PolypsNCT02478918

Automated Telephone Reminder for Colonoscopy

A study testing Phone call in people with Polyps, run by Queen's University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Polyps
What is being tested?: Phone call
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 234 participants
Where: 1 siteCanada
Study dates: Jun 2015to 15 May 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Hotel Dieu Hospital
Kingston, Ontario, K7L5G2

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions: Polyps
Being tested: Phone call
Medical subject headings: Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phone callOther
Automated phone call reminder

Study groups in NCT02478918
Study group	Role	What they receive
Receiving reminder phone call	Experimental	Will receive phone call to remind colonoscopy date and bowel prep Receives: Other: Phone call
Not receiving reminder phone call	No intervention	Will not receive phone call to remind colonoscopy date and bowel prep

What is being measured

The primary outcome is the main question the study is designed to answer.

Ottawa preparation scale score
measures the cleanliness of each part of the colon and the overall fluid volume as assessed by the endoscopist
Measured: Immediately after procedure

Secondary outcomes (1)

Number of glasses of fluid consumed pre-colonoscopy
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201515 May 2016

First posted23 Jun 2015 (estimated)
Study startJun 2015
Primary completion15 May 2016
Study completion15 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for PolypsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02478918
Sponsor's protocol ID: 6013364
Status last verified: Feb 2017
First submitted: 18 Jun 2015
Last updated: 16 Feb 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 11419830
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.
PubMed 21168840
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.
PubMed 23503044
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.
PubMed 20051190
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.
PubMed 11419832
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.
PubMed 15044882
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.
PubMed 19940781
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.
PubMed 24454341
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.
PubMed 21483463
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.
PubMed 22840295

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
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Active, not recruitingPhase 2
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All Polyps trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Automated Telephone Reminder Prior to Outpatient Colonoscopy and the Effect on Bowel Preparation Quality
ClinicalTrials.gov ID: NCT02478918
Acronym / sponsor ID: 6013364
Conditions: Polyps
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: Queen's UniversityUniversity, hospital or other
Study start: Jun 2015
Primary completion: 15 May 2016 (actual)
Study completion: 15 May 2016 (actual)
First posted: 23 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Receiving reminder phone call	Experimental	Other: Phone callWill receive phone call to remind colonoscopy date and bowel prep
Not receiving reminder phone call	No intervention	–Will not receive phone call to remind colonoscopy date and bowel prep

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Phone callAutomated phone call reminder	Other	Receiving reminder phone call

Primary outcome

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

1 secondary outcome

Number of glasses of fluid consumed pre-colonoscopy
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
Background: PubMed 11419830Abuksis 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.
Background: PubMed 21168840Calderwood 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.
Background: PubMed 23503044Liu 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.
Background: PubMed 20051190Modi 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.
Background: PubMed 11419832Ness 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.
Background: PubMed 15044882Rostom 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.
Background: PubMed 19940781Shaikh 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.
Background: PubMed 24454341Shieh 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.
Background: PubMed 21483463Spiegel 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.
Background: PubMed 22840295Tae 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.
Individual participant dataSharing planned: No

Related trials for Polyps

Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Not yet recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of MG-K10 in Adults With Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 2
Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
Chronic Rhinosinusitis With Nasal Polyps

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lawrence Hookey, MD principal investigator

Queen's University

Matthew Church study director

Queen's University

Natalie Rubinger study director

Queen's University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Phone call in people with Polyps, run by Queen's University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ottawa preparation scale score (time frame: Immediately after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02478918, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.