Impact of Digital Tools on the Quality of Bowel Preparation for Colonoscopy

Trial Title: Impact of Digital Tools on the Quality of Bowel Preparation for Colonoscopy

NCT ID: NCT05734079

Condition: Colonoscopy

Conditions: Keywords:
colonoscopy
gastroenterology
bowel preparation
digital
colorectal cancer screening

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Standard of care
Description: A written hand out containing all information required for bowel preparation
Arm group label: Standard of care

Intervention type: Other
Intervention name: Standard of care + Video call
Description: Standard of 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)
Arm group label: Standard of care + Video call

Intervention type: Other
Intervention name: Standard of care + Video call + Educational video film
Description: Standard of care and in addition to a video call, an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer
Arm group label: Standard of care + Video call + Educational video film

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.

Criteria for 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Start date: April 1, 2023

Completion date: July 1, 2024

Lead sponsor:
Agency: Ziv Hospital
Agency class: Other

Source: Ziv Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05734079