NCT02478918

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2016

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

12 months

First QC Date

June 18, 2015

Last Update Submit

February 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ottawa preparation scale score

    measures the cleanliness of each part of the colon and the overall fluid volume as assessed by the endoscopist

    Immediately after procedure

Secondary Outcomes (1)

  • Number of glasses of fluid consumed pre-colonoscopy

    24 hours

Study Arms (2)

Receiving reminder phone call

EXPERIMENTAL

Will receive phone call to remind colonoscopy date and bowel prep

Other: Phone call

Not receiving reminder phone call

NO INTERVENTION

Will not receive phone call to remind colonoscopy date and bowel prep

Interventions

Automated phone call reminder

Receiving reminder phone call

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • Scheduled for outpatient colonoscopy at a later date
  • Prescribed evening-before or split-dose low volume preparation regimens

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L5G2, Canada

Location

Related Publications (10)

  • 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.

    PMID: 11419830BACKGROUND
  • 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.

    PMID: 21168840BACKGROUND
  • 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.

    PMID: 23503044BACKGROUND
  • 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.

    PMID: 20051190BACKGROUND
  • 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.

    PMID: 11419832BACKGROUND
  • 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.

    PMID: 15044882BACKGROUND
  • 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.

    PMID: 19940781BACKGROUND
  • 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.

    PMID: 24454341BACKGROUND
  • 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.

    PMID: 21483463BACKGROUND
  • 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.

    PMID: 22840295BACKGROUND

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lawrence Hookey, MD

    Queen's University

    PRINCIPAL INVESTIGATOR
  • Matthew Church

    Queen's University

    STUDY DIRECTOR
  • Natalie Rubinger

    Queen's University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Division of Gastroenterology

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 23, 2015

Study Start

June 1, 2015

Primary Completion

May 15, 2016

Study Completion

May 15, 2016

Last Updated

February 16, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations