Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000454774
Ethics application status
Not yet submitted
Date submitted
17/04/2013
Date registered
19/04/2013
Date last updated
4/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does telephoning patients before the procedure improve patients' understanding of the risks of colonoscopy? A randomised controlled trial
Scientific title
In outpatients undergoing elective colonoscopy, does a telephone call 2 weeks prior to procedure improve patient's understanding of the risks of colonoscopy?
Secondary ID [1] 282358 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Informed consent - patient understanding of colonoscopy 288929 0
Condition category
Condition code
Oral and Gastrointestinal 289269 289269 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
The intervention group of patients will receive a telephone call 2 weeks prior to procedure. The details of the procedure, the complications and risks of the procedure will be re-stated. Patients will also be reminded of bowel preparation compliance.

The telephone call will be administered by one of the investigators, primarily Miss Brianne Lauritz. The duration of the call will be approximately 10minutes, however may vary if the patient has questions or concerns
Intervention code [1] 286984 0
Other interventions
Comparator / control treatment
Patient control group will not receive a telephone call.
Control group
Active

Outcomes
Primary outcome [1] 289374 0
Patient knowledge of the risks of colonoscopy
Timepoint [1] 289374 0
Understanding will be assessed with a questionnaire on the morning of the procedure. The questionnaire has been created specifically for this study.
Primary outcome [2] 289386 0
Patient perceived helpfulness of pamphlet given during obtaining consent
Timepoint [2] 289386 0
Questionnaire on morning of colonoscopy
Primary outcome [3] 289387 0
Patient's understanding of the details of the colonoscopy procedure
Timepoint [3] 289387 0
Questionnaire on morning of the colonoscopy
Secondary outcome [1] 302370 0
The telephone call will also briefly remind patients to comply with bowel preparation guidelines, and the Boston Bowel Preparation Scale will be completed by the colonoscopist to determine if the telephone call improved bowel preparation in the intervention group
Timepoint [1] 302370 0
The Boston Bowel Preparation Scale will be completed by the colonoscopist after completion of patient's procedure

Eligibility
Key inclusion criteria
Patient undergoing elective colonoscopy.
Can speak English.
Are mentally competent
Those that give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cannot understand nor speak English
Are mentally incompetent
Do not give informed consent

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)
Informed consent for the procedure will be obtained at a General Surgery or Gastroenterology Outpatient Clinic appointment, approximately 4 weeks prior to the procedure date. At the Outpatient Clinic patients will receive an information pamphlet on colonoscopy. Patients will also be asked if they wish to participate in this study and those that do, will sign a consent form. Patients will be informed of the purpose of this study, that that may or may not receive a phone call prior to the procedure and that they have the right to refuse to participate without any compromise to their care.
One of the investigators will be responsible for determining if a patient is eligible for inclusion in the trial and at the time will be unaware which to group the subject will be allocated. Allocation concealment will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation will involve simple randomisation using a randomisation table in statistics book.
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
A minimum of 100 participants per group is estimated to be necessary to yield 80% power at a two-tailed 0.05 level of clinical significance to demonstrate an effect size of 0.5 s.d. allowing for a 15% drop-out rate

Appropriate statistical analysis will be used to compare the two groups in; knowledge of procedure and risks, perceived helpfulness of pamphlet, what questions or concerns were not addressed previously or had to be re-addressed, perceived helpfulness of phone call, quality of bowel preparation. A p value of <0.05 is to be considered clinically significant. We will adjust for patient demographics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287125 0
Self funded/Unfunded
Name [1] 287125 0
Unfunded
Country [1] 287125 0
Primary sponsor type
Individual
Name
Mr Douglas Stupart
Address
Dept. Surgery, Geelong Hospital, Ryrie St, Geelong Vic 3227
Country
Australia
Secondary sponsor category [1] 285898 0
Individual
Name [1] 285898 0
Brianne Lauritz
Address [1] 285898 0
c/o Dept. Surgery, Geelong Hospital, Ryrie St, Geelong Vic 3227
Country [1] 285898 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289132 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 289132 0
Ethics committee country [1] 289132 0
Australia
Date submitted for ethics approval [1] 289132 0
09/04/2013
Approval date [1] 289132 0
Ethics approval number [1] 289132 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39382 0
Miss Brianne Lauritz
Address 39382 0
Dept. Surgery, Geelong Hospital, Ryrie St, Geelong Vic 3227
Country 39382 0
Australia
Phone 39382 0
+61394152011
Fax 39382 0
Email 39382 0
[email protected]
Contact person for public queries
Name 39383 0
Douglas Stupart
Address 39383 0
Dept. Surgery, Geelong Hospital, Ryrie St, Geelong Vic 3227
Country 39383 0
Australia
Phone 39383 0
+61394152011
Fax 39383 0
Email 39383 0
[email protected]
Contact person for scientific queries
Name 39384 0
Douglas Stupart
Address 39384 0
Dept. Surgery, Geelong Hospital, Ryrie St, Geelong Vic 3227
Country 39384 0
Australia
Phone 39384 0
+61394152011
Fax 39384 0
Email 39384 0
[email protected]

No information has been provided regarding IPD availability


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.