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

October 24, 2017 updated by: Robert Enns, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Web Group
Patients given web site (aiddly) instructions for colonoscopy
Device: Aiddly (Web Site)
A website designed to better educate patients on how to prepare for their colonoscopies
No Intervention: Paper Group
Patients given paper instructions for colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with Excelent Colonoscopy preparation
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Benefit and satisfaction to patients of this method of patient education.
Time Frame: Baseline
To determine through follow-up survey the benefit and satisfaction to patients of this method of patient education.
Baseline
Bowel preparation tolerability with this method of patient education.
Time Frame: Baseline
To determine through follow-up survey differences in bowel preparation tolerability with this method of patient education.
Baseline
Use of web-based educational platform
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Robert Enns, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-02390

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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