Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000650594
Ethics application status
Approved
Date submitted
11/06/2015
Date registered
24/06/2015
Date last updated
2/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of increased allied health services in two medical units: comparison with an historical cohort.
Scientific title
Evaluating the effect of increased allied health services in two medical units: comparison with an historical cohort.
Secondary ID [1] 286898 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
general medical 295303 0
acute medical 295304 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295572 295572 0 0
Physiotherapy
Physical Medicine / Rehabilitation 295573 295573 0 0
Occupational therapy
Physical Medicine / Rehabilitation 295574 295574 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to evaluate the effect of increasing allied health services in two medical areas of the Central Adelaide Local Health Network. Specifically, the effect of increasing allied health services by virtue of increased staffing (total increase of 13 full-time equivalents across all areas) in the Acute Medical Unit and in General Medicine at the Royal Adelaide Hospital and The Queen Elizabeth Hospital will be evaluated by collecting outcome data (e.g., hospital length of stay, discharge destination, re-admission rate) for the first 6 months post-implementation and comparing these to historical data from Central Adelaide Local Health Network and also with Australia-wide data from a national database.
Intervention code [1] 292078 0
Treatment: Other
Intervention code [2] 292079 0
Rehabilitation
Intervention code [3] 292080 0
Early detection / Screening
Comparator / control treatment
Historical control group for the same time period in the previous calendar year. Data will be retrieved from databases including the Central Adelaide Clinical Casemix and Costing databases, Health Round Table reports and Client Management Engine
Control group
Historical

Outcomes
Primary outcome [1] 295284 0
Length of stay, retrieved from hospital and national databases.
Timepoint [1] 295284 0
Hospital discharge.
Primary outcome [2] 295285 0
Number of referrals to allied health services, retrieved from hospital and national databases.
Timepoint [2] 295285 0
Hospital discharge.
Secondary outcome [1] 315265 0
Discharge destination, retrieved from hospital and national databases.
Timepoint [1] 315265 0
Hospital discharge.
Secondary outcome [2] 315266 0
Adverse events (e.g. falls, death, unplanned re-admission), retrieved from hospital and national databases.
Timepoint [2] 315266 0
Up to 28 days post-discharge.

Eligibility
Key inclusion criteria
The prospective sample will include all patients who receive allied health services in the Acute Medical Unit and General Medicine at the Royal Adelaide Hospital or The Queen Elizabeth Hospital following the increased levels of allied health staffing. The historical cohort will include all patients who received allied health services in these areas in the previous calendar year.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

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)
All patients who are referred for allied health services will be included in the study and data pertaining to all patients admitted during this time period will be reviewed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
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
Statistical methods / analysis
Analyses will predominantly be descriptive in nature, comparing data from the prospective cohort to the historical cohort. All patients who receive allied health interventions will be included in the study and data from all patients admitted during this timer period will be reviewed. Given the nature of the study, sample size calculations were not required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2015
Actual
1/12/2015
Date of last participant enrolment
Anticipated
31/03/2016
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
100
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3912 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 3913 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 9826 0
5000 - Adelaide
Recruitment postcode(s) [2] 9827 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 291452 0
Self funded/Unfunded
Name [1] 291452 0
Kathy Stiller
Country [1] 291452 0
Australia
Primary sponsor type
Individual
Name
Vicki Hume
Address
Hampstead Rehabilitation Centre
207-255 Hampstead Road
Northfield
South Australia 5085
Country
Australia
Secondary sponsor category [1] 290128 0
Individual
Name [1] 290128 0
Kathy Stiller
Address [1] 290128 0
Allied Health Building
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [1] 290128 0
Australia
Secondary sponsor category [2] 290129 0
Individual
Name [2] 290129 0
Ellen Mills
Address [2] 290129 0
Speech Pathology Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [2] 290129 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293002 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 293002 0
Ethics committee country [1] 293002 0
Australia
Date submitted for ethics approval [1] 293002 0
Approval date [1] 293002 0
18/05/2015
Ethics approval number [1] 293002 0
not applicable quality assurance project

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

Contacts
Principal investigator
Name 58030 0
Mrs Vicki Hume
Address 58030 0
Hampstead Rehabilitation Centre
207-255 Hampstead Road
Northfield
South Australia 5085
Country 58030 0
Australia
Phone 58030 0
61 8 82221826
Fax 58030 0
61 8 82221610
Email 58030 0
[email protected]
Contact person for public queries
Name 58031 0
Kathy Stiller
Address 58031 0
Allied Health Building
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 58031 0
Australia
Phone 58031 0
61 8 82225334
Fax 58031 0
61 8 82224279
Email 58031 0
[email protected]
Contact person for scientific queries
Name 58032 0
Kathy Stiller
Address 58032 0
Allied Health Building
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 58032 0
Australia
Phone 58032 0
61 8 82225334
Fax 58032 0
61 8 82224279
Email 58032 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.