ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

PELICAN

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

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]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

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]

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]

Lung function- Forced expiratory volume in one second (FEV1) assessed by spirometry performed according to the standard methods

Timepoint [1]

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]

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]

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]

Inhaler technique - Assessment of inhaler technique assessed using published inhaler technique checklists

Timepoint [3]

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]

Patient report of participation in a pulmonary rehabilitation program

Timepoint [4]

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]

Patient knowledge - Patient knowledge of COPD will be assessed using a previously published measure

Timepoint [5]

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]

Health service use - Patient report of hospital admissions, emergency department attendances, or unscheduled visits to a doctor in the previous 6 months

Timepoint [6]

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]

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]

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]

Immunisation status - Immunisation status (influenza and pneumococcal) by patient report

Timepoint [8]

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]

Validation of COPD Diagnostic Questionnaire (CDQ) in Australian context

Timepoint [9]

At the case-finding visit by practice nurse.

Secondary outcome [10]

COPD Assessment Test (CAT) - a tool to quantify the impact of COPD on patients' health status

Timepoint [10]

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?

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]

2000-2249

Recruitment postcode(s) [2]

2555-2574

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

Prof Nicholas Zwar

Address [1]

School of Public Health and Community Medicine, University of New South Wales, SYDNEY
NSW 2052

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Australian Catholic University

Address [1]

National Centre for Clinical Outcome Research, Nursing & Midwifery Australia, Locked Bag 968, North Sydney, NSW 2059.

Country [1]

Australia

Other collaborator category [2]

Charities/Societies/Foundations

Name [2]

Woolcock Institute of Medical Research

Address [2]

Woolcock Institute of Medical Research, PO Box M77, Missenden Rd Post Office, NSW 2050

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

Maastricht University

Address [3]

Maastricht University, CAPHRI, P.O. Box 616, 6200 MD Maastricht, The Netherlands

Country [3]

Netherlands

Other collaborator category [4]

University

Name [4]

The University of Adelaide

Address [4]

Discipline of General Practice, The University of Adelaide, SA 5005

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Committee

Ethics committee address [1]

The University of New South Wales
SYDNEY
NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/02/2010

Approval date [1]

01/04/2010

Ethics approval number [1]

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

Prof Nicholas Zwar

Address

School of Public Health & Community Medicine The University of New South Wales Sydney, NSW 2052

Country

Australia

Phone

+61 2 93852515

Fax

n.zwar@unsw.edu.au

Contact person for public queries

Name

Prof Nicholas Zwar

Address

School of Public Health & Community Medicine
The University of New South Wales
Sydney, NSW 2052

Country

Australia

Phone

+61 2 9385 2515

Fax

+61 2 9313 6185

n.zwar@unsw.edu.au

Contact person for scientific queries

Name

Prof Nicholas Zwar

Address

School of Public Health & Community Medicine
The University of New South Wales
Sydney, NSW 2052

Country

Australia

Phone

+61 2 9385 2515

Fax

+61 2 9313 6185

n.zwar@unsw.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

Source	Title	Year of Publication	DOI
Dimensions AI	A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol	2012	https://doi.org/10.1186/1748-5908-7-83
Dimensions AI	Barriers and outcomes of an evidence-based approach to diagnosis and management of chronic obstructive pulmonary disease (COPD) in Australia: a qualitative study	2016	https://doi.org/10.1093/fampra/cmw103

N.B. These documents automatically identified may not have been verified by the study sponsor.

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