Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001064099
Ethics application status
Approved
Date submitted
1/12/2010
Date registered
3/12/2010
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Paramedic Assessment and Referral to Access Medical care at Home
Scientific title
A randomised controlled trial to evaluate the cost and acceptability of paramedic referral to a home-based treatment service compared with transport to hospital for people with a low-risk injury or illness who call an ambulance.
Secondary ID [1] 253223 0
Nil
Universal Trial Number (UTN)
Trial acronym
PARAMed Home
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low risk injury suitable for home care (Low risk mechanism of injury with no apparent sequelae or only minor apparent injury. Examples: soft tissue injury; simple laceration; single limb fracture excluding the femur). 257917 0
Low risk infection suitable for home care (Uncomplicated infection in a well immunocompetent patient. Examples: below knee unilateral leg cellulitis; wound infection; flu-like illness; gastroenteritis.) 258758 0
Low risk hardware complication suitable for home treatment (Simple hardware complications. Examples: IDC, NGT, PEG change/replacement). 258759 0
Condition category
Condition code
Public Health 258087 258087 0 0
Health service research
Infection 258088 258088 0 0
Other infectious diseases
Injuries and Accidents 258905 258905 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paramedics will assess for suitability for home care following agreed inclusion and exclusion criteria and will confirm this with the call centre which will provide randomisation. Those randomised to the treatment arm will be referred by the paramedic to the home-based treatment by home hospital team instead of the standard care which is to transport to hospital. The paramedic will provide a clinical assessment, a telephone handover, and clinical documentation which stays with the patient until the home hospital team arrives within 4 hours. The paramedic will also ensure clinical stability and safety and inform participants that they can call the ambulance again if they are concerned prior to the arrival of the home hospital team. Recruitment into the trial will take place over a 6 month period.
Intervention code [1] 256972 0
Other interventions
Intervention code [2] 256973 0
Treatment: Other
Comparator / control treatment
Paramedic transport to hospital emergency department (standard treatment)
Control group
Active

Outcomes
Primary outcome [1] 258947 0
Cost-benefit: the costs of healthcare provision for that episode of care.

Costs will be measured through fixed costs (total equipment costs will be sourced from St John Ambulance, Western Australia and Silver Chain Nursing Association and will be depreciated over the life of the equipment giving annual costs) and variable costs (labour costs for the Home Hospital program service provided as per recorded time sheets and hourly appropriate Silver Chain salary rates and paramedic training costs sourced from St John Ambulance Australia WA Inc.).

Benefits will be measured through ambulance usage (average ambulance transport cost via St John Ambulance Australia WA Inc. applied to the difference between usage for the control and intervention groups), hospital separations (daily average hospital cost (from WA Department of Health annual reports or similar) applied to the difference between lengths of stay for the control and intervention groups), emergency department visits (average emergency department visit cost from WA Department of Health annual reports or similar applied to the difference between visits for the control and intervention groups).
Timepoint [1] 258947 0
3 months from the start of the intervention
Secondary outcome [1] 265114 0
Patient satisfaction will be assessed through the use of a telephone survey. Participants will be asked to report on satisfaction with the timeliness of the services, the explanation received, the care received, convenience of the service, follow up arrangements, staff attitudes and overall service. They will also be asked about their perception of safety within the service, perception of adequate diagnosis and symptom relief, and their preference for treatment at hospital or home hospital.
Timepoint [1] 265114 0
1 month from the start of the intervention.
Secondary outcome [2] 265115 0
Safety will be assessed through the number of unplanned presentations to primary care services and hospital, adverse events and mortality in the month following the intervention. Information on safety will be obtained through hospital, Silver Chain and St John Ambulance records and the patient telephone questionnaire.
Timepoint [2] 265115 0
3 months from the start of the intervention.

Eligibility
Key inclusion criteria
Clinical inclusion: low risk injury, uncomplicated infection in immunocompetent patient, or medical equipment complication (eg. blocked catheter).

