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

NCT ID: NCT02466724

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Web Group

Patients given web site (aiddly) instructions for colonoscopy

Group Type EXPERIMENTAL

Aiddly (Web Site)

Intervention Type DEVICE

A website designed to better educate patients on how to prepare for their colonoscopies

Paper Group

Patients given paper instructions for colonoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aiddly (Web Site)

A website designed to better educate patients on how to prepare for their colonoscopies

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Robert Enns

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Enns, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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Rex DK. Dosing considerations in the use of sodium phosphate bowel preparations for colonoscopy. Ann Pharmacother. 2007 Sep;41(9):1466-75. doi: 10.1345/aph.1K206. Epub 2007 Jul 24.

Reference Type BACKGROUND
PMID: 17652123 (View on PubMed)

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. doi: 10.1055/s-2007-966434.

Reference Type BACKGROUND
PMID: 17611916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20082216 (View on PubMed)

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. doi: 10.1053/gast.2003.50044.

Reference Type BACKGROUND
PMID: 12557158 (View on PubMed)

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. doi: 10.1056/NEJM199312303292701.

Reference Type BACKGROUND
PMID: 8247072 (View on PubMed)

Muller 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. doi: 10.1001/archinte.1995.00430160065007.

Reference Type BACKGROUND
PMID: 7654107 (View on PubMed)

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. doi: 10.1067/mge.2003.294.

Reference Type BACKGROUND
PMID: 12838225 (View on PubMed)

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. doi: 10.1016/s0016-5107(04)02776-2.

Reference Type BACKGROUND
PMID: 15758907 (View on PubMed)

Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. doi: 10.1111/j.1572-0241.2001.03874.x.

Reference Type BACKGROUND
PMID: 11419832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12135020 (View on PubMed)

Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007 Feb 15;25(4):373-84. doi: 10.1111/j.1365-2036.2006.03212.x.

Reference Type BACKGROUND
PMID: 17269992 (View on PubMed)

Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. doi: 10.1111/j.1463-1318.2006.00970.x.

Reference Type BACKGROUND
PMID: 16630226 (View on PubMed)

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. doi: 10.15403/jgld.2014.1121.232.ewh1.

Reference Type BACKGROUND
PMID: 24949604 (View on PubMed)

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. doi: 10.1111/j.1475-6773.2005.00438.x.

Reference Type BACKGROUND
PMID: 16336556 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23381511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23954647 (View on PubMed)

Other Identifiers

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H14-02390

Identifier Type: -

Identifier Source: org_study_id