Study on the Impact of Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

Colon Cancer Clinical Trial

Official title:

Randomized Prospective Study on the Impact of the Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466724
• Other study ID #: H14-02390
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: October 24, 2017
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colorectal cancer (CRC) is a common and life threatening condition that will affect one in thirteen individuals. Colonoscopy is the most commonly used procedure to identify colorectal malignancies or precancerous lesions at an earlier stage, which affords an opportunity for cure. However, low level of bowel cleanliness hinders polyp detection and therefore can limit colonoscopy effectiveness. Historically, the majority of the studies have focused on pharmacological factors to optimize bowel preparation quality. Recently, non-pharmacological factors have been found to have significant increases in bowel preparation quality. The purpose of this study is to evaluate the effectiveness of web-based instructions vs. the historical phone/letter instructions given to patients planning to have a colonoscopy.

Description:

This study is a prospective randomized trial. Four hundred and fifty consecutive eligible patients will be randomized to ideally have two hundred and twenty five patients in each arm. Those who will have traditional paper based instructions and those who will be using an online system. Both groups will receive their instructions by the research assistant prior to leaving the office after being consented. The paper based instructions will be given as a handout and those in the online group will receive their bowel preparation instructions via an email sent by a scheduling assistant

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: June 2017
• Est. primary completion date: May 2016
• 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

Intervention

Device:
• Aiddly (Web Site)
A website designed to better educate patients on how to prepare for their colonoscopies

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

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 instructions for patients preparing for colonoscopy by comparing the percentage of patients that achieve an excellent Boston Bowel Preparation score when following the web-based instructions compared to the control arm of patients receiving paper written instructions.	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