Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000982910
Ethics application status
Approved
Date submitted
12/09/2011
Date registered
14/09/2011
Date last updated
17/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the impact of a new Supported Discharge Team with patients being discharged from hospital in the Waikato region who have recently suffered an acute illness or injury.
Scientific title
A randomised controlled trial evaluating the impact of the new Supported Transfer & Accelerated Rehabilitation Team (START) on hospital length of stay, subsequent hospitalisations, institutionalisation and cost in patients being discharged from hospital in the Waikato region who have recently suffered an acute illness or injury.
Secondary ID [1] 263024 0
Nil Known
Universal Trial Number (UTN)
nil known
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute illness or injury requiring hospitalisation or ED attendance 270750 0
Condition category
Condition code
Physical Medicine / Rehabilitation 270928 270928 0 0
Other physical medicine / rehabilitation
Public Health 270945 270945 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The START team consists of Health Care Assistants (HCA) trained to Level III on the NZQA framework, Registered Nurses working at an advanced level of practice and Allied health (Physiotherapy and Occupational Therapy). In addition, Consultant Geriatricians provide weekly input through case conferencing.
Within the START intervention, the initial visit to the client following discharge will involve the RN and HCA completing the following with the patient:
1. Assessment of need and determination of goals for the patient
2. Development of service plan to support goal attainment
3. Determination of the number of visits required to deliver the service plan
Health Care Assistants will provide up to four visits a day, seven days a week and will utilise functional rehabilitation principles to maximise recovery through incorporating exercises within ADL tasks. For instance, progressively increasing walking distance, sit to stands, lying in bed to standing, carrying groceries home from shops and putting away in cupboards.
The model focuses on maximising independence rather than fostering dependence and aligns with developing research in New Zealand and significantly, such exercise programmes can be successfully implemented by non-health professionals rather than Physiotherapists. Such a staffing compliment within START will maximise patient recovery and responsiveness and reduce fragmentation.
There will be a minimum of weekly reviews / reassessment of the patient by RN and OT/ PT with changes made as required to the service plan.
Once patients have returned home, direct clinical care responsibility returns to the General Practitioner (GP). The team will work in close collaboration with GPs and Practice Nurses as well as the specialist community teams and hospital services.
The team will work with Patients until their return to independence or until stable but requiring continuing input from community nursing or home care support. Patients will be likely limited to six weeks maximum attendance, though the team on an exception basis may choose to extend this to maximise potential recovery. Patients will be supported to develop meaningful distal goals, which will be interpreted into a therapy ladder to support development of a care plan utilising functional rehabilitation principles.
Intervention code [1] 269366 0
Rehabilitation
Comparator / control treatment
The control arm involves usual care. Participants assigned to the control group will be provided with standard care, which will involve discharge planning from the hospital to their place of residence and subsequent community based services as required and as currently happens.
Control group
Active

Outcomes
Primary outcome [1] 279594 0
A Decrease in hospital length of stay and in the number of ED visits.
Information will be collected on patient health service usage through centralised databases as well as direct information obtained through patient/family interview on satisfaction with services.
Timepoint [1] 279594 0
Six months after randomisation
Primary outcome [2] 279613 0
A decrease in Aged Residential Care admissions and Home Care usage.
Information will be collected on patient health service usage through centralised databases as well as direct information obtained through patient/family interview on satisfaction with services. Functional status will be measured using the interRAI contact assessment at baseline and twelve months, which will also include demographic data.
Timepoint [2] 279613 0
At 6months after randomisation
Secondary outcome [1] 294007 0
Gathering information on Patient and practitioner perceptions of the START service.
This outcome will be assessed using a process evaluation method. The process evaluation typically has four steps and will answer questions about what happened in the implementation of the START. These steps are:
1. Development of the programme Logic
2. Examine programme Implementation
3. Examine programme dosage
4. Examine programme fidelity
Timepoint [1] 294007 0
At 6 months post randomisation.
Secondary outcome [2] 294034 0
To identify and analysis the cost of START from a health perspective and a patient perspective.
This question will be answered by cost data collection from the DHB, a START staff log record and by interviewing patients
Timepoint [2] 294034 0
At 6 months post randomisation.

