Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000743369
Ethics application status
Approved
Date submitted
15/05/2017
Date registered
22/05/2017
Date last updated
22/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A national prevalence study of advance care planning documentation and self-reported uptake in Australia
Scientific title
A national prevalence study of advance care planning documentation and self-reported uptake in elderly people in Australia
Secondary ID [1] 291941 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advance care planning 303281 0
Condition category
Condition code
Public Health 302709 302709 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This national multicentre cross-sectional prevalence pilot study consists of two parts: 1) an audit of a person’s records and 2) a survey of those people whose files were audited. It will be conducted in people admitted to hospital, attending general practices, or residing at residential aged care facilities in Australia.

Condition or exposure observed: presence of the advance care planning documentation in health records
Duration of the observation: The study will be conducted on a specific day determined by investigators in advance. Each observation will take up to 40 minutes to complete
Intervention code [1] 298062 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302108 0
Advance care planning (ACP) prevalence, measured by the number of people who have ACP documentation that can be located in records within 15 minutes
Timepoint [1] 302108 0
The outcomes will be assessed upon 48hous after admission to hospital or residential care facilities, and at GP visit in general practices,
Secondary outcome [1] 334804 0
Type of ACP documentation
Timepoint [1] 334804 0
The outcome will be assessed upon 48hous after admission to hospital or residential care facilities, and at GP visit in general practices,
Secondary outcome [2] 334956 0
Validity of ACP documentation. This outcome will be assessed based on the data collected during Part 1 (audit of health records). ACP documents will be considered valid if necessary signatures on the document are present.
Timepoint [2] 334956 0
The outcome will be assessed upon 48hous after admission to hospital or residential care facilities, and at GP visit in general practices,
Secondary outcome [3] 334958 0
Peoples’ self-reported views on ACP and ACP uptake, This is a composite secondary outcome and it will be assessed during Part 2 (survey) of the study.
Timepoint [3] 334958 0
The outcome will be assessed upon 48hous after admission to hospital or residential care facilities, and at GP visit in general practices,
Secondary outcome [4] 334959 0
Consistency between ACP documentation and clinical care plans and medical orders. This outcome and it will be assessed during Part 2 (survey) of the study and the results will be compared with the data collected in Part 1.
Timepoint [4] 334959 0
The outcome will be assessed upon 48hous after admission to hospital or residential care facilities, and at GP visit in general practices,

Eligibility
Key inclusion criteria
Part 1. Records audit
Hospitals, residential aged care facilities, general practices
Males and females
>=65 years of age (>=55 years for ATSI people)
People admitted to hospitals and residential aged car facilities admitted for >48 hours
For general practices: persons visiting general practice on the nominated day/(s) of the study

Part 2. Survey
Everybody included in Part 1
English-speaking
Able to consent
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Part 1. Records audit
<65 years of age (<55 years for ATSI people)
Persons admitted to the ICU
Persons in maternal/obstetric wards
For hospitals and RACFs: People admitted for >48 hours

Part 2. Survey
Non-English speaking persons
Persons who do not have decision making capacity
Persons unable to or elcting not to provide consent
People expected to die within 24 hours

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Both
Statistical methods / analysis
Descriptive statistics will be calculated for the total sample of the study and will be stratified by major grouping variables: organisation type, state, location, age, sex, ethnicity, diagnosis, functional status and outcomes.
Data collectors will judge ACP documentation to be present if they find any documentation of advance care planning (either statutory or non-statutory), or legal appointment of a substitute decision-maker. Presence of ACP documentation, such as ACDs and advance care plans will be described using the mode, frequency, and distribution of the respective categories. Comparisons will be made using t-tests for the continuous type variables and chi-square contingency table analysis for the categorical type variables.
Multivariate logistic regression will be performed, predicting the presence of ACP documentation while controlling for the type of organisation, jurisdictions, location, age, sex and ethnicity. In instances where data is missing, analysis will be performed using list-wise deletion. The level of significance will be set at 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296453 0
Government body
Name [1] 296453 0
Australian Government
Country [1] 296453 0
Australia
Primary sponsor type
Other
Name
Decission Assist/ Advance Care Planning Australia
Address
Advance Care Planning Australia
Austin Hospital
145 Studley Road
Heidelberg VIC: 3084
Country
Australia
Secondary sponsor category [1] 295409 0
None
Name [1] 295409 0
Address [1] 295409 0
Country [1] 295409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297678 0
Austin Health
Ethics committee address [1] 297678 0
Research Ethics
Office for Research
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia 3084
Ethics committee country [1] 297678 0
Australia
Date submitted for ethics approval [1] 297678 0
01/03/2017
Approval date [1] 297678 0
02/05/2017
Ethics approval number [1] 297678 0
HREC/17/Austin/83

Summary
Brief summary
Advance care planning (ACP) is a process between a person, their family/carer(s) and healthcare providers that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future medical care. The Australian government funds a number of national initiatives aimed at increasing ACP uptake, however there is currently no standardised Australian data regarding formal ACP documentation or self-reported uptake. This makes it difficult to evaluate the impact of ACP initiatives. This study aims to determine the prevalence of ACP and completion of Advance Care Directives (ACDs) in hospitals, aged care facilities and general practices. It will also explore people’s self-reported use of ACP, and views about the process.
Researchers will conduct a national multicentre cross-sectional prevalence study, consisting of a record audit and surveys of people over 65 years in three sectors, hospitals, general practices and aged care facilities. Up to 50 records from 48 participating Australian organisations will be audited (total of 2400 records). People whose records were audited, who speak English and have a decision-making capacity will be invited to complete a survey. Up to 50 people associated with each organisation (whose records have been audited) will be surveyed. The primary outcome measure will be the number of people who have formal or informal ACP documentation that can be located in records within 15 minutes. Other outcomes will include specific details of ACP documentation (including type and validity of document), and whether current clinical care plans are consistent with ACP documentation. People will be surveyed to measure self-reported interest, uptake and use of ACP/ACDs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74790 0
Dr Rasa Ruseckaite
Address 74790 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Level 2, 553 St Kilda Rd
Melbourne VIC 3004
Country 74790 0
Australia
Phone 74790 0
+61399030437
Fax 74790 0
Email 74790 0
rasa.ruseckaite@monash.edu
Contact person for public queries
Name 74791 0
Rasa Ruseckaite
Address 74791 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Level 2, 553 St Kilda Rd
Melbourne VIC 3004
Country 74791 0
Australia
Phone 74791 0
+61399030437
Fax 74791 0
Email 74791 0
rasa.ruseckaite@monash.edu
Contact person for scientific queries
Name 74792 0
Rasa Ruseckaite
Address 74792 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Level 2, 553 St Kilda Rd
Melbourne VIC 3004
Country 74792 0
Australia
Phone 74792 0
+61399030437
Fax 74792 0
Email 74792 0
rasa.ruseckaite@monash.edu

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
Dimensions AIProtocol for a national prevalence study of advance care planning documentation and self-reported uptake in Australia2017https://doi.org/10.1136/bmjopen-2017-018024
EmbasePrevalence and correlates of advance care directives among older Australians accessing health and residential aged care services: Multicentre audit study.2019https://dx.doi.org/10.1136/bmjopen-2018-025255
N.B. These documents automatically identified may not have been verified by the study sponsor.