ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000067471

Ethics application status

Approved

Date submitted

29/06/2006

Date registered

22/01/2007

Date last updated

4/01/2010

Type of registration

Retrospectively registered

Titles & IDs

Public title

A randomised controlled trial of the Practitioner Asthma Communication and Education (PACE) Australia Program

Scientific title

A randomised controlled trial to measure the impact of the Practitioner Asthma Communication and Education (PACE) Australia program on the process and outcomes of general practioners' management of children with asthma

Universal Trial Number (UTN)

Trial acronym

PACE Australia Phase 3

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Childhood asthma

Condition category

Condition code

Respiratory

Asthma

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The PACE Australia intervention for General Practitioners (GPs) comprised two structured 3-hour interactive sessions one week apart. Eight PACE workshops were held from February 2007 to April 2008 for intervention group GPs. Attendance was set at a maximum of 15 GPs per workshop. The specific aims of the PACE workshops were to improve GP practice in the following key areas: appropriate use of medications, writing an asthma action plan, communication between patient and doctor to improve adherence and patient education and giving instructions on the correct use of aerosol delivery devices.

Intervention code [1]

Other interventions

Comparator / control treatment

General practitioners (GPs) were randomly allocated to be wait listed to receive the PACE Australia workshops after patients have had 12 months follow up.

Control group

Active

Outcomes

Primary outcome [1]

The proportion of paediatric asthma patients having a written Asthma Action Plan

Timepoint [1]

Measured at baseline and at 12 months follow up post intervention.

Secondary outcome [1]

Process outcomes were assessed at baseline and at 12 months follow up using validated questionnaires: (1) GP communication and teaching behaviour ; (2) GP adherence to National Asthma Council paediatric asthma management guidelines ; (3) Proportion of children who have completed the Asthma Cycle of Care item numbers;

Timepoint [1]

Measured at baseline and at 12 months follow up post intervention.

Secondary outcome [2]

Children's outcomes were collected over 12 months by telephone interviews: (1) Medication use ; (2) Number of unscheduled and scheduled consultations ; (3) Days missed from school or child care ; (4) Satisfaction with care provided by the GP.

Timepoint [2]

Measured at baseline and at 12 months follow up post intervention.

Eligibility

Key inclusion criteria

GPs:All interested GPs in the Western & Central Sydney Area. The inclusion criteria for families were a child between the ages of 2 and 14 years with a diagnosis of asthma; only one child per family was eligible to participate and a level of English fluency was necessary to enable participation in telephone-administered questionnaires.

Minimum age

2 Years

Maximum age

14 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria: only one child per family; parents who aren't fluent in English for interviewing purpose.

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)

Use of an independent body to generate the randomisation sequence by using minimisation to balance participant numbers over three levels (gender; Division of General Practice; FRACGP membership).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated random number sequence.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Double blinded: Family (patient) participants, data analyst

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

17/07/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

360

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Chronic Disease Programs Section, Chronic Disease Branch, Mental Health and Chronic Disease Division, Australian Government Department of Health and Ageing

Address [1]

GPO Box 9848 MDP4
ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Primary Health Care Education & Research Unit, Faculty of Medicine, University of Sydney

Address

Westmead Hospital, PO Box 533, Westmead NSW 2145

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney West Area Health Service-Westmead Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/06/2006

Ethics approval number [1]

2006/4/4/11(2334)

Ethics committee name [2]

University of Sydney

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

27/07/2006

Ethics approval number [2]

9379

Ethics committee name [3]

Sydney South West Area Health Service-Royal Prince Alfred Hospital

Ethics committee address [3]

New ethics address. Please modify.

