Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001095550
Ethics application status
Approved
Date submitted
21/09/2015
Date registered
19/10/2015
Date last updated
19/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect on Hospitalisation and Cost Effectiveness of a Respiratory Coordinated Care Program for patients with Chronic Obstructive Pulmonary Disease.
Scientific title
A study of COPD Patients undergoing a Respiratory Coordinated Care Program and its effect on hospitalisation and cost for the 12 months before and after joining the program.
Secondary ID [1] 287503 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 296259 0
Condition category
Condition code
Respiratory 296529 296529 0 0
Chronic obstructive pulmonary disease
Public Health 296635 296635 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a Respiratory Coordinated Care Program. This is a multidisciplinary program for chronic respiratory disease patients involving regular outpatient follow ups by nurse specialists with liaison with physiotherapists, occupational therapists, respiratory registrars and consultants. These visits involve one on one home visits, initially weekly, then fortnightly and then monthly at the discretion of the treating nurse and team. At each visit, the patient's clinical state is assessed, as well as compliance with treatment, equipment supply and patient understanding of proper usage e.g. inhaler and spacer technique, referral to pulmonary rehabilitation as needed, and recognition of early clinical deterioration prompting an action plan whereby the community nurse would directly contact a respiratory physician or senior registrar, and early community treatment such as antibiotics, bronchodilators and steroids could be implemented. The service also provides close follow up of patients post discharge from hospital in order to facilitate ongoing recovery from their illness, and allow more rapid discharge from hospital. Missed visits are followed up with phone calls.
Intervention code [1] 292890 0
Treatment: Other
Comparator / control treatment
The comparator treatment is the standard of care for COPD patients involving GP and respiratory physician follow ups on an individually determined basis. As this was not a randomised study, the comparator treatment was determined by the care patients received prior to joining the intervention.
Control group
Active

Outcomes
Primary outcome [1] 296155 0
Hospitalisation rate
- measured by using hospital and database records for number of hospitalisations and length of stay in 12 month period
Timepoint [1] 296155 0
12 months
Secondary outcome [1] 317648 0
Cost to hospital
- simple cost analysis of costs of program including staff salaries, motor vehicle costs, medications and medical equipment, and calculating a cost of the program per patient. This was offset against savings made from changes in hospital admission rates and bed days, with 1 hospital bed day of a COPD admission conservatively estimated at $AUD 568 ($USD 400) based on the available literature
Timepoint [1] 317648 0
12 months

Eligibility
Key inclusion criteria
COPD by GOLD criteria, FEV1 < 50% predicted, Age greater than or equal to 60, psychosocial stability
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
other primary respiratory diagnosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not randomised, all patients in the study are enrolled in the program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The intervention and comparator groups were compared using paired t-test and multiple regression analysis to address the impact of confounding factors. No power calculations have been performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4367 0
St George Hospital - Kogarah
Recruitment hospital [2] 4368 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 10592 0
2217 - Kogarah
Recruitment postcode(s) [2] 10593 0
2232 - Sutherland

Funding & Sponsors
Funding source category [1] 292079 0
Self funded/Unfunded
Name [1] 292079 0
Country [1] 292079 0
Primary sponsor type
Hospital
Name
Respiratory Department St George Hospital
Address
St George Hospital, Gray St, Kogarah, NSW, 2217
Country
Australia
Secondary sponsor category [1] 290755 0
None
Name [1] 290755 0
Address [1] 290755 0
Country [1] 290755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293561 0
SESLHD HUMAN RESEARCH ETHICS COMMITTEE (SOUTHERN SECTOR)
Ethics committee address [1] 293561 0
St George Hospital
Gray St, Kogarah, NSW, Australia 2217
Ethics committee country [1] 293561 0
Australia
Date submitted for ethics approval [1] 293561 0
26/03/2012
Approval date [1] 293561 0
18/04/2012
Ethics approval number [1] 293561 0
LNR/12/STG/55

Summary
Brief summary
COPD patients were enrolled into an RCCP coordinated multidisciplinary program aimed at improving health outcomes and decreasing hospitalisation. Data from 2007-2012 was prospectively collected in a database, and retrospectively reviewed. Patients were analysed as to rates of hospitalisation in the 12 months prior to and after joining the program. The cost of the program was analysed against savings from decreased hospitalisation.
Trial website
Trial related presentations / publications
Poster presentation
Aslam P., Man J., Behary J., Riskallah J., Ansary S., Kwan B., "Outcomes and Cost of COPD RCCP Program", Thoracic Society of Australia and New Zealand Respiratory Education Meeting November 15, 2013

Public notes
Ethics approval was obtained after enrollment in the intervention study was complete, as although data was prospectively collected, the intervention was set up in its own right, and it was unclear if a study was to be formally performed on the collected data. When a decision was made that the data was to be retrospectively analysed in a study, ethics approval was then sought and obtained, and data analysis then occurred.

Contacts
Principal investigator
Name 60466 0
Dr Johnathan Man
Address 60466 0
Department of Respiratory Medicine
Sutherland Hospital
Kingsway, Caringbah, NSW 2229
Country 60466 0
Australia
Phone 60466 0
+61434098777
Fax 60466 0
Email 60466 0
johnathanjman@gmail.com
Contact person for public queries
Name 60467 0
Benjamin Kwan
Address 60467 0
Department of Respiratory Medicine
Sutherland Hospital
Kingsway, Caringbah, NSW 2229
Country 60467 0
Australia
Phone 60467 0
+61 2 95407111
Fax 60467 0
Email 60467 0
ben.kwan@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 60468 0
Benjamin Kwan
Address 60468 0
Department of Respiratory Medicine
Sutherland Hospital
Kingsway, Caringbah, NSW 2229
Country 60468 0
Australia
Phone 60468 0
+61 2 95407111
Fax 60468 0
Email 60468 0
ben.kwan@sesiahs.health.nsw.gov.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
No additional documents have been identified.