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1.  A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol 
Background
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care.
Design
A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP) team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD.
The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate), smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities.
The primary outcome measure is health-related quality of life, assessed with the St George’s Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related quality of life measures, smoking and immunisation status, medications, inhaler technique, and lung function. Outcomes will be assessed by project officers blinded to patients’ randomization groups.
Discussion
This study will use proven case-finding methods to identify patients with undiagnosed COPD in general practice, where improved care has the potential for substantial benefit in health and healthcare utilization. The study provides the capacity to trial a new model of team-based assessment and management of newly diagnosed COPD in Australian primary care.
Trial registration
ACTRN12610000592044\
doi:10.1186/1748-5908-7-83
PMCID: PMC3457839  PMID: 22958678
2.  Quit in General Practice: a cluster randomised trial of enhanced in-practice support for smoking cessation 
BMC Family Practice  2010;11:59.
Background
This study will test the uptake and effectiveness of a flexible package of smoking cessation support provided primarily by the practice nurse (PN) and tailored to meet the needs of a diversity of patients.
Methods/Design
This study is a cluster randomised trial, with practices allocated to one of three groups 1) Quit with Practice Nurse 2) Quitline referral 3) GP usual care. PNs from practices randomised to the intervention group will receive a training course in smoking cessation followed by access to mentoring. GPs from practices randomised to the Quitline referral group will receive information about the study and the process of written referral and GPs in the usual care group will receive information about the study. Eligible patients are those aged 18 and over presenting to their GP who are daily or weekly smokers and who are able to give informed consent. Patients on low incomes in all three groups will be able to access free nicotine patches.
Primary outcomes are sustained abstinence and point prevalence abstinence at the three month and 12 month follow-up points; and incremental cost effectiveness ratios at 12 months. Process evaluation on the reach and acceptability of the intervention approached will be collected through Computer Assisted Telephone Interviews (CATI) with patients and semi-structured interviews with PNs and GPs.
The primary analysis will be by intention to treat. Cessation outcomes will be compared between the three arms at three months and 12 month follow-up using multiple logistic regression. The incremental cost effectiveness ratios will be estimated for the 12 month quit rate for the intervention groups compared to usual care and to each other. Analysis of qualitative data on process outcomes will be based on thematic analysis.
Discussion
High quality evidence on effectiveness of practice nurse interventions is needed to inform health policy on development of practice nurse roles. If effective, flexible support from the PN in partnership with the GP and the Quitline could become the preferred model for providing smoking cessation advice in Australian general practice.
Trial Registration
ACTRN12609001040257
doi:10.1186/1471-2296-11-59
PMCID: PMC2931485  PMID: 20701812
3.  A cluster randomised controlled trial of nurse and GP partnership for care of Chronic Obstructive Pulmonary Disease 
Background
Chronic obstructive pulmonary disease (COPD) is a significant health problem worldwide. This randomised controlled trial aims at testing a new approach that involves a registered nurse working in partnership with patients, general practitioners (GPs) and other health professionals to provide care to patients according to the evidence-based clinical practice guidelines. The aim is to determine the impact of this partnership on the quality of care and patient outcomes.
Methods
A cluster randomised control trial design was chosen for this study. Randomisation occurred at practice level. GPs practising in South Western Sydney, Australia and their COPD patients were recruited for the study.
The intervention was implemented by nurses specifically recruited and trained for this study. Nurses, working in partnership with GPs, developed care plans for patients based on the Australian COPDX guidelines. The aim was to optimise patient management, improve function, prevent deterioration and enhance patient knowledge and skills. Control group patients received 'usual' care from their GPs.
Data collection includes patient demographic profiles and their co-morbidities. Spirometry is being performed to assess patients' COPD status and CO analyser to validate their smoking status. Patients' quality of life and overall health status are being measured by St George's Respiratory Questionnaire and SF-12 respectively. Other patient measures being recorded include health service use, immunisation status, and knowledge of COPD. Qualitative methods will be used to explore participants' satisfaction with the intervention and their opinion about the value of the partnership.
Analysis
Analysis will be by intention to treat. Intra-cluster (practice) correlation coefficients will be determined and published for all primary outcome variables to assist future research. The effect of the intervention on outcomes measured on a continuous scale will be estimated and tested using mixed model analysis of variance in which time and treatment group will be fixed effects and GP practice and subject nested within practice will be random effects. The effect of the intervention on the dichotomous variables (such as smoking status, patient knowledge) will be analysed using generalised estimating equations with a logistic link and a model structure that is analogous to that described above.
Trial registration
ACTRN012606000304538
doi:10.1186/1471-2466-8-8
PMCID: PMC2442044  PMID: 18519003
4.  Randomised controlled trial of home based care of patients with chronic obstructive pulmonary disease 
BMJ : British Medical Journal  2002;325(7370):938.
Objectives
To evaluate usefulness of limited community based care for patients with chronic obstructive pulmonary disease after discharge from hospital.
Design
Randomised controlled trial.
Setting
Liverpool Health Service and Macarthur Health Service in outer metropolitan Sydney between September 1999 and July 2000.
Participants
177 patients randomised into an intervention group (84 patients) and a control group (93 patients) which received current usual care.
Interventions
Home visits by community nurse at one and four weeks after discharge and preventive general practitioner care.
Main outcome measures
Frequency of patients' presentation and admission to hospital; changes in patients' disease-specific quality of life, measured with St George's respiratory questionnaire, over three months after discharge; patients' knowledge of illness, self management, and satisfaction with care at discharge and three months later; frequency of general practitioner and nurse visits and their satisfaction with care.
Results
Intervention and control groups showed no differences in presentation or admission to hospital or in overall functional status. However, the intervention group improved their activity scores and the control group worsened their symptom scores. While intervention group patients received more visits from community nurses and were more satisfied with their care, involvement of general practitioners was much less (with only 31% (22) remembering receiving a care plan). Patients in the intervention group had higher knowledge scores and were more satisfied. There were no differences in general practitioner visits or management.
Conclusions
This brief intervention after acute care improved patients' knowledge and some aspects of quality of life. However, it failed to prevent presentation and readmission to hospital.
What is already known on this topicPatients with chronic obstructive pulmonary disease often require hospital care and have impaired quality of lifeHome based care programmes provide viable alternatives to hospital admission for some patients at lower costWhat this study addsA brief, home based nurse intervention after acute care improved patients' knowledge but failed to reduce subsequent presentations or admissions to hospitalAdditional interventions or interventions earlier in the disease process may be required to reduce hospitalisations
PMCID: PMC130059  PMID: 12399344

Results 1-4 (4)