Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000304538
Ethics application status
Approved
Date submitted
13/07/2006
Date registered
14/07/2006
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Date results information initially provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of nurse and GP partnership for care of COPD
Scientific title
A cluster randomised controlled trial of nurse and General Practitioner (GP) partnership for care of Chronic Obstructive Pulmonary Disease (COPD) to improve disease-related quality of life and overall health of patients with COPD and the quality of care provided to these patients with impacts on knowledge, immunisation compliance, smoking cessation and satisfaction with care.
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 1277 0
Condition category
Condition code
Respiratory 1364 1364 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Practices
This structured 6-month intervention involves GP and COPD management nurse working together to provide care for patients with COPD. Standardised training for the COPD Management Nurses to develop specialised skills in COPD management will be provided by the study team under direction of professor Guy Marks (Chief investigator C) who is Director of Respiratory Medicine at Liverpool Hospital with input from respiratory specialist liaison nurses at Liverpool and Fairfield Hospitals.
Intervention process
The COPD Management Nurse will work with the GP, the patients and other care providers. Patients will receive two home visits and five telephone contacts from the nurse and a minimum of two consultations with their GP over a six-month period. The nurse and GP will meet face to face on two occasions and further consultation between the nurse and GP will take place by telephone monthly or more frequently when needed to discuss progress and problems.
Nurse role:
1. 1st Home visit
The nurse will assess the patient, confirm the diagnosis and evaluate severity, assess smoking and immunisation status, assess the patient’s understanding of their condition and management. During this visit, the nurse will identify specific management issues for the patient and provide standardised education.
2. Care plan preparation and implementation
The nurse will initiate preparation of the care plan tailored to the patient’s needs and based on the COPDX guidelines. The nurse will meet with the patient’s GP to discuss the care plan and organise an appointment for the patient with the GP for completion of the plan. The nurse will work with the GP and other health professionals to implement the plan. The nurse will organise an appointment for the patient at 4 months for review with the GP.
3. 2nd home visit
During this consultation the nurse will review the patient’s understanding of the care plan, motivation and progress on implementation of each element of the plan.
4. Telephone calls
The nurse will proactively telephone the patient fortnightly after the 1st home visit and monthly after the 2nd home visit to check understanding, motivate uptake of the plan and address barriers to implementation of each element of the plan.
5. Hand-over of care
At six months the nurse will provide a written report on implementation of the plan for the GP and patient and handover care to the GP and other members of the care team.
GP role:
1. Care plan preparation and implementation
The GP will meet with the nurse to discuss the care plan and then have a consultation with the patient to finalise the plan. Copies of the completed plan will be provided by the GP to the patient, the nurse and other health professionals involved in the patient’s care. The GP will see the patient to implement aspects of the care plan eg medication management, immunisation. GP visits will vary depending on individual patient needs.
2. Review
At four months the GP will review management of the patient.
Care plan content:
The care plan will be based on the recommendations of the COPDX evidence-based guidelines. The plan will seek to optimise management, improve function, prevent deterioration and enhance patient knowledge and skills. he care plan will be individualised to the needs of the patient and contain relevant components of the following:
1. Smoking cessation: recommended management will be based on Smoking Cessation Guidelines for Australian General Practice. Prof Nicholas Zwar, Chief Investigator A (CIA), led the development of these guidelines.
2. Immunisation: Influenza and pneumococcal vaccination status will be assessed. If vaccination is required, the patient will be referred to the GP for this to be done.
3. Pulmonary rehabilitation: Patients with moderate or severe COPD will be referred to a pulmonary rehabilitation program in Sydney South West Area Health Service which incorporates exercise and education.
4. Medication review: This will involve the nurse, GP and/or pharmacist. The review will involve a check of symptom control, compliance, optimising the use of short and long acting bronchodilators and inhaled corticosteroids, education about medications and assessment of and education about inhaler technique.
