Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy.
Primary Purpose
Colon Polyp, Colon Neoplasm
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Enhanced bowel preparation instruction
Sponsored by
About this trial
This is an interventional other trial for Colon Polyp focused on measuring Colonoscopy, Boston bowel preparation scale, Bowel preparation quality, Enhanced bowel preparation instruction
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.
Sites / Locations
- Griffith Base HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Bowel Preparation Instruction
Enhanced Bowel Preparation Instruction
Arm Description
Patients receive the standard-of-care bowel preparation instruction.
Patients receive enhanced instructions (SMS, phone call, info website) in addition to the standard-of-care bowel preparation instruction.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
Polyp detection rate
The proportion of colonoscopies in which a polyp was detected. The rates will be compared between the study groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04898426
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Griffith Base Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp, Colon Neoplasm
Keywords
Colonoscopy, Boston bowel preparation scale, Bowel preparation quality, Enhanced bowel preparation instruction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Bowel Preparation Instruction
Arm Type
No Intervention
Arm Description
Patients receive the standard-of-care bowel preparation instruction.
Arm Title
Enhanced Bowel Preparation Instruction
Arm Type
Experimental
Arm Description
Patients receive enhanced instructions (SMS, phone call, info website) in addition to the standard-of-care bowel preparation instruction.
Intervention Type
Other
Intervention Name(s)
Enhanced bowel preparation instruction
Intervention Description
Automated delivery of SMS, pre-recorded phone call, and link to an information website.
Primary Outcome Measure Information:
Title
Bowel preparation quality
Description
Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (range 0 to 9, with higher scores indicating better bowel preparation quality)
Time Frame
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 Measure Information:
Title
Colonoscopy cancellation rate
Description
The number of colonoscopy being cancelled within 48 hours of the colonoscopy date. The rates will be compared between the study groups.
Time Frame
Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months.
Title
Caecal intubation rate
Description
The proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon. The rates will be compared between the study groups.
Time Frame
Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months.
Title
Polyp detection rate
Description
The proportion of colonoscopies in which a polyp was detected. The rates will be compared between the study groups.
Time Frame
Polyp detection rate will be calculated at the time of study completion, expected to be 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minh Pham
Phone
+61 2 6969 5555
Email
minhpham@medgneer.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kate FitzGerald
Phone
+61 2 6969 5555
Email
Sheila.Fitzgerald@health.nsw.gov.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minh Pham
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Griffith Base Hospital
City
Griffith
State/Province
New South Wales
ZIP/Postal Code
2680
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minh Pham, MBBS
Phone
02 69695555
Email
minhpham@medgneer.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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12135020
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Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy.
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