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Trial registered on ANZCTR


Trial ID
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] 259650 0
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 81 0
Condition category
Condition code
Respiratory 101 101 0 0
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] 21 0
Prevention
Comparator / control treatment
2. Usual care in practices supplied with a portable electronic spirometer
Control group
Active

Outcomes
Primary outcome [1] 125 0
Number of spirometry tests in a six month period. Acceptability of spirometry to patients and GPs experiences of spirometry provision.
Timepoint [1] 125 0
6 months
Primary outcome [2] 126 0
Quality of spirometry in a six month period. Acceptability of spirometry to patients and GPs experiences of spirometry provision.
Timepoint [2] 126 0
6 months
Primary outcome [3] 127 0
Costs of spirometry in a six month period. Acceptability of spirometry to patients and GPs experiences of spirometry provision.
Timepoint [3] 127 0
6 months
Secondary outcome [1] 289 0
New diagnoses of COPD
Timepoint [1] 289 0
3 months post spirometry
Secondary outcome [2] 290 0
Change in intention to quit smoking in current smokers with normal or abnormal lung function.
Timepoint [2] 290 0
3 months post spirometry

Eligibility
Key inclusion criteria
Smokers and ex-smokers
Minimum age
35 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 135 0
University
Name [1] 135 0
University of Tasmania
Address [1] 135 0
University of Tasmania,
PO Box 252-34
Hobart Tasmania 7001
Country [1] 135 0
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] 97 0
None
Name [1] 97 0
none
Address [1] 97 0
Country [1] 97 0

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 36238 0
Address 36238 0
Country 36238 0
Phone 36238 0
Fax 36238 0
Email 36238 0
Contact person for public queries
Name 9210 0
Dr Julia Walters
Address 9210 0
Menzies Research Institute Tasmania
University of Tasmania,
MS1 UTAS, 17 Liverpool Street,
Private Bag 23, Hobart TAS 7000
Country 9210 0
Australia
Phone 9210 0
+61 3 62264798
Fax 9210 0
+61 03 6226 7704
Email 9210 0
jaew@utas.edu.au
Contact person for scientific queries
Name 138 0
Dr Julia Walters
Address 138 0
Menzies Research Institute Tasmania
MS1 UTAS, 17 Liverpool Street,
Private Bag 23, Hobart TAS 7000
Country 138 0
Australia
Phone 138 0
+61 03 6226 4798
Fax 138 0
Email 138 0
Julia.Walters@utas.edu.au