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

17/10/2007

Ethics approval number [3]

X07-0024

Summary

Brief summary

The Practitioner Asthma Communication and Education (PACE) Australia study is a collaborative project of the University of Sydney, The Woolcock Institute of Medical Research, The Royal Children’s Hospital, Melbourne and the University of Michigan, funded by the Australian Government Department of Health and Ageing. 
The aim of the study was to assess the impact of an evidence–based paediatric asthma program for GPs on GP practice and family health outcomes.
We recruited a total of 150 GPs and 221 patients from western and central Sydney. We performed a randomised controlled trial with intervention GPs randomly allocated to receive the PACE workshops. Comparison GPs did not receive the PACE workshops until the end of the study.
The PACE workshops comprised two 3-hour interactive sessions led by asthma experts. These sessions focussed on best practice approaches to paediatric asthma management and communication strategies with parents. 
Outcome measures for both GPs and patients were determined at baseline and 12 months.
Following the PACE Australia workshops:
1.	GPs reported increased use of the recommended communication strategies with their patients; increased use of the Asthma Cycle of Care item numbers and more frequent provision of written asthma action plans.
2.	Families of intervention GPs reported increased receipt of asthma action plans and spacer devices, as well as more appropriate medication use. 
The program resulted in significant improvements in the way in which GPs manage asthma consultations, particularly with regard to doctor-patient communication and adherence to asthma management guidelines with a resultant improvement in key patient outcomes. 
The PACE Australia workshops were highly rated by all participating GPs. Here’s what some GPs said:
“Improved my communication with patients and my knowledge and use of asthma devices.” 
“I have been able to provide more useful education to the patients by using the models provided at the workshop.”
“I have been more interactive with parents & child, involving child more in treatment planning.”

Trial website

The PACE Australia workshop educator’s and train the trainer’s manual will be available online through the Asthma Foundation of Victoria website http://www.asthma.org.au/

Trial related presentations / publications

2010
•	Shah S, SM Sawyer, CM Mellis, BG Toelle, JK Peat, JK Roydhouse, M Lagleva, P Edwards, T Usherwood, CR Jenkins& Clark NM (accepted for oral presentation).  Improving Paediatric Asthma Management Through Provider Education: A Randomised Controlled Trial, 2010 Thoracic Society of Australia and New Zealand Annual Scientific Meeting, March 2010, Brisbane & 2010 American Thoracic Society Annual Meeting, May 2010, New Orleans

o	To be submitted to the British Medical Journal: ?Authors A randomised controlled trial to test the effectiveness of the Practitioner Asthma Communication and Education (PACE) Australia program. 
•	Roydhouse JK, Shah S, Toelle BG, Sawyer SM, Peat JK, Jenkins CR on behalf of PACE Australia (submitted for oral presentation). Paediatric asthma education and communication in general practice: what do doctors and parents say? 2010 Thoracic Society of Australia and New Zealand Annual Scientific Meeting, March 2010, Brisbane & 2010 American Thoracic Society Annual Meeting, May 2010, New Orleans

2009
•	Smita Shah, Jessica K. Roydhouse, Craig Mellis, Brett Toelle, Susan M Sawyer, Christine Jenkins for PACE Australia (accepted for poster presentation), “Evaluation of asthma education and communication skills workshops for general practitioners,” 2009 General Practitioner & Primary Health Care Research Conference, 15 - 17 July 2009, Melbourne

•	Smita Shah, Jessica K. Roydhouse, Brett Toelle, Susan M Sawyer, Christine Jenkins for PACE Australia (accepted for oral presentation), “The status of paediatric asthma management in Australian general practice,” 2009 General Practitioner & Primary Health Care Research Conference, 15 - 17 July 2009, Melbourne

o	To be submitted to the Primary Care Respiratory Journal: Roydhouse JK, Shah S, Toelle B, Sawyer SM, CR Jenkins. Australian GPs’ attitudes, levels of confidence and self-reported practice regarding paediatric asthma management


•	Smita Shah, Jessica K. Roydhouse, Craig Mellis, Brett Toelle, Susan M Sawyer, Christine Jenkins for PACE Australia (accepted for poster presentation), “Evaluation of asthma education and communication skills workshops for general practitioners,” 2009 American Thoracic Society Annual Scientific Meeting, San Diego 

