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Trial registered on ANZCTR


Registration number
ACTRN12614000255684
Ethics application status
Approved
Date submitted
3/03/2014
Date registered
10/03/2014
Date last updated
1/08/2019
Date data sharing statement initially provided
1/08/2019
Date results provided
1/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of the health care needs of people with serious lung disease
Scientific title
Assessing the efficacy and cost-effectiveness of targeted advance care planning interventions among patients with severe respiratory disease in a tertiary hospital and in a rural setting
Secondary ID [1] 284190 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-of-life care 291289 0
Life sustaining treatments 291290 0
Advance care planning 291291 0
Respiratory disease 291292 0
Condition category
Condition code
Respiratory 291642 291642 0 0
Chronic obstructive pulmonary disease
Respiratory 291643 291643 0 0
Other respiratory disorders / diseases
Public Health 291679 291679 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a nurse-led advance care planning (ACP) discussion, in collaboration with the primary treating doctor and usual health care team. The nurse will facilitate the doctor and broader health care team to initiate ACP discussions with eligible patients, and will assist in the documentation, distribution and storage of ACP documents for the duration of the trial. They will also be a 'point of contact' for patients who are recruited to trial, and will be available for further discussion about advance care planning if necessary.

ACP discussions will include the following elements: eliciting patient/carer understanding of current health state, providing information about patient prognosis (if possible and appropriate), eliciting patient/carer perspectives on 'living well', eliciting patient/carer understanding of potential future medical treatments, values and goals of care, cultural/spiritual beliefs, preferences for future medical treatments, understanding of 'medical futility', understanding of 'time limited trials of treatment'. The ACP discussion will also include a discussion about who would be an appropriate person to contact if the patient was unable to communicate.

The ACP discussion intervention is provided at least once, and participants will be assured that if they ever wish to revisit this discussion, they can do so by contacting the research nurse and/or usual healthcare provider. ACP discussions will probably take between 30 minutes and 60 minutes, and may occur over multiple consultations. Follow up ACP discussions with the research nurse will be available from the time of recruitment into the study, through until the completion of follow-up (18 months later after commencement of recruitment phase).
Intervention code [1] 288885 0
Behaviour
Comparator / control treatment
The control condition is an "active control" condition, in which usual care is monitored for the duration of recruitment (12 months) and follow up (6 months). Usual care involves standard evidence-based medical and nursing care, provided by participating hospitals, general practices and residential aged care facilities.

An additional historical control group (decedents treated at Sir Charles Gairdner Hospital Respiratory Unit or Albany Health Campus) is included in this trial, to ensure that the overall management of patients with respiratory disease has not changed during the time of recruitment of intervention and control participants. The historical data will be collected during 2014, and will include the medical records of patients who were deceased post 2010.
Control group
Active

Outcomes
Primary outcome [1] 291570 0
Cost of healthcare utilisation for each patient recruited into the study, (measured by costing hospital admissions, emergency department admissions, outpatient consultations, domicillary care visits and [in rural setting only] general practitioner and residential aged care facility care). This will be costed against the resources associated with delivering the ACP intervention, as compared to usual care.
Timepoint [1] 291570 0
Healthcare utilisation is measured from the time of recruitment into the study, until the end of the study or time of death.
Primary outcome [2] 291571 0
Patient satisfaction with care, as measured by a validated questionnaire (Patient Satisfaction Index, Guyatt et al. 1995). There are versions of the Patient Satisfaction Index that can be completed by a family member (if the patient is deceased or has become incompetent).
Timepoint [2] 291571 0
Time of recruitment, 3 months following recruitment, 6 months following recruitment
Primary outcome [3] 291572 0
Uptake of advance care planning as assessed by the number of patients who have undertaken formal or informal advance care planning at follow up.
Timepoint [3] 291572 0
Baseline, 3 month follow up, 6 month follow up
Secondary outcome [1] 307089 0
Place of death, as assessed by the match between preferred and actual place of death, for those patients who die during the course of the trial.
Timepoint [1] 307089 0
Time of death
Secondary outcome [2] 307090 0
Concordance between preferred and actual end-of-life care among those with ACP (decedents from historical control condition compared to recruited patients who die during the course of the trial).
Timepoint [2] 307090 0
Time of death

Eligibility
Key inclusion criteria
Cognitively competent to provide consent and undertake ACP
English speaking
Severe respiratory disease
Treated at participating healthcare settings
Identified as high risk, based on fulfilling one or more general triggers or 'disease specific' triggers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of capacity to provide informed consent or participate in ACP
Non-English speaking patient
Patient expected to die within 48 hours
Formal advance care planning already in place
Currently on an end-of-life care pathway

