An Open Label Trial Examining Web Based Colonoscopy Preparation Instruction

Colon Cancer Clinical Trial

Official title:

A New Standard: An Open Label Trial Examining the Effectiveness of Individualized Web Based Colonoscopy Preparation Instruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725176
• Other study ID #: H15-03326
• Status: Completed
• Start date: April 6, 2016
• Est. completion date: February 11, 2018

Study information

• Verified date: October 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Current pre-colonoscopy instructions are given to patients in the form of a written or printed instruction set. We have developed a web-based instruction system which aims to provide a more effective instructional experience for the patient in hopes in increase their adherence to pre-colonoscopy guidelines. After trialing this approach, we are ready to implement this medium of instruction for all patients receiving colonoscopies.

Description:

This is a prospective, single-center, open label study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: February 11, 2018
• Est. primary completion date: February 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age 19 or greater

• Patients scheduled for a colonoscopy using a doctors "normal prep" as outpatients

• Willing to participate by filling out the survey

• Must be able to read and understand English

• Must have ability to use email, have a functioning email account, and are willing to be contacted by email.

Exclusion Criteria:

• Unable to speak English

• Unwilling to participate in reading online materials

Related Conditions & MeSH terms

• Colon Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

References & Publications (16)

Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007 Feb 15;25(4):373-84. Review. — View Citation

Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. — View Citation

Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. — View Citation

Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061. Review. — View Citation

Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. — View Citation

Holt EW, Yimam KK, Ma H, Shaw RE, Sundberg RA, Verhille MS. Patient tolerability of bowel preparation is associated with polyp detection rate during colonoscopy. J Gastrointestin Liver Dis. 2014 Jun;23(2):135-40. — View Citation

Müller AD, Sonnenberg A. Protection by endoscopy against death from colorectal cancer. A case-control study among veterans. Arch Intern Med. 1995 Sep 11;155(16):1741-8. — View Citation

Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. — View Citation

Park JS, Sohn CI, Hwang SJ, Choi HS, Park JH, Kim HJ, Park DI, Cho YK, Jeon WK, Kim BI. Quality and effect of single dose versus split dose of polyethylene glycol bowel preparation for early-morning colonoscopy. Endoscopy. 2007 Jul;39(7):616-9. — View Citation

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

Rex DK. Dosing considerations in the use of sodium phosphate bowel preparations for colonoscopy. Ann Pharmacother. 2007 Sep;41(9):1466-75. Epub 2007 Jul 24. Review. — View Citation

Serper M, Gawron AJ, Smith SG, Pandit AA, Dahlke AR, Bojarski EA, Keswani RN, Wolf MS. Patient factors that affect quality of colonoscopy preparation. Clin Gastroenterol Hepatol. 2014 Mar;12(3):451-7. doi: 10.1016/j.cgh.2013.07.036. Epub 2013 Aug 15. — View Citation

Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. Review. — View Citation

Unger RZ, Amstutz SP, Seo DH, Huffman M, Rex DK. Willingness to undergo split-dose bowel preparation for colonoscopy and compliance with split-dose instructions. Dig Dis Sci. 2010 Jul;55(7):2030-4. doi: 10.1007/s10620-009-1092-x. Epub 2010 Jan 16. — View Citation

Winawer S, Fletcher R, Rex D, Bond J, Burt R, Ferrucci J, Ganiats T, Levin T, Woolf S, Johnson D, Kirk L, Litin S, Simmang C; Gastrointestinal Consortium Panel. Colorectal cancer screening and surveillance: clinical guidelines and rationale-Update based on new evidence. Gastroenterology. 2003 Feb;124(2):544-60. — View Citation

Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with Excelent Colonoscopy preparation	To determine the effectiveness of web-based pre-colonoscopy instructions for patients, as measured by the percentage of patients achieving a level of colon cleanliness equivalent to Boston Bowel Preparation Score (BBPS) of = 8.	Baseline
Secondary	Benefit and satisfaction to patients of this method of patient education	To determine through follow-up survey the benefit and satisfaction to patients of this method of patient education.	Baseline
Secondary	Bowel preparation tolerability with this method of patient education	To determine through follow-up survey differences in bowel preparation tolerability with this method of patient education.	Baseline
Secondary	Use of web-based educational platform	To determine the number of patients who cannot use or participate in the web-based educational platform and through survey results determine limiting factors of access and use.	Baseline