Digitising colonoscopy care pathways and enhancing bowel preparation quality with patient reported measures (DIGICLEAN).

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: Participants in the interventional arm of the study will receive their bowel preparation instructions delivered via scheduled SMS, web‐based smartphone application, email, and videos. All enrolled participants must possess a smartphone device. The interventional arm will occur in parallel design with the control arm. Depending on whether participants have a history of constipation, bloating, or diverticular disease as assessed by the faecal occult blood test (FOBT) nurse or the gastroenterologist at the initial phone call, participants will be stratified into one of two groups depending on their indicated bowel preparation regimens. Participants will be either given Standard Bowel Preparation instructions with PLENVU [macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride, potassium chloride; polyethylene glycol containing ascorbic acid (PEG‐ASC)], or Enhanced Bowel Preparation [PLENVU plus daily Movicol (sodium chloride, potassium chloride, bicarbonate, macrogol 3350) and Senokot (sennoside)]. Additional aperients, such as Movicol and Senokot, will be encouraged in the interventional arm through dynamic multimedia instructions if indicated. Participants will be asked to take PLENVU over a two‐day split dosing schedule with the first 500 mL dose of PLENVU (including additional 500 mL of clear fluid) taken in the evening before the clinical procedure (at 6 pm) and the second 500 mL dose (including additional 500 mL of clear fluid) in the early morning of the day of the clinical procedure (at 5 am for morning procedure or 8 am for afternoon procedures). Participants in the Enhanced Bowel Preparation group will also take 1 sachet of Movicol and 2 Senokot tablets daily at 0800 in the week leading up to the colonoscopy. In t CONDITION: Cancer ‐ Bowel ‐ Back passage (rectum) or large bowel (colon) colorectal cancer; ; colorectal cancer PRIMARY OUTCOME: Compare the patient reported measures using the validated colonoscopy‐specific Newcastle ENDOPREM Questionnaire on the day after colonoscopy between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.[One day after colonoscopy assessment.] Comparison of the adenoma detection rate based on histopathology assessment of biopsy samples collected at the time of colonoscopy in patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive verbal and/or written bowel preparation instructions.[At the time of colonoscopy assessment.] INCLUSION CRITERIA: 1. Indicated for colonoscopy as an outpatient with a positive faecal occult blood test, rectal bleeding, or iron deficiency anaemia 2. Aged 45 years and above 3. Have a smartphone device which can support web browsing and use the web‐based application 4. Be able to independently give informed consent by verbal means 5. Possess a working email address for the purposes of consenting and information sharing SECONDARY OUTCOME: Compare the Boston Bowel Preparation Score at the time of colonoscopy in patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive verbal and/or written bowel preparation instructions.[At the time of colonoscopy assessment.] Compare the caecal intubation success rate at the time of colonoscopy on review of the procedural report between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.[At the time of colonoscopy assessment.] Compare the cancellation and non‐presentation rate related to patient factors on review of medical records between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.[At the time of colonoscopy assessment.] Compare the mean procedural time duration measured in minutes from the time of colonoscope insertion through to removal from the anal canal on review of the procedural report between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions. [At the time of colonoscopy assessment.]
Epistemonikos ID: 63ffc6b2e9ebcfaa34b9d226cb5694417549d2d1
First added on: Aug 25, 2024