Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000999235
Ethics application status
Approved
Date submitted
12/11/2009
Date registered
18/11/2009
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Up-skilling patients in active self-management to reduce length of inpatient hospital stay
Scientific title
‘Hospital Education, Activities and Living to Take Home [HEALTH] project. Up-skilling surgical (general, orthopaedic and vascular) patients in active self-management health strategies to reduce length of inpatient stay
Secondary ID [1] 283876 0
No known secondary ID
Universal Trial Number (UTN)
U1111-1112-4821
Trial acronym
HEALTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public Health 252219 0
Condition category
Condition code
Public Health 252405 252405 0 0
Health promotion/education
Surgery 252407 252407 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health advice will be provided on a one-to-one basis from members of the ‘Hospital Education, Activities and Living to Take Home [HEALTH] team as appropriate between randmosied control trial allocation and discharge from hospital. Education will include the importance of self-management options for co-existing symptoms and chronic disease, physiotherapy on pacing and mobility, aids in the community and how to access these, goal setting and education on graded activity, diet and up-skilling food benefits, social work for discharge planning and linking with community supports, clinical psychology for coping skills and behaviours for health,
Intervention code [1] 241546 0
Early detection / Screening
Intervention code [2] 241547 0
Lifestyle
Intervention code [3] 241548 0
Behaviour
Comparator / control treatment
Standard usual post surgical care (nursing advice during inpatient stay and at discharge and mobilisation as per surgical consultant advice). No specific systematic health professional advice
Control group
Active

Outcomes
Primary outcome [1] 253258 0
Length of hospital inpatient stay from medical records
Timepoint [1] 253258 0
days of inpatient stay calculated from admission to discharge from medical records
Primary outcome [2] 253300 0
Unit cost of inpatient stay (including direct surgical, pharmaceutical costs, and HEALTH
team costs) from medical records and time spent with patient per HEALTH professional
Timepoint [2] 253300 0
from admission to discharge from medical records
Secondary outcome [1] 262246 0
Re-admission of the patient to any hospital related to their primary admission
from medical records
Timepoint [1] 262246 0
within 30 days of initial hospital admission as indicated from medical records
Secondary outcome [2] 262247 0
Death as recorded from hospital clinical data and medical records
Timepoint [2] 262247 0
within 30 days of discharge from hospital as recorded from clinical data and medical records
Secondary outcome [3] 262296 0
Unit cost of inpatient stay (including direct surgical, pharmaceutical costs, and HEALTH
team costs) from medical records and time spent with patient per HEALTH professional
Timepoint [3] 262296 0
Admission to discharge as recorded through medical records and clinical data

Eligibility
Key inclusion criteria
Admitted in a surgical team with consultant consenting to patient participating in this trial, length of stay reaches the threshold (preliminary analysis suggests day 3) for inclusion in this study, voluntary informed written consent provided by patient for inclusion in the study. Threshold for inclusion as inpatient is minimum stay of 3 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to complete questionnaires, overt psychotic features, inpatient at any hospital within the 30 days prior to their current admission, inadequate English.

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)
All surgical inpatients recruited to the study will be asked to complete a screening tool. Patients identified by the screening tool with one of more problems (needs) will be randomly allocated to either receive assistance from the HEALTH multidisciplinary team or continue with usual care. Before the start of the study, a list of study numbers and treatment allocations (control or HEALTH team intervention) will be prepared. The allocation for each study number will then be printed and sealed in an opaque envelope. Once a subject has been identified as eligible for the study, and has provided written consent to take part, they will be allocated the next available study number. The envelope belonging to their study number will then be opened and they will be allocated to the stated treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocations will be assigned from computer generated random numbers using a permuted random blocking strategy in order to accumulate subjects to the two treatments at a similar rate.
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
Completed
Date of first participant enrolment
Anticipated
4/01/2010
Actual
24/04/2010
Date of last participant enrolment
Anticipated
Actual
27/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
460
Accrual to date
Final
234
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 244013 0
Government body
Name [1] 244013 0
Western Australian Department of Health, State Health Research Advisory Council
Country [1] 244013 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital and Health Service
Address
PO BOX 480 Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 251364 0
None
Name [1] 251364 0
Address [1] 251364 0
Country [1] 251364 0
Other collaborator category [1] 955 0
University
Name [1] 955 0
Curtin University of Technology
Address [1] 955 0
GPO BOX U1987 Perth WA 6845
Country [1] 955 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244120 0
Government of WA, Department of Health, South Metropolitan Area Health Service
Ethics committee address [1] 244120 0
Ethics committee country [1] 244120 0
Australia
Date submitted for ethics approval [1] 244120 0
Approval date [1] 244120 0
24/09/2009
Ethics approval number [1] 244120 0
1/09/0269

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

Contacts
Principal investigator
Name 30506 0
Dr Dr Stephanie Davies
Address 30506 0
Pain Medicine Unit, Fremantle Hospital and Health Service, PO BOX 480 Fremantle WA 6959, Perth, Australia
Country 30506 0
Australia
Phone 30506 0
+61 8 9431 3696
Fax 30506 0
Email 30506 0
[email protected]
Contact person for public queries
Name 13753 0
Helen Slater
Address 13753 0
School of Physiotherapy and Exercise Science, Curtin University
GPO Box U1987, Perth WA 6845
Country 13753 0
Australia
Phone 13753 0
+61 8 9266 3099
Fax 13753 0
+61 8 9266 3699
Email 13753 0
[email protected]
Contact person for scientific queries
Name 4681 0
A/Prof Helen Slater
Address 4681 0
School of Physiotherapy and Exercise Science, Curtin University
Country 4681 0
Australia
Phone 4681 0
+ 61 89 266 3099
Fax 4681 0
Email 4681 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.