopy patients given 1 of 2 on-site videos and written/verbal instruction. Experimentals saw a 5 min video on the purpose of colonoscopy, bowel preparation, pre-colonoscopy diet, and proper laxative use. Controls saw a 5 min video from the same spokesperson on upper endoscopy; which was trivial. Both groups were given a quiz within 30 days of the colonoscopy on demographics, and 14 test questions about colonoscopy and preparation. Subsequently, endoscopists used the additive Ottawa scale to rate quality of preparation (range 0-14) via: fluid (0=sm,1=mod, 2=lg) and cleanliness in each the right, mid and rectosigmoid colon, (0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Exclusion Criteria:

• Patients were excluded if they had dementia or

• cognitive impairment or

• if they did not have a pre-procedural office visit.

Inclusion Criteria:

• age 18-85

• undergoing initial outpatient colonoscopy

• willing to participate in and sign consent for this study

• Morning session of colonoscopy procedure

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Other Surgical Procedures

Intervention

Other:
• Colonoscopy Educational Video
Brief Video utilization to assess comprehension and evaluation bowel preparation quality
• Placebo Educational Video
Brief Video utilization to provide placebo information and evaluation bowel preparation quality

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

References & Publications (2)

Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. — View Citation

Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome improvement in adequate bowel preparations	Bowel preparation quality indicator using Ottawa bowel prep scale.	in 30 days retention from the video	No
Primary	Comprehension of colonoscopy/colorectal cancer screening	Questionnaire	in 30 days retention from the video	No