Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy.

Colon Polyp Clinical Trial

Official title:

Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy: a Randomised Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898426
• Other study ID #: GriffithBH
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: March 2022

Study information

• Verified date: August 2021
• Source: Griffith Base Hospital
• Contact: Minh Pham
• Phone: +61 2 6969 5555
• Email: minhpham[@]medgneer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.

Description:

This is a prospective, randomized, controlled clinical investigation designed to evaluate the efficacy of enhanced bowel preparation instructions (automated SMS, information website, and pre-recorded phone call) in improving bowel preparation quality in elective colonoscopy.

Subjects from the interventional and control group will receive standard of care bowel preparation instruction.

The interventional group will receive enhanced instructions delivered by automated SMS, information website and pre-recorded phone calls in the 48 hours leading up to the colonoscopy day. The intention is to provide a reminder, to reiterate instruction on clear fluid diet and timing of bowel preparation medication, and to provide additional graphical illustration on the information website.

Subjects in the interventional group must reply "OK" to each automated SMS or press "1" on the keypad at the end of the automated phone call to acknowledge understanding and receipt of instruction. Failure to acknowledge trigger an alert for a booking office staff member to directly call the patient and confirm compliance.

The clinical investigation will be conducted at one hospital in the state of New South Wales, Australia.

Subjects will be randomized to the interventional group (enhanced instruction) versus the control group (standard instruction).

The proceduralist assessing outcome measures at the time of colonoscopy is blinded to the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective colonoscopy booking at Griffith Base Hospital.

Exclusion Criteria:

• Emergency colonoscopy

• Patients who are unable to understand bowel preparation instructions in the following languages: English, Italian, Punjabi, Gujarati, Samoan, Mandarin.

Related Conditions & MeSH terms

• Colon Neoplasm
• Colon Polyp
• Colonic Neoplasms

Intervention

Other:
• Enhanced bowel preparation instruction
Automated delivery of SMS, pre-recorded phone call, and link to an information website.

Locations

Country	Name	City	State
Australia	Griffith Base Hospital	Griffith	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Griffith Base Hospital

Country where clinical trial is conducted

Australia, 

References & Publications (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. — View Citation

Chokshi RV, Hovis CE, Hollander T, Early DS, Wang JS. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012 Jun;75(6):1197-203. doi: 10.1016/j.gie.2012.01.005. Epub 2012 Feb 28. — View Citation

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. — View Citation

Guo X, Yang Z, Zhao L, Leung F, Luo H, Kang X, Li X, Jia H, Yang S, Tao Q, Pan Y, Guo X. Enhanced instructions improve the quality of bowel preparation for colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc. 2017 Jan;85(1):90-97.e6. doi: 10.1016/j.gie.2016.05.012. Epub 2016 May 14. Review. — View Citation

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. — View Citation

Janahiraman S, Tay CY, Lee JM, Lim WL, Khiew CH, Ishak I, Onn ZY, Ibrahim MR, Chew CK. Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial. BMJ Open Gastroenterol. 2020 May;7(1). pii: e000376. doi: 10.1136/bmjgast-2020-000376. — View Citation

Kang X, Zhao L, Leung F, Luo H, Wang L, Wu J, Guo X, Wang X, Zhang L, Hui N, Tao Q, Jia H, Liu Z, Chen Z, Liu J, Wu K, Fan D, Pan Y, Guo X. Delivery of Instructions via Mobile Social Media App Increases Quality of Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Mar;14(3):429-435.e3. doi: 10.1016/j.cgh.2015.09.038. Epub 2015 Oct 20. — View Citation

Lee YJ, Kim ES, Choi JH, Lee KI, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study. Endoscopy. 2015 Nov;47(11):1018-27. doi: 10.1055/s-0034-1392406. Epub 2015 Jul 16. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Walter B, Frank R, Ludwig L, Dikopoulos N, Mayr M, Neu B, Mayer B, Hann A, Meier B, Caca K, Seufferlein T, Meining A. Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Feb;19(2):331-338.e5. doi: 10.1016/j.cgh.2020.03.051. Epub 2020 Mar 30. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel preparation quality	Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (range 0 to 9, with higher scores indicating better bowel preparation quality)	Bowel preparation quality is scored once for each patient at the time of colonoscopy completion. We expect to conduct this score in 500 patients over the study period of approximately 12 months.
Secondary	Colonoscopy cancellation rate	The number of colonoscopy being cancelled within 48 hours of the colonoscopy date. The rates will be compared between the study groups.	Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months.
Secondary	Caecal intubation rate	The proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon. The rates will be compared between the study groups.	Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months.
Secondary	Polyp detection rate	The proportion of colonoscopies in which a polyp was detected. The rates will be compared between the study groups.	Polyp detection rate will be calculated at the time of study completion, expected to be 12 months.

External Links

•   Information website provided to intervention group.