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Trial registered on ANZCTR


Registration number
ACTRN12607000334404
Ethics application status
Approved
Date submitted
18/06/2007
Date registered
21/06/2007
Date last updated
21/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility, acceptability and cost-effectiveness of nurse-led models of chronic disease management in general practice
Scientific title
A comparison of the feasibility, acceptability and cost-effectiveness of a nurse-led collaborative care model versus the normal General Practitioner care model of chronic disease management in three general practice locations.
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type II diabetes 1883 0
Hypertension 1884 0
Ischemic heart disease 1885 0
Condition category
Condition code
Metabolic and Endocrine 1978 1978 0 0
Diabetes
Cardiovascular 1979 1979 0 0
Hypertension
Cardiovascular 1980 1980 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention = patients in primary care who are having their chronic disease (diabetes Type II, hypertension or ischemic heart disease) managed by a PN. This means that a PN will manage these patients, following protocols for each disease. The patient will only see the GP if the PN has a concern regarding the patient’s condition or if the patient requests this. Otherwise, all management will be undertaken by the PN.
Intervention code [1] 1837 0
Treatment: Other
Comparator / control treatment
Control = patients in primary care who are having their chronic disease (diabetes Type II, hypertension or ischemic heart disease) managed as usual by their GP within their general practice.
The intervention will last for 18 months.
Control group
Active

Outcomes
Primary outcome [1] 2798 0
Any change in health related quality of life and health status to patients with chronic disease in the PN-led arm of the project.
Timepoint [1] 2798 0
A minimum of six monthly intervals
Primary outcome [2] 2799 0
An assessment of patient satisfaction, confidence and ‘acceptability’ of this model.
Timepoint [2] 2799 0
Before and after the intervention
Primary outcome [3] 2800 0
The use of PNs to decrease the GP’s caseload of patients with chronic illness
Timepoint [3] 2800 0
At completion of the study – 18 months
Primary outcome [4] 2801 0
Estimate the costs and any cost-savings to patients, general practices and the government, and identify any shifts of costs between these and other institutions in the health sector.
Timepoint [4] 2801 0
At completion of the study – 18 months
Secondary outcome [1] 4718 0
Improvement of professionals’ adherence to protocols
Timepoint [1] 4718 0
At completion of the study – 18 month
Secondary outcome [2] 4719 0
Patients, GPs and nurses are satisfied with a nurse-led model
Timepoint [2] 4719 0
At completion of the study – 18 month
Secondary outcome [3] 4720 0
Impact, if any, of a nurse-led model of care on the number of visits needed by patients to general practitioners, hospital admissions and after hours presentations
Timepoint [3] 4720 0
At completion of the study – 18 month
Secondary outcome [4] 4721 0
The PN model has an impact on teamwork and collaboration in a general practice
Timepoint [4] 4721 0
At completion of the study – 18 month
Secondary outcome [5] 4722 0
Provide information on whether this model helps address the systemic impediments to current health workforce models and make recommendations on its progression.
Timepoint [5] 4722 0
At completion of the study – 18 month
Secondary outcome [6] 4723 0
Estimate the costs and any cost-savings to patients, general practices and the government, and identify any shifts of costs between these and other institutions in the health sector.
Timepoint [6] 4723 0
At completion of the study – 18 month

Eligibility
Key inclusion criteria
Patients who are currently being managed for Diabetes Type II, Hypertension, Ischemic Heart DiseasePatients with heart disease (angina, following MI) included in the intervention arm must be twelve months post acute incidence.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Each General Practitioner can decide if a patient is deemed unsuitable for management through this study.

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)
Allocation concealment by central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation conducted externally. Stratified allocation was also used. Participants were stratified according to disease type i.e. diabetes type II, hypertension, ischemic heart disease.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2120 0
Government body
Name [1] 2120 0
Australian Research Council (ARC) Discovery Grant
Country [1] 2120 0
Australia
Primary sponsor type
University
Name
Department of Nursing and Midwifery, Research and Practice Development Centre, University of Queensland and Blue Care.
Address
Country
Australia
Secondary sponsor category [1] 1926 0
None
Name [1] 1926 0
Nil
Address [1] 1926 0
Country [1] 1926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3910 0
University of Queensland
Ethics committee address [1] 3910 0
Ethics committee country [1] 3910 0
Australia
Date submitted for ethics approval [1] 3910 0
Approval date [1] 3910 0
12/10/2004
Ethics approval number [1] 3910 0
2004000718
Ethics committee name [2] 3911 0
University of Southern Queensland
Ethics committee address [2] 3911 0
Ethics committee country [2] 3911 0
Australia
Date submitted for ethics approval [2] 3911 0
Approval date [2] 3911 0
04/10/2004
Ethics approval number [2] 3911 0
H04STU419
Ethics committee name [3] 3912 0
Griffith University
Ethics committee address [3] 3912 0
Ethics committee country [3] 3912 0
Australia
Date submitted for ethics approval [3] 3912 0
Approval date [3] 3912 0
30/03/2007
Ethics approval number [3] 3912 0
NRS/08/07/HREC
Ethics committee name [4] 3913 0
Bond University
Ethics committee address [4] 3913 0
Ethics committee country [4] 3913 0
Australia
Date submitted for ethics approval [4] 3913 0
Approval date [4] 3913 0
12/02/2007
Ethics approval number [4] 3913 0
R0633

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27651 0
Address 27651 0
Country 27651 0
Phone 27651 0
Fax 27651 0
Email 27651 0
Contact person for public queries
Name 11026 0
Professor Desley Hegney
Address 11026 0
Research and Practice Development Centre
University of Queensland and Blue Care
PO Box 1539
Milton BC QLD 4064
Country 11026 0
Australia
Phone 11026 0
+61 7 37205302
Fax 11026 0
+61 7 37205332
Email 11026 0
[email protected]
Contact person for scientific queries
Name 1954 0
Professor Desley Hegney
Address 1954 0
Research and Practice Development Centre
University of Queensland and Blue Care
PO Box 1539
Milton BC QLD 4064
Country 1954 0
Australia
Phone 1954 0
+61 7 37205302
Fax 1954 0
+61 7 37205332
Email 1954 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
No additional documents have been identified.