•	Jessica K. Roydhouse, Smita Shah, Brett Toelle, Susan M Sawyer, Christine Jenkins for PACE Australia (accepted for oral presentation), “The status of paediatric asthma management in Australian general practice,” 2009 American Thoracic Society Annual Meeting, San Diego

•	Smita Shah, Jessica K. Roydhouse, Craig Mellis, Brett Toelle, Susan M Sawyer, Christine Jenkins for PACE Australia (oral presentation), “Evaluation of asthma education and communication skills workshops for general practitioners,” 2009 Thoracic Society of Australia and New Zealand Annual Scientific Meeting, Darwin
o	Published as: S Shah, JK Roydhouse, B Toelle, SM Sawyer, C Jenkins. Evaluation of asthma education and communication skills workshops for general practitioners, Respirology 2009 14, (Suppl 1) A 30 

•	Jessica K. Roydhouse, Smita Shah, Brett Toelle, Susan M Sawyer, Christine Jenkins for PACE Australia (poster presentation), “The status of paediatric asthma management in NSW general practice,” 2009 Thoracic Society of Australia and New Zealand Annual Scientific Meeting, Darwin
o	Published as: Jessica K Roydhouse, Smita Shah, Brett Toelle, Susan M Sawyer, Christine Jenkins, for PACE Australia. The status of paediatric asthma management in NSW general practice, Respirology 2009 14, (Suppl 1) A 80 

2008
•	Smita Shah, Jessica K. Roydhouse, Brett Toelle, Susan Sawyer, Christine Jenkins, for the PACE Australia Management Committee (poster presentation), “Recruitment For A RCT In Primary Care: What works best?” 27 – 29 August 2008, Westmead Hospital Research Week, Sydney

•	Smita Shah, Jessica K. Roydhouse, Brett Toelle, Susan Sawyer, Christine Jenkins, for the PACE Australia Management Committee, “Recruitment For A RCT In Primary Care: What works best?” 28 – 31 May 2008, International Primary Care Respiratory Group 4th World Conference, Seville (oral presentation)

•	Roydhouse JK, Shah S, Toelle B, Sawyer S, Mellis C, Jenkins C, for the PACE Australia Management Committee, “Strategies used in Recruitment for a Randomised Controlled Trial in Primary Care,” 16 – 21 May 2008, American Thoracic Society Annual Meeting, Toronto (poster presentation) 
o	Published as: Roydhouse JK, Shah S, Toelle B, Sawyer S, Jenkins C. Strategies used in Recruitment for a RCT in Primary Care, Am J Respir Crit Care Med 2008 April; 177 (Abstracts Issue), A576.

•	Smita Shah, Jessica K. Roydhouse, Brett Toelle, Susan Sawyer, Christine Jenkins, for the PACE Australia Management Committee, “Strategies Used In Recruitment For A RCT In Primary Care,” 29 March – 3 April 2008, Thoracic Society of Australia and New Zealand Annual Meeting, Melbourne (poster presentation).
o	Published as: Shah S, Roydhouse JK, Toelle B, Sawyer S, Jenkins C. Strategies used in Recruitment for a RCT in Primary Care, Respirology 2008 13, (2) A 68 

2007
•	Shah S, Toelle B, Roydhouse J, Sawyer S & Jenkins C, “Partnerships and challenges in recruitment for a RCT in primary care,” 29 November 2007, 4th Biennial NSW Primary Health Care Research & Evaluation Conference, Sydney (oral presentation)

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Smita Shah

Address

Primary Health Care Education and Research Unit, University of Sydney, Westmead Hospital PO Box 533 Westmead NSW 2145

Country

Australia

Phone

+61 2 98456505

Fax

+61 2 98455310

smita_shah@wsahs.nsw.gov.au

Contact person for scientific queries

Name

Dr Smita Shah

Address

Primary Health Care Education and Research Unit, University of Sydney, Westmead Hospital PO Box 533 Westmead NSW 2145

Country

Australia

Phone

+61 2 98456505

Fax

+61 2 98455310

smita_shah@wsahs.nsw.gov.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

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