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Trial registered on ANZCTR


Registration number
ACTRN12613000413729
Ethics application status
Not yet submitted
Date submitted
9/04/2013
Date registered
15/04/2013
Date last updated
15/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Education – Does it alter representations for Medical Care post Ureteric Stent Insertion?
Scientific title
In patients receiving ureteric stents for calculus disease, does different levels of formal education compared with standard care affect representation for medical attention?
Secondary ID [1] 282280 0
nil
Universal Trial Number (UTN)
U1111-1141-6661
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Colic (Urinary Calculus disease) 288816 0
Public Health 288866 0
Condition category
Condition code
Renal and Urogenital 289175 289175 0 0
Other renal and urogenital disorders
Public Health 289208 289208 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: Formal education in form of Written Handout
- Written handout will include subtitles of: What is a Stent? Why do you need a stent? What side effects should I expect? When should I see a doctor for stent symptoms? When will the stent be removed? What can I do with the stent in place? It will also include a visual image of the stent within kidney, ureter and bladder.
- Written information will be provided on the ward after stent insertion and prior to discharge. Patients will be given this information handout to keep.
- This intervention will technically last until their followup phone call which will occur within 3 months and after their stent is removed (stents are usually removed between 2-6 weeks).

Intervention 2: Formal education in form of Written Handout AND Informative Video
- The Written handout is exactly the same as Intervention 1.
- The informative video will include a visual(animated) projection of the stent and where it lies anatomically. Otherwise, the information provided will be the same as the written handout except that it will include audio as well as visual information. Again, it will be the same information as the written handout.
- Both these forms of education will occur after stent insertion and before discharge. Patients can keep their written handout and will be able to view the informative video only once.
- The duration of the intervention will be until they receive their phone call after stent extraction and within 3 months.
Intervention code [1] 286911 0
Other interventions
Comparator / control treatment
Comparator is standard education (verbal non-prepared information).
This standard education varies between which doctor relays information to the patient. Generally, it is expected of the doctors in the department to cover with the patient what a stent is, what it is used for and also what side-effects are to be expected with a stent. Patients are also advised of when to seek medical attention.
Standard education is provided after a stent is inserted prior to discharge.
The duration of the compariator is within 3 months after the stent is removed (usually after 2-6 weeks).
Control group
Historical

Outcomes
Primary outcome [1] 289286 0
Presentation to medical service (General Practitioner or Emergency Department)

Patients will be contacted over the telephone and asked a series of questions. The first question will ensure the patient has consented to be questioned for research purposes. The second question will be whether the patient has presented to an emergency department or general practitioner with stent related symptoms. To check that these are stent symptoms, they will be asked if they experienced abdominal, pelvic or flank pain, increased urinary frequency, pain on passing urine, symptoms of sepsis (fevers, night sweats, rigors) or asked to elaborate on any other symptoms

Results will be recorded on a database
Timepoint [1] 289286 0
Patients will be contacted within 3 months of stent insertion and after they have received intervention or comparator (usually immediately after stent insertion) AND after they have had their stent out (usually within 2-6 weeks)
Secondary outcome [1] 302167 0
Prescription of antibiotics

During the phone questionnaire, patients will be asked if they were prescribed antibiotics by the health service provider that they saw. Results will be recorded on a database.
Timepoint [1] 302167 0
Patients will be contacted within 3 months of stent insertion and after they have received intervention or comparator (usually immediately after stent insertion) AND after they have had their stent out (usually within 2-6 weeks)

Eligibility
Key inclusion criteria
All patients receiving ureteric stents as part of usual management for calculus disease.
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they have stents put in for non-calculus disease, for calculus disease in the presence of urinary infection or if they are non-english speaking.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who have had ureteric stents inserted as part of regular management of their stone disease will be approached and consented for the study. The allocation of participants to the trial's intervention and comparator groups will be based on their time of presentation (order in which they are included int he study). Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
-
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Main data for analysis will include whether or not patients present to their GP, ED or neither. Patient symptoms will be analysed as well as what treatment was provided to the patient.
The overall cohort of 150 patients is an estimate of how many stents will be inserted in the time-frame allowable for this research project (1 year).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 853 0
The Alfred - Prahran
Recruitment postcode(s) [1] 6666 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 287049 0
Self funded/Unfunded
Name [1] 287049 0
Unfunded
Country [1] 287049 0
Primary sponsor type
Individual
Name
Dr Gideon Blecher
Address
Urology Office - The Alfred
55 Commercial Road
Melbourne 3004
Victoria
Country
Australia
Secondary sponsor category [1] 285823 0
None
Name [1] 285823 0
Address [1] 285823 0
Country [1] 285823 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289079 0
The Alfred Research and Ethics Unit
Ethics committee address [1] 289079 0
OFFICE OF ETHICS & RESEARCH GOVERNANCE - Ground Floor, Linay Pavilion, The Alfred
55 Commercial Road
Melbourne 3004
Victoria
Ethics committee country [1] 289079 0
Australia
Date submitted for ethics approval [1] 289079 0
15/04/2013
Approval date [1] 289079 0
Ethics approval number [1] 289079 0

Summary
Brief summary
The aim of this research study is to assess whether patient education alters the frequency of representations to a doctor, following insertion of a ureteric stent for calculus (stone) disease.
Patients who have ureteric stents placed for stone disease will be approached for this study. They will be consented to:
1. Placement of their name on a register
2. Being contacted within 3 months by telephone where they will be asked whether they presented to their General Practitioner (GP) or Emergency Department (ED) for stent symptoms and if so, what the symptoms were.
3. GP may be called to clarify further information

Patients involved in the study will be randomised (through time of presentation) to either standard care, education leaflet or education leaflet as well as educational video.
Participants in the study will then be contacted by telephone within 3 months of stent insertion and questioned regarding presentations to their GP or ED. If they did, they will be asked regarding what symptoms they presented for and the health provider may be contacted to clarify further information.
The data will be evaluated to review if different levels of education may affect the representation rate following stent insertion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39130 0
Dr Gideon Blecher
Address 39130 0
Urology Office, Level 6, Centre Block, The Alfred. 55 Commercial Road, Melbourne 3004, Victoria.
Country 39130 0
Australia
Phone 39130 0
+61390762000
Fax 39130 0
Email 39130 0
[email protected]
Contact person for public queries
Name 39131 0
Gideon Blecher
Address 39131 0
Urology Office, Level 6, Centre Block, The Alfred. 55 Commercial Road, Melbourne 3004, Victoria
Country 39131 0
Australia
Phone 39131 0
+61390762000
Fax 39131 0
Email 39131 0
[email protected]
Contact person for scientific queries
Name 39132 0
Gideon Blecher
Address 39132 0
Urology Office, Level 6, Centre Block, The Alfred. 55 Commercial Road, Melbourne 3004, Victoria.
Country 39132 0
Australia
Phone 39132 0
+61390762000
Fax 39132 0
Email 39132 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

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