Clinical trial NCT05734079: Impact of Digital Tools on the Quality of Bowel Preparation for Colonoscopy
Official title: Impact of Digital Tools on the Quality of Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Keywords: colonoscopy
gastroenterology
bowel preparation
digital
colorectal cancer screening
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2023-02-17
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a single blinded randomized controlled study. The main question of this study is whether better preparation by making full use of digital tools can increase patient compliance with the preparation methods for colonoscopy, and as a result improve bowel preparation quality and colonoscopy outcomes in a cost-effective manner.

Participants will randomly assigned to one of three colonoscopy preparation groups (i) a written hand out containing all information required for bowel preparation (standard care) (ii) standard care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application) (iii) standard care and in addition to a video call as described above using an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer.

Detailed description: Adequate bowel preparation is crucial for a successful and effective colonoscopy examination. Nevertheless, poor bowel preparation in patients is common and may lead to a lower quality of the examination that means a reduction in the rate of cecum intubation and lower detection rate of early and advanced adenoma. Finally, poor bowel preparation can lead to an abruption of the examination.

Digital advancement has been made in the context of colonoscopy bowel preparation, however high quality studies are still needed Ziv Medical Centre (ZMC) is a 300 bed governmental hospital located in Safed, Northern Israel that serves a diverse population. The gastroenterology department carries out approximately 1300 colonoscopies per year. A rapid audit has shown that approximately 15% of colonoscopies are stopped and up to 40% are incomplete, partly as a result of sub-optimal preparation.

The aim of this study is to determine whether better preparation by making full use of digital tools can increase patient compliance with the preparation methods for colonoscopy, and as a result improve bowel preparation quality and colonoscopy outcomes in a cost-effective manner.

This single blinded randomized controlled trial compares the effectiveness of bowel preparation in participants randomly assigned to one of three colonoscopy preparation groups (i) a written hand out containing all information required for bowel preparation (standard care) (ii) standard care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application) (iii) standard care and in addition to a video call as described above using an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer.

All patients included in the trial will receive standard care 10 days before the examination. Patients randomized to the groups with a video call or a video call + video film will be contacted by a nurse to determine an appointment to the 10th day before examination. Patients randomized to the study arm including an educational video film will be sent a link to the video film after the video call. On the day of the exam, during the examination, the medical doctor records an OBPS score as described. After the exam, the medical doctor will register whether the exam was complete, incomplete, stopped and whether hospitalization was needed. After the examination and recovery, all patients will receive a short satisfaction questionnaire.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* access to a digital device (smart phone, tablet, personal computer, laptop- this includes individuals who can use devices from household of relatives)
* ability to understand instructions in Hebrew or Arabic
* ability to sign a digital consent

Exclusion Criteria:

• pregnancy (first trimester)

Primary outcomes:
measure: The Ottawa Bowel Preparation Scale (OBPS)
timeFrame: OBPS will be evaluated during the colonoscopy procedure
Secondary outcomes:
measure: Patient's satisfaction questionaire
timeFrame: Questionnaires will be given to the patients immediately after the colonoscopy
measure: Colonoscopy completion
timeFrame: Colonoscopy completion will be recorded for 1 year
measure: The proportional change in the annual cost of treatment services
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Ziv Medical Center
name: Toni Ashqar, Dr.
role: PRINCIPAL_INVESTIGATOR
References: