Clinical trial NCT04898426: Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy.
Official title: Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Polyp
Colon Neoplasm
Keywords: Colonoscopy
Boston bowel preparation scale
Bowel preparation quality
Enhanced bowel preparation instruction
Lead sponsor: Griffith Base Hospital
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.

Detailed description: This is a prospective, randomized, controlled clinical investigation designed to evaluate the efficacy of enhanced bowel preparation instructions (automated SMS, information website, and pre-recorded phone call) in improving bowel preparation quality in elective colonoscopy.

Subjects from the interventional and control group will receive standard of care bowel preparation instruction.

The interventional group will receive enhanced instructions delivered by automated SMS, information website and pre-recorded phone calls in the 48 hours leading up to the colonoscopy day. The intention is to provide a reminder, to reiterate instruction on clear fluid diet and timing of bowel preparation medication, and to provide additional graphical illustration on the information website.

Subjects in the interventional group must reply "OK" to each automated SMS or press "1" on the keypad at the end of the automated phone call to acknowledge understanding and receipt of instruction. Failure to acknowledge trigger an alert for a booking office staff member to directly call the patient and confirm compliance.

The clinical investigation will be conducted at one hospital in the state of New South Wales, Australia.

Subjects will be randomized to the interventional group (enhanced instruction) versus the control group (standard instruction).

The proceduralist assessing outcome measures at the time of colonoscopy is blinded to the intervention.

Eligibility criteria: Inclusion Criteria:

* Elective colonoscopy booking at Griffith Base Hospital.

Exclusion Criteria:

* Emergency colonoscopy
* Patients who are unable to understand bowel preparation instructions in the following languages: English, Italian, Punjabi, Gujarati, Samoan, Mandarin.

Primary outcomes:
measure: Bowel preparation quality
timeFrame: Bowel preparation quality is scored once for each patient at the time of colonoscopy completion. We expect to conduct this score in 500 patients over the study period of approximately 12 months.
Secondary outcomes:
measure: Colonoscopy cancellation rate
timeFrame: Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months.
measure: Caecal intubation rate
timeFrame: Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months.
measure: Polyp detection rate
timeFrame: Polyp detection rate will be calculated at the time of study completion, expected to be 12 months.
Other outcomes:
Locations:
city: Griffith
country: Australia
facility: Griffith Base Hospital
state: New South Wales
Study officials:
affiliation: Researcher
name: Minh Pham
role: PRINCIPAL_INVESTIGATOR
References:
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