Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy

Study Overview
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Brief Summary
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In order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. Patients who undergo ambulatory colonoscopy are randomly assigned into a control group with standard preparation, a phone call supported preparation group or a group supported by an artificial intelligence based chatbot. Primary endpoint is defined as quality of bowel preparation (Boston Bowel Preparation Score), secondary endpoints are patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation and the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support.

Detailed Description
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Adequate bowel preparation is crucial for detection of adenoma and polyps of the colon, which can transform into malignant and premalignant lesions. In particular ambulatory performed colonoscopy is often insufficient due to inadequate preparation by patients at home. To focus this issue, a artificial intelligence based chatbot was developed to help patients who undergo bowel preparation by answering questions concerning bowel preparation. To compare the effect of this program, a three-arm randomized, controled multicentric clinical trial was developed. All patients who undergo ambulatory colonoscopy and meet the inclusion criteria (18 y.o., informed consent, WhatsApp access) were randomized in a standard preparation group (medical briefing and preparation brochure), a group receiving phone calls with instructions for bowel preparation and a third group with access to the chat bot answering questions concerning bowel preparation and examination conduct. As the primary end point, the quality of bowel preparation measured as Boston Bowel Preparation Scale was defined. As secondary endpoints patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation, the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support were measured.

Official Title
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Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy

Conditions
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Bowel Preparation

Intervention / Treatment
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* Other: Chatbot
* Other: Phone call


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent smartphone with access to WhatsApp indication for ambulatory colonoscopy ASA I or II Exclusion Criteria: no informed consent given or possible no access to a smartphone with WhatsApp <18 years old Pregnancy/Lactation Allergy to Moviprep© ASA (American Society of Anesthesiologists) state >II extended abdominal surgery in past history no indication for ambulatory colonoscopy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Preparation<br>Control arm; patients receive a standard support for bowel preparation consisting of a explanatory dialogue with a gastroenterologist and a brochure with a structurated description of bowel preparation and colonoscopy conduct | |
| Active Comparator: Phone-call Supported Preparation<br>In addition to standard preparation, patients receive a phone call every day starting at 3 days before colonoscopy in which a investigator explains key points of bowel preparation and patients can ask questions concerning bowel preparation and colonoscopy conduct. | Other: Phone call<br>* A phone call is performed every day starting at 3 days before colonoscopy to support bowel preparation.<br>|
| Experimental: Chatbot Supported Preparation<br>In addition to standard preparation, patients receive an access to a chatbot which can be contacted via Whats App starting at 3 days before colonoscopy. The chatbot is programed to answer questions concerning bowel preparation and colonoscopy conduct. | Other: Chatbot<br>* A artificial-intelligence based chatbot is provided 3 days before colonoscopy to answer questions concerning bowel preparation and colonoscopy conduct.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of bowel preparation | evaluated with the Boston Bowel Preparation Scale (0-9, 1=worst preparation, 9= best preparation) | During colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients satisfaction with bowel preparation | Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied) | Immediately after the intervention | 
| Comprehensiveness of bowel preparation | Rate of successfully completed colonoscopy without premature termination due to remaining feces(from anus to terminal ileum) | During colonoscopy | 
| Sedation dose | Total amount of administered sedation per examination | During colonoscopy | 
| Coecal intubation | Successful coecal intubation during colonoscopy | During colonoscopy | 
| Polyp and adenoma detection rate | Rate of detected polyps and adenomas | During colonoscopy | 
| Patients satisfaction with preparation support | Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied) | Within 3 days after the intervention | 
| Anxiety referred to colonoscopy | German ABI-MS questionnaire (questionnaire on overcoming fear considering medical therapy; | Within 3 days before the intervention and 3 days after the intervention; 8 items with binary answer yes/no) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel Preparation, Artificial Intelligence, Polyp Detection