5. Nutrition: Patients with Body Mass Index outside the health weight range will be identified. Management will include nurse and/or GP advice about diet and exercise and referral to a dietician.
6. Psychosocial issues: Patients with known anxiety and/or depression will be assisted by the nurse to access counselling by the GP, referral to a psychologist or psychiatrist and medication.
7. Patient education: Patients will be provided with written information about COPD and its management. Patients will also be provided with information about local patient support groups (Lung Savers Group) which provide emotional support and enhance education provided by health professionals.
8. Co-morbidities and complications of COPD: Patients with co-morbidities and complications such as pulmonary hypertension, sleep apnoea and right heart failure will be referred for specialist assessment where the GP and nurse identify that further investigation and management are needed.
Intervention code [1] 1202 0
Prevention
Comparator / control treatment
Control Practices
Control patients will receive ‘usual’ care plus their GPs will be provided with a copy of the COPDX guidelines. ‘Usual’ care will be defined by what the GP and the patient normally do regarding review, pharmacological therapy and management of COPD and will be informed by the information in the COPDX guidelines.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1858 0
Patient quality of life: will be assessed using the St George Respiratory Questionnaire (SGRQ). The SGRQ is a self-administered instrument designed specifically for respiratory disease. It is a 50-item instrument from which are calculated a total score and three component scores: symptoms (distress caused by respiratory symptoms), activity (physical activities that are limited by breathlessness) and impacts (social and psychological effects of the disease). The SGRQ is scored from zero to 100 where zero indicates best quality of life and 100 worst. A change in score of four is considered clinically significant.
Timepoint [1] 1858 0
At baseline and 12 month follow up
Primary outcome [2] 1859 0
Lung function: Spirometry will be used to assess lung function. The project officer will perform spirometry, before and 10 minutes after the administration of salbutamol 200 µg via large volume spacer, according to standard methods.
Timepoint [2] 1859 0
This will be assessed at baseline, 6 months from baseline and 12 months from baseline.
Primary outcome [3] 1860 0
Patient health status: will be measured using the SF-12, a generic measure of health impairment. The SF-12 gives two scores, the mental components scale and the physical component scale, which both have a mean of 50 and a standard deviation of 10.
Timepoint [3] 1860 0
This will be administered at baseline, 6 months from baseline and 12 months from baseline.
Primary outcome [4] 1861 0
Health service use: the number and type of general practice, specialist, community health, and hospital services used during the previous 3 months will be recorded using a patient checklist of services.
Timepoint [4] 1861 0
This will be assessed at baseline, 6 months from baseline and 12 months from baseline.
Primary outcome [5] 1862 0
Immunisation status: details of immunisation status for influenza and pneumococcal infection will be collected by patient report.
Timepoint [5] 1862 0
This will be assessed at baseline and 12 months from baseline.
Primary outcome [6] 1863 0
Patient knowledge: of the steps that can be taken to reduce the progression of COPD will be assessed using the same measure as our earlier trial1. Patient will be asked to name up to three things that they can do to prevent progression of their lung disease.
Timepoint [6] 1863 0
This will be assessed at baseline and 12 months from baseline
Primary outcome [7] 1864 0
Patient satisfaction: with overall management will be measured using the project data collection tool. This instrument measures satisfaction with access, GP and nursing,
Timepoint [7] 1864 0
At 12 months
Primary outcome [8] 1865 0
Smoking status and cessation: the smoking status of patients at baseline will be established. Information on the number of cigarettes smoked and the time before the first cigarette in the morning (a measure of addiction), will be assessed. Attendance at a smoking cessation program and quit rates will be recorded. A Smokerlyser will be used to validate patient report of smoking status. This is a portable hand held instrument used to detect carbon monoxide in the breath.
Timepoint [8] 1865 0
This will be assessed at baseline, 6 months from baseline and 12 months from baseline
Secondary outcome [1] 3279 0
Value of the nurse and GP partnership: Structured interviews with the study nurses and the GPs will examine satisfaction with the program and perceptions of the value of working together.
Timepoint [1] 3279 0
Interviews will be conducted at the end of the study (12 months from baseline).
Secondary outcome [2] 3280 0
Structured interviews with patients will explore the effects and value of the nurse input into COPD care. The software package NVivo® will be used to facilitate coding, and exploration of the data.
Timepoint [2] 3280 0
Interviews will be conducted at the end of the study (12 months from baseline).