Capable of providing informed consent or is cognitively impaired and has the support of a parent/guardian/carer/relative who agrees to his/her participation.

Medicare eligible
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not at own residence at time of call-out, lives in an unsafe environment or lives alone.

>22 wks pregnant

Abnormal vital signs

Pain requiring narcotics

Safe and suitable to wait up to 4 hours for the arrival of the home hospital team

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)
If the patient meets the inclusion criteria and has no exclusion criteria, the paramedic will obtain informed consent for the trial. On confirmation of written informed consent, the paramedic contacts the call centre to be given the computerised randomisation. Data collected is based on intention to treat.

Participants have a 50/50 chance of being in the intervention or control arm. There is allocation concealment as the paramedic is unaware of the randomisation outcome.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation is performed at the call centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
30/06/2012
Date of last data collection
Anticipated
Actual
18/11/2018
Sample size
Target
128
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 257428 0
Government body
Name [1] 257428 0
State Health Research Advisory Council, Western Australia
Country [1] 257428 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Moira Sim
Address
Systems Intervention Research Centre for Health
Edith Cowan University
270 Joondalup Drive
Joondalup 6027
Western Australia
Country
Australia
Secondary sponsor category [1] 256659 0
Individual
Name [1] 256659 0
Associate Professor Glenn Arendts
Address [1] 256659 0
Western Australian Institute for Medical Research
University of Western Australia
Level 5 & 6, MRF Building
Rear 50 Murray Street
PERTH WA 6000
AUSTRALIA
Country [1] 256659 0
Australia
Other collaborator category [1] 251425 0
Charities/Societies/Foundations
Name [1] 251425 0
St John Ambulance WA Inc
Address [1] 251425 0
PO Box 183
BELMONT WA 6984
Country [1] 251425 0
Australia
Other collaborator category [2] 251426 0
Commercial sector/Industry
Name [2] 251426 0
Silver Chain
Address [2] 251426 0
Silver Chain House
6 Sundercombe Street
Osborne Park WA 6017
Country [2] 251426 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260143 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 260143 0
Ethics committee country [1] 260143 0
Australia
Date submitted for ethics approval [1] 260143 0
Approval date [1] 260143 0
19/10/2010
Ethics approval number [1] 260143 0
5249 SIM
Ethics committee name [2] 260144 0
Department of Health Western Australia Human Research Ethics Committee
Ethics committee address [2] 260144 0
Ethics committee country [2] 260144 0
Australia
Date submitted for ethics approval [2] 260144 0
Approval date [2] 260144 0
10/11/2010
Ethics approval number [2] 260144 0
2010/45
Ethics committee name [3] 260145 0
Silver Chain Human Research Ethics Commitee
Ethics committee address [3] 260145 0
Ethics committee country [3] 260145 0
Australia
Date submitted for ethics approval [3] 260145 0
Approval date [3] 260145 0
04/11/2010
Ethics approval number [3] 260145 0
EC App 066

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

Contacts
Principal investigator
Name 31496 0
Prof Moira Sim
Address 31496 0
Edith Cowan University, 270 Joondalup Drive, Joondalup 6027, Western Australia.
Country 31496 0
Australia
Phone 31496 0
+61 8 6304 3678
Fax 31496 0
Email 31496 0
m.sim@ecu.edu.au
Contact person for public queries
Name 14743 0
Moira Sim
Address 14743 0
Edith Cowan University
270 Joondalup Drive
Joondalup 6027
Western Australia
Country 14743 0
Australia
Phone 14743 0
+61863043678
Fax 14743 0
+618 63042323
Email 14743 0
m.sim@ecu.edu.au
Contact person for scientific queries
Name 5671 0
Moira Sim
Address 5671 0
Edith Cowan University
270 Joondalup Drive
Joondalup 6027
Western Australia
Country 5671 0
Australia
Phone 5671 0
+61863043678
Fax 5671 0
+618 63042323
Email 5671 0
m.sim@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Unresolvable inconsistencies in data


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.