Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000933954
Ethics application status
Approved
Date submitted
29/08/2011
Date registered
30/08/2011
Date last updated
28/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial to improve quality of life in aged care
Scientific title
A cluster clinical trial in residential aged care facility (RACF) patients to determine whether care coordination is superior to usual care in reducing hospital transfer and improving resident quality of life.
Secondary ID [1] 262950 0
Nil
Universal Trial Number (UTN)
U1111-1124-0819
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary/acute healthcare needs of residential aged care facility patients 270676 0
Condition category
Condition code
Public Health 270849 270849 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A coordinated care planning intervention with three key components
a. Comprehensive assessment which will incorporate an initial individual needs assessment focussing on current and likely future healthcare needs. The needs assessment will particularly focus on identifying patient preferences and goals (utilising informant perspectives where necessary) with respect to palliative care. It is anticipated the needs assessment will require at least two hour long sessions soon after enrolment.
b. Individualised care planning utilising six strategies that are most likely to impact on hospital transfer and quality of life.
1. Patient +/- family education regarding diagnosis and prognosis. A research nurse will provide clear simple language verbal and written information regarding illness and expected clinical course.
2. An advanced care plan incorporating preferences of the patient and family for the setting of limits, if any, on hospitalisation, interventions, and resuscitation.
3. A palliative care plan for management of current and anticipated future symptoms.
4. Primary care and assessment plan for the management of minor injury and illness tailored to the patient and RACF requirements. This may involve use of the patient’s regular general practitioner or other existing primary care services that augment general practice.
5. Clinical practice guideline package for the management of major injury and illness. Tailored guidelines will be provided to deal with common acute complications requiring hospitalisation.
6. Root cause analysis of all hospitalisations. We will use QI methodology to assess any hospitalisations in the intervention group and determine whether they were possibly avoidable and if so, what changes would be required to prevent a similar hospitalisation.
Whilst it is impossible to be proscriptive about how much contact will be required for each patient in the intervention arm, there will be minimum weekly contact with the patient and facility to manage the care planning.
c. Coordination of these strategies, and their systematic application, based on individual patient needs identified through comprehensive assessment. Each patient in the intervention arm will be assigned to a research nurse who will be directly responsible for providing key aspects of the intervention (including some primary care surveillance and service provision) and coordinate other aspects that require specialist and/or multidisciplinary involvement.
From enrolment, patients will be exposed to the intervention for a minimum period of eighteen months unless they die or return to live in the community on a permanent basis.
Intervention code [1] 269293 0
Prevention
Comparator / control treatment
Usual (not specified) care, which for the purposes of the trial will be provided at the discretion of general practitioner/s and nursing staff within the RACF.
Control group
Active

Outcomes
Primary outcome [1] 279531 0
Total number and rate of transfers to a hospital emergency department (ED) measured using hospital ED information surveillance supllemented by clinical records within each facility
Timepoint [1] 279531 0
Up to 18 months post enrolment
Secondary outcome [1] 287849 0
Quality of life (QoL) measured using the HUI2 and the EQ5D
Timepoint [1] 287849 0
Every 3 months up to 18 months post enrolment
Secondary outcome [2] 287850 0
Functional status measured using the modified Barthel Index
Timepoint [2] 287850 0
Every 6 months up to 18 months post enrolment
Secondary outcome [3] 287851 0
Death
Timepoint [3] 287851 0
Up to 18 months post enrolment
Secondary outcome [4] 287852 0
Cost effectiveness. The economic evaluation will take the perspective of the health care funder and will include analyses for health outcomes measured in terms of the primary clinical outcome (cost per ED transfer prevented) and secondary clinical outcomes (cost per life year saved, cost per quality adjusted life year gained).
Timepoint [4] 287852 0
Up to 18 months post enrolment
Secondary outcome [5] 287853 0
Patient and care provider satisfaction. We will use discrete choice methods to quantify the aspects of care most valued by participants and others associated with the trial
Timepoint [5] 287853 0
Study completion

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion if they are residents in a permanent high level care bed in an accredited RACF
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they meet any of the following criteria
1. Not eligible for Medicare
2. Age < 65 years
3. Patient not expected to survive more than 60 days after entry to the facility
4. Patient already resident within a low care facility with a support package to manage them as a high care patient

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to intervention versus control facility will occur. Within either facility, individual patients will be approached for recruitment.Potentially eligible patients will be enrolled by trained research staff. Because of the high (>70%) rate of significant cognitive impairment in this population, it is recognised that a large number of patients will be incapable of providing informed consent. In these circumstances we will be guided by the NHMRC National Statement on Ethical Conduct in Human Research, in particular paragraphs 4.5.5 to 4.5.10.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised cluster allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
11/06/2012
Date of last participant enrolment
Anticipated
Actual
5/03/2014
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
250
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 269766 0
Charities/Societies/Foundations
Name [1] 269766 0
JO & JR Wicking Trust
Country [1] 269766 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy
Crawley
Western Australia
6009
Country
Australia
Secondary sponsor category [1] 268793 0
None
Name [1] 268793 0
Address [1] 268793 0
Country [1] 268793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271719 0
University of Western Australia HREC
Ethics committee address [1] 271719 0
Ethics committee country [1] 271719 0
Australia
Date submitted for ethics approval [1] 271719 0
Approval date [1] 271719 0
23/03/2012
Ethics approval number [1] 271719 0
RA/4/1/5123

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

Contacts
Principal investigator
Name 33090 0
A/Prof Glenn Arendts
Address 33090 0
Emergency Medicine School of Primary, Aboriginal and Rural Health Care Level 2 R Block QE II Medical Centre, Monash Avenue, Nedlands WA 6009
Country 33090 0
Australia
Phone 33090 0
61 8 92248458
Fax 33090 0
Email 33090 0
[email protected]
Contact person for public queries
Name 16337 0
Roz Jaworski
Address 16337 0
Emergency Medicine
School of Primary, Aboriginal and Rural Health Care
Level 2 R Block
QE II Medical Centre
Nedlands WA 6009
Country 16337 0
Australia
Phone 16337 0
61 8 93464354
Fax 16337 0
Email 16337 0
[email protected]
Contact person for scientific queries
Name 7265 0
Glenn Arendts
Address 7265 0
Emergency Medicine, Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 7265 0
Australia
Phone 7265 0
61 8 92248458
Fax 7265 0
Email 7265 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
SourceTitleYear of PublicationDOI
EmbaseA clinical trial of nurse practitioner care in residential aged care facilities.2018https://dx.doi.org/10.1016/j.archger.2018.05.001
N.B. These documents automatically identified may not have been verified by the study sponsor.