Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000592044
Ethics application status
Approved
Date submitted
27/05/2010
Date registered
21/07/2010
Date last updated
11/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Earlier diagnosis and management of Chronic Obstructive Pulmonary Disease (COPD) in general practice
Scientific title
A cluster randomised trial to examine the impact of early intervention by practice nurse-general practitioner (GP) teams on quality of life, health status and lung function of Chronic Obstructive Pulmonary Disease (COPD) patients.
Secondary ID [1] 251862 0
None
Universal Trial Number (UTN)
Trial acronym
PELICAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 257461 0
Condition category
Condition code
Respiratory 257609 257609 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Practice nurse will work in partnership with the GP and patients newly diagnosed with COPD to develop a care plan, which will contain relevant components of the following: 1) Smoking cessation as per current guidelines for current smokers 2) Immunisation - influenza and pneumococcal vaccination status will be assessed and updated 3) Pulmonary rehabilitation for patients with COPD. 4) Current medications and education about potential future indications for pharmacotherapy will be assessed. For patients already using any inhaler, inhaler technique will be checked using published checklists. Patients for whom inhalers are indicated will be educated on the appropriate use of these using established protocols. 5) Nutrition: Advice about diet and exercise and referral to a dietician if appropriate for overweight or underweight patients. 6) Psychosocial issues: identification and management of anxiety and/or depression. 7) Patient education: patients will be provided with written information about COPD and its management and with information about local patient support groups which provide emotional support and self-management information. 8) Co-morbidities and complications of COPD will be assessed and managed.

The GP and the practice nurse involved with patient care will decide the frequency of visit and the intervention will be of 12 months duration.
Intervention code [1] 256488 0
Diagnosis / Prognosis
Intervention code [2] 256489 0
Treatment: Other
Intervention code [3] 256490 0
Lifestyle
Comparator / control treatment
Nurse will recommend that patients with newly diagnosed COPD see their GP who will have been mailed a copy of COPD-X guidelines. Usual care for the purpose of this study will thus be the normal pattern of care by a GP, supported by the re-circulation of widely available guidelines without any supporting educational activities.
Control group
Active

Outcomes
Primary outcome [1] 258522 0
The St George Respiratory Questionnaire (SGRQ) will be used for two purposes: 1) to collect patients' COPD related quality of data and 2) patients overall health status data (from the preamble question of (SGRQ)
Timepoint [1] 258522 0
1) at the first visit by project officer soon after the case-finding visit by practice nurse 2) 6 months from the first visit 3) 12 months from the first visit
Secondary outcome [1] 264352 0
Lung function- Forced expiratory volume in one second (FEV1) assessed by spirometry performed according to the standard methods
Timepoint [1] 264352 0
1) at the first visit by project officer soon after the case-finding visit by practice nurse 2) 12 months from the first visit
Secondary outcome [2] 264353 0
Medication audit - Patient report of medication use. This data will be collected by project officer at all three visits just that at 6 month data will only be collected about respiratory medications.
Timepoint [2] 264353 0
1) at the first visit by project officer soon after the case-finding visit by practice nurse 2) 6 months from the first visit 3) 12 months from the first visit
Secondary outcome [3] 264354 0
Inhaler technique - Assessment of inhaler technique assessed using published inhaler technique checklists
Timepoint [3] 264354 0
1) at first visit by project officer soon after the case-finding visit by practice nurse 2) 12 months from the first visit
Secondary outcome [4] 264356 0
Patient report of participation in a pulmonary rehabilitation program
Timepoint [4] 264356 0
1) at the first visit by project officer soon after the case-finding visit by practice nurse 2) 6 months from the first visit 3) 12 months from the first visit
Secondary outcome [5] 264357 0
Patient knowledge - Patient knowledge of COPD will be assessed using a previously published measure
Timepoint [5] 264357 0
1) at the first visit by project officer soon after the case-finding visit by practice nurse 2) 12 months from the first visit
Secondary outcome [6] 264359 0
Health service use - Patient report of hospital admissions, emergency department attendances, or unscheduled visits to a doctor in the previous 6 months
Timepoint [6] 264359 0
1) at the first visit by project officer soon after the case-finding visit by practice nurse 2) 6 months from the first visit 3) 12 months from the first visit
Secondary outcome [7] 264913 0
Smoking status- Attendance at a smoking cessation program and quit rates will be recorded (patient report). Validation of patient report of smoking status using Smokerlyser analysis
Timepoint [7] 264913 0
1) at the first visit by project officer soon after the case-finding visit by practice nurse 2) 12 months from the first visit
Secondary outcome [8] 264915 0
Immunisation status - Immunisation status (influenza and pneumococcal) by patient report
Timepoint [8] 264915 0
1) at the first visit by project officer soon after the case-finding visit by practice nurse 2) 12 months from the first visit
Secondary outcome [9] 264916 0
Validation of COPD Diagnostic Questionnaire (CDQ) in Australian context
Timepoint [9] 264916 0
At the case-finding visit by practice nurse.
Secondary outcome [10] 264917 0
COPD Assessment Test (CAT) - a tool to quantify the impact of COPD on patients' health status
Timepoint [10] 264917 0
1) at the first visit by project officer soon after the case-finding visit by practice nurse 2) 6 months from the first visit 3) 12 months from the first visit

