Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000764033
Ethics application status
Approved
Date submitted
7/09/2010
Date registered
15/09/2010
Date last updated
15/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Referral Writer: exploring the value of computer generated referral letters
Scientific title
A before and after study assessing the quality of referral letter from general practitioners without and with the use of the interactive software program Referral Writer.
Secondary ID [1] 252648 0
Nil
Universal Trial Number (UTN)
Trial acronym
RW Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
How information documented in referral letters may impact on specialist triage following the introduction of a computerised interactive referral pro-forma. 258144 0
Condition category
Condition code
Other 258321 258321 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
Part 1: For three months the participating General Practitioners (GPs) were asked to consent patients to allow access to their referral letters. The consent included access to the specialist diagnosis.
Part 2: The practitioners were invited to use the Referral Writer software to refer patients to the specialists. As in the phase before the Referral Writer we recorded the diagnosis of each patient referred to the specialists. The information relayed in each letter was scored before and after the Referral Writer with reference to a published measure of the quality of referral letters in six specialties (Urology, Breast, Gynaecology, Upper Gastrointestinal, Colorectal, Respiratory). The duration of part 2 was four months, including one month to allow the practitioners to become familiar with the software.
Part 1 and part 2 were back-to-back and the overall duration of the trial was a period of seven months.
Intervention code [1] 257159 0
Other interventions
Comparator / control treatment
For the first three months of the trial, participating General Practices(GPs) refered eligible patients to specialists as per standard protocol.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259177 0
Quality of referral letter standard protocol versus those developed using the Referral Writer.

The amount of clinically relevant information relayed in the referral letters was scored before and after introduction of the Referral Writer, by two specialists from each discipline (lung, breast, gynaecology, colorectal, upper gastrointestinal and genitourinary) using a validated data collection form (questionnaire)
Timepoint [1] 259177 0
At three months and seven months from the start of the study
Secondary outcome [1] 265522 0
Specialist triage factors

The specialists scored their confidence about triaging the patient based on information recorded in the letter using the data collection form
Timepoint [1] 265522 0
At nine months from the beginning of the study (two months of data assessment)
Secondary outcome [2] 265523 0
Patient outcome (diagnosis)

The specialists identifies the likelihood of the patient having benign pathology or a condition that warrants a specialist opinion for urgent surgical treatment, an acute exacerbation of a chronic condition or a life limiting condition using the data collection form
Timepoint [2] 265523 0
At nine months from the beginning of the study (two months of data assessment)

Eligibility
Key inclusion criteria
To be eligible for inclusion, a patient must satisfy ALL of the following:
a) Present with symptoms that warrant specialist investigation;
b) Receive a referral to an oncology breast, colorectal, lung, gynaecology,
genitourinary or upper gastrointestinal specialist (surgical, medical or radiation);
c) Able to undergo referral in Western Australia;
d) >18 years of age;
e) Available for follow-up for a minimum of three (3) months;
f) Able to provide informed consent.

General Practitioners in the Perth metropolitan area who use the following clinical management softwares were invited to participate:
i)Medical Director II or III
ii)Best Practice Software
iii)Zedmed
iv)Medtech
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded from the study if they are unable to provide informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A list of 116 practitioners, obtained from web and yellow pages searches were contacted. Of these 13 practioners from metropolitan Perth agreed to participate.

The participating practitioners were asked to consent patients to allow access to their referral letters.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A before and after study comparing outcomes before and after the intoduction of software to assist referral writing
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3246 0
6030
Recruitment postcode(s) [2] 3247 0
6018
Recruitment postcode(s) [3] 3248 0
6090
Recruitment postcode(s) [4] 3249 0
6056
Recruitment postcode(s) [5] 3250 0
6112
Recruitment postcode(s) [6] 3251 0
6027
Recruitment postcode(s) [7] 3252 0
6111
Recruitment postcode(s) [8] 3253 0
6027
Recruitment postcode(s) [9] 3254 0
6009

Funding & Sponsors
Funding source category [1] 257616 0
Other Collaborative groups
Name [1] 257616 0
WA Cancer and Palliative Care Network
Country [1] 257616 0
Australia
Primary sponsor type
Other Collaborative groups
Name
WA Cancer and Palliative Care Network
Address
Department of Health
189 Royal Street
East Perth WA 6004
Australia
Country
Australia
Secondary sponsor category [1] 256838 0
None
Name [1] 256838 0
Address [1] 256838 0
Country [1] 256838 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259634 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 259634 0
Ethics committee country [1] 259634 0
Australia
Date submitted for ethics approval [1] 259634 0
22/09/2008
Approval date [1] 259634 0
28/10/2008
Ethics approval number [1] 259634 0
RD-54-08

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

Contacts
Principal investigator
Name 31617 0
Address 31617 0
Country 31617 0
Phone 31617 0
Fax 31617 0
Email 31617 0
Contact person for public queries
Name 14864 0
Moyez Jiwa
Address 14864 0
GPO Box U1987
Perth Western Australia 6845
Country 14864 0
Australia
Phone 14864 0
+61 8 9266 1768
Fax 14864 0
+61 8 9266 9801
Email 14864 0
M.Jiwa@curtin.edu.au
Contact person for scientific queries
Name 5792 0
Moyez Jiwa
Address 5792 0
GPO Box U1987
Perth Western Australia 6845
Country 5792 0
Australia
Phone 5792 0
+61 8 9266 1768
Fax 5792 0
+61 8 9266 9801
Email 5792 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
No additional documents have been identified.