Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000760976
Ethics application status
Approved
Date submitted
19/07/2011
Date registered
20/07/2011
Date last updated
20/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of referral letters on patient outcomes: A randomised control trial with video vignettes in Australian general practice.
Scientific title
A Modified Randomised Control Trial to identify whether any difference exists in the ability of specialists to triage patients based on referral letters created by GPs using their existing clinical systems compared with the Referral Writer software.
Secondary ID [1] 262534 0
Nil
Universal Trial Number (UTN)
nil
Trial acronym
RW study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Comparing the quality of referral letters from general practitioners using Referral Writing software with those not using the Referral Writer software and how this impacts on specialist triage of cancer patients. 268202 0
Condition category
Condition code
Other 268329 268329 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess the effectiveness of a computerised referral system, the Referral Writer (RW), to improve the quality of GP referral letters and the ability of specialists to prioritise patient appointments and make a diagnosis. Phase 1: 10 Actor-patient consultations based on a pre-determined script will be video recorded and posted onto a secure password protected website. 'Patients" will present with symptoms of one of six cancers. The 88 Participants (GPs) will asked to view the 10 video consultations, decide whether to refer the ‘patient’ and produce referral letters to specialists. This is envisaged to take a period of one month. Phase 2: Stratified randomisation of the 88 Participants (GPs) will occur and they will be split them into two groups of 44. These groups will be asked to view, over one month, 14 new different video consultations of actor patients presenting with symptoms of one of the six cancers. One group of GP participants, will decide whether to refer the ‘patient’ and produce referral letters to specialists using their standard system of generating letters. The second group of GP participants decide whether to refer the ‘patient’ and produce referral letters to specialists using the RW software. The ability of specialists to triage patients using referral letters produced by standard systems will be compared with triage from referral letters written using the RW software. It is envisaged that phase 2 will take one month. This randomised control trial hopes to provide evidence needed to support the integration of RW into existing clinical systems to enhance the referral process and improve outcomes for patients.
Intervention code [1] 266878 0
Other interventions
Comparator / control treatment
To determine whether any differences exist in specialists ability to schedule patient appointments (triage) and make a diagnoses based on referral letters created with GPs own standard protocol (control) compared to those created by the RW program.
Control group
Active

Outcomes
Primary outcome [1] 269213 0
The proportion of subjects able to be triaged with confidence by 2 specialists working independently (Phase 2) will be compared using multiwariable logistic regression, taking into account cluster randomisation and after adjusting for possible confounders such as demographic variables. The effect of Referral Writer as compared with Standard Practice will be presented as odds-ratio and associated with 95% confidence interval. P-values less than 0.05 will be considered as statistically significant. SAS (Version 9.2) and Stata (Version 11) will be used to perform the analyses of all data in this study.
Timepoint [1] 269213 0
At two months from the start of the study.
Secondary outcome [1] 279132 0
Secondarily; multivariable linear and logistic regressions will be used to determine if any identifiable subgroups of GPs have a high chance of referring patients who cannot be triaged with confidence, taking into account cluster randomisation and possible confounders. These identifiable subgroups will be determined for each arm and compared. Prior to randomisation, all practitoners will be operating under Standard Practice (Phase 1), the data from which will be instrumental to establish the baseline and determine identifiable subgroups of GPs writing letters that cannot be triaged with confidence.
Timepoint [1] 279132 0
At one and two months from the start of the study.

Eligibility
Key inclusion criteria
Participants will be general practitioners (GPs) registered with the appropariate state authority and working in community based practices across Australia.

Actors to take part in the simulated consultations will be recruited from an existing pool of actors the research team has used previously.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
GP participants will be excluded from the study if they are unable to provide 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)
Participants will be general practitioners (GPs) working in community based practices across Australia and will be recruited through email via the primary researcher's contacts (who is a practicing GP and has links to various GP networks) using purposive sampling methods (snowball, volunteer, convenience sampling). Allocation is not concealed. A flyer will be emailed to GPs with information on the study asking for their reply if they are interested in participating. To be eligible, participants must be available for the duration of the study (Phase 1 and 2). Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Phase 2 of the study will involve randomisation of GP participants to two arms - the RW arm and standard referral arm. Simple randomisation will occur in Phase 2 using a randomised table created by computer software (i.e. computer sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Multivariable linear and logistic regressions will be used to determine if any identifiable subgroups of GPs have a high chance of referring patients who cannot be triaged with confidence, taking into account cluster randomisation and possible confounders.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
1/08/2011
Date of last participant enrolment
Anticipated
1/08/2012
Actual
1/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA
Recruitment postcode(s) [1] 4252 0
Various; NSW and WA
Recruitment outside Australia
Country [1] 3681 0
United States of America
State/province [1] 3681 0
Country [2] 3682 0
Malaysia
State/province [2] 3682 0
Country [3] 3683 0
Iran, Islamic Republic Of
State/province [3] 3683 0
Country [4] 3684 0
United Kingdom
State/province [4] 3684 0

Funding & Sponsors
Funding source category [1] 267433 0
Other Collaborative groups
Name [1] 267433 0
WA Cancer and Palliative Care Network
Country [1] 267433 0
Australia
Primary sponsor type
Other Collaborative groups
Name
WA Cancer and Palliative Care Network
Address
Department of Health
189 Royal Street
East Perth WA6004
Australia
Country
Australia
Secondary sponsor category [1] 266531 0
None
Name [1] 266531 0
Address [1] 266531 0
Country [1] 266531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269408 0
Curtin University Human Research Ethics Comittee
Ethics committee address [1] 269408 0
Ethics committee country [1] 269408 0
Australia
Date submitted for ethics approval [1] 269408 0
Approval date [1] 269408 0
18/05/2011
Ethics approval number [1] 269408 0
RD-14-4

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

Contacts
Principal investigator
Name 32814 0
Prof Moyez Jiwa
Address 32814 0
Curtin Health Inovation Research Institute GPO Box U1987 Perth WA6845
Country 32814 0
Australia
Phone 32814 0
+61 8 9266 1768
Fax 32814 0
Email 32814 0
m.jiwa@curtin.edu.au
Contact person for public queries
Name 16061 0
Professor Moyez Jiwa
Address 16061 0
Curtin Health Inovation Research Institute
GPO Box U1987
Perth WA6845
Country 16061 0
Australia
Phone 16061 0
+61 8 9266 1768
Fax 16061 0
+61 8 9266 2608
Email 16061 0
M.Jiwa@curtin.edu.au
Contact person for scientific queries
Name 6989 0
Professor Moyez Jiwa
Address 6989 0
Curtin Health Inovation Research Institute
GPO Box U1987,
Perth WA6845
Country 6989 0
Australia
Phone 6989 0
+61 8 9266 1768
Fax 6989 0
+61 8 9266 2608
Email 6989 0
M.Jiwa@curtin.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseHow do general practitioners manage patients with cancer symptoms? A video-vignette study.2015https://dx.doi.org/10.1136/bmjopen-2015-008525
N.B. These documents automatically identified may not have been verified by the study sponsor.