Eligibility
Key inclusion criteria
1. The client is over 65 years (or close in age and interest) and lives within the catchment area Waikato DHB; 2. The client does not require acute hospital based treatment; 3. The client consents to being treated at home by the team, is aware of and is in agreement with the objectives set by the referring inter-disciplinary team; 4. Following assessment, the client is considered to have potential for partial or complete recovery with suitable home rehabilitation within six weeks; 5. The client is able to stand and transfer with one person (with or without the help of a resident carer); 6. The client's home is judged to be safe for the client in addition to the visiting staff and; 7. The client has had a recent acute illness or injury or is at a borderline level of function with an associated reduction in personal (PADL) and / or extended (EADL) activities of daily living and who without input from the team is: I. likely to fail to recuperate full potential of functional recovery; II. or is likely to fail to manage satisfactorily at home despite conventional community support and therefore would be at risk of hospital re-admission or institutionalisation.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clients who have been discharged from acute hospital care for more than 48 hours
2. Clients without clinical need, only social need, e.g. clients needing support during usual caregivers admission to hospital
3. Where the home environment is not conducive to achieving the rehabilitation outcomes for the client
4. Where the clients primary rehabilitation intervention is provided in an outpatient setting
5. Clients with progressive or deteriorating conditions where partial or full recovery cannot be reasonably expected within six weeks (e.g. Palliative care):
6. The client is eligible for assessment, treatment and rehabilitation funded under the injury Prevention, Rehabilitation and Compensation Act (2001)
7. The clients service needs are covered under another service specification or funding stream

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)
Recruitment and consent for participation will be undertaken in the hospital (either on the ward or in the Emergency department), prior to discharge, by the START liaison nurse (a clinical nurse specialist employed by specialist services for older people, who is based within the hospital). Simple randomisation will either allocate the participants to the intervention group or control using a computer generated randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The proposed randomised controlled trial methodology is the strongest research design to answer the central question concerning the effectiveness of the intervention in relation to decreasing hospital length of stay, time in hospital over a year, Emergency Department use and reduction in institutionalisation.
It will not be possible to conceal randomisation allocation but the analysis will be undertaken blinded to the intervention / control allocation. In addition, primary endpoints are collected through DHB datasets and are not reliant on researchers to gather data.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2011
Actual
1/12/2011
Date of last participant enrolment
Anticipated
30/06/2013
Actual
30/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 3836 0
New Zealand
State/province [1] 3836 0
Waikato DHB region

Funding & Sponsors
Funding source category [1] 269826 0
Government body
Name [1] 269826 0
Health Research Council RPNZHD funding
Country [1] 269826 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato District Health Board.
Address
Waikato District Health Board
Hockin Building
Waikato Hospital Campus
Selwyn Street
PO Box 934
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 268858 0
None
Name [1] 268858 0
Address [1] 268858 0
Country [1] 268858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271793 0
Health and Disability Ethics Committee, Northern X
Ethics committee address [1] 271793 0
Ethics committee country [1] 271793 0
New Zealand
Date submitted for ethics approval [1] 271793 0
24/08/2011
Approval date [1] 271793 0
28/09/2011
Ethics approval number [1] 271793 0
NTX/11/09/088

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

Contacts
Principal investigator
Name 33141 0
Prof Matthew Parsons
Address 33141 0
The University of Auckland
Department of Nursing
Level 2 building 505
Grafton Auckland
1142
Country 33141 0
New Zealand
Phone 33141 0
+64 021753204
Fax 33141 0
Email 33141 0
[email protected]
Contact person for public queries
Name 16388 0
Sarah Masson
Address 16388 0
The University of Auckland
3 Ferncroft Street
Grafton
Ecom House
4th Floor
School of nursing
Auckland, 1142
Country 16388 0
New Zealand
Phone 16388 0
+64 9 3737599 ext 83935
Fax 16388 0
+ 64 (0) 9 367 7158
Email 16388 0
[email protected]
Contact person for scientific queries
Name 7316 0
Professor Matthew Parsons PhD
Address 7316 0
Matthew Parsons
Professor
Waikato DHB / The University of Auckland
Level 2, Building 505
85 Park Road, Grafton
Auckland 1142
Country 7316 0
New Zealand
Phone 7316 0
+ 64 (0) 9 373 7599, Ext 83033, Mobile: + 64 (0) 21 753 204
Fax 7316 0
64 (0) 9 367 7158
Email 7316 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
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