ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12605000019606

Ethics application status

Approved

Date submitted

14/07/2005

Date registered

18/07/2005

Date last updated

21/02/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

A comparison of two models of spirometry in general practice in the identification and prevention of COPD.

Scientific title

A cluster randomised crossover study comparing the efficacy of two models of spirometry provision in general practice on the identification and prevention of chronic obstructive pulmonary disease in smokers and ex-smokers over 35 years.

Secondary ID [1]

New secondary ID. Please modify.

Universal Trial Number (UTN)

Trial acronym

MYLF STUDY

Linked study record

Health condition

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

Chronic Obstructive Pulmonary Disease

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1.Trained nurse provision of spirometry to people aged over 35 at risk of COPD in general practice using a portable electronic spirometer.

Intervention code [1]

Prevention

Comparator / control treatment

2. Usual care in practices supplied with a portable electronic spirometer

Control group

Active

Outcomes

Primary outcome [1]

Number of spirometry tests in a six month period. Acceptability of spirometry to patients and GPs experiences of spirometry provision.

Timepoint [1]

6 months

Primary outcome [2]

Quality of spirometry in a six month period. Acceptability of spirometry to patients and GPs experiences of spirometry provision.

Timepoint [2]

6 months

Primary outcome [3]

Costs of spirometry in a six month period. Acceptability of spirometry to patients and GPs experiences of spirometry provision.

Timepoint [3]

6 months

Secondary outcome [1]

New diagnoses of COPD

Timepoint [1]

3 months post spirometry

Secondary outcome [2]

Change in intention to quit smoking in current smokers with normal or abnormal lung function.

Timepoint [2]

3 months post spirometry

Eligibility

Key inclusion criteria

Smokers and ex-smokers

Minimum age

35 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Unable to perform spirometry manoeuvres

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Third party code generation by random numbers

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

Cluster randomisation at practice level, stratification by socio-economc status and geography. Random sequence generation by coin toss.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Longitudinal follow up of current smokers in intervention 1 arm for smoking cessation and intention to quit smoking (stage of change)

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/11/2004

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

1500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Tasmania

Address [1]

University of Tasmania,
PO Box 252-34
Hobart Tasmania 7001

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Richard Wood-Baker

Address

Department of Respiratory Medicine,
Royal Hobart Hospital,
GPO Box 1061L
Hobart, Tasmania, 7001

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

To increase recognition of airflow obstruction in primary care, two models of spirometry delivery in a target group at risk of chronic obstructive pulmonary disease (COPD) were compared in a  qualitative/quantitative cluster randomised study in eight practices over 6 months; opportunistic spirometry by ‘‘visiting trained nurses’’ (TN) and optimised ‘‘usual care’’ (UC). In the eligible target population of smokers and ex-smokers aged over 35 years, 531/904 (59%) patients underwent spirometry in the TN model and 87/ 1130 (8%) patients in the UC model (p,0.0001). ATS spirometry standards for acceptability and reproducibility were met by 76% and 44% of tests in the TN and UC models, respectively (p,0.0001). GPs valued high quality spirometry and increased testing of patients at risk of COPD in the TN model. They identified limitations, including the need for better systematic follow-up of abnormal spirometry and support with interpretation, which may explain persisting underdiagnosis of COPD in practice records. Conclusions: Although opportunistic testing by visiting trained nurses substantially increased and improved spirometry performance compared with usual care, translating increased detection of airflow obstruction into diagnosis of COPD requires further support.

Trial website

Trial related presentations / publications

1.	Walters JA, Hansen E, Johns D, Blizzard L, Walters E, Wood-Baker R. A mixed methods study to compare models of spirometry delivery in primary care for patients at risk of Chronic Obstructive Pulmonary Disease. Thorax. 2008;63:408-14.
2.	Walters JA, Hansen E, Walters EH, Wood Baker R. Under-diagnosis of Chronic obstructive Pulmonary Disease: a qualitative study in primary care. Respir Med. 2008;102(5):738-43.
3.	Walters J, Johns DP, Blizzard L, Walters EH, Wood-Baker R. Effects of 
4.	feedback on spirometry in primary care on motivation for smoking cessation. Journal of Smoking Cessation. 2009;4(1):34-41.
5.	Walters J, Wood-Baker R, Walls J, Johns D. Stability of the EasyOne ultrasonic spirometer for use in general practice. Respirology. 2006;11(3):306-10.
6.	Walters JA, Hansen E, Mudge P, Johns DP, Walters EH, Wood-Baker R. Barriers to the use of spirometry in general practice. Aust Fam Physician. 2005;34(3):201-3.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Julia Walters

Address

Menzies Research Institute Tasmania
University of Tasmania,
MS1 UTAS, 17 Liverpool Street,
Private Bag 23, Hobart TAS 7000

Country

Australia

Phone

+61 3 62264798

Fax

+61 03 6226 7704

jaew@utas.edu.au

Contact person for scientific queries

Name

Dr Julia Walters

Address

Menzies Research Institute Tasmania
MS1 UTAS, 17 Liverpool Street,
Private Bag 23, Hobart TAS 7000

Country

Australia

Phone

+61 03 6226 4798

Fax

Julia.Walters@utas.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.

Trial Review

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