Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000327088
Ethics application status
Not yet submitted
Date submitted
21/04/2010
Date registered
22/04/2010
Date last updated
22/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Would an Extended Care Paramedic model of care improve outcomes for patients?
Scientific title
Would an Extended Care Paramedic model of care improve outcomes for patients that are not high-risk served by Wellington Free Ambulance.
Secondary ID [1] 251641 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Improvement in emergency patient outcomes using and Extended Care Paramedic (ECP) model of care for paramedics 257225 0
Improvement in emergency patient outcomes using and Extended Care Paramedic (ECP) model of care for paramedics 257234 0
Condition category
Condition code
Other 257361 257361 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ambulance service tends to transport the majority of patients they see to emergency departments. This places a burden on emergency departments and inconveniences the patient. The Extended Care Paramedic (ECP) model of care is based on training standard paramedics with a broader range of assessment and treatment skills that enables them to treat a large group of these patients at home and in their local community. The training is given to a small group of 6 Paramedics to enable a 24hr roster. The training is over a month with monthly ongoing clinical training days. This model requires formal evaluation through a randomised controlled trial (RCT) to establish whether this is an improvement in patient outcome. The RCT will then be assessed after training and will last unitl 1000 patients have been treated or 1 year whichever comes first.
Intervention code [1] 256343 0
Other interventions
Comparator / control treatment
Control group will be patients treated by standard paramedics, the clinical diagnosis and patient outcomes
Control group
Active

Outcomes
Primary outcome [1] 258273 0
The primary endpoint will be the proportion of patients treated in the community and not presenting acutely within 72 hrs for the same condition. These proprtions will be compared between the two groups using Fisher's exact test.
Timepoint [1] 258273 0
When 1000 patients have been treated or 1 year whichever comes first
Primary outcome [2] 258278 0
When 72hrs post treatment the patient hasn't required further unexpected medical care for the same condition.
Timepoint [2] 258278 0
72hrs post initial treatment
Secondary outcome [1] 263942 0
The proportion of patient not presenting acutely for the same condition within 1 week.
Timepoint [1] 263942 0
When 1000 patients have been treated or 1 year whichever comes first
Secondary outcome [2] 263947 0
Unexpected attendance for further medical care within 1 week for same condition
Timepoint [2] 263947 0
1 week post initial treatment
Secondary outcome [3] 263948 0
Unexpected attendance for further medical care within 1 week for same condition
Timepoint [3] 263948 0
1 week post treatment

Eligibility
Key inclusion criteria
The study will be limited to the Kapiti region served by Wellington Free Ambulance. All calls coming in via the 111 system classified by the Medical Priority Dispatch System (MPDS) as category A, B and C. The electronic form of this system is called ProQA.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any call classified as an Echo life threatening call that require dual response.
Categories 8, 9,14,15,22,24,33, and 40 as they are cases that would automatically require transport or are for patient transfer services.

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)
The randomisation will happen at the Communication dispatch where either a standard Paramedic or Extended Care Paramedic will be dispatched to calls meeting the study inclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 2596 0
New Zealand
State/province [1] 2596 0

Funding & Sponsors
Funding source category [1] 256850 0
Self funded/Unfunded
Name [1] 256850 0
Wellington Free Ambulance
Country [1] 256850 0
New Zealand
Primary sponsor type
Individual
Name
Sarah Hoyle
Address
Wellington Free Ambulance
19 Davis St
Thorndon
Wellington 6011
Country
New Zealand
Secondary sponsor category [1] 256122 0
Individual
Name [1] 256122 0
Dr Andrew Swain
Address [1] 256122 0
Department of Surgery & Anaesthesia
University of Otago, Wellington
P O Box 7343
Wellington 6242
Country [1] 256122 0
New Zealand
Other collaborator category [1] 1214 0
Individual
Name [1] 1214 0
Ass Prof Peter Larsen
Address [1] 1214 0
Department of Surgery & Anaesthesia
University of Otago, Wellington
P O Box 7343
Wellington 6242
Country [1] 1214 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258863 0
Central Ethics Committee
Ethics committee address [1] 258863 0
Ministry of Health
2nd floor 1-3 The Terrace
Wellington 6011
Ethics committee country [1] 258863 0
New Zealand
Date submitted for ethics approval [1] 258863 0
22/04/2010
Approval date [1] 258863 0
Ethics approval number [1] 258863 0

Summary
Brief summary
The ambulance service tends to transport the majority of patients they see to emergency departments for definitive assessment and treatment, despite the fact that many of these patients are not in need of emergency department care. This places a burden on the emergency department in terms of workload, and adds inconvenience to the patient due to transport to a hospital. The Extended Care Paramedic (ECP) model of care is based on training paramedics in acute assessment and treatment, so that they can recognise patients who do not require hospital admission, and treat these patients at home. This model of care has not been formally evaluated to ensure that the correct patients are identified to be treated in the community, and that this treatment is satisfactory.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31079 0
Address 31079 0
Country 31079 0
Phone 31079 0
Fax 31079 0
Email 31079 0
Contact person for public queries
Name 14326 0
Sarah Hoyle
Address 14326 0
Wellington Free Ambulance
P O Box 601
Wellington 6140
Country 14326 0
New Zealand
Phone 14326 0
+64 0272013987
Fax 14326 0
Email 14326 0
[email protected]
Contact person for scientific queries
Name 5254 0
Dr Andrew Swain
Address 5254 0
Department of Surgery & Anaesthesia
University of Otago, Wellington
P O Box 7343
Wellington 6242
Country 5254 0
New Zealand
Phone 5254 0
+64 021440557
Fax 5254 0
Email 5254 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.