Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001033235
Ethics application status
Approved
Date submitted
25/11/2009
Date registered
30/11/2009
Date last updated
2/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health care communication in general and specialist practice
Scientific title
Health care communication in general and specialist practice
Secondary ID [1] 283126 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
ACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Communication about treatments and tests in clinical practice 3182 0
Condition category
Condition code
Public Health 3343 3343 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Communication intervention
Intervention code [1] 2914 0
Other interventions
Intervention code [2] 241615 0
Behaviour
Comparator / control treatment
No communication intervention
Control group
Placebo

Outcomes
Primary outcome [1] 4232 0
Assessment of nature and variability of patient-doctor communication in both general and specialist practice in Australia.
Timepoint [1] 4232 0
Primary outcome 1 will be measured from the audio-recordings
Primary outcome [2] 4233 0
2. Length of consultation
Timepoint [2] 4233 0
Primary outcome 2 will be measured from the audio-recordings
Secondary outcome [1] 7148 0
1. Differences in mean score on the coding scheme for quality and nature of communication , elicitation of patient preferences and explicit consideration of individual circumstances
Timepoint [1] 7148 0
Outcomes will be measured from the audio-recordings
Secondary outcome [2] 7149 0
2. Differences in management recommended in consultations.
Timepoint [2] 7149 0
Outcome will be recorded by Standardised Patient (SP) immediately after consultation or measured from the audio-recording

Eligibility
Key inclusion criteria
Practicing medical oncologists or general practitioners
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
non-practicing medical oncologists or general practitioners

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2008
Actual
14/04/2008
Date of last participant enrolment
Anticipated
Actual
22/09/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 863 0
2000

Funding & Sponsors
Funding source category [1] 3420 0
Charities/Societies/Foundations
Name [1] 3420 0
Foundation for Informed Medical Decision Making
Country [1] 3420 0
United States of America
Primary sponsor type
University
Name
School of Public Health
Address
University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 3063 0
None
Name [1] 3063 0
Address [1] 3063 0
Country [1] 3063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5443 0
University of Sydney HREC
Ethics committee address [1] 5443 0
Ethics committee country [1] 5443 0
Australia
Date submitted for ethics approval [1] 5443 0
Approval date [1] 5443 0
05/03/2008
Ethics approval number [1] 5443 0
10482

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

Contacts
Principal investigator
Name 28611 0
A/Prof Alexandra Barratt
Address 28611 0
School of Public Health Edward Ford Building, A27 The University of Sydney NSW 2006
Country 28611 0
Australia
Phone 28611 0
+61 2 93515103
Fax 28611 0
Email 28611 0
alexandra.barratt@sydney.edu.au
Contact person for public queries
Name 11768 0
Heather Shepherd
Address 11768 0
CeMPED Dept of Cancer Medicine
Blackburn Building, D06
The University of Sydney
NSW 2006
Country 11768 0
Australia
Phone 11768 0
+61 2 9036 5419
Fax 11768 0
Email 11768 0
heathers@med.usyd.edu.au
Contact person for scientific queries
Name 2696 0
A/Prof Alex Barratt
Address 2696 0
School of Public Health
Edward Ford Building, A27
The University of Sydney
NSW 2006
Country 2696 0
Australia
Phone 2696 0
+61 2 9351 1503
Fax 2696 0
Email 2696 0
alexb@health.usyd.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.