ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

advance care planning

Condition category

Condition code

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Type of ACP documentation

Timepoint [1]

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]

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]

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]

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]

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]

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]

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]

Government body

Name [1]

Australian Government

Address [1]

Commonwealth of Australia
GPO Box 9848,
Canberra, ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health

Ethics committee address [1]

Research Ethics
 Office for Research
 Level 8, Harold Stokes Building 
 Austin Health
 PO Box 5555
 Heidelberg
 Victoria
 Australia 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/03/2017

Approval date [1]

02/05/2017

Ethics approval number [1]

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

Dr Rasa Ruseckaite

Address

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

Australia

Phone

+61399030437

Fax

rasa.ruseckaite@monash.edu

Contact person for public queries

Name

Rasa Ruseckaite

Address

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

Australia

Phone

+61399030437

Fax

rasa.ruseckaite@monash.edu

Contact person for scientific queries

Name

Rasa Ruseckaite

Address

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

Australia

Phone

+61399030437

Fax

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

Source	Title	Year of Publication	DOI
Dimensions AI	Protocol for a national prevalence study of advance care planning documentation and self-reported uptake in Australia	2017	https://doi.org/10.1136/bmjopen-2017-018024
Embase	Prevalence and correlates of advance care directives among older Australians accessing health and residential aged care services: Multicentre audit study.	2019	https://dx.doi.org/10.1136/bmjopen-2018-025255

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically