Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000741785
Ethics application status
Approved
Date submitted
7/06/2013
Date registered
3/07/2013
Date last updated
3/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An unblinded, randomised, controlled trial to assess patient care and outcomes of standard outpatient care and telephone consultation.
Scientific title
An unblinded, randomised, controlled trial to assess the care given to patients, who have been referred to a nephrologist, and, assess the outcomes of standard outpatient care and telephone consultation care group.
Secondary ID [1] 282594 0
Nil
Universal Trial Number (UTN)
U1111-1143-6974
Trial acronym
TOOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People who have been referred to a Nephrologist and ongoing care 289290 0
kidney disease 289544 0
Condition category
Condition code
Renal and Urogenital 289610 289610 0 0
Kidney disease
Public Health 289868 289868 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Upon referral to a nephrologist at the Sunshine Coast Hospital and Health Service (SCHHS), an appointment will be made with the GP and the consultation with nephrologist will occur over the telephone. The appointment will be arranged between the nephrologist and the GP at a mutually convenient time.
The telephone consultation will take approximatley 15 mins.
The intervention and follow up period will be two years.
Intervention code [1] 287266 0
Other interventions
Comparator / control treatment
Upon referral to a nephrologist at SCHHS, an appointment will be made at the Renal Outpatient Department at Nambour General Hospital and the patient will come to have consultation with a nephrologist or the junior doctor assisting the nephrologist.
Control group
Active

Outcomes
Primary outcome [1] 289746 0
Feasibility of Recruitment. This will be assessed on the number of patients recruited (up to 60) before 36 months time frame. Study Coordinator will keep a diary of recruitment barriers and or issues for discussion at 3 monthly trial progress meetings.
Timepoint [1] 289746 0
36 Months after recruitment first commences
Secondary outcome [1] 303173 0
Patient and GP satisfaction for standard and telemedicine clinics. Questionnaires will be issued to patients and GP's after each visit
Timepoint [1] 303173 0
Baseline, 6 month, 12 month 18 month and 24 month timepoints
Secondary outcome [2] 303586 0
Patient travel time for standard and telemedicine clinics. Recording where and how (ie: car, bus, taxi) patient travelled from and to at each visit timepoint.
Timepoint [2] 303586 0
Baseline, 6 month, 12 month 18 month and 24 month timepoints
Secondary outcome [3] 303587 0
Patient's clinical progress. Assessed by blood and urine test results and examination of blood pressure.
Timepoint [3] 303587 0
Base line, 6 month, 12 month, 18month and 24 month time points
Secondary outcome [4] 303588 0
Consultation time for standard and telemedicine clinics, time will be recorded at commencement and completion of each visit
Timepoint [4] 303588 0
Base line, 6 month, 12 month, 18month and 24 month time points

Eligibility
Key inclusion criteria
1. Patient referred to the SCHHS renal service and triaged (as per triage guidelines) as category 2 or 3
2. Age >18
3. Patient able to give informed consent
4. GP gives informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient or GP declines consent for the study
2. Specialist or GP decision on clinical grounds that standard care would be more appropriate
3. Interpreter required
4. Severe cognitive impairment
5. Pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following receipt of initial referral and triage, patients deemed suitable for the study will be identified by a consultant nephrologist. Investigations required prior to initial consultation will be requested as per current standard practice. Both the patient and referring GP will receive information and consent forms to participate in the study. Provided both consent to the study, the patient will be randomised 1:1 to standard care or telemedicine care. Allocation is concealed by use of central randomisation by computer generation. An appointment date and time will be made. The telemedicine appointment will involve the patient attending the GP surgery with the GP in attendance during the consultation. This will facilitate 3 way transfer of information between the GP, patient, and specialist on the telephone. A letter will be sent by the specialist to the GP following the initial consultation (standard care and telemedicine care).

A survey will be sent for the GP and patient to complete following the initial appointment. Follow-up appointments will be made as necessary (either ongoing standard care or telemedicine clinic).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer block adaptive design
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
To ascertain differences between the two groups at baseline, demographic, comorbidity, and physiological data will be analysed using mean (standard deviation) or median (interquartile range) where appropriate. Differences in satisfaction will be examined in the same way.
Serial data including pathological and physiological, will be analysed using a linear and correlated regression model.
Time to event data (eg time from triage to appointment) will be analysed using a Cox type regression model.
For all analyses, the level of significance will be set at P < 0.05.
Data will be analysed using STATATM version 12.0.

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
8/07/2013
Actual
11/09/2013
Date of last participant enrolment
Anticipated
Actual
27/01/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1095 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 6948 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 287412 0
Charities/Societies/Foundations
Name [1] 287412 0
Wish List Foundation
Country [1] 287412 0
Australia
Primary sponsor type
Hospital
Name
Nambour General Hospital
Address
Hospital Road
Nambour
Queensland
4560
Country
Australia
Secondary sponsor category [1] 286158 0
None
Name [1] 286158 0
nil
Address [1] 286158 0
Country [1] 286158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289389 0
The Prince Charles Hospital, Metro North Hospital and Health Service Human Research Ethics Committee (HREC)
Ethics committee address [1] 289389 0
Research and Governance Unit
Lower ground, Administration building
The Prince Charles Hospital
Rode Road
Chermside
Queensland
4032
Ethics committee country [1] 289389 0
Australia
Date submitted for ethics approval [1] 289389 0
21/03/2013
Approval date [1] 289389 0
20/05/2013
Ethics approval number [1] 289389 0
HREC/13/QPCH/90

Summary
Brief summary
This project is to assess the feasibility of comparing the current standard care of a patient referred to the Sunshine Coast Hospital and Health Service-renal services, with a novel approach where the referred patient has a telephone consultation with the specialist while with his/her GP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40430 0
Dr Nicholas Gray
Address 40430 0
Renal Out-Patient Department
Nambour General Hospital
PO BOx 547
Nambour 4560
Country 40430 0
Australia
Phone 40430 0
+61 7 5470 6504
Fax 40430 0
+61 7 5470 6129
Email 40430 0
[email protected]
Contact person for public queries
Name 40431 0
Ms Andrea Pollock
Address 40431 0
Renal Out-Patient Department
Nambour General Hospital
PO BOx 547
Nambour 4560
Country 40431 0
Australia
Phone 40431 0
+61 7 5370 3514
Fax 40431 0
+61 7 5470 6129
Email 40431 0
[email protected]
Contact person for scientific queries
Name 40432 0
Dr Nicholas Gray
Address 40432 0
Renal Out-Patient Department
Nambour General Hospital
PO BOx 547
Nambour 4560
Country 40432 0
Australia
Phone 40432 0
+61 7 5470 6504
Fax 40432 0
+61 7 5470 6129
Email 40432 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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