Eligibility
Key inclusion criteria
The aim is to recruit 40 GPs and 400 patients. A list of about 120 GPs practicing in South Western Sydney divisions of general practice (Bankstown, Fairfield, Liverpool and Macarthur divisions of general practice) will be constructed based on previous participation in research, attendance to division Continuation of Medical Education (CME) activities related to respiratory conditions and chief investigators personal contacts. Chief investigators will contact these GP and those GPs who express interest on the phone will be visited by one of the chief investigators. The GP will be eligible if he/she:• Practices within one of the above divisions• Has seen COPD patients in the last 12 months• Uses electronic prescribingPatients of these GPs are eligible if they:• Are 40 – 80 years of age• Have been diagnosed with COPD• Have seen their GPs in the last 12 months• Reside within the areas covered by the eligible divisions of general practice
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient exclusion criteria include:• Reside outside the area• Significant cognitive impairment• Poor English languageParticipating GPs will asked to identify COPD patients by searching their medical software. The search criteria include the following:• All patients (males and females) will be searched• Patients who are 40 to 80 years of age• Have used the practice in the last 12 months• Take drugs commonly used to treat COPDGPs will review the list of identified patients to:• Confirm COPD diagnosis• Exclude ineligible patients and document the reason for exclusion.

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)
Sequential sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design with fixed block sizes will be used to randomise participating GPs into intervention and control groups. Practices will be allocated to either group using computer generated random numbers. In each practice, if more than 30 COPD patients are identified, a random sample of 30 patients will be selected using computer generated random numbers. If less than 30 patients are identified all patients will be selected.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
30/09/2012
Date of last data collection
Anticipated
Actual
30/08/2013
Sample size
Target
400
Accrual to date
Final
287
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1498 0
Government body
Name [1] 1498 0
NHMRC Project Grant
Country [1] 1498 0
Australia
Funding source category [2] 1499 0
Government body
Name [2] 1499 0
Australian Government Department of Health and Ageing Primary Health Care Research, Evaluation and Development Strategy
Country [2] 1499 0
Australia
Primary sponsor type
Individual
Name
Prof Nicholas Zwar
Address
Country
Secondary sponsor category [1] 1316 0
None
Name [1] 1316 0
Nil
Address [1] 1316 0
Country [1] 1316 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2917 0
Human Research Ethic Committee of the University of NSW
Ethics committee address [1] 2917 0
Ethics committee country [1] 2917 0
Australia
Date submitted for ethics approval [1] 2917 0
Approval date [1] 2917 0
22/06/2006
Ethics approval number [1] 2917 0
06124

Summary
Brief summary
This cluster randomised controlled trial (RCT) tests a new approach to improving the care of patients with Chronic Obstructive Pulmonary Disease (COPD) managed in general practice. The intervention involves a registered nurse with specific training and the general practitioner (GP) working in partnership with the patient and other health professionals to provide evidence-based care according to the Australian COPDX guidelines. The research aims to determine the impact of this partnership on the quality of care and health outcomes for patients with COPD at six and 12 months follow-up. The hypotheses to be tested are:
1. The intervention improves disease-related quality of life and overall health of patients with COPD measured by patient health status, lung function and health service use
2. The intervention improves the quality of care provided to patients with COPD with impacts on knowledge, immunisation compliance, smoking cessation and satisfaction with care.

Since this trial is Single Blind, the data collection staff will be blinded to group allocation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35889 0
Prof Nicholas Zwar
Address 35889 0
School of Public Health and Community Medicine
University of NSW, Sydney NSW 2052
Country 35889 0
Australia
Phone 35889 0
+61 0293853811
Fax 35889 0
Email 35889 0
[email protected]
Contact person for public queries
Name 10391 0
Professor Nicholas Zwar
Address 10391 0
General Practice Unit
Fairfield Hospital
PO Box 6732
Wetherill Park NSW 1851
Country 10391 0
Australia
Phone 10391 0
+ 61 2 96168520
Fax 10391 0
+ 61 2 96168400
Email 10391 0
[email protected]
Contact person for scientific queries
Name 1319 0
Professor Nicholas Zwar
Address 1319 0
General Practice Unit
Fairfield Hospital
PO Box 6732
Wetherill Park NSW 1851
Country 1319 0
Australia
Phone 1319 0
+ 61 2 96168520
Fax 1319 0
+ 61 2 96168400
Email 1319 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
data not available in this format


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes https://doi.org/10.1093/fampra/cmw077 1461-(Uploaded-16-12-2018-09-17-55)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.