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

NCT05734079 | Unknown

• 1 other identifier: 0085-22-ZIV
• Study Type: interventional
• Target: 825
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonoscopy

Keywords

colonoscopy; gastroenterology; bowel preparation; digital; colorectal cancer screening

Outcome Measures

Primary Outcomes (1)

• The Ottawa Bowel Preparation Scale (OBPS)

  A standard method used to assess a patient's bowel preparation for colonoscopies. The bowel preparation score is a sum of a segmental score (right-colon, mid-colon and rectosigmoid-colon) and a fluid quantity score. The segmental score is quantified on a scale of 0 to 4, with; 0 indicating perfect cleansing, 1 indicating good cleansing, 2 indicating Fair cleansing, 3 indicating poor cleansing and 4 indicating inadequate cleansing. Overall fluid quantity is quantified on a scale of 0 to 2, with; 0 indicating no fluid in the colon and 2 indicating a large amount of fluid in the colon. Both the colon score and fluid score result in an overall score ranging from 0 to 14, with; 0 an Excellent cleansing quality and 14 indicates the worst cleansing quality. Estimations of the scores are made by the medical doctors during the exam and are fed into a commercial software that calculates the overall OBPS score.

  OBPS will be evaluated during the colonoscopy procedure

Secondary Outcomes (3)

• Patient's satisfaction questionaire

  Questionnaires will be given to the patients immediately after the colonoscopy

• Colonoscopy completion

  Colonoscopy completion will be recorded for 1 year

• The proportional change in the annual cost of treatment services

  1 year

Study Arms (3)

Standard of care

ACTIVE COMPARATOR

Standard of care includes a written paper sheet that summarizes information about the colonoscopy procedure and bowel preparation.

Other: Standard of care

Standard of care + Video call

EXPERIMENTAL

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.

Other: Standard of care + Video call

Standard of care + Video call + Educational video film

EXPERIMENTAL

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).

Other: Standard of care + Video call + Educational video film

Interventions

Standard of care OTHER

A written hand out containing all information required for bowel preparation

Standard of care

Standard of care + Video call OTHER

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)

Standard of care + Video call

Standard of care + Video call + Educational video film OTHER

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

Standard of care + Video call + Educational video film

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy (first trimester)

Sponsors & Collaborators

• Ziv Hospital: lead

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Toni Ashqar, Dr.

  Ziv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toni Ashqar, Dr.

CONTACT

+972528225103; toniashqar@gmail.com

Neta Tuvia, Dr.

CONTACT

+972-583971644; netat@ziv.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Toni Ashqar, Senior gastroenterologist

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 17, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share