Eligibility
Key inclusion criteria
Inclusion criteria:

1) attended the practice at least twice and with at least one visit in the preceding 12 months

2) aged between 40 and 85 years

3) history of smoking recorded or uncertain
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1) a recorded diagnosis of COPD

2) age less than 40 or greater than 85

3) inability to understand English

4) cognitive impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur at the practice level rather than at the level of individual patients to either practice nurse-GP management team or usual care by GP alone. "STATA statistical package will be used to generate the randomisation sequence. Practices will be stratified by size and randomised in blocks. Randomisation will be carried out using a computer-generated randomization program, with a minimisation algorithm to ensure a balance of practice characteristics that could potentially affect study outcomes (practice size, socio-economic status, and participation by the GP in COPD education activities in the last 6 months).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
STATA statistical package will be used to generate the randomisation sequence. Practices will be stratified by size and randomised in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
6/04/2011
Date of last participant enrolment
Anticipated
Actual
17/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2930 0
2000-2249
Recruitment postcode(s) [2] 2931 0
2555-2574

Funding & Sponsors
Funding source category [1] 257061 0
Government body
Name [1] 257061 0
National Health and Medical Research Council
Country [1] 257061 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
The University of New South Wales
SYDNEY
NSW 2052
Country
Australia
Secondary sponsor category [1] 256314 0
Individual
Name [1] 256314 0
Prof Nicholas Zwar
Address [1] 256314 0
School of Public Health and Community Medicine, University of New South Wales, SYDNEY
NSW 2052
Country [1] 256314 0
Australia
Other collaborator category [1] 1301 0
University
Name [1] 1301 0
Australian Catholic University
Address [1] 1301 0
National Centre for Clinical Outcome Research, Nursing & Midwifery Australia, Locked Bag 968, North Sydney, NSW 2059.
Country [1] 1301 0
Australia
Other collaborator category [2] 1302 0
Charities/Societies/Foundations
Name [2] 1302 0
Woolcock Institute of Medical Research
Address [2] 1302 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Rd Post Office, NSW 2050
Country [2] 1302 0
Australia
Other collaborator category [3] 1303 0
University
Name [3] 1303 0
Maastricht University
Address [3] 1303 0
Maastricht University, CAPHRI, P.O. Box 616, 6200 MD Maastricht, The Netherlands
Country [3] 1303 0
Netherlands
Other collaborator category [4] 1304 0
University
Name [4] 1304 0
The University of Adelaide
Address [4] 1304 0
Discipline of General Practice, The University of Adelaide, SA 5005
Country [4] 1304 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259082 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 259082 0
The University of New South Wales
SYDNEY
NSW 2052
Ethics committee country [1] 259082 0
Australia
Date submitted for ethics approval [1] 259082 0
01/02/2010
Approval date [1] 259082 0
01/04/2010
Ethics approval number [1] 259082 0
HREC 10015

