| Registry | NCT05734079 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, health services research |
| Enrollment | 825 (Estimated) |
| Sponsor | Ziv Hospital (Other gov) |
| Conditions | Colonoscopy |
| Interventions | Standard of care, Standard of care + Video call, Standard of care + Video call + Educational video film (Other) |
| Dates | start 2023-04-01 (estimated), primary completion 2024-04-01 (estimated), completion 2024-07-01 (estimated), first posted 2023-02-17, last updated 2023-02-17 |
Related Papers Related Patents Related Grants Related Experts
All trials for Colonoscopy All trials of Standard of care All trials of Standard of care + Video call
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standard of care | Active comparator | Other: Standard of care | Standard of care includes a written paper sheet that summarizes information about the colonoscopy procedure and bowel preparation. |
| Standard of care + Video call | Experimental | Other: Standard of care + Video call | The video call will be performed at a designated time with a GE educated nurse. The purpose of the video call is (i) to clarify the patient in person about the colonoscopy procedure (ii) efficiently prepare the patient for bowel preparation by; asking the patient about her/his medical condition, the indication for colonoscopy, medical history, current medical status and medications currently taken. The patient will be inquired, whether she/he went through colonoscopy in the past, what preparation methods were undertaken and what the outcome of the examination was. Based on the information collected during the conversation, the designated nurse performing the interview will tailor the method of bowel preparation for the patient in terms of kind of relaxant, adjustment of medication intake and dietary adjustments before the examination. |
| Standard of care + Video call + Educational video film | Experimental | Other: Standard of care + Video call + Educational video film | The video film will explain the colonoscopy procedure and the bowel preparation procedure, in layman's terms and in the patient's preferred language (Hebrew or Arabic). |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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)