NCT02906969

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

June 13, 2016

Last Update Submit

September 15, 2016

Conditions

Other Surgical Procedures

Outcome Measures

Primary Outcomes (2)

  • Primary outcome improvement in adequate bowel preparations

    Bowel preparation quality indicator using Ottawa bowel prep scale.

    in 30 days retention from the video

  • Comprehension of colonoscopy/colorectal cancer screening

    Questionnaire

    in 30 days retention from the video

Study Arms (2)

Colonoscopy educational Video

EXPERIMENTAL

Brief educational video of colonoscopy to determine comprehension and quality of bowel preparation.

Other: Colonoscopy Educational Video

Control

PLACEBO COMPARATOR

Non-colonoscopy video as a control.

Other: Placebo Educational Video

Interventions

Colonoscopy Educational VideoOTHER

Brief Video utilization to assess comprehension and evaluation bowel preparation quality

Colonoscopy educational Video
Placebo Educational VideoOTHER

Brief Video utilization to provide placebo information and evaluation bowel preparation quality

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients were excluded if they had dementia or
  • cognitive impairment or
  • if they did not have a pre-procedural office visit.
  • age 18-85
  • undergoing initial outpatient colonoscopy
  • willing to participate in and sign consent for this study
  • Morning session of colonoscopy procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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. doi: 10.1111/j.1572-0241.2002.05827.x.

    PMID: 12135020BACKGROUND

  • 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.

    PMID: 21483463BACKGROUND

  • Pillai A, Menon R, Oustecky D, Ahmad A. Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population. J Clin Gastroenterol. 2018 Jul;52(6):515-518. doi: 10.1097/MCG.0000000000000893.

    PMID: 28742732DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

September 20, 2016

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share