Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000761662
Ethics application status
Approved
Date submitted
1/07/2014
Date registered
17/07/2014
Date last updated
17/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the impact of the Supported Transfer & Accelerated Rehabilitation Team (START) for Accident Compensation Corporation (ACC) clients and how this compares to the usual ACC pathway of care for people over 65 years of age who have sustained an injury. The trial outcomes will focus on on hospital length of stay, subsequent hospitalisations, and cost for patients being discharged from hospital in the Waikato region who have recently sustained an injury.
Scientific title
Evaluating the impact of The Supported Transfer & Accelerated Rehabilitation Team (START) with ACC (Accident Corporation Compensation) participants with regard to hospital length of stay, patient rehabilitation costs and functional rehabiliation outcomes for people over the age of 65 years.
Secondary ID [1] 284893 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injury based health conditions such as fractured Neck of Femurs 292346 0
Condition category
Condition code
Injuries and Accidents 292674 292674 0 0
Fractures
Physical Medicine / Rehabilitation 292725 292725 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In 2010 Waikato DHB commenced a pilot supported discharge service (Supported Transfer and Accelerated Rehabilitation Team, or START). A randomised controlled trial was carried out and completed, which compared this service to usual care in terms of client satisfaction, rehabilitation outcomes, hospital length of stay, subsequent hospitalisations, entry to residential care and cost. This trial did not include Accident Compensation Corporation (ACC) clients.
This current study focusses on recruitment of ACC clients using a Randomised Control Trial methodology to investigate the benefits and costs of long-term funding of early supported discharge services for our clients and the usual care ACC pathway for people over the age of 65years.
The service provides the following:
1. Facilitate timely and coordinated discharge home for medically stable adults who require ongoing support at home
2. Provide an immediate or rapid response to older people presenting in the emergency department who could be discharged directly home if appropriate home support services were established on discharge.
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] 289706 0
Rehabilitation
Comparator / control treatment
Those people randomised into the control group will recieve the usual ACC pathway of care.
Control group
Active

Outcomes
Primary outcome [1] 292519 0
A Decrease in hospital length of stay and in the number of ED visits. The results will provide ACC with an understanding of how the START model compares with ACC usual care pathways for people over the age of 65years when they enter and leave hospital. Information will be collected on patient health service usage (length of stay in hospital, number of admissions to hospital, time in hospital, ED presentations, time to hospital admission and to Aged Residential Care admission, GP visits) through centralised databases; as well as direct information obtained through patient/family interviews on satisfaction with services.
Timepoint [1] 292519 0
The timepoints for data collection are:
- baseline data at time of entry into the study
- 4months, post trial entry date for each participants.
- 12 months, post trial entry date for each participants.
For all of these timepoints the same data collection will be gathered for all participants.
Primary outcome [2] 292569 0
A reduction in ACC patient rehabilitation costs under the START model. This will provide a basis for ACC to make long-term funding and contract management decisions regarding START and similar services.
Timepoint [2] 292569 0
Full financial Data will be available at the end of the trial at 2 years to compare intervention and usual care groups.
Primary outcome [3] 292570 0
Reported and demonstrated improvements in participants Functional independence under START, as measured, using the InterRai Contact Assessment, the Nottingham EADL and the EuroQol 5D. These assessments will be carried out at 3 time points: at baseline, 4 month and 12 months follow-up
Timepoint [3] 292570 0
The timepoints for data collection are:
- baseline data at time of entry into the study
- 4months, post trial entry date for each participants.
- 12 months, post trial entry date for each participants.
For all of these timepoints the same data collection will be gathered for all participants.
Secondary outcome [1] 309256 0
nil
Timepoint [1] 309256 0
nil