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)
Consenting subjects will be asked to state their preference for receiving or not receiving the ACP intervention. Those who strongly prefer to receive ACP, or not receive ACP, will not be randomised, but will receive their preference. Those with ambivalent preferences will be randomised, on a 1:1 schedule. Random allocation will be achieved by asking subjects to select an opaque, sealed envelope, from a box.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The box will initially be stocked with 20 sealed, opaque envelopes (10 specifying intervention, 10 specifying control). Each subject who is randomly allocated will select their own envelope from the box. When the box has only 4 envelopes left, the researcher will add a new set of 21 envelopes to the remaining 4 envelopes, and continue the process of allocating newly consented subjects by selection of envelopes from the box.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients are recruited into the trial in two distinct geographical regions (with little prospect of cross-over).
In addition to the random allocation process, the recruitment procedure also includes a patient preference component. This means that those patients with strong preferences can be allocated directly into their preferred condition, while those with ambivalent preferences can be randomly allocated.
Collection of data from a sample of historical control patients (decedents with respiratory disease from Albany Health Campus or Sir Charles Gairdner Hospital) will be used to ensure that there have been no changes to the normal management of patients with respiratory disease.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We have designed a study protocol with 80% power to detect a 75% ratio of geometric means between the intervention and usual care conditions, assuming a coefficient of variation equal to or less than 0.4. This would require 40 participants to be randomly allocated into the intervention condition, and uptake ACP. We expect that 50% of those offered ACP will uptake ACP, hence this requires 120 participants to be recruited with a 2:1 randomisation schedule favouring the intervention. Hence a sample of 150 patients in each study setting will enable sufficient power to answer the primary research questions.

Data analysis to test the research hypotheses will be done on an intention to treat basis, with the metropolitan and rural samples being treated separately. Covariates will be tested for balance between groups. Data analysis techniques are chi squared (for categorical variables), t test (for numerical variables) and Kruskal Wallis for ordinal variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2014
Actual
1/07/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
16/09/2015
Date of last data collection
Anticipated
Actual
16/01/2016
Sample size
Target
300
Accrual to date
Final
149
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2160 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 2161 0
Albany Hospital - Albany
Recruitment postcode(s) [1] 7833 0
6009 - Crawley
Recruitment postcode(s) [2] 7834 0
6330 - Albany

Funding & Sponsors
Funding source category [1] 288813 0
Government body
Name [1] 288813 0
State Health Research Advisory Committee
Country [1] 288813 0
Australia
Primary sponsor type
University
Name
Rural Clinical School of WA, University of Western Australia
Address
Rural Clinical School of WA (Albany)
UWA Albany Centre
31 Stirling Terrace
Albany, WA
6330
Country
Australia
Secondary sponsor category [1] 287508 0
Hospital
Name [1] 287508 0
Sir Charles Gairdner Hospital (Lung Institute of WA)
Address [1] 287508 0
B Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA
6009
Country [1] 287508 0
Australia
Other collaborator category [1] 277853 0
Government body
Name [1] 277853 0
WA Cancer & Palliative Care Network
Address [1] 277853 0
189 Royal Street
East Perth, WA
6004
Country [1] 277853 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290658 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 290658 0
Ethics committee country [1] 290658 0
Australia
Date submitted for ethics approval [1] 290658 0
15/01/2014
Approval date [1] 290658 0
Ethics approval number [1] 290658 0
2013-173
Ethics committee name [2] 303987 0
WA Country Health Service Human Research Ethics Committee
Ethics committee address [2] 303987 0
Ethics committee country [2] 303987 0
Australia
Date submitted for ethics approval [2] 303987 0
25/10/2013
Approval date [2] 303987 0
17/03/2014
Ethics approval number [2] 303987 0
WACHS 1305
Ethics committee name [3] 303988 0
WA Department of Health Human Research Ethics Committee
Ethics committee address [3] 303988 0
Ethics committee country [3] 303988 0
Australia
Date submitted for ethics approval [3] 303988 0
17/06/2014
Approval date [3] 303988 0
09/10/2014
Ethics approval number [3] 303988 0
2014/46
Ethics committee name [4] 303989 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [4] 303989 0
Ethics committee country [4] 303989 0
Australia
Date submitted for ethics approval [4] 303989 0
23/05/2014
Approval date [4] 303989 0
27/05/2014
Ethics approval number [4] 303989 0
RA/4/1/6547

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

Contacts
Principal investigator
Name 46654 0
A/Prof Craig Sinclair
Address 46654 0
Rural Clinical School of WA
UWA Albany Centre
31 Stirling Terrace
Albany, WA, 6330
Country 46654 0
Australia
Phone 46654 0
+61 8 9842 0829
Fax 46654 0
+61 8 9842 0879
Email 46654 0
craig.sinclair@rcswa.edu.au
Contact person for public queries
Name 46655 0
Craig Sinclair
Address 46655 0
Rural Clinical School of WA
UWA Albany Centre
31 Stirling Terrace
Albany, WA, 6330
Country 46655 0
Australia
Phone 46655 0
+61 8 9842 0829
Fax 46655 0
+61 8 9842 0879
Email 46655 0
craig.sinclair@rcswa.edu.au
Contact person for scientific queries
Name 46656 0
Craig Sinclair
Address 46656 0
Rural Clinical School of WA
UWA Albany Centre
31 Stirling Terrace
Albany, WA, 6330
Country 46656 0
Australia
Phone 46656 0
+61 8 9842 0829
Fax 46656 0
+61 8 9842 0879
Email 46656 0
craig.sinclair@rcswa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to agreements with the Health Department of Western Australia and data linkage custodians, data sharing is not allowed for this study.


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
EmbaseAdvance care planning uptake among patients with severe lung disease: A randomised patient preference trial of a nurse-led, facilitated advance care planning intervention.2017https://dx.doi.org/10.1136/bmjopen-2016-013415
N.B. These documents automatically identified may not have been verified by the study sponsor.