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

Sponsor

Griffith Base Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04898426

Collaborator

(none)

500

Enrollment

Location

Arms

6.6

Anticipated Duration (Months)

76.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.

Condition or Disease	Intervention/Treatment	Phase
Colon Polyp Colon Neoplasm	Other: Enhanced bowel preparation instruction	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The patient cannot be blinded to the allocation. The colonoscopist (care provider) is blinded to the allocation. The investigator and statistician will remain blinded to the allocation until analysis has been conducted.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 13, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Standard Bowel Preparation Instruction

Patients receive the standard-of-care bowel preparation instruction.

Experimental: Enhanced Bowel Preparation Instruction

Patients receive enhanced instructions (SMS, phone call, info website) in addition to the standard-of-care bowel preparation instruction.

Other: Enhanced bowel preparation instruction

Automated delivery of SMS, pre-recorded phone call, and link to an information website.

Outcome Measures

Primary Outcome Measures

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.]
Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (range 0 to 9, with higher scores indicating better bowel preparation quality)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.