- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02478918
Automated Telephone Reminder for Colonoscopy
February 14, 2017 updated by: Dr. Lawrence Hookey, Queen's University
Automated Telephone Reminder Prior to Outpatient Colonoscopy and the Effect on Bowel Preparation Quality
This is a quality improvement study to determine the impact of an automated telephone reminder on the quality of bowel preparation in patients undergoing outpatient colonoscopy.
Study Overview
Detailed Description
Randomized trial of automated reminders with bowel prep instructions and encouraging clear fluid ingestion. The phone calls will occur 48-96 hours prior to the scheduled colonoscopy.
All patients undergoing outpatient colonoscopy and prescribed sodium picosulfate plus magnesium citrate will be eligible for enrollment.
Study Type
Interventional
Enrollment (Actual)
234
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
-
-
Ontario
-
Kingston, Ontario, Canada, K7L5G2
- Hotel Dieu 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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients
- Scheduled for outpatient colonoscopy at a later date
- Prescribed evening-before or split-dose low volume preparation regimens
Exclusion Criteria:
- Refusal to receive automated telephone reminder
- No access to telephone
- Urgent/emergent indication for colonoscopy
- Prescribed a bowel prep other than Pico-Salax/Purgodan
- Receiving upper and lower combined procedure
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Receiving reminder phone call
Will receive phone call to remind colonoscopy date and bowel prep
|
Automated phone call reminder
|
No Intervention: Not receiving reminder phone call
Will not receive phone call to remind colonoscopy date and bowel prep
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ottawa preparation scale score
Time Frame: Immediately after procedure
|
measures the cleanliness of each part of the colon and the overall fluid volume as assessed by the endoscopist
|
Immediately after procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of glasses of fluid consumed pre-colonoscopy
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Matthew Church, Queen's University
- Study Director: Natalie Rubinger, Queen's University
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
- 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.
- Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x. Erratum In: Gastrointest Endosc. 2004 Aug;60(2):326.
- Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16.
- 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.
- Calderwood AH, Lai EJ, Fix OK, Jacobson BC. An endoscopist-blinded, randomized, controlled trial of a simple visual aid to improve bowel preparation for screening colonoscopy. Gastrointest Endosc. 2011 Feb;73(2):307-14. doi: 10.1016/j.gie.2010.10.013. Epub 2010 Dec 18.
- Tae JW, Lee JC, Hong SJ, Han JP, Lee YH, Chung JH, Yoon HG, Ko BM, Cho JY, Lee JS, Lee MS. Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy. Gastrointest Endosc. 2012 Oct;76(4):804-11. doi: 10.1016/j.gie.2012.05.026. Epub 2012 Jul 27.
- Abuksis G, Mor M, Segal N, Shemesh I, Morad I, Plaut S, Weiss E, Sulkes J, Fraser G, Niv Y. A patient education program is cost-effective for preventing failure of endoscopic procedures in a gastroenterology department. Am J Gastroenterol. 2001 Jun;96(6):1786-90. doi: 10.1111/j.1572-0241.2001.03872.x.
- Modi C, Depasquale JR, Digiacomo WS, Malinowski JE, Engelhardt K, Shaikh SN, Kothari ST, Kottam R, Shakov R, Maksoud C, Baddoura WJ, Spira RS. Impact of patient education on quality of bowel preparation in outpatient colonoscopies. Qual Prim Care. 2009;17(6):397-404.
- Shaikh AA, Hussain SM, Rahn S, Desilets DJ. Effect of an educational pamphlet on colon cancer screening: a randomized, prospective trial. Eur J Gastroenterol Hepatol. 2010 Apr;22(4):444-9. doi: 10.1097/MEG.0b013e328333fca6.
- Shieh TY, Chen MJ, Chang CW, Hung CY, Hu KC, Kuo YC, Shih SC, Wang HY. Effect of physician-delivered patient education on the quality of bowel preparation for screening colonoscopy. Gastroenterol Res Pract. 2013;2013:570180. doi: 10.1155/2013/570180. Epub 2013 Dec 17.
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
June 1, 2015
Primary Completion (Actual)
May 15, 2016
Study Completion (Actual)
May 15, 2016
Study Registration Dates
First Submitted
June 18, 2015
First Submitted That Met QC Criteria
June 22, 2015
First Posted (Estimate)
June 23, 2015
Study Record Updates
Last Update Posted (Actual)
February 16, 2017
Last Update Submitted That Met QC Criteria
February 14, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 6013364
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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