ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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Go to the Login page, click ‘reset password’ and follow the instructions.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Communication intervention

Intervention code [1]

Other interventions

Intervention code [2]

Behaviour

Comparator / control treatment

No communication intervention

Control group

Placebo

Outcomes

Primary outcome [1]

Assessment of nature and variability of patient-doctor communication in both general and specialist practice in Australia.

Timepoint [1]

Primary outcome 1 will be measured from the audio-recordings

Primary outcome [2]

2. Length of consultation

Timepoint [2]

Primary outcome 2 will be measured from the audio-recordings

Secondary outcome [1]

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]

Outcomes will be measured from the audio-recordings

Secondary outcome [2]

2. Differences in management recommended in consultations.

Timepoint [2]

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]

2000

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Foundation for Informed Medical Decision Making

Address [1]

Foundation for Informed Medical Decision Making 40 Court Street, Suite 300 Boston, MA 02108

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney HREC

Ethics committee address [1]

University of Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

05/03/2008

Ethics approval number [1]

10482

Summary

Brief summary

The aim of this study is to evaluate the effect of consumers asking targeted questions to prompt evidence-based, shared decision making on the frequency and nature of evidence-based, shared decision making behaviours. 


Asking these three questions improved information given by family physicians and increased physician facilitation of patient involvement. Practice implications. These questions can drive evidence-based practice, strengthen patient–physician communication, and improve safety and quality.

Heather L. Shepherd, Alexandra Barratt, Lyndal J. Trevena et al. Three questions that patients can ask to improve the quality of information physicians give about treatment options: A cross-over trial Patient Education and Counseling, 2011 84(3) 379-385

Trial website

n/a

Trial related presentations / publications

Oral presentations
1.	HL Shepherd, A Barratt, MHN Tattersall, LJ Trevena, PN Butow CB Del Mar, K McGeechan, K Carey Hazell. The use of Standardised Patients (SPs) to assess, audit and improve oncologists’ consultation skills.   Australia & New Zealand Joint Scientific Meeting of Medical Oncology Group of Australia, Faculty of Radiation Oncology, New Zealand Society of Oncology and New Zealand Association of Cancer Specialists Clinical Oncological Society of Australia (COSA) 35th Annual Scientific Meeting, Sydney NSW November 2008 

Poster presentations
1.	HL Shepherd, A Barratt, LJ Trevena, PN Butow, MHN Tattersall,  RM Epstein, CB Del Mar, K McGeechan, V Entwistle, K Carey Hazell.  Questions To Prompt Communication About Evidence. A Feasibility Study Using Standardised Patients. International Shared Decision Making Conference June 2009 Boston USA.
2.	HL Shepherd, A Barratt, LJ Trevena, PN Butow, K McGeechan1, V Entwistle. The ACE coding scheme: development of a measure of to assess communication about evidence International Shared Decision Making Conference June 2009 Boston USA.
3.	HL Shepherd, A Barratt, MHN Tattersall, LJ Trevena, PN Butow CB Del Mar, K McGeechan, K Carey Hazell. The use of Standardised Patients (SPs) to assess, audit and improve oncologists’ consultation skills.   Australia & New Zealand Joint Scientific Meeting of Medical Oncology Group of Australia, Faculty of Radiation Oncology, New Zealand Society of Oncology and New Zealand Association of Cancer Specialists, August 2008, Christchurch, NZ.

Public notes

Contacts

Principal investigator

Name

A/Prof Alexandra Barratt

Address

School of Public Health Edward Ford Building, A27 The University of Sydney NSW 2006

Country

Australia

Phone

+61 2 93515103

Fax

[email protected]

Contact person for public queries

Name

Heather Shepherd

Address

CeMPED Dept of Cancer Medicine Blackburn Building, D06 The University of Sydney NSW 2006

Country

Australia

Phone

+61 2 9036 5419

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Alex Barratt

Address

School of Public Health Edward Ford Building, A27 The University of Sydney NSW 2006

Country

Australia

Phone

+61 2 9351 1503

Fax

[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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically