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

NCT04898426 | Unknown

• 1 other identifier: GriffithBH
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.

Conditions

Colon Polyp; Colon Neoplasm

Keywords

Colonoscopy; Boston bowel preparation scale; Bowel preparation quality; Enhanced bowel preparation instruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Colonoscopy cancellation rate

  Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months.

• Caecal intubation rate

  Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months.

• Polyp detection rate

  Polyp detection rate will be calculated at the time of study completion, expected to be 12 months.

Study Arms (2)

Standard Bowel Preparation Instruction

NO INTERVENTION

Patients receive the standard-of-care bowel preparation instruction.

Enhanced Bowel Preparation Instruction

EXPERIMENTAL

Patients receive enhanced instructions (SMS, phone call, info website) in addition to the standard-of-care bowel preparation instruction.

Other: Enhanced bowel preparation instruction

Interventions

Enhanced bowel preparation instruction OTHER

Automated delivery of SMS, pre-recorded phone call, and link to an information website.

Enhanced Bowel Preparation Instruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective colonoscopy booking at Griffith Base Hospital.

You may not qualify if:

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

Sponsors & Collaborators

• Griffith Base Hospital: lead

Study Sites (1)

Griffith Base Hospital

Griffith, New South Wales, 2680, Australia

RECRUITING

Related Publications (12)

• 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. doi: 10.1111/j.1572-0241.2002.05827.x.

  PMID: 12135020 BACKGROUND

• 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.

  PMID: 22381531 BACKGROUND

• 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. doi: 10.1016/s0016-5107(04)02776-2.

  PMID: 15758907 BACKGROUND

• 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. doi: 10.1067/mge.2003.294.

  PMID: 12838225 BACKGROUND

• 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.

  PMID: 27189659 BACKGROUND

• 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.

  PMID: 26492848 BACKGROUND

• 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: 23503044 BACKGROUND

• 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.

  PMID: 26182387 BACKGROUND

• 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: 21483463 BACKGROUND

• 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: 21168840 BACKGROUND

• 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):e000376. doi: 10.1136/bmjgast-2020-000376.

  PMID: 32371502 BACKGROUND

• 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.

  PMID: 32240835 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Minh Pham

  Researcher

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minh Pham

CONTACT

+61 2 6969 5555; minhpham@medgneer.com

Kate FitzGerald

CONTACT

+61 2 6969 5555; Sheila.Fitzgerald@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient cannot be blinded to the allocation. The colonoscopist (care provider) is blinded to the allocation. The investigator and statistician will remain blinded to the allocation until analysis has been conducted.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 24, 2021
• Study Start: August 13, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)