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Trial registered on ANZCTR


Registration number
ACTRN12616001473459
Ethics application status
Approved
Date submitted
19/10/2016
Date registered
24/10/2016
Date last updated
10/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An additional Saturday allied health service for Geriatric Evaluation and Management to reduce patient length of stay and increase functional independence
Scientific title
An additional Saturday allied health service for Geriatric Evaluation and Management to reduce patient length of stay and increase functional independence
Secondary ID [1] 290357 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geriatric Evaluation and Management 300645 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300490 300490 0 0
Other physical medicine / rehabilitation
Public Health 300509 300509 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An allied health service for Geriatric Evaluation and Management will be provided on Saturdays in addition to the usual Monday to Friday service for a period of 6 months in the intervention Geriatric and Evaluation Management ward. The additional allied health service will be provided at levels that approximate Monday to Friday service levels for: occupational therapy, physiotherapy, social work, and allied health assistants. In addition on Saturdays speech pathology, psychology and dietetics in the intervention ward will be available to provide an on-call service. The additional allied health services on a Saturday will provide additional therapy for patients admitted the intervention ward for Geriatric Evaluation and Management. There are no minimal years of experience requirements for allied health clinicians providing the Saturday service but will be expected to have experience working in Geriatric Evaluation and Management. Occasions of service provided by the allied health clinicians will be monitored using the health service data base each month.
Intervention code [1] 296171 0
Rehabilitation
Intervention code [2] 296179 0
Treatment: Other
Comparator / control treatment
The primary control treatment is Monday to Friday allied health services (occupational therapy, physiotherapy, social work, allied health assistants plus part-time speech pathology, psychology and dietetics provided in a second Geriatric Evaluation and Management ward at Eastern Health in the same 6 month period. Allied health services are not available on this ward to Geriatric and Evaluation management patients during the weekend. Occasions of service provided by the allied health clinicians will be monitored using the health service data base each month.

The secondary control period will include routinely collected data from the two participating wards during the same 6 month period in the previous year (historical control) during which allied health services were offered from Monday to Friday only.
Control group
Active

Outcomes
Primary outcome [1] 299921 0
Length of stay in Geriatric Evaluation and Management
Timepoint [1] 299921 0
Discharge from Geriatric Evaluation and Management
Primary outcome [2] 299922 0
Functional Independence Measure (FIM) expressed as difference between discharge and admission, and FIM efficiency (change in FIM per day)
Timepoint [2] 299922 0
Discharge from Geriatric Evaluation and Management
Primary outcome [3] 299924 0
Incremental cost effectiveness ratio incorporating the FIM score
Timepoint [3] 299924 0
30 days post discharge from Geriatric Evaluation and Management
Secondary outcome [1] 328538 0
Discharge destination categorised as a) home fully independent, b) home informal support, c) home professional support, d) residential care, e) transition care program, e) other
Timepoint [1] 328538 0
Discharge from Geriatric Evaluation and Management
Secondary outcome [2] 328541 0
Readmission to Eastern Health hospital in the first 30 days after discharge describing length of stay and reason for readmission
Timepoint [2] 328541 0
30 days post discharge from Geraitric Evaluation and Management

Eligibility
Key inclusion criteria
All patients admitted for Geriatric Evaluation and Management in the two participating wards during the data collection phase
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients not admitted under Geriatric Evaluation and Management (e.g. for Transition Care Program).
2. Patients admitted prior to the data collection phase will be excluded.
3. Patients readmitted to Geriatric Evaluation and Management after a previous Geriatric Evaluation and Management admission during the data collection phase will be considered to have been admitted during the initial admission.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on average length of stay for the 2 participant wards (ward 1 = 25.8 days and ward 2 = 27.6 days) the total sample will be approximately 900 patients, approximately n = 436 in the pre-intervention and approximately n = 460 in the post-intervention phase. Based on an assumption that a 3-day reduction in length of stay (with a SD of 12 days) in the intervention ward will be clinically and economically significant, the sample will provide approximately 75% power at a 5% alpha level using 2-tailed tests.
Length of stay and functional independence will be compared using 2-way analysis of variance with the 2 independent factors of site (intervention versus control) and time (pre-intervention versus post-intervention). Significant interaction effects will be explored with simple main effects. Comparisons involving post-intervention data only will be analysed using either independent t tests or the Mann-Whitney U test as appropriate. Categorical outcomes will be compared using chi-square statistics. Sensitivity analyses will be completed excluding patients who have completed active treatment and waiting for placement. An interim analysis on length of stay data in the intervention ward will be conducted after 3 months.
As part of the health economic analysis from a health service perspective, mean cost difference will be determined between the two groups using an independent t-test to report statistical significance. Incremental cost effectiveness ratios (ICERs) will be determined on the functional independence score and the mean difference between groups for cost. Confidence intervals around the individual ICERs for the functional independence score will be calculated using the bootstrap method. The ICERs will also be reported with confidence ellipses to represent a two-dimensional measure of variance, taking into account the variance of the cost and functional independence scores. In addition, the ICER will be reported as a cost effectiveness acceptability curve with a willingness to pay for the probability of achieving cost effectiveness.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/11/2016
Actual
12/12/2016
Date of last participant enrolment
Anticipated
19/05/2017
Actual
28/05/2017
Date of last data collection
Anticipated
18/06/2017
Actual
10/06/2017
Sample size
Target
900
Accrual to date
Final
793
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6842 0
Wantirna Health - Wantirna
Recruitment hospital [2] 6843 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 14507 0
3152 - Wantirna
Recruitment postcode(s) [2] 14508 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 294741 0
Hospital
Name [1] 294741 0
Eastern Health
Country [1] 294741 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
5 Arnold Street, Box Hill, Victoria 3128
Country
Australia
Secondary sponsor category [1] 293590 0
None
Name [1] 293590 0
Address [1] 293590 0
Country [1] 293590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296158 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 296158 0
Ethics committee country [1] 296158 0
Australia
Date submitted for ethics approval [1] 296158 0
16/09/2016
Approval date [1] 296158 0
06/10/2016
Ethics approval number [1] 296158 0
LR83/2016

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

Contacts
Principal investigator
Name 69794 0
Prof Nicholas Taylor
Address 69794 0
level 2/5 Arnold Street Box Hill, Victoria 3128
Eastern Health - La Trobe University
Country 69794 0
Australia
Phone 69794 0
+61 3 90918874
Fax 69794 0
Email 69794 0
N.Taylor@latrobe.edu.au
Contact person for public queries
Name 69795 0
Nicholas Taylor
Address 69795 0
level 2/5 Arnold Street Box Hill, Victoria 3128
Eastern Health - La Trobe University
Country 69795 0
Australia
Phone 69795 0
+61 3 90918874
Fax 69795 0
Email 69795 0
N.Taylor@latrobe.edu.au
Contact person for scientific queries
Name 69796 0
Nicholas Taylor
Address 69796 0
level 2/5 Arnold Street Box Hill, Victoria 3128
Eastern Health - La Trobe University
Country 69796 0
Australia
Phone 69796 0
+61 3 90918874
Fax 69796 0
Email 69796 0
N.Taylor@latrobe.edu.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.