Eligibility
Key inclusion criteria
The eligibility criterion for inclusion into this study are as follows: (1) The client has been accepted OR is pending decision by ACC for the provision of services following an accident; (2) The client is over 65 years (or close in age and interest) and lives within the START catchment area; (3) The client does not require acute hospital based treatment; (4) 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; (5) Following assessment, the client is considered to have potential for partial or complete recovery with suitable home rehabilitation within six weeks; (6) The client is able to stand and transfer with one person (with or without the help of a resident carer); (8) The client's home is judged to be safe for the client in addition to the visiting staff and; (9) The client has had a recent injury and 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; and (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; AND the client consents to participate in the trial.
The client eligibility for ACC START is the same whether the client is being referred for the rapid response or supported discharge. The point of difference is in the location of the client at the point of referral and therefore the process following referral, namely ED versus ward. Specifically, the rapid response component prevents admission through providing an immediate responsive and coordinated service delivered to clients in their own home where as the supported discharge reduces length of hospital stay.
Minimum age
65 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The person place of discharge is not directly to their own home.
2. The person is younger than 65 years.
3. The person is declined by ACC
4. The person does not fit the inclusion criteria stated above

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)
1. A person on the ward is assessed as ACC client. Necessary paperwork for ACC carried out and sent to ACC.
2. Person identified by Older Persons team that they are suitable for START service.
3. Referral sent to START team and Research assistant alerted.
4. START staff person meets person and confirms their eligibility for START and consequently RCT trial.
5. Research assistant asks person if they would like to participate in the RCT trial. PIS shared and discussed.
6. Person consents to participate.
7. Baseline assesment data collected.
8. Person is randomised into START group or usual ACC care group. This is carried out by the researcher opening a sealed opaque envelope with the randomised group coded inside.
9. Interventions commence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will either allocate the participants to the intervention group or control using a computer generated randomisation sequence.
The 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.

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
The number of ACC clients to be recruited is 472 a total of236 for each arm. The statistical significance enables a minimum difference in length of stay of 1.5 days at the 95% level.
All statistical tests will be two-tailed and a 5% significance level will be maintained throughout the analysis. The differences in Length of Stay (LOS) between the two groups will be investigated using linear regression models. A log transformation will be used if the distribution of the LOS is skewed. Mixed model analyses with repeated measures will be undertaken on secondary end-points (functional endpoints) to measure changes over time points. Cox’s proportional hazards models will be used to investigate differences in time to hospital and aged residential care admission. All models will include relevant demographic and clinical factors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2013
Actual
2/12/2013
Date of last participant enrolment
Anticipated
2/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
472
Accrual to date
Final
Recruitment outside Australia
Country [1] 6185 0
New Zealand
State/province [1] 6185 0

Funding & Sponsors
Funding source category [1] 289517 0
Government body
Name [1] 289517 0
Accident Compensation Corporation
Country [1] 289517 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Level 2
Building 505
85 Park Road
Grafton
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288205 0
Government body
Name [1] 288205 0
Accident Compensation Corportation
Address [1] 288205 0
Claims Management Health Procurement
Level 11, Vogel House, 19 Aitken Street
PO Box 242
Wellington 6011
+64 4 816 7356
Country [1] 288205 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291262 0
Health and Disability Ethics Committee
Ethics committee address [1] 291262 0
Ethics committee country [1] 291262 0
New Zealand
Date submitted for ethics approval [1] 291262 0
Approval date [1] 291262 0
20/08/2013
Ethics approval number [1] 291262 0
NXT/11/09/088/AM02

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

Contacts
Principal investigator
Name 49574 0
Prof Matthew Parsons
Address 49574 0
The University of Auckland
Level 2
Building 505
85 Grafton Road
Grafton
Auckland 1142
Country 49574 0
New Zealand
Phone 49574 0
+64 021753204
Fax 49574 0
+64 09 3677158
Email 49574 0
[email protected]
Contact person for public queries
Name 49575 0
Matthew Parsons
Address 49575 0
The University of Auckland
Level 2
Building 505
85 Grafton Road
Grafton
Auckland 1142
Country 49575 0
New Zealand
Phone 49575 0
+64 021753204
Fax 49575 0
+64 09 3677158
Email 49575 0
[email protected]
Contact person for scientific queries
Name 49576 0
Matthew Parsons
Address 49576 0
The University of Auckland
Level 2
Building 505
85 Grafton Road
Grafton
Auckland 1142
Country 49576 0
New Zealand
Phone 49576 0
+64 021753204
Fax 49576 0
+64 09 3677158
Email 49576 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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