Summary
Brief summary
COPD is a common problem for current or ex smokers but is often undiagnosed or diagnosed late when the condition has deteriorated significantly. Effective treatment is available so early diagnosis is very important. In this study practice nurses will identify patients who are at risk of COPD and undertake case finding. Patients newly diagnosed with COPD who attend the “intervention practices” will be offered a management involving the GP and practice nurse working in partnership. The patients who attend the “control practices” will receive usual care from their GPs. We will then primarily examine the impact of the “intervention” or the “usual care” on patients' quality of life, health status and lung function and draw a comparison between the two groups in order to asses the effectiveness of the intervention.
Trial website
Trial related presentations / publications
Nicholas Zwar; Sandy Middleton, PhD; Helen Reddel, PhD; Onno Van Schayck, PhD; Allan Crockett, PhD; Sarah Dennis, PhD; Guy Marks, PhD; Jeremy Bunker, MBBS; Sanjyot Vagholkar, MBBS; Oshana Hermiz, MBBS; Iqbal Hasan, MBBS. Primary Care Early Intervention for COPD Management (PELICAN) Study: Progress on a Cluster Randomised Trial. NAPCRG’s 39th Annual Meeting
Zwar N, Middleton S, Reddel H, Bunker J, Crockett A, Dennis S, van Schayck CP, Liaw T, Vagholkar S, Hermiz O, Hasan I. The PELICAN study: Progress of a trial of early intervention for Chronic Obstructive Pulmonary Disease by practice nurse and GP teams. Plenary Presentation. Australian Practice Nurses Association Annual Conference 2011. Sydney 7th - 9th April 2011
Zwar NA, Middleton S, Reddel HK, van Schayck CP, Crockett A, Dennis S, Marks G, Bunker J, Vagholkar S, Liaw T. Hasan I, Hermiz O. Primary care EarLy Intervention for Copd mANagement (PELICAN) study: progress on a cluster randomised trial. Oral presentation. 6th World Conference of the International Primary Care Respiratory Group. Edinburgh 25th-28th April 2012.
Zwar N, Middleton S, Reddel H, van Schayck O, Crockett A, Dennis S, Marks G, Bunker J, Hasan I, Hermiz O, Liaw T. Primary care EarLy Intervention for Copd mANagement (PELICAN) study: progress on a cluster randomised trial. 2012 Primary Health Care Research Conference. Canberra 18-20 July 2012.
Hermiz O, Zwar N, Reddel H, Crockett A, Middleton S, Dennis S, Hasan I, Marks G, Liaw T. A cluster randomized trial of early intervention for chronic obstructive pulmonary disease by practice nurse-GP teams – baseline participant attributes. 2012 Primary Health Care Research Conference. Canberra 18-20 July 2012.
Dennis S, Reddel H, Middleton S, Crockett A, Vagholkar S, Hasan I, Marks G, Zwar N. COPDX guideline ownership by GPs in Sydney. 2012 Primary Health Care Research Conference. Canberra 18-20 July 2012.
Bunker J†, Reddel HK, Dennis S, Middleton S, Van Schayck CP, Crockett AJ, Hasan I, Hermiz O, Vagholkar S, Marks GB, Zwar NA. Protocol: A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse GP teams. Implementation Science 2012, 7:83 (7 September 2012)
Zwar NA, Middleton S, Reddel HK, van Schayck CP, Crockett A, Dennis S, Marks G, Bunker J, Vagholkar S, Liaw T. Hasan I, Hermiz O. Primary care EarLy Intervention for Copd mANagement (PELICAN) study: progress on a cluster randomised trial. Poster Presentation. 40th North American Primary Care Research Group Annual Meeting. New Orleans. 1-5 December 2012
Reddel HK, Dennis SM, Hasan I, Hermiz O, Bunker J, Middleton S, Van Schayck CP, Crockett AJ, Vagholkar S, Marks GB, Zwar NA. Accuracy of case-finding for COPD by practice nurses. Respirology, 2013. 19(S2): 37
N. Zwar, H. Reddel, J. Bunker, S. Middleton, A. Crockett, S. Dennis, I. Hasan, O. Hermiz, O. van Schayck, G. Marks Accuracy of Case Finding for COPD by Practice Nurses. International Primary Care Respiratory Group International Research Conference. Uppsala, Sweden 23-24 May 2013
Nicholas Zwar, Helen Reddel, Jeremy Bunker, Sandy Middleton, Alan Crockett, Sarah Dennis, Iqbal Hasan, Oshana Hermiz, Onno van Schayck, Guy Marks. Accuracy of case finding for Chronic Obstructive Pulmonary Disease by Practice Nurses. 2013 Primary Health Care Research Conference. Sydney, 10-12 July 2013.
HK Reddel, SM Dennis, I Hasan, O Hermiz, J Bunker, S Middleton, CP van Schayck, AJ Crockett, S Vagholkar, GB Marks, NA Zwar. Accuracy of case-finding for COPD by Australian Practice Nurses. North American Primary Care Research Group 41st Annual Meeting. Ottawa, Ontario November 9-13, 2013
Stanley AJ, Crockett AJ, Hasan I, Van Schayck CP and Zwar NA. Validation of the COPD Diagnostic Questionnaire in an Australian general practice cohort: a cross-sectional study. Accepted for publication: Primary Care Respiratory Journal.
Public notes

Contacts
Principal investigator
Name 31173 0
Prof Nicholas Zwar
Address 31173 0
School of Public Health & Community Medicine The University of New South Wales Sydney, NSW 2052
Country 31173 0
Australia
Phone 31173 0
+61 2 93852515
Fax 31173 0
Email 31173 0
[email protected]
Contact person for public queries
Name 14420 0
Prof Prof Nicholas Zwar
Address 14420 0
School of Public Health & Community Medicine
The University of New South Wales
Sydney, NSW 2052
Country 14420 0
Australia
Phone 14420 0
+61 2 9385 2515
Fax 14420 0
+61 2 9313 6185
Email 14420 0
[email protected]
Contact person for scientific queries
Name 5348 0
Prof Prof Nicholas Zwar
Address 5348 0
School of Public Health & Community Medicine
The University of New South Wales
Sydney, NSW 2052
Country 5348 0
Australia
Phone 5348 0
+61 2 9385 2515
Fax 5348 0
+61 2 9313 6185
Email 5348 0
[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
SourceTitleYear of PublicationDOI
Dimensions AIA pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol2012https://doi.org/10.1186/1748-5908-7-83
Dimensions AIBarriers and outcomes of an evidence-based approach to diagnosis and management of chronic obstructive pulmonary disease (COPD) in Australia: a qualitative study2016https://doi.org/10.1093/fampra/cmw103
N.B. These documents automatically identified may not have been verified by the study sponsor.