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Trial registered on ANZCTR


Registration number
ACTRN12619001198112
Ethics application status
Approved
Date submitted
19/07/2019
Date registered
27/08/2019
Date last updated
27/08/2019
Date data sharing statement initially provided
27/08/2019
Date results information initially provided
27/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of a behavioural incentive and intensive education on the quality of bowel preparation prior to diagnostic colonoscopies
Scientific title
Influence of a behavioural incentive (reward) and of intensive nurse-led education on the quality of bowel preparation prior to diagnostic colonoscopies
Secondary ID [1] 298765 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel preparation for colonoscopy 313701 0
Condition category
Condition code
Oral and Gastrointestinal 312116 312116 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Standard care.
Patients were prescribed a 3-litre split-dose PEG bowel preparation and a 12-page colour information booklet (Princess Alexandra Hospital resource: "Preparing for your colonoscopy")was mailed to them a month prior to the procedure.

Arm 2: Reward.
As per standard care plus offered a financial reward (an instant scratchie ticket for a state-wide lottery with a jackpot of up to $25,000) if they achieve a “good or very good” quality rating of the preparation.

Arm 3: Intensified education.
As per standard care (12-page education booklet mailed out a month prior to procedure) plus additional one-on-one education two weeks prior to their procedure, delivered by an endoscopy nurse over the phone (duration 5 to 20 minutes where bowel preparation instructions were reviewed, and patient's queries answered).
Intervention code [1] 315028 0
Behaviour
Comparator / control treatment
The control treatment is that of our standard care, as per explanation in Arm 1 (3 L PEG bowel preparation, 12-page instructional booklet).
Control group
Active

Outcomes
Primary outcome [1] 320756 0
Quality of bowel preparation for their colonoscopy procedure (by using the Boston Bowel Preparation Scale)
Timepoint [1] 320756 0
At the time of patient's colonoscopy procedure
Secondary outcome [1] 372742 0
Polyp detection rate by polypectomy at the time of the procedure
Timepoint [1] 372742 0
At the time of patient's colonoscopy procedure (once pathology is processed
Secondary outcome [2] 373413 0
Adenoma detection rate by polypectomy at the time of procedure
Timepoint [2] 373413 0
Once pathology results become available post the colonoscopy procedure
Secondary outcome [3] 374274 0
SAGIS questionnaire score (overall score that is calculated based on upper and lower gastrointestinal symptoms that patient experiences)
Timepoint [3] 374274 0
At data analysis stage, once the study is concluded

Eligibility
Key inclusion criteria
Adults from the general gastroenterology clinic referred for an elective colonoscopy
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cognitive or mental impairment
Known need for interventional procedures (e.g. resection of large polyps)
Language barriers

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The trials nurse recruiting patients was totally unaware of the randomisation schedule that was held under lock and key by one of the researchers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
t-tests, Pearson’s bivariate correlations., chi-square, logistic regression

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
5/11/2015
Date of last participant enrolment
Anticipated
Actual
30/01/2017
Date of last data collection
Anticipated
Actual
17/03/2017
Sample size
Target
300
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14245 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 27242 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303322 0
Charities/Societies/Foundations
Name [1] 303322 0
PA Foundation
Country [1] 303322 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
PA Foundation
Address
199 Ipswich Rd, Woolloongabba, Queensland 4102
Country
Australia
Secondary sponsor category [1] 303344 0
None
Name [1] 303344 0
Address [1] 303344 0
Country [1] 303344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303856 0
Metro South Ethics Committee
Ethics committee address [1] 303856 0
Metro South Health HREC
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 303856 0
Australia
Date submitted for ethics approval [1] 303856 0
13/05/2015
Approval date [1] 303856 0
25/05/2015
Ethics approval number [1] 303856 0
HREC/15/QPAH/221

Summary
Brief summary
Research Aims:
To test the effect of a patient reward system (Instant scratchie lottery ticket) or augmented education improves:
a) quality of bowel preparations
b) and the polyp detection rate
To test whether the total SAGIS score correlates with the number of polyps found

Research Design & Methods to Achieve Aims:
During one calendar year 300 outpatients referred for a colonoscopy will be recruited who have consented to the study. The quality of bowel preparation will be scored via the Boston bowel preparation scale, which is the most extensively validated scoring system. Block randomisation will be used to allocate all patients consented on a given day into one of three treatment groups (Scratchie ticket lottery ticket reward vs. no reward vs. intensified education).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95034 0
Prof Gerald Holtmann
Address 95034 0
Princess Alexandra Hospital
199 Ipswich Rd,
Woolloongabba, Qld, 4102
Country 95034 0
Australia
Phone 95034 0
+617 3176 2613
Fax 95034 0
Email 95034 0
[email protected]
Contact person for public queries
Name 95035 0
Gerald Holtmann
Address 95035 0
Princess Alexandra Hospital
199 Ipswich Rd,
Woolloongabba, Qld, 4102
Country 95035 0
Australia
Phone 95035 0
+617 3176 2613
Fax 95035 0
Email 95035 0
[email protected]
Contact person for scientific queries
Name 95036 0
Gerald Holtmann
Address 95036 0
Princess Alexandra Hospital
199 Ipswich Rd,
Woolloongabba, Qld, 4102
Country 95036 0
Australia
Phone 95036 0
+617 3176 2613
Fax 95036 0
Email 95036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The consent form indicates that individual data will only be made available to the listed researchers.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.