Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy.

Study Overview
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Brief Summary
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Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.

Detailed Description
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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.

Official Title
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Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy: a Randomised Controlled Trial.

Conditions
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Colon Polyp, Colon Neoplasm

Intervention / Treatment
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* Other: Enhanced bowel preparation instruction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Bowel Preparation Instruction<br>Patients receive the standard-of-care bowel preparation instruction. | |
| Experimental: Enhanced Bowel Preparation Instruction<br>Patients receive enhanced instructions (SMS, phone call, info website) in addition to the standard-of-care bowel preparation instruction. | Other: Enhanced bowel preparation instruction<br>* Automated delivery of SMS, pre-recorded phone call, and link to an information website.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation quality | Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (range 0 to 9, with higher scores indicating better bowel preparation quality) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonoscopy cancellation rate | The number of colonoscopy being cancelled within 48 hours of the colonoscopy date. The rates will be compared between the study groups. | Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months. | 
| Caecal intubation rate | The proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon. The rates will be compared between the study groups. | Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months. | 
| Polyp detection rate | The proportion of colonoscopies in which a polyp was detected. The rates will be compared between the study groups. | Polyp detection rate will be calculated at the time of study completion, expected to be 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Boston bowel preparation scale, Bowel preparation quality, Enhanced bowel preparation instruction